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NCT0531xxxx/NCT05315193.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/NCT05315193</url>
</required_header>
<id_info>
<org_study_id>Rec/01279 Umair Ahmad</org_study_id>
<nct_id>NCT05315193</nct_id>
</id_info>
<brief_title>Effect of Exercise Training in Coronary Artery Disease Patients After Stenting</brief_title>
<official_title>Effects of Exercise Training on Ankle-brachial Index and Quality of Life in Coronary Artery Disease Patients After Stenting.</official_title>
<sponsors>
<lead_sponsor>
<agency>Riphah International University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Riphah International 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>
To determine the effects of exercise training on ankle-brachial index and Quality of Life in
coronary artery disease patients after stenting. There is a need to develop strategies, not
only to prevent restenosis but also to improve patients' functional status and perception of
well-being. In particular, it is not well defined whether exercise training can reduce the
restenosis rate and improve the outcome after percutaneous intervention (PCI), and its
effects on the Ankle-brachial index are not yet well known.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The existence of PAD in patients with Coronary artery disease (CAD) remarkably increases the
risk of cardiovascular morbidity and mortality. Almost half of the patients, after an initial
encouraging improvement in functional capacity and quality of life (QOL) after the PCI, deal
with recurrent chest pain that requires medical attention, reduces functional capacity, and
creates a status of psychological distress.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">October 18, 2022</start_date>
<completion_date type="Actual">April 30, 2023</completion_date>
<primary_completion_date type="Actual">April 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 (Participant)</masking>
</study_design_info>
<primary_outcome>
<measure>Ankle-brachial index</measure>
<time_frame>12 weeks</time_frame>
<description>Changes From the Baseline,6th week and 12 weeks, measured through the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery to detect Peripheral Artery Disease. Normal Ankle-brachial index ranges from 1.0 to 1.4.</description>
</primary_outcome>
<primary_outcome>
<measure>Quality of life index cardiac version -IV</measure>
<time_frame>12 weeks</time_frame>
<description>Changes From the Baseline, 6th week and 12 weeks measured through Quality of life index cardiac version -IV. It consists of 70 items. Each item used a six-point Likert rating scale. Scores calculated for overall quality of life in four domains: health and functioning (15 items), social and economic (8 items), psychological/spiritual (7 items), and family (5 items). High scores indicated a better quality of life.</description>
</primary_outcome>
<secondary_outcome>
<measure>Dyspnea</measure>
<time_frame>3-5 days</time_frame>
<description>Changes From the Baseline, measured through Rose Dyspnea Scale. The scale consists of four items, with scores ranging from 0 to 4, where 0 indicates no dyspnea with activity, and increasing scores indicate greater limitations because of dyspnea.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Rate of perceived exertion (RPE)</measure>
<time_frame>12 weeks</time_frame>
<description>Changes From the Baseline,6th week and 12 weeks, measured through Borg RPE scale which measures a person's perception of their effort and exertion breathlessness, and fatigue during physical work rating between 6 and 20. The higher the number, the more intense the exercise. An RPE of 6 is often referred to as just above rest, hardly any exertion, while an RPE of 20 is a maximal effort.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Forced Expiratory Volume in 1 second (FEV1)</measure>
<time_frame>12 weeks</time_frame>
<description>Changes from the Baseline,6th week and 12 weeks, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters</description>
</secondary_outcome>
<secondary_outcome>
<measure>Forced vital Capacity (FVC)</measure>
<time_frame>12 weeks</time_frame>
<description>Changes From the Baseline,6th week and 12 weeks, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">73</enrollment>
<condition>Stent Restenosis</condition>
<condition>Coronary Artery Disease</condition>
<arm_group>
<arm_group_label>Structured In-patient and Home plan</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Structured In-patient and Home plan</description>
</arm_group>
<arm_group>
<arm_group_label>Conventional therapy</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Conventional protocol as per guidelines</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Structured In-patient and Home plan</intervention_name>
<description>A patient education session and a protocol comprise of 3 days. It consists of three different levels having progressive activities. The in-patient protocol will start from the day of the procedure. Each level contains 2 to 6 tasks, performed in sets of 5-10 repetitions 3 times a day. Home plan: Walking 3 days a week starting from normal pace ((RPE: 8-9) for10 minutes and progressively increased intensity and duration over the period of 12 weeks (RPE: 13-14).</description>
<arm_group_label>Structured In-patient and Home plan</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Conventional Therapy</intervention_name>
<description>In-Patient: Wound care, Bed mobility:
AROMS (10 Reps*3sets*TD), Breathing Exercise (10 Reps*3sets*TD), Mobilization (Walk as per patient tolerance) Patient Education: To keep the heart healthy Diet Avoid strenuous exercise and lifting heavy objects Avoid valsalva manure, Quit smoking Lower cholesterol levels, Maintain a healthy weight Control other conditions, such as diabetes and high blood pressure Take medications as prescribed by your doctor Get regular exercise: Walking at a normal pace as per tolerance (RPE up to 10)</description>
<arm_group_label>Conventional therapy</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- GCS = 15

- Disease chronicity: 1-3 years Elective / stenting procedure

- Single or Double vessel stunting EF: 35 above

Exclusion Criteria:

- Unwilling to participate in research

- Known cases of Uncontrolled DM or HTN

- Known cases of Cognitive/memory/neurological disorders

- Known cases of any Systemic disease
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>45 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Mehwish Waseem, MSPT(CPPT)</last_name>
<role>Principal Investigator</role>
<affiliation>Riphah International University</affiliation>
</overall_official>
<location>
<facility>
<name>Peshawar Institute of cardiology</name>
<address>
<city>Peshawar</city>
<state>KPK</state>
<zip>25000</zip>
<country>Pakistan</country>
</address>
</facility>
</location>
<location_countries>
<country>Pakistan</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>May 17, 2023</last_update_submitted>
<last_update_submitted_qc>May 17, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 18, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Ankle-Brachial Index</keyword>
<keyword>Coronary artery diseases</keyword>
<keyword>Exercise training</keyword>
<keyword>Quality of life</keyword>
<keyword>Stenting</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Coronary Artery Disease</mesh_term>
<mesh_term>Myocardial Ischemia</mesh_term>
<mesh_term>Coronary Disease</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 determine the effects of exercise training on ankle-brachial index and Quality of Life in
coronary artery disease patients after stenting. There is a need to develop strategies, not
only to prevent restenosis but also to improve patients' functional status and perception of
well-being. In particular, it is not well defined whether exercise training can reduce the
restenosis rate and improve the outcome after percutaneous intervention (PCI), and its
effects on the Ankle-brachial index are not yet well known.
The existence of PAD in patients with Coronary artery disease (CAD) remarkably increases the
risk of cardiovascular morbidity and mortality. Almost half of the patients, after an initial
encouraging improvement in functional capacity and quality of life (QOL) after the PCI, deal
with recurrent chest pain that requires medical attention, reduces functional capacity, and
creates a status of psychological distress.
Inclusion Criteria:
- GCS = 15
- Disease chronicity: 1-3 years Elective / stenting procedure
- Single or Double vessel stunting EF: 35 above
Exclusion Criteria:
- Unwilling to participate in research
- Known cases of Uncontrolled DM or HTN
- Known cases of Cognitive/memory/neurological disorders
- Known cases of any Systemic disease
|
NCT0531xxxx/NCT05315206.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/NCT05315206</url>
</required_header>
<id_info>
<org_study_id>128/21/FB</org_study_id>
<nct_id>NCT05315206</nct_id>
</id_info>
<brief_title>Multimodal Morpho-functional Study in Glaucoma Patients-Citicoline Oral Solution</brief_title>
<official_title>Modulation of Neuronal Connettivity Along the Visual Pathways in Patients Affected by Glaucoma Throug Treatment With Citicoline Oral Solution: Multimodal Morpho-funcional Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Fondazione G.B. Bietti, IRCCS</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Fondazione G.B. Bietti, IRCCS</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 prospective, multicentre, randomized, blinded, masked study that involves the enrollment of
60 patients affected by open angle glaucoma (OAG).

Patients selected according to the inclusion / exclusion criteria, after signing the informed
consent, will be randomized into two groups:

1. In a group of patients with OAG, Citicoline in oral solution (10 ml / day, Neurotidine®)
will be administered for 12 months (Citicoline Treated Group, TC Group)

2. in another group of patients with OAG will be administered Placebo (Containing all
excipients of Neurotidine ®) (10 ml / day) for 12 months (Placebo Treated Group, TP
Group) Randomization will be done by dividing the selected patients into two groups
based on similar characteristics of: age, perimetric defect and, mainly,
retinal-cortical time (RCT) values.

Patients will be assigned to each group by an investigator not involved in functional and
structural testing.

The key will be opened only at the end of the treatment in order to evaluate the first
effects.

The Primary Objective was to evaluate whether treatment with Citicoline in oral solution can
produce an improvement of the post-retinal neural conduction, that is delayed in patients
with OAG.

The Secondary objective was to evaluate in patients with OAG whether the possible changes in
post-retinal neural conduction induced by treatment with Citicoline in oral solution
(information obtained through electrophysiological recordings) are associated or not with
morphological and functional variations of the nervous structures forming the visual pathways
(nucleus geniculatus lateral, optic tract, visual cortex, information obtained through the
acquisition of structural and functional magnetic resonance imaging) and whether both
conditions can be related to the morpho-functional variations of the retinal ganglion cells
and of the visual field (VF).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Sixty patients affected by bilateral open angle glaucoma, between the ages of 20 and 70, will
be enrolled in the study within a maximum time frame of 12 months. The enrollment will be
performed at T0 (screening), in this occasion an extensive ophthalmological evaluation will
be performed after the signature of the informed consent. The patient will be undergoing to
the evaluation of Best corrected Visual Acuity (BCVA), intraocular pressure (IOP), fundus
examination, Visual Field (VF) exam (Humphrey 24-2and 10-2 standard SITA) Visual Evoked
Potentials (VEP) and pattern electroretinogram (PERG). Moreover a morphological examination
of optic nerve and macular area was assessed by Optical Coherence Tomography (OCT) with the
analysis of retinal nerve fiber layer (RNFL) and retinal ganglion cells (RGCs).

Patients included in the study present a Mean Deviation defect (MD), tested at the VF
examination, between -6 and -25 dB and an increase in Retinal-Cortical Time (RCT) response.
RCT is a measure derived through the difference of Implicit Time values of latency of
simultaneous recording of visual evoked potential (VEP) and pattern electroretinogram (PERG),
which represent a post-retinal nerve conduction delay.

About 7-15 days after T0 a new ophthalmological examination will be performed (T1). The
patient will be undergoing to the evaluation of BCVA, IOP, fundus examination, VF exam
(Humphrey 24-2and 10-2 standard SITA), VEP, PERG and OCT. In this occasion a Magnetic
Resonance Imaging (MRI) of the brain will be performed.

At the end of this evaluation, the patient will be given 4 bottles containing 500 ml of
Citicoline in oral solution (Neurotidine®) or Placebo and will be given the relative
instructions for administration. The posology will be 10 ml once a day in the morning for 6
months. At the end of the 6 month period the patient will be asked to hand over the used
bottles.

After 6 months ± 10 days, a novel complete ophthalmologic evaluation will be performed (T2)
(BCVA, IOP, VF exam, VEP, PERG, OCT), and patients will be given an additional 4 bottles
containing Neurotidine ® or Placebo and will be given instructions for their administration.
Again at the end of this 6 month period the patient will bring back the used bottles.

One year after T0, a last complete ophthalmological visit (BCVA, IOP, VF exam, VEP, PERG,
OCT) will be performed (T3). In this visit MRI will be repeated. At the end of the visit, the
patient will bring back the used bottles. Will be asked to the patient if adverse events will
occurs during such period.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">January 25, 2022</start_date>
<completion_date type="Anticipated">April 2024</completion_date>
<primary_completion_date type="Anticipated">April 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>Patients selected according to the inclusion / exclusion criteria, after signing the informed consent, will be randomized into two groups:
In a group of patients with open angle glaucoma (OAG), Citicoline in oral solution (10 ml / day, Neurotidine®) will be administered for 12 months (Citicoline Treated Group, TC Group)
in another group of patients with OAG will be administered Placebo (Containing all excipients of Neurotidine ®) (10 ml / day) for 12 months (Placebo Treated Group, TP Group)</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Triple (Participant, Care Provider, Investigator)</masking>
<masking_description>Only after the signing of the informed consent, a single investigator ("enrolling physician"), not involved in the clinical and instrumental evaluations, will decide whether to assign the selected patient to one of two groups: treated-Citicoline or treated-Placebo.
Randomization will be done by dividing the selected patients into two groups based on similar characteristics of: age, perimetric defect and, mainly,retinal cortical time (RCT) values.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Retino-cortical time (RCT) changes after treatment with citicoline in oral solution.</measure>
<time_frame>One year</time_frame>
<description>The changes of the retino-cortical time (RCT) in patients affected by open angle glaucoma after one years of treatment with Citicoline in oral solution compared to patients affected by open angle glaucoma treated with placebo.</description>
</primary_outcome>
<secondary_outcome>
<measure>Correlation between RCT changes and morpho-functional parameters changes after treatment with citicoline in oral solution.</measure>
<time_frame>one year</time_frame>
<description>In patients with open angle glaucoma, the changes of retino-cortical time (RCT) are associated or not with morphological and functional changes in the nerve structures that form the optical pathways, measured by OCT (RNFL and RGCs), visual field (MD) and magnetic resonance, after one year of treatment with Citicoline in oral solution respect to patients treated with Placebo.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">60</enrollment>
<condition>Primary Open Angle Glaucoma</condition>
<arm_group>
<arm_group_label>Citicoline Treated Group, TC Group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>In a group of patients with open angle glaucoma (OAG), Citicoline in oral solution (10 ml / day) will be administered for 12 months (Citicoline Treated Group, TC Group)</description>
</arm_group>
<arm_group>
<arm_group_label>Placebo Treated Group, TP Group</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>in another group of patients with open angle glaucoma (OAG) will be administered Placebo (Containing all excipients of Citicoline in oral solution) (10 ml / day) for 12 months (Placebo Treated Group, TP Group)</description>
</arm_group>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Citicoline</intervention_name>
<description>The patient will be given 10 ml of Citicoline oral solution (Neurotidine ®) once a day in the morning for 1 year. To patients will be given 4 bottles containing 500 ml of Citicoline and the relative instructions for administration. After 6 months, the patient will bring back the used bottles and will be given additional 4 bottles containing Citicoline (Neurotidine ®). Again at the end of this 6 month period the patient will bring back the used bottles.
Each bottle of Neurotidine will contain: water; fructose; Citicoline (500 mg per 10 ml); acidity regulators: sodium citrate, sodium hydroxide; preservative: potassium sorbate; dye: riboflavine.</description>
<arm_group_label>Citicoline Treated Group, TC Group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>The patient will be given 10 ml of an oral solution of Placebo. Each bottle of Placebo, the solution of which will be indistinguishable from the active product in terms of appearance and flavor, will contain: water; fructose; acidity regulators: sodium citrate, sodium hydroxide; preservative: potassium sorbate; dye: riboflavin</description>
<arm_group_label>Placebo Treated Group, TP Group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Age between 20 and 70 years old

- Diagnosis of glaucoma. Glaucoma is defined as: glaucomatous damage of the CV (Humphrey
24-2 standard SITA with mean deviation between -6 and -25 dB) and glaucomatous
appearance of the optic nerve

- Visual acuity not less than 5/10

- Eye pressure below 21 mmHg with the use of ocular hypotonizing drugs including
sympathomimetics, beta-blockers, prostaglandins, beta-adrenergics, carbonic anhydrase
inhibitors. Such drugs can be used both alone and in combination with each other.

- Documented post-retinal nerve conduction delay through simultaneous recording of VEP
and PERG showing an increase in RCT

Exclusion Criteria:

- Ocular surgery in the 3 months preceding the study, including surgery for cataracts in
the previous three months.

- Cataract or maculopathy

- Argon laser trabeculoplasty (ALT) within the previous 6 months

- Known hypersensitivity to the study product

- Secondary causes of ocular hypertension, including systemic or topical use of steroids

- Positive history of ocular or systemic diseases that could preclude enrollment in the
study in the opinion of the investigators

- Changes in systemic therapies that could compromise intraocular pressure values
(beta-blockers, alpha and beta adrenergics, calcium inhibitors, ACE inhibitors) in the
30 days prior to enrollment

- Ongoing therapy with vasoactive cerebral drugs, neurotrophic, lutein, zeaxanthin,
retinal, acid, docosahexaenoic, Ubiquinone and / or its derivatives, Citicoline and /
or its derivatives (possible previous treatment with Ubiquinone, L-Carnitine,
Citicoline and / or its derivatives must have been suspended at least 6 months prior
to inclusion in the study)

- Pregnancy, breastfeeding

- Diabetes

- Systemic lupus erythematosus, rheumatoid arthritis, connectivitis

- Concomitant use of anticoagulants and lithium
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>20 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Vincenzo VP Parisi, MD</last_name>
<role>Principal Investigator</role>
<affiliation>IRCSS Fondazione Bietti</affiliation>
</overall_official>
<overall_contact>
<last_name>Vincenzo VP Parisi, MD</last_name>
<phone>+39(06)77052962</phone>
<email>vincenzo.parisi@fondazionebietti.it</email>
</overall_contact>
<location>
<facility>
<name>Fondazione BIetti, Britannico Hospital</name>
<address>
<city>Roma</city>
<zip>00184</zip>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Vincenzo MF Parisi, MD</last_name>
<phone>+39(0)677052962</phone>
<email>vincenzo.parisi@fondazionebietti.it</email>
</contact>
<investigator>
<last_name>Vincenzo MF Parisi, MD</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Francesco Oddone, MD</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Fondazione G.B. Bietti-IRCCS</name>
<address>
<city>Rome</city>
<zip>00199</zip>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Vincenzo Parisi, MD</last_name>
<phone>+390685356727</phone>
<email>vmparisi@gmail.com</email>
</contact>
<investigator>
<last_name>Vincenzo Parisi, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>Italy</country>
</location_countries>
<results_reference>
<citation>Quigley HA, McKinnon SJ, Zack DJ, Pease ME, Kerrigan-Baumrind LA, Kerrigan DF, Mitchell RS. Retrograde axonal transport of BDNF in retinal ganglion cells is blocked by acute IOP elevation in rats. Invest Ophthalmol Vis Sci. 2000 Oct;41(11):3460-6.</citation>
<PMID>11006239</PMID>
</results_reference>
<results_reference>
<citation>Lipton SA, Rosenberg PA. Excitatory amino acids as a final common pathway for neurologic disorders. N Engl J Med. 1994 Mar 3;330(9):613-22. doi: 10.1056/NEJM199403033300907. No abstract available.</citation>
<PMID>7905600</PMID>
</results_reference>
<results_reference>
<citation>Oddone F, Lucenteforte E, Michelessi M, Rizzo S, Donati S, Parravano M, Virgili G. Macular versus Retinal Nerve Fiber Layer Parameters for Diagnosing Manifest Glaucoma: A Systematic Review of Diagnostic Accuracy Studies. Ophthalmology. 2016 May;123(5):939-49. doi: 10.1016/j.ophtha.2015.12.041. Epub 2016 Feb 15.</citation>
<PMID>26891880</PMID>
</results_reference>
<results_reference>
<citation>Parisi V. Impaired visual function in glaucoma. Clin Neurophysiol. 2001 Feb;112(2):351-8. doi: 10.1016/s1388-2457(00)00525-3.</citation>
<PMID>11165541</PMID>
</results_reference>
<results_reference>
<citation>Burgoyne CF, Downs JC, Bellezza AJ, Suh JK, Hart RT. The optic nerve head as a biomechanical structure: a new paradigm for understanding the role of IOP-related stress and strain in the pathophysiology of glaucomatous optic nerve head damage. Prog Retin Eye Res. 2005 Jan;24(1):39-73. doi: 10.1016/j.preteyeres.2004.06.001.</citation>
<PMID>15555526</PMID>
</results_reference>
<results_reference>
<citation>Furlanetto RL, Teixeira SH, Gracitelli CPB, Lottenberg CL, Emori F, Michelan M, Amaro E Jr, Paranhos A Jr. Structural and functional analyses of the optic nerve and lateral geniculate nucleus in glaucoma. PLoS One. 2018 Mar 23;13(3):e0194038. doi: 10.1371/journal.pone.0194038. eCollection 2018.</citation>
<PMID>29570721</PMID>
</results_reference>
<results_reference>
<citation>Schmidt MA, Knott M, Heidemann R, Michelson G, Kober T, Dorfler A, Engelhorn T. Investigation of lateral geniculate nucleus volume and diffusion tensor imaging in patients with normal tension glaucoma using 7 tesla magnetic resonance imaging. PLoS One. 2018 Jun 7;13(6):e0198830. doi: 10.1371/journal.pone.0198830. eCollection 2018.</citation>
<PMID>29879191</PMID>
</results_reference>
<results_reference>
<citation>Aksoy DO, Umurhan Akkan JC, Alkan A, Aralasmak A, Otcu Temur H, Yurtsever I. Magnetic Resonance Spectroscopy Features of the Visual Pathways in Patients with Glaucoma. Clin Neuroradiol. 2019 Dec;29(4):615-621. doi: 10.1007/s00062-018-0728-7. Epub 2018 Oct 5.</citation>
<PMID>30291364</PMID>
</results_reference>
<results_reference>
<citation>Wang Y, Wang X, Zhou J, Qiu J, Yan T, Xie Y, Li L, Lu W. Brain morphological alterations of cerebral cortex and subcortical nuclei in high-tension glaucoma brain and its associations with intraocular pressure. Neuroradiology. 2020 Apr;62(4):495-502. doi: 10.1007/s00234-019-02347-1. Epub 2019 Dec 23.</citation>
<PMID>31872278</PMID>
</results_reference>
<results_reference>
<citation>Gracitelli CPB, Duque-Chica GL, Sanches LG, Moura AL, Nagy BV, Teixeira SH, Amaro E Jr, Ventura DF, Paranhos A Jr. Structural Analysis of Glaucoma Brain and its Association With Ocular Parameters. J Glaucoma. 2020 May;29(5):393-400. doi: 10.1097/IJG.0000000000001470.</citation>
<PMID>32079996</PMID>
</results_reference>
<results_reference>
<citation>Parisi V, Manni G, Colacino G, Bucci MG. Cytidine-5'-diphosphocholine (citicoline) improves retinal and cortical responses in patients with glaucoma. Ophthalmology. 1999 Jun;106(6):1126-34. doi: 10.1016/S0161-6420(99)90269-5.</citation>
<PMID>10366081</PMID>
</results_reference>
<results_reference>
<citation>Parisi V, Centofanti M, Ziccardi L, Tanga L, Michelessi M, Roberti G, Manni G. Treatment with citicoline eye drops enhances retinal function and neural conduction along the visual pathways in open angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2015 Aug;253(8):1327-40. doi: 10.1007/s00417-015-3044-9. Epub 2015 May 26.</citation>
<PMID>26004075</PMID>
</results_reference>
<results_reference>
<citation>Parisi V. Electrophysiological assessment of glaucomatous visual dysfunction during treatment with cytidine-5'-diphosphocholine (citicoline): a study of 8 years of follow-up. Doc Ophthalmol. 2005 Jan;110(1):91-102. doi: 10.1007/s10633-005-7348-7.</citation>
<PMID>16249960</PMID>
</results_reference>
<results_reference>
<citation>Parisi V, Coppola G, Centofanti M, Oddone F, Angrisani AM, Ziccardi L, Ricci B, Quaranta L, Manni G. Evidence of the neuroprotective role of citicoline in glaucoma patients. Prog Brain Res. 2008;173:541-54. doi: 10.1016/S0079-6123(08)01137-0.</citation>
<PMID>18929133</PMID>
</results_reference>
<results_reference>
<citation>Parisi V, Barbano L, Di Renzo A, Coppola G, Ziccardi L. Neuroenhancement and neuroprotection by oral solution citicoline in non-arteritic ischemic optic neuropathy as a model of neurodegeneration: A randomized pilot study. PLoS One. 2019 Jul 26;14(7):e0220435. doi: 10.1371/journal.pone.0220435. eCollection 2019. Erratum In: PLoS One. 2019 Aug 14;14(8):e0221313.</citation>
<PMID>31348806</PMID>
</results_reference>
<results_reference>
<citation>Parisi V, Oddone F, Ziccardi L, Roberti G, Coppola G, Manni G. Citicoline and Retinal Ganglion Cells: Effects on Morphology and Function. Curr Neuropharmacol. 2018;16(7):919-932. doi: 10.2174/1570159X15666170703111729.</citation>
<PMID>28676014</PMID>
</results_reference>
<results_reference>
<citation>Oddone F, Rossetti L, Parravano M, Sbardella D, Coletta M, Ziccardi L, Roberti G, Carnevale C, Romano D, Manni G, Parisi V. Citicoline in Ophthalmological Neurodegenerative Disease: A Comprehensive Review. Pharmaceuticals (Basel). 2021 Mar 20;14(3):281. doi: 10.3390/ph14030281.</citation>
<PMID>33804675</PMID>
</results_reference>
<results_reference>
<citation>Rejdak R, Toczolowski J, Kurkowski J, Kaminski ML, Rejdak K, Stelmasiak Z, Grieb P. Oral citicoline treatment improves visual pathway function in glaucoma. Med Sci Monit. 2003 Mar;9(3):PI24-8.</citation>
<PMID>12640353</PMID>
</results_reference>
<results_reference>
<citation>Virno M, Pecori-Giraldi J, Liguori A, De Gregorio F. The protective effect of citicoline on the progression of the perimetric defects in glaucomatous patients (perimetric study with a 10-year follow-up). Acta Ophthalmol Scand Suppl. 2000;(232):56-7. doi: 10.1111/j.1600-0420.2000.tb01107.x. No abstract available.</citation>
<PMID>11235540</PMID>
</results_reference>
<results_reference>
<citation>Roberti G, Tanga L, Parisi V, Sampalmieri M, Centofanti M, Manni G. A preliminary study of the neuroprotective role of citicoline eye drops in glaucomatous optic neuropathy. Indian J Ophthalmol. 2014 May;62(5):549-53. doi: 10.4103/0301-4738.133484.</citation>
<PMID>24881599</PMID>
</results_reference>
<results_reference>
<citation>Parisi V, Gallinaro G, Ziccardi L, Coppola G. Electrophysiological assessment of visual function in patients with non-arteritic ischaemic optic neuropathy. Eur J Neurol. 2008 Aug;15(8):839-45. doi: 10.1111/j.1468-1331.2008.02200.x. Epub 2008 Jun 28.</citation>
<PMID>18557920</PMID>
</results_reference>
<results_reference>
<citation>Parisi V, Miglior S, Manni G, Centofanti M, Bucci MG. Clinical ability of pattern electroretinograms and visual evoked potentials in detecting visual dysfunction in ocular hypertension and glaucoma. Ophthalmology. 2006 Feb;113(2):216-28. doi: 10.1016/j.ophtha.2005.10.044. Epub 2006 Jan 10.</citation>
<PMID>16406535</PMID>
</results_reference>
<verification_date>September 2023</verification_date>
<study_first_submitted>February 4, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>September 13, 2023</last_update_submitted>
<last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">September 14, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Fondazione G.B. Bietti, IRCCS</investigator_affiliation>
<investigator_full_name>Dr. Vincenzo Parisi</investigator_full_name>
<investigator_title>Head of Neurophysiology and Neurophthalmology Research Unit</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Glaucoma</mesh_term>
<mesh_term>Glaucoma, Open-Angle</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cytidine Diphosphate Choline</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>all collected IPD</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>As soon as possible when the study will be completed. About 6 months after the end of the data collection</ipd_time_frame>
<ipd_access_criteria>The results of this study will be avaiable after end of the study ( 18-24 months) and their publication on a scientific journal.</ipd_access_criteria>
</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>October 15, 2021</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT05315206/Prot_000.pdf</document_url>
</provided_document>
<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>October 15, 2021</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT05315206/ICF_001.pdf</document_url>
</provided_document>
</provided_document_section>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
A prospective, multicentre, randomized, blinded, masked study that involves the enrollment of
60 patients affected by open angle glaucoma (OAG).
Patients selected according to the inclusion / exclusion criteria, after signing the informed
consent, will be randomized into two groups:
1. In a group of patients with OAG, Citicoline in oral solution (10 ml / day, Neurotidine®)
will be administered for 12 months (Citicoline Treated Group, TC Group)
2. in another group of patients with OAG will be administered Placebo (Containing all
excipients of Neurotidine ®) (10 ml / day) for 12 months (Placebo Treated Group, TP
Group) Randomization will be done by dividing the selected patients into two groups
based on similar characteristics of: age, perimetric defect and, mainly,
retinal-cortical time (RCT) values.
Patients will be assigned to each group by an investigator not involved in functional and
structural testing.
The key will be opened only at the end of the treatment in order to evaluate the first
effects.
The Primary Objective was to evaluate whether treatment with Citicoline in oral solution can
produce an improvement of the post-retinal neural conduction, that is delayed in patients
with OAG.
The Secondary objective was to evaluate in patients with OAG whether the possible changes in
post-retinal neural conduction induced by treatment with Citicoline in oral solution
(information obtained through electrophysiological recordings) are associated or not with
morphological and functional variations of the nervous structures forming the visual pathways
(nucleus geniculatus lateral, optic tract, visual cortex, information obtained through the
acquisition of structural and functional magnetic resonance imaging) and whether both
conditions can be related to the morpho-functional variations of the retinal ganglion cells
and of the visual field (VF).
Sixty patients affected by bilateral open angle glaucoma, between the ages of 20 and 70, will
be enrolled in the study within a maximum time frame of 12 months. The enrollment will be
performed at T0 (screening), in this occasion an extensive ophthalmological evaluation will
be performed after the signature of the informed consent. The patient will be undergoing to
the evaluation of Best corrected Visual Acuity (BCVA), intraocular pressure (IOP), fundus
examination, Visual Field (VF) exam (Humphrey 24-2and 10-2 standard SITA) Visual Evoked
Potentials (VEP) and pattern electroretinogram (PERG). Moreover a morphological examination
of optic nerve and macular area was assessed by Optical Coherence Tomography (OCT) with the
analysis of retinal nerve fiber layer (RNFL) and retinal ganglion cells (RGCs).
Patients included in the study present a Mean Deviation defect (MD), tested at the VF
examination, between -6 and -25 dB and an increase in Retinal-Cortical Time (RCT) response.
RCT is a measure derived through the difference of Implicit Time values of latency of
simultaneous recording of visual evoked potential (VEP) and pattern electroretinogram (PERG),
which represent a post-retinal nerve conduction delay.
About 7-15 days after T0 a new ophthalmological examination will be performed (T1). The
patient will be undergoing to the evaluation of BCVA, IOP, fundus examination, VF exam
(Humphrey 24-2and 10-2 standard SITA), VEP, PERG and OCT. In this occasion a Magnetic
Resonance Imaging (MRI) of the brain will be performed.
At the end of this evaluation, the patient will be given 4 bottles containing 500 ml of
Citicoline in oral solution (Neurotidine®) or Placebo and will be given the relative
instructions for administration. The posology will be 10 ml once a day in the morning for 6
months. At the end of the 6 month period the patient will be asked to hand over the used
bottles.
After 6 months ± 10 days, a novel complete ophthalmologic evaluation will be performed (T2)
(BCVA, IOP, VF exam, VEP, PERG, OCT), and patients will be given an additional 4 bottles
containing Neurotidine ® or Placebo and will be given instructions for their administration.
Again at the end of this 6 month period the patient will bring back the used bottles.
One year after T0, a last complete ophthalmological visit (BCVA, IOP, VF exam, VEP, PERG,
OCT) will be performed (T3). In this visit MRI will be repeated. At the end of the visit, the
patient will bring back the used bottles. Will be asked to the patient if adverse events will
occurs during such period.
Inclusion Criteria:
- Age between 20 and 70 years old
- Diagnosis of glaucoma. Glaucoma is defined as: glaucomatous damage of the CV (Humphrey
24-2 standard SITA with mean deviation between -6 and -25 dB) and glaucomatous
appearance of the optic nerve
- Visual acuity not less than 5/10
- Eye pressure below 21 mmHg with the use of ocular hypotonizing drugs including
sympathomimetics, beta-blockers, prostaglandins, beta-adrenergics, carbonic anhydrase
inhibitors. Such drugs can be used both alone and in combination with each other.
- Documented post-retinal nerve conduction delay through simultaneous recording of VEP
and PERG showing an increase in RCT
Exclusion Criteria:
- Ocular surgery in the 3 months preceding the study, including surgery for cataracts in
the previous three months.
- Cataract or maculopathy
- Argon laser trabeculoplasty (ALT) within the previous 6 months
- Known hypersensitivity to the study product
- Secondary causes of ocular hypertension, including systemic or topical use of steroids
- Positive history of ocular or systemic diseases that could preclude enrollment in the
study in the opinion of the investigators
- Changes in systemic therapies that could compromise intraocular pressure values
(beta-blockers, alpha and beta adrenergics, calcium inhibitors, ACE inhibitors) in the
30 days prior to enrollment
- Ongoing therapy with vasoactive cerebral drugs, neurotrophic, lutein, zeaxanthin,
retinal, acid, docosahexaenoic, Ubiquinone and / or its derivatives, Citicoline and /
or its derivatives (possible previous treatment with Ubiquinone, L-Carnitine,
Citicoline and / or its derivatives must have been suspended at least 6 months prior
to inclusion in the study)
- Pregnancy, breastfeeding
- Diabetes
- Systemic lupus erythematosus, rheumatoid arthritis, connectivitis
- Concomitant use of anticoagulants and lithium
|
NCT0531xxxx/NCT05315219.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/NCT05315219</url>
</required_header>
<id_info>
<org_study_id>2021-0439</org_study_id>
<nct_id>NCT05315219</nct_id>
</id_info>
<brief_title>A Follow-up Study on Total Endoscopic Thyroidectomy Bilateral Areola Approach</brief_title>
<official_title>A Follow-up Study on the Long-term Treatment Effect and Quality of Life of Thyroid Cancer After Total Endoscopic Thyroidectomy Bilateral Areola Approach</official_title>
<sponsors>
<lead_sponsor>
<agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Second Affiliated Hospital, School of Medicine, Zhejiang 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>
Endoscopic thyroidectomy bilateral areola approach (ETBAA) is one of the most widely applied
approach in China, meanwhile its safety and effectiveness has been broadly discussed since
being introduced. However, these studies are generally with small sample size and short
follow-up duration. The lack of long-term follow-up on oncological outcomes makes it
inaccurate to evaluate the effectiveness of ETBAA versus OT. Thus, in this study, we
evaluated long-term QoL and outcomes of patients with PTC underwent thyroidectomy via ETBAA
versus OT.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">January 1, 2014</start_date>
<completion_date type="Actual">December 31, 2017</completion_date>
<primary_completion_date type="Actual">December 31, 2017</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>Crossover Assignment</intervention_model>
<primary_purpose>Screening</primary_purpose>
<masking>Single (Participant)</masking>
</study_design_info>
<primary_outcome>
<measure>Quality of life</measure>
<time_frame>5 years</time_frame>
<description>measured by THYCA-QoL questionaire</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">295</enrollment>
<condition>Quality of Life</condition>
<arm_group>
<arm_group_label>Endoscopic Thyroidectomy Bilateral Areola Approach</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Open Thyroidectomy</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Endoscopic Thyroidectomy Bilateral Areola Approach</intervention_name>
<description>The endoscopic thyroidectomy achieves better cosmetic effects than open thyroidectomy, and is one of the most widely applied approach in China, meanwhile its safety and effectiveness has been broadly discussed since being introduced.</description>
<arm_group_label>Endoscopic Thyroidectomy Bilateral Areola Approach</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- 1) Female patients under 55 years old; 2) no lateral cervical lymph node or distant
metastasis were detected before the operation; 3) postoperative pathology confirmed
the diagnosis of papillary thyroid carcinoma.

Exclusion Criteria:

- 1) Previous history of thyroid surgery; 2) lateral cervical lymph node dissection in
the operation; 3) past or current history of underlying diseases including
hyperthyroidism, hypertension, diabetes, coagulation dysfunction.
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>55 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 30, 2022</last_update_submitted>
<last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Endoscopic thyroidectomy bilateral areola approach (ETBAA) is one of the most widely applied
approach in China, meanwhile its safety and effectiveness has been broadly discussed since
being introduced. However, these studies are generally with small sample size and short
follow-up duration. The lack of long-term follow-up on oncological outcomes makes it
inaccurate to evaluate the effectiveness of ETBAA versus OT. Thus, in this study, we
evaluated long-term QoL and outcomes of patients with PTC underwent thyroidectomy via ETBAA
versus OT.
Inclusion Criteria:
- 1) Female patients under 55 years old; 2) no lateral cervical lymph node or distant
metastasis were detected before the operation; 3) postoperative pathology confirmed
the diagnosis of papillary thyroid carcinoma.
Exclusion Criteria:
- 1) Previous history of thyroid surgery; 2) lateral cervical lymph node dissection in
the operation; 3) past or current history of underlying diseases including
hyperthyroidism, hypertension, diabetes, coagulation dysfunction.
|
NCT0531xxxx/NCT05315232.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/NCT05315232</url>
</required_header>
<id_info>
<org_study_id>Glanzmanns 360</org_study_id>
<nct_id>NCT05315232</nct_id>
</id_info>
<brief_title>The Experiences of People Who Live With Glanzmanns Thrombasthenia.</brief_title>
<official_title>Glanzmanns 360. The Lived Experience of People With Glanzmanns.</official_title>
<sponsors>
<lead_sponsor>
<agency>Haemnet</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Hemab Therapeutics</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Haemnet</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 understand the lived experiences of people with Glanzmanns Thrombasthenia
</textblock>
</brief_summary>
<detailed_description>
<textblock>
A qualitative study of people with Glanzmanns Thrombasthenia including an on-line survey,
qualitative in-depth interviews and bleed diary completion.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 27, 2022</start_date>
<completion_date type="Actual">April 27, 2023</completion_date>
<primary_completion_date type="Actual">April 27, 2023</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>to understand the impact of GT on quality of life of affected individuals and their families.</measure>
<time_frame>one year</time_frame>
<description>Incidence of reported impact of GT on daily life using validated questionnaires EQ5D, MIQ, PHQ9, Rosenbergs self esteem scale.</description>
</primary_outcome>
<secondary_outcome>
<measure>Identify levels of acceptability of current treatments and management approaches</measure>
<time_frame>one year</time_frame>
<description>Rate of reported satisfaction with current treatments using self efficacy to manage disease assessment tool</description>
</secondary_outcome>
<secondary_outcome>
<measure>Identify areas of unmet need among people with GT</measure>
<time_frame>one year</time_frame>
<description>Rate of reported unmet need using ED5D and MIQ</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Actual">122</enrollment>
<condition>Glanzmann Thrombasthenia</condition>
<arm_group>
<arm_group_label>Qualitative assessment</arm_group_label>
<description>Survey (using validated quality of life assessment questionnaires) and one to one interviews of people and family members living with Glanzmanns Thrombasthenia</description>
</arm_group>
<arm_group>
<arm_group_label>Bleed diary</arm_group_label>
<description>Daily bleed diary completion over 12 weeks</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>survey and interview</intervention_name>
<description>qualitative assessment</description>
<arm_group_label>Bleed diary</arm_group_label>
<arm_group_label>Qualitative assessment</arm_group_label>
<other_name>diary completion</other_name>
</intervention>
<eligibility>
<study_pop>
<textblock>
People with Glanzmanns Thrombasthenia or parents of children with Glanzmanns
Thrombasthenia.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

Clinical diagnosis of congenital (inherited) Glanzmanns Thrombasthenia

Exclusion Criteria:

Acquired Glanzmanns Thrombasthenia
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>0 Years</minimum_age>
<maximum_age>100 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Mike Holland, BSC</last_name>
<role>Study Director</role>
<affiliation>Haemnet</affiliation>
</overall_official>
<location>
<facility>
<name>Oxford University Hospitals NHS Foundation Trust</name>
<address>
<city>Oxford</city>
<state>Oxfordshire</state>
<zip>OX3 7LE</zip>
<country>United Kingdom</country>
</address>
</facility>
</location>
<location_countries>
<country>United Kingdom</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 15, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>July 13, 2023</last_update_submitted>
<last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">July 17, 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>Thrombasthenia</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>The second part of the study will be conducted by Haemnet and Hemab - participant information will be shared after reconsenting</ipd_description>
<ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
<ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
<ipd_time_frame>3-6 months</ipd_time_frame>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
To understand the lived experiences of people with Glanzmanns Thrombasthenia
A qualitative study of people with Glanzmanns Thrombasthenia including an on-line survey,
qualitative in-depth interviews and bleed diary completion.
People with Glanzmanns Thrombasthenia or parents of children with Glanzmanns
Thrombasthenia.
Inclusion Criteria:
Clinical diagnosis of congenital (inherited) Glanzmanns Thrombasthenia
Exclusion Criteria:
Acquired Glanzmanns Thrombasthenia
|
NCT0531xxxx/NCT05315245.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/NCT05315245</url>
</required_header>
<id_info>
<org_study_id>19-04-0471</org_study_id>
<nct_id>NCT05315245</nct_id>
</id_info>
<brief_title>Acute Gastrointestinal Injury in Pediatrics</brief_title>
<acronym>AGI</acronym>
<official_title>Acute Gastrointestinal Injury in Critically Ill Children in Pediatric Intensive Care Unit of Cipto Mangunkusumo Hospital</official_title>
<sponsors>
<lead_sponsor>
<agency>Indonesia University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Indonesia 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>
Critically Ill children may develop acute gastrointestinal injury secondary to severe
inflammation.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Data collection from enrolled subjects including profile, laboratory examinations,
inflammatory markers on day 1 and day 3, nutritional support and daily calorie intake, and
finally outcome of the patient
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 1, 2019</start_date>
<completion_date type="Anticipated">December 1, 2022</completion_date>
<primary_completion_date type="Anticipated">December 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>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>PELOD-2 score</measure>
<time_frame>time of AGI diagnosis, day-1 PELOD-2 score</time_frame>
<description>The Pediatric Logistic Organ Dysfunction (PELOD)-2 score is used to predict mortality and assess organ dysfunction. It consist of 10 components, assessing 5 organ dysfunction. The minimum score of PELOD-2 is 0 and the maximum score is 33. With the increasing organ dysfunction, the probability of death also increases.</description>
</primary_outcome>
<primary_outcome>
<measure>mortality</measure>
<time_frame>days from PICU admission date up to 28 days follow-up</time_frame>
<description>PICU mortality</description>
</primary_outcome>
<enrollment type="Anticipated">90</enrollment>
<condition>Acute Gastrointestinal Injury</condition>
<condition>Gastrointestinal Failure</condition>
<condition>Critical Illness</condition>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>AGI</intervention_name>
<description>no intervention, only observation</description>
</intervention>
<eligibility>
<study_pop>
<textblock>
All critically ill patients admitted to PICU
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- critically ill pediatric patients receiving care at the PICU

- presence of AGI (any degree)

Exclusion Criteria:

- patients who's body weight cannot be measured
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>1 Month</minimum_age>
<maximum_age>18 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Antonius H Pudjiadi, MD, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Indonesia University</affiliation>
</overall_official>
<overall_contact>
<last_name>Antonius H Pudjiadi, MD, PhD</last_name>
<phone>+628164812035</phone>
<email>ahpudjiadi@gmail.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Gryselda Hanafi, MD</last_name>
<phone>087170113134</phone>
<phone_ext>00</phone_ext>
<email>gryseldahanafi@gmail.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Cipto Mangunkusumo Hospital</name>
<address>
<city>Jakarta Pusat</city>
<state>DKI Jakarta</state>
<zip>10430</zip>
<country>Indonesia</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Antonius Pudjiadi, MD, PhD</last_name>
<phone>+621500135</phone>
<email>info@rscm.co.id</email>
</contact>
<investigator>
<last_name>Fatima Safira Alatas, MD, PhD</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location_countries>
<country>Indonesia</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>September 18, 2020</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 29, 2022</last_update_submitted>
<last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Indonesia University</investigator_affiliation>
<investigator_full_name>Dr. dr. Antonius Hocky Pudjiadi, SpA(K)</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>Critical Illness</mesh_term>
<mesh_term>Wounds and Injuries</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Critically Ill children may develop acute gastrointestinal injury secondary to severe
inflammation.
Data collection from enrolled subjects including profile, laboratory examinations,
inflammatory markers on day 1 and day 3, nutritional support and daily calorie intake, and
finally outcome of the patient
All critically ill patients admitted to PICU
Inclusion Criteria:
- critically ill pediatric patients receiving care at the PICU
- presence of AGI (any degree)
Exclusion Criteria:
- patients who's body weight cannot be measured
|
NCT0531xxxx/NCT05315258.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/NCT05315258</url>
</required_header>
<id_info>
<org_study_id>OCTO_101</org_study_id>
<secondary_id>2019-003946-34</secondary_id>
<nct_id>NCT05315258</nct_id>
</id_info>
<brief_title>Tebentafusp in Molecular Relapsed Disease (MRD) Melanoma</brief_title>
<acronym>TebeMRD</acronym>
<official_title>A Phase II Non-Randomized, Open-label, Multi-centre Study of the Safety and Efficacy of Tebentafusp in Melanoma With Molecular Relapsed Disease</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Oxford</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Immunocore Ltd</agency>
<agency_class>Industry</agency_class>
</collaborator>
<collaborator>
<agency>Natera, Inc.</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>University of Oxford</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>
Researchers are trying to find ways to improve the management of people with intermediate or
high risk resected cutaneous melanoma or with primary uveal melanoma.

This research study is investigating using a new blood test to decide when to give a drug
called tebentafusp. Tebentafusp has been used in clinical trials in patients with advanced
cutaneous and uveal melanoma. This study is designed to determine if tebentafusp can help
patients with cutaneous or uveal melanoma live longer.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
TebeMRD is an unblinded non-randomised, open labelled, safety and efficacy study involving 2
patient cohorts:

- A: Cutaneous melanoma with molecular relapsed disease (MRD)

- B: Uveal melanoma with MRD

Approximately 850 patients (600 cutaneous melanoma, 250 uveal melanoma) will be enrolled from
50 centres to screen for HLA-A*0201 status and then followed for up to 12 months for MRD at
those same centres. Patients identified with MRD will be invited to be treated with
tebentafusp at up to 10 treating centres in the UK. Patients in cohorts A and B will receive
up to six months of tebentafusp, administered weekly IV, and then will be followed-up for 12
months for molecular and clinical relapse.

Patients will be in the pre-screening phase for determination of HLA-A*0201 status for up to
2 weeks. Those patients who are positive for HLA-A*0201 will be followed for MRD and will
attend the clinical sites for 3 monthly testing for up to 12 months. Patients will leave the
study if no molecular relapse is detected during the molecular screening period. When MRD is
identified, patients will be evaluated for eligibility to enter the main study at one of up
to 10 specialist treatment centres, where patients will enter the screening period for
determination of eligibility to start tebentafusp administration within 6 weeks. After a
maximum 6 months treatment patients will be followed up for 12 months, or until the study is
completed, if this is longer.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">July 25, 2022</start_date>
<completion_date type="Anticipated">June 30, 2026</completion_date>
<primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
<phase>Phase 2</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>Estimate the rate of molecular response (MR) to tebentafusp in each of 2 cohorts A. Cutaneous melanoma with MRD B. Uveal melanoma with MRD</measure>
<time_frame>ctDNA taken at baseline until end of treatment (maximum of 6 months)</time_frame>
<description>Best response to treatment, with partial molecular response (pMR) defined as a decrease in the allele frequency of the index mutation(s), and complete molecular response (cMR) as no detectable mutation(s)</description>
</primary_outcome>
<secondary_outcome>
<measure>Efficacy of tebentafusp</measure>
<time_frame>ctDNA taken at baseline until end of treatment (maximum of 6 months); CT or MRI assessment as per standard of care</time_frame>
<description>Evaluate the efficacy of tebentafusp in each cohort - Relapse free survival at 12 months; duration of MR; overall survival</description>
</secondary_outcome>
<secondary_outcome>
<measure>Safety and tolerability of tebentafusp</measure>
<time_frame>Up to 6 months of treatment</time_frame>
<description>Assess the safety and tolerability of tebentafusp in MRD. Incidence and severity of adverse events according to NCIC CTCAE v5.0/2019 Lee et all criteria; dose reductions, interruptions and cessations in the course of treatment</description>
</secondary_outcome>
<secondary_outcome>
<measure>Assess the rate of molecular relapse in; A. Cutaneous melanoma B. Uveal melanoma</measure>
<time_frame>ctDNA taken at baseline and every 3 months during molecular screening</time_frame>
<description>Percentage of patients with molecular relapse at baseline, within 6 months and over 12 months of monitoring</description>
</secondary_outcome>
<other_outcome>
<measure>Changes in peripheral T cell populations and in serum cytokines and other analytes</measure>
<time_frame>Up to 6 months of treatment</time_frame>
<description>From blood drawn every 4 weeks</description>
</other_outcome>
<other_outcome>
<measure>Preliminary evaluation of response rate in gp100 expressing melanoma</measure>
<time_frame>ctDNA taken at baseline until end of treatment (maximum of 6 months)</time_frame>
<description>Best molecular response in cohorts A and B</description>
</other_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">850</enrollment>
<condition>Melanoma (Skin)</condition>
<condition>Melanoma, Uveal</condition>
<arm_group>
<arm_group_label>Cutaneous melanoma with molecular relapsed disease</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>tebentafusp weekly IV escalating in the first treatment cycle with dose 20 mcg on day 1, 30 mcg on day 8, 68 mcg on days 15 and 22. Thereafter weekly doses will be 68 mcg IV for 6 months.</description>
</arm_group>
<arm_group>
<arm_group_label>Uveal melanoma with molecular relapsed disease</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>tebentafusp weekly IV escalating in the first treatment cycle with dose 20 mcg on day 1, 30 mcg on day 8, 68 mcg on days 15 and 22. Thereafter weekly doses will be 68 mcg IV for 6 months.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Tebentafusp</intervention_name>
<description>Tebentafusp supplied as concentrate for solution for infusion and diluted prior to administration. 0.2 mg/mL drug product will be provided as a sterile, refrigerated solution in glass vials.</description>
<arm_group_label>Cutaneous melanoma with molecular relapsed disease</arm_group_label>
<arm_group_label>Uveal melanoma with molecular relapsed disease</arm_group_label>
<other_name>IMCgp100</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

A patient will be eligible for inclusion in cohort A or B if all of the following criteria
apply:

1. Uveal or cutaneous melanoma with MRD detected in molecular screening.

2. Written (signed and dated) informed consent.

3. Male or female, Age 18 years and above.

4. Life expectancy of at least 3 months.

5. ECOG performance score of 0 or 1.

6. No evidence of metastatic disease on a CT scan of neck/thorax/abdomen/pelvis for
cohorts A and B and also on MRI liver for uveal melanoma for cohort B.

7. Those receiving prior immunotherapy must have recovered from any immune-mediated
adverse events (≤ grade 1) other than endocrinopathies on stable replacement therapy.

8. Haematological and biochemical indices within normal ranges (refer to protocol for
ranges)

Exclusion Criteria:

A patient will not be eligible for tebentafusp administration if any of the following
apply:

1. Treatment with any other investigational agent, or participation in another
interventional clinical trial within 28 days prior to enrolment.

2. Uveal or cutaneous melanoma patients who present radiologically or clinically
detectable disease during screening.

3. Active infection requiring systemic antibiotic therapy. Patients requiring systemic
antibiotics for infection must have completed therapy before Screening is initiated

4. Other psychological, social or medical condition, physical examination finding or a
laboratory abnormality that the Investigator considers would make the patient a poor
trial candidate or could interfere with protocol compliance or the interpretation of
trial results.

5. Any other active malignancy, with the exception of malignancies that were treated
curatively and have not recurred within 2 years after completion of treatment;
completely resected basal cell and squamous cell skin cancers; any malignancy
considered to be indolent and that has never required therapy; and completely resected
carcinoma in situ of any type

6. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or
HIV. This study does not require testing to confirm eligibility unless clinically
indicated.

7. Clinically significant cardiac disease or impaired cardiac function (New York Heart
Association grade ≥ 2), including myocardial infarction or unstable angina pectoris
within 6 months of screening.

8. Active autoimmune disease or a documented history of autoimmune disease within 3 years
of screening (diabetes mellitus, vitiligo, managed hypothyroidism, psoriasis and
managed asthma are not exclusions).

9. Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For
cytotoxic agents that have major delayed toxicity and any prior immunotherapy
approach, 4 weeks is indicated as washout period

10. Presence of NCI CTCAE ≥ grade 2 toxicity (except alopecia, peripheral neuropathy, and
ototoxicity, which are excluded if ≥ NCI CTCAE grade 3) due to prior cancer therapy.

11. Patients currently requiring chronic, systemic corticosteroid therapy at any dose for
longer than 2 weeks. Replacement treatment for pituitary or adrenal insufficiency is
permitted. Local steroid therapies (e.g. otic, ophthalmic, intra-articular, or inhaled
medications) are acceptable.

12. Use of any live vaccines against infectious diseases within 4 weeks of initiation of
study treatment. Non-live vaccination (e.g. influenza) are permitted anytime during
treatment.

13. Major surgery as defined by the investigator within 2 weeks of the first dose of study
treatment (minimally invasive procedures such as bronchoscopy, insertion of a central
venous access device, and insertion of a feeding tube are not considered major
surgery).

14. Pregnant or lactating women, or women of childbearing potential unless effective
methods of contraception are used.

15. Women of child-bearing potential who are sexually active with a non-sterilized male
partner, defined as all women physiologically capable of becoming pregnant, unless
they are using highly effective contraception during study treatment, and must agree
to continue using such precautions for 6 months after the final dose of
investigational product; cessation of birth control after this point should be
discussed with a responsible physician.

16. Male patients must be surgically sterile or use double barrier contraception method
from enrolment through treatment and for 6 months following administration of the last
dose of study drug.
</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>Mark Middleton</last_name>
<role>Principal Investigator</role>
<affiliation>Consultant Medical Oncologist and Professor of Experimental Cancer Medicine</affiliation>
</overall_official>
<overall_contact>
<last_name>Lisa Poulton</last_name>
<phone>01865617075</phone>
<email>octo-tebemrd@oncology.ox.ac.uk</email>
</overall_contact>
<overall_contact_backup>
<last_name>Lakisha Marshall</last_name>
<email>octo-tebemrd@oncology.ox.ac.uk</email>
</overall_contact_backup>
<location>
<facility>
<name>The Clatterbridge Cancer Centre</name>
<address>
<city>Liverpool</city>
<country>United Kingdom</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Joesph Sacco</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>University College London Hospital</name>
<address>
<city>London</city>
<country>United Kingdom</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Heather Shaw</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>The Christie Hospital</name>
<address>
<city>Manchester</city>
<country>United Kingdom</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Rebecca Lee</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Mount Vernon Cancer Centre</name>
<address>
<city>Middlesex</city>
<country>United Kingdom</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Paul Nathan</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Churchill Hospital, Oxford University Hospitals NHS Trust</name>
<address>
<city>Oxford</city>
<zip>OX3 7LE</zip>
<country>United Kingdom</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Mark Middleton</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United Kingdom</country>
</location_countries>
<verification_date>July 2022</verification_date>
<study_first_submitted>August 23, 2021</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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 7, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>D008545</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Melanoma</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Researchers are trying to find ways to improve the management of people with intermediate or
high risk resected cutaneous melanoma or with primary uveal melanoma.
This research study is investigating using a new blood test to decide when to give a drug
called tebentafusp. Tebentafusp has been used in clinical trials in patients with advanced
cutaneous and uveal melanoma. This study is designed to determine if tebentafusp can help
patients with cutaneous or uveal melanoma live longer.
TebeMRD is an unblinded non-randomised, open labelled, safety and efficacy study involving 2
patient cohorts:
- A: Cutaneous melanoma with molecular relapsed disease (MRD)
- B: Uveal melanoma with MRD
Approximately 850 patients (600 cutaneous melanoma, 250 uveal melanoma) will be enrolled from
50 centres to screen for HLA-A*0201 status and then followed for up to 12 months for MRD at
those same centres. Patients identified with MRD will be invited to be treated with
tebentafusp at up to 10 treating centres in the UK. Patients in cohorts A and B will receive
up to six months of tebentafusp, administered weekly IV, and then will be followed-up for 12
months for molecular and clinical relapse.
Patients will be in the pre-screening phase for determination of HLA-A*0201 status for up to
2 weeks. Those patients who are positive for HLA-A*0201 will be followed for MRD and will
attend the clinical sites for 3 monthly testing for up to 12 months. Patients will leave the
study if no molecular relapse is detected during the molecular screening period. When MRD is
identified, patients will be evaluated for eligibility to enter the main study at one of up
to 10 specialist treatment centres, where patients will enter the screening period for
determination of eligibility to start tebentafusp administration within 6 weeks. After a
maximum 6 months treatment patients will be followed up for 12 months, or until the study is
completed, if this is longer.
Inclusion Criteria:
A patient will be eligible for inclusion in cohort A or B if all of the following criteria
apply:
1. Uveal or cutaneous melanoma with MRD detected in molecular screening.
2. Written (signed and dated) informed consent.
3. Male or female, Age 18 years and above.
4. Life expectancy of at least 3 months.
5. ECOG performance score of 0 or 1.
6. No evidence of metastatic disease on a CT scan of neck/thorax/abdomen/pelvis for
cohorts A and B and also on MRI liver for uveal melanoma for cohort B.
7. Those receiving prior immunotherapy must have recovered from any immune-mediated
adverse events (≤ grade 1) other than endocrinopathies on stable replacement therapy.
8. Haematological and biochemical indices within normal ranges (refer to protocol for
ranges)
Exclusion Criteria:
A patient will not be eligible for tebentafusp administration if any of the following
apply:
1. Treatment with any other investigational agent, or participation in another
interventional clinical trial within 28 days prior to enrolment.
2. Uveal or cutaneous melanoma patients who present radiologically or clinically
detectable disease during screening.
3. Active infection requiring systemic antibiotic therapy. Patients requiring systemic
antibiotics for infection must have completed therapy before Screening is initiated
4. Other psychological, social or medical condition, physical examination finding or a
laboratory abnormality that the Investigator considers would make the patient a poor
trial candidate or could interfere with protocol compliance or the interpretation of
trial results.
5. Any other active malignancy, with the exception of malignancies that were treated
curatively and have not recurred within 2 years after completion of treatment;
completely resected basal cell and squamous cell skin cancers; any malignancy
considered to be indolent and that has never required therapy; and completely resected
carcinoma in situ of any type
6. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or
HIV. This study does not require testing to confirm eligibility unless clinically
indicated.
7. Clinically significant cardiac disease or impaired cardiac function (New York Heart
Association grade ≥ 2), including myocardial infarction or unstable angina pectoris
within 6 months of screening.
8. Active autoimmune disease or a documented history of autoimmune disease within 3 years
of screening (diabetes mellitus, vitiligo, managed hypothyroidism, psoriasis and
managed asthma are not exclusions).
9. Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For
cytotoxic agents that have major delayed toxicity and any prior immunotherapy
approach, 4 weeks is indicated as washout period
10. Presence of NCI CTCAE ≥ grade 2 toxicity (except alopecia, peripheral neuropathy, and
ototoxicity, which are excluded if ≥ NCI CTCAE grade 3) due to prior cancer therapy.
11. Patients currently requiring chronic, systemic corticosteroid therapy at any dose for
longer than 2 weeks. Replacement treatment for pituitary or adrenal insufficiency is
permitted. Local steroid therapies (e.g. otic, ophthalmic, intra-articular, or inhaled
medications) are acceptable.
12. Use of any live vaccines against infectious diseases within 4 weeks of initiation of
study treatment. Non-live vaccination (e.g. influenza) are permitted anytime during
treatment.
13. Major surgery as defined by the investigator within 2 weeks of the first dose of study
treatment (minimally invasive procedures such as bronchoscopy, insertion of a central
venous access device, and insertion of a feeding tube are not considered major
surgery).
14. Pregnant or lactating women, or women of childbearing potential unless effective
methods of contraception are used.
15. Women of child-bearing potential who are sexually active with a non-sterilized male
partner, defined as all women physiologically capable of becoming pregnant, unless
they are using highly effective contraception during study treatment, and must agree
to continue using such precautions for 6 months after the final dose of
investigational product; cessation of birth control after this point should be
discussed with a responsible physician.
16. Male patients must be surgically sterile or use double barrier contraception method
from enrolment through treatment and for 6 months following administration of the last
dose of study drug.
|
NCT0531xxxx/NCT05315271.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/NCT05315271</url>
</required_header>
<id_info>
<org_study_id>soh-Med-21-10-07</org_study_id>
<nct_id>NCT05315271</nct_id>
</id_info>
<brief_title>Supraclavicular Brachial Plexus Block During Upper Limb Surgeries</brief_title>
<official_title>Comparative Study Between Ketamine-Bupivacaine Versus Bupivacaine With Intravenous Ketamine Infusion In Supraclavicular Brachial Plexus Block During Upper Limb Surgeries</official_title>
<sponsors>
<lead_sponsor>
<agency>Sohag University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Sohag 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>
Comparative Study Between Ketamine-Bupivacaine Versus Bupivacaine With Intravenous Ketamine
Infusion In Supraclavicular Brachial Plexus Block During Upper limb Surgeries The techniques
of regional anesthesia have become very popular as they provide several advantages in
comparison with general anesthesia and systemic analgesia.

They provide perfect pain control, decreased complications and reduced post-anesthesia care
unit stay.

Regional anesthesia provides more patient safety and better outcomes, which leads to the fact
that ultrasound-guided regional anesthesia became more popular.

Ultrasound provides clinicians with real-time images which are useful for better
identification of the anatomical structures, safe needle placement and adequate local
anesthetic spread.

Brachial plexus blocks are commonly achieved via an interscalene, supraclavicular,
infraclavicular or axillary approach.

The supraclavicular level is an ideal site to achieve anesthesia of the entire upper
extremity just distal to the shoulder as the plexus remains relatively tightly packed at this
level, resulting in a rapid and high-quality block. For this reason, the supraclavicular
block is often called the ''spinal of the arm'' Using the local anesthetics alone for
supraclavicular brachial plexus block provide good operative conditions but have the
disadvantage of shorter duration of postoperative analgesia. Various adjuvants such as
opioids, dexmedetomidine, dexamethasone, midazolam, ketamine, etc., were added to local
anesthetics in brachial plexus block to achieve quick and prolonged block.

Ketamine is a noncompetitive antagonist of the N-methyl-D aspartate receptor(NMDAR).

It is used as a premedication, and for sedation, induction and maintenance of general
anesthesia.

Local anesthetic and analgesic properties have been reported for ketamine. Intravenous
administration of low-dose ketamine decreases postoperative opioid use and improves
analgesia.

Ketamine has been added to bupivacaine to prolong the duration of regional anesthesia and
postoperative analgesia.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">June 1, 2022</start_date>
<completion_date type="Actual">January 20, 2023</completion_date>
<primary_completion_date type="Actual">January 1, 2023</primary_completion_date>
<phase>Early 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>Screening</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Comparison of the efficacy of adding ketamine to bupivacaine versus intravenous ketamine infusion with supraclavicular brachial plexus block in upper limb surgeries of sensory block</measure>
<time_frame>24 hours</time_frame>
<description>-Sensory block will be assessed by pin prick test using a 3-point scale : Grade 0 = normal sensation. Grade 1 = loss of sensation of pin prick (analgesia). Grade 2 = loss of sensation of touch (anesthesia).
Onset of sensory block: the time interval between the end of local anesthetic administration and complete sensory block by min.
Duration of sensory block: the time interval between the complete sensory block and complete resolution of anesthesia.
Intraoperative: sensory block level will be assessed by a pin prick at in the dermatomal areas corresponding to the median, radial, ulnar, and musculocutaneous nerves every 15 minutes at (15 min, 30 min, 45 min ,60 min, Etc.) till end of the operation.
Postoperative: will be checked every 30minutes until regain of pinprick sensation at (1/2hr, 1hr, 1.5hr and2hr) then at (3hrs, 6hrs, 12hrs and 24hrs).</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">60</enrollment>
<condition>Brachial Plexus Block</condition>
<arm_group>
<arm_group_label>Group 1</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>All patients will be randomly allocated into two equal groups: each group will contain 30patients:</description>
</arm_group>
<arm_group>
<arm_group_label>Group 2</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>All patients will be randomly allocated into two equal groups: each group will contain 30patients:</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Bupivacaine-ketamine injection</intervention_name>
<description>20 ml volume bupivacaine only (0.5%concentration) (with maximum dose not exceeding 4mg/kg ) plus ketamine (1 mg/kg) with maximum dose 100mg ; the total volume is 30 ml with the infusion of 100 ml normal saline at a rate of 100ml/h.</description>
<arm_group_label>Group 1</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Bupivacaine injection with intravenous ketamine infusion</intervention_name>
<description>20 ml volume bupivacaine only (0.5%concentration) (with maximum dose not exceeding 4mg/kg ) plus 10 ml saline ; the total volume is 30 ml with the infusion of ketamine 0.15 mg/kg added to 100 ml normal saline and will be infused at a rate of 100 ml/h, which will be stopped 5 min before the end of surgery.</description>
<arm_group_label>Group 2</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Age 18 to 75 years.

- ASA physical status I-II, scheduled.

- Patients of either sex.

- Unilateral elective upper limb surgeries undergoing under ultrasound guided
supraclavicular brachial plexus block.

Exclusion Criteria:

- Patient refusal.

- Patients with peripheral neuropathy of the upper limb.

- Infection at the injection site.

- Uncontrolled diabetes, epilepsy, obstructive pulmonary disease and neuromuscular
disease.

- Altered mental status.

- Hypersensitivity to bupivacaine and ketamine.

- Patients with coagulopathy.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Sohag University</name>
<address>
<city>Sohag</city>
<country>Egypt</country>
</address>
</facility>
</location>
<location_countries>
<country>Egypt</country>
</location_countries>
<reference>
<citation>1. Abdallah F, Brull R Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth 110(6):915-925,2013. 2. Hanumanthaiah D, Vaidiyanathan S, Garstka M, Szucs S, Iohom G Ultrasound guided supraclavicular block. Med Ultrason 15(3):224-229,2013. 3. Argiriadou KS, McEwen A, Matthew G: Ultrasound-Guided Supraclavicular Brachial Plexus Block https: //www.wfsahq.org/components/com_virtual_library/media/2ffc0a053d75e1cae94f9 3f57cddb8ff-atow-384-00-01.pdf,2018. 4. Swami SS, Keniya VM, Ladi SD, et al. Comparison of dexmedetomidine and clonidine (α2 agonist drugs) as an adjuvant to local anaesthesia in supraclavicular brachial plexus block: a randomised double-blind prospective study. Indian J Anaesth; 56:243-249,2012. 5. Kohli S, Kaur M, Sahoo S, et al. Brachial plexus block: comparison of two different doses of clonidine added to bupivacaine. J Anaesthesiol Clin Pharmacol; 29:491-495, 2013. 6. Reves JG, Glass PS, Lubarsky DA, et al. Intravenous anesthetic. In: Miller R, editor. Miller's anesthesia. 7th ed. Philadelphia: Churchill Livingstone; 724-726, 2010.</citation>
</reference>
<verification_date>May 2022</verification_date>
<study_first_submitted>March 8, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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>Sohag University</investigator_affiliation>
<investigator_full_name>Ahmed Gamal Abdelah</investigator_full_name>
<investigator_title>Resident of Anesthesiology , Intensive care unit and Pain management.</investigator_title>
</responsible_party>
<keyword>Bupivacaine</keyword>
<keyword>ketamine</keyword>
<keyword>Brachial Plexus Block</keyword>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ketamine</mesh_term>
<mesh_term>Bupivacaine</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<pending_results>
<submitted>February 11, 2023</submitted>
<submission_canceled>February 15, 2023</submission_canceled>
<submitted>February 15, 2023</submitted>
<submission_canceled>March 1, 2023</submission_canceled>
<submitted>March 1, 2023</submitted>
</pending_results>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Comparative Study Between Ketamine-Bupivacaine Versus Bupivacaine With Intravenous Ketamine
Infusion In Supraclavicular Brachial Plexus Block During Upper limb Surgeries The techniques
of regional anesthesia have become very popular as they provide several advantages in
comparison with general anesthesia and systemic analgesia.
They provide perfect pain control, decreased complications and reduced post-anesthesia care
unit stay.
Regional anesthesia provides more patient safety and better outcomes, which leads to the fact
that ultrasound-guided regional anesthesia became more popular.
Ultrasound provides clinicians with real-time images which are useful for better
identification of the anatomical structures, safe needle placement and adequate local
anesthetic spread.
Brachial plexus blocks are commonly achieved via an interscalene, supraclavicular,
infraclavicular or axillary approach.
The supraclavicular level is an ideal site to achieve anesthesia of the entire upper
extremity just distal to the shoulder as the plexus remains relatively tightly packed at this
level, resulting in a rapid and high-quality block. For this reason, the supraclavicular
block is often called the ''spinal of the arm'' Using the local anesthetics alone for
supraclavicular brachial plexus block provide good operative conditions but have the
disadvantage of shorter duration of postoperative analgesia. Various adjuvants such as
opioids, dexmedetomidine, dexamethasone, midazolam, ketamine, etc., were added to local
anesthetics in brachial plexus block to achieve quick and prolonged block.
Ketamine is a noncompetitive antagonist of the N-methyl-D aspartate receptor(NMDAR).
It is used as a premedication, and for sedation, induction and maintenance of general
anesthesia.
Local anesthetic and analgesic properties have been reported for ketamine. Intravenous
administration of low-dose ketamine decreases postoperative opioid use and improves
analgesia.
Ketamine has been added to bupivacaine to prolong the duration of regional anesthesia and
postoperative analgesia.
Inclusion Criteria:
- Age 18 to 75 years.
- ASA physical status I-II, scheduled.
- Patients of either sex.
- Unilateral elective upper limb surgeries undergoing under ultrasound guided
supraclavicular brachial plexus block.
Exclusion Criteria:
- Patient refusal.
- Patients with peripheral neuropathy of the upper limb.
- Infection at the injection site.
- Uncontrolled diabetes, epilepsy, obstructive pulmonary disease and neuromuscular
disease.
- Altered mental status.
- Hypersensitivity to bupivacaine and ketamine.
- Patients with coagulopathy.
|
NCT0531xxxx/NCT05315284.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/NCT05315284</url>
</required_header>
<id_info>
<org_study_id>Soh-Med-22-02-08</org_study_id>
<nct_id>NCT05315284</nct_id>
</id_info>
<brief_title>The Clinical and Radiological Outcomes of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle</brief_title>
<official_title>The Clinical and Radiological Outcomes of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle</official_title>
<sponsors>
<lead_sponsor>
<agency>Sohag University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Sohag 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 Clinical and Radiological Outcomes of the Use of Titanium Elastic Nail in The Fixation of
Fresh Non-comminuted Fracture Mid-shaft Clavicle
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Introduction:

The midshaft clavicle fractures account for 3 to 5% of all injuries and 70 to 80% of all
clavicle fractures.[1,2] In young adults, these fractures are usually related to sports or
vehicle accidents, whereas in children and elderly, they are usually related to falls.[1,2]
In general, clavicle fractures are treated conservatively and have a good outcome. In 1960,
Neer reported a non-union rate of 0.1% with conservative treatment[3] and Rowe corroborated
these findings in 1968 and showed a nonunion rate of 0.8% in conservatively managed
patients.[4] Since then, however, other authors have failed to demonstrate similar good
results with conservative treatment.[5,6] This may be due to the fact that the initial series
included children and adolescents and their enormous potential for bone healing may have
skewed the results, and that patient-based scoring systems were not used in the initial
series to record the outcome.[7] Hill et al. showed that displacement of more than 20 mm
resulted in 15% non-union and 18% of the patients had thoracic outlet syndrome following
union.[5] McKee et al. noted reduced patient satisfaction due to asymmetry and cosmesis
following malunion in patients with more than 20 mm shortening.[6] Hence, more recently,
there has been a trend toward surgical fixation.

Surgery has been indicated for completely displaced fractures, potential skin perforation,
shortening of clavicle by more than 20 mm, neurovascular injury, and floating injury.[8] The
gold standard for the surgical treatment has been open reduction and plate fixation through a
large incision.[8] Other surgical options include intramedullary pinning with Kirschner wire,
Rush pins, Knolwes pin, Steinman pin, Haige pin, ESIN (elastic stable intramedullary
nailing), and external fixation.[9] Intramedullary fixation for clavicular fractures was
first described by Peroni in 1950.[10] A systematic review showed relative risk reduction of
72% and 57% for non-union when using intramedullary fixation and plate fixation,
respectively, when compared with non-operative treatment of midshaft clavicle fractures.[11]
Intramedullary devices behave as internal splints that maintain alignment without rigid
fixation. The use of an intramedullary device carries advantages of a smaller incision, less
soft tissue dissection, load sharing fixation with relative stability that encourages copious
callus formation.[12] The titanium ESIN has been successfully used in fixation of pediatric
long bone fractures. One advantage of the titanium ESIN is that it can block itself in the
bone and provide a three-point fixation within the Sshaped clavicle.[8,13] However, some
studies have shown a relatively high complication rate and technical difficulties with
intramedullary nailing.[7,8] The aim of this study was to investigate the union rate and
complication rate of our patients with displaced midshaft clavicle fractures treated with
titanium ESIN. Aim of the study Investigating the union rate and complications rate following
titanium elastic stable intramedullary nailing (ESIN) for midshaft non-comminuted clavicle
fractures with >20 mm shortening/displacement. Materials and methods Place of the study:
Orthopaedics and Traumatology Department, Sohag University Hospital. Type of the study:
Prospective study. Study period: from December,2021 till December,2022. Inclusion criteria:
(1) Type IIA2 (angulation > 45 ) or IIB1 (shortening or overlapping displacement length > 2
cm) fresh unilateral midshaft clavicular fractures according to Robinson classification. (2)
Patient without underlying diseases such as primary hypertension and cardiac diseases.
Exclusion criteria: (1) pathological fractures. (2) multiple injuries of upper limbs. (3)
open fractures. (4) combined with injuries of blood vessels or nerves. (5) other diseases
which affected the functions of upper limbs. (6) Proximal and distal clavicular fractures.
(7) Comminuted clavicular fractures. Preoperative assessment: (1) Clinical evaluation: pain,
tenderness, deformity, shortening, skin tethering and loss of function. (2) Radiological
assessment: plain X-ray imaging is the corner stone for establishing the diagnoses of
clavicular fractures. CT scans can be used to exclude comminuted clavicular fractures if the
comminution of the fracture couldn't be visualized by the plain X-ray studies (3) Laboratory
assessment: routine laboratory investigations for any surgery.

Standard protocol approvals and patient consents:

This study will be approved by the Medical Research Ethics committee at faculty of medicine,
Sohag University. An informed written consent will be obtained from each patient.

Surgical technique:

After administration of anesthesia, the patient is placed in beach chair position with
injured extremity prepared and draped from the midline to the upper arm. Care is taken to
make sure that the sternoclavicular joint was accessible for the entry point. Preoperatively,
the shoulder region is screened using image intensifier to confirm this access. A vertical
skin incision is made just lateral to the sternoclavicular joint. The subcutaneous fat is
incised along with platysma. The pectoral fascia is divided in line with the skin incision
followed by careful elevation of the underlying musculature from the clavicle. The entry
point in the anterior cortex with a 3.2 mm drill bit and guide. The entry portal may be
enlarged with an awl and appropriate sized titanium ESIN is inserted (The size of the nail
was measured using this formula = 0.4 × canal diameter in mm). Attempt is made to close
reduce the fracture. If the fracture could not be reduced by closed means, then a separate
vertical incision is used at the fracture site to aid fracture reduction. Vertical incision
is used as it is parallel to Langer's lines and minimizes the risk of damage to
supraclavicular nerves to avoid dysesthesia of skin and scar neuromas. The nail is used to
create a path in the lateral end of the clavicle for subsequent easy access.

The nail is then passed from the medial side and across the reduced fracture into the lateral
end of clavicle.

Postoperative management:

All patients are treated with arm sling after operation for 6 weeks. In addition, 3 days
after surgery, patients are allowed to do passive anteflexion and abduction motion of
shoulder joint under the guidance of physiotherapists, and the motion range could be
increased gradually depending on the degree of pain. However, the range of passive
anteflexion and abduction motion is kept within 90 degrees in 6 weeks after surgery, and the
weight-bearing exercise is not allowed. The range of passive and active motion is increased
gradually according to the condition of fracture union and the weight-bearing exercise is
started gradually after 6 weeks post-operatively. The postoperative follow-up visits are
scheduled every two weeks until bone union and every 3 months after bone union.
Post-Operative Evaluation

Evaluation of therapeutic efficiency:

The operative data is recorded and analyzed, including operation time, blood loss, hospital
stays and postoperative complications. The standards of bone union includes the formation of
continuous callus and the disappearance of fracture line, no tenderness of the fracture ends,
and no subjective pain when performing active sports and weight-bearing activities on the
clinical examinations.

Scoring system:

Improvement of subjective pain is assessed using a visual analog scale (VAS) at 1 day before
surgery and 3 days after surgery. The flexion and abduction motion ranges of shoulder joint
were recorded from one day before surgery to the last follow-up.24 Shoulder function is
assessed with the Constant-Murley score (range: 0-100 points, best: 100) and the Disabilities
of the Arm, Shoulder and Hand (DASH) score (range: 0- 100 points, best: 0) at the last
follow-up. In detail, Constant-Murley scores are categorized as follows: excellent (90-100),
good (80-89), satisfactory (70-79), and fair (<70). DASH scores of 0-10 are considered as an
excellent result, and score >40 is associated with poor shoulder function.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">December 1, 2021</start_date>
<completion_date type="Anticipated">December 1, 2022</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>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 Clinical Outcome of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle</measure>
<time_frame>3 months</time_frame>
<description>Investigating the union rate and complications rate following titanium elastic stable intramedullary nailing (ESIN) clinically for midshaft non-comminuted clavicle fractures with >20 mm shortening/displacement.</description>
</primary_outcome>
<primary_outcome>
<measure>The Radiological Outcome of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle</measure>
<time_frame>3 months</time_frame>
<description>Investigating the union rate and complications rate following titanium elastic stable intramedullary nailing (ESIN) radiologically for midshaft non-comminuted clavicle fractures with >20 mm shortening/displacement.</description>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">20</enrollment>
<condition>Fracture Clavicle</condition>
<arm_group>
<arm_group_label>Patients with fresh non-comminuted fracture mid-shaft clavicle</arm_group_label>
<arm_group_type>Other</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle</intervention_name>
<description>Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle</description>
<arm_group_label>Patients with fresh non-comminuted fracture mid-shaft clavicle</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- : (1) Type IIA2 (angulation > 45 ) or IIB1 (shortening or overlapping displacement
length > 2 cm) fresh unilateral midshaft clavicular fractures according to Robinson
classification. (2) Patient without underlying diseases such as primary hypertension
and cardiac diseases.

Exclusion Criteria:

- (1) pathological fractures. (2) multiple injuries of upper limbs. (3) open fractures.
(4) combined with injuries of blood vessels or nerves. (5) other diseases which
affected the functions of upper limbs. (6) Proximal and distal clavicular fractures.
(7) Comminuted clavicular fractures.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Mostafa Salah, Bachelor of Medicine, Bachelor</last_name>
<phone>01002397597</phone>
<phone_ext>+20</phone_ext>
<email>doc.mostafasala7@gmail.com</email>
</overall_contact>
<location>
<facility>
<name>Sohag university Hospital</name>
<address>
<city>Sohag</city>
<zip>82511</zip>
<country>Egypt</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Mostafa SALAH, Bachelor of Medicine, Bachelor</last_name>
<phone>01002397597</phone>
<email>doc.mostafasala7@gmail.com</email>
</contact>
</location>
<location_countries>
<country>Egypt</country>
</location_countries>
<results_reference>
<citation>1. Duan X, Zhong G, Cen S, Huang F, Xiang Z. Plating versus intramedullary pin or conservative treatment for midshaft fracture of clavicle: A meta-analysis of randomized controlled trials. J Shoulder Elbow Surg 2011;20:1008-15. 2. Schiffer G, Faymonville C, Skouras E, Andermahr J, Jubel A. Midclavicular fracture: not just a trivial injury: Current treatment options. Dtsch Arztebl Int 2010;107:711-7. 3. Neer CS 2nd. Nonunion of the clavicle. J Am Med Assoc 1960;172:1006-11. 4. Rowe CR. An atlas of anatomy and treatment of midclavicular fractures. Clin Orthop Relat Res 1968;58:29-42. 5. Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br 1997;79:537-9. 6. McKee MD, Pedersen EM, Jones C, Stephen DJ, Kreder HJ, Schemitsch EH. Deficits following nonoperative treatment of displaced midshaft clavicular fractures. J Bone Joint Surg Am 2006;88:35-40. 7. Smekal V, Irenberger A, Struve P, Wambacher M, Krappinger D, Kralinger FS. Elastic stable intramedullary nailing versus nonoperative treatment of displaced midshaft clavicular fractures-a randomized, controlled, clinical trial. J Orthop Trauma 2009;23:106-12. 8. Frigg A, Rillmann P, Perren T, Gerber M, Ryf C. Intramedullary nailing of clavicular midshaft fractures with the titanium elastic nail: Problems and complications. Am J Sports Med 2009;37:352-9. 9. Khalil A. Intramedullary screw fixation for midshaft fractures of the clavicle. Int Orthop 2009;33:1421-4. 10. Peroni L. Medullary osteosynthesis in the treatment of clavicle fractures. Arch Ortop 1950;63:398-405. 11. Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD, EvidenceBased Orthopaedic Trauma Working G. Treatment of acute midshaft clavicle fractures: Systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma 2005;19:504-7. 12. Millett PJ, Hurst JM, Horan MP, Hawkins RJ. Complications of clavicle fractures treated with intramedullary fixation. J Shoulder Elbow Surg 2011;20:86-91. 13. Mueller M, Rangger C, Striepens N, Burger C. Minimally invasive intramedullary nailing of midshaft clavicular fractures using titanium elastic nails. J Trauma 2008;64:1528-34. 14. Dawson J, Hill G, Fitzpatrick R, Carr A. The benefits of using patient-based methods of assessment. Medium-term results of an observational study of shoulder surgery. J Bone Joint Surg Br 2001;83:877-82. 15. Beaton DE, Wright JG, Katz JN, Upper Extremity Collaborative G. Development of the QuickDASH: Comparison of three itemreduction approaches. J Bone Joint Surg Am 2005;87:1038-46. 16. Canadian Orthopaedic Trauma S. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am 2007;89:1-10. 17. Mullaji AB, Jupiter JB. Low-contact dynamic compression plating of the clavicle. Injury 1994;25:41-5. 18. Schuind F, Pay-Pay E, Andrianne Y, Donkerwolcke M, Rasquin C, Burny F. External fixation of the clavicle for fracture or nonunion in adults. J Bone Joint Surg Am 1988;70:692-5. 19. Ferran NA, Hodgson P, Vannet N, Williams R, Evans RO. Locked intramedullary fixation vs plating for displaced and shortened mid-shaft clavicle fractures: A randomized clinical trial. J Shoulder Elbow Surg 2010;19:783-9. 20. Kleweno CP, Jawa A, Wells JH, O'Brien TG, Higgins LD, Harris MB. Midshaft clavicular fractures: Comparison of intramedullary pin and plate fixation. J Shoulder Elbow Surg 2011;20:1114-7. 21. Liu HH, Chang CH, Chia WT, Chen CH, Tarng YW, Wong CY. Comparison of plates versus intramedullary nails for fixation of displaced midshaft clavicular fractures. J Trauma 2010;69:E82-7. 22. Smekal V, Irenberger A, Attal RE, Oberladstaetter J, Krappinger D, Kralinger F. Elastic stable intramedullary nailing is best for midshaft clavicular fractures without comminution: Results in 60 patients. Injury 2011;42:324-9. 23. Jubel A, Andemahr J, Bergmann H, Prokop A, Rehm KE. Elastic stable intramedullary nailing of midclavicular fractures in athletes. Br J Sports Med 2003;37:480-3; discussion 4. 24. Chen YF, Wei HF, Zhang C, Zeng BF, Zhang CQ, Xue JF. Retrospective comparison of titanium elastic nail (TEN) and reconstruction plate repair of displaced midshaft clavicular fractures. J Shoulder Elbow Surg 2012;21:495-501. 25. Smekal V, Oberladstaetter J, Struve P, Krappinger D. Shaft fractures of the clavicle: Current concepts. Arch Orthop Trauma Surg 2009;129:807-15.</citation>
</results_reference>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 18, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 29, 2022</last_update_submitted>
<last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Sohag University</investigator_affiliation>
<investigator_full_name>Mostafa Salah Mohamed</investigator_full_name>
<investigator_title>Resident Doctor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Fractures, Bone</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<study_docs>
<study_doc>
<doc_type>Study Protocol</doc_type>
<doc_url>https://drive.google.com/file/d/1yvhKi3IduZrFVwrustNb4xt9ZyM7itN7/view?usp=sharing</doc_url>
</study_doc>
</study_docs>
<pending_results>
<submitted>May 8, 2023</submitted>
</pending_results>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The Clinical and Radiological Outcomes of the Use of Titanium Elastic Nail in The Fixation of
Fresh Non-comminuted Fracture Mid-shaft Clavicle
Introduction:
The midshaft clavicle fractures account for 3 to 5% of all injuries and 70 to 80% of all
clavicle fractures.[1,2] In young adults, these fractures are usually related to sports or
vehicle accidents, whereas in children and elderly, they are usually related to falls.[1,2]
In general, clavicle fractures are treated conservatively and have a good outcome. In 1960,
Neer reported a non-union rate of 0.1% with conservative treatment[3] and Rowe corroborated
these findings in 1968 and showed a nonunion rate of 0.8% in conservatively managed
patients.[4] Since then, however, other authors have failed to demonstrate similar good
results with conservative treatment.[5,6] This may be due to the fact that the initial series
included children and adolescents and their enormous potential for bone healing may have
skewed the results, and that patient-based scoring systems were not used in the initial
series to record the outcome.[7] Hill et al. showed that displacement of more than 20 mm
resulted in 15% non-union and 18% of the patients had thoracic outlet syndrome following
union.[5] McKee et al. noted reduced patient satisfaction due to asymmetry and cosmesis
following malunion in patients with more than 20 mm shortening.[6] Hence, more recently,
there has been a trend toward surgical fixation.
Surgery has been indicated for completely displaced fractures, potential skin perforation,
shortening of clavicle by more than 20 mm, neurovascular injury, and floating injury.[8] The
gold standard for the surgical treatment has been open reduction and plate fixation through a
large incision.[8] Other surgical options include intramedullary pinning with Kirschner wire,
Rush pins, Knolwes pin, Steinman pin, Haige pin, ESIN (elastic stable intramedullary
nailing), and external fixation.[9] Intramedullary fixation for clavicular fractures was
first described by Peroni in 1950.[10] A systematic review showed relative risk reduction of
72% and 57% for non-union when using intramedullary fixation and plate fixation,
respectively, when compared with non-operative treatment of midshaft clavicle fractures.[11]
Intramedullary devices behave as internal splints that maintain alignment without rigid
fixation. The use of an intramedullary device carries advantages of a smaller incision, less
soft tissue dissection, load sharing fixation with relative stability that encourages copious
callus formation.[12] The titanium ESIN has been successfully used in fixation of pediatric
long bone fractures. One advantage of the titanium ESIN is that it can block itself in the
bone and provide a three-point fixation within the Sshaped clavicle.[8,13] However, some
studies have shown a relatively high complication rate and technical difficulties with
intramedullary nailing.[7,8] The aim of this study was to investigate the union rate and
complication rate of our patients with displaced midshaft clavicle fractures treated with
titanium ESIN. Aim of the study Investigating the union rate and complications rate following
titanium elastic stable intramedullary nailing (ESIN) for midshaft non-comminuted clavicle
fractures with >20 mm shortening/displacement. Materials and methods Place of the study:
Orthopaedics and Traumatology Department, Sohag University Hospital. Type of the study:
Prospective study. Study period: from December,2021 till December,2022. Inclusion criteria:
(1) Type IIA2 (angulation > 45 ) or IIB1 (shortening or overlapping displacement length > 2
cm) fresh unilateral midshaft clavicular fractures according to Robinson classification. (2)
Patient without underlying diseases such as primary hypertension and cardiac diseases.
Exclusion criteria: (1) pathological fractures. (2) multiple injuries of upper limbs. (3)
open fractures. (4) combined with injuries of blood vessels or nerves. (5) other diseases
which affected the functions of upper limbs. (6) Proximal and distal clavicular fractures.
(7) Comminuted clavicular fractures. Preoperative assessment: (1) Clinical evaluation: pain,
tenderness, deformity, shortening, skin tethering and loss of function. (2) Radiological
assessment: plain X-ray imaging is the corner stone for establishing the diagnoses of
clavicular fractures. CT scans can be used to exclude comminuted clavicular fractures if the
comminution of the fracture couldn't be visualized by the plain X-ray studies (3) Laboratory
assessment: routine laboratory investigations for any surgery.
Standard protocol approvals and patient consents:
This study will be approved by the Medical Research Ethics committee at faculty of medicine,
Sohag University. An informed written consent will be obtained from each patient.
Surgical technique:
After administration of anesthesia, the patient is placed in beach chair position with
injured extremity prepared and draped from the midline to the upper arm. Care is taken to
make sure that the sternoclavicular joint was accessible for the entry point. Preoperatively,
the shoulder region is screened using image intensifier to confirm this access. A vertical
skin incision is made just lateral to the sternoclavicular joint. The subcutaneous fat is
incised along with platysma. The pectoral fascia is divided in line with the skin incision
followed by careful elevation of the underlying musculature from the clavicle. The entry
point in the anterior cortex with a 3.2 mm drill bit and guide. The entry portal may be
enlarged with an awl and appropriate sized titanium ESIN is inserted (The size of the nail
was measured using this formula = 0.4 × canal diameter in mm). Attempt is made to close
reduce the fracture. If the fracture could not be reduced by closed means, then a separate
vertical incision is used at the fracture site to aid fracture reduction. Vertical incision
is used as it is parallel to Langer's lines and minimizes the risk of damage to
supraclavicular nerves to avoid dysesthesia of skin and scar neuromas. The nail is used to
create a path in the lateral end of the clavicle for subsequent easy access.
The nail is then passed from the medial side and across the reduced fracture into the lateral
end of clavicle.
Postoperative management:
All patients are treated with arm sling after operation for 6 weeks. In addition, 3 days
after surgery, patients are allowed to do passive anteflexion and abduction motion of
shoulder joint under the guidance of physiotherapists, and the motion range could be
increased gradually depending on the degree of pain. However, the range of passive
anteflexion and abduction motion is kept within 90 degrees in 6 weeks after surgery, and the
weight-bearing exercise is not allowed. The range of passive and active motion is increased
gradually according to the condition of fracture union and the weight-bearing exercise is
started gradually after 6 weeks post-operatively. The postoperative follow-up visits are
scheduled every two weeks until bone union and every 3 months after bone union.
Post-Operative Evaluation
Evaluation of therapeutic efficiency:
The operative data is recorded and analyzed, including operation time, blood loss, hospital
stays and postoperative complications. The standards of bone union includes the formation of
continuous callus and the disappearance of fracture line, no tenderness of the fracture ends,
and no subjective pain when performing active sports and weight-bearing activities on the
clinical examinations.
Scoring system:
Improvement of subjective pain is assessed using a visual analog scale (VAS) at 1 day before
surgery and 3 days after surgery. The flexion and abduction motion ranges of shoulder joint
were recorded from one day before surgery to the last follow-up.24 Shoulder function is
assessed with the Constant-Murley score (range: 0-100 points, best: 100) and the Disabilities
of the Arm, Shoulder and Hand (DASH) score (range: 0- 100 points, best: 0) at the last
follow-up. In detail, Constant-Murley scores are categorized as follows: excellent (90-100),
good (80-89), satisfactory (70-79), and fair (<70). DASH scores of 0-10 are considered as an
excellent result, and score >40 is associated with poor shoulder function.
Inclusion Criteria:
- : (1) Type IIA2 (angulation > 45 ) or IIB1 (shortening or overlapping displacement
length > 2 cm) fresh unilateral midshaft clavicular fractures according to Robinson
classification. (2) Patient without underlying diseases such as primary hypertension
and cardiac diseases.
Exclusion Criteria:
- (1) pathological fractures. (2) multiple injuries of upper limbs. (3) open fractures.
(4) combined with injuries of blood vessels or nerves. (5) other diseases which
affected the functions of upper limbs. (6) Proximal and distal clavicular fractures.
(7) Comminuted clavicular fractures.
|
NCT0531xxxx/NCT05315297.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/NCT05315297</url>
</required_header>
<id_info>
<org_study_id>64143</org_study_id>
<nct_id>NCT05315297</nct_id>
</id_info>
<brief_title>Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis</brief_title>
<official_title>Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis</official_title>
<sponsors>
<lead_sponsor>
<agency>Stanford University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Stanford University</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>
Long-Term Objective: Determine if high-frequency PEMF therapy reduces pain in patients with
thumb carpometacarpal (CMC) joint osteoarthritis (OA).

Study Design and Methods: This will be a randomized controlled pilot study with 60 subjects
with CMC OA randomly divided in two groups. Thirty subjects will receive high-frequency PEMF
therapy overlying the CMC joint overnight daily for four weeks. The other 30 subjects will
receive a sham PEMF therapy device applied to the same joint overnight daily for four weeks.
Pain and function questionnaires will be obtained for all patients at enrollment, four weeks,
and six weeks.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 20, 2023</start_date>
<completion_date type="Anticipated">December 30, 2024</completion_date>
<primary_completion_date type="Anticipated">February 28, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Numeric Pain Rating Scale (NPRS)</measure>
<time_frame>4 weeks</time_frame>
<description>NPRS is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").</description>
</primary_outcome>
<secondary_outcome>
<measure>Numeric Pain Rating Scale (NPRS)</measure>
<time_frame>6 weeks</time_frame>
<description>NPRS is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").</description>
</secondary_outcome>
<secondary_outcome>
<measure>Patient-Rated Wrist/Hand Evaluation (PRWHE)</measure>
<time_frame>4 and 6 weeks</time_frame>
<description>PRWHE consists of 15 questions on symptoms with daily activities scored on a 11-point numeric scale, in which '0' represents no difficulty or pain. The total score is then scaled from '0' representing no disability to '100' representing most severe disability.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Single Assessment Numeric Evaluation (SANE)</measure>
<time_frame>4 and 6 weeks</time_frame>
<description>SANE is a single-question outcome measure that asks patient to rate their function of the treated area on a scale from '0' to '100' ("For the problem that you are seeking treatment for today, out of 100% (100% being normal), how would you rate the function of your RIGHT/LEFT thumb today?").</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">60</enrollment>
<condition>Thumb Osteoarthritis</condition>
<arm_group>
<arm_group_label>PEMF device</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Sham PEMF device</arm_group_label>
<arm_group_type>Sham Comparator</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>PEMF device</intervention_name>
<description>PEMF device wear overnight daily for four weeks</description>
<arm_group_label>PEMF device</arm_group_label>
<other_name>ActiPatch</other_name>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Sham PEMF device</intervention_name>
<description>Sham PEMF device wear overnight daily for four weeks. Sham PEMF devices do not emit a radiofrequency electromagnetic field but are otherwise identical in appearance to the PEMF device</description>
<arm_group_label>Sham PEMF device</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- an existing diagnosis of CMC OA by a hand specialist based on clinically (tenderness
to palpation at the CMC joint and/or positive CMC grind test) and/or radiographically
identified CMC OA

- reported pain intensity during activities of daily living less than 7 on the Numeric
Pain Rating Scale (NPRS)

Exclusion Criteria:

- pregnant

- unable to consent

- with current infection in hand or upper extremity

- have had prior fracture, significant hand injury, tenosynovitis, complex regional pain
syndrome, and/or Dupuytren's disease affecting the thumb

- history of surgical or procedural intervention for CMC OA in the hand of study
interest

- do not speak English

- have hand or wrist implants

- have heart or brain implants
</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>Raymond Chou, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Stanford University</affiliation>
</overall_official>
<overall_contact>
<last_name>Raymond Chou, MD</last_name>
<phone>(650) 723-5256</phone>
<email>aleary18@stanford.edu</email>
</overall_contact>
<overall_contact_backup>
<last_name>Deborah Kenney</last_name>
<email>dkenney@stanford.edu</email>
</overall_contact_backup>
<location>
<facility>
<name>Stanford Medicine Outpatient Center</name>
<address>
<city>Redwood City</city>
<state>California</state>
<zip>94063</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Raymond Chou, MD</last_name>
</contact>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>March 15, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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>Stanford University</investigator_affiliation>
<investigator_full_name>Raymond Chou</investigator_full_name>
<investigator_title>Clinical Assistant Professor of Orthopaedic Surgery</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Arthritis</mesh_term>
<mesh_term>Osteoarthritis</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Long-Term Objective: Determine if high-frequency PEMF therapy reduces pain in patients with
thumb carpometacarpal (CMC) joint osteoarthritis (OA).
Study Design and Methods: This will be a randomized controlled pilot study with 60 subjects
with CMC OA randomly divided in two groups. Thirty subjects will receive high-frequency PEMF
therapy overlying the CMC joint overnight daily for four weeks. The other 30 subjects will
receive a sham PEMF therapy device applied to the same joint overnight daily for four weeks.
Pain and function questionnaires will be obtained for all patients at enrollment, four weeks,
and six weeks.
Inclusion Criteria:
- an existing diagnosis of CMC OA by a hand specialist based on clinically (tenderness
to palpation at the CMC joint and/or positive CMC grind test) and/or radiographically
identified CMC OA
- reported pain intensity during activities of daily living less than 7 on the Numeric
Pain Rating Scale (NPRS)
Exclusion Criteria:
- pregnant
- unable to consent
- with current infection in hand or upper extremity
- have had prior fracture, significant hand injury, tenosynovitis, complex regional pain
syndrome, and/or Dupuytren's disease affecting the thumb
- history of surgical or procedural intervention for CMC OA in the hand of study
interest
- do not speak English
- have hand or wrist implants
- have heart or brain implants
|
NCT0531xxxx/NCT05315310.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/NCT05315310</url>
</required_header>
<id_info>
<org_study_id>5520-m</org_study_id>
<nct_id>NCT05315310</nct_id>
</id_info>
<brief_title>Robotic Exosuit Augmented Locomotion (REAL) in the Clinic and Community</brief_title>
<acronym>REAL-m</acronym>
<official_title>Robotic Exosuit Augmented Locomotion (REAL) in the Clinic and Community - a Mechanistic Clinical Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Boston University Charles River Campus</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Harvard University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Spaulding Rehabilitation Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Boston University Charles River Campus</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>
Previous studies of the exosuit technology have culminated in strong evidence for the
gait-restorative effects of soft robotic exosuits for patients post-stroke by means of
substitution for lost function. The present study builds on this work by suggesting that an
exosuit's immediate gait-restorative effects can be leveraged during high intensity gait
training to produce long-lasting gait restoration. Current gait training efforts are focused
on either quality or intensity. They focus on gait quality often by reducing the training
intensity to allow patients to achieve a more normal gait. In contrast, efforts focused on
training intensity push participants without focusing on the quality of their movements.
These intervention paradigms generally fail to substantially impact community mobility. In
this study, the investigators posit that exosuits can uniquely enable an integration of these
paradigms (ie, high intensity gait training that promotes quality of movements). For this
protocol, exosuits developed in collaboration with an industry partner, ReWalk™ Robotics will
be used. To evaluate the effects of REAL gait training, the investigators will use clinical
measures of motor and gait function, locomotor mechanics and energetics, and physiologic
measures that may infer on motor learning. The spectrum of behavioral and physiologic data
that we will collect will enable us to understand more comprehensively the gait-restorative
effects of REAL. This study is a single-arm mechanistic clinical trial that will examine
clinical and physiological factors that determine response to the intervention. This study
will assist in informing best candidates and outcomes for future randomized controlled
trials.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Weakness of the ankle plantarflexors after a stroke results in impaired forward propulsion
during walking, which consequently impacts walking efficiency and speed - parameters that are
necessary for community participation. Next-generation soft, wearable robots, known as soft
robotic exosuits, were developed to assist paretic ankle dorsiflexion during its swing phase
and paretic ankle plantarflexion during push off. Prior observational studies of the exosuit
technology have culminated in strong evidence of immediate gait-restorative effects for
patients post-stroke through improved forward propulsion, and faster and farther walking. The
investigators posit that gait training using exosuits will leverage these immediate
gait-restorative effects to facilitate gait training at higher intensities without
compromising gait quality. This type of training will facilitate lasting rehabilitative
effects that persist beyond the use of exosuit. Leveraging a systematic approach in the
staging of pilot studies toward larger clinical trials, this clinical validation was
initiated with a single-subject study design followed by a case series, which both provided
early evidence for the potential of gait training with exosuits in restoring propulsion and
speed. As a next step, the investigators seek to examine clinical and physiological factors
that determine response to the intervention to assist in informing best candidates and
outcomes for future randomized controlled trials.

The primary aim of the current study seeks to understand the rehabilitative effects of a
Robotic Exosuit Augmented Locomotion (REAL) gait training program on walking and propulsion
function after stroke. The investigators hypothesize that REAL training will result in
substantial gains in walking function that are achieved through improved propulsion function.

A secondary aim of this study is to evaluate single day changes in neuromuscular control
following REAL intervention, as measured by muscle synergies and the dynamic motor control
index. The investigators hypothesize that neuromuscular control will immediately improve
during powered use of a soft-robotic exosuit (i.e., immediate) and exosuit-induced
improvements in neuromuscular control will show continued improvement over a single session
of REAL gait training (i.e., adaptation), and persisting improvement to unassisted walking
after a single session of REAL gait training (i.e., retention). An additional secondary aim
is to identify neuromuscular predictors of training-related improvements in walking and
propulsion function. It is hypothesized that positive relationships will be observed between
single-day changes in neuromuscular control and training-induced improvements in walking and
propulsion function after 12 sessions of gait training. Moreover, the investigators
hypothesize that regardless of baseline walking speed, individuals with higher baseline
neuromuscular control will have the greatest training-induced improvements in propulsion and
walking function after 12 sessions of gait training.

For this protocol, exosuits developed in collaboration with an industry partner (ReWalk™
Robotics) will be used. To examine the effects of REAL gait training, the investigators will
use clinical measures of motor and gait function, locomotor mechanics, and physiologic
measures that may infer on motor learning. The spectrum of behavioral and physiologic data
that will be collected will enable a more comprehensive understanding of the gait-restorative
effects of REAL.

This study will be implemented by carrying out the following study visits: (1) Primary screen
over the phone, (2) Clinical screen & fit, (3) Exposure, (4) Pre-training evaluations, (5)
REAL Training (12 sessions) (6) Post-training evaluation, and (7) Retention evaluation. A
washout period up to 4 weeks will precede Retention evaluation.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 14, 2022</start_date>
<completion_date type="Anticipated">August 1, 2023</completion_date>
<primary_completion_date type="Anticipated">July 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>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>Single intervention arm</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>6-Minute Walk Test (6MWT)</measure>
<time_frame>Baseline (Pre-training Evaluation)</time_frame>
<description>This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test. This will be performed without wearing the soft exosuit (No Suit) regardless of intervention.</description>
</primary_outcome>
<primary_outcome>
<measure>6-Minute Walk Test (6MWT)</measure>
<time_frame>Post-training Evaluation (up to 6 weeks)</time_frame>
<description>This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test. This will be performed without wearing the soft exosuit (No Suit) regardless of intervention.</description>
</primary_outcome>
<primary_outcome>
<measure>6-Minute Walk Test (6MWT)</measure>
<time_frame>Retention Evaluation (up to 4 weeks post-washout)</time_frame>
<description>This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test. This will be performed without wearing the soft exosuit (No Suit) regardless of intervention.</description>
</primary_outcome>
<primary_outcome>
<measure>10-Meter Walk Test (10MWT)</measure>
<time_frame>Baseline (Pre-training Evaluation)</time_frame>
<description>This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.</description>
</primary_outcome>
<primary_outcome>
<measure>10-Meter Walk Test (10MWT)</measure>
<time_frame>Post-training Evaluation (up to 6 weeks)</time_frame>
<description>This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.</description>
</primary_outcome>
<primary_outcome>
<measure>10-Meter Walk Test (10MWT)</measure>
<time_frame>Retention Evaluation (up to 4 weeks post-washout)</time_frame>
<description>This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.</description>
</primary_outcome>
<primary_outcome>
<measure>Forward propulsion</measure>
<time_frame>Baseline (Pre-training Evaluation)</time_frame>
<description>Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.</description>
</primary_outcome>
<primary_outcome>
<measure>Forward propulsion</measure>
<time_frame>Post-training Evaluation (up to 6 weeks)</time_frame>
<description>Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.</description>
</primary_outcome>
<primary_outcome>
<measure>Forward propulsion</measure>
<time_frame>Retention Evaluation (up to 4 weeks post-washout)</time_frame>
<description>Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.</description>
</primary_outcome>
<secondary_outcome>
<measure>Muscle Synergies</measure>
<time_frame>Baseline (Pre-training Evaluation)</time_frame>
<description>Muscle synergies refers to the coordinated co-activation of muscles during walking. Electromyography data will be collected bilaterally from up to 12 lower-limb muscles during treadmill walking with and without the exosuit. The number, timing, and composition of muscle synergies will be calculated using standard non-negative matrix factorization techniques.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Dynamic Motor Control Index</measure>
<time_frame>Baseline (Pre-training Evaluation)</time_frame>
<description>The dynamic motor control index is a continuous summary metric of muscle co-activations during walking. Electromyography data will be collected bilaterally from up to 12 lower-limb muscles during treadmill walking with and without the exosuit. Using non-negative matrix factorization, the variability accounted for by the one-muscle synergy solution is converted into a z-score centered around 100. A value of 100 indicates neuromuscular control similar to neuro-typical adults and each 10-point deviation represents a difference of one-standard deviation from neuro-typical adults.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Fugl-Meyer Assessment - Lower Extremity Subsection</measure>
<time_frame>Baseline (Clinical Screening)</time_frame>
<description>The Fugl-Meyer Assessment is a multi-item Likert-type scale that evaluates motor recovery from hemiplegic stroke. Items are scored on a 3-point ordinal scale (0=cannot perform; 1=performs partially; 2=performs fully). The Lower Extremity Subsection has a total of 34 points, with higher score indicate of lesser impairment.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">25</enrollment>
<condition>Stroke</condition>
<arm_group>
<arm_group_label>REAL Training</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Robotic Exosuit Augmented Locomotion (REAL) refers to gait training with soft robotic exosuits, performed under a speed-based approach where participants are asked to walk at faster speeds in treadmill and overground environments. Cues and summary feedback emphasizing walking speed and forward propulsion are provided by the physical therapist to facilitate goal-directed walking practice. Training is progressively challenging based on environmental complexity and practice variability. REAL includes 12 training sessions, administered 2-3x/week. Each session includes 30 minutes of total walking time.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Soft Exosuit</intervention_name>
<description>A soft exosuit is a textile-based wearable robot that is worn on the paretic ankle. Soft exosuits provide assistive torques through retraction of Bowden cables that connect distally to anchor points on front and back of the ankle, assisting with dorsiflexion during swing for foot clearance, and plantarflexion during late stance to assist with propulsion, respectively. Exosuit assistance is provided synchronously based on the wearer's gait, as detected by integrated inertial measurement units.</description>
<arm_group_label>REAL Training</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Age 18 - 80 years old

- Stroke event occurred at least 6 months ago

- Observable gait deficits

- Gait speed equal to or less than 1 m/s

- Able to walk without the support of another person for at least 6 minutes (may use an
assistive device as needed, but without use of an ankle foot orthosis or brace)

- Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e.,
able to achieve an angle of 90 degrees between the shank and the foot)

- Resting heart rate between 40 - 100 bpm, inclusive

- Resting blood pressure between 90/60 and 170/90 mmHg, inclusive

Exclusion Criteria:

- Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale

- Inability to communicate with investigators

- Neglect or hemianopia

- Actively receiving physical therapy for walking

- History of cerebellar strokes

- Known recurring or repeating strokes

- Unexplained dizziness in the last 6 months

- Pressure ulcers or skin wounds located at human-device interface sites

- Other medical, orthopedic, and neurological conditions that prevent full participation
in the research
</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>Louis N Awad, PhD, PT</last_name>
<role>Principal Investigator</role>
<affiliation>Boston University</affiliation>
</overall_official>
<overall_contact>
<last_name>Franchino Porciuncula, EdD, PT</last_name>
<phone>617-500-3645</phone>
<email>fporciun@bu.edu</email>
</overall_contact>
<overall_contact_backup>
<last_name>Lillian Ribeirinha-Braga</last_name>
<phone>617-500-3645</phone>
<email>lcrbraga@bu.edu</email>
</overall_contact_backup>
<location>
<facility>
<name>Boston University</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02215</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Louis N Awad, PT, PhD</last_name>
<phone>617-500-3645</phone>
<email>lowawad@bu.edu</email>
</contact>
<contact_backup>
<last_name>Lillian Braga</last_name>
<phone>617-500-3645</phone>
<email>lcrbraga@bu.edu</email>
</contact_backup>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Awad LN, Bae J, Kudzia P, Long A, Hendron K, Holt KG, O'Donnell K, Ellis TD, Walsh CJ. Reducing Circumduction and Hip Hiking During Hemiparetic Walking Through Targeted Assistance of the Paretic Limb Using a Soft Robotic Exosuit. Am J Phys Med Rehabil. 2017 Oct;96(10 Suppl 1):S157-S164. doi: 10.1097/PHM.0000000000000800.</citation>
<PMID>28777105</PMID>
</reference>
<reference>
<citation>Awad LN, Bae J, O'Donnell K, De Rossi SMM, Hendron K, Sloot LH, Kudzia P, Allen S, Holt KG, Ellis TD, Walsh CJ. A soft robotic exosuit improves walking in patients after stroke. Sci Transl Med. 2017 Jul 26;9(400):eaai9084. doi: 10.1126/scitranslmed.aai9084.</citation>
<PMID>28747517</PMID>
</reference>
<reference>
<citation>Bae J, Awad LN, Long A, O'Donnell K, Hendron K, Holt KG, Ellis TD, Walsh CJ. Biomechanical mechanisms underlying exosuit-induced improvements in walking economy after stroke. J Exp Biol. 2018 Mar 7;221(Pt 5):jeb168815. doi: 10.1242/jeb.168815.</citation>
<PMID>29361587</PMID>
</reference>
<reference>
<citation>Ardestani MM, Kinnaird CR, Henderson CE, Hornby TG. Compensation or Recovery? Altered Kinetics and Neuromuscular Synergies Following High-Intensity Stepping Training Poststroke. Neurorehabil Neural Repair. 2019 Jan;33(1):47-58. doi: 10.1177/1545968318817825. Epub 2018 Dec 29.</citation>
<PMID>30595090</PMID>
</reference>
<reference>
<citation>Holleran CL, Straube DD, Kinnaird CR, Leddy AL, Hornby TG. Feasibility and potential efficacy of high-intensity stepping training in variable contexts in subacute and chronic stroke. Neurorehabil Neural Repair. 2014 Sep;28(7):643-51. doi: 10.1177/1545968314521001. Epub 2014 Feb 10.</citation>
<PMID>24515925</PMID>
</reference>
<reference>
<citation>Hesse S, Bertelt C, Jahnke MT, Schaffrin A, Baake P, Malezic M, Mauritz KH. Treadmill training with partial body weight support compared with physiotherapy in nonambulatory hemiparetic patients. Stroke. 1995 Jun;26(6):976-81. doi: 10.1161/01.str.26.6.976.</citation>
<PMID>7762049</PMID>
</reference>
<reference>
<citation>Paci M. Physiotherapy based on the Bobath concept for adults with post-stroke hemiplegia: a review of effectiveness studies. J Rehabil Med. 2003 Jan;35(1):2-7. doi: 10.1080/16501970306106.</citation>
<PMID>12610841</PMID>
</reference>
<reference>
<citation>Ardestani MM, Henderson CE, Hornby TG. Improved walking function in laboratory does not guarantee increased community walking in stroke survivors: Potential role of gait biomechanics. J Biomech. 2019 Jun 25;91:151-159. doi: 10.1016/j.jbiomech.2019.05.011. Epub 2019 May 17.</citation>
<PMID>31122660</PMID>
</reference>
<reference>
<citation>Roelker SA, Bowden MG, Kautz SA, Neptune RR. Paretic propulsion as a measure of walking performance and functional motor recovery post-stroke: A review. Gait Posture. 2019 Feb;68:6-14. doi: 10.1016/j.gaitpost.2018.10.027. Epub 2018 Oct 25.</citation>
<PMID>30408710</PMID>
</reference>
<reference>
<citation>Bowden MG, Balasubramanian CK, Neptune RR, Kautz SA. Anterior-posterior ground reaction forces as a measure of paretic leg contribution in hemiparetic walking. Stroke. 2006 Mar;37(3):872-6. doi: 10.1161/01.STR.0000204063.75779.8d. Epub 2006 Feb 2.</citation>
<PMID>16456121</PMID>
</reference>
<reference>
<citation>Bae J, Siviy C, Rouleau M, et al. A lightweight and efficient portable soft exosuit for paretic ankle assistance in walking after stroke. Proc - IEEE Int Conf Robot Autom. 2018:2820-2827. doi:10.1109/ICRA.2018.8461046</citation>
</reference>
<reference>
<citation>Awad LN, Bae J, O'Donnell K, et al. Soft exosuits increase walking speed and distance after stroke. In: International Symposium on Wearable Robotics and Rehabilitation (WeRob). Houston, TX: IEEE; 2; 2017.</citation>
</reference>
<reference>
<citation>Awad LN, Kudzia P, Revi DA, Ellis TD, Walsh CJ. Walking faster and farther with a soft robotic exosuit: Implications for post-stroke gait assistance and rehabilitation. IEEE Open J Eng Med Biol. 2020;1:108-115. doi: 10.1109/ojemb.2020.2984429. Epub 2020 Apr 2.</citation>
<PMID>33748765</PMID>
</reference>
<reference>
<citation>Dobkin BH. Progressive Staging of Pilot Studies to Improve Phase III Trials for Motor Interventions. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):197-206. doi: 10.1177/1545968309331863.</citation>
<PMID>19240197</PMID>
</reference>
<reference>
<citation>Porciuncula F, Baker TC, Arumukhom Revi D, et al. Soft robotic exosuits for targeted gait rehabilitation after stroke: A case study. Neurorehabil Neural Repair. 2019;33(12):1082-1083.</citation>
</reference>
<reference>
<citation>Porciuncula F, Arumukhom Revi D, Baker TC, et al. Speed-Based Gait Training with Soft Robotic Exosuits Improves Walking after Stroke: A Crossover Pilot Study. In: American Physical Therapy Association Combined Sections Meeting. ; 2021.</citation>
</reference>
<reference>
<citation>Porciuncula F, Baker TC, Arumukhom Revi D, Bae J, Sloutsky R, Ellis TD, Walsh CJ, Awad LN. Targeting Paretic Propulsion and Walking Speed With a Soft Robotic Exosuit: A Consideration-of-Concept Trial. Front Neurorobot. 2021 Jul 28;15:689577. doi: 10.3389/fnbot.2021.689577. eCollection 2021.</citation>
<PMID>34393750</PMID>
</reference>
<verification_date>March 2023</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 10, 2023</last_update_submitted>
<last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 13, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Exosuit</keyword>
<keyword>Soft Robotics</keyword>
<keyword>Wearable Robots</keyword>
<keyword>Gait Rehabilitation</keyword>
<keyword>Propulsion</keyword>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Previous studies of the exosuit technology have culminated in strong evidence for the
gait-restorative effects of soft robotic exosuits for patients post-stroke by means of
substitution for lost function. The present study builds on this work by suggesting that an
exosuit's immediate gait-restorative effects can be leveraged during high intensity gait
training to produce long-lasting gait restoration. Current gait training efforts are focused
on either quality or intensity. They focus on gait quality often by reducing the training
intensity to allow patients to achieve a more normal gait. In contrast, efforts focused on
training intensity push participants without focusing on the quality of their movements.
These intervention paradigms generally fail to substantially impact community mobility. In
this study, the investigators posit that exosuits can uniquely enable an integration of these
paradigms (ie, high intensity gait training that promotes quality of movements). For this
protocol, exosuits developed in collaboration with an industry partner, ReWalk™ Robotics will
be used. To evaluate the effects of REAL gait training, the investigators will use clinical
measures of motor and gait function, locomotor mechanics and energetics, and physiologic
measures that may infer on motor learning. The spectrum of behavioral and physiologic data
that we will collect will enable us to understand more comprehensively the gait-restorative
effects of REAL. This study is a single-arm mechanistic clinical trial that will examine
clinical and physiological factors that determine response to the intervention. This study
will assist in informing best candidates and outcomes for future randomized controlled
trials.
Weakness of the ankle plantarflexors after a stroke results in impaired forward propulsion
during walking, which consequently impacts walking efficiency and speed - parameters that are
necessary for community participation. Next-generation soft, wearable robots, known as soft
robotic exosuits, were developed to assist paretic ankle dorsiflexion during its swing phase
and paretic ankle plantarflexion during push off. Prior observational studies of the exosuit
technology have culminated in strong evidence of immediate gait-restorative effects for
patients post-stroke through improved forward propulsion, and faster and farther walking. The
investigators posit that gait training using exosuits will leverage these immediate
gait-restorative effects to facilitate gait training at higher intensities without
compromising gait quality. This type of training will facilitate lasting rehabilitative
effects that persist beyond the use of exosuit. Leveraging a systematic approach in the
staging of pilot studies toward larger clinical trials, this clinical validation was
initiated with a single-subject study design followed by a case series, which both provided
early evidence for the potential of gait training with exosuits in restoring propulsion and
speed. As a next step, the investigators seek to examine clinical and physiological factors
that determine response to the intervention to assist in informing best candidates and
outcomes for future randomized controlled trials.
The primary aim of the current study seeks to understand the rehabilitative effects of a
Robotic Exosuit Augmented Locomotion (REAL) gait training program on walking and propulsion
function after stroke. The investigators hypothesize that REAL training will result in
substantial gains in walking function that are achieved through improved propulsion function.
A secondary aim of this study is to evaluate single day changes in neuromuscular control
following REAL intervention, as measured by muscle synergies and the dynamic motor control
index. The investigators hypothesize that neuromuscular control will immediately improve
during powered use of a soft-robotic exosuit (i.e., immediate) and exosuit-induced
improvements in neuromuscular control will show continued improvement over a single session
of REAL gait training (i.e., adaptation), and persisting improvement to unassisted walking
after a single session of REAL gait training (i.e., retention). An additional secondary aim
is to identify neuromuscular predictors of training-related improvements in walking and
propulsion function. It is hypothesized that positive relationships will be observed between
single-day changes in neuromuscular control and training-induced improvements in walking and
propulsion function after 12 sessions of gait training. Moreover, the investigators
hypothesize that regardless of baseline walking speed, individuals with higher baseline
neuromuscular control will have the greatest training-induced improvements in propulsion and
walking function after 12 sessions of gait training.
For this protocol, exosuits developed in collaboration with an industry partner (ReWalk™
Robotics) will be used. To examine the effects of REAL gait training, the investigators will
use clinical measures of motor and gait function, locomotor mechanics, and physiologic
measures that may infer on motor learning. The spectrum of behavioral and physiologic data
that will be collected will enable a more comprehensive understanding of the gait-restorative
effects of REAL.
This study will be implemented by carrying out the following study visits: (1) Primary screen
over the phone, (2) Clinical screen & fit, (3) Exposure, (4) Pre-training evaluations, (5)
REAL Training (12 sessions) (6) Post-training evaluation, and (7) Retention evaluation. A
washout period up to 4 weeks will precede Retention evaluation.
Inclusion Criteria:
- Age 18 - 80 years old
- Stroke event occurred at least 6 months ago
- Observable gait deficits
- Gait speed equal to or less than 1 m/s
- Able to walk without the support of another person for at least 6 minutes (may use an
assistive device as needed, but without use of an ankle foot orthosis or brace)
- Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e.,
able to achieve an angle of 90 degrees between the shank and the foot)
- Resting heart rate between 40 - 100 bpm, inclusive
- Resting blood pressure between 90/60 and 170/90 mmHg, inclusive
Exclusion Criteria:
- Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
- Inability to communicate with investigators
- Neglect or hemianopia
- Actively receiving physical therapy for walking
- History of cerebellar strokes
- Known recurring or repeating strokes
- Unexplained dizziness in the last 6 months
- Pressure ulcers or skin wounds located at human-device interface sites
- Other medical, orthopedic, and neurological conditions that prevent full participation
in the research
|
NCT0531xxxx/NCT05315323.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/NCT05315323</url>
</required_header>
<id_info>
<org_study_id>D8851R00001</org_study_id>
<nct_id>NCT05315323</nct_id>
</id_info>
<brief_title>Clinical Use of EVUSHELD as Pre-exposure Prophylaxis in Real-world Setting in Gulf Cooperation Council Countries</brief_title>
<acronym>EVOLVE</acronym>
<official_title>Clinical Use of EVUSHELD as Pre-exposure Prophylaxis in Real-world Setting - A Multi-center Observational Prospective Study to Determine Utilization and Clinical Outcomes of EVUSHELD in Gulf Cooperation Council Countries</official_title>
<sponsors>
<lead_sponsor>
<agency>AstraZeneca</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>AstraZeneca</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>
Study on Clinical Use of EVUSHELD (AZD7442) as Pre-exposure Prophylaxis in the Real-world
Setting - A Multi-Centre Observational Prospective Study to Determine the Utilization and
Clinical Outcomes of EVUSHELD in Gulf Cooperation Council Countries
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Study on Clinical use of EVUSHELD (AZD7442) as pre-exposure prophylaxis in the Real-world
Setting Observational Prospective Study to determine the utilization and Clinical Outcomes of
EVUSHELD in GCC.

This will be a multi-country, multi-centre, single-arm, observational, prospective study
using primary data collection to describe the demographic and clinical characteristics of
patients who received the first dose of AZD7442 for the prevention of SARS-CoV-2 infection
causing symptomatic COVID-19 illness. The study will be conducted in the hospital/centers
that are authorized to administer AZD7442, agree to participate in the study, and wherein
investigators have access to all medical records (electronic/paper) for individual patients.
The physicians at the hospital/centers will make a decision to administer AZD7442 to patients
according to the local regulations (including the prescribing information) and such a
decision to use AZD7442 is independent of the study.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 23, 2022</start_date>
<completion_date type="Anticipated">June 30, 2024</completion_date>
<primary_completion_date type="Anticipated">June 30, 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>Demographics</measure>
<time_frame>12 month</time_frame>
<description>To describe the baseline demographic of individuals receiving AZD7442 for pre-exposure prophylaxis</description>
</primary_outcome>
<primary_outcome>
<measure>clinical characteristics</measure>
<time_frame>12 month</time_frame>
<description>To describe the clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis</description>
</primary_outcome>
<primary_outcome>
<measure>baseline and repeat administration</measure>
<time_frame>12 month</time_frame>
<description>To describe the baseline and repeat administration(s) of AZD7442 for prevention of SARS-CoV-2 infection</description>
</primary_outcome>
<secondary_outcome>
<measure>Incidence of SARS-CoV-2 infection</measure>
<time_frame>12 Month</time_frame>
<description>To describe the incidence of SARS-CoV-2 infection (asymptomatic or symptomatic), medically attended COVID-19, and COVID-19 related hospitalization and death up to 12 months after administration of AZD7442 for prevention of SARS-CoV-2 infection</description>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of all-cause hospitalization and mortality</measure>
<time_frame>12 Month</time_frame>
<description>To describe the incidence of all-cause hospitalization and mortality during the 12 months after administration of AZD7442 for prevention of SAR-CoV-2 infection</description>
</secondary_outcome>
<secondary_outcome>
<measure>COVID-19 risk behavior at time of AZD7442</measure>
<time_frame>12 Month</time_frame>
<description>To describe COVID-19 risk behavior at the time of AZD7442 injection and during the 12 months after first administration of AZD7442 for prevention of SARS-CoV-2 infection</description>
</secondary_outcome>
<secondary_outcome>
<measure>Describe health-related quality of life</measure>
<time_frame>12 Month</time_frame>
<description>To describe health-related quality of life (QoL) at the time of AZD7442 first injection and during the 12 months after first administration of AZD7442 for prevention of SARS-CoV-2 infection</description>
</secondary_outcome>
<secondary_outcome>
<measure>describe COVID-19-related healthcare resource utilization</measure>
<time_frame>12 Month</time_frame>
<description>To describe COVID-19-related healthcare resource utilization during the 12 months after first administration of AZD7442 for prevention of SARS-CoV-2 infection</description>
</secondary_outcome>
<other_outcome>
<measure>Describe the demographic and clinical characteristics</measure>
<time_frame>12 Month</time_frame>
<description>To describe the demographic and clinical characteristics of SARS-CoV-2 infection (asymptomatic or symptomatic), medically attended COVID-19, and COVID-19 related hospitalized cases occurring up to 12 months following AZD7442 first administration for prevention of SARS-CoV-2 infection in comparison to non-cases</description>
</other_outcome>
<other_outcome>
<measure>Describe the incidence of long COVID syndrome</measure>
<time_frame>12 Month</time_frame>
<description>To describe the incidence of long COVID syndrome following AZD7442 administration for prevention of SARS-CoV-2 infection</description>
</other_outcome>
<other_outcome>
<measure>Describe all-cause HCRU</measure>
<time_frame>12 Month</time_frame>
<description>To describe all-cause HCRU in the 12 months prior to and during the 12 months after AZD7442 first injection for prevention of SARS-CoV-2 infection</description>
</other_outcome>
<other_outcome>
<measure>Describe COVID-19-related work loss/school absenteeism</measure>
<time_frame>12 Month</time_frame>
<description>To describe COVID-19-related work loss/school absenteeism at baseline (last 6 months) and during the 12 months after first administration of AZD7442 for prevention of SARS-CoV-2 infection</description>
</other_outcome>
<enrollment type="Anticipated">2000</enrollment>
<condition>COVID-19</condition>
<eligibility>
<study_pop>
<textblock>
Participants included in this this study are all individuals who have received a AZD7442
first ever dose for the prevention of SARS-CoV-2 infection. In most countries this will be
primarily subjects aged 12+ years.
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Individuals receiving their first dose of AZD7442 for the prevention of SARS-CoV-2
infection within the 30 days prior to study enrolment.

- The ability or willingness to sign informed consent/assent forms

Exclusion Criteria:

- Patients currently participating in interventional clinical trials of SARS-CoV-2
vaccines, other SARS-CoV-2 prophylactic interventions, or COVID-19 treatments.

- Patients with an ongoing COVID-19 infection at the time of AZD7442 administration as
judged by the study physician.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>AstraZeneca Clinical Study Information Center</last_name>
<phone>1-877-240-9479</phone>
<email>information.center@astrazeneca.com</email>
</overall_contact>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Riyadh</city>
<country>Saudi Arabia</country>
</address>
</facility>
<status>Withdrawn</status>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Abu Dhabi</city>
<country>United Arab Emirates</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Sharjah</city>
<country>United Arab Emirates</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location_countries>
<country>Saudi Arabia</country>
<country>United Arab Emirates</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>June 13, 2023</last_update_submitted>
<last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 15, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>COVID-19</keyword>
<keyword>SARS-CoV-2</keyword>
<keyword>AZD7442</keyword>
<keyword>EVUSHELD</keyword>
<keyword>Real-world Setting</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>COVID-19</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ is accepting requests for IPD, but this does not mean all requests will be shared.</ipd_description>
<ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
<ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.
For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Url Preview for AstraZeneca Clinical Trials Website AstraZeneca Clinical Trials Website This web site provides clinical trial data, results and other information regarding clinical trials astrazenecagrouptrials.pharmacm.com</ipd_access_criteria>
<ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Study on Clinical Use of EVUSHELD (AZD7442) as Pre-exposure Prophylaxis in the Real-world
Setting - A Multi-Centre Observational Prospective Study to Determine the Utilization and
Clinical Outcomes of EVUSHELD in Gulf Cooperation Council Countries
Study on Clinical use of EVUSHELD (AZD7442) as pre-exposure prophylaxis in the Real-world
Setting Observational Prospective Study to determine the utilization and Clinical Outcomes of
EVUSHELD in GCC.
This will be a multi-country, multi-centre, single-arm, observational, prospective study
using primary data collection to describe the demographic and clinical characteristics of
patients who received the first dose of AZD7442 for the prevention of SARS-CoV-2 infection
causing symptomatic COVID-19 illness. The study will be conducted in the hospital/centers
that are authorized to administer AZD7442, agree to participate in the study, and wherein
investigators have access to all medical records (electronic/paper) for individual patients.
The physicians at the hospital/centers will make a decision to administer AZD7442 to patients
according to the local regulations (including the prescribing information) and such a
decision to use AZD7442 is independent of the study.
Participants included in this this study are all individuals who have received a AZD7442
first ever dose for the prevention of SARS-CoV-2 infection. In most countries this will be
primarily subjects aged 12+ years.
Inclusion Criteria:
- Individuals receiving their first dose of AZD7442 for the prevention of SARS-CoV-2
infection within the 30 days prior to study enrolment.
- The ability or willingness to sign informed consent/assent forms
Exclusion Criteria:
- Patients currently participating in interventional clinical trials of SARS-CoV-2
vaccines, other SARS-CoV-2 prophylactic interventions, or COVID-19 treatments.
- Patients with an ongoing COVID-19 infection at the time of AZD7442 administration as
judged by the study physician.
|
NCT0531xxxx/NCT05315336.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/NCT05315336</url>
</required_header>
<id_info>
<org_study_id>L-DEP, PD-1, HLH</org_study_id>
<nct_id>NCT05315336</nct_id>
</id_info>
<brief_title>L-DEP/DEP Regimen and PD-1 Antibody as a Treatment for Relapse/Refractory EBV-HLH</brief_title>
<official_title>L-DEP/DEP Regimen and PD-1 Antibody as a Treatment for Relapse/Refractory EBV Associated Hemophagocytic Lymphohistiocytosis (HLH)</official_title>
<sponsors>
<lead_sponsor>
<agency>Beijing Friendship Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Beijing Friendship 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>
This study aimed to investigate the efficacy and safety of L-DEP (L-Asparaginasum, liposomal
doxorubicin, etoposide and methylprednisolone) together with PD-1 antibody as an treatment
for relapse/refractory EBV associated hemophagocytic lymphohistiocytosis.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
PD-1 antibody added to the DEP regimen （with or without asparaginases） in EBV-HLH
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">June 1, 2022</start_date>
<completion_date type="Anticipated">June 1, 2026</completion_date>
<primary_completion_date type="Anticipated">June 1, 2025</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>All patients with R/R EBV- HLH receive DEP combine with PD-1 antibody as an treatment.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Evaluation of treatment response</measure>
<time_frame>Change from before and 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy</time_frame>
<description>The primary observed endpoint is the objective remission rate (ORR): cases that include complete remission (CR) and partial remission (PR).CR was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, and triglyceride; hemoglobin; neutrophil counts; platelet counts; and alanine aminotransferase (ALT). PR was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25 response was>1.5-fold decreased; ferritin and triglyceride decreased at least 25%; for patients with an initial neutrophil count of<0.5 ×109/L, a response was defined as an increase by at least 100% to>0.5× 109/L; for patients with a neutrophil count of 0.5 to 2.0 × 109/L, an increase by at least 100% to >2.0 × 109/L was considered a response; and for patients with ALT >400 U/L, response was defined as an ALT decrease of at least 50%.</description>
</primary_outcome>
<secondary_outcome>
<measure>EBV-DNA</measure>
<time_frame>Change from before and 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy</time_frame>
<description>Outcome of patients with EBV-HLH</description>
</secondary_outcome>
<secondary_outcome>
<measure>Survival</measure>
<time_frame>3 months after the intervention</time_frame>
<description>Outcome of patients with EBV-HLH</description>
</secondary_outcome>
<secondary_outcome>
<measure>Adverse events that are related to treatment</measure>
<time_frame>2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy</time_frame>
<description>Incidence of events that are related to treatment including myelosuppression, infection, bleeding and so on.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">50</enrollment>
<condition>Hemophagocytic Lymphohistiocytosis</condition>
<arm_group>
<arm_group_label>L-DEP and PD-1 antibody</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Doxorubicin (doxorubicin hydrochloride liposome injection) 25 mg/m2 day 1; etoposide 100 mg/m2 was administered day1; methylprednisolone 2mg/kg days 1 to 3,then 0.25mg/kg day 4 to 14; PD-1 antibody injection 200mg day 5; L-asparaginases 6000iu/m2 day2, day4. This regimen was repeated after 2 weeks.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>L-DEP and PD-1 antibody</intervention_name>
<description>Doxorubicin (doxorubicin hydrochloride liposome injection) 25 mg/m2 day 1; etoposide 100 mg/m2 was administered day1; methylprednisolone 2mg/kg days 1 to 3,then 0.25mg/kg day 4 to 14; PD-1 antibody injection 200mg day 5; L-asparaginases 6000iu/m2 day2, day4. This regimen was repeated after 2 weeks.</description>
<arm_group_label>L-DEP and PD-1 antibody</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria;patients were
diagnosed with EBV associated HLH (EBV-HLH).

2. EBV-DNA in peripheral blood or EBER in tissue were positive.

3. Treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at
least partial response

4. The patient is expected to be unable to undergo allogeneic hematopoietic stem cell
transplantation in the short term due to various reasons (physical status, economic
reasons, donor reasons, etc.)

5. The expected survival time is more than 1 month.

6. Age ≤ years old, gender is not limited.

7. Serum creatinine ≤ 1.5 times normal；After infusion, fibrinogen can be corrected to
≥0.6g/L.

8. Serum human immunodeficiency virus(HIV) antigen or antibody negative； Hepatitis C
virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is
negative；HBV copies less than 1E+03 copies/ml.

9. The left ventricular ejection fraction (LVEF) was normal.

10. No uncontrollable infection.

11. Contraception for both male or female.

12. Informed consent obtained.

Exclusion Criteria:

1. Allergic to doxorubicin and/or etoposide and/or PD-1 antibody Injection

2. Severe myocardial injury, myocardial enzymes CK, CK-MB increased more than 3 times ULN
(upper limit of normal)

3. Heart function above grade II (NYHA).

4. Thyroid dysfunction

5. Serious mental illness;

6. Active hemorrhage of internal organs

7. Previously received L-DEP regimen for HLH-targeted treatment, but the treatment was
ineffective or relapsed

8. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2

9. Participate in other clinical research at the same time.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>1 Year</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Zhao Wang</last_name>
<phone>86-010-63139862</phone>
<email>wangzhao@ccmu.edu.cn</email>
</overall_contact>
<location>
<facility>
<name>Beijing Friendship Hospital, Capital Medical University</name>
<address>
<city>Beijing</city>
<country>China</country>
</address>
</facility>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>April 19, 2022</last_update_submitted>
<last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 26, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
<investigator_full_name>Zhao Wang</investigator_full_name>
<investigator_title>Department of Hematology, Beijing Friendship Hospital</investigator_title>
</responsible_party>
<keyword>Hemophagocytic Lymphohistiocytosis</keyword>
<keyword>DEP</keyword>
<keyword>L-Asparaginasum</keyword>
<keyword>PD-1 antibody</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Lymphohistiocytosis, Hemophagocytic</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Antibodies</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study aimed to investigate the efficacy and safety of L-DEP (L-Asparaginasum, liposomal
doxorubicin, etoposide and methylprednisolone) together with PD-1 antibody as an treatment
for relapse/refractory EBV associated hemophagocytic lymphohistiocytosis.
PD-1 antibody added to the DEP regimen （with or without asparaginases） in EBV-HLH
Inclusion Criteria:
1. Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria;patients were
diagnosed with EBV associated HLH (EBV-HLH).
2. EBV-DNA in peripheral blood or EBER in tissue were positive.
3. Treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at
least partial response
4. The patient is expected to be unable to undergo allogeneic hematopoietic stem cell
transplantation in the short term due to various reasons (physical status, economic
reasons, donor reasons, etc.)
5. The expected survival time is more than 1 month.
6. Age ≤ years old, gender is not limited.
7. Serum creatinine ≤ 1.5 times normal；After infusion, fibrinogen can be corrected to
≥0.6g/L.
8. Serum human immunodeficiency virus(HIV) antigen or antibody negative； Hepatitis C
virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is
negative；HBV copies less than 1E+03 copies/ml.
9. The left ventricular ejection fraction (LVEF) was normal.
10. No uncontrollable infection.
11. Contraception for both male or female.
12. Informed consent obtained.
Exclusion Criteria:
1. Allergic to doxorubicin and/or etoposide and/or PD-1 antibody Injection
2. Severe myocardial injury, myocardial enzymes CK, CK-MB increased more than 3 times ULN
(upper limit of normal)
3. Heart function above grade II (NYHA).
4. Thyroid dysfunction
5. Serious mental illness;
6. Active hemorrhage of internal organs
7. Previously received L-DEP regimen for HLH-targeted treatment, but the treatment was
ineffective or relapsed
8. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2
9. Participate in other clinical research at the same time.
|
NCT0531xxxx/NCT05315349.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/NCT05315349</url>
</required_header>
<id_info>
<org_study_id>ARNOULD 2021</org_study_id>
<nct_id>NCT05315349</nct_id>
</id_info>
<brief_title>Retinal Microvascular Network and Coronary Revascularization Surgery at the Dijon University Hospital</brief_title>
<acronym>MRCC</acronym>
<official_title>Retinal Microvascular Network and Coronary Revascularization Surgery at the Dijon University Hospital: Pilot Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Centre Hospitalier Universitaire Dijon</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Centre Hospitalier Universitaire Dijon</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>
When coronary artery disease cannot be treated with medication, revascularization surgery can
be performed. Although there have been many advances in recent years, this surgery is still
associated with a high incidence of cardiovascular complications.

These complications are more frequent in patients with microscopic vessel damage. In clinical
practice, microvascular status is difficult to characterize. Several models have been
proposed, but they remain imprecise and are difficult to reproduce.

However, the study of the retinal microvascular network has recently emerged as a promising
model. It is simple, quick and non-invasive thanks to the use of photographs or CT scans of
the fundus (by optical coherence tomography angiography = OCT-A). Thus, the retinal
vasculature is very often presented as an in vivo access that provides a window into systemic
peripheral vasculature.

Despite the systematic assessment of cardiovascular risk by the usual risk factors (diabetes,
hypertension, sex, etc.), risk stratification remains imperfect in coronary revascularization
surgery and remains associated with a high incidence of complications, the most frequent
being acute kidney injury (AKI).

Preoperative screening for retinal microvascular data could improve surgical risk
stratification and better predict the potential occurrence of severe renal complications.
Patient management could thus tailored to avoid such complications.

The main objective of the study is to investigate, in patients scheduled for coronary
revascularization surgery with extracorporeal circulation, the discriminative capacity of
retinal vascular density to predict the occurrence of AKI within 7 days after surgery.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 7, 2022</start_date>
<completion_date type="Anticipated">August 2024</completion_date>
<primary_completion_date type="Anticipated">August 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>Acute Kidney Failure (AKI) rate based on the Kidney Disease Improving Global Outcomes (KDIGO) Criteria</measure>
<time_frame>7 days post-surgery</time_frame>
<description>Discriminative ability of mean retinal vascular density to predict acute kidney injury (defined by the KDIGO criteria) following coronary artery bypass grafting with extracorporeal circulation</description>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">120</enrollment>
<condition>Myocardial Revascularization Surgery With Extracorporeal Circulation</condition>
<arm_group>
<arm_group_label>Patient requiring cardiac surgery for myocardial revascularization</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Complete ophthalmological check-up</intervention_name>
<description>Preoperatively, 3 to 7 days after surgery and 1 to 2 months after surgery: fundus, optical coherence tomography angiography (OCT-A)</description>
<arm_group_label>Patient requiring cardiac surgery for myocardial revascularization</arm_group_label>
</intervention>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>Blood sampling</intervention_name>
<description>Preoperatively and on Day 1 of surgery: 6 tubes of approximately 5 ml each, i.e. 30 ml</description>
<arm_group_label>Patient requiring cardiac surgery for myocardial revascularization</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Adult patient who has given oral, free and informed consent

- Patient who is to undergo cardiac surgery for myocardial revascularization (coronary
bypass surgery) with extracorporeal circulation at the Dijon University Hospital

Exclusion Criteria:

- Patient not covered by national health insurance

- Patient subject to a measure of legal protection (curatorship, guardianship)

- Acute circulatory collapse prior to surgery (amine, inotrope, circulatory assistance)
preventing preoperative OCT-A

- Patient with macular disease (age-related macular degeneration, diabetic maculopathy,
vascular occlusion)

- Pregnant, parturient or breastfeeding women

- Adult unable to express 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_contact>
<last_name>Louis ARNOULD</last_name>
<phone>03.80.29.37.56</phone>
<email>louis.arnould@chu-dijon.fr</email>
</overall_contact>
<location>
<facility>
<name>Chu Dijon Bourgogne</name>
<address>
<city>Dijon</city>
<zip>21000</zip>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Louis ARNOULD</last_name>
<phone>03.80.29.37.56</phone>
<email>louis.arnould@chu-dijon.fr</email>
</contact>
</location>
<location_countries>
<country>France</country>
</location_countries>
<verification_date>June 2022</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>June 13, 2022</last_update_submitted>
<last_update_submitted_qc>June 13, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">June 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>
|
When coronary artery disease cannot be treated with medication, revascularization surgery can
be performed. Although there have been many advances in recent years, this surgery is still
associated with a high incidence of cardiovascular complications.
These complications are more frequent in patients with microscopic vessel damage. In clinical
practice, microvascular status is difficult to characterize. Several models have been
proposed, but they remain imprecise and are difficult to reproduce.
However, the study of the retinal microvascular network has recently emerged as a promising
model. It is simple, quick and non-invasive thanks to the use of photographs or CT scans of
the fundus (by optical coherence tomography angiography = OCT-A). Thus, the retinal
vasculature is very often presented as an in vivo access that provides a window into systemic
peripheral vasculature.
Despite the systematic assessment of cardiovascular risk by the usual risk factors (diabetes,
hypertension, sex, etc.), risk stratification remains imperfect in coronary revascularization
surgery and remains associated with a high incidence of complications, the most frequent
being acute kidney injury (AKI).
Preoperative screening for retinal microvascular data could improve surgical risk
stratification and better predict the potential occurrence of severe renal complications.
Patient management could thus tailored to avoid such complications.
The main objective of the study is to investigate, in patients scheduled for coronary
revascularization surgery with extracorporeal circulation, the discriminative capacity of
retinal vascular density to predict the occurrence of AKI within 7 days after surgery.
Inclusion Criteria:
- Adult patient who has given oral, free and informed consent
- Patient who is to undergo cardiac surgery for myocardial revascularization (coronary
bypass surgery) with extracorporeal circulation at the Dijon University Hospital
Exclusion Criteria:
- Patient not covered by national health insurance
- Patient subject to a measure of legal protection (curatorship, guardianship)
- Acute circulatory collapse prior to surgery (amine, inotrope, circulatory assistance)
preventing preoperative OCT-A
- Patient with macular disease (age-related macular degeneration, diabetic maculopathy,
vascular occlusion)
- Pregnant, parturient or breastfeeding women
- Adult unable to express consent
|
NCT0531xxxx/NCT05315362.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/NCT05315362</url>
</required_header>
<id_info>
<org_study_id>NL80101.058.22</org_study_id>
<nct_id>NCT05315362</nct_id>
</id_info>
<brief_title>Establishing Immunogenicity and Safety of Needle-free Intradermal Delivery of mRNA COVID-19 Vaccine</brief_title>
<acronym>MILESTONE</acronym>
<official_title>Establishing Immunogenicity and Safety of Needle-free Intradermal Delivery by Solid Micro Needle Skin Patch of mRNA SARS-CoV-2 Vaccine as a Revaccination Strategy in Healthy Volunteers</official_title>
<sponsors>
<lead_sponsor>
<agency>Leiden University Medical Center</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Leiden 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>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
COVID-19 vaccines are limited in supply, especially in low- and middle-income countries,
leading to substantial morbidity and mortality. Despite the COVID-19 Vaccines Global Access
(COVAX) Facility initiated by the WHO to provide vaccine access for low-income countries,
probably 80% of the vaccine needs of participating countries will not be met soon.

In addition, there is an increasing demand for revaccination of the population globally,
because of waning immunity which will further limit vaccine supplies. Exploring dose-sparing
techniques, could therefore provide the solution to immunise more people with the same
vaccine stockpile.

The intramuscular injection (IM) is the standard inoculation route of vaccines. However, the
skin (dermis) is much richer in antigen presenting dendritic cells than muscle. As a
consequence, a fractional vaccine dose introduced directly into the dermis (intradermal
administration, ID) might be as effective as the intramuscular administration of the full
standard dose to achieve a protective immune response. This principle has recently been
demonstrated for the ID dermal delivery of one-fifth fractional dose mRNA-1273 (Spikevax,
Moderna) vaccine.

However, needle-based immunisation has several limitations. Fear of needles makes
immunisation a stressful event. In addition, needle stick injuries, as well as unsafe
injection practices carry serious health risks. Therefore, the development of needle-free
delivery has been identified as an important goal in global health care. The WHO reported
that microneedle vaccine delivery is top priority and requires additional research to explore
the benefits in more detail. A big advantage of intradermal delivery via a solid needle patch
is not only the absence of needles and pain since no nerves are at the proximity where the
needles are presented, but also the local delivery close to immune cells as with the above
mentioned intradermal injection enables a much lower dose as compared to IM dosing. And since
with the patch a larger skin surface is involved as compared to intradermal injection, even
lower doses are possibly still immunogenic.

In this study, we will investigate the immunogenicity and safety in healthy volunteers of the
needle-free intradermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine
(Spikevax, Moderna) more than 3 months after primary vaccination with Comirnaty (Pfizer)
vaccine and/or after having contracted COVID-19.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Objectives Primary objective

- to describe immunogenicity and safety in healthy volunteers of the needle-free
intradermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine
(Spikevax, Moderna) more than 3 months after primary vaccination with Comirnaty (Pfizer)
vaccine and/or after have contracted COVID-19.

Secondary objectives

- to describe the kinetics of the SARS-CoV-2 anti-Spike1 (S1) and Region Binding Domain
(RBD) IgG binding antibodies elicited by needle-free intradermal or intramuscular
delivery of mRNA-1273 vaccine in healthy volunteers after a single fractional dose of
20µg mRNA-1273 LNP vaccine

- to describe the kinetics of the SARS-CoV-2 neutralising antibodies elicited by
needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine in healthy
volunteers after a single fractional dose of 20µg mRNA-1273 LNP vaccine

Exploratory objectives:

- to describe the kinetics of memory B-cell and plasma cell responses elicited by
needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine of a single
fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna)

- to describe the interferon-gamma release in whole blood in response to SARS-CoV 2
peptides after needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine of
a single fractional doses of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna)

Study design:

This is a Phase 2a, open-label, randomised-controlled, proof-of-concept vaccine study

Study population:

Healthy volunteers aged 18 - 40 years who have been vaccinated with Comirnaty (Pfizer)
vaccine at least 3 months before

Intervention group:

Participants will receive 20 µg of mRNA-1273 vaccine through the needle-free intradermal
route using a micro-needle delivery system.

Control group:

Participants will receive 20 µg of mRNA-1273 vaccine through the intramuscular route

Main study parameters/endpoints:

- Solicited local reactions and systemic events self-reported by diary on a daily basis
over a 2-week period, telephone interview on D4, as well as by on site visits on D15 and
D29

- Adverse events (AEs) until two weeks after administration

- Serious AEs (SAEs) until six months after administration

- Seroconversion for anti-spike IgG antibodies (D29)

- Geometric mean concentrations (GMC) for anti-spike IgG antibodies (D1, D29)
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Anticipated">May 1, 2022</start_date>
<completion_date type="Anticipated">May 1, 2023</completion_date>
<primary_completion_date type="Anticipated">September 1, 2022</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>open-label, randomised-controlled, proof-of-concept vaccine study</intervention_model_description>
<primary_purpose>Prevention</primary_purpose>
<masking>None (Open Label)</masking>
<masking_description>only laboratory personnel is masked. Because of the different administration routes it is not possible to mask the participants or investigators</masking_description>
</study_design_info>
<primary_outcome>
<measure>SARS-CoV-2-spike protein-specific binding IgG antibody levels</measure>
<time_frame>3 months</time_frame>
<description>SARS-CoV-2-spike protein-specific binding IgG antibody levels</description>
</primary_outcome>
<primary_outcome>
<measure>adverse events</measure>
<time_frame>1 month</time_frame>
<description>local and systemic reactions after intradermal vaccination with a solid microneedle patch</description>
</primary_outcome>
<secondary_outcome>
<measure>SARS CoV 2 neutralizing antibody levels</measure>
<time_frame>3 months</time_frame>
<description>SARS CoV 2 neutralizing antibody levels</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of Spike-protein specific proliferating B-cells, plasma cells and B-memory cells</measure>
<time_frame>6 months</time_frame>
<description>Number of Spike-protein specific proliferating B-cells, plasma cells and B-memory cells</description>
</secondary_outcome>
<secondary_outcome>
<measure>INF-gamma concentration and other cytokine responses after over-night incubation</measure>
<time_frame>3 months</time_frame>
<description>INF-gamma concentration and other cytokine responses after over-night incubation</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">20</enrollment>
<condition>Vaccination; Infection</condition>
<condition>COVID-19</condition>
<arm_group>
<arm_group_label>Intervention group - intradermal vaccination with patch</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive 20 µg of mRNA-1273 vaccine through the intradermal route using a solid micro needle delivery system</description>
</arm_group>
<arm_group>
<arm_group_label>Control group - intramuscular vaccination with standard needle</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Participants will receive 20 µg of mRNA-1273 vaccine through the intramuscular route</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>solid microneedle skin patch</intervention_name>
<description>intradermal vaccination with a skin patch</description>
<arm_group_label>Intervention group - intradermal vaccination with patch</arm_group_label>
</intervention>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>mRNA-1273</intervention_name>
<description>administration of mRNA-1273 vaccine</description>
<arm_group_label>Control group - intramuscular vaccination with standard needle</arm_group_label>
<arm_group_label>Intervention group - intradermal vaccination with patch</arm_group_label>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>standard needle</intervention_name>
<description>intramuscular vaccination with a standard needle</description>
<arm_group_label>Control group - intramuscular vaccination with standard needle</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Previously vaccinated with Comirnaty (Pfizer) and/or previously contracted COVID-19 at
least 3 months before inclusion

- Healthy participants who are determined by medical history and clinical judgment of
the investigator to be eligible for inclusion in the study. Healthy participants with
preexisting stable disease, defined as disease not requiring significant change in
therapy or hospitalisation for worsening disease during the 6 weeks before enrolment,
can be included.

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

- Participants are willing to postpone their regular COVID-19 revaccination upon
invitation by the municipal health center or general practitioner until four weeks
after receiving the intervention (after the last sampling of D29).

- Capable of giving personal signed informed consent as described in Appendix 1, which
includes compliance with the requirements and restrictions listed in the ICD and in
this protocol.

Exclusion Criteria:

- Other medical or psychiatric condition including recent (within the past year) or
active suicidal ideation/behaviour or laboratory abnormality that may increase the
risk of study participation or, in the investigator's judgment, make the participant
inappropriate for the study.

- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (e.g., anaphylaxis) to any component of the study intervention(s).

- Receipt of medications intended to prevent COVID-19.

- Previous microbiological diagnosis of COVID-19.

- Previous COVID-19 vaccination other than Comirnaty (Pfizer)

- Individuals at high risk for severe COVID-19 (e.g. BMI > 40, diabetes, heart- end/or
lung disease), who are planned to receive COVID vaccine within the next two months.

- Immunosuppressed individuals with known or suspected immunodeficiency, as determined
by history.

- Individuals with an active autoimmune disease requiring therapeutic intervention.

- Receipt of systemic or topical corticosteroids.

- Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection.

- Women who are pregnant or breastfeeding.

- Planned pregnancy within four weeks after injection.

- Positive serological test for SARS-CoV-2 anti-N IgM and/or IgG antibodies at screening
visit.

- SARS-CoV-2 PCR-positive mid-turbinate/throat swab at the screening before receipt of
the vaccine dose.

- Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation.

- Receipt of any other non-study vaccine within 28 days, before receipt of the study
dose.

- Anticipated receipt of any other non-study vaccine within 28 days, after the study
dose administration.
</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>
<overall_official>
<last_name>Anna H Roukens, MD PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Leiden University Medical Center</affiliation>
</overall_official>
<overall_contact>
<last_name>Anna H Roukens, MD PhD</last_name>
<phone>+31715262613</phone>
<email>a.h.e.roukens@lumc.nl</email>
</overall_contact>
<overall_contact_backup>
<last_name>Leo G Visser, MD PhD</last_name>
<phone>+31715262613</phone>
<email>l.g.visser@lumc.nl</email>
</overall_contact_backup>
<location>
<facility>
<name>Leiden University Medical Center</name>
<address>
<city>Leiden</city>
<zip>2333ZA</zip>
<country>Netherlands</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Anna H Roukens, MD, PhD</last_name>
<phone>+31715262613</phone>
<email>a.h.e.roukens@lumc.nl</email>
</contact>
<contact_backup>
<last_name>Leo G Visser, MD, PhD</last_name>
<phone>+31715262613</phone>
<email>l.g.visser@lumc.nl</email>
</contact_backup>
</location>
<location_countries>
<country>Netherlands</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>April 6, 2022</study_first_submitted>
<study_first_submitted_qc>April 6, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>April 14, 2022</last_update_submitted>
<last_update_submitted_qc>April 14, 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>Leiden University Medical Center</investigator_affiliation>
<investigator_full_name>aheroukens</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>COVID-19</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
COVID-19 vaccines are limited in supply, especially in low- and middle-income countries,
leading to substantial morbidity and mortality. Despite the COVID-19 Vaccines Global Access
(COVAX) Facility initiated by the WHO to provide vaccine access for low-income countries,
probably 80% of the vaccine needs of participating countries will not be met soon.
In addition, there is an increasing demand for revaccination of the population globally,
because of waning immunity which will further limit vaccine supplies. Exploring dose-sparing
techniques, could therefore provide the solution to immunise more people with the same
vaccine stockpile.
The intramuscular injection (IM) is the standard inoculation route of vaccines. However, the
skin (dermis) is much richer in antigen presenting dendritic cells than muscle. As a
consequence, a fractional vaccine dose introduced directly into the dermis (intradermal
administration, ID) might be as effective as the intramuscular administration of the full
standard dose to achieve a protective immune response. This principle has recently been
demonstrated for the ID dermal delivery of one-fifth fractional dose mRNA-1273 (Spikevax,
Moderna) vaccine.
However, needle-based immunisation has several limitations. Fear of needles makes
immunisation a stressful event. In addition, needle stick injuries, as well as unsafe
injection practices carry serious health risks. Therefore, the development of needle-free
delivery has been identified as an important goal in global health care. The WHO reported
that microneedle vaccine delivery is top priority and requires additional research to explore
the benefits in more detail. A big advantage of intradermal delivery via a solid needle patch
is not only the absence of needles and pain since no nerves are at the proximity where the
needles are presented, but also the local delivery close to immune cells as with the above
mentioned intradermal injection enables a much lower dose as compared to IM dosing. And since
with the patch a larger skin surface is involved as compared to intradermal injection, even
lower doses are possibly still immunogenic.
In this study, we will investigate the immunogenicity and safety in healthy volunteers of the
needle-free intradermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine
(Spikevax, Moderna) more than 3 months after primary vaccination with Comirnaty (Pfizer)
vaccine and/or after having contracted COVID-19.
Objectives Primary objective
- to describe immunogenicity and safety in healthy volunteers of the needle-free
intradermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine
(Spikevax, Moderna) more than 3 months after primary vaccination with Comirnaty (Pfizer)
vaccine and/or after have contracted COVID-19.
Secondary objectives
- to describe the kinetics of the SARS-CoV-2 anti-Spike1 (S1) and Region Binding Domain
(RBD) IgG binding antibodies elicited by needle-free intradermal or intramuscular
delivery of mRNA-1273 vaccine in healthy volunteers after a single fractional dose of
20µg mRNA-1273 LNP vaccine
- to describe the kinetics of the SARS-CoV-2 neutralising antibodies elicited by
needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine in healthy
volunteers after a single fractional dose of 20µg mRNA-1273 LNP vaccine
Exploratory objectives:
- to describe the kinetics of memory B-cell and plasma cell responses elicited by
needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine of a single
fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna)
- to describe the interferon-gamma release in whole blood in response to SARS-CoV 2
peptides after needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine of
a single fractional doses of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna)
Study design:
This is a Phase 2a, open-label, randomised-controlled, proof-of-concept vaccine study
Study population:
Healthy volunteers aged 18 - 40 years who have been vaccinated with Comirnaty (Pfizer)
vaccine at least 3 months before
Intervention group:
Participants will receive 20 µg of mRNA-1273 vaccine through the needle-free intradermal
route using a micro-needle delivery system.
Control group:
Participants will receive 20 µg of mRNA-1273 vaccine through the intramuscular route
Main study parameters/endpoints:
- Solicited local reactions and systemic events self-reported by diary on a daily basis
over a 2-week period, telephone interview on D4, as well as by on site visits on D15 and
D29
- Adverse events (AEs) until two weeks after administration
- Serious AEs (SAEs) until six months after administration
- Seroconversion for anti-spike IgG antibodies (D29)
- Geometric mean concentrations (GMC) for anti-spike IgG antibodies (D1, D29)
Inclusion Criteria:
- Previously vaccinated with Comirnaty (Pfizer) and/or previously contracted COVID-19 at
least 3 months before inclusion
- Healthy participants who are determined by medical history and clinical judgment of
the investigator to be eligible for inclusion in the study. Healthy participants with
preexisting stable disease, defined as disease not requiring significant change in
therapy or hospitalisation for worsening disease during the 6 weeks before enrolment,
can be included.
- Participants who are willing and able to comply with all scheduled visits, vaccination
plan, laboratory tests, lifestyle considerations, and other study procedures.
- Participants are willing to postpone their regular COVID-19 revaccination upon
invitation by the municipal health center or general practitioner until four weeks
after receiving the intervention (after the last sampling of D29).
- Capable of giving personal signed informed consent as described in Appendix 1, which
includes compliance with the requirements and restrictions listed in the ICD and in
this protocol.
Exclusion Criteria:
- Other medical or psychiatric condition including recent (within the past year) or
active suicidal ideation/behaviour or laboratory abnormality that may increase the
risk of study participation or, in the investigator's judgment, make the participant
inappropriate for the study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (e.g., anaphylaxis) to any component of the study intervention(s).
- Receipt of medications intended to prevent COVID-19.
- Previous microbiological diagnosis of COVID-19.
- Previous COVID-19 vaccination other than Comirnaty (Pfizer)
- Individuals at high risk for severe COVID-19 (e.g. BMI > 40, diabetes, heart- end/or
lung disease), who are planned to receive COVID vaccine within the next two months.
- Immunosuppressed individuals with known or suspected immunodeficiency, as determined
by history.
- Individuals with an active autoimmune disease requiring therapeutic intervention.
- Receipt of systemic or topical corticosteroids.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection.
- Women who are pregnant or breastfeeding.
- Planned pregnancy within four weeks after injection.
- Positive serological test for SARS-CoV-2 anti-N IgM and/or IgG antibodies at screening
visit.
- SARS-CoV-2 PCR-positive mid-turbinate/throat swab at the screening before receipt of
the vaccine dose.
- Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation.
- Receipt of any other non-study vaccine within 28 days, before receipt of the study
dose.
- Anticipated receipt of any other non-study vaccine within 28 days, after the study
dose administration.
|
NCT0531xxxx/NCT05315375.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/NCT05315375</url>
</required_header>
<id_info>
<org_study_id>vlift</org_study_id>
<nct_id>NCT05315375</nct_id>
</id_info>
<brief_title>Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages</brief_title>
<official_title>Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages: Comprehensive Long-term Follow-up Outcomes</official_title>
<sponsors>
<lead_sponsor>
<agency>Centre de l'arthrose, Paris</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Centre de l'arthrose, Paris</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>Yes</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
INTRODUCTION

The expandable cage technology is not new, but several questions remain under-studied. Among
them, there are the sagittal balance, the subsidence and the adjacent disc degeneration.
Moreover, assessment of the correction and kyphosis regardless of the physiological angles
can possibly lead to calculation bias.

The objective of this study was to assess the extent to which the functional outcomes were
correlated to the quality of the reduction, within a homogeneous series of lumbar vertebral
body reconstruction with expandable cages for trauma.

MATERIAL AND METHODS Twenty-seven patients with a mean follow-up of 3.9 years were
retrospectively analyzed. The Oswestry Disability Index (ODI) was the main outcome and its
association with other variables was sought. The local kyphosis and the regional traumatic
angle using Stagnara's physiological angles were measured. The lumbar lordosis (LL) was
compared to the Pelvic Incidence (PI). The subsidence of the cage and the adjacent disc
degeneration (using the UCLA grading score) were quantified. Bone quality was assessed
through the Hounsfield Unit of the vertebral body.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">January 2, 2010</start_date>
<completion_date type="Actual">March 30, 2022</completion_date>
<primary_completion_date type="Actual">December 31, 2017</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>Oswestry Disability Index (ODI)</measure>
<time_frame>4 years</time_frame>
<description>specific lumbar surgery score</description>
</primary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Actual">27</enrollment>
<condition>Disc Degeneration</condition>
<arm_group>
<arm_group_label>Corpectomy</arm_group_label>
<description>surgical procedure using expandable cage</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>corpectomy</intervention_name>
<description>vertebral corpectomy using expandable cage</description>
<arm_group_label>Corpectomy</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
All patients suffered from a traumatic lumbar fracture requiring a posterior fusion first
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- All patients suffered from a traumatic lumbar fracture requiring a posterior fusion
first

Exclusion Criteria:

-
</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>cedric maillot</last_name>
<role>Study Director</role>
<affiliation>APHP</affiliation>
</overall_official>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 30, 2022</last_update_submitted>
<last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 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>Intervertebral Disc Degeneration</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
The expandable cage technology is not new, but several questions remain under-studied. Among
them, there are the sagittal balance, the subsidence and the adjacent disc degeneration.
Moreover, assessment of the correction and kyphosis regardless of the physiological angles
can possibly lead to calculation bias.
The objective of this study was to assess the extent to which the functional outcomes were
correlated to the quality of the reduction, within a homogeneous series of lumbar vertebral
body reconstruction with expandable cages for trauma.
MATERIAL AND METHODS Twenty-seven patients with a mean follow-up of 3.9 years were
retrospectively analyzed. The Oswestry Disability Index (ODI) was the main outcome and its
association with other variables was sought. The local kyphosis and the regional traumatic
angle using Stagnara's physiological angles were measured. The lumbar lordosis (LL) was
compared to the Pelvic Incidence (PI). The subsidence of the cage and the adjacent disc
degeneration (using the UCLA grading score) were quantified. Bone quality was assessed
through the Hounsfield Unit of the vertebral body.
All patients suffered from a traumatic lumbar fracture requiring a posterior fusion first
Inclusion Criteria:
- All patients suffered from a traumatic lumbar fracture requiring a posterior fusion
first
Exclusion Criteria:
-
|
NCT0531xxxx/NCT05315388.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/NCT05315388</url>
</required_header>
<id_info>
<org_study_id>21-2021</org_study_id>
<nct_id>NCT05315388</nct_id>
</id_info>
<brief_title>Effects of "Vitamin N" Nature Immersion Therapy on Stress Levels in Health Care Workers in the City of Bogotá</brief_title>
<official_title>Effects of "Vitamin N" Nature Immersion Therapy on Stress Levels in Health Care Workers in the City of Bogotá: an Intervention Evaluation Study, 2022 - 2024.</official_title>
<sponsors>
<lead_sponsor>
<agency>Jeadran N. Malagón-Rojas</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Instituto Nacional de Salud, Colombia</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>
Recent studies on health personnel in Colombia have evidenced the considerable increase in
the levels of stress and anxiety, among other psychological disorders, as a product of the
COVID-19 pandemic that is being experienced since 2019 and that implies a greater demand for
attention from the affected citizens, with the consequent work overload and tension due to
the risk of contagion.

Thus, the present work will allow the generation of new knowledge in relation to the benefits
of Vitamin N therapy in Colombia; which can contribute quickly and effectively to the
reduction of stress levels, anxiety, insomnia, and depression in individuals, when compared
with conventional interventions and result in possible benefits such as the reduction of
health problems such as obesity, diabetes, high blood pressure, and diseases associated with
the immune system.
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">October 15, 2022</start_date>
<completion_date type="Anticipated">October 30, 2024</completion_date>
<primary_completion_date type="Anticipated">December 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>Parallel intervention evaluation study that will consider two interventions; the conscious immersion therapy in nature (Vitamin N) and the usual intervention designed by the company for psychosocial risk reduction.</intervention_model_description>
<primary_purpose>Prevention</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Concentration of Cortisol in saliva</measure>
<time_frame>1 time per month for 6 months</time_frame>
<description>Saliva samples from each subject will be obtained with the Salivette device during each day of the intervention.</description>
</primary_outcome>
<primary_outcome>
<measure>Outcome Measures in Arterial pressure levels</measure>
<time_frame>4 time per month for 6 months</time_frame>
<description>Blood pressure in mm Hg before and after surgery</description>
</primary_outcome>
<primary_outcome>
<measure>Outcome Measures in Heart rate levels</measure>
<time_frame>4 time per month for 6 months</time_frame>
<description>Determination by digital sphygmomanometers</description>
</primary_outcome>
<primary_outcome>
<measure>Change Psychological stress measurement scale levels</measure>
<time_frame>Three times for 6 months</time_frame>
<description>Determination of a score of the level of occupational stress through different</description>
</primary_outcome>
<secondary_outcome>
<measure>Natural Killer</measure>
<time_frame>1 time per month for 6 months</time_frame>
<description>Proportion of natural killer cells by flow cytometry.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Beck Anxiety Inventory levels</measure>
<time_frame>Three times for 6 months</time_frame>
<description>Determination of a score of the level of anxiety through different items taken into account in this instrument.</description>
</secondary_outcome>
<secondary_outcome>
<measure>NR3C1 and FKBP5 gene methylation.</measure>
<time_frame>Two times for 6 months</time_frame>
<description>Percentage of methylation of NR3C1 and FKBP5 genes.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Pittsburgh Sleep Quality levels</measure>
<time_frame>Three times for 6 months</time_frame>
<description>Determination of a sleep quality score through different items taken into account in this instrument.</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">118</enrollment>
<condition>Cortisol Excess</condition>
<condition>Stress, Psychological</condition>
<condition>Anxiety</condition>
<condition>Epigenetic Disorder</condition>
<condition>Natural Killer Cell Cytokine Production</condition>
<condition>Environmental Exposure</condition>
<arm_group>
<arm_group_label>Group 1. Regular therapy group</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Group without intervention during the study period no changes will be made in their daily routine. They will receive a weekly intervention operationalized for psychosocial risk.</description>
</arm_group>
<arm_group>
<arm_group_label>Group 2A: Vitamin N therapy group - metropolitan park environment</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Group with periodic outings to a neighborhood or metropolitan natural park (once a week) for approximately 2 hours for a minimum period of six months.</description>
</arm_group>
<arm_group>
<arm_group_label>Group 2B: Vitamin N therapy group - forest forest environment</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Group with periodic outings to a forest environment (once a week) for a time of approximately 2 hours for a minimum period of six months</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Immersion therapy in nature - Vitamin N</intervention_name>
<description>Usual therapy group The first saliva sample will be taken upon awakening to determine cortisol concentration. At their workplace, they will be asked to remain seated and silent for 3 minutes, the following will be taken: blood pressure, heart rate, psychological instruments (stress-anxiety), blood sample.
Group 2A and Group 2B In the natural environment, a saliva sample will be taken upon awakening to determine cortisol concentration. After arrival at the site, they will be asked to remain seated and silent for 3 minutes, the following will be taken: blood pressure, heart rate, psychological instruments (stress-anxiety), blood sample.
The first phase is a session of observation of the site for 15 minutes. A slow, unhurried walk will be performed for 1 hour and 45 minutes. The order of activities (sitting and walking) will be established to ensure reliability of physiological measurements.</description>
<arm_group_label>Group 2A: Vitamin N therapy group - metropolitan park environment</arm_group_label>
<arm_group_label>Group 2B: Vitamin N therapy group - forest forest environment</arm_group_label>
<other_name>Shinrin-yoku</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Persons over 18 years of age

- Health care workers

- Prioritized by the psychosocial risk program

- Complete vaccination schedule for COVID-19

Exclusion Criteria:

- Undergraduate students in the area of health sciences

- Pregnant women

- Allergies or sensitivity to the intervention

- Workers who consume immunosuppressants or corticosteroids

- Workers diagnosed with any type of disease or who have undergone chemotherapy or
radiotherapy treatment during the last year

- Persons who have had exposure to X-rays in the last 6 months
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>62 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Jeadran Malagon, MSc PhD (C)</last_name>
<phone>+57 2207720</phone>
<phone_ext>1216</phone_ext>
<email>jmalagon@ins.gov.co</email>
</overall_contact>
<overall_contact_backup>
<last_name>Diana Marcela Paredes Céspedes, MSc PhD</last_name>
<phone>+57 2207720</phone>
<phone_ext>1216</phone_ext>
<email>dianis910326@gmail.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Instituto Nacional de Salud</name>
<address>
<city>Bogotá</city>
<zip>111321</zip>
<country>Colombia</country>
</address>
</facility>
<contact>
<last_name>Jeadran Malagón, Msc PhD (c)</last_name>
<phone>+572007720</phone>
<phone_ext>1216</phone_ext>
<email>jmalagon@ins.gov.co</email>
</contact>
<investigator>
<last_name>Diana M Paredes Céspedes, Msc PhD</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Norida N Vélez Cuellar, Msc PhD</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Yesith Toloza, Basic</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Eliana Tellez, Lda</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Eliana Parra, Msc</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Julia Almentero, Lda</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location_countries>
<country>Colombia</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 18, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 29, 2022</last_update_submitted>
<last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>Instituto Nacional de Salud, Colombia</investigator_affiliation>
<investigator_full_name>Jeadran N. Malagón-Rojas</investigator_full_name>
<investigator_title>Coordinator, Grupo de Salud Ambiental Laboral, Principal Investigator, Medicine, Msc, PhD(c)</investigator_title>
</responsible_party>
<keyword>Forest therapy</keyword>
<keyword>Nature therapy</keyword>
<keyword>Cortisol</keyword>
<keyword>Psychological stress</keyword>
<keyword>Physiological stress</keyword>
<keyword>Anxiety</keyword>
<keyword>Blood pressure</keyword>
<keyword>Natural Killer</keyword>
<keyword>DNA Methylation</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cushing Syndrome</mesh_term>
<mesh_term>Stress, Psychological</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Vitamins</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Recent studies on health personnel in Colombia have evidenced the considerable increase in
the levels of stress and anxiety, among other psychological disorders, as a product of the
COVID-19 pandemic that is being experienced since 2019 and that implies a greater demand for
attention from the affected citizens, with the consequent work overload and tension due to
the risk of contagion.
Thus, the present work will allow the generation of new knowledge in relation to the benefits
of Vitamin N therapy in Colombia; which can contribute quickly and effectively to the
reduction of stress levels, anxiety, insomnia, and depression in individuals, when compared
with conventional interventions and result in possible benefits such as the reduction of
health problems such as obesity, diabetes, high blood pressure, and diseases associated with
the immune system.
Inclusion Criteria:
- Persons over 18 years of age
- Health care workers
- Prioritized by the psychosocial risk program
- Complete vaccination schedule for COVID-19
Exclusion Criteria:
- Undergraduate students in the area of health sciences
- Pregnant women
- Allergies or sensitivity to the intervention
- Workers who consume immunosuppressants or corticosteroids
- Workers diagnosed with any type of disease or who have undergone chemotherapy or
radiotherapy treatment during the last year
- Persons who have had exposure to X-rays in the last 6 months
|
NCT0531xxxx/NCT05315401.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/NCT05315401</url>
</required_header>
<id_info>
<org_study_id>JEP-2021-606</org_study_id>
<nct_id>NCT05315401</nct_id>
</id_info>
<brief_title>The Efficacy of Probiotic Compared With Placebo Commitment Therapy for Treatment of Major Depressive Disorder</brief_title>
<official_title>The Efficacy of Probiotic Compared With Placebo and Acceptance and Commitment Therapy for the Treatment of Major Depressive Disorder Among Adult Females</official_title>
<sponsors>
<lead_sponsor>
<agency>Min-Tze LIONG</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National University of Malaysia</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Universiti Sains Malaysia</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 evaluate the efficacy of oral administration of probiotic at
9 log CFU/day as adjunctive treatment in reducing the severity of depression in female
patients with major depressive disorder with treatment-as-usual compared to placebo and ACT
via the use of questionnaires.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
1. To assess the differences in quality of life among patients on probiotic, placebo and
ACT via the use of questionnaire, at 4 timelines (baseline, 6 weeks after starting
intervention, 12 weeks after starting intervention, and 24 weeks after starting
intervention which is 12 weeks post-termination of intervention).

2. To assess the differences in blood biological markers such as BDNF, TNF-α, IL-6, IL-1β,
CRP, and VEGF among patients on probiotic, placebo and ACT via blood biochemical
analyses, at 4 timelines (baseline, 6 weeks after starting intervention, 12 weeks after
starting intervention, and 24 weeks after starting intervention which is 12 weeks
post-termination of intervention).

3. To assess the differences in gut microbiota profiles of patients on probiotic, placebo
and ACT via the use of fecal samples, at 3 timelines (baseline, 12 weeks after starting
intervention, and 24 weeks after starting intervention which is 12 weeks
post-termination of intervention).
</textblock>
</detailed_description>
<overall_status>Withdrawn</overall_status>
<why_stopped>
Fail to recruit
</why_stopped>
<start_date type="Actual">October 1, 2021</start_date>
<completion_date type="Actual">December 31, 2022</completion_date>
<primary_completion_date type="Actual">December 31, 2022</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>A double-blind three-armed randomized controlled trial design has been chosen. Randomization for the parallel prevention phase will be carried out after checking the inclusion and exclusion criteria</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Triple (Participant, Care Provider, Investigator)</masking>
<masking_description>. The randomization will be performed by the study statistician, who had no contact with the patients and not involve in the research project. The allocation sequence will not be available to any member of the research team until databases had been completed and locked. Since this is a double-blinded study, both the research team and subject will not know in which group the subject is assigned to.</masking_description>
</study_design_info>
<primary_outcome>
<measure>differences in severity of depression in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.</measure>
<time_frame>24 weeks</time_frame>
<description>To evaluate differences in severity of depression via the use of the Montgomery and Åsberg (MADRS) Depression Rating Scale questionnaire containing 10-items on a 7-point scale with higher scores indicating more severe depression</description>
</primary_outcome>
<secondary_outcome>
<measure>differences in quality of life in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.</measure>
<time_frame>24 weeks</time_frame>
<description>To evaluate differences in quality of life via the use of the RAND-36 questionnaire containing 36-items on a varying point scale including some items with reverse scoring, with higher scores indicating better health status.</description>
</secondary_outcome>
<secondary_outcome>
<measure>differences in blood depression biomarkers in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.</measure>
<time_frame>24 weeks</time_frame>
<description>To evaluate differences in depression blood biological markers such as BDNF, TNF-α, IL-6, IL-1β, CRP, and VEGF via measuring concentrations using commercially available ELISA kit.</description>
</secondary_outcome>
<secondary_outcome>
<measure>differences in gut microbiota profiles of patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.</measure>
<time_frame>24 weeks</time_frame>
<description>To evaluate differences in gut microbiota profiles via microbiota profiling using DNA of fecal samples amplified for bacterial 16S rRNA and analyzed for high-throughput community sequencing.</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Actual">0</enrollment>
<condition>Major Depressive Disorder</condition>
<arm_group>
<arm_group_label>Probiotic 9 log CFU/day</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The intervention consists of daily administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic.</description>
</arm_group>
<arm_group>
<arm_group_label>Placebo</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>placebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as a light-yellow powder.</description>
</arm_group>
<arm_group>
<arm_group_label>Acceptance and commitment therapy (ACT)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients will be provided with ACT for 12 weeks with treatment as usual. The ACT intervention will be conducted in a group of 10 for each session. The ACT modules covered over 12 sessions, 1 hour in each session. The sessions will be held every week</description>
</arm_group>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Probiotic</intervention_name>
<description>This project aims to evaluate the efficacy of oral administration of probiotic at 9 log CFU/day as adjunctive treatment in reducing the severity depression in female patients with major depressive disorder with treatment-as-usual compared to placebo and ACT via use of questionnaires.</description>
<arm_group_label>Probiotic 9 log CFU/day</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>This project aims to evaluate the efficacy of oral administration of probiotic at 9 log CFU/day as adjunctive treatment in reducing the severity depression in female patients with major depressive disorder with treatment-as-usual compared to placebo and ACT via use of questionnaires.</description>
<arm_group_label>Placebo</arm_group_label>
</intervention>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Acceptance and commitment therapy (ACT)</intervention_name>
<description>Patients will be provided with ACT for 12 weeks with treatment as usual. The ACT intervention will be conducted in a group of 10 for each session. The ACT modules covered over 12 sessions, 1 hour in each session. The sessions will be held every week.</description>
<arm_group_label>Acceptance and commitment therapy (ACT)</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Female patient diagnosed with major depressive disorder (confirmed by DSM-5 for
depression). There is a strong gender predisposition in depression and anxiety
disorders, in which females are more prone to have depressive disorders and anxiety
disorders than males. Hence, we will only recruit female patients in this study to
control for confounding bias.

- Those with score of more than 8 based on Hamilton Depression Rating Scale (HAMD),
indicative of mild to moderate severity of depressive symptoms.

- Age 18 to 35 years old

Exclusion Criteria:

- Pregnant women

- Those who have current and lifetime history of engaging in any psychotherapy

- Those who consumed alcohol and illicit drugs (Heavy or mild)

- Those who has current and lifetime history of other psychiatric illnesses, such as
other depressive disorders (persistent depressive disorder, premenstrual dysphoric
disorder), anxiety disorders (panic disorder, agoraphobia, generalized anxiety
disorder, specific anxiety disorder, and social anxiety disorder), psychotic disorders
(schizophrenia, schizophreniform disorder, schizoaffective disorders, brief psychotic
disorder, and delusional disorder), bipolar mood disorder, obsessive compulsive
disorder, posttraumatic stress disorder, and attention deficit hyperactive disorder,
and autism spectrum disorder

- Those who are on medications that can induce psychiatric symptoms, such as
cardiovascular agents (clonidine, guanethidine, methyldopa, reserpine, beta blockers),
dermatologic agents (isotretinoin), anticonvulsants (levetiracetam), antimigraine
medications (triptans), hormonal agents (corticosteroids, oral contraceptives,
gonadotropin-releasing hormone agonists, tamoxifen), varenicline, immunological agents
(interferons), and levodopa

- Severe gastritis with regular intake omeprazole medication (proton pump inhibitors)

- Women on regular steroid treatment

- Those on long term medication for any illnesses (≥ 6 months)

- Those who are currently on antibiotics or with history of taking antibiotic for the
past 2 weeks.

- Those with abnormal full blood count, renal profile, liver function test, fasting
blood glucose, fasting lipid profile and ESR (blood collection for all these blood
investigations will be carried out in the pre-intervention assessment).

- Patient who has suicidal tendency
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>35 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Min Tze Liong, Prof.Dr</last_name>
<role>Study Director</role>
<affiliation>School of Industrial Technology, University of Science Malaysia</affiliation>
</overall_official>
<overall_official>
<last_name>Luke Woon Sy-Cherng, Dr</last_name>
<role>Principal Investigator</role>
<affiliation>Department of Psychiatry Hospital Canselor Tuanku Muhriz UKM medical Centre</affiliation>
</overall_official>
<location>
<facility>
<name>Hospital Canselor Tuanku Muhriz UKM Medical Centre</name>
<address>
<city>Cheras</city>
<state>Kuala Lumpur</state>
<zip>56000</zip>
<country>Malaysia</country>
</address>
</facility>
</location>
<location_countries>
<country>Malaysia</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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 10, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>Universiti Sains Malaysia</investigator_affiliation>
<investigator_full_name>Min-Tze LIONG</investigator_full_name>
<investigator_title>Professor.Dr</investigator_title>
</responsible_party>
<keyword>Probiotics</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Depressive Disorder</mesh_term>
<mesh_term>Depression</mesh_term>
<mesh_term>Depressive Disorder, Major</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 efficacy of oral administration of probiotic at
9 log CFU/day as adjunctive treatment in reducing the severity of depression in female
patients with major depressive disorder with treatment-as-usual compared to placebo and ACT
via the use of questionnaires.
1. To assess the differences in quality of life among patients on probiotic, placebo and
ACT via the use of questionnaire, at 4 timelines (baseline, 6 weeks after starting
intervention, 12 weeks after starting intervention, and 24 weeks after starting
intervention which is 12 weeks post-termination of intervention).
2. To assess the differences in blood biological markers such as BDNF, TNF-α, IL-6, IL-1β,
CRP, and VEGF among patients on probiotic, placebo and ACT via blood biochemical
analyses, at 4 timelines (baseline, 6 weeks after starting intervention, 12 weeks after
starting intervention, and 24 weeks after starting intervention which is 12 weeks
post-termination of intervention).
3. To assess the differences in gut microbiota profiles of patients on probiotic, placebo
and ACT via the use of fecal samples, at 3 timelines (baseline, 12 weeks after starting
intervention, and 24 weeks after starting intervention which is 12 weeks
post-termination of intervention).
Inclusion Criteria:
- Female patient diagnosed with major depressive disorder (confirmed by DSM-5 for
depression). There is a strong gender predisposition in depression and anxiety
disorders, in which females are more prone to have depressive disorders and anxiety
disorders than males. Hence, we will only recruit female patients in this study to
control for confounding bias.
- Those with score of more than 8 based on Hamilton Depression Rating Scale (HAMD),
indicative of mild to moderate severity of depressive symptoms.
- Age 18 to 35 years old
Exclusion Criteria:
- Pregnant women
- Those who have current and lifetime history of engaging in any psychotherapy
- Those who consumed alcohol and illicit drugs (Heavy or mild)
- Those who has current and lifetime history of other psychiatric illnesses, such as
other depressive disorders (persistent depressive disorder, premenstrual dysphoric
disorder), anxiety disorders (panic disorder, agoraphobia, generalized anxiety
disorder, specific anxiety disorder, and social anxiety disorder), psychotic disorders
(schizophrenia, schizophreniform disorder, schizoaffective disorders, brief psychotic
disorder, and delusional disorder), bipolar mood disorder, obsessive compulsive
disorder, posttraumatic stress disorder, and attention deficit hyperactive disorder,
and autism spectrum disorder
- Those who are on medications that can induce psychiatric symptoms, such as
cardiovascular agents (clonidine, guanethidine, methyldopa, reserpine, beta blockers),
dermatologic agents (isotretinoin), anticonvulsants (levetiracetam), antimigraine
medications (triptans), hormonal agents (corticosteroids, oral contraceptives,
gonadotropin-releasing hormone agonists, tamoxifen), varenicline, immunological agents
(interferons), and levodopa
- Severe gastritis with regular intake omeprazole medication (proton pump inhibitors)
- Women on regular steroid treatment
- Those on long term medication for any illnesses (≥ 6 months)
- Those who are currently on antibiotics or with history of taking antibiotic for the
past 2 weeks.
- Those with abnormal full blood count, renal profile, liver function test, fasting
blood glucose, fasting lipid profile and ESR (blood collection for all these blood
investigations will be carried out in the pre-intervention assessment).
- Patient who has suicidal tendency
|
NCT0531xxxx/NCT05315414.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/NCT05315414</url>
</required_header>
<id_info>
<org_study_id>C-PT-21-001</org_study_id>
<nct_id>NCT05315414</nct_id>
<nct_alias>NCT05387421</nct_alias>
</id_info>
<brief_title>Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations</brief_title>
<official_title>An Open, Prospective, Multicenter Investigation to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Extraction Sockets and Healed Ridges - A 5 Year Follow-up</official_title>
<sponsors>
<lead_sponsor>
<agency>Dentsply Sirona Implants and Consumables</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Dentsply Sirona Implants and Consumables</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 evaluate the clinical outcome of implant survival of the
PrimeTaper EV implant in single tooth restorations 1 year after permanent restoration.
</textblock>
</brief_summary>
<overall_status>Active, not recruiting</overall_status>
<start_date type="Actual">May 3, 2022</start_date>
<completion_date type="Anticipated">May 2028</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>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Implant survival, i.e. number of implants in place counted clinically, 1 year after permanent restoration.</measure>
<time_frame>One year post permanent restoration (anticipated average 3 months after implant placement).</time_frame>
<description>Implant survival rate is a binary variable evaluated clinically, i.e. 'Yes' or 'No' where 'Yes' means that the implant is still in place and 'No' means that the implant is not in place. Any implant that has been removed or lost after implant placement visit will be considered a failure, whatever the reason for removal/loss.</description>
</primary_outcome>
<secondary_outcome>
<measure>Implant survival, i.e. number of implants in place counted clinically, 2, 3, 4 and 5 years after permanent restoration.</measure>
<time_frame>2, 3, 4 and 5 years post permanent restoration (anticipated average 3 months after implant placement).</time_frame>
<description>Implant survival rate is a binary variable evaluated clinically, i.e. 'Yes' or 'No' where 'Yes' means that the implant is still in place and 'No' means that the implant is not in place. Any implant that has been removed or lost after implant placement visit will be considered a failure, whatever the reason for removal/loss.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of implant stability quotient value (ISQ) between implant placement and permanent restoration.</measure>
<time_frame>From date of implant placement (anticipated average 1 month after inclusion) to date of permanent restoration (anticipated average 3 months after implant placement).</time_frame>
<description>Implant stability will be evaluated through ISQ value using Resonance Frequency Analysis (RFA). The stability is presented as an ISQ value. The higher the ISQ value the higher the stability. Recorded as a numeric value (1-100).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Maximum insertion torque value for each implant at implant placement.</measure>
<time_frame>At date of implant placement (anticipated average 1 month after inclusion).</time_frame>
<description>Maximum insertion torque value (ITV), based on ITV curve, measured in Ncm.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Final insertion torque value for each implant at implant placement.</measure>
<time_frame>At date of implant placement (anticipated average 1 month after inclusion).</time_frame>
<description>Final insertion torque value (ITV), based on ITV curve, measured in Ncm.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Investigator questionnaire for each investigational medical device after implant placement.</measure>
<time_frame>Immediately after implant placement (anticipated average 1 month after inclusion).</time_frame>
<description>Numerical scale 1-10, where 1 = totally disagree with the statement, and 10 = totally agree with the statement. Statements to be evaluated by the surgeon: "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy", "The implant has a good primary stability", "The drilling protocol is easy to use", "The implant has efficient cutting properties". Each statement will be evaluated separately.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Implant success, i.e., number of implants documented as successful at 1, 2, 3 and 5 years after permanent restoration.</measure>
<time_frame>1, 2, 3 and 5 years post permanent restoration (anticipated average 3 months after implant placement).</time_frame>
<description>Successful implants counted, i.e. 'Yes' or 'No'. An implant will be considered successful if all of the following criteria are fulfilled:
Implant in place.
Lack of evidence of peri-implant radiolucency in X-ray.
Less than 1mm vertical bone loss during first year after loading with permanent restoration and 0,2mm annually thereafter.
Absence of persistent and/or irreversible signs and symptoms such as pain, infections, neuropathies, paresthesia, or violation of the mandibular canal.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of marginal bone level up to 5 years post permanent restoration compared to permanent restoration.</measure>
<time_frame>At permanent restoration (anticipated average 3 months after implant placement) and 1, 2, 3 and 5 years post permanent restoration.</time_frame>
<description>MBL changes determined from radiographs, expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. The average will be calculated and compared for each evaluation period.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of probing pocket depth (PPD) in mm between permanent restoration, and 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.</measure>
<time_frame>At permanent restoration (anticipated average 3 months after implant placement) and 6 months, 1, 2, 3, 4 and 5 years post permanent restoration.</time_frame>
<description>Probing Pocket Depth (PPD) measured as the distance from the mucosal margin to the bottom of the probe-able pocket in mm.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Presence of bleeding on probing (BoP), at permanent restoration, and 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.</measure>
<time_frame>At permanent restoration (anticipated average 3 months after implant placement) and 6 months, 1, 2, 3, 4 and 5 years post permanent restoration.</time_frame>
<description>Bleeding on Probing (BoP) recorded as presence or absence of bleeding when probing to the bottom of the pocket.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Presence of plaque at 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.</measure>
<time_frame>6 months, 1, 2, 3, 4 and 5 years post permanent restoration (anticipated average 3 months after implant placement).</time_frame>
<description>Plaque recorded as presence or absence of plaque by visual inspection on four surfaces at each implant site.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation.</measure>
<time_frame>Up to 5 years after permanent restoration (anticipated average 3 months after implant placement).</time_frame>
<description>Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">144</enrollment>
<condition>Jaw, Edentulous, Partially</condition>
<arm_group>
<arm_group_label>Single tooth restorations</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>A single, open-label group with patients in need of single tooth restorations will receive PrimeTaper EV implant system with diameters 3.6, 4.2, 4.8, 5.4 mm, and lengths 6.5, 8, 9, 11, 13, 15 and 17 mm.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>PrimeTaper EV implant</intervention_name>
<description>Tapered dental implant developed by Dentsply Sirona</description>
<arm_group_label>Single tooth restorations</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Adult aged 18-75 years.

- Willing and able to sign and date the informed consent form.

- In need of an implant in position 16 to 26 or 36 to 46, and each subject can only
receive one implant.

- Deemed by the investigator as likely to present with an initially stable implant
situation.

- A stable occlusion, i.e. an opposing natural dentition, a crown, an implant-supported
fixed or removable prosthesis, a partial removable prosthesis or a full denture.

- An adjacent tooth (root with natural or artificial crown) or an implant-supported
crown mesially and distally. Exemption: If the planned implant is in the first molar
position, an edentulous space is accepted distally

Exclusion Criteria:

- Not willing to participate in the clinical investigation or not able to understand the
content of the clinical investigation.

- Unlikely to be able to comply with clinical investigation procedures according to
investigator's judgement.

- Unable or unwilling to return for follow-up visits for a period of 5 years.

- Known allergy or hypersensitivity to titanium and/or stainless steel.

- Uncontrolled pathological process in the oral cavity, e.g. untreated rampant caries
and uncontrolled periodontal disease.

- Uncontrolled para-functional habits, e.g. bruxism.

- Current need of any Guided Bone Regeneration (GBR) procedure in the planned implant
area (gap filling at immediate placement and soft tissue grafting are allowed).

- Systemic or local disease or condition that would compromise post-operative healing
and/ or osseointegration.

- Immunosuppression, use of corticosteroids, per-os or intravenous bisphosphonate use,
or any other medication such as anti-resorptive therapy or monoclonal antibodies that
could compromise post-operative healing and/or osseointegration.

- Any other condition that would make the subject unsuitable for participation,
including but not limited to;

- History of radiation therapy in the head and neck region.

- History of chemotherapy within 5 years prior to surgery.

- Present alcohol and/or drug abuse.

- Ongoing psychiatric illness.

- Current smoking/use of tobacco, including e-cigarettes.

- Any ongoing disease that would make the subject unsuitable for participation,
including but not limited to;

- Recent myocardial infarction (< 3 months*).

- Recent cerebrovascular accident (< 3 months*).

- Recent cardiac-valvular prosthesis placement (< 3 months*).

- Hemorrhagic diathesis.

- Severe liver dysfunction.

- Known or suspected current malignancy.

- Uncontrolled diabetes mellitus.

- Florid infection.

- Pregnant or breastfeeding females. (Pregnancy tests will be performed as per local
requirements).

- Previous enrolment in the present clinical investigation.

- Involvement in the planning and conduct of the clinical investigation (applies to both
Dentsply Sirona staff and the clinical investigation site).

- Simultaneous participation in another clinical investigation, or participation in a
clinical investigation during the last 6 months that may interfere with the present
clinical investigation.

- < 3 months is a strict exclusion criterion. After 3 month it is up to the
investigator to judge whether the subject is considered suitable for
participation or not.
</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>Andy Temmerman, Prof.</last_name>
<role>Principal Investigator</role>
<affiliation>KU Leuven</affiliation>
</overall_official>
<location>
<facility>
<name>University of Iowa</name>
<address>
<city>Iowa City</city>
<state>Iowa</state>
<zip>52242-1010</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Catholic University of Leuven</name>
<address>
<city>Leuven</city>
<zip>B-3000</zip>
<country>Belgium</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Dental practice Dr Mischa Krebs</name>
<address>
<city>Alzey</city>
<zip>DE-55232</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Studio Toia</name>
<address>
<city>Busto Arsizio</city>
<zip>IT-21052</zip>
<country>Italy</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Dr.F.L.Guljé, De Mondhoek</name>
<address>
<city>Apeldoorn</city>
<zip>7315CA</zip>
<country>Netherlands</country>
</address>
</facility>
</location>
<location_countries>
<country>Belgium</country>
<country>Germany</country>
<country>Italy</country>
<country>Netherlands</country>
<country>United States</country>
</location_countries>
<verification_date>August 2023</verification_date>
<study_first_submitted>March 16, 2022</study_first_submitted>
<study_first_submitted_qc>April 6, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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>Jaw, Edentulous</mesh_term>
<mesh_term>Jaw, Edentulous, Partially</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to evaluate the clinical outcome of implant survival of the
PrimeTaper EV implant in single tooth restorations 1 year after permanent restoration.
Inclusion Criteria:
- Adult aged 18-75 years.
- Willing and able to sign and date the informed consent form.
- In need of an implant in position 16 to 26 or 36 to 46, and each subject can only
receive one implant.
- Deemed by the investigator as likely to present with an initially stable implant
situation.
- A stable occlusion, i.e. an opposing natural dentition, a crown, an implant-supported
fixed or removable prosthesis, a partial removable prosthesis or a full denture.
- An adjacent tooth (root with natural or artificial crown) or an implant-supported
crown mesially and distally. Exemption: If the planned implant is in the first molar
position, an edentulous space is accepted distally
Exclusion Criteria:
- Not willing to participate in the clinical investigation or not able to understand the
content of the clinical investigation.
- Unlikely to be able to comply with clinical investigation procedures according to
investigator's judgement.
- Unable or unwilling to return for follow-up visits for a period of 5 years.
- Known allergy or hypersensitivity to titanium and/or stainless steel.
- Uncontrolled pathological process in the oral cavity, e.g. untreated rampant caries
and uncontrolled periodontal disease.
- Uncontrolled para-functional habits, e.g. bruxism.
- Current need of any Guided Bone Regeneration (GBR) procedure in the planned implant
area (gap filling at immediate placement and soft tissue grafting are allowed).
- Systemic or local disease or condition that would compromise post-operative healing
and/ or osseointegration.
- Immunosuppression, use of corticosteroids, per-os or intravenous bisphosphonate use,
or any other medication such as anti-resorptive therapy or monoclonal antibodies that
could compromise post-operative healing and/or osseointegration.
- Any other condition that would make the subject unsuitable for participation,
including but not limited to;
- History of radiation therapy in the head and neck region.
- History of chemotherapy within 5 years prior to surgery.
- Present alcohol and/or drug abuse.
- Ongoing psychiatric illness.
- Current smoking/use of tobacco, including e-cigarettes.
- Any ongoing disease that would make the subject unsuitable for participation,
including but not limited to;
- Recent myocardial infarction (< 3 months*).
- Recent cerebrovascular accident (< 3 months*).
- Recent cardiac-valvular prosthesis placement (< 3 months*).
- Hemorrhagic diathesis.
- Severe liver dysfunction.
- Known or suspected current malignancy.
- Uncontrolled diabetes mellitus.
- Florid infection.
- Pregnant or breastfeeding females. (Pregnancy tests will be performed as per local
requirements).
- Previous enrolment in the present clinical investigation.
- Involvement in the planning and conduct of the clinical investigation (applies to both
Dentsply Sirona staff and the clinical investigation site).
- Simultaneous participation in another clinical investigation, or participation in a
clinical investigation during the last 6 months that may interfere with the present
clinical investigation.
- < 3 months is a strict exclusion criterion. After 3 month it is up to the
investigator to judge whether the subject is considered suitable for
participation or not.
|
NCT0531xxxx/NCT05315427.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/NCT05315427</url>
</required_header>
<id_info>
<org_study_id>PROICM 2021-10 OMS</org_study_id>
<secondary_id>2021-A02020-41</secondary_id>
<nct_id>NCT05315427</nct_id>
</id_info>
<brief_title>Impact of Music Therapy on Pain in Patients Treated for Advanced Cancer</brief_title>
<acronym>MSPD</acronym>
<official_title>Impact of Music Therapy on Pain in Patients Treated for Advanced Cancer</official_title>
<sponsors>
<lead_sponsor>
<agency>Institut du Cancer de Montpellier - Val d'Aurelle</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Institut du Cancer de Montpellier - Val d'Aurelle</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 is to assess the impact of music therapy on the pain of patients cared
at the Montpellier Cancer Institute (ICM) for advanced cancer in a palliative situation and
requiring full hospitalization or on an outpatient basis.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Music therapy is a care practice that falls within the field of support, help and
accompaniment therapies. Sound, musical and music are the means used to support, maintain or
improve a person's physical and mental health.

The patients involved in the study are patients cared at the ICM for advanced cancer in a
palliative situation and requiring full hospitalization or on an outpatient basis.

The aim is to assess the impact of music therapy on the pain of these patients. The patient
is proposed to participate in a music therapy session. Before this session, the music
therapist will assess the pain and the presence of symptoms with the patient.

Following this exchange, she will define the device best suited to his expectations and his
needs and will propose his a relaxation session induced by music.

After the session the music therapist will assess with the patient the pain and the presence
of symptoms.

The patient's feelings and satisfaction about this music therapy session as well as his
possible wish to participate in another session will also be evaluated.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">May 2, 2022</start_date>
<completion_date type="Actual">January 5, 2023</completion_date>
<primary_completion_date type="Actual">January 5, 2023</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Crossover</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Change between before and after music therapy session on patients pain</measure>
<time_frame>at day 1 (before and after the music therapy session)</time_frame>
<description>Evolution of pain assessed by a numerical pain scale ranging from 0 to 10 (10 indicating the highest degree of pain)</description>
</primary_outcome>
<secondary_outcome>
<measure>Description of symptom management</measure>
<time_frame>at day 1 (before and after the music therapy session)</time_frame>
<description>By the Edmonton Symptom Assessment System scale symptom score. This is a self-assessment scale of the most common symptoms in palliative care:pain, dyspnoea, fatigue, drowsiness, appetite, anxiety, depression, well-being and other possible symptoms. It's a numerical scale ranging from 0 to 10 (with higher scores indicating more severe symptoms).
The Edmonton Symptom Assessment System scale allows to:
Detect the symptoms present, quantify them and follow their evolution
Validate with the patient the symptoms that bother him and that he wishes to be treated as a priority
Communicate quickly between the different professionals involved in the treatment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Patient wishing a second session of music therapy</measure>
<time_frame>at day 1 (after the music therapy session)</time_frame>
<description>Proportion of Patient wishing a second session of music therapy</description>
</secondary_outcome>
<secondary_outcome>
<measure>Patient satisfaction of the music therapy session</measure>
<time_frame>at day 1 (after the music therapy session)</time_frame>
<description>Assessment of the satisfaction of the music therapy session. Assessment made by a numerical scale ranging from 0 to 10 (10 indicating high satisfaction)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Agreement to participate in the study</measure>
<time_frame>at inclusion</time_frame>
<description>Proportion of patients agreeing to participate among the eligible patients to whom the study was proposed</description>
</secondary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Actual">41</enrollment>
<condition>Advanced Cancer</condition>
<arm_group>
<arm_group_label>Evaluation of the impact of music therapy on the pain of patients</arm_group_label>
<description>One music therapy session</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>one music therapy session</intervention_name>
<description>Edmonton Symptom Assessment System (ESAS) scale (before and after music therapy session), Numerical pain scale (before and after music therapy session)</description>
<arm_group_label>Evaluation of the impact of music therapy on the pain of patients</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
The 40 patients will be included among the patients cared at the ICM for advanced cancer in
a palliative situation and requiring full hospitalization or on an outpatient basis.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Male/female over 18 years old

- Patient cared for at the ICM for advanced cancer followed by the Mobile Palliative
and/or Pain Care Team

- Patient with pain score >= 3 (cancer related)

- Patient who accepts a music therapy session

- Patient having expressed his oral non-opposition

- Patient able to communicate

- Patient affiliated to the French Social Security System.

Exclusion Criteria:

- Patient with uncorrected hearing loss to normal

- Patient under guardianship, curatorship or safeguard of justice
</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>Caroline GALLAY</last_name>
<role>Study Chair</role>
<affiliation>Institut du Cancer de Montpellier</affiliation>
</overall_official>
<location>
<facility>
<name>Institut du Cancer de Montpellier</name>
<address>
<city>Montpellier</city>
<zip>34298</zip>
<country>France</country>
</address>
</facility>
</location>
<location_countries>
<country>France</country>
</location_countries>
<reference>
<citation>Siedliecki SL, Good M. Effect of music on power, pain, depression and disability. J Adv Nurs. 2006 Jun;54(5):553-62. doi: 10.1111/j.1365-2648.2006.03860.x.</citation>
<PMID>16722953</PMID>
</reference>
<reference>
<citation>Beck SL. The therapeutic use of music for cancer-related pain. Oncol Nurs Forum. 1991 Nov-Dec;18(8):1327-37.</citation>
<PMID>1762973</PMID>
</reference>
<reference>
<citation>Huang ST, Good M, Zauszniewski JA. The effectiveness of music in relieving pain in cancer patients: a randomized controlled trial. Int J Nurs Stud. 2010 Nov;47(11):1354-62. doi: 10.1016/j.ijnurstu.2010.03.008. Epub 2010 Apr 18.</citation>
<PMID>20403600</PMID>
</reference>
<reference>
<citation>Krishnaswamy P, Nair S. Effect of Music Therapy on Pain and Anxiety Levels of Cancer Patients: A Pilot Study. Indian J Palliat Care. 2016 Jul-Sep;22(3):307-11. doi: 10.4103/0973-1075.185042.</citation>
<PMID>27559260</PMID>
</reference>
<reference>
<citation>Alcantara-Silva TR, de Freitas-Junior R, Freitas NMA, de Paula Junior W, da Silva DJ, Machado GDP, Ribeiro MKA, Carneiro JP, Soares LR. Music Therapy Reduces Radiotherapy-Induced Fatigue in Patients With Breast or Gynecological Cancer: A Randomized Trial. Integr Cancer Ther. 2018 Sep;17(3):628-635. doi: 10.1177/1534735418757349. Epub 2018 Apr 10.</citation>
<PMID>29633652</PMID>
</reference>
<reference>
<citation>Boyde C, Linden U, Boehm K, Ostermann T. The Use of Music Therapy During the Treatment of Cancer Patients: A Collection of Evidence. Glob Adv Health Med. 2012 Nov;1(5):24-9. doi: 10.7453/gahmj.2012.1.5.009. Epub 2012 Nov 1.</citation>
<PMID>27257528</PMID>
</reference>
<reference>
<citation>Bradt J, Dileo C, Magill L, Teague A. Music interventions for improving psychological and physical outcomes in cancer patients. Cochrane Database Syst Rev. 2016 Aug 15;(8):CD006911. doi: 10.1002/14651858.CD006911.pub3.</citation>
<PMID>27524661</PMID>
</reference>
<reference>
<citation>Lesiuk T. The Development of a Mindfulness-Based Music Therapy (MBMT) Program for Women Receiving Adjuvant Chemotherapy for Breast Cancer. Healthcare (Basel). 2016 Aug 9;4(3):53. doi: 10.3390/healthcare4030053.</citation>
<PMID>27517966</PMID>
</reference>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 17, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>February 15, 2023</last_update_submitted>
<last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 16, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>music therapy</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>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 this study is to assess the impact of music therapy on the pain of patients cared
at the Montpellier Cancer Institute (ICM) for advanced cancer in a palliative situation and
requiring full hospitalization or on an outpatient basis.
Music therapy is a care practice that falls within the field of support, help and
accompaniment therapies. Sound, musical and music are the means used to support, maintain or
improve a person's physical and mental health.
The patients involved in the study are patients cared at the ICM for advanced cancer in a
palliative situation and requiring full hospitalization or on an outpatient basis.
The aim is to assess the impact of music therapy on the pain of these patients. The patient
is proposed to participate in a music therapy session. Before this session, the music
therapist will assess the pain and the presence of symptoms with the patient.
Following this exchange, she will define the device best suited to his expectations and his
needs and will propose his a relaxation session induced by music.
After the session the music therapist will assess with the patient the pain and the presence
of symptoms.
The patient's feelings and satisfaction about this music therapy session as well as his
possible wish to participate in another session will also be evaluated.
The 40 patients will be included among the patients cared at the ICM for advanced cancer in
a palliative situation and requiring full hospitalization or on an outpatient basis.
Inclusion Criteria:
- Male/female over 18 years old
- Patient cared for at the ICM for advanced cancer followed by the Mobile Palliative
and/or Pain Care Team
- Patient with pain score >= 3 (cancer related)
- Patient who accepts a music therapy session
- Patient having expressed his oral non-opposition
- Patient able to communicate
- Patient affiliated to the French Social Security System.
Exclusion Criteria:
- Patient with uncorrected hearing loss to normal
- Patient under guardianship, curatorship or safeguard of justice
|
NCT0531xxxx/NCT05315440.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/NCT05315440</url>
</required_header>
<id_info>
<org_study_id>0002771</org_study_id>
<nct_id>NCT05315440</nct_id>
</id_info>
<brief_title>The Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Range of Motion After Arthroscopic Cuff Repair.</brief_title>
<acronym>GRA-RCR</acronym>
<official_title>The Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Shoulder Range of Motion After Arthroscopic Cuff Repair.</official_title>
<sponsors>
<lead_sponsor>
<agency>Istituto Ortopedico Rizzoli</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Istituto Ortopedico Rizzoli</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 shoulder rehabilitation after arthroscopic cuff repair, one of first objectives coincides
with improving the range of passive movement: this process often requires considerable time
of both patients and physiotherapists. This study aims to verify whether it is useful to add
instruments assisted soft-tissue mobilization according to Graston Tecnique to the classic
rehabilitation protocol in order to accelerate recovery times of passive range of motion.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
There is conflicting evidence about early versus delayed postoperative rehabilitation after
arthroscopic cuff repair: early protocol seems to reduce the risk of stiffness but could
increase the risk of rupture of the tendon in long time, especially for large tears; delayed
protocol impose a period of shoulder immobilization (from 2 weeks to 40-day) that can promote
tendons healing but could determine shoulder stiffness. Our research question is if after the
delayed protocol used in our institute (40 -day immobilization period) it migh be useful to
add soft-tissue mobilization assisted by instruments according to Graston Tecnique to the
classic rehabilitation protocol of the shoulder in order to speed up recovery times of the
passive movement range.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">November 12, 2020</start_date>
<completion_date type="Anticipated">February 29, 2024</completion_date>
<primary_completion_date type="Anticipated">February 29, 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>Single (Outcomes Assessor)</masking>
<masking_description>outcome assessor doesn't know allocation concealment</masking_description>
</study_design_info>
<primary_outcome>
<measure>Passive Range of Motion Recovery of the Shoulder</measure>
<time_frame>after 2 weeks of treatment</time_frame>
<description>Passive Range of Motion Recovery of the Shoulder in elevation and abduction measured by digital inclinometer</description>
</primary_outcome>
<secondary_outcome>
<measure>Reduction of pain measured by Visual Analogue Scale (VAS)</measure>
<time_frame>after 2 weeks of treatment</time_frame>
<description>The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 ("no pain") and 10 ("worst pain").</description>
</secondary_outcome>
<secondary_outcome>
<measure>Shoulder function improvement measured by Constant Murley and Dash scales</measure>
<time_frame>after 2 weeks of treatment</time_frame>
<description>The Constant-Murley score is a 100-points scale composed of a number of individual parameters that define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into 4 subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion (40 points). The higher the score, the higher the quality of the function. Since the test is carried out in an acute post-surgery phase, it is not possible to carry out the evaluation of strength, which is assigned a score of zero for all patients. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.The score ranges from 0 (no disability) to 100 (most severe disability).</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">70</enrollment>
<condition>Cuff Tear Arthropathy</condition>
<arm_group>
<arm_group_label>control group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>The treatment of control group will be organized according to the classic protocol currently in use in our Institute which consists of:
30 minutes of passive and active assisted mobilization guided by the therapist, 30 min of Continous passive movement in flexion and abduction and 30 minutes of electrostimulation.</description>
</arm_group>
<arm_group>
<arm_group_label>experimental group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>30 minutes of passive and active assisted mobilization guided by the therapist associated with instrument assisted soft tissue mobilization, 30 min of Continous passive movement in flexion and abduction and 30 minutes of electrostimulation.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>graston tecnique</intervention_name>
<description>Graston technique involves the use of steel tools that are used non-invasively on the skin to identify and treat areas that have stiffness or inflammation. These areas can be located with greater precision than the manual technique precisely because the instruments do not compress in contact with the patient's skin, as is the case with the physiotherapist's fingertips. Thanks to the instruments it is therefore possible to detect the areas of altered consistency and to treat them by pressing a minimum pressure.</description>
<arm_group_label>experimental group</arm_group_label>
<other_name>instrument soft tissue mobilization</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Conventional rehabilitation</intervention_name>
<description>30 minutes of passive and active assisted mobilization guided by the therapist, 30 min of Continous passive movement in flexion and abduction and 30 minutes of electrostimulation.</description>
<arm_group_label>control group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- arthroscopic rotator cuff repair

- partial lesion due to tendon degeneration (1 or 2 anchors reparation)

Exclusion Criteria:

- traumatic tendon lesions

- associated conditions as arthritis, loss of superficial sensitivity, loss of muscle
tone, mental impairment, oncological conditions

- shoulder stiffness before surgery due to calcific tendonitis, adhesive capsulitis
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>40 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Angela Gallo</last_name>
<phone>3337489277</phone>
<email>angelagallo87@gmail.com</email>
</overall_contact>
<location>
<facility>
<name>Istituto Ortopedico Rizzoli</name>
<address>
<city>Bologna</city>
<state>BO</state>
<zip>40136</zip>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location_countries>
<country>Italy</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>September 14, 2021</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>May 16, 2023</last_update_submitted>
<last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 17, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Istituto Ortopedico Rizzoli</investigator_affiliation>
<investigator_full_name>Angela</investigator_full_name>
<investigator_title>physiotherapist</investigator_title>
</responsible_party>
<keyword>shoulder rehabilitation</keyword>
<keyword>range of motion</keyword>
<keyword>rotator cuff repair</keyword>
<keyword>instrument assisted soft tissue mobilitation</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Rotator Cuff Tear Arthropathy</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
In shoulder rehabilitation after arthroscopic cuff repair, one of first objectives coincides
with improving the range of passive movement: this process often requires considerable time
of both patients and physiotherapists. This study aims to verify whether it is useful to add
instruments assisted soft-tissue mobilization according to Graston Tecnique to the classic
rehabilitation protocol in order to accelerate recovery times of passive range of motion.
There is conflicting evidence about early versus delayed postoperative rehabilitation after
arthroscopic cuff repair: early protocol seems to reduce the risk of stiffness but could
increase the risk of rupture of the tendon in long time, especially for large tears; delayed
protocol impose a period of shoulder immobilization (from 2 weeks to 40-day) that can promote
tendons healing but could determine shoulder stiffness. Our research question is if after the
delayed protocol used in our institute (40 -day immobilization period) it migh be useful to
add soft-tissue mobilization assisted by instruments according to Graston Tecnique to the
classic rehabilitation protocol of the shoulder in order to speed up recovery times of the
passive movement range.
Inclusion Criteria:
- arthroscopic rotator cuff repair
- partial lesion due to tendon degeneration (1 or 2 anchors reparation)
Exclusion Criteria:
- traumatic tendon lesions
- associated conditions as arthritis, loss of superficial sensitivity, loss of muscle
tone, mental impairment, oncological conditions
- shoulder stiffness before surgery due to calcific tendonitis, adhesive capsulitis
|
NCT0531xxxx/NCT05315453.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/NCT05315453</url>
</required_header>
<id_info>
<org_study_id>STUDY00013494</org_study_id>
<nct_id>NCT05315453</nct_id>
</id_info>
<brief_title>Brief Telehealth Cognitive Rehabilitation Following Mild TBI</brief_title>
<acronym>On-TRACC</acronym>
<official_title>Brief Telehealth Cognitive Rehabilitation Following Mild Traumatic Brain Injury: A Pilot Study</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Washington</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>VA Puget Sound Health Care System</agency>
<agency_class>U.S. Fed</agency_class>
</collaborator>
</sponsors>
<source>University of Washington</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 the United States, more than a million people sustain a mild traumatic brain injury (mTBI)
every year. Although many recover fully, emerging literature suggests a high number of
individuals report chronic, and functionally disabling, cognitive difficulties. Among
Veterans, a nationwide survey found that more than 75% of 55,000 Veterans with a history of
mTBI reported persistent moderate to severe levels of forgetfulness and poor concentration.

Reduced cognitive functioning following mTBI contributes to significant functional
impairment, including underemployment, relationship difficulties, and reduced community
integration for years post injury. Despite the significant individual and societal impact,
evidence to guide interventions and treatment for this population remains limited. Even more
limited are validated telehealth options for these symptoms, a critical means by which access
to care can be improved, especially during the COVID-19 pandemic. The proposed pilot study
will address this gap by evaluating the feasibility, acceptability, and preliminary
effectiveness of a brief (5-session) cognitive rehabilitation intervention that was developed
for individuals with mTBI and that will be administered over video-based telehealth
technology. The development of this intervention was supported by a grant from the Department
of Defense, with critical elements identified through surveys completed by clinicians and
veterans with a history of mTBI, and also the clinical expertise of the team.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">December 13, 2021</start_date>
<completion_date type="Actual">October 13, 2022</completion_date>
<primary_completion_date type="Actual">October 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>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>Feasibility of administering the On-TRACC intervention to individuals with mTBI</measure>
<time_frame>At the completion of 5 week intervention</time_frame>
<description>Feasibility measures will include rate of enrollment of eligible individuals as well as dropout rate for enrolled participants. We will also evaluate participant adherence, including proportion of treatment sessions attended and number of days that homework was completed.</description>
</primary_outcome>
<secondary_outcome>
<measure>Participant satisfaction with On-TRACC intervention</measure>
<time_frame>End of each treatment session and at treatment completion, 5 weeks total.</time_frame>
<description>Participants will provide feedback on individual treatment sessions and at the end of treatment regarding intervention content. Participants will complete a Weekly Therapy Rating form after each treatment session and an End of Treatment Patient Feedback Form at the end of treatment to provide satisfaction ratings.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Preliminary effectiveness of On-TRACC intervention in decreasing post-concussive symptoms</measure>
<time_frame>Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average</time_frame>
<description>Pre-post treatment change in post-concussive symptoms (Neurobehavioral Symptom Inventory) will be evaluated.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Preliminary effectiveness of On-TRACC intervention at decreasing self-reported cognitive difficulties</measure>
<time_frame>Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average</time_frame>
<description>Pre-post treatment change in self-reported cognitive difficulties (NeuroQol Item Bank Cognitive Function SF) will be evaluated.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Preliminary effectiveness of On-TRACC intervention at improving self-efficacy</measure>
<time_frame>Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average</time_frame>
<description>Pre-post treatment change in self-efficacy (Cognitive Concerns Self-Efficacy Scale) will be evaluated.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">28</enrollment>
<condition>Mild Traumatic Brain Injury</condition>
<condition>Cognitive Impairment</condition>
<arm_group>
<arm_group_label>Brief Cognitive Rehabilitation</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>5-session Cognitive Rehabilitation intervention administered over telehealth</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Brief Cognitive Rehabilitation</intervention_name>
<description>5-session Cognitive Rehabilitation intervention that can be administered over telehealth.</description>
<arm_group_label>Brief Cognitive Rehabilitation</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Age 18+;

- Read, speak, understand English;

- History of at least one mTBI;

- Endorses moderate to severe cognitive difficulties in one or more of Neurobehavioral
Symptom Inventory items M-P;

- Ability and willingness to participate in audio recorded sessions over video
telehealth platform in a private setting, including equipment and internet access;

- Lives within 2 hours of VA Puget Sound or affiliated clinics/University of Washington;

- Will be in Washington State when engaging in treatment sessions

Exclusion Criteria:

- Significant cognitive impairment that would limit ability to engage on treatment;

- Neurologic injury or illness that affects cognitive functioning, including history of
moderate or severe TBI;

- History of TBI in the past 3 months, from the date of screening;

- History of serious mental illness involving psychotic symptoms;

- Current psychotic or manic symptoms;

- Current or active flag, or documentation in medical record, for behavior or suicide
risk;

- Current (within the past 3 months) Substance Use Disorder (not including caffeine or
nicotine disorder)
</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>Kathleen Pagulayan, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>VA Puget Sound Health Care System/University of Washington</affiliation>
</overall_official>
<location>
<facility>
<name>VA Puget Sound Health Care System</name>
<address>
<city>Seattle</city>
<state>Washington</state>
<zip>98108</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>December 13, 2021</study_first_submitted>
<study_first_submitted_qc>April 2, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 22, 2023</last_update_submitted>
<last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 24, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Washington</investigator_affiliation>
<investigator_full_name>Kathleen Pagulayan</investigator_full_name>
<investigator_title>Associate Professor, School of Medicine: Psychiatry</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Brain Injuries</mesh_term>
<mesh_term>Brain Injuries, Traumatic</mesh_term>
<mesh_term>Brain Concussion</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
In the United States, more than a million people sustain a mild traumatic brain injury (mTBI)
every year. Although many recover fully, emerging literature suggests a high number of
individuals report chronic, and functionally disabling, cognitive difficulties. Among
Veterans, a nationwide survey found that more than 75% of 55,000 Veterans with a history of
mTBI reported persistent moderate to severe levels of forgetfulness and poor concentration.
Reduced cognitive functioning following mTBI contributes to significant functional
impairment, including underemployment, relationship difficulties, and reduced community
integration for years post injury. Despite the significant individual and societal impact,
evidence to guide interventions and treatment for this population remains limited. Even more
limited are validated telehealth options for these symptoms, a critical means by which access
to care can be improved, especially during the COVID-19 pandemic. The proposed pilot study
will address this gap by evaluating the feasibility, acceptability, and preliminary
effectiveness of a brief (5-session) cognitive rehabilitation intervention that was developed
for individuals with mTBI and that will be administered over video-based telehealth
technology. The development of this intervention was supported by a grant from the Department
of Defense, with critical elements identified through surveys completed by clinicians and
veterans with a history of mTBI, and also the clinical expertise of the team.
Inclusion Criteria:
- Age 18+;
- Read, speak, understand English;
- History of at least one mTBI;
- Endorses moderate to severe cognitive difficulties in one or more of Neurobehavioral
Symptom Inventory items M-P;
- Ability and willingness to participate in audio recorded sessions over video
telehealth platform in a private setting, including equipment and internet access;
- Lives within 2 hours of VA Puget Sound or affiliated clinics/University of Washington;
- Will be in Washington State when engaging in treatment sessions
Exclusion Criteria:
- Significant cognitive impairment that would limit ability to engage on treatment;
- Neurologic injury or illness that affects cognitive functioning, including history of
moderate or severe TBI;
- History of TBI in the past 3 months, from the date of screening;
- History of serious mental illness involving psychotic symptoms;
- Current psychotic or manic symptoms;
- Current or active flag, or documentation in medical record, for behavior or suicide
risk;
- Current (within the past 3 months) Substance Use Disorder (not including caffeine or
nicotine disorder)
|
NCT0531xxxx/NCT05315466.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/NCT05315466</url>
</required_header>
<id_info>
<org_study_id>RF MINSAL2009.STENOSI</org_study_id>
<nct_id>NCT05315466</nct_id>
</id_info>
<brief_title>Comparison Between Surgical and Conservative Treatment for Lumbar Stenosis</brief_title>
<official_title>Comparison Between Surgical and Conservative Treatment for Lumbar Stenosis</official_title>
<sponsors>
<lead_sponsor>
<agency>Istituto Ortopedico Rizzoli</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Istituto Ortopedico Rizzoli</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 compare the outcomes of surgical treatment and conservative treatment at
medium- and long-term period (minimum 2 years) in patients with lumbar stenosis who come to
the observation of the PI's Team at the Rizzoli Orthopaedic Institute, through a series
exhaustive questionnaires to self-administer to patients in order to define a path of
"decision-making" as effective as possible for the patient and the doctor.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Non-surgical treatment:

Conservative treatment may include different approaches, such as analgesics,
anti-inflammatories, muscle relaxants, physical therapy, Global Postural Rehabilitation,
magnetic therapy, laser therapy, TENS, massage, cognitive-behavioral therapy and all those
procedures that can bring benefit in back and legs pain.

Surgical treatment:

Surgical treatment of lumbar stenosis is the decompression surgery which relieves the nerve
structures to prevent permanent neurological damage. Decompression can be made on one or more
segments of the spine and can be done with laminectomy, hemilaminectomy, laminotomy.

During a laminotomy part of the vertebral lamina is removed above and below the compressed
nerve. The opening created is sometimes enough to relieve the compression on the nerve. In
most cases, also the disc material and bone spur that compress the nerve are removed.

During a laminectomy the vertebral lamina is completely removed, along with the disc and the
bone material that compress the nerves. The opening produced by the removal of the lamina is
protected by back muscles and ligaments.

If the damage has occurred at several levels and bone of the vertebral support structures
must be removed to achieve decompression, it can be performed a stabilization surgery with
vertebral bone fusion (arthrodesis) in order to avoid instability of the column. Fusion is
carried out to eliminate the mobility between different vertebrae and it is achieved using
bone derived from the patient's iliac crest or from a donor. The bone gradually grows and
melts with the same vertebrae. This limits the movements that may have been one of the causes
of back pain. It takes about six months for it to achieve a solid bony spinal fusion.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">August 8, 2012</start_date>
<completion_date type="Actual">June 16, 2017</completion_date>
<primary_completion_date type="Actual">June 16, 2017</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>
<intervention_model_description>Patients affected by lumbar spinal stenosis who are designated to surgical or conservative treatment</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Back and leg pain assessed by VAS</measure>
<time_frame>Change from baseline VAS at 3, 6, 12, 24 months</time_frame>
<description>Self-administered questionnaires for patients to evaluate back and leg pain (VAS score)</description>
</primary_outcome>
<primary_outcome>
<measure>Functional activity assessed by ODI</measure>
<time_frame>Change from baseline ODI at 3, 6, 12, 24 months</time_frame>
<description>Self-administered questionnaires for patients to evaluate a disability index (ODI)</description>
</primary_outcome>
<primary_outcome>
<measure>Quality of life assessed by EQ-5D</measure>
<time_frame>Change from baseline EQ-5D at 3, 6, 12, 24 months</time_frame>
<description>Self-administered questionnaires for patients to evaluate the quality of life (EQ-5D)</description>
</primary_outcome>
<secondary_outcome>
<measure>Complications</measure>
<time_frame>6, 12, 24 months</time_frame>
<description>Evaluation of complications associated to the surgical treatment</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">30</enrollment>
<condition>Lumbar Spinal Stenosis</condition>
<arm_group>
<arm_group_label>Non-surgical treatment</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Different types of non-surgical treatments</description>
</arm_group>
<arm_group>
<arm_group_label>Surgical treatment</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Surgical treatment for spinal stenosis</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Non-surgical treatment</intervention_name>
<description>Analgesics, anti-inflammatories, muscle relaxants, physical therapy, Global Postural Rehabilitation, magnetic therapy, laser therapy, transcutaneous electrical nervous stimulation (TENS), massage, cognitive-behavioral therapy and all those procedures that can bring benefit to back and leg pain.</description>
<arm_group_label>Non-surgical treatment</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Surgical treatment for spinal stenosis</intervention_name>
<description>Decompression of nerve structures by laminotomy or laminectomy and posterior lumbar fusion if stabilization of the column is required.</description>
<arm_group_label>Surgical treatment</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Confirmatory imaging study (MRI or CT) showing lumbar spinal stenosis at one or more
levels (L2 to sacrum) defined as narrowing of the central spinal canal, lateral
recesses, or neural foramens due to encroachment on the neural structures by the
surrounding bone and soft tissue.

Exclusion Criteria:

- Patients are not eligible if they have evidence of instability on lateral flexion-
extension radiographs, defined as a change of #10° of angulation of adjacent segments
by Cobb measurement or a change of more than 4 mm of anteroposterior or
posteroanterior translation.
</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>Alessandro Gasbarrini, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Istituto Ortopedico Rizzoli</affiliation>
</overall_official>
<location>
<facility>
<name>Istituto Ortopedico Rizzoli</name>
<address>
<city>Bologna</city>
<zip>40136</zip>
<country>Italy</country>
</address>
</facility>
</location>
<location_countries>
<country>Italy</country>
</location_countries>
<reference>
<citation>Kovacs FM, Urrutia G, Alarcon JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine (Phila Pa 1976). 2011 Sep 15;36(20):E1335-51. doi: 10.1097/BRS.0b013e31820c97b1.</citation>
<PMID>21311394</PMID>
</reference>
<reference>
<citation>Amundsen T, Weber H, Nordal HJ, Magnaes B, Abdelnoor M, Lilleas F. Lumbar spinal stenosis: conservative or surgical management?: A prospective 10-year study. Spine (Phila Pa 1976). 2000 Jun 1;25(11):1424-35; discussion 1435-6. doi: 10.1097/00007632-200006010-00016.</citation>
<PMID>10828926</PMID>
</reference>
<reference>
<citation>Malmivaara A, Slatis P, Heliovaara M, Sainio P, Kinnunen H, Kankare J, Dalin-Hirvonen N, Seitsalo S, Herno A, Kortekangas P, Niinimaki T, Ronty H, Tallroth K, Turunen V, Knekt P, Harkanen T, Hurri H; Finnish Lumbar Spinal Research Group. Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial. Spine (Phila Pa 1976). 2007 Jan 1;32(1):1-8. doi: 10.1097/01.brs.0000251014.81875.6d.</citation>
<PMID>17202885</PMID>
</reference>
<reference>
<citation>Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136.</citation>
<PMID>18287602</PMID>
</reference>
<reference>
<citation>Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Puccio ST, Cauthen JC, Ozuna RM. A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results. Spine (Phila Pa 1976). 2005 Jun 15;30(12):1351-8. doi: 10.1097/01.brs.0000166618.42749.d1.</citation>
<PMID>15959362</PMID>
</reference>
<verification_date>March 2017</verification_date>
<study_first_submitted>March 1, 2017</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 29, 2022</last_update_submitted>
<last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 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>Spinal Stenosis</mesh_term>
<mesh_term>Constriction, Pathologic</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 compare the outcomes of surgical treatment and conservative treatment at
medium- and long-term period (minimum 2 years) in patients with lumbar stenosis who come to
the observation of the PI's Team at the Rizzoli Orthopaedic Institute, through a series
exhaustive questionnaires to self-administer to patients in order to define a path of
"decision-making" as effective as possible for the patient and the doctor.
Non-surgical treatment:
Conservative treatment may include different approaches, such as analgesics,
anti-inflammatories, muscle relaxants, physical therapy, Global Postural Rehabilitation,
magnetic therapy, laser therapy, TENS, massage, cognitive-behavioral therapy and all those
procedures that can bring benefit in back and legs pain.
Surgical treatment:
Surgical treatment of lumbar stenosis is the decompression surgery which relieves the nerve
structures to prevent permanent neurological damage. Decompression can be made on one or more
segments of the spine and can be done with laminectomy, hemilaminectomy, laminotomy.
During a laminotomy part of the vertebral lamina is removed above and below the compressed
nerve. The opening created is sometimes enough to relieve the compression on the nerve. In
most cases, also the disc material and bone spur that compress the nerve are removed.
During a laminectomy the vertebral lamina is completely removed, along with the disc and the
bone material that compress the nerves. The opening produced by the removal of the lamina is
protected by back muscles and ligaments.
If the damage has occurred at several levels and bone of the vertebral support structures
must be removed to achieve decompression, it can be performed a stabilization surgery with
vertebral bone fusion (arthrodesis) in order to avoid instability of the column. Fusion is
carried out to eliminate the mobility between different vertebrae and it is achieved using
bone derived from the patient's iliac crest or from a donor. The bone gradually grows and
melts with the same vertebrae. This limits the movements that may have been one of the causes
of back pain. It takes about six months for it to achieve a solid bony spinal fusion.
Inclusion Criteria:
- Confirmatory imaging study (MRI or CT) showing lumbar spinal stenosis at one or more
levels (L2 to sacrum) defined as narrowing of the central spinal canal, lateral
recesses, or neural foramens due to encroachment on the neural structures by the
surrounding bone and soft tissue.
Exclusion Criteria:
- Patients are not eligible if they have evidence of instability on lateral flexion-
extension radiographs, defined as a change of #10° of angulation of adjacent segments
by Cobb measurement or a change of more than 4 mm of anteroposterior or
posteroanterior translation.
|
NCT0531xxxx/NCT05315479.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/NCT05315479</url>
</required_header>
<id_info>
<org_study_id>BDX-20-002</org_study_id>
<nct_id>NCT05315479</nct_id>
</id_info>
<brief_title>Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery</brief_title>
<official_title>A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery</official_title>
<sponsors>
<lead_sponsor>
<agency>Baudax Bio</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Baudax Bio</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>
This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539
in postoperative Pediatric subjects aged 2 to <17 years.
</textblock>
</brief_summary>
<overall_status>Terminated</overall_status>
<why_stopped>
Anjeso (N1539) NDA Withdrawn
</why_stopped>
<start_date type="Actual">February 24, 2022</start_date>
<completion_date type="Actual">July 7, 2022</completion_date>
<primary_completion_date type="Actual">July 7, 2022</primary_completion_date>
<phase>Phase 4</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>Number of Subjects Experiencing an AE</measure>
<time_frame>Through study completion, approximately 28 Days</time_frame>
<description>Number of study subjects who experienced an AE</description>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">19</enrollment>
<condition>Post Operative Pain</condition>
<arm_group>
<arm_group_label>N1539</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>N1539</intervention_name>
<description>Once daily</description>
<arm_group_label>N1539</arm_group_label>
<other_name>Meloxicam IV</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Male or female 2 to <17 years of age before dosing on Day 1

- Eligible for elective surgery that will be performed according to standard surgical
technique under appropriate anesthesia

- Be premenarche or have confirmed negative urine pregnancy testing before surgery on
Day 1, if an adolescent female of childbearing potential

- Willing and able to cooperate with all the requirements of the study; including
providing appropriate informed consent/assent

Exclusion Criteria:

- Have a known allergy or hypersensitivity to meloxicam, aspirin, other non-steroidal
anti-inflammatory drugs (NSAIDs), or any excipient of N1539

- Have a known bleeding disorder that may be worsened with the administration of an
NSAID

- Be undergoing cardiothoracic surgery

- Has used meloxicam within 7 days before the surgical procedure on Day 1

- Has any clinically significant medical history or clinical manifestations of
significant disease or any other condition that increases the risk associated with the
subject's participation in the study or compromises the scientific objectives of the
study.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>2 Years</minimum_age>
<maximum_age>16 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Research Center</name>
<address>
<city>Sheffield</city>
<state>Alabama</state>
<zip>35660</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Center</name>
<address>
<city>Bakersfield</city>
<state>California</state>
<zip>93301</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Center</name>
<address>
<city>Salt Lake City</city>
<state>Utah</state>
<zip>84107</zip>
<country>United States</country>
</address>
</facility>
</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 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<results_first_submitted>July 28, 2023</results_first_submitted>
<results_first_submitted_qc>August 22, 2023</results_first_submitted_qc>
<results_first_posted type="Actual">September 13, 2023</results_first_posted>
<last_update_submitted>August 22, 2023</last_update_submitted>
<last_update_submitted_qc>August 22, 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>meloxicam</keyword>
<keyword>pediatric</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Pain, Postoperative</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Meloxicam</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<provided_document_section>
<provided_document>
<document_type>Study Protocol and Statistical Analysis Plan</document_type>
<document_has_protocol>Yes</document_has_protocol>
<document_has_icf>No</document_has_icf>
<document_has_sap>Yes</document_has_sap>
<document_date>August 23, 2021</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT05315479/Prot_SAP_002.pdf</document_url>
</provided_document>
</provided_document_section>
<clinical_results>
<participant_flow>
<group_list>
<group group_id="P1">
<title>N1539</title>
<description>N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
N1539: Once daily</description>
</group>
</group_list>
<period_list>
<period>
<title>Overall Study</title>
<milestone_list>
<milestone>
<title>STARTED</title>
<participants_list>
<participants group_id="P1" count="19"/>
</participants_list>
</milestone>
<milestone>
<title>COMPLETED</title>
<participants_list>
<participants group_id="P1" count="19"/>
</participants_list>
</milestone>
<milestone>
<title>NOT COMPLETED</title>
<participants_list>
<participants group_id="P1" count="0"/>
</participants_list>
</milestone>
</milestone_list>
</period>
</period_list>
</participant_flow>
<baseline>
<group_list>
<group group_id="B1">
<title>N1539</title>
<description>N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
N1539: Once daily</description>
</group>
</group_list>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Overall</scope>
<count_list>
<count group_id="B1" value="19"/>
</count_list>
</analyzed>
</analyzed_list>
<measure_list>
<measure>
<title>Age</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title><=18 years</title>
<measurement_list>
<measurement group_id="B1" value="19"/>
</measurement_list>
</category>
<category>
<title>Between 18 and 65 years</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
</measurement_list>
</category>
<category>
<title>>=65 years</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Age</title>
<units>years</units>
<param>Median</param>
<dispersion>Full Range</dispersion>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="16" lower_limit="12" upper_limit="16"/>
</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="9"/>
</measurement_list>
</category>
<category>
<title>Male</title>
<measurement_list>
<measurement group_id="B1" value="10"/>
</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="2"/>
</measurement_list>
</category>
<category>
<title>Native Hawaiian or Other Pacific Islander</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
</measurement_list>
</category>
<category>
<title>Black or African American</title>
<measurement_list>
<measurement group_id="B1" value="2"/>
</measurement_list>
</category>
<category>
<title>White</title>
<measurement_list>
<measurement group_id="B1" value="15"/>
</measurement_list>
</category>
<category>
<title>More than one race</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
</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>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="19"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</measure_list>
</baseline>
<outcome_list>
<outcome>
<type>Primary</type>
<title>Number of Subjects Experiencing an AE</title>
<description>Number of study subjects who experienced an AE</description>
<time_frame>Through study completion, approximately 28 Days</time_frame>
<group_list>
<group group_id="O1">
<title>N1539</title>
<description>N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
N1539: Once daily</description>
</group>
</group_list>
<measure>
<title>Number of Subjects Experiencing an AE</title>
<description>Number of study subjects who experienced an AE</description>
<units>Participants</units>
<param>Count of Participants</param>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="19"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="3"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
</outcome_list>
<reported_events>
<time_frame>28 Days following study dosing</time_frame>
<group_list>
<group group_id="E1">
<title>N1539</title>
<description>N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
N1539: Once daily</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="19"/>
</event>
<event>
<sub_title>Total, serious adverse events</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
</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="3" subjects_at_risk="19"/>
</event>
</event_list>
</category>
<category>
<title>Gastrointestinal disorders</title>
<event_list>
<event>
<sub_title>Nausea</sub_title>
<counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
</event>
</event_list>
</category>
<category>
<title>General disorders</title>
<event_list>
<event>
<sub_title>Pyrexia</sub_title>
<counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
</event>
</event_list>
</category>
<category>
<title>Infections and infestations</title>
<event_list>
<event>
<sub_title>Tooth infection</sub_title>
<counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
</event>
</event_list>
</category>
<category>
<title>Respiratory, thoracic and mediastinal disorders</title>
<event_list>
<event>
<sub_title>Oropharyngeal pain</sub_title>
<counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
</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>Discussion and/or publication of data generated is not permitted without the prior written consent of the sponsor.</restrictive_agreement>
</certain_agreements>
<point_of_contact>
<name_or_title>Development</name_or_title>
<organization>Baudax Bio</organization>
<phone>484-395-2440</phone>
<email>info@baudaxbio.com</email>
</point_of_contact>
</clinical_results>
</clinical_study>
|
This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539
in postoperative Pediatric subjects aged 2 to <17 years.
Inclusion Criteria:
- Male or female 2 to <17 years of age before dosing on Day 1
- Eligible for elective surgery that will be performed according to standard surgical
technique under appropriate anesthesia
- Be premenarche or have confirmed negative urine pregnancy testing before surgery on
Day 1, if an adolescent female of childbearing potential
- Willing and able to cooperate with all the requirements of the study; including
providing appropriate informed consent/assent
Exclusion Criteria:
- Have a known allergy or hypersensitivity to meloxicam, aspirin, other non-steroidal
anti-inflammatory drugs (NSAIDs), or any excipient of N1539
- Have a known bleeding disorder that may be worsened with the administration of an
NSAID
- Be undergoing cardiothoracic surgery
- Has used meloxicam within 7 days before the surgical procedure on Day 1
- Has any clinically significant medical history or clinical manifestations of
significant disease or any other condition that increases the risk associated with the
subject's participation in the study or compromises the scientific objectives of the
study.
|
NCT0531xxxx/NCT05315492.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/NCT05315492</url>
</required_header>
<id_info>
<org_study_id>Vietnam Addiction Care</org_study_id>
<nct_id>NCT05315492</nct_id>
</id_info>
<brief_title>Strengthening Community Addiction Services in Vietnam</brief_title>
<official_title>Strengthening Addiction Care Continuum Through Community Consortium in Vietnam</official_title>
<sponsors>
<lead_sponsor>
<agency>University of California, Los Angeles</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of California, Los Angeles</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 study aims to develop and test an intervention to enhance the addiction service
continuum with the joint effort of commune health workers and family members of people who
use drugs in Vietnam.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The study will develop and test an intervention to strengthen a continuum of addiction
services. The intervention, entitled "Community Care Consortium (CCC)," features community
health workers' joint effort with family members to provide patient-centered, individualized
addiction care and support. The intervention will be developed and tested through three
phases in three regions of Vietnam (Ninh Binh, Da Nang, and Can Tho).

In Phase 1, we will conduct formative studies with commune (community) health workers (CHW),
community representatives, PWUD, and their family members to identify barriers to addiction
service utilization and discuss potential strategies to establish a continuum of addiction
services. Based on the formative study findings, the CCC Intervention and its implementation
plans will be developed through workgroup meetings with researchers, community members, and
target users.

In Phase 2, the CCC Intervention will be piloted in three communes and revised based on
acceptability/feasibility data, process evaluation, and feedback from field staff and
participants.

In Phase 3, a randomized controlled trial of the CCC Intervention will be conducted in 60
communes, which will be randomized to either an intervention condition or a control condition
(30 communes in each condition). A total of 720 PWUD, 720 of their family members, and 180
commune health workers (CHW) will participate in the study. The intervention outcomes on
PWUD, CHW, and family members will be assessed with the data collected at baseline, 3-, 6-,
9- and 12-month follow-ups.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">May 2022</start_date>
<completion_date type="Anticipated">July 2026</completion_date>
<primary_completion_date type="Anticipated">January 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>Supportive Care</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>PWUD's STTR fulfillment score</measure>
<time_frame>Changes from baseline to 3-, 6-, 9- and 12- month follow-ups</time_frame>
<description>This overall score consists of individual indicators in 4 domains: Seek,Test, Treat, Retain</description>
</primary_outcome>
<secondary_outcome>
<measure>CHW's addiction-related service provision and support</measure>
<time_frame>Changes from baseline to 3-, 6-, 9- and 12- month follow-ups</time_frame>
<description>CHW's service provision and support such as patient referrals and support for treatment retention measured by frequencies of appointment reminder, follow-up activities</description>
</secondary_outcome>
<other_outcome>
<measure>Family members' support in the 4 domains:Seek,Test, Treat, Retain</measure>
<time_frame>Changes from baseline to 3-, 6-, 9- and 12- month follow-ups</time_frame>
<description>Family member's emotional, informational, monetary support, logistic assistance for PWUD treatment and retention as well as scale measures in their caregiver burden and coping.</description>
</other_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">1620</enrollment>
<condition>Addiction, Opioid</condition>
<arm_group>
<arm_group_label>Intervention communes</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>CCC intervention</description>
</arm_group>
<arm_group>
<arm_group_label>Control communes</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Standard care</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Community Care Consortium (CCC)</intervention_name>
<description>The intervention will train community health workers to take an active role in the drug control and addiction service delivery in the community.</description>
<arm_group_label>Intervention communes</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Age 18 or older

- Having a history of drug use

- Having disclosed drug using status to at least one of his/her family members and is
willing to invite this family member to our study

- Currently residing in the selected communes

- Voluntary written informed consent

Exclusion Criteria:

- Inability to give informed consent
</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>Li Li, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>University of California, Los Angeles</affiliation>
</overall_official>
<overall_contact>
<last_name>Li Li, PhD</last_name>
<phone>13107942446</phone>
<email>lililili@ucla.edu</email>
</overall_contact>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 21, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 29, 2022</last_update_submitted>
<last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</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>Li Li</investigator_full_name>
<investigator_title>Professor-in-Residence</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
<mesh_term>Behavior, Addictive</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 develop and test an intervention to enhance the addiction service
continuum with the joint effort of commune health workers and family members of people who
use drugs in Vietnam.
The study will develop and test an intervention to strengthen a continuum of addiction
services. The intervention, entitled "Community Care Consortium (CCC)," features community
health workers' joint effort with family members to provide patient-centered, individualized
addiction care and support. The intervention will be developed and tested through three
phases in three regions of Vietnam (Ninh Binh, Da Nang, and Can Tho).
In Phase 1, we will conduct formative studies with commune (community) health workers (CHW),
community representatives, PWUD, and their family members to identify barriers to addiction
service utilization and discuss potential strategies to establish a continuum of addiction
services. Based on the formative study findings, the CCC Intervention and its implementation
plans will be developed through workgroup meetings with researchers, community members, and
target users.
In Phase 2, the CCC Intervention will be piloted in three communes and revised based on
acceptability/feasibility data, process evaluation, and feedback from field staff and
participants.
In Phase 3, a randomized controlled trial of the CCC Intervention will be conducted in 60
communes, which will be randomized to either an intervention condition or a control condition
(30 communes in each condition). A total of 720 PWUD, 720 of their family members, and 180
commune health workers (CHW) will participate in the study. The intervention outcomes on
PWUD, CHW, and family members will be assessed with the data collected at baseline, 3-, 6-,
9- and 12-month follow-ups.
Inclusion Criteria:
- Age 18 or older
- Having a history of drug use
- Having disclosed drug using status to at least one of his/her family members and is
willing to invite this family member to our study
- Currently residing in the selected communes
- Voluntary written informed consent
Exclusion Criteria:
- Inability to give informed consent
|
NCT0531xxxx/NCT05315505.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/NCT05315505</url>
</required_header>
<id_info>
<org_study_id>136/CES/JAS</org_study_id>
<nct_id>NCT05315505</nct_id>
</id_info>
<brief_title>Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients</brief_title>
<acronym>Rehab2life</acronym>
<official_title>Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients</official_title>
<sponsors>
<lead_sponsor>
<agency>Unidade Local de Saúde de Matosinhos, EPE</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Unidade Local de Saúde de Matosinhos, EPE</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 study aims to develop and test the effectiveness of a new home-based pulmonary
rehabilitation program comprising two distinct phases, the first in which an 8-week
respiratory rehabilitation program is carried out the second in which a maintenance pulmonary
rehabilitation program is carried out.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 9, 2022</start_date>
<completion_date type="Anticipated">April 2024</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>
<intervention_model_description>Randomization will be performed after verifying the inclusion and exclusion criteria in the study and the informed, free and informed consent of the individuals. Randomization will be carried out by permuted blocks of 4 to guarantee the same number of participants in each group.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Outcomes Assessor)</masking>
<masking_description>The outcome evaluation will be performed by a cardiopulmonary technician that has no information about the patient group</masking_description>
</study_design_info>
<primary_outcome>
<measure>Distance in meters covered over a time of 6 minutes 0</measure>
<time_frame>Baseline</time_frame>
<description>Distance in meters covered over a time of 6 minutes 0 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.</description>
</primary_outcome>
<primary_outcome>
<measure>Distance in meters covered over a time of 6 minutes 1</measure>
<time_frame>8 weeks</time_frame>
<description>Distance in meters covered over a time of 6 minutes 1 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.</description>
</primary_outcome>
<primary_outcome>
<measure>Distance in meters covered over a time of 6 minutes 2</measure>
<time_frame>7 months</time_frame>
<description>Distance in meters covered over a time of 6 minutes 2 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.</description>
</primary_outcome>
<primary_outcome>
<measure>Distance in meters covered over a time of 6 minutes 3</measure>
<time_frame>12 months</time_frame>
<description>Distance in meters covered over a time of 6 minutes 3 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.</description>
</primary_outcome>
<secondary_outcome>
<measure>Dyspnoea 0</measure>
<time_frame>Baseline</time_frame>
<description>modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea</description>
</secondary_outcome>
<secondary_outcome>
<measure>Dyspnoea 1</measure>
<time_frame>8 weeks</time_frame>
<description>modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea</description>
</secondary_outcome>
<secondary_outcome>
<measure>Dyspnoea 2</measure>
<time_frame>7 months</time_frame>
<description>modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea</description>
</secondary_outcome>
<secondary_outcome>
<measure>Dyspnoea 3</measure>
<time_frame>12 months</time_frame>
<description>modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea</description>
</secondary_outcome>
<secondary_outcome>
<measure>Health-Related Quality of Life 0</measure>
<time_frame>Baseline</time_frame>
<description>European quality of life-5 dimensions (EQ5D)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Health-Related Quality of Life 1</measure>
<time_frame>8 weeks</time_frame>
<description>European quality of life-5 dimensions (EQ5D)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Health-Related Quality of Life 2</measure>
<time_frame>7 months</time_frame>
<description>European quality of life-5 dimensions (EQ5D)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Health-Related Quality of Life 3</measure>
<time_frame>12 months</time_frame>
<description>European quality of life-5 dimensions (EQ5D)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of emergency department visits due to COPD exacerbation 0</measure>
<time_frame>Baseline</time_frame>
<description>Number of exacerbations (accessing to emergency department)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of emergency department visits due to COPD exacerbation 1</measure>
<time_frame>8 weeks</time_frame>
<description>Number of exacerbations (accessing to emergency department)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of emergency department visits due to COPD exacerbation 2</measure>
<time_frame>7 months</time_frame>
<description>Number of exacerbations (accessing to emergency department)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of emergency department visits due to COPD exacerbation 3</measure>
<time_frame>12 months</time_frame>
<description>Number of exacerbations (accessing to emergency department)</description>
</secondary_outcome>
<secondary_outcome>
<measure>COPD symptom control 0</measure>
<time_frame>Baseline</time_frame>
<description>COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control</description>
</secondary_outcome>
<secondary_outcome>
<measure>COPD symptom control 1</measure>
<time_frame>8 weeks</time_frame>
<description>COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control</description>
</secondary_outcome>
<secondary_outcome>
<measure>COPD symptom control 2</measure>
<time_frame>7 months</time_frame>
<description>COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control</description>
</secondary_outcome>
<secondary_outcome>
<measure>COPD symptom control 3</measure>
<time_frame>12 months</time_frame>
<description>COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control</description>
</secondary_outcome>
<secondary_outcome>
<measure>Anxiety and Depression 0</measure>
<time_frame>Baseline</time_frame>
<description>Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring</description>
</secondary_outcome>
<secondary_outcome>
<measure>Anxiety and Depression 1</measure>
<time_frame>8 weeks</time_frame>
<description>Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring</description>
</secondary_outcome>
<secondary_outcome>
<measure>Anxiety and Depression 2</measure>
<time_frame>7 months</time_frame>
<description>Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring</description>
</secondary_outcome>
<secondary_outcome>
<measure>Anxiety and Depression 3</measure>
<time_frame>12 months</time_frame>
<description>Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring</description>
</secondary_outcome>
<secondary_outcome>
<measure>Physical activity 0</measure>
<time_frame>Baseline</time_frame>
<description>Counting steps per day with the pedometer Yamax EX510</description>
</secondary_outcome>
<secondary_outcome>
<measure>Physical activity 1</measure>
<time_frame>8 weeks</time_frame>
<description>Counting steps per day with the pedometer Yamax EX510</description>
</secondary_outcome>
<secondary_outcome>
<measure>Physical activity 2</measure>
<time_frame>7 months</time_frame>
<description>Counting steps per day with the pedometer Yamax EX510</description>
</secondary_outcome>
<secondary_outcome>
<measure>Physical activity 3</measure>
<time_frame>12 months</time_frame>
<description>Counting steps per day with the pedometer Yamax EX510</description>
</secondary_outcome>
<secondary_outcome>
<measure>Functional capacity 0</measure>
<time_frame>Baseline</time_frame>
<description>Number of times per minute an individual is able to stand up and sit down on a chair standardised for height</description>
</secondary_outcome>
<secondary_outcome>
<measure>Functional capacity 1</measure>
<time_frame>8 weeks</time_frame>
<description>Number of times per minute an individual is able to stand up and sit down on a chair standardised for height</description>
</secondary_outcome>
<secondary_outcome>
<measure>Functional capacity 2</measure>
<time_frame>7 months</time_frame>
<description>Number of times per minute an individual is able to stand up and sit down on a chair standardised for height</description>
</secondary_outcome>
<secondary_outcome>
<measure>Functional capacity 3</measure>
<time_frame>12 months</time_frame>
<description>Number of times per minute an individual is able to stand up and sit down on a chair standardised for height</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">160</enrollment>
<condition>Chronic Obstructive Pulmonary Disease</condition>
<condition>Pulmonary Rehabilitation</condition>
<arm_group>
<arm_group_label>Maintenance</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will undergo an initial home-based pulmonary rehabilitation program for eight weeks.
At the end of the eight weeks, the participants will be randomly assigned into two groups, one receiving the maintenance pulmonary rehabilitation program and the other receiving the usual care.
The maintenance arm will receive home visits for supervised physical exercise and progressively alternated with phone calls to motivation and feedback</description>
</arm_group>
<arm_group>
<arm_group_label>control</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Participants will undergo an initial home-based pulmonary rehabilitation program for eight weeks.
At the end of the eight weeks, the participants will be randomly assigned into two groups, one receiving the maintenance pulmonary rehabilitation program and the other receiving the usual care.
The control group will have access to the usual follow.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Maintenance programme</intervention_name>
<description>Continuous educational support, exercise training, behaviour change intervention, and self-management.
Maintenance home-based pulmonary rehabilitation programme for ten months with alternate supervision</description>
<arm_group_label>Maintenance</arm_group_label>
<other_name>Physical exercise</other_name>
<other_name>Behaviour change</other_name>
<other_name>Self-management</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Usual Care</intervention_name>
<description>No maintenance programme, and the patient has the usual follow-up and medical appointments</description>
<arm_group_label>control</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- COPD diagnose with B or E characterization according to GOLD criteria;

- Residence in the area covered by the institution where the study is carried out

Exclusion Criteria:

- Frequency of a PR programme in the previous six months

- COPD exacerbation for less than one week;

- Presence of unstable comorbidities (List of predetermined diagnoses that constitute
absolute exclusion criteria);

- Presence of comorbidities that constitute relative exclusion criteria through a
medical evaluation.

- Score of the Clinical Frailty Scale 2.0 above six or above five in case of not having
a responsible caregiver and living alone

- SpO2 below 85% in the 6-minute walk test
</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>Liliana Silva, MSc</last_name>
<role>Principal Investigator</role>
<affiliation>Matosinhos Local Health Unit</affiliation>
</overall_official>
<overall_contact>
<last_name>Liliana Silva, MSc</last_name>
<phone>+351917556931</phone>
<email>enf.lilianasilva@gmail.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Miguel Padilha, PhD</last_name>
<email>miguelpadilha@esenf.pt</email>
</overall_contact_backup>
<location>
<facility>
<name>Unidade Local de Saúde de Matosinhos</name>
<address>
<city>Matosinhos</city>
<state>Porto</state>
<zip>4450</zip>
<country>Portugal</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Liliana Silva, MSc</last_name>
<phone>+351917556931</phone>
<email>enf.lilianasilva@gmail.com</email>
</contact>
<contact_backup>
<last_name>Liliana Silva, MSc</last_name>
<email>liliana.silva@ulsm.min-saude.pt</email>
</contact_backup>
</location>
<location_countries>
<country>Portugal</country>
</location_countries>
<verification_date>August 2023</verification_date>
<study_first_submitted>March 21, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>August 21, 2023</last_update_submitted>
<last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">August 24, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Unidade Local de Saúde de Matosinhos, EPE</investigator_affiliation>
<investigator_full_name>Liliana Silva</investigator_full_name>
<investigator_title>RN</investigator_title>
</responsible_party>
<keyword>COPD</keyword>
<keyword>Pulmonary rehabilitation</keyword>
<keyword>Maintenance pulmonary rehabilitation</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Lung Diseases, Obstructive</mesh_term>
<mesh_term>Pulmonary Disease, Chronic Obstructive</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 study aims to develop and test the effectiveness of a new home-based pulmonary
rehabilitation program comprising two distinct phases, the first in which an 8-week
respiratory rehabilitation program is carried out the second in which a maintenance pulmonary
rehabilitation program is carried out.
Inclusion Criteria:
- COPD diagnose with B or E characterization according to GOLD criteria;
- Residence in the area covered by the institution where the study is carried out
Exclusion Criteria:
- Frequency of a PR programme in the previous six months
- COPD exacerbation for less than one week;
- Presence of unstable comorbidities (List of predetermined diagnoses that constitute
absolute exclusion criteria);
- Presence of comorbidities that constitute relative exclusion criteria through a
medical evaluation.
- Score of the Clinical Frailty Scale 2.0 above six or above five in case of not having
a responsible caregiver and living alone
- SpO2 below 85% in the 6-minute walk test
|
NCT0531xxxx/NCT05315518.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/NCT05315518</url>
</required_header>
<id_info>
<org_study_id>OPR 14/3/2022</org_study_id>
<nct_id>NCT05315518</nct_id>
</id_info>
<brief_title>Effect of Using Shade Blocker Versus Chameleon Effect of Two Single Shade of Resin Composite in Class IV Restorations</brief_title>
<official_title>Effect of Using Shade Blocker Versus Chameleon Effect on Shade Matching of Two Single-shade Resin Composite Materials in Class IV Restorations: A One Year Randomized Clinical Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Cairo University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Cairo 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>
Aim of this study will be conducted to compare the shade matching and clinical performance of
shade blocker versus chameleon effect of two single-shade of universal resin composite in
class IV restorations over 1 year evaluation period
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The color matching of both groups will be evaluated visually using modified USPH criteria
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">September 5, 2022</start_date>
<completion_date type="Anticipated">April 7, 2023</completion_date>
<primary_completion_date type="Anticipated">October 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>Treatment</primary_purpose>
<masking>Single (Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>shade matching</measure>
<time_frame>12 months</time_frame>
<description>the shade matching of both groups will be assessed visually by using modified USPH criteria.
score: 1- Alpha : the restoration match the shade and translucency of the adjacent tooth 2-Bravo : there is a mismatch in the shade and translucency but it is within a normal range of tooth shade 3- Charlie: the mismatch is beyond the normal range of the tooth shade and translucency</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">22</enrollment>
<condition>Discoloration, Tooth</condition>
<arm_group>
<arm_group_label>single shade universal resin composite (omnichroma) with blocker</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>(OMNICHROMA BLOCKER) is indicated for preventing shade-matching interference in Class IV restorations, Masking dark dentition and dentin. In cases where there is a lack of tooth structure to bond to, (BLOCKER) works as a supplementary product to provide a lingual wall to the restoration, prevent shade-match obstruction and mask staining.</description>
</arm_group>
<arm_group>
<arm_group_label>single shade universal resin composite(GC solare sculpt) with chameleon effect</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>One-shade universal resin composite (GC solare sculpt) gives very natural appearance, High gloss retention over time, time saving regarding to layering technique, wide shade matching range (chameleon effect) and delivering lifelike aesthetic restorations. These features can be offered by supra-nano spherical filler which have controlled refractive index, records excellent esthetic properties in small and medium class IV restorations.</description>
</arm_group>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)</intervention_name>
<description>(OMNICHROMA BLOCKER) is indicated for preventing shade-matching interference in Class IV restorations, Masking dark dentition and dentin. In cases where there is a lack of tooth structure to bond to, (BLOCKER) works as a supplementary product to provide a lingual wall to the restoration, prevent shade-match obstruction and mask staining.</description>
<arm_group_label>single shade universal resin composite (omnichroma) with blocker</arm_group_label>
<arm_group_label>single shade universal resin composite(GC solare sculpt) with chameleon effect</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

moderate class IV defect with no lingual wall presence of favorable occlusion and teeth are
in normal contact with the adjacent teeth good oral hygiene cooperative patients

-

Exclusion Criteria:

- tooth hypersensitivity severe periodontal affection non vital teeth heavy smoking
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>20 Years</minimum_age>
<maximum_age>45 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>sarah ahmed, master</last_name>
<role>Principal Investigator</role>
<affiliation>Cairo University</affiliation>
</overall_official>
<overall_contact>
<last_name>sarah ahmed, master</last_name>
<phone>01015139628</phone>
<email>sarah.mohamed@dentistry.cu.edu.eg</email>
</overall_contact>
<verification_date>July 2022</verification_date>
<study_first_submitted>March 17, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>July 18, 2022</last_update_submitted>
<last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">July 19, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Cairo University</investigator_affiliation>
<investigator_full_name>sarah ali mohamed ahmed</investigator_full_name>
<investigator_title>Master's degree student-faculty of dentistry</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Tooth Discoloration</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>The aim of the study is to compare the shade matching and clinical performance of shade blocker versus chameleon effect of two single-shade universal resin composite in class IV restorations over 1year evaluation period.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_time_frame>The restorations will be evaluated at T1= after 1 week T2= 3months T3= 6 months T4= 12 months</ipd_time_frame>
<ipd_access_criteria>Patients with class IV defects (due to caries lesions, trauma…etc.)
Young adult (20 : 40 years old)
Good oral hygiene
Co-operative patients approving to participate in the study</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Aim of this study will be conducted to compare the shade matching and clinical performance of
shade blocker versus chameleon effect of two single-shade of universal resin composite in
class IV restorations over 1 year evaluation period
The color matching of both groups will be evaluated visually using modified USPH criteria
Inclusion Criteria:
moderate class IV defect with no lingual wall presence of favorable occlusion and teeth are
in normal contact with the adjacent teeth good oral hygiene cooperative patients
-
Exclusion Criteria:
- tooth hypersensitivity severe periodontal affection non vital teeth heavy smoking
|
NCT0531xxxx/NCT05315531.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/NCT05315531</url>
</required_header>
<id_info>
<org_study_id>WatUP</org_study_id>
<nct_id>NCT05315531</nct_id>
</id_info>
<brief_title>The Effects of Hydration on Gut Health and Thinking</brief_title>
<acronym>WatUP</acronym>
<official_title>Investigating the Effects of Increased Water Consumption on Markers of Gut Health, Microbiota, and Executive Function</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Illinois at Urbana-Champaign</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Division of Nutritional Sciences, University of Illinois at Urbana-Champaign</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>University of Illinois at Urbana-Champaign</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 central hypothesis is that improving hydration through increased water consumption will
change the relative abundance of mucolytic bacteria found in the stool. Therefore the
specific aims are 1) to quantify intervention effects on fecal microbiota relative abundance
and plasma lipopolysaccharide binding protein, 2) observe the effects of the intervention on
bowel frequency and signs/symptoms of gastrointestinal stress, and 3) to investigate
relations between executive function and hydration status.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
A single arm 3-week hydration intervention will be employed where participants increase their
water consumption to 2 (F) or 2.5(M) liters per day which is approximately 70% of the AI for
daily water consumption. Pre-test and follow-up measures of fecal microbiota, urinary
hydration status, cognitive function, circulating markers, and dietary intake will be
assessed at baseline and at 3-week follow up via laboratory visits.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">August 23, 2021</start_date>
<completion_date type="Anticipated">May 31, 2023</completion_date>
<primary_completion_date type="Anticipated">May 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>Single arm hydration water intake intervention with a baseline urine concentration threshold for eligibility</intervention_model_description>
<primary_purpose>Prevention</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Fecal microbiota relative abundance</measure>
<time_frame>3 weeks (baseline vs. follow-up)</time_frame>
<description>changes in the relative abundance of fecal microbiota</description>
</primary_outcome>
<primary_outcome>
<measure>Plasma lipopolysaccharide (LPS)</measure>
<time_frame>3 weeks (baseline vs. follow-up)</time_frame>
<description>changes in circulating LPS</description>
</primary_outcome>
<secondary_outcome>
<measure>Copeptin</measure>
<time_frame>3 weeks (baseline vs. follow-up)</time_frame>
<description>changes in plasma copeptin concentration</description>
</secondary_outcome>
<secondary_outcome>
<measure>24hr Urine Osmolality</measure>
<time_frame>3 weeks (baseline vs. follow-up)</time_frame>
<description>changes in osmolality (mOsmol/kg) of urine samples</description>
</secondary_outcome>
<secondary_outcome>
<measure>Attentional accuracy</measure>
<time_frame>3 weeks (baseline vs. follow-up)</time_frame>
<description>Accuracy (%) on a computerized flanker task</description>
</secondary_outcome>
<secondary_outcome>
<measure>Attentional Reaction Time</measure>
<time_frame>3 weeks (baseline vs. follow-up)</time_frame>
<description>Reaction time (ms) on a computerized flanker task</description>
</secondary_outcome>
<secondary_outcome>
<measure>Attentional processing speed</measure>
<time_frame>3 weeks (baseline vs. follow-up)</time_frame>
<description>P3 event related potential latency (ms) using a computerized flanker task</description>
</secondary_outcome>
<secondary_outcome>
<measure>24hr Urine Specific Gravity</measure>
<time_frame>3 weeks (baseline vs. follow-up)</time_frame>
<description>changes in specific gravity (USG) of urine samples</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">50</enrollment>
<condition>Dehydration</condition>
<condition>Cognitive Change</condition>
<condition>Gastrointestinal Microbiota</condition>
<arm_group>
<arm_group_label>Water Intake</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>3-week intervention period during which articipants will be asked to increase their daily plain water consumption to at least 2.5 L/d of water for males and 2L/d for females.</description>
</arm_group>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Water Intake</intervention_name>
<description>Participants will increase plain water consumption to at least 70% of the daily adequate intake for Americans depending on their sex.</description>
<arm_group_label>Water Intake</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- 19-50 years of age

- 18.5-34.49 kg/m2

- 24-hour UOsm above 500 mOsm/kg

- No antibiotic use over the past 3 months

- Absence of metabolic diseases and use of diuretics

- Agree to maintain typical diet intake (e.g., dietary fiber) patterns during
intervention

- Avoid consuming prebiotic and probiotic supplements during study participation

- Not pregnant

- Agree to follow the study protocol

Exclusion Criteria:

- <19 or >50 years of age

- <18.5 or >34.49 kg/m2

- 24-hour UOsm <500 mOsm/kg

- Antibiotic use over the past 3 months

- Metabolic diseases and use of diuretics

- Not agree to maintain typical diet intake (e.g., dietary fiber) patterns for the
duration of the

- intervention

- Not agree with avoiding consuming prebiotic and probiotic supplements during study
participation

- Pregnant

- Not agree to follow study protocol
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>19 Years</minimum_age>
<maximum_age>50 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Naiman A Khan, PhD, RD</last_name>
<phone>217-300-2197</phone>
<email>nakhan2@illinois.edu</email>
</overall_contact>
<location>
<facility>
<name>University of Illinois at Urbana-Champaign</name>
<address>
<city>Urbana</city>
<state>Illinois</state>
<zip>61801</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Naiman A Khan, PhD, RD</last_name>
<phone>217-300-2197</phone>
<email>nakhan2@illinois.edu</email>
</contact>
<investigator>
<last_name>Naiman A Khan, PhD, RD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>October 1, 2021</study_first_submitted>
<study_first_submitted_qc>April 6, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Illinois at Urbana-Champaign</investigator_affiliation>
<investigator_full_name>Naiman Khan</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>Dehydration</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 central hypothesis is that improving hydration through increased water consumption will
change the relative abundance of mucolytic bacteria found in the stool. Therefore the
specific aims are 1) to quantify intervention effects on fecal microbiota relative abundance
and plasma lipopolysaccharide binding protein, 2) observe the effects of the intervention on
bowel frequency and signs/symptoms of gastrointestinal stress, and 3) to investigate
relations between executive function and hydration status.
A single arm 3-week hydration intervention will be employed where participants increase their
water consumption to 2 (F) or 2.5(M) liters per day which is approximately 70% of the AI for
daily water consumption. Pre-test and follow-up measures of fecal microbiota, urinary
hydration status, cognitive function, circulating markers, and dietary intake will be
assessed at baseline and at 3-week follow up via laboratory visits.
Inclusion Criteria:
- 19-50 years of age
- 18.5-34.49 kg/m2
- 24-hour UOsm above 500 mOsm/kg
- No antibiotic use over the past 3 months
- Absence of metabolic diseases and use of diuretics
- Agree to maintain typical diet intake (e.g., dietary fiber) patterns during
intervention
- Avoid consuming prebiotic and probiotic supplements during study participation
- Not pregnant
- Agree to follow the study protocol
Exclusion Criteria:
- <19 or >50 years of age
- <18.5 or >34.49 kg/m2
- 24-hour UOsm <500 mOsm/kg
- Antibiotic use over the past 3 months
- Metabolic diseases and use of diuretics
- Not agree to maintain typical diet intake (e.g., dietary fiber) patterns for the
duration of the
- intervention
- Not agree with avoiding consuming prebiotic and probiotic supplements during study
participation
- Pregnant
- Not agree to follow study protocol
|
NCT0531xxxx/NCT05315544.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/NCT05315544</url>
</required_header>
<id_info>
<org_study_id>CLN-0015-P</org_study_id>
<nct_id>NCT05315544</nct_id>
</id_info>
<brief_title>Cardiovascular Systems Inc. (CSI) pVAD First in Human Study</brief_title>
<official_title>CSI Percutaneous Ventricular Assist Device (pVAD) First in Human Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Abbott Medical Devices</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
<collaborator>
<agency>Clinical Accelerator</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Abbott Medical Devices</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>Yes</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
This study will collect initial clinical data on the CSI pVAD system to inform device design
and finalization.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">March 14, 2022</start_date>
<completion_date type="Actual">March 16, 2022</completion_date>
<primary_completion_date type="Actual">March 16, 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>Device Feasibility</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Procedural success</measure>
<time_frame>Intraprocedural</time_frame>
<description>Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system</description>
</primary_outcome>
<primary_outcome>
<measure>Intraprocedural Major Device-Related Adverse Events</measure>
<time_frame>24-hours Post-Index Procedure</time_frame>
<description>Composite incidence of:
Cardiovascular death
Clinically significant myocardial infarction (MI) defined as the composite of MI events per Society for Cardiovascular Angiography and Intervention (SCAI) periprocedural MI and Fourth Universal MI definitions
Any repeat revascularization (PCI or CABG)
Stroke defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.</description>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">5</enrollment>
<condition>Coronary Artery Disease</condition>
<arm_group>
<arm_group_label>CSI pVAD</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>CSI pVAD system</intervention_name>
<description>The CSI percutaneous ventricular assist device (pVAD) is being investigated as a temporary left ventricular system intended to support and/or provide hemodynamic stability during high-risk percutaneous coronary interventions.</description>
<arm_group_label>CSI pVAD</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Male or non- pregnant female ≥ 18 years of age

2. Life expectancy ≥ 1 year

3. Ejection Fraction (EF) >15% and ≤ 40%

4. Scheduled for an elective high risk percutaneous coronary intervention

Exclusion Criteria:

1. Hemodynamically unstable MI with elevated cardiac biomarker and no evidence of at
least 1 consecutive CK-MB or troponin value trending downward from a previous value OR
ST-Elevation Myocardial Infarction (STEMI) within 14 days of Index Procedure

2. Pre-Procedure cardiac arrest within 24 hours of enrollment requiring cardiopulmonary
resuscitation

3. Cardiogenic shock

4. Left ventricular (LV) mural thrombus

5. Presence of a prosthetic valve or a heart constrictive device

6. Aortic stenosis

7. Moderate or severe aortic regurgitation (≥ 2+ by echo)

8. Severe peripheral vascular disease that will preclude the use of a 12F access sheath,
which is required for the insertion of the CSI pVAD catheter

9. Severe aortic tortuosity

10. Severe aortic calcification

11. Vasculature will not tolerate a right heart catheterization

12. Renal dysfunction (serum creatinine ≥ 2.5 mg/dl) or requirement for hemodialysis

13. Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3X upper
lab normal (ULN) or Internationalized Normalized Ratio (INR) ≥ 2 or lactate
dehydrogenase (LDH) > 2.5X ULN

14. Uncorrectable abnormal coagulation parameters

15. History of heparin induced thrombocytopenia

16. Sustained ventricular tachycardia

17. Stroke or transient ischemic attack (TIA) within 6 months or any permanent
neurological deficit

18. Chronic anemia (hemoglobin < 8 g/dL)

19. Subject may require long term support with a commercially available hemodynamic
support device

20. Active systemic infection requiring oral or intravenous antibiotics

21. Allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or
antiplatelet therapy drugs that cannot be adequately premedicated

22. Allergy or intolerance to system components

23. Participation in another investigational drug or device 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>Jeff Chambers, MD</last_name>
<role>Study Director</role>
<affiliation>Abbott Medical Devices</affiliation>
</overall_official>
<location>
<facility>
<name>Tbilisi Heart & Vascular</name>
<address>
<city>Tbilisi</city>
<country>Georgia</country>
</address>
</facility>
</location>
<location_countries>
<country>Georgia</country>
</location_countries>
<verification_date>May 2022</verification_date>
<study_first_submitted>March 26, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>May 2, 2022</last_update_submitted>
<last_update_submitted_qc>May 2, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">May 3, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>pVAD</keyword>
<keyword>High risk PCI</keyword>
<keyword>Cardiovascular Systems, Inc.</keyword>
<keyword>Mechanical Circulatory Support (MCS)</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Coronary Artery Disease</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 collect initial clinical data on the CSI pVAD system to inform device design
and finalization.
Inclusion Criteria:
1. Male or non- pregnant female ≥ 18 years of age
2. Life expectancy ≥ 1 year
3. Ejection Fraction (EF) >15% and ≤ 40%
4. Scheduled for an elective high risk percutaneous coronary intervention
Exclusion Criteria:
1. Hemodynamically unstable MI with elevated cardiac biomarker and no evidence of at
least 1 consecutive CK-MB or troponin value trending downward from a previous value OR
ST-Elevation Myocardial Infarction (STEMI) within 14 days of Index Procedure
2. Pre-Procedure cardiac arrest within 24 hours of enrollment requiring cardiopulmonary
resuscitation
3. Cardiogenic shock
4. Left ventricular (LV) mural thrombus
5. Presence of a prosthetic valve or a heart constrictive device
6. Aortic stenosis
7. Moderate or severe aortic regurgitation (≥ 2+ by echo)
8. Severe peripheral vascular disease that will preclude the use of a 12F access sheath,
which is required for the insertion of the CSI pVAD catheter
9. Severe aortic tortuosity
10. Severe aortic calcification
11. Vasculature will not tolerate a right heart catheterization
12. Renal dysfunction (serum creatinine ≥ 2.5 mg/dl) or requirement for hemodialysis
13. Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3X upper
lab normal (ULN) or Internationalized Normalized Ratio (INR) ≥ 2 or lactate
dehydrogenase (LDH) > 2.5X ULN
14. Uncorrectable abnormal coagulation parameters
15. History of heparin induced thrombocytopenia
16. Sustained ventricular tachycardia
17. Stroke or transient ischemic attack (TIA) within 6 months or any permanent
neurological deficit
18. Chronic anemia (hemoglobin < 8 g/dL)
19. Subject may require long term support with a commercially available hemodynamic
support device
20. Active systemic infection requiring oral or intravenous antibiotics
21. Allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or
antiplatelet therapy drugs that cannot be adequately premedicated
22. Allergy or intolerance to system components
23. Participation in another investigational drug or device study
|
NCT0531xxxx/NCT05315557.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/NCT05315557</url>
</required_header>
<id_info>
<org_study_id>ILBS-Cirrhosis-48</org_study_id>
<nct_id>NCT05315557</nct_id>
</id_info>
<brief_title>Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic Shock- the VITEL-C Trial</brief_title>
<official_title>Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic Shock- the VITEL-C Trial.</official_title>
<sponsors>
<lead_sponsor>
<agency>Institute of Liver and Biliary Sciences, India</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Institute of Liver and Biliary Sciences, India</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>
Sepsis is a life-threatening organ dysfunction caused by dysregulated host response. A Subset
of sepsis is septic shock which has almost 4-6 times the mortality when compared to sepsis.
Septic shock has underlying cellular and metabolic abnormalities in addition to circulatory
dysfunction. The circulatory dysfunction in sepsis is in the form of severe vasodilatation
with high cardiac index. Cirrhosis is a state of hyperdynamic circulation. The mortality of
septic shock in these group of patients is still higher.

At the onset of septic shock there is initially an increased secretion of Arginine
vasopressin. However, this initial rise is short lasting, and the vasopressin levels come
back to normal or low serum levels with continued hypotension. However, even normal levels
are too low for the degree of hypotension in septic shock. This causes a relative deficiency
of vasopressin in septic shock. The exact time when this fall happens is not known and it is
likely to be variable. Vasopressin was therefore tried as an agent in septic shock.
Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1
receptor. Terlipressin is also shown to be effective in septic shock in cirrhotics3. Other
vasoactive agents are not preferred in cirrhotics - dopamine due to high risk of arrhythmias
and dobutamine as baseline cardiac output of cirrhotics is high which further increases in
sepsis and dobutamine would further add to it. However, it may be given in myocardial
dysfunction. Noradrenaline is recommended as the first vasopressor to be started in general
in septic shock population. No study has compared the effectiveness of vasopressin and
Terlipressin when added to noradrenaline in patients with cirrhosis. Acute kidney injury is a
very common complication of septic shock in cirrhotics.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Hypothesis: We hypothesise that vasopressin would be non-inferior to terlipressin as a second
vasopressor in critically ill cirrhotics with septic shock and would have lesser adverse
effects when compared to terlipressin.

Aim: To compare the efficacy of adding continuous infusion of terlipressin versus vasopressin
to noradrenaline in causing improvement in systemic hemodynamics and microcirculation.

Methodology:

Study population:

1. Critically ill cirrhotic - Defined as a cirrhotic patient who presents with at least one
organ failure, defined by SOFA score WITH

2. septic shock - Defined as a patient in septic shock after initial fluid resuscitation
and antibiotic administration, requiring a noradrenaline of at least 2.6mcg/min to
maintain a MAP more than 65mmHg.

Study design: Prospective open label randomised controlled study. The study will be conducted
in Department of Hepatology ILBS- intensive care unit.

Study period: 1 year

Sample size: Based on the previous studies it is assumed that terlipressin + noradrenaline
group would give a response rate of 93%, it was assumed that vasopressin and noradrenaline
would give a response rate 15% less than the terlipressin and noradrenaline group and a
response rate of 78% was assumed. Further considering an alpha error of 5% and power 95% with
a non-inferiority margin of 10% we need to enroll 82 cases Assuming a 10% dropout rate we
need to enroll 90 cases with 45 in each arm. However, we decided to enroll 100 cases
randomized into 2 groups, 50 each by block randomization method by taking a block size of 10

Patients will be evaluated in the Emergency Room. Detailed history and clinical examination
and investigation accordingly will be sent when septic shock is clinically suspected

Fluid Resuscitation Initially a 16G peripheral line will be placed. CVP line and arterial
line preferably in the radial artery will be placed as soon as possible.

5% albumin will be used as the resuscitation fluids according to the FRISC protocol.

Fluid response will be assessed at the end of 1 hour

Antibiotics Antibiotics will be given according to the institutional policy

Vasopressors Noradrenaline will be started at a dose of 0.05mcg/kg/min and titrated. All the
infusions will be given via central line placed in the jugular, subclavian or femoral vein by
a critical care expert under USG guidance.

Intervention:Patients after screening for all exclusion criteria will be randomised into 2
arms (group-1, Terlipressin arm) and (group-2, Vasopressin arm) in a ratio 1:1

- STATISTICAL ANALYSIS: Continuous data- Student's t test

- Nonparametric analysis- Mann Whitney test

- Survival outcome By Kaplan-Meier method curve.

- For all tests, p≤ 0.05 will be considered statistically significant.

- Analysis will be performed using SPSS.

- The analysis will be done with intention to treat and per protocol analysis if
applicable.

Stopping rule: Side effects or toxicities that are severe -arrhythmia, AMI, Cardiomyopathy
(defined later) Cyanosis.

- Suspicion or confirmed bowel ischemia.

- Patient unwilling for further hospital stay.

- Study unrelated complication here the drug effects could not be assessed (massive

- GI bleed uncontrolled, bowel perforation or any surgical intervention).
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 5, 2022</start_date>
<completion_date type="Anticipated">March 31, 2023</completion_date>
<primary_completion_date type="Anticipated">March 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>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Improvement in systemic hemodynamics at 6 hours after randomization</measure>
<time_frame>6 hours after randomization</time_frame>
<description>Improvement in systemic hemodynamics defined as discontinuation of noradrenaline infusion OR reversal of shock</description>
</primary_outcome>
<secondary_outcome>
<measure>Reduction in dose of noradrenaline at the end of 6 hours</measure>
<time_frame>6 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Amount of noradrenaline requirements between in each arm at the end of 6 hours</measure>
<time_frame>6 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in Systemic Vascular Resistance (SVR) by 10% or above 500 at 6 hours</measure>
<time_frame>6 hours</time_frame>
<description>Systemic Vascular Resistance will be measured by using pulmonary thermodilution</description>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in SVR by 10% or above 500 at 12 hours</measure>
<time_frame>12 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in SVR by 10% or above 500 at 48 hours</measure>
<time_frame>48 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Decrease in Cardiac output by 10% or less than 6L after 6 hours of randomization</measure>
<time_frame>6 hour of randomization</time_frame>
<description>Cardiac output will be measured by using pulmonary thermodilution</description>
</secondary_outcome>
<secondary_outcome>
<measure>KDIGO criteria - increase in urine output in 6 hours</measure>
<time_frame>6 hour</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>KDIGO criteria - increase in urine output in 12 hours.</measure>
<time_frame>12 hour</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>KDIGO criteria - increase in urine output in 24 hours</measure>
<time_frame>24 hour</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>KDIGO criteria - increase in urine output in 48 hours.</measure>
<time_frame>48 hour</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>improvement in serum creatinine in 24 (Improvement in KDIGO stage at 24)</measure>
<time_frame>24 hour</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in serum creatinine in 48 hours (Improvement in KDIGO stage at 48 hours)</measure>
<time_frame>48 hour</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Need of Renal Replacement Therapy</measure>
<time_frame>Day 28</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in microcirculation as measured by improvement in lactate</measure>
<time_frame>6 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in microcirculation as measured by improvement in capillary refill time at 6 hours</measure>
<time_frame>6 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in microcirculation as measured by Near IR spectroscopy ina subset of patients whenever feasible</measure>
<time_frame>6 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in microcirculation as measured by improvement in lactate</measure>
<time_frame>24 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in microcirculation as measured by improvement in capillary refill time at 24 hours.</measure>
<time_frame>24 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in microcirculation as measured by Near IR spectroscopy ina subset of patients whenever feasible</measure>
<time_frame>24 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in microcirculation as measured by improvement in lactate</measure>
<time_frame>48 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in microcirculation as measured by improvement in capillary refill time at 48 hours.</measure>
<time_frame>48 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in microcirculation as measured by Near IR spectroscopy ina subset of patients whenever feasible</measure>
<time_frame>48 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in renal resistive index at 24 hours</measure>
<time_frame>24 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Improvement in renal resistive index at 48 hours</measure>
<time_frame>48 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of adverse effects till 48 hours after randomization including incidence of rebound hypertension</measure>
<time_frame>48 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Mortality at day 28</measure>
<time_frame>Day 28</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Days of mechanical ventilation</measure>
<time_frame>Day 28</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Days of Intensive Care Unit stay.</measure>
<time_frame>Day 28</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Endothelial function will be measured in a subset of patients</measure>
<time_frame>48 hours</time_frame>
<description>Endothelial function will be assessed from a change in endothelin-1 and von Willebrand Factor (vWF) levels in a subset of patients whereever feasible</description>
</secondary_outcome>
<secondary_outcome>
<measure>Coagulation function will measure in a subset of patients</measure>
<time_frame>48 hours</time_frame>
<description>Coagulation function will be measured by change in rotational thromboelastometry test</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">100</enrollment>
<condition>Septic Shock</condition>
<condition>Cirrhosis, Liver</condition>
<arm_group>
<arm_group_label>Terlipressin</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Terlipressin 1mg/24 hours</description>
</arm_group>
<arm_group>
<arm_group_label>Vasopressin</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Vasopressin 0.03 U/hour</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Terlipressin</intervention_name>
<description>1mg/24 hour and titrate according to MAP</description>
<arm_group_label>Terlipressin</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>vasopressin</intervention_name>
<description>0.03 U/hour and titrate according to MAP</description>
<arm_group_label>Vasopressin</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Age 18-70yrs

2. An informed consent from the patient or relative

Exclusion Criteria:

1. Age <18 years and > 70 years

2. Stroke

3. Severe sepsis requiring higher dose of noradrenaline (>1mcg/Kg/min)

4. Myocardial dysfunction, Coronary artery disease, Arrhythmias

5. Peripheral Vascular disease

6. Gut Paralysis

7. Acute on chronic liver failure (ACLF)

8. Hepato-cellular carcinoma (HCC), intrahepatic or extrahepatic malignancy

9. Complete portal vein thrombosis

10. Hepatic vein outflow tract obstruction (HVOTO)

11. Pregnancy

12. Patients with Pa02/FiO2 ratio <150

13. CKD

14. COPD

15. Severe coagulopathy - platelets <20,000 and INR > 4

16. Active Bleed or DIC

17. Patients already on terlipressin or vasopressin in the last 48 hours

18. Extremely moribund patients with an expected life expectancy of less than 24 hours

19. Failure to give informed consent from family members.

20. Patient enrolled in other clinical trial
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Dr Vishnu Girish, MD</last_name>
<phone>01146300000</phone>
<email>vishnugirish@gmail.com</email>
</overall_contact>
<location>
<facility>
<name>Institute of Liver & Biliary Sciences</name>
<address>
<city>New Delhi</city>
<state>Delhi</state>
<zip>110070</zip>
<country>India</country>
</address>
</facility>
<contact>
<last_name>Dr Vishnu Girish, MD</last_name>
<phone>01146300000</phone>
<email>vishnugirish@gmail.com</email>
</contact>
</location>
<location_countries>
<country>India</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 7, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 30, 2022</last_update_submitted>
<last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 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>Shock, Septic</mesh_term>
<mesh_term>Liver Cirrhosis</mesh_term>
<mesh_term>Shock</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Terlipressin</mesh_term>
<mesh_term>Vasopressins</mesh_term>
<mesh_term>Arginine Vasopressin</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Sepsis is a life-threatening organ dysfunction caused by dysregulated host response. A Subset
of sepsis is septic shock which has almost 4-6 times the mortality when compared to sepsis.
Septic shock has underlying cellular and metabolic abnormalities in addition to circulatory
dysfunction. The circulatory dysfunction in sepsis is in the form of severe vasodilatation
with high cardiac index. Cirrhosis is a state of hyperdynamic circulation. The mortality of
septic shock in these group of patients is still higher.
At the onset of septic shock there is initially an increased secretion of Arginine
vasopressin. However, this initial rise is short lasting, and the vasopressin levels come
back to normal or low serum levels with continued hypotension. However, even normal levels
are too low for the degree of hypotension in septic shock. This causes a relative deficiency
of vasopressin in septic shock. The exact time when this fall happens is not known and it is
likely to be variable. Vasopressin was therefore tried as an agent in septic shock.
Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1
receptor. Terlipressin is also shown to be effective in septic shock in cirrhotics3. Other
vasoactive agents are not preferred in cirrhotics - dopamine due to high risk of arrhythmias
and dobutamine as baseline cardiac output of cirrhotics is high which further increases in
sepsis and dobutamine would further add to it. However, it may be given in myocardial
dysfunction. Noradrenaline is recommended as the first vasopressor to be started in general
in septic shock population. No study has compared the effectiveness of vasopressin and
Terlipressin when added to noradrenaline in patients with cirrhosis. Acute kidney injury is a
very common complication of septic shock in cirrhotics.
Hypothesis: We hypothesise that vasopressin would be non-inferior to terlipressin as a second
vasopressor in critically ill cirrhotics with septic shock and would have lesser adverse
effects when compared to terlipressin.
Aim: To compare the efficacy of adding continuous infusion of terlipressin versus vasopressin
to noradrenaline in causing improvement in systemic hemodynamics and microcirculation.
Methodology:
Study population:
1. Critically ill cirrhotic - Defined as a cirrhotic patient who presents with at least one
organ failure, defined by SOFA score WITH
2. septic shock - Defined as a patient in septic shock after initial fluid resuscitation
and antibiotic administration, requiring a noradrenaline of at least 2.6mcg/min to
maintain a MAP more than 65mmHg.
Study design: Prospective open label randomised controlled study. The study will be conducted
in Department of Hepatology ILBS- intensive care unit.
Study period: 1 year
Sample size: Based on the previous studies it is assumed that terlipressin + noradrenaline
group would give a response rate of 93%, it was assumed that vasopressin and noradrenaline
would give a response rate 15% less than the terlipressin and noradrenaline group and a
response rate of 78% was assumed. Further considering an alpha error of 5% and power 95% with
a non-inferiority margin of 10% we need to enroll 82 cases Assuming a 10% dropout rate we
need to enroll 90 cases with 45 in each arm. However, we decided to enroll 100 cases
randomized into 2 groups, 50 each by block randomization method by taking a block size of 10
Patients will be evaluated in the Emergency Room. Detailed history and clinical examination
and investigation accordingly will be sent when septic shock is clinically suspected
Fluid Resuscitation Initially a 16G peripheral line will be placed. CVP line and arterial
line preferably in the radial artery will be placed as soon as possible.
5% albumin will be used as the resuscitation fluids according to the FRISC protocol.
Fluid response will be assessed at the end of 1 hour
Antibiotics Antibiotics will be given according to the institutional policy
Vasopressors Noradrenaline will be started at a dose of 0.05mcg/kg/min and titrated. All the
infusions will be given via central line placed in the jugular, subclavian or femoral vein by
a critical care expert under USG guidance.
Intervention:Patients after screening for all exclusion criteria will be randomised into 2
arms (group-1, Terlipressin arm) and (group-2, Vasopressin arm) in a ratio 1:1
- STATISTICAL ANALYSIS: Continuous data- Student's t test
- Nonparametric analysis- Mann Whitney test
- Survival outcome By Kaplan-Meier method curve.
- For all tests, p≤ 0.05 will be considered statistically significant.
- Analysis will be performed using SPSS.
- The analysis will be done with intention to treat and per protocol analysis if
applicable.
Stopping rule: Side effects or toxicities that are severe -arrhythmia, AMI, Cardiomyopathy
(defined later) Cyanosis.
- Suspicion or confirmed bowel ischemia.
- Patient unwilling for further hospital stay.
- Study unrelated complication here the drug effects could not be assessed (massive
- GI bleed uncontrolled, bowel perforation or any surgical intervention).
Inclusion Criteria:
1. Age 18-70yrs
2. An informed consent from the patient or relative
Exclusion Criteria:
1. Age <18 years and > 70 years
2. Stroke
3. Severe sepsis requiring higher dose of noradrenaline (>1mcg/Kg/min)
4. Myocardial dysfunction, Coronary artery disease, Arrhythmias
5. Peripheral Vascular disease
6. Gut Paralysis
7. Acute on chronic liver failure (ACLF)
8. Hepato-cellular carcinoma (HCC), intrahepatic or extrahepatic malignancy
9. Complete portal vein thrombosis
10. Hepatic vein outflow tract obstruction (HVOTO)
11. Pregnancy
12. Patients with Pa02/FiO2 ratio <150
13. CKD
14. COPD
15. Severe coagulopathy - platelets <20,000 and INR > 4
16. Active Bleed or DIC
17. Patients already on terlipressin or vasopressin in the last 48 hours
18. Extremely moribund patients with an expected life expectancy of less than 24 hours
19. Failure to give informed consent from family members.
20. Patient enrolled in other clinical trial
|
NCT0531xxxx/NCT05315570.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/NCT05315570</url>
</required_header>
<id_info>
<org_study_id>INT 267-21</org_study_id>
<nct_id>NCT05315570</nct_id>
</id_info>
<brief_title>Big Data for Quality of Life in Head and Neck Cancer</brief_title>
<acronym>BD4QoL</acronym>
<official_title>A Multicenter Randomized Trial for Quality of Life Evaluation by Non-invasive Intelligent Tools During Post-curative Treatment Follow-up for Head and Neck Cancer</official_title>
<sponsors>
<lead_sponsor>
<agency>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>University of Birmingham</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University Hospital Birmingham NHS Foundation Trust</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Dotsoft Olokliromenes Efarmoges Diadiktioy kai Vaseon Dedomenon AE</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>IBM Ireland limited</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>INETUM</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Multimed Engineers srl</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Regione Lombardia</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Universidad de la Iglesia de Deusto Entidad Religiosa</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Universidad Politecnica de Madrid</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of Milan</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of Oslo</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Johannes Gutenberg University Mainz</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Aria S.p.A.</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of Bristol</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Casa Sollievo della Sofferenza IRCCS</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</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>
Depending on disease stage, head and neck cancer (HNC) can be cured either with a single
modality or with multimodal treatments, consisting of various combinations of surgery,
radiotherapy, and chemotherapy. Despite treatment with curative intent, loco-regional
recurrences and/or distant relapses are frequent. Moreover, these therapeutic approaches
result in significant acute toxicities and late sequelae. Therefore, quality of life (QoL) is
often impaired in these survivors. It is known that QoL is a prognostic factor because it is
related to overall survival in cancer patients and to loco-regional control in HNC patients.

The adoption of mobile technologies of common use (i.e. embedded into standard mobile phones)
for behavior reconstruction and linkage of behavior modifications to quality of life
indicators, and the realization of predictive models for quality of life modifications will
allow seamless and unobtrusive data capture over time, making the execution of clinical
investigations more precise and less burdensome as compared to standard (manual) data
capture.

The main aim of the present study is to reduce and to anticipate, with the use of the
non-invasive Big data for quality of life (BD4QoL) platform, the proportion of HNC survivors
experiencing a clinically meaningful reduction in QoL.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The BD4QoL platform consists of a set of services to allow patient monitoring and
empowerment, through two main tools: Point of Care application to manage all patients data
and follow-up by clinical investigators, and a mobile application (App) installed on
participating subject's smartphone. Also, a web-form tool is delivered to allow the QoL
questionnaire completion.

To achieve the study objectives, the BD4QoL platform will use the following sensors embedded
in a smartphone to collect data which will be used to identify behavioral and affective
traits associated with study outcomes. Sensors at mobile phone used to collect relevant data
are the following:

- Accelerometer (x,y,z measurements)

- Global Positioning System - GPS (Lat, Long)

- Ambient light (measurement of light in the room / area where the mobile device is
located)

- Screen (Status ON or OFF for smartphone device screen)

- Activity (type of activity with which the person engages,which can be one of these:
Still, Walking, Running, On_Bicycle, In_Vehicle)

- Steps (total number of steps per day and per hour)

- Daily connections to wifi networks (naming of wifi connections as well as corresponding
duration)

- Data detected from the mobile device's operating system (phone usage logs, phone
applications usage) and from external datasets (steps, identification of places (Points
of Interest) visited based on participant's permissions, through the correlation of
one's GPS signal with external datasets from Foursquare and OpenStreet maps) The above
data will be used to detect activities and behaviors which have a high likelihood of
being meaningfully related with participants' QoL trajectories.

The BD4QoL App, available for Android, will be able to collect and store data about the
following domains: mobility, physical activity, activities of daily living, instrumental
activities of daily living, socialization, cognitive function, health related activities as
well as affective personal data. A summary of the findings and the supporting data will be
available to the patient and clinical investigators , through a dashboard available on mobile
devices for patients and through the Point of Care (PoC) web tool for clinical investigators.
The data collected by the mobile App will not be available to the technology manufacturer and
will be transferred in almost-real-time (real-time when possible, as soon as data transfer is
available) to the central BD4QoL repository (as long as there is available storage in the
local memory storage of the mobile device).

In the interval between visits, study participants, allocated in the intervention arm, will
be able to interact electronically with a chatbot, which will be part of the BD4QoL platform,
implementation based on IBM Watson technology. The chatbot is an application to empower
patients to manage their QoL and health, under the supervision of clinical investigators. The
chatbot will have a series of e-coaching (electronic coaching) functions that include: (i)
dialogue management that allows the patient to be counselled by chatting electronically in a
structured and effective way; (ii) management of two-way communications with healthcare
professionals [e.g. for the patient to request specific support in case of special needs, or
for the chatbot to invite the patient for a visit in case of an early detection of
health-related QoL (HRQoL) or health issues; identified people will have to be listed on the
delegation log by the Principal Investigator (PI)]; (iii) detection of affective traits
embodied in the e-coach / patient dialogue, through sentiment analysis and emotion analysis
technologies to gather data about the participant mood. The latter element can be used to
both re-adapt the chatbot counselling strategy, as well as to provide additional information
on subjects mood to clinical investigators. The adverse events that the chatbot will be able
to recognise will be the following: fatigue, malaise, fever, excessive sleepiness, difficulty
sleeping, depression, change in social circumstances, neck swelling, facial pain, difficulty
breathing, nose bleeds, difficulty speaking, dry mouth, tooth loss, muscle weakness, ear
pain, difficulty hearing, tinnitus, vertigo, nausea, diarrhea, constipation, difficulty
seeing, dry eye, eye pain, nervous eyelid, eye floaters, swollen eye, bleeding eyes, eye
watering, sexuality issues, weight loss, difficulty swallowing, mouth sores, appetite loss,
difficulty opening mouth, difficulty eating, increased sensitivity to smells, no taste.

The platform will provide the investigators with real time data of device usage (e.g number
and type of alerts and chatbot interactions by patients) and it will integrate the electronic
case report forms (eCRFs) as a study monitoring dashboard.

The BD4QoL platform used in this trial is not to be considered a medical device and is used
for experimental assessment only. No drugs will be suggested by the automated chatbot
responses. Tips provided by the chatbot regarding detected symptoms are also not to be
considered clinical advice by any means and should not be a substitute for conversations with
a member of a trained medical personnel.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 28, 2022</start_date>
<completion_date type="Anticipated">January 1, 2025</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>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Multicenter, international, randomized (2:1 ratio), open-label, superiority trial</intervention_model_description>
<primary_purpose>Other</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Clinically meaningful deterioration of global QoL between at least 2 visits during post-treatment follow-up</measure>
<time_frame>6-24 months</time_frame>
<description>Proportion of HNC survivors experiencing a clinically meaningful global health-related EORTC QLQ-C30 QoL deterioration (decrease ≥10 points)</description>
</primary_outcome>
<secondary_outcome>
<measure>Time to the first clinically meaningful deterioration of global QoL between at least 2 visits during post-treatment follow-up</measure>
<time_frame>6-24 months</time_frame>
<description>Time to first clinically relevant deterioration of EORTC QLQ-C30 global score (decrease ≥10 points)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Clinically meaningful deterioration of pre-specified EORTC-QLQ-C30 scales QoL between at least 2 visits during post-treatment follow-up</measure>
<time_frame>6-24 months</time_frame>
<description>Pre-specified C30 scales (emotional functioning, role functioning, insomnia). Score range: 0-100 (higher score = higher/healthier level of functioning for emotional and role functioning; higher score = higher level of symptomatology / problems for insomnia)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Clinically meaningful deterioration of pre-specified EORTC-QLQ-HN43 scales QoL between at least 2 visits during post-treatment follow-up</measure>
<time_frame>6-24 months</time_frame>
<description>Pre-specified HN43 scales (swallowing, teeth, opening mouth, speech problems, trouble with social eating, fear of progression, emotional functioning, fatigue). Score range: 0-100 (higher score = higher/healthier level of functioning for emotional functioning; higher score = higher level of symptomatology / problems for the remaining specified scales)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Clinically meaningful deterioration of pre-specified EQ-5D-5L domains between at least 2 visits during post-treatment follow-up</measure>
<time_frame>6-24 months</time_frame>
<description>EQ-5D-5L domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). For each dimension, levels of perceived problems are coded from level 1 (minimum) to level 5 (maximum): no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5).</description>
</secondary_outcome>
<other_outcome>
<measure>Association of clinically relevant variations in QoL with disease recurrence and survival</measure>
<time_frame>24 months</time_frame>
<description>Association of DFS, EFS and OS with clinically relevant variations of EORTC QLQ-C30 and HN43 scales</description>
</other_outcome>
<other_outcome>
<measure>Correlation of time-dependent variations in QoL with disease-free survival (DFS)</measure>
<time_frame>24 months</time_frame>
<description>Correlation of DFS with time-dependent clinically relevant variations of EORTC QLQ-C30 and HN43 scales (variations > +10 points or < -10 points in each previously cited questionnaire scale)</description>
</other_outcome>
<other_outcome>
<measure>Correlation of time-dependent variations in QoL with event-free survival (EFS)</measure>
<time_frame>24 months</time_frame>
<description>Correlation of EFS with time-dependent clinically relevant variations of EORTC QLQ-C30 and HN43 scales (variations > +10 points or < -10 points in each previously cited questionnaire scale)</description>
</other_outcome>
<other_outcome>
<measure>Correlation of time-dependent variations in QoL with overall survival (OS)</measure>
<time_frame>24 months</time_frame>
<description>Correlation of OS with time-dependent clinically relevant variations of EORTC QLQ-C30 and HN43 scales (variations > +10 points or < -10 points in each previously cited questionnaire scale)</description>
</other_outcome>
<other_outcome>
<measure>Correlation of time-dependent variations in QoL with disease-free survival (DFS) in nasopharyngeal carcinoma</measure>
<time_frame>24 months</time_frame>
<description>Correlation of DFS with time-dependent clinically relevant variations of EORTC QLQ-C30 and HN43 scales (variations > +10 points or < -10 points in each previously cited questionnaire scale) in nasopharyngeal carcinoma patients</description>
</other_outcome>
<other_outcome>
<measure>Correlation of time-dependent variations in QoL with event-free survival (EFS) in nasopharyngeal carcinoma</measure>
<time_frame>24 months</time_frame>
<description>Correlation of EFS with time-dependent clinically relevant variations of EORTC QLQ-C30 and HN43 scales (variations > +10 points or < -10 points in each previously cited questionnaire scale) in nasopharyngeal carcinoma patients</description>
</other_outcome>
<other_outcome>
<measure>Correlation of time-dependent variations in QoL with overall survival (OS) in nasopharyngeal carcinoma</measure>
<time_frame>24 months</time_frame>
<description>Correlation of OS with time-dependent clinically relevant variations of EORTC QLQ-C30 and HN43 scales (variations > +10 points or < -10 points in each previously cited questionnaire scale) in nasopharyngeal carcinoma patients</description>
</other_outcome>
<other_outcome>
<measure>Clinically meaningful deterioration of further pre-specified EORTC-QLQ-HN43 scales QoL between at least 2 visits during post-treatment follow-up</measure>
<time_frame>6-24 months</time_frame>
<description>Pre-specified HN43 scales non included in secondary endpoints (pain, senses problems, body image, dry mouth, sticky saliva, coughing, trouble social contact, neurological problems, less sexuality, problems with shoulder, skin problems). Score range: 0-100 (higher score = higher level of symptomatology / problems)</description>
</other_outcome>
<other_outcome>
<measure>Development of predictive models through artificial intelligence techniques</measure>
<time_frame>24 months</time_frame>
<description>Association of health-related data recorded by the BD4QoL platform registered continuously within the study observation period (Data detected from the mobile device's operating system: Phone usage logs, Phone applications usage; Data from external datasets: steps, identification of places through the correlation of one's GPS signal per day with external datasets from Foursquare and OpenStreet maps) with clinically relevant variations of EORTC QLQ-C30 and HN43 scales (variations > +10 points or < -10 points in each previously cited questionnaire scale)</description>
</other_outcome>
<other_outcome>
<measure>Correlation of clinically relevant QoL variations with self-efficacy for coping with cancer</measure>
<time_frame>24 months</time_frame>
<description>Correlation of clinically relevant variations of EORTC QLQ-C30 and HN43 scales (variations > +10 points or < -10 points in each previously cited questionnaire scale) and CBI-B item scores. CBI-B consists of 12 items (rated 1 = not at all confident to 7 = totally confident) and is derived from the longer version of the Cancer Behavior Inventory (CBI). The CBI-B total score can be computed by averaging single item scores through arithmetic mean and, thus, ranges in value from 1 to 7.</description>
</other_outcome>
<other_outcome>
<measure>Clinically meaningful deterioration of global QoL according to time from treatment completion</measure>
<time_frame>24 months</time_frame>
<description>Analysis of the primary endpoint stratifying subjects according to timing after study completion (less than 12 months versus more than 12 months)</description>
</other_outcome>
<other_outcome>
<measure>Economic impact on HNC survivor care and the viability, usability, and trust of using the BD4QoL platform</measure>
<time_frame>24 months</time_frame>
<description>Incremental Cost-Effectiveness Ratio measured in €/QALY. Measures of viability, usability, and trust</description>
</other_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">420</enrollment>
<condition>Head and Neck Cancer</condition>
<condition>Survivorship</condition>
<condition>Quality of Life</condition>
<arm_group>
<arm_group_label>Intervention arm</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Study participants will be followed up as per clinical practice and will receive the investigational electronic platform, including an Android-based app. Study subjects will be asked to fill in questionnaires at study entry and during follow-up.</description>
</arm_group>
<arm_group>
<arm_group_label>Control arm</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>No specific mobile apps will be provided to study participants, who will be followed as per clinical practice. Study subjects will be asked to fill in questionnaires at study entry and during follow-up.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>BD4QoL platform</intervention_name>
<description>The BD4QoL platform consists of a set of services to allow patient monitoring and empowerment, through two main tools: Point of Care application to manage all patients data and follow-up by clinical investigators, and a mobile application (App) installed on participating subject's smartphone. Also, a web-form tool is delivered to allow the QoL questionnaire completion.</description>
<arm_group_label>Intervention arm</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Effectively cured histologically defined head and neck squamous cell carcinoma (HNSCC)
from one of these subsites: oral cavity, nasopharynx, hypopharynx, larynx, Human
Papillomavirus (HPV)-positive or negative oropharynx, nasal cavity, paranasal sinuses
(ICD codes in Annex 12). Non-metastatic salivary gland cancer (SGC) of any
histological type can be included only if curative or postoperative radiotherapy
included the neck:

1. For p16-negative or p16-unknown HNSCC (including nasal cavity and paranasal
sinuses), stage I, II, III, IVa or IVb (no IVc) according to UICC/AJCC 8th
edition22. Regional neck metastases from squamous cell carcinoma from unknown
primary head and neck sites are allowed.

2. For nasopharyngeal cancer (NPC), stage I, II, III, IVa (no IVb) according to
UICC/AJCC 8th edition22. Regional neck metastases from EBV-positive carcinoma
from unknown primary head and neck sites are allowed.

3. For SGCs, stage III, IVa or IVb according to UICC/AJCC 8th edition22 treated with
radiotherapy that included the neck (either post-operative radiation or radical
treatment in case of unresectable disease).

4. For p16-positive oropharyngeal squamous cell carcinoma, stage I, II or III
according to UICC/AJCC 8th edition22. Regional neck metastases from p16-positive
and/or HPV-positive squamous cell carcinoma from unknown primary head and neck
sites are allowed.

2. Patients having completed treatment with curative intent (including any single
modality or multimodal approach) within 10 years at the time of accrual.

3. Patients being disease-free at the time of accrual. Patients will be deemed in
complete remission if the clinical examination is negative for recurrence; clinical
examination should be preferably, but not mandatorily, integrated with unequivocal
radiological imaging that shows the absence of disease (in case of doubt, further
radiological imaging should be performed or integrated with cyto/histological samples
of the area with suspected disease persistence and the exams will have to be
consistently negative) after at least three months following treatment completion.

4. Ability to fill in questionnaires as per protocol.

5. Geographical accessibility and willingness to be followed-up for up to 2 years with
information-technology (IT) devices in addition to questionnaires.

6. Age ≥ 18 years.

7. Signed informed consent.

8. Willingness to use their smartphone and their Internet access for the study.

9. Smartphone having the following minimum characteristics:

1. RAM: Minimum of 2 GB

2. Storage: Minimum of 512 MB free storage

3. Operating system: Android version 7 (Nougat) or upper.

Exclusion Criteria:

1. Distant metastases (the following populations are excluded: stage IVc HPV-negative
HNSCC and SGC, stage IV p16-positive oropharyngeal squamous cell carcinoma, stage IVb
NPC).

2. Thyroid cancers, non-melanoma skin cancers (e.g. squamous cell carcinoma of the skin,
skin basal cell carcinoma, skin adnexal carcinoma), and non-carcinoma of the head and
neck area (e.g. melanoma, sarcoma, etc.) are excluded.

3. Subjects with previous malignancies (except localized non-melanoma skin cancers, and
the following in situ cancers: bladder, gastric, colon, esophageal, endometrial,
cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at
least 5 years prior to study entry AND no additional therapy is required during the
study period. Premalignant lesions (e.g. leukoplakia, erythroplakia, lichen etc.) are
allowed.

4. Participation in clinical trials with other experimental agents within 30 days of
study entry or concomitant treatment with experimental drugs.

5. Patients unable to comply with the protocol, in the opinion of the investigator.

6. Any known or underlying medical conditions that, in the opinion of the investigator,
could adversely affect the ability of the participating subject to comply with the
study.

7. Having a smartphone operating system other than Android.
</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>Carlo Resteghini, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori di Milano</affiliation>
</overall_official>
<overall_official>
<last_name>Alfonso Manfuso, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Fondazione Casa Sollievo della Sofferenza</affiliation>
</overall_official>
<overall_official>
<last_name>Paul Nankivell, MD</last_name>
<role>Principal Investigator</role>
<affiliation>University Hospital Birmingham NHS Foundation Trust</affiliation>
</overall_official>
<overall_contact>
<last_name>Lisa Licitra, MD, Prof</last_name>
<phone>+39 02 2390 2810</phone>
<email>bd4qol@unimi.it</email>
</overall_contact>
<overall_contact_backup>
<last_name>Stefano Cavalieri, MD</last_name>
</overall_contact_backup>
<location>
<facility>
<name>Fondazione IRCCS Istituto Nazionale dei Tumori</name>
<address>
<city>Milano</city>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Carlo Resteghini, MD</last_name>
</contact>
</location>
<location>
<facility>
<name>Fondazione Casa Sollievo della Sofferenza</name>
<address>
<city>San Giovanni Rotondo</city>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Alfonso Manfuso, MD</last_name>
</contact>
</location>
<location>
<facility>
<name>University Hospitals Birmingham NHS Foundation Trust</name>
<address>
<city>Birmingham</city>
<country>United Kingdom</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Hisham Mehanna, MD, Prof</last_name>
</contact>
<investigator>
<last_name>Paul Nankivell, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>Italy</country>
<country>United Kingdom</country>
</location_countries>
<verification_date>March 2023</verification_date>
<study_first_submitted>March 11, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 9, 2023</last_update_submitted>
<last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 13, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>mHealth</keyword>
<keyword>eHealth</keyword>
<keyword>remote monitoring</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Head and Neck Neoplasms</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Depending on disease stage, head and neck cancer (HNC) can be cured either with a single
modality or with multimodal treatments, consisting of various combinations of surgery,
radiotherapy, and chemotherapy. Despite treatment with curative intent, loco-regional
recurrences and/or distant relapses are frequent. Moreover, these therapeutic approaches
result in significant acute toxicities and late sequelae. Therefore, quality of life (QoL) is
often impaired in these survivors. It is known that QoL is a prognostic factor because it is
related to overall survival in cancer patients and to loco-regional control in HNC patients.
The adoption of mobile technologies of common use (i.e. embedded into standard mobile phones)
for behavior reconstruction and linkage of behavior modifications to quality of life
indicators, and the realization of predictive models for quality of life modifications will
allow seamless and unobtrusive data capture over time, making the execution of clinical
investigations more precise and less burdensome as compared to standard (manual) data
capture.
The main aim of the present study is to reduce and to anticipate, with the use of the
non-invasive Big data for quality of life (BD4QoL) platform, the proportion of HNC survivors
experiencing a clinically meaningful reduction in QoL.
The BD4QoL platform consists of a set of services to allow patient monitoring and
empowerment, through two main tools: Point of Care application to manage all patients data
and follow-up by clinical investigators, and a mobile application (App) installed on
participating subject's smartphone. Also, a web-form tool is delivered to allow the QoL
questionnaire completion.
To achieve the study objectives, the BD4QoL platform will use the following sensors embedded
in a smartphone to collect data which will be used to identify behavioral and affective
traits associated with study outcomes. Sensors at mobile phone used to collect relevant data
are the following:
- Accelerometer (x,y,z measurements)
- Global Positioning System - GPS (Lat, Long)
- Ambient light (measurement of light in the room / area where the mobile device is
located)
- Screen (Status ON or OFF for smartphone device screen)
- Activity (type of activity with which the person engages,which can be one of these:
Still, Walking, Running, On_Bicycle, In_Vehicle)
- Steps (total number of steps per day and per hour)
- Daily connections to wifi networks (naming of wifi connections as well as corresponding
duration)
- Data detected from the mobile device's operating system (phone usage logs, phone
applications usage) and from external datasets (steps, identification of places (Points
of Interest) visited based on participant's permissions, through the correlation of
one's GPS signal with external datasets from Foursquare and OpenStreet maps) The above
data will be used to detect activities and behaviors which have a high likelihood of
being meaningfully related with participants' QoL trajectories.
The BD4QoL App, available for Android, will be able to collect and store data about the
following domains: mobility, physical activity, activities of daily living, instrumental
activities of daily living, socialization, cognitive function, health related activities as
well as affective personal data. A summary of the findings and the supporting data will be
available to the patient and clinical investigators , through a dashboard available on mobile
devices for patients and through the Point of Care (PoC) web tool for clinical investigators.
The data collected by the mobile App will not be available to the technology manufacturer and
will be transferred in almost-real-time (real-time when possible, as soon as data transfer is
available) to the central BD4QoL repository (as long as there is available storage in the
local memory storage of the mobile device).
In the interval between visits, study participants, allocated in the intervention arm, will
be able to interact electronically with a chatbot, which will be part of the BD4QoL platform,
implementation based on IBM Watson technology. The chatbot is an application to empower
patients to manage their QoL and health, under the supervision of clinical investigators. The
chatbot will have a series of e-coaching (electronic coaching) functions that include: (i)
dialogue management that allows the patient to be counselled by chatting electronically in a
structured and effective way; (ii) management of two-way communications with healthcare
professionals [e.g. for the patient to request specific support in case of special needs, or
for the chatbot to invite the patient for a visit in case of an early detection of
health-related QoL (HRQoL) or health issues; identified people will have to be listed on the
delegation log by the Principal Investigator (PI)]; (iii) detection of affective traits
embodied in the e-coach / patient dialogue, through sentiment analysis and emotion analysis
technologies to gather data about the participant mood. The latter element can be used to
both re-adapt the chatbot counselling strategy, as well as to provide additional information
on subjects mood to clinical investigators. The adverse events that the chatbot will be able
to recognise will be the following: fatigue, malaise, fever, excessive sleepiness, difficulty
sleeping, depression, change in social circumstances, neck swelling, facial pain, difficulty
breathing, nose bleeds, difficulty speaking, dry mouth, tooth loss, muscle weakness, ear
pain, difficulty hearing, tinnitus, vertigo, nausea, diarrhea, constipation, difficulty
seeing, dry eye, eye pain, nervous eyelid, eye floaters, swollen eye, bleeding eyes, eye
watering, sexuality issues, weight loss, difficulty swallowing, mouth sores, appetite loss,
difficulty opening mouth, difficulty eating, increased sensitivity to smells, no taste.
The platform will provide the investigators with real time data of device usage (e.g number
and type of alerts and chatbot interactions by patients) and it will integrate the electronic
case report forms (eCRFs) as a study monitoring dashboard.
The BD4QoL platform used in this trial is not to be considered a medical device and is used
for experimental assessment only. No drugs will be suggested by the automated chatbot
responses. Tips provided by the chatbot regarding detected symptoms are also not to be
considered clinical advice by any means and should not be a substitute for conversations with
a member of a trained medical personnel.
Inclusion Criteria:
1. Effectively cured histologically defined head and neck squamous cell carcinoma (HNSCC)
from one of these subsites: oral cavity, nasopharynx, hypopharynx, larynx, Human
Papillomavirus (HPV)-positive or negative oropharynx, nasal cavity, paranasal sinuses
(ICD codes in Annex 12). Non-metastatic salivary gland cancer (SGC) of any
histological type can be included only if curative or postoperative radiotherapy
included the neck:
1. For p16-negative or p16-unknown HNSCC (including nasal cavity and paranasal
sinuses), stage I, II, III, IVa or IVb (no IVc) according to UICC/AJCC 8th
edition22. Regional neck metastases from squamous cell carcinoma from unknown
primary head and neck sites are allowed.
2. For nasopharyngeal cancer (NPC), stage I, II, III, IVa (no IVb) according to
UICC/AJCC 8th edition22. Regional neck metastases from EBV-positive carcinoma
from unknown primary head and neck sites are allowed.
3. For SGCs, stage III, IVa or IVb according to UICC/AJCC 8th edition22 treated with
radiotherapy that included the neck (either post-operative radiation or radical
treatment in case of unresectable disease).
4. For p16-positive oropharyngeal squamous cell carcinoma, stage I, II or III
according to UICC/AJCC 8th edition22. Regional neck metastases from p16-positive
and/or HPV-positive squamous cell carcinoma from unknown primary head and neck
sites are allowed.
2. Patients having completed treatment with curative intent (including any single
modality or multimodal approach) within 10 years at the time of accrual.
3. Patients being disease-free at the time of accrual. Patients will be deemed in
complete remission if the clinical examination is negative for recurrence; clinical
examination should be preferably, but not mandatorily, integrated with unequivocal
radiological imaging that shows the absence of disease (in case of doubt, further
radiological imaging should be performed or integrated with cyto/histological samples
of the area with suspected disease persistence and the exams will have to be
consistently negative) after at least three months following treatment completion.
4. Ability to fill in questionnaires as per protocol.
5. Geographical accessibility and willingness to be followed-up for up to 2 years with
information-technology (IT) devices in addition to questionnaires.
6. Age ≥ 18 years.
7. Signed informed consent.
8. Willingness to use their smartphone and their Internet access for the study.
9. Smartphone having the following minimum characteristics:
1. RAM: Minimum of 2 GB
2. Storage: Minimum of 512 MB free storage
3. Operating system: Android version 7 (Nougat) or upper.
Exclusion Criteria:
1. Distant metastases (the following populations are excluded: stage IVc HPV-negative
HNSCC and SGC, stage IV p16-positive oropharyngeal squamous cell carcinoma, stage IVb
NPC).
2. Thyroid cancers, non-melanoma skin cancers (e.g. squamous cell carcinoma of the skin,
skin basal cell carcinoma, skin adnexal carcinoma), and non-carcinoma of the head and
neck area (e.g. melanoma, sarcoma, etc.) are excluded.
3. Subjects with previous malignancies (except localized non-melanoma skin cancers, and
the following in situ cancers: bladder, gastric, colon, esophageal, endometrial,
cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at
least 5 years prior to study entry AND no additional therapy is required during the
study period. Premalignant lesions (e.g. leukoplakia, erythroplakia, lichen etc.) are
allowed.
4. Participation in clinical trials with other experimental agents within 30 days of
study entry or concomitant treatment with experimental drugs.
5. Patients unable to comply with the protocol, in the opinion of the investigator.
6. Any known or underlying medical conditions that, in the opinion of the investigator,
could adversely affect the ability of the participating subject to comply with the
study.
7. Having a smartphone operating system other than Android.
|
NCT0531xxxx/NCT05315583.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/NCT05315583</url>
</required_header>
<id_info>
<org_study_id>CHRO-2022-03</org_study_id>
<nct_id>NCT05315583</nct_id>
</id_info>
<brief_title>Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies</brief_title>
<acronym>PNAS</acronym>
<official_title>Study of the Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies</official_title>
<sponsors>
<lead_sponsor>
<agency>Centre Hospitalier Régional d'Orléans</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Centre Hospitalier Régional d'Orléans</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>
Natural infection, vaccines and treatments (like monoclonal antibodies) lead to the
appearance of a neutralizing power in the serum (due to induced or injected antibodies). This
neutralizing power is recognized as a correlate of protection against a (new) infection. This
study aims to measure the neutralizing power of the serum of patients (whether or not they
have been infected with SARS-CoV-2) according to the treatments and/or vaccines received and
to assess the durability of this power in the time.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Infection, vaccines and treatments (like monoclonal antibodies) lead to the appearance of a
neutralizing power in the serum (due to induced or injected antibodies). This neutralizing
power is recognized as a correlate of protection against (new) infection. The purpose of this
study is to measure the neutralizing power of the serum of patients (whether or not they have
been infected with SARS-CoV-2) depending on the treatments and/or vaccines received and to
assess the durability of this power over time.

The main objective is to measure and describe the evolution of the serum humoral response
(titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention
inducing or conferring neutralizing anti-SARS-CoV-2 antibodies (vaccines - whatever the mode
of action -, monoclonal antibodies).

The secondary objectives are:

- to measure and describe the antibody response at the level of the nasal mucosa (titer
and neutralizing capacity of anti-SARS-CoV-2 antibodies, collected by means of a nasal
swab) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2
antibodies SARS-CoV-2.

- to describe the incidence of COVID in the study patients.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">December 1, 2022</start_date>
<completion_date type="Anticipated">December 1, 2026</completion_date>
<primary_completion_date type="Anticipated">December 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>
<intervention_model_description>Collection of biological samples (Day 0, D3, D15, Month 1, M2, M3, M4, M5, M6, M9, M12, M18) with associated data for the study of the kinetics of antibodies against COVID-19. All participants will have at each of the visits: a venipuncture sample of 2 dry tubes of 7 mL to make up 3 aliquots and a nasopharyngeal swab (optional). The aliquots of serum / plasma and the nasopharyngeal swab will be stored at -80°C until sent to the Pasteur Institute.</intervention_model_description>
<primary_purpose>Basic Science</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Day 0</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Day 0</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Day 3</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Day 3</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Day 15</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Day 15</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 1</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 1</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 2</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 2</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 3</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 3</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 4</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 4</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 5</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 5</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 6</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 6</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 9</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 9</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 12</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 12</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 18</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</primary_outcome>
<primary_outcome>
<measure>Evolution of the serum humoral response</measure>
<time_frame>Month 18</time_frame>
<description>Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</primary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Day 0</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Day 0</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Day 3</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Day 3</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Day 15</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Day 15</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 1</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 1</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 2</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 2</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 3</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 3</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 4</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 4</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 5</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 5</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 6</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 6</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 9</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 9</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 12</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 12</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 18</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evolution of the mucosal humoral response</measure>
<time_frame>Month 18</time_frame>
<description>Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of participants developing COVID-19 infection after these treatments</measure>
<time_frame>Day 0</time_frame>
<description>Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of participants developing COVID-19 infection after these treatments</measure>
<time_frame>Day 3</time_frame>
<description>Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of participants developing COVID-19 infection after these treatments</measure>
<time_frame>Day 15</time_frame>
<description>Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of participants developing COVID-19 infection after these treatments</measure>
<time_frame>Month 1</time_frame>
<description>Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of participants developing COVID-19 infection after these treatments</measure>
<time_frame>Month 2</time_frame>
<description>Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of participants developing COVID-19 infection after these treatments</measure>
<time_frame>Month 3</time_frame>
<description>Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of participants developing COVID-19 infection after these treatments</measure>
<time_frame>Month 4</time_frame>
<description>Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of participants developing COVID-19 infection after these treatments</measure>
<time_frame>Month 5</time_frame>
<description>Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of participants developing COVID-19 infection after these treatments</measure>
<time_frame>Month 6</time_frame>
<description>Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of participants developing COVID-19 infection after these treatments</measure>
<time_frame>Month 9</time_frame>
<description>Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of participants developing COVID-19 infection after these treatments</measure>
<time_frame>Month 12</time_frame>
<description>Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of participants developing COVID-19 infection after these treatments</measure>
<time_frame>Month 18</time_frame>
<description>Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">400</enrollment>
<condition>COVID-19</condition>
<condition>SARS CoV 2 Infection</condition>
<arm_group>
<arm_group_label>Group with collection of biological samples</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>All participants will have at each of the visits: a venipuncture sample of 2 dry tubes of 7 mL to make up 3 aliquots and a nasopharyngeal swab (optional). The aliquots of serum / plasma and the nasopharyngeal swab will be stored at -80°C until sent to the Pasteur Institute.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Collection of biological samples</intervention_name>
<description>All participants will have at each of the visits: a venipuncture sample of 2 dry tubes of 7 mL to make up 3 aliquots and a nasopharyngeal swab (optional). The aliquots of serum / plasma and the nasopharyngeal swab will be stored at -80°C until sent to the Pasteur Institute.</description>
<arm_group_label>Group with collection of biological samples</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Adult volunteers for the study, having received or about to receive any intervention
inducing or conferring neutralizing anti-SARS-CoV-2 antibodies (vaccines - whatever
the mode of action -, monoclonal antibodies).

- Having given their consent to participate in the study

Exclusion Criteria:

- Minors

- Pregnant women

- Persons under tutorship or curatorship

- Protected adults

- Person under legal protection

- Person not affiliated to a social security scheme

- Persons unable to express their 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>Thierry PRAZUCK, Dr</last_name>
<role>Principal Investigator</role>
<affiliation>CHR d'Orléans</affiliation>
</overall_official>
<overall_contact>
<last_name>Laurent HOCQUELOUX, Dr</last_name>
<phone>0033238229588</phone>
<email>laurent.hocqueloux@chr-orleans.fr</email>
</overall_contact>
<location>
<facility>
<name>Centre Hospitalier Régional d'Orléans, France</name>
<address>
<city>Orléans</city>
<zip>45000</zip>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Thierry PRAZUCK, MD</last_name>
<email>thierry.prazuck@chr-orleans.fr</email>
</contact>
<investigator>
<last_name>Thierry PRAZUCK, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>France</country>
</location_countries>
<reference>
<citation>Grzelak L, Temmam S, Planchais C, Demeret C, Tondeur L, Huon C, Guivel-Benhassine F, Staropoli I, Chazal M, Dufloo J, Planas D, Buchrieser J, Rajah MM, Robinot R, Porrot F, Albert M, Chen KY, Crescenzo-Chaigne B, Donati F, Anna F, Souque P, Gransagne M, Bellalou J, Nowakowski M, Backovic M, Bouadma L, Le Fevre L, Le Hingrat Q, Descamps D, Pourbaix A, Laouenan C, Ghosn J, Yazdanpanah Y, Besombes C, Jolly N, Pellerin-Fernandes S, Cheny O, Ungeheuer MN, Mellon G, Morel P, Rolland S, Rey FA, Behillil S, Enouf V, Lemaitre A, Creach MA, Petres S, Escriou N, Charneau P, Fontanet A, Hoen B, Bruel T, Eloit M, Mouquet H, Schwartz O, van der Werf S. A comparison of four serological assays for detecting anti-SARS-CoV-2 antibodies in human serum samples from different populations. Sci Transl Med. 2020 Sep 2;12(559):eabc3103. doi: 10.1126/scitranslmed.abc3103. Epub 2020 Aug 17.</citation>
<PMID>32817357</PMID>
</reference>
<reference>
<citation>Planas D, Bruel T, Grzelak L, Guivel-Benhassine F, Staropoli I, Porrot F, Planchais C, Buchrieser J, Rajah MM, Bishop E, Albert M, Donati F, Prot M, Behillil S, Enouf V, Maquart M, Smati-Lafarge M, Varon E, Schortgen F, Yahyaoui L, Gonzalez M, De Seze J, Pere H, Veyer D, Seve A, Simon-Loriere E, Fafi-Kremer S, Stefic K, Mouquet H, Hocqueloux L, van der Werf S, Prazuck T, Schwartz O. Sensitivity of infectious SARS-CoV-2 B.1.1.7 and B.1.351 variants to neutralizing antibodies. Nat Med. 2021 May;27(5):917-924. doi: 10.1038/s41591-021-01318-5. Epub 2021 Mar 26.</citation>
<PMID>33772244</PMID>
</reference>
<verification_date>December 2022</verification_date>
<study_first_submitted>March 16, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>December 27, 2022</last_update_submitted>
<last_update_submitted_qc>December 27, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">December 29, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>COVID-19</keyword>
<keyword>Vaccines</keyword>
<keyword>Monoclonal antibodies</keyword>
<keyword>Neutralization</keyword>
<keyword>Serum</keyword>
<keyword>Nasal mucosa</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>COVID-19</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Natural infection, vaccines and treatments (like monoclonal antibodies) lead to the
appearance of a neutralizing power in the serum (due to induced or injected antibodies). This
neutralizing power is recognized as a correlate of protection against a (new) infection. This
study aims to measure the neutralizing power of the serum of patients (whether or not they
have been infected with SARS-CoV-2) according to the treatments and/or vaccines received and
to assess the durability of this power in the time.
Infection, vaccines and treatments (like monoclonal antibodies) lead to the appearance of a
neutralizing power in the serum (due to induced or injected antibodies). This neutralizing
power is recognized as a correlate of protection against (new) infection. The purpose of this
study is to measure the neutralizing power of the serum of patients (whether or not they have
been infected with SARS-CoV-2) depending on the treatments and/or vaccines received and to
assess the durability of this power over time.
The main objective is to measure and describe the evolution of the serum humoral response
(titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention
inducing or conferring neutralizing anti-SARS-CoV-2 antibodies (vaccines - whatever the mode
of action -, monoclonal antibodies).
The secondary objectives are:
- to measure and describe the antibody response at the level of the nasal mucosa (titer
and neutralizing capacity of anti-SARS-CoV-2 antibodies, collected by means of a nasal
swab) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2
antibodies SARS-CoV-2.
- to describe the incidence of COVID in the study patients.
Inclusion Criteria:
- Adult volunteers for the study, having received or about to receive any intervention
inducing or conferring neutralizing anti-SARS-CoV-2 antibodies (vaccines - whatever
the mode of action -, monoclonal antibodies).
- Having given their consent to participate in the study
Exclusion Criteria:
- Minors
- Pregnant women
- Persons under tutorship or curatorship
- Protected adults
- Person under legal protection
- Person not affiliated to a social security scheme
- Persons unable to express their consent
|
NCT0531xxxx/NCT05315596.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/NCT05315596</url>
</required_header>
<id_info>
<org_study_id>JenaUH_pain</org_study_id>
<nct_id>NCT05315596</nct_id>
</id_info>
<brief_title>Longitudinal Assessment of Pain-Related Patient-Reported Outcomes After Surgery</brief_title>
<official_title>Longitudinal Assessment of Pain-related Patient-reported Outcomes in the Sub-acute Phase After Surgery: a Registry Study From PAIN OUT</official_title>
<sponsors>
<lead_sponsor>
<agency>Jena University Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Centro Medico Nacional Siglo XXI IMSS</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital de Traumatología y Ortopedia Lomas Verdes</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital Angeles Puebla</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital Angeles Lomas</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital San Javier Guadalajara</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital Aranda de La Parra (Leon Guanajuato)</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Fundación Clínica Médica Sur</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Instituto Nacional de Cancerologia de Mexico</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital General Dr. Ruben Leñero</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital Central "Dr. Ignacio Morones Prieto"</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital General Regional Número 2 Dr. Guillermo Fajardo Ortiz</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Instituto Nacional de Enfermedades Respiratorias</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital Central Militar</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Jena University Hospital</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
</oversight_info>
<brief_summary>
<textblock>
Little is known about pain-related outcomes experienced by patients in the first few weeks
after surgery, once they are discharged from hospital.

This study aims to characterize pain, pain-related interference, and early neuropathic pain
in the sub-acute phase after surgery.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
A high proportion of patients experience moderate to severe pain after surgery. However, most
of the knowledge about this comes from studies where patients are evaluated in the hours and
up until the first postoperative day. Alternatively, patients are assessed several months (eg
3 or later) after surgery, to evaluate the development of chronic pain related to surgery
(CPSP) and most patients do not develop CPSP.

This study aims to learn how patients recover concerning pain and function once they return
home after surgery. How long is it before they can resume their daily activities and to do so
in comfort? Do they take treatment for pain? Do they have pain restricted to the surgical
incision or it is more widespread? There is little knowledge as to whether there are signs of
nerve injury in the days close to surgery. This type of pain might lead to chronic pain in
later stages.

Patients will be assessed at three time points: the first day after surgery, the 7th day
after surgery, and 1 month.

The information we obtain will offer healthcare providers, from multiple hospitals,
information about the care they provide to their patients for pain while patients are still
in hospital and insights as to how the care might be improved, once they are discharged.
</textblock>
</detailed_description>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Actual">February 1, 2022</start_date>
<completion_date type="Anticipated">December 31, 2030</completion_date>
<primary_completion_date type="Anticipated">December 31, 2030</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>1 Month</target_duration>
<primary_outcome>
<measure>The difference in pain interference scores between postoperative day 7 (POD7) and 1 month after surgery (POM1).</measure>
<time_frame>7th day after surgery (POD7) and 1 Month (M1) after surgery</time_frame>
<description>We will assess whether pain-related functional impairment on postoperative day 7 is associated with functional pain-related impairment 1 month after surgery. Functional pain impairment will be assessed using the BPI short-form questionnaire and calculated as a Pain Interference Total Score (PITS) from the 7 interference questions in the BPI. Patients will be allocated to groups of no (PITS=0)/mild-(PITS=1-2)/ moderate /(PITS=2-5) and severe interference (PITS>5). Mean scores of the 2 domains within the functional items, physical interference (general activity, walking ability, and work) and effective interference (mood, enjoyment of life, and relations with other persons) will also be calculated. Sleep will addressed separately as it does not improve psychometric properties of the BPI interference scale. This methodology has been used in another PAIN OUT study, evaluating function at 6 months after surgery (Stamer et al, Pain. 2019 Aug;160(8):1856-1865).</description>
</primary_outcome>
<primary_outcome>
<measure>The number of patients with high pain interference on the 7th day after surgery (POD7).</measure>
<time_frame>Day 7 after surgery</time_frame>
<description>Number of patients with high pain interference at postoperative day 7 (POD7, BPI-PITS >5).</description>
</primary_outcome>
<secondary_outcome>
<measure>Differences in pain severity (BPI-PSVS, pain severity scale) between postoperative day 7 and 1 month after surgery (POM1).</measure>
<time_frame>Day 7 after surgery and Month 1 after surgery</time_frame>
<description>We will use the pain severity variables in the BPI to assess pain on postoperative day 7 compared to Month 1 after surgery.</description>
</secondary_outcome>
<secondary_outcome>
<measure>The differences in pain interference (BPI-PITS) between surgical disciplines on postoperative day 7.</measure>
<time_frame>Day 7 after surgery</time_frame>
<description>This will be a cohort of patients undergoing surgeries from different disciplines. We anticipate that median pain interference scores will not differ between the disciplines.</description>
</secondary_outcome>
<secondary_outcome>
<measure>The differences in pain interference (BPI-PITS) between surgical disciplines at month 1 after surgery.</measure>
<time_frame>1 Month after surgery</time_frame>
<description>This will be a cohort of patients undergoing surgeries from different disciplines. We anticipate that median pain interference scores will not differ between the disciplines.</description>
</secondary_outcome>
<secondary_outcome>
<measure>The difference in the number of patients with signs of neuropathy on postoperative day 7 between the surgical disciplines.</measure>
<time_frame>Day 7 after surgery</time_frame>
<description>The difference in the number of patients with signs of neuropathy on postoperative day 7 (DN2 score ≥ 3/7) between the surgical disciplines.
Neuropathy will be screened for using the 'Douleur Neuropathique en 2 Questions' (DN2) . Neuropathy is indicated for a score of >3/7 items in the questionnaire (Beloeil et al Early postoperative neuropathic pain assessed by the DN4 score predicts an increased risk of persistent postsurgical neuropathic pain. Eur J Anesthesiology 2017;34:652-7).</description>
</secondary_outcome>
<secondary_outcome>
<measure>The difference in the number of patients with signs of neuropathy at 1 month after surgery (POM1) between the surgical disciplines.</measure>
<time_frame>1 Month after surgery</time_frame>
<description>The difference in the number of patients with signs of neuropathy at POM1 (DN2 score ≥ 3/7) between the surgical disciplines.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Differences in pain interference scores between patients with vs without signs of neuropathy on postoperative day 7</measure>
<time_frame>Day 7 after surgery</time_frame>
<description>Differences in pain interference (BPI-PITS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) on postoperative day 7.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Differences in pain interference (BPI-PITS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) at POM1.</measure>
<time_frame>1 Month after surgery</time_frame>
<description>Differences in pain interference (BPI-PITS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) at POM1.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Differences in pain severity between patients with vs without signs of neuropathy at POM1</measure>
<time_frame>1 Month after surgery</time_frame>
<description>Differences in pain severity (BPI-PSVS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) at POM1.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Assess the difference in the number of patients taking analgesics o POD7 vs POD1.</measure>
<time_frame>Day 7 after surgery and 1 Month after surgery</time_frame>
<description>The difference in the number of patients taking analgesics between postoperative day 7 and POM1. Patients will be asked if they are taking an analgesic at both time points.</description>
</secondary_outcome>
<other_outcome>
<measure>Exploratory regression analysis for improving understanding of pain interference on day 7 after surgery</measure>
<time_frame>First postoperative day and postoperative day 7</time_frame>
<description>Exploratory regression analysis for pain interference on postoperative day 7 (BPI-PITS, dependent variable), demographic variables, perioperative treatment variables and patient-reported outcomes (International Pain Out Questionnaire) from the first post-operative day (POD1).</description>
</other_outcome>
<other_outcome>
<measure>Exploratory regression analysis for improving understanding of pain intensity on postoperative day 7.</measure>
<time_frame>First postoperative day and postoperative day 7</time_frame>
<description>Exploratory regression analysis for pain intensity on postoperative day 7 (BPI-PSVS, dependent variable). Independent variables will include demographic variables, perioperative treatment variables and patient-reported outcomes obtained on the first postoperative day (POD1)</description>
</other_outcome>
<other_outcome>
<measure>Exploratory regression analysis for improving understanding of pain intensity at POM1</measure>
<time_frame>First postoperative day and 1 month after surgery</time_frame>
<description>Exploratory regression analysis for pain intensity at POM1 (BPI-PSVS, dependent variable). Independent variables will include: demographic variables, perioperative treatment variables and patient reported outcomes (International Pain Out Questionnaire) from the first postoperative day (POD1).</description>
</other_outcome>
<enrollment type="Anticipated">1000</enrollment>
<condition>Pain, Postoperative</condition>
<condition>Adult</condition>
<condition>Pain Measurement</condition>
<condition>Functional Status</condition>
<condition>Pain Management</condition>
<condition>Neuralgia</condition>
<condition>Analgesia</condition>
<eligibility>
<study_pop>
<textblock>
Adult patients after surgery
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. Adult

2. On the first post-operative day and back on the ward for at least 6 hours

3. Gives consent for assessment at 3-time points

Exclusion Criteria:

1. The patient is unable to communicate

2. The patient is cognitively impaired

3. The patient is asleep

4. The patient is too ill or in too much pain and does not wish to be interviewed

5. The patient does not wish to fill in the outcomes questionnaire
</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>Ana L Garduño López, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
</overall_official>
<overall_official>
<last_name>Vicotor M Acosta-Nava, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
</overall_official>
<overall_official>
<last_name>Ruth Zaslansky, DSc</last_name>
<role>Principal Investigator</role>
<affiliation>Jena University Hospital</affiliation>
</overall_official>
<location>
<facility>
<name>Jena University Hospital</name>
<address>
<city>Jena</city>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital Central Militar</name>
<address>
<city>Mexico City</city>
<state>Cdmx</state>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital General de Chihuahua Salvador Zubirán Anchondo</name>
<address>
<city>El Bajo</city>
<state>Chihuahua</state>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital Aranda de La Parra (Leon Guanajuato)</name>
<address>
<city>León</city>
<state>Guanajuato</state>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital San Javier Guadalajara</name>
<address>
<city>Guadalajara</city>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Centro Nacional SIGLO XXI (IMSS)</name>
<address>
<city>Mexico City</city>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital Angeles Interlomas CDMX</name>
<address>
<city>Mexico City</city>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital de traumatologia y Ortopedia Lomas Verdes (IMSS)</name>
<address>
<city>Mexico City</city>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital fundación Medica Sur</name>
<address>
<city>Mexico City</city>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital General de Villacoapa (IMSS)</name>
<address>
<city>Mexico City</city>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital Ruben Leñero</name>
<address>
<city>Mexico City</city>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Instituto Nacional de Cancerología</name>
<address>
<city>Mexico City</city>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán</name>
<address>
<city>Mexico City</city>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Instituto Nacional de Enfermedades Respiratorias Cosio Villegas (INER)</name>
<address>
<city>Mexico City</city>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital Angeles Puebla</name>
<address>
<city>Puebla</city>
<country>Mexico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital Central Morones Prieto San Luis Potosi</name>
<address>
<city>San Luis Potosi</city>
<country>Mexico</country>
</address>
</facility>
</location>
<location_countries>
<country>Germany</country>
<country>Mexico</country>
</location_countries>
<link>
<url>http://www.pain-out.eu</url>
<description>Website of PAIN OUT, a perioperative pain registry and research network</description>
</link>
<verification_date>March 2022</verification_date>
<study_first_submitted>February 23, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 29, 2022</last_update_submitted>
<last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Jena University Hospital</investigator_affiliation>
<investigator_full_name>Ruth Zaslansky</investigator_full_name>
<investigator_title>PAIN OUT - scientific director</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Neuralgia</mesh_term>
<mesh_term>Pain, Postoperative</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
<ipd_description>Data collected by each hospital belongs to them.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Little is known about pain-related outcomes experienced by patients in the first few weeks
after surgery, once they are discharged from hospital.
This study aims to characterize pain, pain-related interference, and early neuropathic pain
in the sub-acute phase after surgery.
A high proportion of patients experience moderate to severe pain after surgery. However, most
of the knowledge about this comes from studies where patients are evaluated in the hours and
up until the first postoperative day. Alternatively, patients are assessed several months (eg
3 or later) after surgery, to evaluate the development of chronic pain related to surgery
(CPSP) and most patients do not develop CPSP.
This study aims to learn how patients recover concerning pain and function once they return
home after surgery. How long is it before they can resume their daily activities and to do so
in comfort? Do they take treatment for pain? Do they have pain restricted to the surgical
incision or it is more widespread? There is little knowledge as to whether there are signs of
nerve injury in the days close to surgery. This type of pain might lead to chronic pain in
later stages.
Patients will be assessed at three time points: the first day after surgery, the 7th day
after surgery, and 1 month.
The information we obtain will offer healthcare providers, from multiple hospitals,
information about the care they provide to their patients for pain while patients are still
in hospital and insights as to how the care might be improved, once they are discharged.
Adult patients after surgery
Inclusion Criteria:
1. Adult
2. On the first post-operative day and back on the ward for at least 6 hours
3. Gives consent for assessment at 3-time points
Exclusion Criteria:
1. The patient is unable to communicate
2. The patient is cognitively impaired
3. The patient is asleep
4. The patient is too ill or in too much pain and does not wish to be interviewed
5. The patient does not wish to fill in the outcomes questionnaire
|
NCT0531xxxx/NCT05315609.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/NCT05315609</url>
</required_header>
<id_info>
<org_study_id>IUSMD-21-48</org_study_id>
<nct_id>NCT05315609</nct_id>
</id_info>
<brief_title>Effects of Virtual Reality Meditation in Older Adults</brief_title>
<official_title>Effects of Virtual Reality Meditation in Older Adults: A Randomized Controlled Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Lady Davis Institute</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Lady Davis Institute</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>
Virtual reality (VR) allows users to interact within a simulated environment using electronic
devices such as a VR headset or goggles. Multiple studies with younger adults have
demonstrated that VR meditation can be an important tool in reducing stress, however, this
has not been studied in older adults. In this study, the investigators aim to assess the
effects of a 4-week program of 15-minutes sessions, twice per week of meditation delivered
through VR with the aim of evaluating its impact on stress in older adults.
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 2022</start_date>
<completion_date type="Anticipated">September 2022</completion_date>
<primary_completion_date type="Anticipated">May 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>Single (Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Changes in stress scores as measured by the Perceived Stress Scale (PSS) for treatment group versus control group</measure>
<time_frame>Baseline, Once weekly during intervention</time_frame>
<description>To assess the effectiveness of the virtual reality meditation program in reducing stress in older adults.
Scores on the PSS can range from 0-40, with higher scores indicating higher perceived stress.</description>
</primary_outcome>
<secondary_outcome>
<measure>Changes in symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) questionnaire for treatment group versus control group</measure>
<time_frame>Baseline, Once weekly during intervention</time_frame>
<description>To assess the effects of the virtual reality meditation program on symptoms of anxiety in older adults.
Scores on the GAD-7 range from 0-21, with higher scores indicating more severe anxiety.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in symptoms of depression as measured by the Patient Health Questionnaire-9 (PHQ-9) scale for treatment group versus control group</measure>
<time_frame>Baseline, Once weekly during intervention</time_frame>
<description>To assess the effects of the virtual reality meditation program on symptoms of depression in older adults.
Scores on the PHQ-9 can range from 0-27, with higher scores indicating more severe depression.</description>
</secondary_outcome>
<other_outcome>
<measure>Changes in symptoms of mindfulness skills</measure>
<time_frame>Baseline, Once weekly during intervention</time_frame>
<description>To assess the effects of the virtual reality meditation program on mindfulness skills in older adults.
Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) is a 24-item scale that is used to assess whether mindfulness is related to a decrease in clinical symptoms of depression, anxiety, and stress.</description>
</other_outcome>
<other_outcome>
<measure>Qualitative Component: Participant observation, semi-structured interviews, and a focus group with participants.</measure>
<time_frame>Post intervention (4-weeks)</time_frame>
<description>Qualitative interviews to examine users' experience of the virtual reality meditation program.
We will conduct qualitative evaluations through participant observation and semi-structured interviews and a focus group with participants. The qualitative part of the study will analyze service users' experience, engagement, and challenges throughout the study. Participant observation will be used to provide a context for the interviews. It will also help to observe clients' engagement, usage, expressions, physical movements, and barriers.</description>
</other_outcome>
<other_outcome>
<measure>Changes in simulator sickness as measured by the Simulator Sickness Questionnaire</measure>
<time_frame>Baseline, Once weekly during intervention</time_frame>
<description>To assess participants' acceptability of the virtual reality guided meditation program.
Simulator Sickness Questionnaire is a 16-item scale that is widely used to assess simulator sickness.</description>
</other_outcome>
<other_outcome>
<measure>Changes in loneliness sentiments as measured by the University of California-3 (UCLA-3) item loneliness questionnaire</measure>
<time_frame>Baseline, Once weekly during intervention</time_frame>
<description>To assess the effects of the virtual reality meditation program on feelings of loneliness measured through the University of California-3 (UCLA 3-item) loneliness scale.
The Three-Item Loneliness Scale is an interviewer-administered questionnaire developed from the Revised UCLA Loneliness Scale. Each question is rated on a 3-point scale: 1 = Hardly Ever; 2 = Some of the Time; 3 = Often. All items are summed to give a total score.
Higher scores indicate greater feelings of loneliness</description>
</other_outcome>
<other_outcome>
<measure>Changes in symptoms of sleep quality as measured by the Athens Insomnia Scale (AIS)</measure>
<time_frame>Baseline, Once weekly during intervention</time_frame>
<description>To assess the effects of the virtual reality meditation program on sleep quality in older adults.
Each item is rated on a 4-point numerical rating scale (NRS; where 0= no problem at all and 3= very serious problem). Total scores range from 0 to 24 in the AIS-8 and from 0 to 15 in the AIS-5. Higher scores in these AIS measures indicate that responders have severe insomnia symptoms.</description>
</other_outcome>
<other_outcome>
<measure>Changes in symptoms of quality of life in older adults as measured by the European Quality of Life (Euro-QoL) measure.</measure>
<time_frame>Baseline, Once weekly during intervention</time_frame>
<description>To assess the effects of the virtual reality meditation program on quality of life in older adults.
Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). The score from Part II can be used to track changes in health, on an individual or group level, over time (McDowell & Newell, 1996).</description>
</other_outcome>
<other_outcome>
<measure>Changes in sense of presence as measured by the ITC-Sense of Presence Inventory</measure>
<time_frame>Baseline, Once weekly during intervention</time_frame>
<description>The ITC-Sense of Presence Inventory is a self-report presence measure to evaluate experiential aspects of immersive technology.</description>
</other_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">30</enrollment>
<condition>Older Adults</condition>
<condition>Stress</condition>
<condition>Mental Disorder</condition>
<arm_group>
<arm_group_label>Intervention: Virtual Reality Mindfulness Group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The intervention will be 4-weeks, twice per week, 15-minute/session VR-mindfulness intervention group.</description>
</arm_group>
<arm_group>
<arm_group_label>No intervention: Waitlist Control Group</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>These participants will be on a waitlist to receive the VR guided meditation program after data collection has been completed (after the 4 weeks)</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>VR Meditation</intervention_name>
<description>This 4-week VR program will use the Oculus Pro-Quest 2 headsets for the 15-minute seated VR meditation twice per week for a total of 8 sessions over the 4 weeks.</description>
<arm_group_label>Intervention: Virtual Reality Mindfulness Group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Living in the Greater Montreal area and able to speak English or French

- Perceived Stress Score (PSS)equal or greater than 10

- Over >=60 years of age

Exclusion Criteria:

- Diagnosis of epilepsy, schizophrenia, brain tumor

- History of recurrent migraines or seizures or TBI in the past year

- Substance use disorders in the last year

- Psychiatric hospitalizations in the last year.

- Acute psychotic symptoms

- Acute suicidal ideation or intent

- Glaucoma

- PTSD

- Changes to psychoactive medications in the past 4 weeks

- Alcohol, caffeine or cannabis consumption within 24 hr before the session, or nicotine
consumption within 15 min of the session

- Important hearing impairment

- Recovery phase of any eye surgery
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>60 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Paola Lavín</last_name>
<phone>5147616131</phone>
<phone_ext>3330</phone_ext>
<email>maria.lavingonzalez@mail.mcgill.ca</email>
</overall_contact>
<overall_contact_backup>
<last_name>Karin Cinalioglu</last_name>
<phone>5145508683</phone>
<email>karin.cinalioglu@mail.mcgill.ca</email>
</overall_contact_backup>
<location>
<facility>
<name>Douglas Mental Health University Institute</name>
<address>
<city>Montréal</city>
<state>Quebec</state>
<zip>H4H 1R3</zip>
<country>Canada</country>
</address>
</facility>
<contact>
<last_name>Paola Lavin, MD,MSc</last_name>
<email>maria.lavingonzalez@mail.mcgill.ca</email>
</contact>
</location>
<location>
<facility>
<name>Lady Davis Institute/ Jewish General Hospital</name>
<address>
<city>Montréal</city>
<country>Canada</country>
</address>
</facility>
<contact>
<last_name>Karin Cinalioglu, BA</last_name>
<email>karin.cinalioglu@mail.mcgill.ca</email>
</contact>
</location>
<location_countries>
<country>Canada</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>August 11, 2021</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 29, 2022</last_update_submitted>
<last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Lady Davis Institute</investigator_affiliation>
<investigator_full_name>Soham Rej MD, MSc</investigator_full_name>
<investigator_title>Primary Investigator</investigator_title>
</responsible_party>
<keyword>Virtual reality</keyword>
<keyword>Meditation</keyword>
<keyword>Mindfulness</keyword>
<keyword>Stress</keyword>
<keyword>Older adults</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Mental 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>
|
Virtual reality (VR) allows users to interact within a simulated environment using electronic
devices such as a VR headset or goggles. Multiple studies with younger adults have
demonstrated that VR meditation can be an important tool in reducing stress, however, this
has not been studied in older adults. In this study, the investigators aim to assess the
effects of a 4-week program of 15-minutes sessions, twice per week of meditation delivered
through VR with the aim of evaluating its impact on stress in older adults.
Inclusion Criteria:
- Living in the Greater Montreal area and able to speak English or French
- Perceived Stress Score (PSS)equal or greater than 10
- Over >=60 years of age
Exclusion Criteria:
- Diagnosis of epilepsy, schizophrenia, brain tumor
- History of recurrent migraines or seizures or TBI in the past year
- Substance use disorders in the last year
- Psychiatric hospitalizations in the last year.
- Acute psychotic symptoms
- Acute suicidal ideation or intent
- Glaucoma
- PTSD
- Changes to psychoactive medications in the past 4 weeks
- Alcohol, caffeine or cannabis consumption within 24 hr before the session, or nicotine
consumption within 15 min of the session
- Important hearing impairment
- Recovery phase of any eye surgery
|
NCT0531xxxx/NCT05315622.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/NCT05315622</url>
</required_header>
<id_info>
<org_study_id>FLM012022</org_study_id>
<nct_id>NCT05315622</nct_id>
</id_info>
<brief_title>Effects of the T12-L1 Vertebral Manipulation on Body Temperature, Arterial Tension and Cardiac Frequency</brief_title>
<official_title>Effects of the T12-L1 Vertebral Manipulation on Body Temperature, Arterial Tension and Cardiac Frequency</official_title>
<sponsors>
<lead_sponsor>
<agency>Universidad de Murcia</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>UCAM university</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Universidad de Murcia</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>
Single-blinded Randomized Controlled Trial conducted amongst a sample of healthy subjects
divided into two different groups: the experimental treatment will consist in bilateral
T12-L1 vertebral manipulation, whereas the control group will receive a sham intervention
consisting solely in applying tension without properly manipulating. Body temperature,
arterial tension and cardiac frequency will be measured before and after the intervention.
Changes in the aforementioned variables will be measured.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The current study will correspond to a single-blinded Randomized Controlled Trial with two
arms, conducted amongst a sample of healthy subjects, who will be divided into two different
groups: the experimental treatment will consist in bilateral T12-L1 vertebral manipulation,
whereas the control group will receive a sham intervention consisting solely in applying
tension without properly manipulating. Three different variables will be measured prior to
and after the intervention: body temperature, arterial tension and cardiac frequency, to
subsequently calculate possible changes in the variables, with the aim of establishing the
effect of the manipulation and/or sham treatment.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 4, 2022</start_date>
<completion_date type="Actual">October 19, 2022</completion_date>
<primary_completion_date type="Actual">June 16, 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>Single-blinded Randomized Controlled Trial</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Participant)</masking>
<masking_description>Participants will be unaware of their group assignment</masking_description>
</study_design_info>
<primary_outcome>
<measure>Body temperature</measure>
<time_frame>Change from baseline Body Temperature to ten minutes after the intervention</time_frame>
<description>Body temperature: Celsius degree will be measured by means of a digital thermometer</description>
</primary_outcome>
<primary_outcome>
<measure>Body temperature</measure>
<time_frame>Change from baseline Body Temperature to seven days after the intervention</time_frame>
<description>Body temperature: Celsius degree will be measured by means of a digital thermometer</description>
</primary_outcome>
<primary_outcome>
<measure>Cardiac frequency</measure>
<time_frame>Change from baseline Cardiac Frequency to ten minutes after the intervention</time_frame>
<description>Cardiac frequency: Beats per minute will be measured by means of OMRON M4 device, in compliance with the European Directive 93/42/EEC</description>
</primary_outcome>
<primary_outcome>
<measure>Cardiac frequency</measure>
<time_frame>Change from baseline Cardiac Frequency to seven days after the intervention</time_frame>
<description>Cardiac frequency: Beats per minute will be measured by means of OMRON M4 device, in compliance with the European Directive 93/42/EEC</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial tension</measure>
<time_frame>Change from baseline arterial tension to ten minutes after the intervention</time_frame>
<description>Arterial tension (systolic/diastolic) will be measured by means of OMRON M4 device, in compliance with the European Directive 93/42/EEC</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial tension</measure>
<time_frame>Change from baseline arterial tension to seven days after the intervention</time_frame>
<description>Arterial tension (systolic/diastolic) will be measured by means of OMRON M4 device, in compliance with the European Directive 93/42/EEC</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">73</enrollment>
<condition>Healthy Subjects</condition>
<condition>Spinal Manipulation</condition>
<condition>Manual Therapy</condition>
<arm_group>
<arm_group_label>Intervention</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Bilateral vertebral manipulation of the T12-L1 vertebra</description>
</arm_group>
<arm_group>
<arm_group_label>Placebo</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Application of slight manual tension to the vertebra without reaching a manipulation thrust</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy</intervention_name>
<description>Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy</description>
<arm_group_label>Intervention</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>Manual tension without reaching the manipulation "thrust"</description>
<arm_group_label>Placebo</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Both genders;

- Over 18 years of age;

- Minimal amount of exercise per week: 1 hour/week;

- Covid-related aspects: Negative antigen-test 24 hours before the test or negative PCR
48 hours before the test.

Exclusion Criteria:

- Surgical intervention in the 5 years previous to the study;

- Any acute or chronic medical condition;

- Any pharmacological treatment;

- Osteosynthetic implants.
</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>UCAM</name>
<address>
<city>Murcia</city>
<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 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>November 28, 2022</last_update_submitted>
<last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">December 1, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>Individual participant data (IPD) will not be available to other researchers</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Single-blinded Randomized Controlled Trial conducted amongst a sample of healthy subjects
divided into two different groups: the experimental treatment will consist in bilateral
T12-L1 vertebral manipulation, whereas the control group will receive a sham intervention
consisting solely in applying tension without properly manipulating. Body temperature,
arterial tension and cardiac frequency will be measured before and after the intervention.
Changes in the aforementioned variables will be measured.
The current study will correspond to a single-blinded Randomized Controlled Trial with two
arms, conducted amongst a sample of healthy subjects, who will be divided into two different
groups: the experimental treatment will consist in bilateral T12-L1 vertebral manipulation,
whereas the control group will receive a sham intervention consisting solely in applying
tension without properly manipulating. Three different variables will be measured prior to
and after the intervention: body temperature, arterial tension and cardiac frequency, to
subsequently calculate possible changes in the variables, with the aim of establishing the
effect of the manipulation and/or sham treatment.
Inclusion Criteria:
- Both genders;
- Over 18 years of age;
- Minimal amount of exercise per week: 1 hour/week;
- Covid-related aspects: Negative antigen-test 24 hours before the test or negative PCR
48 hours before the test.
Exclusion Criteria:
- Surgical intervention in the 5 years previous to the study;
- Any acute or chronic medical condition;
- Any pharmacological treatment;
- Osteosynthetic implants.
|
NCT0531xxxx/NCT05315635.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/NCT05315635</url>
</required_header>
<id_info>
<org_study_id>2022-A00126-37</org_study_id>
<nct_id>NCT05315635</nct_id>
</id_info>
<brief_title>Substance Use and Eating Disorders : Food Craving and Addiction Transfer</brief_title>
<acronym>SUED</acronym>
<official_title>Substance Use and Eating Disorders : Food Craving and Addiction Transfer</official_title>
<sponsors>
<lead_sponsor>
<agency>Centre Hospitalier Charles Perrens, Bordeaux</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Centre Hospitalier Charles Perrens, Bordeaux</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>
Substance Use Disorder (SUD) and Eating Disorders (ED) are severe and persistent disturbances
that are associated with significant harm. These two disorders have many clinical
similarities, including craving and behavioral loss of control. Recently, craving for food
has been described in newly abstinent patients with SUD. the aim of the study is to verify
the hypothesis of addiction transfer based on common neurobiological mechanisms between
substance craving and food craving, that postulates that food craving would correspond to an
attempt to regulate substance craving (or vice versa).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The knowledge of existence of common addictive, neurobiological and clinical processes
between substance use disorders and eating disorders has been a promising approach for a
better understanding of the factors involved in the emergence and maintenance of these
disorders. Several studies have shown that increased palatable food with high sugar or fat
content causes brain neurochemistry changes similar to those observed after use of addictive
drugs. Clinical and behavioral similarities concerning craving, loss of control and use as a
coping strategy have also been highlighted. Craving is considered as a clinical marker of
addiction and a potent predictor of relapse vulnerability. In substance addiction, the link
between craving, use and relapse has been previously demonstrated in experimental and daily
life studies. The main objective of this study is to examine the hypothesis of addiction
transfer between Substance Use Disorders and Eating Disorders, according to which food
craving for palatable foods would correspond to an attempt to regulate substance craving or
vice versa. One assumption is that food intake could be used to alleviate craving for
substances in patients hospitalized for substance use disorder. The secondary objective is to
explore psychopathological, addictive, and medical similarities between substance use
disorder and eating disorder participants. Included patients (group 1: substance use disorder
participants and group 2: eating disorder) will be asked to answer different
self-questionnaires, as well as a clinical psychiatric (MINI) and cognitive (MoCA)
assessment.
</textblock>
</detailed_description>
<overall_status>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">March 1, 2024</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>Craving for substance</measure>
<time_frame>At the inclusion</time_frame>
<description>Measurement of craving for substances by Visual Analogue Scale (VAS) - from 0 (no desire at all) to 10 (very much in demand) / higher scores mean a worse outcome</description>
</primary_outcome>
<primary_outcome>
<measure>Craving for substance</measure>
<time_frame>At week-3</time_frame>
<description>Measurement of craving for substances by Visual Analogue Scale (VAS) - from 0 (no desire at all) to 10 (very much in demand) / higher scores mean a worse outcome</description>
</primary_outcome>
<primary_outcome>
<measure>Craving for food</measure>
<time_frame>At the inclusion</time_frame>
<description>Measurement of food craving by Food Cravings Questionnaire-Trait-Reduced (FCQ-Tr) - from NEVER to ALLWAYS / higher scores mean a worse or better outcome, depending of the question</description>
</primary_outcome>
<secondary_outcome>
<measure>Identify common determinants of food craving in patients suffering from ED</measure>
<time_frame>At inclusion</time_frame>
<description>Questionnaires for Addictive characteristics : Modified Yale Food Addiction</description>
</secondary_outcome>
<secondary_outcome>
<measure>Identify common determinants of food craving in patients suffering from ED & SUD - Addictive characteristics :</measure>
<time_frame>At inclusion</time_frame>
<description>Impulsive Behavior Scale 4-point Likert scale: 1 (Agree Strongly), 2 (Agree Some), 3 (Disagree Some), and 4 (Disagree Strongly)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Identify common determinants of food craving in patients suffering from ED & SUD - Emotional characteristics</measure>
<time_frame>At inclusion</time_frame>
<description>Trait Meta-Mood Scale from NOT AT ALL AGREE to TOTALLY AGREE / higher scores mean a worse or better outcome, depending of the question</description>
</secondary_outcome>
<secondary_outcome>
<measure>Identify common determinants of food craving in patients suffering from ED & SUD - Psychopathological and cognitive characteristics</measure>
<time_frame>At inclusion</time_frame>
<description>Eating Disorder Examination-Questionnaire, from NEVER to EVERY DAY / higher scores mean a worse or better outcome, depending of the question</description>
</secondary_outcome>
<secondary_outcome>
<measure>Identify Medical characteristics : of food craving in patients suffering from ED - Medical characteristics :</measure>
<time_frame>At inclusion</time_frame>
<description>BMI in kg/m²</description>
</secondary_outcome>
<secondary_outcome>
<measure>Identify Medical characteristics : of food craving in patients suffering from SUD</measure>
<time_frame>At inclusion and at week-3</time_frame>
<description>BMI in kg/m²</description>
</secondary_outcome>
<secondary_outcome>
<measure>Identify cognitive characteristics of food craving in patients suffering from ED</measure>
<time_frame>At inclusion</time_frame>
<description>Pittsburgh Sleep Quality Index (21 self-rated items are combined to form seven "component scores", each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.) Montreal Cognitive Assessment (30-question test - score of 25 and under is considered at-risk of dementia)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Identify cognitive characteristics of food craving in patients suffering from SUD</measure>
<time_frame>At inclusion and at week-3</time_frame>
<description>Pittsburgh Sleep Quality Index (21 self-rated items are combined to form seven "component scores", each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.) Montreal Cognitive Assessment (30-question test - score of 25 and under is considered at-risk of dementia)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Identify addictive characteristics of substances craving in patients suffering from SUD</measure>
<time_frame>At week-3 At inclusion and at week-3</time_frame>
<description>Impulsive Behavior Scale 4-point Likert scale: 1 (Agree Strongly), 2 (Agree Some), 3 (Disagree Some), and 4 (Disagree Strongly)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Identify emotional characteristics of substances craving in patients suffering from SUD</measure>
<time_frame>At week-3</time_frame>
<description>Trait Meta-Mood Scale, from NOT AT ALL AGREE to TOTALLY AGREE / higher scores mean a worse or better outcome, depending of the question</description>
</secondary_outcome>
<secondary_outcome>
<measure>Identify psychopathological characteristics of substances craving in patients suffering from SUD</measure>
<time_frame>At week-3</time_frame>
<description>Eating Disorder Examination-Questionnaire, from NEVER to EVERY DAY / higher scores mean a worse or better outcome, depending of the question</description>
</secondary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Anticipated">280</enrollment>
<condition>Substance Use Disorders</condition>
<condition>Eating Disorders</condition>
<arm_group>
<arm_group_label>Epidemiology</arm_group_label>
<description>Inpatients who initiate treatment for a substance use disorder (SUD) will have to complete self-questionnaires, a clinical psychiatric assessment (MINI) and a cognitive assessment (MoCA).
These participants will be assessed at admission in addiction unit and at discharge, 3 weeks after withdrawal.
Outpatients who begin treatment for an eating disorder (ED) will have to complete self-questionnaires and a clinical psychiatric assessment (MINI) at the beginning of the outpatient treatment program</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Questionnaire</intervention_name>
<description>Patients treated for substance use disorders and patients treated for eating disorders will have to complete self-questionnaires and a clinical psychiatric (MINI) at the inclusion.
Patients suffering from substance use disorder will be assessed 3 weeks after inclusion.
Questionnaires are :
Modified Yale Food Addiction (mYFAS 2.0) and Impulsive Behavior Scale (UPPS-P)
Trait Meta-Mood Scale (TMMS), Hospital Anxiety and Depression Scale (HADs), Emotional Appetite Questionnaire (EMAQ), Perceived Stress Scale (PSS-10), Multidimensional Assessment of Interoceptive Awareness (MAIA) and Five Facet Mindfulness Questionnaire (FFMQ)
Mini International Neuropsychiatric Interview (MINI), Eating Disorder Examination-Questionnaire (EDE-Q), Rosenberg's Self Esteem (RSE) and Ruminative Response Scale for Eating disorders (RRS-ED)
Pittsburgh Sleep Quality Index (PSQI) and Montreal Cognitive Assessment (MoCA)</description>
<arm_group_label>Epidemiology</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Diagnostic and Statistical Manual (DSM)-5 diagnostic criteria for substance use
disorder/behavioral addiction (gambling) or DSM-5 diagnostic criteria for eating disorders
(Anorexia nervosa, Bulimia nervosa, Hyperphagia access)
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- DSM-5 diagnostic criteria for substance use disorder/behavioral addiction (gambling)
or an eating disorder (Anorexia nervosa, Bulimia nervosa or Hyperphagia access).

- Begin treatment in addiction complex care unit, located in inter-hospital unit Charles
Perrens Hospital and Bordeaux University Hospital

- Non-opposition formulated

Exclusion Criteria:

- Severely impaired physical and/or mental health that, according to the investigator,
may affect the participant's compliance with the study and understanding of assessment
tools

- Trouble in understanding/writing French

- Hospitalization for less than 3-weeks for patients with substance use disorders or
behavioral addiction (gambling)

- Individuals participating in another study that includes an ongoing exclusion period.

- Be under guardianship

- Pregnant and/or lactating woman
</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>Mélina FATSEAS, Prof, MD</last_name>
<role>Study Director</role>
<affiliation>Physician</affiliation>
</overall_official>
<overall_contact>
<last_name>Mélina FATSEAS, Prof, MD</last_name>
<phone>(+33) 524 549 000</phone>
<email>melina.fatseas@chu-bordeaux.fr</email>
</overall_contact>
<overall_contact_backup>
<last_name>Helen SAVARIEAU</last_name>
<phone>(+33) 556 563 556</phone>
<email>hsavarieau@ch-perrens.fr</email>
</overall_contact_backup>
<location>
<facility>
<name>Centre Hospitalier Universitaire de Bordeaux</name>
<address>
<city>Bordeaux</city>
<state>Gironde</state>
<zip>33000</zip>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Mélina FATSEAS, Prof MD PhD</last_name>
<phone>(+33) 554 549 000</phone>
<email>melina.fatseas@chu-bordeaux.fr</email>
</contact>
<contact_backup>
<last_name>Lea MARINELLI</last_name>
<phone>(+33) 554 549 000</phone>
<email>lea.marinelli@chu-bordeaux.fr</email>
</contact_backup>
</location>
<location_countries>
<country>France</country>
</location_countries>
<results_reference>
<citation>Atkinson TJ. Central and peripheral neuroendocrine peptides and signalling in appetite regulation: considerations for obesity pharmacotherapy. Obes Rev. 2008 Mar;9(2):108-20. doi: 10.1111/j.1467-789X.2007.00412.x.</citation>
<PMID>18257752</PMID>
</results_reference>
<results_reference>
<citation>Avena NM, Murray S, Gold MS. Comparing the effects of food restriction and overeating on brain reward systems. Exp Gerontol. 2013 Oct;48(10):1062-7. doi: 10.1016/j.exger.2013.03.006. Epub 2013 Mar 25.</citation>
<PMID>23535488</PMID>
</results_reference>
<results_reference>
<citation>Bydlowski S, Corcos M, Jeammet P, Paterniti S, Berthoz S, Laurier C, Chambry J, Consoli SM. Emotion-processing deficits in eating disorders. Int J Eat Disord. 2005 May;37(4):321-9. doi: 10.1002/eat.20132.</citation>
<PMID>15856501</PMID>
</results_reference>
<results_reference>
<citation>Calero-Elvira A, Krug I, Davis K, Lopez C, Fernandez-Aranda F, Treasure J. Meta-analysis on drugs in people with eating disorders. Eur Eat Disord Rev. 2009 Jul;17(4):243-59. doi: 10.1002/erv.936.</citation>
<PMID>19475697</PMID>
</results_reference>
<results_reference>
<citation>Canan F, Karaca S, Sogucak S, Gecici O, Kuloglu M. Eating disorders and food addiction in men with heroin use disorder: a controlled study. Eat Weight Disord. 2017 Jun;22(2):249-257. doi: 10.1007/s40519-017-0378-9. Epub 2017 Apr 22.</citation>
<PMID>28434177</PMID>
</results_reference>
<verification_date>March 2023</verification_date>
<study_first_submitted>March 4, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 29, 2023</last_update_submitted>
<last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 30, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Substance Use Disorders</keyword>
<keyword>Eating Disorders</keyword>
<keyword>Food craving</keyword>
<keyword>Addiction transfer</keyword>
<keyword>Addiction</keyword>
<keyword>Craving</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Substance-Related Disorders</mesh_term>
<mesh_term>Behavior, Addictive</mesh_term>
<mesh_term>Feeding and Eating 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>
|
Substance Use Disorder (SUD) and Eating Disorders (ED) are severe and persistent disturbances
that are associated with significant harm. These two disorders have many clinical
similarities, including craving and behavioral loss of control. Recently, craving for food
has been described in newly abstinent patients with SUD. the aim of the study is to verify
the hypothesis of addiction transfer based on common neurobiological mechanisms between
substance craving and food craving, that postulates that food craving would correspond to an
attempt to regulate substance craving (or vice versa).
The knowledge of existence of common addictive, neurobiological and clinical processes
between substance use disorders and eating disorders has been a promising approach for a
better understanding of the factors involved in the emergence and maintenance of these
disorders. Several studies have shown that increased palatable food with high sugar or fat
content causes brain neurochemistry changes similar to those observed after use of addictive
drugs. Clinical and behavioral similarities concerning craving, loss of control and use as a
coping strategy have also been highlighted. Craving is considered as a clinical marker of
addiction and a potent predictor of relapse vulnerability. In substance addiction, the link
between craving, use and relapse has been previously demonstrated in experimental and daily
life studies. The main objective of this study is to examine the hypothesis of addiction
transfer between Substance Use Disorders and Eating Disorders, according to which food
craving for palatable foods would correspond to an attempt to regulate substance craving or
vice versa. One assumption is that food intake could be used to alleviate craving for
substances in patients hospitalized for substance use disorder. The secondary objective is to
explore psychopathological, addictive, and medical similarities between substance use
disorder and eating disorder participants. Included patients (group 1: substance use disorder
participants and group 2: eating disorder) will be asked to answer different
self-questionnaires, as well as a clinical psychiatric (MINI) and cognitive (MoCA)
assessment.
Diagnostic and Statistical Manual (DSM)-5 diagnostic criteria for substance use
disorder/behavioral addiction (gambling) or DSM-5 diagnostic criteria for eating disorders
(Anorexia nervosa, Bulimia nervosa, Hyperphagia access)
Inclusion Criteria:
- DSM-5 diagnostic criteria for substance use disorder/behavioral addiction (gambling)
or an eating disorder (Anorexia nervosa, Bulimia nervosa or Hyperphagia access).
- Begin treatment in addiction complex care unit, located in inter-hospital unit Charles
Perrens Hospital and Bordeaux University Hospital
- Non-opposition formulated
Exclusion Criteria:
- Severely impaired physical and/or mental health that, according to the investigator,
may affect the participant's compliance with the study and understanding of assessment
tools
- Trouble in understanding/writing French
- Hospitalization for less than 3-weeks for patients with substance use disorders or
behavioral addiction (gambling)
- Individuals participating in another study that includes an ongoing exclusion period.
- Be under guardianship
- Pregnant and/or lactating woman
|
NCT0531xxxx/NCT05315648.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/NCT05315648</url>
</required_header>
<id_info>
<org_study_id>SAHoWMU-CR2021-03-109</org_study_id>
<nct_id>NCT05315648</nct_id>
</id_info>
<brief_title>Effect of General and Non-general Anesthesia on Perioperative Depression or Anxiety</brief_title>
<official_title>The Associations Between Perioperative Depression or Anxiety, Salivary Cortisol and α-amylase, and Administered Anesthesia Type in Knee Arthroscopy With Anterior Cruciate Ligament Reconstruction (ACLR): Prospective, Randomized Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Second Affiliated Hospital of Wenzhou Medical University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Second Affiliated Hospital of Wenzhou Medical 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>
Perioperative depression and/or anxiety play a critical role in patient presentation,
satisfaction and outcomes. The aim of this study is to assess the level of perioperative
depression and/or anxiety in patients with arthroscopic knee surgery and to evaluate their
relationship with anesthesia approach (general anesthesia or non general anesthesia). The
perioperative characteristic of depression or anxiety is assessed by Hospital Anxiety and
Depression Scale (HADS) questionnaires and the level of salivary cortisol, salivary α-amylase
(sAA) and blood glucose.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The incidence of perioperative anxiety has been reported to range from 11% to 80% among adult
patients. Perioperative depression and/or anxiety may increase the risk of poor postoperative
outcomes including increased morbidity and mortality , increased health care utilization,
increased opioid consumptions and pain scores, and decreased quality of recovery. Previous
studies have found that worrying about postoperative pain, unease of separation from family,
loss of selfcare and work ability, fear of surgery and even death are common factors leading
to perioperative anxiety symptoms.

The investigators found there were not enough studies to gain insights into the public's
knowledges, attitudes, and concerns regarding the risks associated with anesthesia. To some,
the fear of general anesthesia (GA) remains prevalent, especially with regard to possible
brain damage, death, and intraoperative awareness. The others, neuraxial anesthesia was
supposed to result in potentially complications, including postdural puncture headache,
backache, transient neurological symptoms, epidural hematoma and abscess, meningitis,
arachnoiditis, postoperative urinary retention, local anesthetic systemic toxicity.

Such fears can even exceed the anxiety about actual surgery. Actually, anesthesia approach
can be selected based on patients and anesthesiologists preference.

The investigators assumed from clinical experiences that effects of different anesthetic
approach and anesthetic drugs on stress reaction, perioperative blood glucose, immunity or
neuroendocrine during surgical operation were different, which resulted different prognosis
of patients.

The perioperative characteristic of depression or anxiety is assessed by Hospital Anxiety and
Depression Scale (HADS) questionnaires, salivary cortisol, salivary α-amylase (sAA) and blood
glucose.

Salivary cortisol and a-amylase are produced respectively by the
hypothalamus-pituitary-adrenal (HPA) axis and the sympathetic-adrenomedullary (SAM) system
during stress response, still not included in the routine evaluation of perioperative
physiological stress response. The application of these tests require additional and
definitive validation. In our study, salivary cortisol and a-amylase are measured as stress
biomarkers to examine their associations with anesthetic approach.The correlation between
salivary cortisol and serum cortisol was excellent in dynamic tests of adrenal function
(dexamethasone suppression, adreno-cortico-tropic-hormone stimulation), in healthy subjects
and in patients with adrenal insufficiency, in tests of circadian variation and in randomly
collected samples. The rate of equilibrium of cortisol between blood and saliva was very
fast, being less than 5 minutes. Since only free levels of cortisol are detected in saliva,
salivary cortisol is suggested to be a more appropriate measure for the clinical assessment
of adrenocortical function than serum cortisol. sAA has been proposed as a sensitive
biomarker for stress-related changes in the body that reflect the activity of the sympathetic
nervous system, and a growing body of research is accumulating to support the validity and
reliability of this parameter. Numerous studies applying stress protocols have demonstrated
that salivary a-amylase is highly sensitive to stress-related changes.

The investigators are trying to recruit patients who are scheduled to undergo knee
arthroscopy with anterior cruciate ligament reconstruction (ACLR) for the first time. Those
patients will be randomly assigned to general anesthesia (GA) group or non-general anesthesia
(NGA) group. Patients in GA group will received general anesthesia combined with femoral
nerve block (FNB). Patients in NGA group will received neuraxial anesthesia combined with
FNB, and without sedation. All patients received routine anesthesia and surgical protocols
and will be sent to the postoperative recovery unit (PACU) after surgery. Intraoperative
vital signs, analgesic usage, and duration of surgery were recorded.

The primary outcomes are HADS scores , salivary cortisol, sAA, blood glucose，swelling ratings
postoperatively, temperature ratings postoperatively and hospital stay. Secondary outcomes
are analgesic usage intraoperative and postoperative, anesthesia induction pain score,
postoperative pain score, duration of stay in the recovery unit, incidences of complications
about relevant anesthesia.

The Patients Hospital Anxiety and Depression Scale (HADS), a 14-item scale (7 items each for
anxiety and depression), with each item scored from 0 to 3. Salivary cortisol, sAA and blood
glucose levels will be tested in the morning one day before operation (T0), on the day of
operation (T1), 2 hours after operation (T2), the first morning after operation (T3), the
second morning after operation (T4).

The investigators will conduct subgroup analysis based on the patients' anesthesia wishes
(conform to patient's wishes, against patient's wishes, no original opinion) to address the
influence of anaesthesia practice and perioperative stress response.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">October 20, 2021</start_date>
<completion_date type="Actual">August 10, 2023</completion_date>
<primary_completion_date type="Actual">August 10, 2023</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>Prospective</time_perspective>
</study_design_info>
<target_duration>1 Month</target_duration>
<primary_outcome>
<measure>The changes of Hospital anxiety and Depression scale (HADS)</measure>
<time_frame>one day before surgery, 1day, 3 days after surgery and one day before discharge</time_frame>
<description>The HADS scale includes two dimensions of anxiety and depression, with a total of 14 questions, 7 questions for anxiety and 7 questions for depression. And the total score is 42. If the score was 0-7, indicating that there was no anxiety / depression; the score was 8-10, suspected anxiety / depression; 11-14, moderate anxiety / depression; the score was 15-21, severe anxiety / depression. If the score is ≥ 8, it will be rated as positive, otherwise it will be rated as negative.</description>
</primary_outcome>
<primary_outcome>
<measure>The changes of Salivary cortisol concentration</measure>
<time_frame>on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)</time_frame>
<description>Enzyme immunoassay for the quantitative determination of free Cortisol in human saliva.The patient should not eat, drink, chew gums or brush teeth for 30 min before sampling.Otherwise rinse mouth thoroughly with cold water 5 min prior to sample collection.A minimum of 0.5 mL liquid should be collected. Saliva flow can be stimulated by chewing on a piece of Parafilm.</description>
</primary_outcome>
<primary_outcome>
<measure>The changes of Saliva α- amylase activity</measure>
<time_frame>on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)</time_frame>
<description>Enzymatic assay for the determination of alpha amylase activity in human saliva.The patient should not eat, drink, chew gums or brush teeth for 30 min before sampling.Otherwise rinse mouth thoroughly with cold water 5 min prior to sample collection.A minimum of 0.5 mL liquid should be collected. Saliva flow can be stimulated by chewing on a piece of Parafilm.</description>
</primary_outcome>
<primary_outcome>
<measure>The changes of Blood glucose level</measure>
<time_frame>on the day of surgery (6 - 8 am), at 2 hours after surgery, one day after surgery (6 - 8 am) and two days after surgery (6 - 8 am)</time_frame>
<description>Using a glucose meter to check and monitor blood sugar via fingerstick</description>
</primary_outcome>
<primary_outcome>
<measure>The changes of swelling rating</measure>
<time_frame>at 6, 12, 24, 48, and 72 hours after surgery</time_frame>
<description>To assess swelling, knee circumference was measured at 2 cm above the superior border of the patella at 6, 12, 24, 48, and 72 h after surgery. The postoperative knee swelling rating on the injured side is defined as the knee circumference on the injured side minus the knee circumference on the uninjured side, both measured in centimeters.</description>
</primary_outcome>
<primary_outcome>
<measure>The changes of skin temperature rating</measure>
<time_frame>at 1, 3, and 5 days after surgery.</time_frame>
<description>Skin temperature of the knee is measured at the center of the anterior patella on postoperative days 1, 3, and 5. Limbs will be exposed to room temperature for 5 minutes bilaterally and then the skin temperature was measured with a skin temperature gun. The skin temperature on the injured side was defined as the skin temperature on the injured side minus the skin temperature on the uninjured side, both measured in degrees centigrade (°C) .</description>
</primary_outcome>
<primary_outcome>
<measure>postoperative hospital stay</measure>
<time_frame>the time of staying in hospital after surgery, an anticipated hospital stay of at least 3 days</time_frame>
<description>Duration of postoperative hospital stay</description>
</primary_outcome>
<secondary_outcome>
<measure>Numeric Rating Scales (NRS) of anesthesia induction</measure>
<time_frame>during the induction of general anesthesia or the puncture of combined spinal-epidural anesthesia intraoperatively</time_frame>
<description>patients who receive general anesthesia will evaluate the pain induced by propofol infusion. patients receive non-general anesthesia will evaluate the puncture pain during CSEA. NRS will be used to assess the intensity of pain, ranged from 0-10, 0 means no pain and 10 means severe pain.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Intraoperative opioid consumption</measure>
<time_frame>start from the beginning of induction of general anesthesia or the puncture of CSEA to discharge of operation room, average 2 hours</time_frame>
<description>the consumption of sufentanil and remifentanil during induction and maintain of anesthesia, both will be converted into morphine equivalents</description>
</secondary_outcome>
<secondary_outcome>
<measure>PACU stay</measure>
<time_frame>about 30 minutes to 60 minutes after surgery</time_frame>
<description>the time of staying in post-anesthesia care unit(PACU), about 30 minutes to 60 minutes after surgery</description>
</secondary_outcome>
<secondary_outcome>
<measure>Post-operative opioid consumptions</measure>
<time_frame>from arrived at PACU to the first 72 post-operative hours</time_frame>
<description>postoperative opioid consumption including sufentanil consumptions in PACU and the rescue analgesics (morphine 0.05 mg/kg) when NRS > 3. (sufentanil will be converted into morphine equivalents)</description>
</secondary_outcome>
<secondary_outcome>
<measure>The changes of NRS of postoperative pain</measure>
<time_frame>at 2, 6, 12, 24, 48, and 72 hours after surgery</time_frame>
<description>Patients evaluate the pain at rest and on knee flexion after surgery. NRS will be used to assess the intensity of pain, ranged from 0-10, 0 means no pain and 10 means severe pain.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Complications related to general anesthesia</measure>
<time_frame>started from the induction of general anesthesia to the first 72 post-operative hours</time_frame>
<description>such as intraoperative hypoxemia, postoperative nausea and vomiting , postoperative deliriums, postoperative cognitive dysfunction</description>
</secondary_outcome>
<secondary_outcome>
<measure>Complications related to combined spinal-epidural anesthesia</measure>
<time_frame>started from the beginning of combined spinal-epidural anesthesia to the first 72 post-operative hours</time_frame>
<description>such as postdural puncture headache, backache, transient neurological symptoms, epidural hematoma and abscess, meningitis, arachnoiditis, postoperative urinary retention, local anesthetic systemic toxicity and infection</description>
</secondary_outcome>
<secondary_outcome>
<measure>Complications related to femoral nerve block</measure>
<time_frame>started from the puncture of nerve block to the first 72 post-operative hours</time_frame>
<description>such as nerve injury, hematoma, local anesthetic systemic toxicity and infection</description>
</secondary_outcome>
<secondary_outcome>
<measure>Costs of hospitalization</measure>
<time_frame>through study completion, an average of 1 week</time_frame>
<description>Costs will be calculated about total standardized costs before healthcare coverage，such as social medical reimbursement or health insurance.Costs will be evaluated in 2022 renminbi (RMB) yuans.</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Actual">117</enrollment>
<condition>Depression, Anxiety</condition>
<arm_group>
<arm_group_label>General anesthesia group</arm_group_label>
<description>Patients in GA group will receive general anesthesia combined with FNB. All patients received routine anesthesia and surgical protocols. GA will be induced by intravenously administering propofol 2-4 mg/kg, cisatracurium 0.2mg/kg, sufentanil 0.2-0.3 μg/kg and maintained with remifentanil at 0.15-0.2 μg/kg/min and 2%-3% sevoflurane to keep bispectral index (BIS) values at 40 - 60. FNB will be performed under ultrasound-guieded and combined with nerve stimulation. Using an in-plane technique, a 10-cm long 18- gauge (G) Tuohy needle will be inserted in the lateral to medial direction towards the femoral nerve (FN). As the needle is being advanced toward the FN, the nerve stimulator is set at 1 mA, 0.1-millisecond pulse duration, and 2-Hz frequency. When the muscle contraction of the quadriceps muscle is identified, the current is reduced to 0.5 mA. After the negative aspiration, 20 mL of ropivacaine 0.375% is injected.</description>
</arm_group>
<arm_group>
<arm_group_label>Non-general anesthesia group</arm_group_label>
<description>Patients in NGA group will receive combined spinal-epidural anesthesia（CSEA）at L3 to L4 interspace with 3.0 ml of 0.5% hyperbaric ropivacaine followed with FNB , and without sedation. The FNB will be performed under aseptic precautions using ultrasound guidance and nerve stimulation. A high frequency linear ultrasound transducer 5-12 MHz (Sonosite, Inc. Bothell WA 98021 USA) was placed on the inguinal crease to identify the femoral artery and nerve. Using an in-plane technique, a 10-cm long 18- gauge (G) Tuohy needle connected to the nerve stimulator will be inserted in the lateral to medial direction towards the femoral nerve. When the muscle contraction of the quadriceps muscle and negative aspiration are identified, 20 mL of ropivacaine 0.375% is injected.
If the CSEA analgesia is invalid (two times of epidural remedial analgesia) , change non-general anesthesia to general anesthesia, and the subjects withdrew from the trial.</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>anesthesia approach (general anesthesia or non-general anesthesia)</intervention_name>
<description>patients in group GA received general anesthesia followed with FNB. patients in group NGA received CSEA followed with FNB</description>
<arm_group_label>General anesthesia group</arm_group_label>
<arm_group_label>Non-general anesthesia group</arm_group_label>
</intervention>
<biospec_retention>Samples Without DNA</biospec_retention>
<biospec_descr>
<textblock>
saliva, serum and fingertip blood
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
The patients from citizen or town whose ASA I or II, aged 18 to 60, will be scheduled to
receive anterior cruciate ligament reconstruction of knee joint for the first time.This
single centre, randomized, blinded trial was approved by the institutional ethics committee
of the second affiliated hospital of Wenzhou medical university.
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Patients aged between 18 to 60 years with American Society of Anesthesiologists (ASA)
physical status I or II, who will be scheduled to receive anterior cruciate ligament
reconstruction of knee joint for the first time. The operation time is less than 2
hours (from the beginning use of the tourniquet to the release).

Exclusion Criteria:

- previous history of anxiety or depression or mania; systemic diseases (systemic
sclerosis, systemic lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis,
primary aldosteronism, Cushing syndrome); taking cortisol or sedative hypnotic drugs;
tumor patients; smoking; pregnancy status; diabetes; drinking coffee or alcohol drinks
during perioperative period.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
</eligibility>
<overall_official>
<last_name>CongCong Huang, Master</last_name>
<role>Study Director</role>
<affiliation>Second Affiliated Hospital of Wenzhou Medical University</affiliation>
</overall_official>
<location>
<facility>
<name>Second Affiliated Hospital of WenZhou Medical University</name>
<address>
<city>Wenzhou</city>
<state>Zhejiang</state>
<zip>325000</zip>
<country>China</country>
</address>
</facility>
</location>
<location_countries>
<country>China</country>
</location_countries>
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<verification_date>August 2023</verification_date>
<study_first_submitted>October 26, 2021</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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>Second Affiliated Hospital of Wenzhou Medical University</investigator_affiliation>
<investigator_full_name>Congcong Huang</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>perioperative anxiety or depression</keyword>
<keyword>general anesthesia</keyword>
<keyword>salivary cortisol</keyword>
<keyword>salivary α-amylase</keyword>
<keyword>Hospital Anxiety and Depression Scale</keyword>
<keyword>stress response</keyword>
<keyword>non-general anesthesia</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Depression</mesh_term>
<mesh_term>Depressive Disorder</mesh_term>
<mesh_term>Anxiety Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Anesthetics</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Perioperative depression and/or anxiety play a critical role in patient presentation,
satisfaction and outcomes. The aim of this study is to assess the level of perioperative
depression and/or anxiety in patients with arthroscopic knee surgery and to evaluate their
relationship with anesthesia approach (general anesthesia or non general anesthesia). The
perioperative characteristic of depression or anxiety is assessed by Hospital Anxiety and
Depression Scale (HADS) questionnaires and the level of salivary cortisol, salivary α-amylase
(sAA) and blood glucose.
The incidence of perioperative anxiety has been reported to range from 11% to 80% among adult
patients. Perioperative depression and/or anxiety may increase the risk of poor postoperative
outcomes including increased morbidity and mortality , increased health care utilization,
increased opioid consumptions and pain scores, and decreased quality of recovery. Previous
studies have found that worrying about postoperative pain, unease of separation from family,
loss of selfcare and work ability, fear of surgery and even death are common factors leading
to perioperative anxiety symptoms.
The investigators found there were not enough studies to gain insights into the public's
knowledges, attitudes, and concerns regarding the risks associated with anesthesia. To some,
the fear of general anesthesia (GA) remains prevalent, especially with regard to possible
brain damage, death, and intraoperative awareness. The others, neuraxial anesthesia was
supposed to result in potentially complications, including postdural puncture headache,
backache, transient neurological symptoms, epidural hematoma and abscess, meningitis,
arachnoiditis, postoperative urinary retention, local anesthetic systemic toxicity.
Such fears can even exceed the anxiety about actual surgery. Actually, anesthesia approach
can be selected based on patients and anesthesiologists preference.
The investigators assumed from clinical experiences that effects of different anesthetic
approach and anesthetic drugs on stress reaction, perioperative blood glucose, immunity or
neuroendocrine during surgical operation were different, which resulted different prognosis
of patients.
The perioperative characteristic of depression or anxiety is assessed by Hospital Anxiety and
Depression Scale (HADS) questionnaires, salivary cortisol, salivary α-amylase (sAA) and blood
glucose.
Salivary cortisol and a-amylase are produced respectively by the
hypothalamus-pituitary-adrenal (HPA) axis and the sympathetic-adrenomedullary (SAM) system
during stress response, still not included in the routine evaluation of perioperative
physiological stress response. The application of these tests require additional and
definitive validation. In our study, salivary cortisol and a-amylase are measured as stress
biomarkers to examine their associations with anesthetic approach.The correlation between
salivary cortisol and serum cortisol was excellent in dynamic tests of adrenal function
(dexamethasone suppression, adreno-cortico-tropic-hormone stimulation), in healthy subjects
and in patients with adrenal insufficiency, in tests of circadian variation and in randomly
collected samples. The rate of equilibrium of cortisol between blood and saliva was very
fast, being less than 5 minutes. Since only free levels of cortisol are detected in saliva,
salivary cortisol is suggested to be a more appropriate measure for the clinical assessment
of adrenocortical function than serum cortisol. sAA has been proposed as a sensitive
biomarker for stress-related changes in the body that reflect the activity of the sympathetic
nervous system, and a growing body of research is accumulating to support the validity and
reliability of this parameter. Numerous studies applying stress protocols have demonstrated
that salivary a-amylase is highly sensitive to stress-related changes.
The investigators are trying to recruit patients who are scheduled to undergo knee
arthroscopy with anterior cruciate ligament reconstruction (ACLR) for the first time. Those
patients will be randomly assigned to general anesthesia (GA) group or non-general anesthesia
(NGA) group. Patients in GA group will received general anesthesia combined with femoral
nerve block (FNB). Patients in NGA group will received neuraxial anesthesia combined with
FNB, and without sedation. All patients received routine anesthesia and surgical protocols
and will be sent to the postoperative recovery unit (PACU) after surgery. Intraoperative
vital signs, analgesic usage, and duration of surgery were recorded.
The primary outcomes are HADS scores , salivary cortisol, sAA, blood glucose，swelling ratings
postoperatively, temperature ratings postoperatively and hospital stay. Secondary outcomes
are analgesic usage intraoperative and postoperative, anesthesia induction pain score,
postoperative pain score, duration of stay in the recovery unit, incidences of complications
about relevant anesthesia.
The Patients Hospital Anxiety and Depression Scale (HADS), a 14-item scale (7 items each for
anxiety and depression), with each item scored from 0 to 3. Salivary cortisol, sAA and blood
glucose levels will be tested in the morning one day before operation (T0), on the day of
operation (T1), 2 hours after operation (T2), the first morning after operation (T3), the
second morning after operation (T4).
The investigators will conduct subgroup analysis based on the patients' anesthesia wishes
(conform to patient's wishes, against patient's wishes, no original opinion) to address the
influence of anaesthesia practice and perioperative stress response.
saliva, serum and fingertip blood
The patients from citizen or town whose ASA I or II, aged 18 to 60, will be scheduled to
receive anterior cruciate ligament reconstruction of knee joint for the first time.This
single centre, randomized, blinded trial was approved by the institutional ethics committee
of the second affiliated hospital of Wenzhou medical university.
Inclusion Criteria:
- Patients aged between 18 to 60 years with American Society of Anesthesiologists (ASA)
physical status I or II, who will be scheduled to receive anterior cruciate ligament
reconstruction of knee joint for the first time. The operation time is less than 2
hours (from the beginning use of the tourniquet to the release).
Exclusion Criteria:
- previous history of anxiety or depression or mania; systemic diseases (systemic
sclerosis, systemic lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis,
primary aldosteronism, Cushing syndrome); taking cortisol or sedative hypnotic drugs;
tumor patients; smoking; pregnancy status; diabetes; drinking coffee or alcohol drinks
during perioperative period.
|
NCT0531xxxx/NCT05315661.xml | <clinical_study>
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<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/NCT05315661</url>
</required_header>
<id_info>
<org_study_id>2022-02-089</org_study_id>
<nct_id>NCT05315661</nct_id>
</id_info>
<brief_title>The Safety and The Efficacy Evaluation of ET-STEM in Patients With Frontotemporal Dementia</brief_title>
<acronym>FTD_ET-STEM</acronym>
<official_title>Clinical Assessment on the Safety and Potential Efficacy of Mesenchymal Stem Cells Preconditioned With Ethionamide (ET-STEM) in Patients With Frontotemporal Dementia (FTD)</official_title>
<sponsors>
<lead_sponsor>
<agency>Samsung Medical Center</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Samsung 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>
The primary purpose of this study is to evaluate the safety and the tolerability of 3
repeated doses of ET-STEM (Mesenchymal stem cells preconditioned with ethionamide) in
patients with FTD.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Subjects with FTD, who signed the informed consent form and meet the eligibility criteria
will undergo Ommaya reservoir insertion. 2 weeks after Ommaya reservoir insertion, the
subjects will be injected with 3x10^7 cells/2mL of ET-STEM to intraventricular space via an
Ommaya reservoir. The injection will be repeated 3 times at 4 week intervals. The subjects
will be hospitalized for 24 hours and observed for acute adverse events. 4 weeks after the
3rd injection, safety and potential efficacy will be assessed.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">July 6, 2022</start_date>
<completion_date type="Anticipated">December 31, 2026</completion_date>
<primary_completion_date type="Anticipated">December 31, 2026</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>
<intervention_model_description>Single Group</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>To determine DLT (Dose limiting toxicity)</measure>
<time_frame>First 3-week cycle of treatment</time_frame>
<description>incidence rate of DLT (Dose limiting toxicity)</description>
</primary_outcome>
<primary_outcome>
<measure>adverse events as assessed by CTCAE v5.0</measure>
<time_frame>up to 5years</time_frame>
<description>all potentially treated subjects to assess the safety</description>
</primary_outcome>
<secondary_outcome>
<measure>ADAS-Cog 13 response rate</measure>
<time_frame>Screening, after the first administration12weeks, 48weeks, 96weeks, 144weeks, 192weeks, 240weeks</time_frame>
<description>response rate, no change or improvement on ADAS cog 13 score</description>
</secondary_outcome>
<secondary_outcome>
<measure>The Clinical Dementia Rating Sum of Boxes</measure>
<time_frame>Screening, after the first administration12weeks, 48weeks, 96weeks, 144weeks, 192weeks, 240weeks</time_frame>
<description>Change from the baseline in CDR-SB, min 0, max 24, higher scores mean a worse outcome</description>
</secondary_outcome>
<secondary_outcome>
<measure>Alzheimer's Disease Cooperative Study- instrumental items of the Activities of Daily Living Inventory</measure>
<time_frame>the first administration12weeks, 48weeks, 96weeks, 144weeks, 192weeks, 240weeks</time_frame>
<description>Change from the baseline in ADCS-iADL, min 0, max78, higher scores mean a better outcome</description>
</secondary_outcome>
<secondary_outcome>
<measure>Caregiver-administered Neuropsychiatric Inventory</measure>
<time_frame>the first administration12weeks, 48weeks, 96weeks, 144weeks, 192weeks, 240weeks</time_frame>
<description>Change from the baseline in CGA-NPI, min 0, max 144, higher scores mean a worse outcome</description>
</secondary_outcome>
<secondary_outcome>
<measure>preliminary efficacy</measure>
<time_frame>up to 12weeks</time_frame>
<description>Change from the baseline in CSF biomarkers</description>
</secondary_outcome>
<secondary_outcome>
<measure>K-MMSE</measure>
<time_frame>the first administration12weeks, 48weeks, 96weeks, 144weeks, 192weeks, 240weeks</time_frame>
<description>Korean Mini-Mental State Examination(MMSE), min 0, max 30, higher scores mean a better outcome</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">12</enrollment>
<condition>Frontotemporal Dementia</condition>
<arm_group>
<arm_group_label>Treatment Arm</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>injected with 3x10^7 cells/2mL of ET-STEM to intraventricular space via an Ommaya reservoir. repeated 3 times at 4 week intervals</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>ET-STEM</intervention_name>
<description>mesenchymal stem cells preconditioned with ethionamide</description>
<arm_group_label>Treatment Arm</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Korean male or female at 40-85 years of age

2. Diagnosis of one of the 3 subtyes of FTD according to the diagnostic criteria for 3
subtypes of FTD

① Probable bvFTD (behavior variant FTD)

② svPPA (semantic variant primary progressive aphasia)

③ nfvPPA (nonfluent/agrammatic variant primary progressive aphasia)

3. K-MMSE ≥ 10

4. Subjects with trusted caregivers who regularly contact the subjects and can accompany
the subjects when visiting the hospital.

5. Negative result of amyloid PET imaging

6. A subject who is informed of the clinical trial and signs a consent form (If unable to
sign, a consent from a legally acceptable representative is required)

Exclusion Criteria:

1. Subjects with dementia cause by other than FTD (i.e. infection of central nervous
system, Creutzfeld-Jacob disease, severer head trauma, Huntington's disease,
Parkinson's disease, Alzheimer's disease and vascular dementia)

2. Subjects with psychological disorder. (i.e. depression, schizophrenia , bipolar
disorder, etc) (except for subjects who were misdiagnosed with psychological disease
due to the initial neuropsychiatric symptoms of FTD)

3. Subjects with uncontrolled hypotension, hypertension, diabetes and thyroid disease.

4. Subjects with a cancer (including brain tumor)

5. Subjects with bleeding disorder

6. Woman of childbearing age who refused to practice medically acceptable contraceptive
method (post menopausal patient with no menstruation for at least 12 months is
considered as infertile)

7. Pregnant or lactating females

8. History of stroke within 3 months prior to study enrollment

9. Substance/alcohol abuse 1

10. Contraindicated for any of the tests performed during the clinical trial period(for
example, MRI, CT,PET)

11. A subject in whom Ommaya reservoir insertion and general anesthesia are considered
difficult

12. Abnormal Laboratory findings at Screening

13. Suspected active lung disease based on chest X-ray at Screening

14. Positive hepatitis B nuclear antibody and hpatitis C antibody

15. Subjects who the principal investigator considers inappropriate for participation in
the study due to the possible harmful effect on the subjects,difficulty in study
completion, or previous or current medical conditions that may disturb evaluation of
study results

16. Subjects who the principal investigator considers impossible to comply with clinical
research procedures.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>40 Years</minimum_age>
<maximum_age>85 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>HeeJin Kim</last_name>
<role>Principal Investigator</role>
<affiliation>Samsung Medical Center</affiliation>
</overall_official>
<overall_contact>
<last_name>HeeJin Kim</last_name>
<phone>82-10-8654-7347</phone>
<email>evekhj@gmail.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>HeeJin Kim</last_name>
<phone>82-10-8654-7347</phone>
</overall_contact_backup>
<location>
<facility>
<name>Samsung Medical Center</name>
<address>
<city>Seoul</city>
<state>Gangnam-gu</state>
<zip>06351</zip>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Heejin Kim</last_name>
<phone>82-10-8654-7347</phone>
<email>evekhj@gmail.com</email>
</contact>
</location>
<location_countries>
<country>Korea, Republic of</country>
</location_countries>
<verification_date>October 2022</verification_date>
<study_first_submitted>March 1, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>October 24, 2022</last_update_submitted>
<last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">October 27, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Samsung Medical Center</investigator_affiliation>
<investigator_full_name>Hee Jin Kim</investigator_full_name>
<investigator_title>assistant professor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Dementia</mesh_term>
<mesh_term>Frontotemporal Dementia</mesh_term>
<mesh_term>Aphasia, Primary Progressive</mesh_term>
<mesh_term>Pick Disease of the Brain</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 primary purpose of this study is to evaluate the safety and the tolerability of 3
repeated doses of ET-STEM (Mesenchymal stem cells preconditioned with ethionamide) in
patients with FTD.
Subjects with FTD, who signed the informed consent form and meet the eligibility criteria
will undergo Ommaya reservoir insertion. 2 weeks after Ommaya reservoir insertion, the
subjects will be injected with 3x10^7 cells/2mL of ET-STEM to intraventricular space via an
Ommaya reservoir. The injection will be repeated 3 times at 4 week intervals. The subjects
will be hospitalized for 24 hours and observed for acute adverse events. 4 weeks after the
3rd injection, safety and potential efficacy will be assessed.
Inclusion Criteria:
1. Korean male or female at 40-85 years of age
2. Diagnosis of one of the 3 subtyes of FTD according to the diagnostic criteria for 3
subtypes of FTD
① Probable bvFTD (behavior variant FTD)
② svPPA (semantic variant primary progressive aphasia)
③ nfvPPA (nonfluent/agrammatic variant primary progressive aphasia)
3. K-MMSE ≥ 10
4. Subjects with trusted caregivers who regularly contact the subjects and can accompany
the subjects when visiting the hospital.
5. Negative result of amyloid PET imaging
6. A subject who is informed of the clinical trial and signs a consent form (If unable to
sign, a consent from a legally acceptable representative is required)
Exclusion Criteria:
1. Subjects with dementia cause by other than FTD (i.e. infection of central nervous
system, Creutzfeld-Jacob disease, severer head trauma, Huntington's disease,
Parkinson's disease, Alzheimer's disease and vascular dementia)
2. Subjects with psychological disorder. (i.e. depression, schizophrenia , bipolar
disorder, etc) (except for subjects who were misdiagnosed with psychological disease
due to the initial neuropsychiatric symptoms of FTD)
3. Subjects with uncontrolled hypotension, hypertension, diabetes and thyroid disease.
4. Subjects with a cancer (including brain tumor)
5. Subjects with bleeding disorder
6. Woman of childbearing age who refused to practice medically acceptable contraceptive
method (post menopausal patient with no menstruation for at least 12 months is
considered as infertile)
7. Pregnant or lactating females
8. History of stroke within 3 months prior to study enrollment
9. Substance/alcohol abuse 1
10. Contraindicated for any of the tests performed during the clinical trial period(for
example, MRI, CT,PET)
11. A subject in whom Ommaya reservoir insertion and general anesthesia are considered
difficult
12. Abnormal Laboratory findings at Screening
13. Suspected active lung disease based on chest X-ray at Screening
14. Positive hepatitis B nuclear antibody and hpatitis C antibody
15. Subjects who the principal investigator considers inappropriate for participation in
the study due to the possible harmful effect on the subjects,difficulty in study
completion, or previous or current medical conditions that may disturb evaluation of
study results
16. Subjects who the principal investigator considers impossible to comply with clinical
research procedures.
|
NCT0531xxxx/NCT05315674.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/NCT05315674</url>
</required_header>
<id_info>
<org_study_id>MARKED</org_study_id>
<nct_id>NCT05315674</nct_id>
</id_info>
<brief_title>Markers of COPD Exacerbations</brief_title>
<acronym>MARKED</acronym>
<official_title>Early Diagnostic BioMARKers in Exacerbations of COPD: the MARKED Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Center of Expertise for Chronic Organ Failure</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>AstraZeneca</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>Center of Expertise for Chronic Organ Failure</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>
Acute exacerbations of COPD (AECOPD) are episodes of acute worsening of respiratory symptoms
that require additional therapy. Exacerbations play a pivotal role in the burden and
progressive course of COPD (1). Each event contributes to a progressive decline in lung
function (2), reduced health status, low physical activity level (3) and increased health
care costs (4). As such, disease management is predominantly based on the prevention of these
episodes (1). Yet, in the Netherlands, 30.000 people are admitted to the hospital for an
AECOPD every year (5). Although most AECOPD have an infectious origin (6), the underlying
mechanisms are heterogeneous and predicting their occurrence in individual patients currently
remains unsuccessful (7-9). Furthermore, there is a lack of our understanding in the
longitudinal alterations in microbial composition and host-microbiome interactions in the
stable state, at AECOPD and during recovery in patients with COPD. This knowledge is
essential to improve the early and accurate diagnosis of (the different types of) AECOPD, and
for the development of novel antimicrobial and other therapeutic targets and subsequent
personalized treatment. These challenges need to be addressed in order to reduce the future
impact of these events, avoid unnecessary treatments of individual patients, reduce
healthcare utilization and improve overall care for patients with COPD. The current 'Early
diagnostic BioMARKers in Exacerbations of COPD' (MARKED) study was designed to investigate
several of these gaps in the management of COPD exacerbations.

It is anticipated that complex biomarker panels, rather than a single biomarker, will be
identified. Since AECOPD are heterogeneous events in terms of origin, trigger, severity,
duration, need for treatment and overall clinical presentation (1, 6, 10-15), we expect to
identify different biomarker panels for different subtypes of AECOPD. Furthermore, AECOPD
diagnosis relies heavily on the exclusion of differential diagnoses (1), which further rules
out the potential of a single predictive AECOPD biomarker.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The MARKED study is an exploratory, prospective, single-center, longitudinal, observational
study with eight weeks follow-up. The primary objective is to explore which biomarkers from a
panel of frequently measured biomarkers (symptoms, vital signs, lung function parameters and
spontaneous sputum, nasopharyngeal swabs, stool and blood samples) predict an exacerbation
and/or respiratory infection in patients with COPD. Furthermore, secondary objectives are:

I. to investigate longitudinal alterations in microbial composition and host-microbiome
interactions in the stable state, at AECOPD and during recovery.

II. to study the heterogeneity of AECOPD by comprehensive clinical, functional, microbial,
proteomic, transcriptomic, genetic, metabolomic, inflammatory and biochemical
characterization of these events.

III. to determine the correlation between microbial alterations in the airways/gut and
inflammatory biomarkers in blood during longitudinal follow up.

IV. to longitudinally investigate biomarkers of AECOPD in clinically relevant subgroups of
patients with COPD (e.g. current versus ex-smokers, high versus low blood eosinophils,
frequent vs. infrequent exacerbators).

V. to comprehensively investigate whether host-microbiome interactions, biomarkers and
predictive models identify those patients that do not exacerbate despite having a respiratory
infection.

All AECOPD evaluated by the physician in Ciro as moderate or severe will be recorded in this
study. Moderate AECOPD are defined by a worsening of symptoms >2 consecutive days leading to
treatment with systemic glucocorticoids, antibiotics or both. Severe events are characterized
by (enhanced) oxygen therapy, non-invasive ventilation (NIV) or hospital admission that
lasted >24 hours, in addition to treatment with systemic glucocorticoids, antibiotics or
both.

Whilst aiming to include at least 50 patients experiencing an AECOPD and at least 50 patients
without an AECOPD, up to 150 consecutive patients with a primary diagnosis of COPD admitted
for inpatient pulmonary rehabilitation at Ciro will be recruited for the study. Although
sample size rules of thumb exist for multivariable regression modelling and prediction
modelling strategies, this study is explorative in nature. Therefore, the amount of
biomarkers exceeds the amount when applying the rule of thumb that states that for each
potential predictive variable, 10 events should be observed. The study aims to include at
least 50 unique individual patients who experience ≥1 AECOPD, and at least 50 individual
patients without an AECOPD, to provide accurate benchmark data (i.e. sufficient precision to
estimate mean and standard deviation [SD]) for exploratory biomarkers. From previous studies
in Ciro it is known that approximately 42% of patients will develop at least one AECOPD
during admission (16). Because AECOPD are unpredictable and variable, which is an important
rationale for the present study, the study will expectedly need 100-150 patients to be
included. The goal of this study is not to develop a multivariate model, but rather to
explore the associations between biomarkers and the occurrence of an event.

Baseline characteristics will be reported as mean and SD or as median and interquartile range
(IQR) for continuous variables, as appropriate, and as count and percentage for categorical
characteristics. Predictors of time-to-first AECOPD during the study period will be modelled
using univariate and multivariable Cox proportional hazards regression. Associations will be
presented as hazard ratio (HR) and 95% confidence interval (CI). The dependency of the
predictive performance of biomarkers will be tested using interaction terms. The
concordance-statistic, or c-statistic, will be estimated to assess discriminative ability.
Time-dependent AUC-Receiver Operating Characteristics (ROC) plots will furthermore be
created. Calibration will be assessed by comparing the predicted probability with the
observed probability of an AECOPD, and examined with a calibration plot and calibration
slope, assuming no data censoring before the end of follow-up.

Characterization of the microbiome will be determined by alpha- and beta-diversity and
relative abundance of bacterial taxa. Alpha-diversity will be treated as a continuous
variable and analysed using appropriate statistical tests, whereas ordination of
beta-diversity distances will be done using principal component analysis. Multiomic analyses
will be used to generate hypotheses about the drivers that promote progression to AECOPD.
Differential enrichment analysis for feature selection across all 'omics will be done after
accounting for multiple hypothesis testing using a robust model that considers distributional
assumptions. The association between genetic variants and (AE)COPD and microbial infections
will be studied using whole-exome sequencing data.

Self-organizing maps (SOMs, also referred to as Kohonen maps) will be used to create an
ordered representation of the selected attributes at the time of AECOPD by using Viscovery
Profiler 7.1 (Viscovery Software GmbH, Vienna, Austria). Based on the identified homogeneous
data groups created in the SOM model, clusters will be generated using Viscovery's SOM-Ward
Cluster algorithm. Summary variables of clinical characteristics for the total sample, and
for clusters, will be presented as mean and SD for quantitative variables, and as percentages
for discrete variables. Differences between groups will be assessed using integrated
two-sided t-tests. Repeated measure correlations will be used to determine the
within-individual association between microbial alterations in the airways/gut and systemic
inflammatory biomarkers across patients.

In case of missing data on predictors, stochastic regression imputation with fully
conditional specification will be used to impute the dataset to allow the use of all included
patients for the analyses. Values will be drawn using predictive mean matching. Statistical
significance will be denoted by p<0.05.

The current study is classified as research with negligible risk. There are no serious risks
associated with participation in this study. Hematomas might occur from venous blood
sampling. Nasal discomfort might be experienced during nasal sampling. Patients might
experience breathlessness and fatigue due to additional daily measurements (e.g.
questionnaires, lung function) and/or might refuse participation or drop-out of the study
because of the burden of frequent sampling and other assessments. Extensive guidelines have
been established to monitor scientific research in a structured and protocol-based manner at
Ciro. In the context of the NFU report 'Quality assurance for people-related research', the
current investigator initiated research was classified as research with negligible risk. The
assigned study site monitor will monitor the safety of the participants, and the accuracy of
following procedures as described in the protocol by the research staff, on an annual basis.
Monitoring will be performed in compliance with Good Clinical Practice (GCP) in order to
achieve high quality research and secure patient safety.

In accordance with the Medical Research Involving Human Subjects Act (WMO) the study will be
suspended if the health or safety of subjects will be jeopardised. The accredited Medical
Ethical Teaching Committee (Medical Research Ethics Committees United [MEC-U], Nieuwegein,
the Netherlands) will be notified without undue delay after obtaining knowledge of these
events. Adverse and serious adverse events will be recorded. Hospitalized AECOPD will not be
considered as serious adverse events. Exacerbations and hospitalized AECOPD will be annually
reported to MEC-U. Ciro has established protocols for the management of AECOPD; these
protocols will also be followed for patients included in the study. Moderate AECOPD are
treated at Ciro, the pulmonary rehabilitation program will be adjusted as needed. Patients
with severe AECOPD requiring hospital admission will be referred to a nearby hospital.

Ethical approval for the study has been granted by MEC-U (NL71364.100.19). The study will be
conducted according to the principles of the Declaration of Helsinki (64th WMA General
Assembly, Fortaleza, Brazil, October 2013 (17)) and in accordance with the WMO. Written
informed consent will be obtained from all participants before study participation. Results
of the study will be published in peer-reviewed scientific journals and will be presented at
(inter)national conferences. If desired, participants will be informed about the outcomes of
the study.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">July 25, 2022</start_date>
<completion_date type="Anticipated">December 2025</completion_date>
<primary_completion_date type="Anticipated">January 2025</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>Respiratory symptoms: EXACT</measure>
<time_frame>8 weeks</time_frame>
<description>The EXAcerbations of Chronic pulmonary disease Tool (EXACT). The higher the score, the higher the disease burden. Scale: total score 0-100 points. Assessment: daily.</description>
</primary_outcome>
<primary_outcome>
<measure>Respiratory symptoms: c-LRTI-VAS</measure>
<time_frame>8 weeks</time_frame>
<description>The COPD- Lower Respiratory Tract Infection Visual Analogue Scales (c-LRTI-VAS). The higher the score, the higher the disease burden. Scale: 0-100 mm. Assessment: daily.</description>
</primary_outcome>
<primary_outcome>
<measure>Vital signs: blood pressure</measure>
<time_frame>8 weeks</time_frame>
<description>Systolic and diastolic blood pressure (mmHg). Assessment: daily.</description>
</primary_outcome>
<primary_outcome>
<measure>Vital signs: heart rate</measure>
<time_frame>8 weeks</time_frame>
<description>Heart rate (beats per minute). Assessment: daily.</description>
</primary_outcome>
<primary_outcome>
<measure>Vital signs: oxygen saturation</measure>
<time_frame>8 weeks</time_frame>
<description>Oxygen saturation (SpO2). Assessment: daily.</description>
</primary_outcome>
<primary_outcome>
<measure>Vital signs: body temperature</measure>
<time_frame>8 weeks</time_frame>
<description>Body temperature (degree Celsius). Assessment: daily.</description>
</primary_outcome>
<primary_outcome>
<measure>Vital signs: breathing frequency</measure>
<time_frame>8 weeks</time_frame>
<description>Breathing frequency (breaths per minute). Assessment: daily.</description>
</primary_outcome>
<primary_outcome>
<measure>Pre-bronchodilator FEV1</measure>
<time_frame>8 weeks</time_frame>
<description>Absolute (L) and percentage of predicted (% pred) of the forced expiratory volume in 1 second (FEV1). Assessment: daily.</description>
</primary_outcome>
<primary_outcome>
<measure>Pre-bronchodilator FVC</measure>
<time_frame>8 weeks</time_frame>
<description>Absolute (L) and percentage of predicted (% pred) of the forced vital capacity (FVC). Assessment: daily.</description>
</primary_outcome>
<primary_outcome>
<measure>Pre-bronchodilator PEF</measure>
<time_frame>8 weeks</time_frame>
<description>Absolute (L/s) and percentage of predicted (% pred) of the peak expiratory flow (PEF). Assessment: daily.</description>
</primary_outcome>
<primary_outcome>
<measure>Biomarkers: nasopharyngeal swabs</measure>
<time_frame>8 weeks</time_frame>
<description>16S rRNA and ITS sequencing, and whole metatranscriptomic sequencing (WMTS). Assessment: enrollment, thrice-weekly (Monday-Wednesday-Friday) and exacerbation.</description>
</primary_outcome>
<primary_outcome>
<measure>Biomarkers: venous blood</measure>
<time_frame>8 weeks</time_frame>
<description>SNP (associated with COPD, exacerbations and microbial infections) sequencing. Assessment: enrollment.
WMTS. Assessment: enrollment, exacerbation and outcome assessment.
ELISA-based multiplex cytokine analysis, anti-bacterial titer analysis, metabolomics, proteomics and WMTS. Assessment: enrollment, thrice-weekly (M-W-F), exacerbation and outcome assessment.</description>
</primary_outcome>
<primary_outcome>
<measure>Biomarkers: spontaneous sputum</measure>
<time_frame>8 weeks</time_frame>
<description>16S rRNA and ITS sequencing, WMTS, proteomics and metabolomics. Assessment: enrollment, thrice-weekly (M-W-F) and exacerbation.
Cell differentials and traditional bacterial culture at enrollment and exacerbation.</description>
</primary_outcome>
<primary_outcome>
<measure>Biomarkers: stool</measure>
<time_frame>8 weeks</time_frame>
<description>Whole metagenomic shotgun sequencing, and metabolomics. Assessment: enrollment, exacerbation, and outcome assessment.</description>
</primary_outcome>
<secondary_outcome>
<measure>Basic characteristics</measure>
<time_frame>8 weeks</time_frame>
<description>Age (years), sex (M/F), race (caucasian, negroid, asian), marital status (married/living together, divorced/separated, widow, single), smoking status (never smoked, ex-smoker, current smoker) and smoking history (pack years and type of tobacco), medical history and comorbidities (self- and physician reported), current medication use, chronic oxygen and non-invasive ventilation (L/min), as well as total number of moderate AECOPD and COPD-related hospitalizations in the previous 12 months, body length (m), body weight (kg), body mass index (BMI, kg/m2), fat free mass index (FFMI, kg/m2) and chest high-resolution computer tomography (HRCT) for post-hoc radiological quantification of pulmonary and extra-pulmonary features of COPD.
These outcomes are aggregated to report the patient's overall basic characteristics.
Assessment: enrollment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Post-bronchodilator FEV1</measure>
<time_frame>8 weeks</time_frame>
<description>Absolute (L) and percentage of predicted (% pred) of the forced expiratory volume in 1 second (FEV1). Assessment: baseline and outcome assessment, as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Post-bronchodilator FVC</measure>
<time_frame>8 weeks</time_frame>
<description>Absolute (L) and percentage of predicted (% pred) of the forced vital capacity (FVC). Assessment: baseline and outcome assessment, as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Post-bronchodilator PEF</measure>
<time_frame>8 weeks</time_frame>
<description>Absolute (L/s) and percentage of predicted (% pred) of the peak expiratory flow (PEF). Assessment: baseline and outcome assessment, as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Body plethysmography</measure>
<time_frame>8 weeks</time_frame>
<description>Body plethysmography is performed to assess the absolute (L) and percentage of predicted (% pred) total lung capacity (TLC) and residual volume (RV), as well as the absolute (L/s) and percentage of predicted (% pred) intrathoracic gas volume (ITGV). Assessment: baseline assessment, as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Diffusing capacity</measure>
<time_frame>8 weeks</time_frame>
<description>The total (L) and % pred of the diffusing capacity (DLCO) and the DLCO per unit alveolar volume (KCO) are recorded. Additionally, DLCO and KCO will also be calculated corrected for hemoglobin. Assessment: baseline assessment, as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Respiratory muscle strength</measure>
<time_frame>8 weeks</time_frame>
<description>The absolute (cmH2O) and % pred maximal static inspiratory (MIP) and expiratory mouth pressures (MEP) are measured. Assessment: baseline assessment, as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>mMRC</measure>
<time_frame>8 weeks</time_frame>
<description>The modified Medical Research Council (mMRC) is assessed to capture the severity of dyspnea. Scale: 0 to 4. Higher scores indicate a worse degree of dyspnea.
Assessment: baseline and outcome assessment, as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>CAT</measure>
<time_frame>8 weeks</time_frame>
<description>The COPD Assessment Test (CAT) is assessed to capture the health status. The total score ranges from 0 to 40 points, higher scores indicating a worse health status. Assessment: baseline and outcome assessment, as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>HADS</measure>
<time_frame>8 weeks</time_frame>
<description>The Hospital Anxiety and Depression scale (HADS) questionnaire is assessed to indicate the level of anxiety and depression. Total scores for each subscale range from 0 (optimal) to 21 points (worst). A score of ≥10 points indicates the presence of symptoms of anxiety and depression. Assessment: baseline and outcome assessment, as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Exercise capacity</measure>
<time_frame>8 weeks</time_frame>
<description>The cardiopulmonary exercise test (CPET) is performed to capture the maximal exercise capacity (peak work rate [Wmax]). Assessment: baseline assessment.
The constant work rate cycle test (CWRT) is performed to capture the submaximal work rate, 75% of the Wmax. Assessment: baseline and outcome assessment.
The six-minute walk test (6MWT) is performed to capture the longest 6MWD for further analyses. Assessment: baseline and outcome assessment.
These tests are performed as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Muscle function</measure>
<time_frame>8 weeks</time_frame>
<description>Muscle function will be determined through isometric and isokinetic quadriceps strength and endurance assessment. The highest peak torque will be determined (Nm) as well as the total amount of delivered work (J). Assessment: baseline and outcome assessment, as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Hematology</measure>
<time_frame>8 weeks</time_frame>
<description>Hemoglobin (mmol/L), hematocrit (L/L), thrombocytes (10E9/L), leukocytes (10E9/L), granulocytes (%), lymphocytes (10E9/L), lymphocytes (%), monocytes (%), eosinophilic granulocytes (10E9/L), eosinophilic granulocytes (%), basophilic granulocytes (%). Assessment: in venous blood at baseline and outcome assessment, as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Chemistry</measure>
<time_frame>8 weeks</time_frame>
<description>Glycated hemoglobin (HbA1c, mmol/mol and %), high density lipoprotein (HDL, mmol/L), low density lipoprotein (LDL, mmol/L), cholesterol (mmol/L), triglycerides (mmol/L), sodium (mmol/L), potassium (mmol/L), urea (mmol/L), creatinine (umol/L), aspartate aminotransferase (ASAT, U/L), alanine aminotransferase (ALAT, U/L), bilirubin (umol/L) and high sensitive C-reactive protein (hs-CRP, mg/L). Assessment: in venous blood at baseline and outcome assessment, as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Arterial blood gas</measure>
<time_frame>8 weeks</time_frame>
<description>An arterial blood sample is collected to determine the resting arterial partial pressure of oxygen (PaO2), carbon dioxide (PaCO2) and oxygen saturation (SpO2). Assessment: baseline assessment and at exacerbation, as part of routine clinical care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Exacerbation markers</measure>
<time_frame>8 weeks</time_frame>
<description>At exacerbation, as part of routine clinical care, venous blood is collected to determine the concentration of leukocytes (10E9/L), eosinophils (10E9/L), hs-CRP (mg/L), d-dimer (ug/L), NT-proBNP (pmol/L), troponin-T (ng/L).</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">150</enrollment>
<condition>COPD</condition>
<condition>COPD Exacerbation</condition>
<arm_group>
<arm_group_label>Exacerbators</arm_group_label>
<description>Patients who experience ≥1 inpatient AECOPD</description>
</arm_group>
<arm_group>
<arm_group_label>Non-exacerbators</arm_group_label>
<description>Patients without inpatient AECOPD</description>
</arm_group>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Frequent assessment of biomarker panel</intervention_name>
<description>During the eight-week inpatient follow-up period there will be daily follow-up of respiratory symptoms, vitals and spirometry, and a thrice weekly collection of spontaneous sputum, nasal swabs and venous blood. These assessments will be repeated at acute worsening of respiratory symptoms at which a stool sample will also be collected.</description>
<arm_group_label>Exacerbators</arm_group_label>
<arm_group_label>Non-exacerbators</arm_group_label>
</intervention>
<biospec_retention>Samples With DNA</biospec_retention>
<biospec_descr>
<textblock>
Biosamples of spontaneous sputum, the nasopharynx, venous blood and stool will be frequently
collected.
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
Patients with a primary diagnosis of COPD admitted for inpatient pulmonary rehabilitation
at Ciro (Horn, The Netherlands).
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- ≥40 years old

- ≥10 pack years of smoking

- primary diagnosis of COPD and post-bronchodilator ratio of forced expiratory volume in
the first second (FEV1) to forced vital capacity (FVC) of less than 0.70.

- clinical indication for inpatient pulmonary rehabilitation in Ciro

- provided written informed consent

Exclusion Criteria:

- current, i.e. <12 months, (secondary) diagnosis of asthma according to the referring
physician

- unstable concurrent cardiovascular, metabolic, renal, gastro-intestinal and
musculoskeletal chronic diseases, as judged by the investigator

- chronic use of oral corticosteroids >10 mg prednisolone/day

- initiation of maintenance therapy with macrolides <6 weeks prior to study entry

- anemia, defined as hemoglobin level <8.1 mmol/L in men and <7.5 mmol/L in women

- participation in a study involving investigational or marketed products concomitantly
or <8 weeks prior to study entry

- unable to read, speak or understand Dutch
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>40 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Frits ME Franssen, Prof. Dr.</last_name>
<role>Principal Investigator</role>
<affiliation>Center of Expertise for Chronic Organ Failure</affiliation>
</overall_official>
<overall_contact>
<last_name>Kiki Waeijen-Smit, MSc</last_name>
<phone>+31475587601</phone>
<email>kikismit@ciro-horn.nl</email>
</overall_contact>
<overall_contact_backup>
<last_name>Frits ME Franssen, Prof. Dr.</last_name>
<phone>+31475587602</phone>
<email>fritsfranssen@ciro-horn.nl</email>
</overall_contact_backup>
<location>
<facility>
<name>Ciro</name>
<address>
<city>Horn</city>
<state>Limburg</state>
<zip>6085 NM</zip>
<country>Netherlands</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Kiki Waeijen-Smit, MSc</last_name>
<phone>+31 (0)475 587 602</phone>
<email>kikismit@ciro-horn.nl</email>
</contact>
</location>
<location_countries>
<country>Netherlands</country>
</location_countries>
<reference>
<citation>GOLD. Global strategy for the prevention, diagnosis and management of chronic obstructive pulmonary disease - 2022 report.</citation>
</reference>
<reference>
<citation>Dransfield MT, Kunisaki KM, Strand MJ, Anzueto A, Bhatt SP, Bowler RP, Criner GJ, Curtis JL, Hanania NA, Nath H, Putcha N, Roark SE, Wan ES, Washko GR, Wells JM, Wendt CH, Make BJ; COPDGene Investigators. Acute Exacerbations and Lung Function Loss in Smokers with and without Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Feb 1;195(3):324-330. doi: 10.1164/rccm.201605-1014OC.</citation>
<PMID>27556408</PMID>
</reference>
<reference>
<citation>Seemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 May;157(5 Pt 1):1418-22. doi: 10.1164/ajrccm.157.5.9709032.</citation>
<PMID>9603117</PMID>
</reference>
<reference>
<citation>European Lung White Book: European Respiratory Society; 2003.</citation>
</reference>
<reference>
<citation>CBS Doodsoorzakenstatistiek [Available from: www.cbs.nl.</citation>
</reference>
<reference>
<citation>Wedzicha JA, Seemungal TA. COPD exacerbations: defining their cause and prevention. Lancet. 2007 Sep 1;370(9589):786-96. doi: 10.1016/S0140-6736(07)61382-8.</citation>
<PMID>17765528</PMID>
</reference>
<reference>
<citation>Vedel-Krogh S, Nielsen SF, Lange P, Vestbo J, Nordestgaard BG. Blood Eosinophils and Exacerbations in Chronic Obstructive Pulmonary Disease. The Copenhagen General Population Study. Am J Respir Crit Care Med. 2016 May 1;193(9):965-74. doi: 10.1164/rccm.201509-1869OC.</citation>
<PMID>26641631</PMID>
</reference>
<reference>
<citation>MacNee W, Donaldson K. Exacerbations of COPD: environmental mechanisms. Chest. 2000 May;117(5 Suppl 2):390S-7S. doi: 10.1378/chest.117.5_suppl_2.390s.</citation>
<PMID>10843983</PMID>
</reference>
<reference>
<citation>Viniol C, Vogelmeier CF. Exacerbations of COPD. Eur Respir Rev. 2018 Mar 14;27(147):170103. doi: 10.1183/16000617.0103-2017. Print 2018 Mar 31.</citation>
<PMID>29540496</PMID>
</reference>
<reference>
<citation>Hurst JR, Vestbo J, Anzueto A, Locantore N, Mullerova H, Tal-Singer R, Miller B, Lomas DA, Agusti A, Macnee W, Calverley P, Rennard S, Wouters EF, Wedzicha JA; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010 Sep 16;363(12):1128-38. doi: 10.1056/NEJMoa0909883.</citation>
<PMID>20843247</PMID>
</reference>
<reference>
<citation>Bafadhel M, McKenna S, Terry S, Mistry V, Reid C, Haldar P, McCormick M, Haldar K, Kebadze T, Duvoix A, Lindblad K, Patel H, Rugman P, Dodson P, Jenkins M, Saunders M, Newbold P, Green RH, Venge P, Lomas DA, Barer MR, Johnston SL, Pavord ID, Brightling CE. Acute exacerbations of chronic obstructive pulmonary disease: identification of biologic clusters and their biomarkers. Am J Respir Crit Care Med. 2011 Sep 15;184(6):662-71. doi: 10.1164/rccm.201104-0597OC.</citation>
<PMID>21680942</PMID>
</reference>
<reference>
<citation>Papi A, Bellettato CM, Braccioni F, Romagnoli M, Casolari P, Caramori G, Fabbri LM, Johnston SL. Infections and airway inflammation in chronic obstructive pulmonary disease severe exacerbations. Am J Respir Crit Care Med. 2006 May 15;173(10):1114-21. doi: 10.1164/rccm.200506-859OC. Epub 2006 Feb 16.</citation>
<PMID>16484677</PMID>
</reference>
<reference>
<citation>Wilkinson TMA, Aris E, Bourne S, Clarke SC, Peeters M, Pascal TG, Schoonbroodt S, Tuck AC, Kim V, Ostridge K, Staples KJ, Williams N, Williams A, Wootton S, Devaster JM; AERIS Study Group. A prospective, observational cohort study of the seasonal dynamics of airway pathogens in the aetiology of exacerbations in COPD. Thorax. 2017 Oct;72(10):919-927. doi: 10.1136/thoraxjnl-2016-209023. Epub 2017 Apr 21.</citation>
<PMID>28432209</PMID>
</reference>
<reference>
<citation>Dima E, Kyriakoudi A, Kaponi M, Vasileiadis I, Stamou P, Koutsoukou A, Koulouris NG, Rovina N. The lung microbiome dynamics between stability and exacerbation in chronic obstructive pulmonary disease (COPD): Current perspectives. Respir Med. 2019 Oct;157:1-6. doi: 10.1016/j.rmed.2019.08.012. Epub 2019 Aug 21.</citation>
<PMID>31450162</PMID>
</reference>
<reference>
<citation>Bouquet J, Tabor DE, Silver JS, Nair V, Tovchigrechko A, Griffin MP, Esser MT, Sellman BR, Jin H. Microbial burden and viral exacerbations in a longitudinal multicenter COPD cohort. Respir Res. 2020 Mar 30;21(1):77. doi: 10.1186/s12931-020-01340-0.</citation>
<PMID>32228581</PMID>
</reference>
<reference>
<citation>Braeken DCW, Spruit MA, Houben-Wilke S, Smid DE, Rohde GGU, Wouters EFM, Franssen FME. Impact of exacerbations on adherence and outcomes of pulmonary rehabilitation in patients with COPD. Respirology. 2017 Jul;22(5):942-949. doi: 10.1111/resp.12987. Epub 2017 Jan 31.</citation>
<PMID>28139873</PMID>
</reference>
<reference>
<citation>World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.</citation>
<PMID>24141714</PMID>
</reference>
<verification_date>September 2023</verification_date>
<study_first_submitted>March 8, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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>Center of Expertise for Chronic Organ Failure</investigator_affiliation>
<investigator_full_name>Frits M. E. Franssen</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>COPD</keyword>
<keyword>COPD Exacerbation</keyword>
<keyword>Microbiota</keyword>
<keyword>Biomarker</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Acute exacerbations of COPD (AECOPD) are episodes of acute worsening of respiratory symptoms
that require additional therapy. Exacerbations play a pivotal role in the burden and
progressive course of COPD (1). Each event contributes to a progressive decline in lung
function (2), reduced health status, low physical activity level (3) and increased health
care costs (4). As such, disease management is predominantly based on the prevention of these
episodes (1). Yet, in the Netherlands, 30.000 people are admitted to the hospital for an
AECOPD every year (5). Although most AECOPD have an infectious origin (6), the underlying
mechanisms are heterogeneous and predicting their occurrence in individual patients currently
remains unsuccessful (7-9). Furthermore, there is a lack of our understanding in the
longitudinal alterations in microbial composition and host-microbiome interactions in the
stable state, at AECOPD and during recovery in patients with COPD. This knowledge is
essential to improve the early and accurate diagnosis of (the different types of) AECOPD, and
for the development of novel antimicrobial and other therapeutic targets and subsequent
personalized treatment. These challenges need to be addressed in order to reduce the future
impact of these events, avoid unnecessary treatments of individual patients, reduce
healthcare utilization and improve overall care for patients with COPD. The current 'Early
diagnostic BioMARKers in Exacerbations of COPD' (MARKED) study was designed to investigate
several of these gaps in the management of COPD exacerbations.
It is anticipated that complex biomarker panels, rather than a single biomarker, will be
identified. Since AECOPD are heterogeneous events in terms of origin, trigger, severity,
duration, need for treatment and overall clinical presentation (1, 6, 10-15), we expect to
identify different biomarker panels for different subtypes of AECOPD. Furthermore, AECOPD
diagnosis relies heavily on the exclusion of differential diagnoses (1), which further rules
out the potential of a single predictive AECOPD biomarker.
The MARKED study is an exploratory, prospective, single-center, longitudinal, observational
study with eight weeks follow-up. The primary objective is to explore which biomarkers from a
panel of frequently measured biomarkers (symptoms, vital signs, lung function parameters and
spontaneous sputum, nasopharyngeal swabs, stool and blood samples) predict an exacerbation
and/or respiratory infection in patients with COPD. Furthermore, secondary objectives are:
I. to investigate longitudinal alterations in microbial composition and host-microbiome
interactions in the stable state, at AECOPD and during recovery.
II. to study the heterogeneity of AECOPD by comprehensive clinical, functional, microbial,
proteomic, transcriptomic, genetic, metabolomic, inflammatory and biochemical
characterization of these events.
III. to determine the correlation between microbial alterations in the airways/gut and
inflammatory biomarkers in blood during longitudinal follow up.
IV. to longitudinally investigate biomarkers of AECOPD in clinically relevant subgroups of
patients with COPD (e.g. current versus ex-smokers, high versus low blood eosinophils,
frequent vs. infrequent exacerbators).
V. to comprehensively investigate whether host-microbiome interactions, biomarkers and
predictive models identify those patients that do not exacerbate despite having a respiratory
infection.
All AECOPD evaluated by the physician in Ciro as moderate or severe will be recorded in this
study. Moderate AECOPD are defined by a worsening of symptoms >2 consecutive days leading to
treatment with systemic glucocorticoids, antibiotics or both. Severe events are characterized
by (enhanced) oxygen therapy, non-invasive ventilation (NIV) or hospital admission that
lasted >24 hours, in addition to treatment with systemic glucocorticoids, antibiotics or
both.
Whilst aiming to include at least 50 patients experiencing an AECOPD and at least 50 patients
without an AECOPD, up to 150 consecutive patients with a primary diagnosis of COPD admitted
for inpatient pulmonary rehabilitation at Ciro will be recruited for the study. Although
sample size rules of thumb exist for multivariable regression modelling and prediction
modelling strategies, this study is explorative in nature. Therefore, the amount of
biomarkers exceeds the amount when applying the rule of thumb that states that for each
potential predictive variable, 10 events should be observed. The study aims to include at
least 50 unique individual patients who experience ≥1 AECOPD, and at least 50 individual
patients without an AECOPD, to provide accurate benchmark data (i.e. sufficient precision to
estimate mean and standard deviation [SD]) for exploratory biomarkers. From previous studies
in Ciro it is known that approximately 42% of patients will develop at least one AECOPD
during admission (16). Because AECOPD are unpredictable and variable, which is an important
rationale for the present study, the study will expectedly need 100-150 patients to be
included. The goal of this study is not to develop a multivariate model, but rather to
explore the associations between biomarkers and the occurrence of an event.
Baseline characteristics will be reported as mean and SD or as median and interquartile range
(IQR) for continuous variables, as appropriate, and as count and percentage for categorical
characteristics. Predictors of time-to-first AECOPD during the study period will be modelled
using univariate and multivariable Cox proportional hazards regression. Associations will be
presented as hazard ratio (HR) and 95% confidence interval (CI). The dependency of the
predictive performance of biomarkers will be tested using interaction terms. The
concordance-statistic, or c-statistic, will be estimated to assess discriminative ability.
Time-dependent AUC-Receiver Operating Characteristics (ROC) plots will furthermore be
created. Calibration will be assessed by comparing the predicted probability with the
observed probability of an AECOPD, and examined with a calibration plot and calibration
slope, assuming no data censoring before the end of follow-up.
Characterization of the microbiome will be determined by alpha- and beta-diversity and
relative abundance of bacterial taxa. Alpha-diversity will be treated as a continuous
variable and analysed using appropriate statistical tests, whereas ordination of
beta-diversity distances will be done using principal component analysis. Multiomic analyses
will be used to generate hypotheses about the drivers that promote progression to AECOPD.
Differential enrichment analysis for feature selection across all 'omics will be done after
accounting for multiple hypothesis testing using a robust model that considers distributional
assumptions. The association between genetic variants and (AE)COPD and microbial infections
will be studied using whole-exome sequencing data.
Self-organizing maps (SOMs, also referred to as Kohonen maps) will be used to create an
ordered representation of the selected attributes at the time of AECOPD by using Viscovery
Profiler 7.1 (Viscovery Software GmbH, Vienna, Austria). Based on the identified homogeneous
data groups created in the SOM model, clusters will be generated using Viscovery's SOM-Ward
Cluster algorithm. Summary variables of clinical characteristics for the total sample, and
for clusters, will be presented as mean and SD for quantitative variables, and as percentages
for discrete variables. Differences between groups will be assessed using integrated
two-sided t-tests. Repeated measure correlations will be used to determine the
within-individual association between microbial alterations in the airways/gut and systemic
inflammatory biomarkers across patients.
In case of missing data on predictors, stochastic regression imputation with fully
conditional specification will be used to impute the dataset to allow the use of all included
patients for the analyses. Values will be drawn using predictive mean matching. Statistical
significance will be denoted by p<0.05.
The current study is classified as research with negligible risk. There are no serious risks
associated with participation in this study. Hematomas might occur from venous blood
sampling. Nasal discomfort might be experienced during nasal sampling. Patients might
experience breathlessness and fatigue due to additional daily measurements (e.g.
questionnaires, lung function) and/or might refuse participation or drop-out of the study
because of the burden of frequent sampling and other assessments. Extensive guidelines have
been established to monitor scientific research in a structured and protocol-based manner at
Ciro. In the context of the NFU report 'Quality assurance for people-related research', the
current investigator initiated research was classified as research with negligible risk. The
assigned study site monitor will monitor the safety of the participants, and the accuracy of
following procedures as described in the protocol by the research staff, on an annual basis.
Monitoring will be performed in compliance with Good Clinical Practice (GCP) in order to
achieve high quality research and secure patient safety.
In accordance with the Medical Research Involving Human Subjects Act (WMO) the study will be
suspended if the health or safety of subjects will be jeopardised. The accredited Medical
Ethical Teaching Committee (Medical Research Ethics Committees United [MEC-U], Nieuwegein,
the Netherlands) will be notified without undue delay after obtaining knowledge of these
events. Adverse and serious adverse events will be recorded. Hospitalized AECOPD will not be
considered as serious adverse events. Exacerbations and hospitalized AECOPD will be annually
reported to MEC-U. Ciro has established protocols for the management of AECOPD; these
protocols will also be followed for patients included in the study. Moderate AECOPD are
treated at Ciro, the pulmonary rehabilitation program will be adjusted as needed. Patients
with severe AECOPD requiring hospital admission will be referred to a nearby hospital.
Ethical approval for the study has been granted by MEC-U (NL71364.100.19). The study will be
conducted according to the principles of the Declaration of Helsinki (64th WMA General
Assembly, Fortaleza, Brazil, October 2013 (17)) and in accordance with the WMO. Written
informed consent will be obtained from all participants before study participation. Results
of the study will be published in peer-reviewed scientific journals and will be presented at
(inter)national conferences. If desired, participants will be informed about the outcomes of
the study.
Biosamples of spontaneous sputum, the nasopharynx, venous blood and stool will be frequently
collected.
Patients with a primary diagnosis of COPD admitted for inpatient pulmonary rehabilitation
at Ciro (Horn, The Netherlands).
Inclusion Criteria:
- ≥40 years old
- ≥10 pack years of smoking
- primary diagnosis of COPD and post-bronchodilator ratio of forced expiratory volume in
the first second (FEV1) to forced vital capacity (FVC) of less than 0.70.
- clinical indication for inpatient pulmonary rehabilitation in Ciro
- provided written informed consent
Exclusion Criteria:
- current, i.e. <12 months, (secondary) diagnosis of asthma according to the referring
physician
- unstable concurrent cardiovascular, metabolic, renal, gastro-intestinal and
musculoskeletal chronic diseases, as judged by the investigator
- chronic use of oral corticosteroids >10 mg prednisolone/day
- initiation of maintenance therapy with macrolides <6 weeks prior to study entry
- anemia, defined as hemoglobin level <8.1 mmol/L in men and <7.5 mmol/L in women
- participation in a study involving investigational or marketed products concomitantly
or <8 weeks prior to study entry
- unable to read, speak or understand Dutch
|
NCT0531xxxx/NCT05315687.xml | <clinical_study>
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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/NCT05315687</url>
</required_header>
<id_info>
<org_study_id>STUDY00002373</org_study_id>
<secondary_id>NCI-2021-03144</secondary_id>
<secondary_id>STUDY00002373</secondary_id>
<secondary_id>RAD5251-21</secondary_id>
<secondary_id>P30CA138292</secondary_id>
<nct_id>NCT05315687</nct_id>
</id_info>
<brief_title>Radioembolization of Metastatic Breast Cancer to the Liver as a 2nd/3rd Line Therapy</brief_title>
<official_title>Safety and Efficacy of Radioembolization of Metastatic Breast Cancer to the Liver as a 2nd/3rd Line Therapy</official_title>
<sponsors>
<lead_sponsor>
<agency>Emory University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Cancer Institute (NCI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
<collaborator>
<agency>Sirtex Medical</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>Emory University</source>
<oversight_info>
<has_dmc>Yes</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>
This phase II trial studies the effects of radioembolization with yttrium Y-90 works as a 2nd
or 3rd line therapy for treating patients with breast cancer that has spread to the liver
(metastatic to the liver). Yttrium Y-90 radioembolization is a therapy that injects
radioactive particles directly into an artery that feeds liver tumors to cut off their blood
supply.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
PRIMARY OBJECTIVE:

I. To evaluate the efficacy of Y90 radioembolization as a 2nd or 3rd line therapeutic option
in conjunction with systemic therapy by assessing progression free survival (PFS).

SECONDARY OBJECTIVES:

I. To evaluate the safety of Y90 radioembolization as a 2nd or 3rd line therapeutic option in
conjunction with systemic therapy by evaluating treatment related toxicities and identifying
baseline predictors of treatment related toxicity.

II. To evaluate the impact of tumor biology i.e. triple negative breast cancer (TNBC) versus
(vs.) non-TNBC on PFS and toxicity.

III. To evaluate quality of life (QOL) changes in patients receiving Y90 versus others.

IV. To evaluate the survival (OS) benefit of addition of Y90 radioembolization to systemic
therapy.

V. To evaluate compare inflammatory changes in the in the targeted tumors before and after
Y90 radioembolization for identification of potential synergistic immunotherapy pathways.

VI. To identify genetic biomarkers of treatment response to Y90 radioembolization.

VII. Evaluation of efficacy and accuracy of hepatobiliary iminodiacetic acid (HIDA) scan as a
tool to objectively quantify baseline and post treatment hepatic dysfunction.

VIII. Evaluating timing of Y90 relative to lines of therapies already utilized and disease
course.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive systemic therapy. Beginning 1-6 weeks after starting systemic
therapy, patients also undergo Y90 radioembolization.

ARM II: Patients receive systemic therapy.

After completion of study treatment, patients are followed up at 4-8 weeks, and then every
12-16 weeks for 2 years.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">December 1, 2022</start_date>
<completion_date type="Anticipated">July 31, 2025</completion_date>
<primary_completion_date type="Anticipated">July 31, 2025</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>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Liver and overall progression free survival (PFS)</measure>
<time_frame>From date of randomization to date of progression or death, where those alive without progression are censored at date of last imaging scan, assessed up to 24 months</time_frame>
<description>Progression of disease is defined objectively by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using magnetic resonance imaging (MRI) or computed tomography (CT) and/or by positron emission tomography (PET) using PET Response Criteria in Solid Tumors (PERCIST) criteria. PFS will be estimated using the Kaplan-Meier method, and treatment groups will be compared using log-rank tests. Median PFS will be reported, along with a 95% confidence interval estimated using the Brookmeyer-Crowley method.</description>
</primary_outcome>
<secondary_outcome>
<measure>Liver progression free survival (PFS)</measure>
<time_frame>From date of randomization to date of liver progression or death, where those alive without liver progression are censored at date of last imaging scan, assessed up to 24 months</time_frame>
<description>Liver progression is defined as progression of disease in the liver only by RECIST 1.1 or PERCIST criteria. Liver PFS will be estimated using the Kaplan-Meier method, and treatment groups will be compared using log-rank tests. Median liver PFS will be reported, along with a 95% confidence interval estimated using the Brookmeyer-Crowley method.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">50</enrollment>
<condition>Anatomic Stage IV Breast Cancer AJCC v8</condition>
<condition>Metastatic Breast Carcinoma</condition>
<condition>Metastatic Carcinoma in the Liver</condition>
<condition>Prognostic Stage IV Breast Cancer AJCC v8</condition>
<arm_group>
<arm_group_label>Arm I (systemic therapy, Y90 radioembolization)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients receive systemic therapy. Beginning 1-6 weeks after starting systemic therapy, patients also undergo Y90 radioembolization.</description>
</arm_group>
<arm_group>
<arm_group_label>Arm II (systemic therapy)</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Patients receive systemic therapy.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Y-90 SIR-Spheres</intervention_name>
<description>Y-90 SIR-Spheres</description>
<arm_group_label>Arm I (systemic therapy, Y90 radioembolization)</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Yttrium-90 Microsphere Radioembolization</intervention_name>
<description>Undergo Y90 radioembolization</description>
<arm_group_label>Arm I (systemic therapy, Y90 radioembolization)</arm_group_label>
<other_name>Yttrium Y 90 Microsphere Therapy</other_name>
<other_name>Yttrium-90 Radioembolization</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Systemic Therapy</intervention_name>
<description>Systemic Therapy</description>
<arm_group_label>Arm I (systemic therapy, Y90 radioembolization)</arm_group_label>
<arm_group_label>Arm II (systemic therapy)</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Male or female

- Age >= 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Biopsy proven metastatic breast cancer to the liver (liver biopsy including routine
genetic profiling) if not performed before, the biopsy will be performed at the time
of shunt of study/mapping.

- The metastatic breast cancer to the liver or the primary metastatic breast cancer with
one of the following receptor profiling: 1. Triple Negative Breast Cancer (TNBC) (i.e
ER-, PR-, HER2-); 2. ER+, PR+, HER2-; 3. ER+, PR-, HER2-; 4. ER-, PR+, HER2-. HER2
negative breast cancer is defined as IHC result of 0 or 1+ in a core needle biopsy
specimen of primary breast cancer.

- Tumor burden =< 50% of liver

- Baseline HIDA scan demonstrating normal liver function

- No radiographic, clinical or biopsy evidence of cirrhosis

- Patients to be enrolled in either arm of the study should be deemed appropriate
candidate for permissible lines of systemic therapies

- If applicable, patients must have stable brain metastasis (mets) defined as unchanged
CNS disease in the past 6 months.

- Life expectancy > 12 weeks as determined by the Investigator

- Hemoglobin >= 8.0 g/dl (within 28 days of cycle 1 day 1)

- White blood cell (WBC) >= 1500/uL (after at least 7 days without growth factor support
or transfusion) (within 28 days of cycle 1 day 1)

- Absolute neutrophil count (ANC) >= 1,000/mcL (after at least 7 days without growth
factor support or transfusion) (within 28 days of cycle 1 day 1)

- Platelets >= 50,000/mcL (no transfusions allowed within 7 days of day 1 to meet entry
criteria) (within 28 days of cycle 1 day 1)

- Prothrombin time (PT)/international normalized ratio (INR) < 1.5 (within 28 days of
cycle 1 day 1)

- Total bilirubin =< 2 X institutional upper limit of normal (ULN) (within 28 days of
cycle 1 day 1)

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5X institutional
upper limit of normal (ULN) (within 28 days of cycle 1 day 1)

- Serum creatinine =< 2 mg/dL (or glomerular filtration rate >= 40 mL/min) (within 28
days of cycle 1 day 1)

- Lipase and amylase =< 1.5 x ULN (within 28 days of cycle 1 day 1)

- The effects of Y90 radioembolization/chemotherapy on the developing human fetus are
unknown. For this reason, female of child-bearing potential (FCBP) must have a
negative serum or urine pregnancy test prior to starting therapy

- FCBP and men treated or enrolled on this protocol must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to study
entry for the duration of study participation, and X months after completion of
treatment. Should a woman become pregnant or suspect she is pregnant while she or her
partner is participating in this study, she should inform her treating physician
immediately

- A female of childbearing potential (FCBP) is a sexually mature woman who:

- Has not undergone a hysterectomy or bilateral oophorectomy; or

- Has not been naturally postmenopausal for at least 12 consecutive months (i.e.,
has had menses at any time in the preceding 12 consecutive months. This will be
assess during screening's H&P by reviewing with subject her reproductive history.

- No surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy
within 14 days of initiation of therapy on study

- Willingness and ability of the subject to comply with scheduled visits, drug & device
administration plan, protocol-specified laboratory tests, other study procedures, and
study restrictions

- Evidence of a personally signed informed consent indicating that the subject is aware
of the neoplastic nature of the disease and has been informed of the procedures to be
followed, the experimental nature of the therapy, alternatives, potential risks and
discomforts, potential benefits, and other pertinent aspects of study participation

Exclusion Criteria:

- HER2+ breast cancer regardless of ER and PR status.

- Patients who have had chemotherapy or within 2 weeks prior to entering the study or
those who have not recovered from adverse events due to agents administered more than
4 weeks earlier (i.e., have residual toxicities > grade 1)

- Patients who are receiving any other investigational agents or an investigational
device within 14 days before starting treatment

- Any prior liver directed intervention (surgical or liver directed therapy for
metastatic breast cancer)

- Extrahepatic disease (other than permissible criteria described above).

- Patient with insurance denial for Y90 treatment Consented participants for which Y90
treatment pre-certification was not obtained. This subjects will be considered as a
screen failure.
</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>Nima Kokabi</last_name>
<role>Principal Investigator</role>
<affiliation>Emory University Hospital/Winship Cancer Institute</affiliation>
</overall_official>
<overall_contact>
<last_name>Nima Kokabi, MD, FRCPC</last_name>
<phone>404-778-1900</phone>
<email>nima.kokabi@emory.edu</email>
</overall_contact>
<location>
<facility>
<name>Emory University Hospital/Winship Cancer Institute</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<zip>30322</zip>
<country>United States</country>
</address>
</facility>
<contact>
<last_name>Maria Rivas</last_name>
<phone>404-712-7962</phone>
<email>mrivas2@emory.edu</email>
</contact>
<investigator>
<last_name>Nima Kokabi, MD,FRCP</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>October 2022</verification_date>
<study_first_submitted>March 22, 2022</study_first_submitted>
<study_first_submitted_qc>April 6, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>October 14, 2022</last_update_submitted>
<last_update_submitted_qc>October 14, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">October 17, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Emory University</investigator_affiliation>
<investigator_full_name>Nima Kokabi</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>Carcinoma</mesh_term>
<mesh_term>Breast Neoplasms</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This phase II trial studies the effects of radioembolization with yttrium Y-90 works as a 2nd
or 3rd line therapy for treating patients with breast cancer that has spread to the liver
(metastatic to the liver). Yttrium Y-90 radioembolization is a therapy that injects
radioactive particles directly into an artery that feeds liver tumors to cut off their blood
supply.
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of Y90 radioembolization as a 2nd or 3rd line therapeutic option
in conjunction with systemic therapy by assessing progression free survival (PFS).
SECONDARY OBJECTIVES:
I. To evaluate the safety of Y90 radioembolization as a 2nd or 3rd line therapeutic option in
conjunction with systemic therapy by evaluating treatment related toxicities and identifying
baseline predictors of treatment related toxicity.
II. To evaluate the impact of tumor biology i.e. triple negative breast cancer (TNBC) versus
(vs.) non-TNBC on PFS and toxicity.
III. To evaluate quality of life (QOL) changes in patients receiving Y90 versus others.
IV. To evaluate the survival (OS) benefit of addition of Y90 radioembolization to systemic
therapy.
V. To evaluate compare inflammatory changes in the in the targeted tumors before and after
Y90 radioembolization for identification of potential synergistic immunotherapy pathways.
VI. To identify genetic biomarkers of treatment response to Y90 radioembolization.
VII. Evaluation of efficacy and accuracy of hepatobiliary iminodiacetic acid (HIDA) scan as a
tool to objectively quantify baseline and post treatment hepatic dysfunction.
VIII. Evaluating timing of Y90 relative to lines of therapies already utilized and disease
course.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive systemic therapy. Beginning 1-6 weeks after starting systemic
therapy, patients also undergo Y90 radioembolization.
ARM II: Patients receive systemic therapy.
After completion of study treatment, patients are followed up at 4-8 weeks, and then every
12-16 weeks for 2 years.
Inclusion Criteria:
- Male or female
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Biopsy proven metastatic breast cancer to the liver (liver biopsy including routine
genetic profiling) if not performed before, the biopsy will be performed at the time
of shunt of study/mapping.
- The metastatic breast cancer to the liver or the primary metastatic breast cancer with
one of the following receptor profiling: 1. Triple Negative Breast Cancer (TNBC) (i.e
ER-, PR-, HER2-); 2. ER+, PR+, HER2-; 3. ER+, PR-, HER2-; 4. ER-, PR+, HER2-. HER2
negative breast cancer is defined as IHC result of 0 or 1+ in a core needle biopsy
specimen of primary breast cancer.
- Tumor burden =< 50% of liver
- Baseline HIDA scan demonstrating normal liver function
- No radiographic, clinical or biopsy evidence of cirrhosis
- Patients to be enrolled in either arm of the study should be deemed appropriate
candidate for permissible lines of systemic therapies
- If applicable, patients must have stable brain metastasis (mets) defined as unchanged
CNS disease in the past 6 months.
- Life expectancy > 12 weeks as determined by the Investigator
- Hemoglobin >= 8.0 g/dl (within 28 days of cycle 1 day 1)
- White blood cell (WBC) >= 1500/uL (after at least 7 days without growth factor support
or transfusion) (within 28 days of cycle 1 day 1)
- Absolute neutrophil count (ANC) >= 1,000/mcL (after at least 7 days without growth
factor support or transfusion) (within 28 days of cycle 1 day 1)
- Platelets >= 50,000/mcL (no transfusions allowed within 7 days of day 1 to meet entry
criteria) (within 28 days of cycle 1 day 1)
- Prothrombin time (PT)/international normalized ratio (INR) < 1.5 (within 28 days of
cycle 1 day 1)
- Total bilirubin =< 2 X institutional upper limit of normal (ULN) (within 28 days of
cycle 1 day 1)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5X institutional
upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Serum creatinine =< 2 mg/dL (or glomerular filtration rate >= 40 mL/min) (within 28
days of cycle 1 day 1)
- Lipase and amylase =< 1.5 x ULN (within 28 days of cycle 1 day 1)
- The effects of Y90 radioembolization/chemotherapy on the developing human fetus are
unknown. For this reason, female of child-bearing potential (FCBP) must have a
negative serum or urine pregnancy test prior to starting therapy
- FCBP and men treated or enrolled on this protocol must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to study
entry for the duration of study participation, and X months after completion of
treatment. Should a woman become pregnant or suspect she is pregnant while she or her
partner is participating in this study, she should inform her treating physician
immediately
- A female of childbearing potential (FCBP) is a sexually mature woman who:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e.,
has had menses at any time in the preceding 12 consecutive months. This will be
assess during screening's H&P by reviewing with subject her reproductive history.
- No surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy
within 14 days of initiation of therapy on study
- Willingness and ability of the subject to comply with scheduled visits, drug & device
administration plan, protocol-specified laboratory tests, other study procedures, and
study restrictions
- Evidence of a personally signed informed consent indicating that the subject is aware
of the neoplastic nature of the disease and has been informed of the procedures to be
followed, the experimental nature of the therapy, alternatives, potential risks and
discomforts, potential benefits, and other pertinent aspects of study participation
Exclusion Criteria:
- HER2+ breast cancer regardless of ER and PR status.
- Patients who have had chemotherapy or within 2 weeks prior to entering the study or
those who have not recovered from adverse events due to agents administered more than
4 weeks earlier (i.e., have residual toxicities > grade 1)
- Patients who are receiving any other investigational agents or an investigational
device within 14 days before starting treatment
- Any prior liver directed intervention (surgical or liver directed therapy for
metastatic breast cancer)
- Extrahepatic disease (other than permissible criteria described above).
- Patient with insurance denial for Y90 treatment Consented participants for which Y90
treatment pre-certification was not obtained. This subjects will be considered as a
screen failure.
|
NCT0531xxxx/NCT05315700.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/NCT05315700</url>
</required_header>
<id_info>
<org_study_id>ORIC-114-01</org_study_id>
<nct_id>NCT05315700</nct_id>
</id_info>
<brief_title>Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration</brief_title>
<official_title>An Open-Label, Phase 1/1b, Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration</official_title>
<sponsors>
<lead_sponsor>
<agency>ORIC Pharmaceuticals</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>ORIC Pharmaceuticals</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 establish the recommended Phase 2 dose (RP2D) and/or maximum
tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD), preliminary
antitumor ORIC-114 when administered to patients with advanced solid tumors harboring an EGFR
or HER2 alteration.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
ORIC-114 is a brain penetrant, selective, orally bioavailable, irreversible small molecule
inhibitor of EGFR and HER2 alterations, including exon 20 insertion mutations.

This is a first-in-human, open-label, single arm, multicenter, dose escalation followed by
dose expansion study to establish the recommended phase 2 dose (RP2D) and preliminary
antitumor activity of ORIC-114 in patients with advanced solid tumors harboring an EGFR or
HER2 alteration who have exhausted available treatment options

The study will begin with dose finding in patients with various solid tumors (Dose
Escalation); additional dose expansion cohorts in specific tumor types (Dose Expansion),
treatment history, and/or expression of a specific biomarker may be initiated via protocol
amendment.

The study will evaluate escalating dose levels of ORIC-114 administered orally, daily in
28-day cycles following an accelerated titration design used for Dose Level 1, after which,
escalating doses of ORIC-114 will be administered following an interval 3+3 design.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 10, 2022</start_date>
<completion_date type="Anticipated">March 2025</completion_date>
<primary_completion_date type="Anticipated">March 2024</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Sequential Assignment</intervention_model>
<intervention_model_description>Interval 3+3 dose escalation design</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Recommended Phase 2 Dose (RP2D)</measure>
<time_frame>12 months</time_frame>
<description>RP2D as determined by interval 3+3 dose escalation design</description>
</primary_outcome>
<primary_outcome>
<measure>Maximum plasma concentration (Cmax)</measure>
<time_frame>28 Days</time_frame>
<description>PK of ORIC-114</description>
</primary_outcome>
<primary_outcome>
<measure>Time of maximum observed concentration (Tmax)</measure>
<time_frame>28 Days</time_frame>
<description>PK of ORIC-114</description>
</primary_outcome>
<primary_outcome>
<measure>Area under the curve (AUC)</measure>
<time_frame>28 Days</time_frame>
<description>PK of ORIC-114</description>
</primary_outcome>
<primary_outcome>
<measure>Apparent plasma terminal elimination half-life (t1/2)</measure>
<time_frame>28 Days</time_frame>
<description>PK of ORIC-114</description>
</primary_outcome>
<secondary_outcome>
<measure>Objective response rate (ORR)</measure>
<time_frame>36 months</time_frame>
<description>Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1</description>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of response (DOR)</measure>
<time_frame>36 months</time_frame>
<description>Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1</description>
</secondary_outcome>
<secondary_outcome>
<measure>Clinical benefit rate (CBR)</measure>
<time_frame>36 months</time_frame>
<description>Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1</description>
</secondary_outcome>
<secondary_outcome>
<measure>Progression-free survival (PFS)</measure>
<time_frame>36 months</time_frame>
<description>Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1</description>
</secondary_outcome>
<secondary_outcome>
<measure>Intracranial response rate (CR and/or PR)</measure>
<time_frame>36 months</time_frame>
<description>Modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1</description>
</secondary_outcome>
<secondary_outcome>
<measure>Intracranial progression-free survival (PFS)</measure>
<time_frame>36 months</time_frame>
<description>Modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">42</enrollment>
<condition>Solid Tumor</condition>
<arm_group>
<arm_group_label>Dose Escalation</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>ORIC-114 dosed orally on a continuous daily dosing regimen in 28-day cycles.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>ORIC-114</intervention_name>
<description>ORIC-114 oral daily for 28 days</description>
<arm_group_label>Dose Escalation</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Histologically or cytologically confirmed locally advanced or metastatic solid tumor
with a documented EGFR or HER2 exon 20 insertion mutation as determined by any nucleic
acid-based diagnostic testing method, or HER2 amplification/overexpression as
determined by an immunohistochemistry (IHC) or an in situ hybridization (ISH) test

- Previously received and progressed on or after available standard therapies and for
whom additional standard therapy is considered unsuitable or intolerable

-- NSCLC patients must have received platinum-based chemotherapy or other chemotherapy
regimen if platinum-based chemotherapy is contraindicated

- Agreement and ability to undergo pretreatment biopsy

- Measurable disease according to RECIST 1.1

- CNS involvement which is either previously treated and controlled, or asymptomatic

- ECOG performance status of 0 or 1

- Adequate organ function

Exclusion Criteria:

- Known EGFR T790M mutation

- Leptomeningeal disease and spinal cord compression

-- Except if LMD has been reported radiographically on baseline MRI, but is not
suspected clinically by the Investigator; the subject must be free of neurological
symptoms of LMD

- History of class III or IV congestive heart failure or severe non-ischemic
cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or
ventricular arrhythmia within the previous 6 months

- Past medical history of interstitial lung disease (ILD), drug induced ILD, radiation
pneumonitis which required steroid treatment, or any evidence of clinically active ILD

- Known, symptomatic human immunodeficiency virus (HIV) infection

- Known active infection requiring treatment or history of hepatitis B virus (HBV) or
hepatitis C virus (HCV). Patients positive for HBsAg but normal HBV DNA level are
allowed.

- Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut
syndrome) or other malabsorption syndromes

- Any other concurrent serious uncontrolled medical, psychological, or addictive
conditions
</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>Pratik S. Multani, MD, MS</last_name>
<role>Study Director</role>
<affiliation>ORIC Pharmaceuticals</affiliation>
</overall_official>
<overall_contact>
<last_name>ORIC Clinical</last_name>
<phone>650-388-5600</phone>
<email>clinical@oricpharma.com</email>
</overall_contact>
<location>
<facility>
<name>University of California, San Diego</name>
<address>
<city>San Diego</city>
<state>California</state>
<zip>92093</zip>
<country>United States</country>
</address>
</facility>
<status>Not yet recruiting</status>
</location>
<location>
<facility>
<name>University of California, San Francisco</name>
<address>
<city>San Francisco</city>
<state>California</state>
<zip>94122</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Yale Cancer Center</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06510</zip>
<country>United States</country>
</address>
</facility>
<status>Not yet recruiting</status>
</location>
<location>
<facility>
<name>Northwestern University</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<zip>60611</zip>
<country>United States</country>
</address>
</facility>
<status>Not yet recruiting</status>
</location>
<location>
<facility>
<name>Dana Farber Cancer Institute</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02215</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Spartanburg Regional Healthcare System</name>
<address>
<city>Spartanburg</city>
<state>South Carolina</state>
<zip>29303</zip>
<country>United States</country>
</address>
</facility>
<status>Not yet recruiting</status>
</location>
<location>
<facility>
<name>Next Oncology</name>
<address>
<city>Fairfax</city>
<state>Virginia</state>
<zip>22031</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Chris O'Brien Lifehouse</name>
<address>
<city>Camperdown</city>
<country>Australia</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>One Clinical Research, Hollywood Medical Centre</name>
<address>
<city>Nedlands</city>
<country>Australia</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Sydney Adventist Health</name>
<address>
<city>Sydney</city>
<country>Australia</country>
</address>
</facility>
<status>Not yet recruiting</status>
</location>
<location>
<facility>
<name>Chungbuk University Hospital</name>
<address>
<city>Cheongju-si</city>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>National Cancer Center</name>
<address>
<city>Goyang-si</city>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Catholic University of Korea, St, Vincent Hospital</name>
<address>
<city>Gyeonggi-do</city>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Gachon University Hospital</name>
<address>
<city>Incheon</city>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Seoul National Bundang Hospital</name>
<address>
<city>Seongnam-si</city>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Asan Medical Center</name>
<address>
<city>Seoul</city>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Samsung Medical Center</name>
<address>
<city>Seoul</city>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Severance Hospital, Yonsei University Health System</name>
<address>
<city>Seoul</city>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location_countries>
<country>Australia</country>
<country>Korea, Republic of</country>
<country>United States</country>
</location_countries>
<verification_date>April 2023</verification_date>
<study_first_submitted>March 24, 2022</study_first_submitted>
<study_first_submitted_qc>April 6, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>April 28, 2023</last_update_submitted>
<last_update_submitted_qc>April 28, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 3, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>EGFR exon 20 insertion mutation</keyword>
<keyword>HER2 exon 20 insertion mutation</keyword>
<keyword>HER2 amplification/overexpression</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Neoplasms</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to establish the recommended Phase 2 dose (RP2D) and/or maximum
tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD), preliminary
antitumor ORIC-114 when administered to patients with advanced solid tumors harboring an EGFR
or HER2 alteration.
ORIC-114 is a brain penetrant, selective, orally bioavailable, irreversible small molecule
inhibitor of EGFR and HER2 alterations, including exon 20 insertion mutations.
This is a first-in-human, open-label, single arm, multicenter, dose escalation followed by
dose expansion study to establish the recommended phase 2 dose (RP2D) and preliminary
antitumor activity of ORIC-114 in patients with advanced solid tumors harboring an EGFR or
HER2 alteration who have exhausted available treatment options
The study will begin with dose finding in patients with various solid tumors (Dose
Escalation); additional dose expansion cohorts in specific tumor types (Dose Expansion),
treatment history, and/or expression of a specific biomarker may be initiated via protocol
amendment.
The study will evaluate escalating dose levels of ORIC-114 administered orally, daily in
28-day cycles following an accelerated titration design used for Dose Level 1, after which,
escalating doses of ORIC-114 will be administered following an interval 3+3 design.
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor
with a documented EGFR or HER2 exon 20 insertion mutation as determined by any nucleic
acid-based diagnostic testing method, or HER2 amplification/overexpression as
determined by an immunohistochemistry (IHC) or an in situ hybridization (ISH) test
- Previously received and progressed on or after available standard therapies and for
whom additional standard therapy is considered unsuitable or intolerable
-- NSCLC patients must have received platinum-based chemotherapy or other chemotherapy
regimen if platinum-based chemotherapy is contraindicated
- Agreement and ability to undergo pretreatment biopsy
- Measurable disease according to RECIST 1.1
- CNS involvement which is either previously treated and controlled, or asymptomatic
- ECOG performance status of 0 or 1
- Adequate organ function
Exclusion Criteria:
- Known EGFR T790M mutation
- Leptomeningeal disease and spinal cord compression
-- Except if LMD has been reported radiographically on baseline MRI, but is not
suspected clinically by the Investigator; the subject must be free of neurological
symptoms of LMD
- History of class III or IV congestive heart failure or severe non-ischemic
cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or
ventricular arrhythmia within the previous 6 months
- Past medical history of interstitial lung disease (ILD), drug induced ILD, radiation
pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- Known, symptomatic human immunodeficiency virus (HIV) infection
- Known active infection requiring treatment or history of hepatitis B virus (HBV) or
hepatitis C virus (HCV). Patients positive for HBsAg but normal HBV DNA level are
allowed.
- Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut
syndrome) or other malabsorption syndromes
- Any other concurrent serious uncontrolled medical, psychological, or addictive
conditions
|
NCT0531xxxx/NCT05315713.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/NCT05315713</url>
</required_header>
<id_info>
<org_study_id>CO43116</org_study_id>
<nct_id>NCT05315713</nct_id>
</id_info>
<brief_title>An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Participants With B-Cell Non-Hodgkin Lymphoma</brief_title>
<official_title>A Phase Ib/II Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma</official_title>
<sponsors>
<lead_sponsor>
<agency>Hoffmann-La Roche</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Hoffmann-La Roche</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 study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab in
combination with tiragolumab, with or without atezolizumab, in participants with relapsed or
refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who have
received at least two previous lines of systemic therapy.
</textblock>
</brief_summary>
<overall_status>Active, not recruiting</overall_status>
<start_date type="Actual">May 10, 2022</start_date>
<completion_date type="Anticipated">December 15, 2023</completion_date>
<primary_completion_date type="Anticipated">December 15, 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>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>Percentage of Participants with Adverse Events (Phase 1b)</measure>
<time_frame>Up to 90 days after the final dose of study treatment (up to Cycle 17; cycle length = 21 days)</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Best Objective Response Rate (ORR) as Determined by the Investigator Using Lugano 2014 Criteria (Phase 2)</measure>
<time_frame>Up to Cycle 17 (cycle length = 21 days)</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Best ORR as Determined by the Investigator Using Lugano 2014 Criteria (Phase 1b)</measure>
<time_frame>Baseline up to approximately 4 years (assessed at screening, and then ever 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal)</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Best Complete Response (CR) Rate as Determined by the Investigator Using Lugano 2014 Criteria (Phase 1b and Phase 2)</measure>
<time_frame>Baseline up to approximately 4 years (assessed at screening, and then ever 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal)</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of Response (DOR) as Determined by the Investigator Using Lugano 2014 Criteria (Phase 1b and Phase 2)</measure>
<time_frame>From the first occurrence of a documented response (CR or partial response (PR)) to disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years)</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Progression-Free Survival (PFS) as Determined by the Investigator Using Lugano 2014 Criteria (Phase 2)</measure>
<time_frame>From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years)</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Event-Free Survival (EFS) as Determined by the Investigator Using Lugano 2014 Criteria (Phase 2)</measure>
<time_frame>From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years)</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Overall Survival (OS) (Phase 2)</measure>
<time_frame>From the time of first study treatment to death from any cause (up to approximately 4 years)</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Percentage of Participants with Adverse Events (Phase 2)</measure>
<time_frame>Up to 90 days after the final dose of study treatment (up to Cycle 17; cycle length = 21 days)</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Serum Concentration of Mosunetuzumab</measure>
<time_frame>Up to Cycle 17 (cycle length = 21 days)</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Serum Concentration of Mosunetuzumab in Combination with Tiragolumab</measure>
<time_frame>Up to Cycle 17 (cycle length = 17 days)</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Serum Concentration of Mosunetuzumab in Combination with Tiragolumab and Atezolizumab</measure>
<time_frame>Up to Cycle 17 (cycle length = 21 days)</time_frame>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">118</enrollment>
<condition>Non-Hodgkin Lymphoma, Follicular Lymphoma</condition>
<arm_group>
<arm_group_label>Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) Tiragolumab</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)</description>
</arm_group>
<arm_group>
<arm_group_label>Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Mosunetuzumab SC</intervention_name>
<description>Participants will receive SC mosunetuzumab for up to 17 treatment cycles (cycle length = 21 days)</description>
<arm_group_label>Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV</arm_group_label>
<arm_group_label>Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) Tiragolumab</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Tiragolumab</intervention_name>
<description>Participants will receive IV tiragolumab every 3 weeks (Q3W) for up to 17 treatment cycles (cycle length = 21 days)</description>
<arm_group_label>Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV</arm_group_label>
<arm_group_label>Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) Tiragolumab</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Atezolizumab</intervention_name>
<description>Participants will receive IV atezolizumab Q3W for up to 17 treatment cycles (cycle length = 21 days)</description>
<arm_group_label>Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Tocilizumab</intervention_name>
<description>Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events</description>
<arm_group_label>Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV</arm_group_label>
<arm_group_label>Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) Tiragolumab</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Aged >/= 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Life expectancy of at least 12 weeks

- Histologically documented FL or DLBCL that has relapsed or failed to respond to at
least two prior systemic treatment regimens and for which no suitable therapy of
curative intent or higher priority exists (e.g., standard chemotherapy, ASCT, CAR T
cells)

- At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or at least one
bi-dimensionally measurable (> 1.0 cm) extranodal lesion

- Participants with FL (including trFL) for whom a bone marrow biopsy and aspirate can
be collected

- Adequate hematologic and organ function

Exclusion Criteria:

- Received any of the following treatments prior to study entry: mosunetuzumab or other
CD20/CD3-directed bispecific antibodies; tiragolumab or other anti-TIGIT agent;
allogenic SCT; solid organ transplantation

- Currently eligible for autologous SCT

- Current or past history of CNS lymphoma or leptomeningeal infiltration

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibody therapy (or recombinant antibody-related fusion proteins)

- Contraindication to atezolizumab (if applicable) or tocilizumab

- Clinically significant toxicities from prior treatment have not resolved to Grade </=
1 (per NCI CTCAE v5.0) prior to the first study drug administration with exceptions
defined by the protocol

- Treatment-emergent immune-mediated adverse events associated with prior
immunotherapeutic agents as defined by the protocol

- Evidence of any significant, concomitant disease as defined by the protocol

- Major surgery within 4 weeks prior to first study treatment administration, with the
exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow
biopsies)

- Significant cardiac, pulmonary, CNS, or liver disease, or known active infections

- History of other malignancy that could affect compliance with the protocol or
interpretation of results

- History of autoimmune disease with exceptions as defined in the protocol
</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>Clinical Trials</last_name>
<role>Study Director</role>
<affiliation>Hoffmann-La Roche</affiliation>
</overall_official>
<location>
<facility>
<name>USC Norris Comprehensive Cancer Center</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90033</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Michigan</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<zip>48109-0934</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Lifespan Cancer Institute</name>
<address>
<city>Providence</city>
<state>Rhode Island</state>
<zip>02905</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>St Vincent's Hospital Sydney</name>
<address>
<city>Darlinghurst</city>
<state>New South Wales</state>
<zip>2010</zip>
<country>Australia</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Eastern Health</name>
<address>
<city>Box Hill</city>
<state>Victoria</state>
<country>Australia</country>
</address>
</facility>
</location>
<location>
<facility>
<name>St Vincent's Hospital Melbourne</name>
<address>
<city>Fitzroy</city>
<state>Victoria</state>
<zip>3065</zip>
<country>Australia</country>
</address>
</facility>
</location>
<location>
<facility>
<name>AZ Sint Jan Brugge Oostende AV</name>
<address>
<city>Brugge</city>
<zip>8000</zip>
<country>Belgium</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Institut Jules Bordet</name>
<address>
<city>Bruxelles</city>
<zip>1000</zip>
<country>Belgium</country>
</address>
</facility>
</location>
<location>
<facility>
<name>AZ Groeninge</name>
<address>
<city>Kortrijk</city>
<zip>8500</zip>
<country>Belgium</country>
</address>
</facility>
</location>
<location>
<facility>
<name>CHU UCL Namur - Mont-Godinne</name>
<address>
<city>Yvoir</city>
<zip>5530</zip>
<country>Belgium</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Tom Baker Cancer Centre-Calgary</name>
<address>
<city>Calgary</city>
<state>Alberta</state>
<zip>T2N 4N2</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Princess Margaret Cancer Centre</name>
<address>
<city>Toronto</city>
<state>Ontario</state>
<zip>M5G 1Z5</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Universitaet Duisburg-Essen</name>
<address>
<city>Essen</city>
<zip>45122</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Beatson West of Scotland Cancer Centre</name>
<address>
<city>Glasgow</city>
<zip>G12 0YN</zip>
<country>United Kingdom</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Royal Marsden Hospital - Institute of Cancer Research - Chelsea</name>
<address>
<city>London</city>
<zip>SE3 6JJ</zip>
<country>United Kingdom</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Plymouth Hospitals NHS Trust - Derriford Hospital</name>
<address>
<city>Plymouth</city>
<country>United Kingdom</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Royal Marsden Hospital - Institute of Cancer Research - Sutton</name>
<address>
<city>Sutton</city>
<zip>SM2 5PT</zip>
<country>United Kingdom</country>
</address>
</facility>
</location>
<location_countries>
<country>Australia</country>
<country>Belgium</country>
<country>Canada</country>
<country>Germany</country>
<country>United Kingdom</country>
<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 7, 2022</study_first_posted>
<last_update_submitted>July 25, 2023</last_update_submitted>
<last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">July 27, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>B-Cell Non-Hodgkin Lymphoma</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Lymphoma</mesh_term>
<mesh_term>Lymphoma, Follicular</mesh_term>
<mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
<mesh_term>Lymphoma, B-Cell</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Atezolizumab</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab in
combination with tiragolumab, with or without atezolizumab, in participants with relapsed or
refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who have
received at least two previous lines of systemic therapy.
Inclusion Criteria:
- Aged >/= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy of at least 12 weeks
- Histologically documented FL or DLBCL that has relapsed or failed to respond to at
least two prior systemic treatment regimens and for which no suitable therapy of
curative intent or higher priority exists (e.g., standard chemotherapy, ASCT, CAR T
cells)
- At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or at least one
bi-dimensionally measurable (> 1.0 cm) extranodal lesion
- Participants with FL (including trFL) for whom a bone marrow biopsy and aspirate can
be collected
- Adequate hematologic and organ function
Exclusion Criteria:
- Received any of the following treatments prior to study entry: mosunetuzumab or other
CD20/CD3-directed bispecific antibodies; tiragolumab or other anti-TIGIT agent;
allogenic SCT; solid organ transplantation
- Currently eligible for autologous SCT
- Current or past history of CNS lymphoma or leptomeningeal infiltration
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibody therapy (or recombinant antibody-related fusion proteins)
- Contraindication to atezolizumab (if applicable) or tocilizumab
- Clinically significant toxicities from prior treatment have not resolved to Grade </=
1 (per NCI CTCAE v5.0) prior to the first study drug administration with exceptions
defined by the protocol
- Treatment-emergent immune-mediated adverse events associated with prior
immunotherapeutic agents as defined by the protocol
- Evidence of any significant, concomitant disease as defined by the protocol
- Major surgery within 4 weeks prior to first study treatment administration, with the
exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow
biopsies)
- Significant cardiac, pulmonary, CNS, or liver disease, or known active infections
- History of other malignancy that could affect compliance with the protocol or
interpretation of results
- History of autoimmune disease with exceptions as defined in the protocol
|
NCT0531xxxx/NCT05315726.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/NCT05315726</url>
</required_header>
<id_info>
<org_study_id>JULLIAND AOIparaM 2021</org_study_id>
<nct_id>NCT05315726</nct_id>
</id_info>
<brief_title>The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population (Acute and Subacute Phases)</brief_title>
<acronym>SPACE-TIC</acronym>
<official_title>The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population (Acute and Subacute Phases)</official_title>
<sponsors>
<lead_sponsor>
<agency>Centre Hospitalier Universitaire Dijon</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Centre Hospitalier Universitaire Dijon</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>
Several studies have recently tested the use of muscle vibration for the rehabilitation of
patients after a stroke. When applied in a repeated and focused manner, this vibration
appears to promote the recovery of functional capacities through the mechanisms of
neuromuscular plasticity. These results are encouraging, showing in particular a significant
decrease in spasticity in post-stroke patients in the chronic phase (> 6 months after
stroke), on the upper and/or lower limbs. However, very few studies have been done on this
type of early intervention. Muscle vibration may therefore be an innovative therapy to
complement the care that is currently offered in the acute and subacute phase of post-stroke
rehabilitation.

Moreover, brain plasticity after a stroke is particularly high in the 3 months after the
accident, but the vast majority of studies having evaluated the impact of vibration in a
chronic phase (> 12 months post-stroke). It is likely, however, that the influence of
vibration, particularly on brain plasticity, is increased in the acute or subacute phase
(first 6 months). To date, the effect of vibration on spinal cord or cortical plasticity has
not been quantified in the acute or subacute phase. This is why the second part of this
project (phase 2) aims to systematically evaluate and quantify the neuroplastic and
functional effects of post-stroke vibration in the early phase.

Phase 1 (duration 2 weeks) - Validation of a method for measuring spasticity (upper limb)
with an isokinetic dynamometer 32 patients with ischemic and/or hemorrhagic stroke (> 3
months after stroke)

Phase 2 (duration 6 months): Use of this objective technique to measure the effect of a
muscle vibration protocol to limit the onset of spasticity in a population of 100 patients
following a stroke, in the acute or subacute phase (< 6 weeks post-stroke) in a randomized
trial:

- intervention group: usual rehabilitation + muscle vibrations

- control group: usual rehabilitation + placebo vibrations
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 14, 2022</start_date>
<completion_date type="Anticipated">June 2027</completion_date>
<primary_completion_date type="Anticipated">June 2027</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>Sequential Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Phase 1: Joint angle (elbow or wrist of the limb contralateral to the brain injury)</measure>
<time_frame>at baseline</time_frame>
<description>Elbow joint angle (elbow or wrist of the limb contralateral to the brain injury) at the onset of a spastic contraction (maximum intensity of resistance to mobilization) recorded by isokinetic dynamometer on a wheelchair during the initial visit</description>
</primary_outcome>
<primary_outcome>
<measure>Phase 2: Scoring wrist flexor muscle spasticity</measure>
<time_frame>at 6 weeks</time_frame>
<description>Scoring of wrist flexor muscle spasticity (especially FCR) by isokinetic dynamometer (angle of onset), at the beginning of the study and at 6 weeks (end of intervention).</description>
</primary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">132</enrollment>
<condition>Post-stroke Patient in Acute or Sub-acute Phase</condition>
<arm_group>
<arm_group_label>Pahse 1</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Phase 2: Intervention group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Phase 2: control group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Dynamometer</intervention_name>
<description>Measurement of elbow/wrist spasticity</description>
<arm_group_label>Pahse 1</arm_group_label>
<arm_group_label>Phase 2: Intervention group</arm_group_label>
<arm_group_label>Phase 2: control group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Muscle vibrations</intervention_name>
<description>1 session of 10 minutes</description>
<arm_group_label>Pahse 1</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Muscle vibrations</intervention_name>
<description>3 times/week for 6 weeks</description>
<arm_group_label>Phase 2: Intervention group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Placebo muscle vibration</intervention_name>
<description>3 times/week for 6 weeks</description>
<arm_group_label>Phase 2: control group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

Phase 1:

- Adult patient,

- Medically stable on medical assessment, with no contraindications to stroke
rehabilitation management management (no medical problems or acute intercurrent
medical events),

- Have had an ischemic and/or hemorrhagic stroke (> 3 months post-stroke), impacting the
motor skills of the upper limbs,

- 1 ≤ MAS < 4 on elbow or wrist flexors,

- Having given oral consent.

Phase 2:

- Adult patient,

- Medically stable on medical evaluation, with no contraindications to stroke
rehabilitation (no medical issues or acute intercurrent medical events),

- With a first stroke < 6 weeks previously, confirmed by imaging,

- Altered motor skills in the upper limb (contralateral to the lesion) (Fugl and Meyer
score), particularly in the wrist and elbow flexors,

- Requiring inpatient or outpatient hospitalization in a rehabilitation center,

- Having given oral consent.

Exclusion Criteria:

- Phases 1 and 2:

- Significant pain on mobilization of the elbow or wrist (visual analog scale > 5/10),

- Presence of other neurological, muscular or osteoarticular conditions altering the
functioning of the upper limb,

- Apparent wound, which may defer inclusion, or very fragile skin,

- Significant cognitive impairment: inability to understand simple instructions or give
consent of any kind (not included if: LAST scores < 5/7 in comprehension, and if
YES/NO answers are unreliable),

- Not covered by national health insurance,

- Pregnant or breastfeeding,

- Being under guardianship or curatorship.

- Person subject to a measure of legal protection
</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>Sophie JULLIAND</last_name>
<phone>03.80.66.94.82</phone>
<email>sophie.julliand@chu-dijon.fr</email>
</overall_contact>
<location>
<facility>
<name>Chu Dijon Bourgogne</name>
<address>
<city>Dijon</city>
<zip>21000</zip>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Sophie JULLIAND</last_name>
<phone>03.80.66.94.82</phone>
<email>sophie.julliand@chu-dijon.fr</email>
</contact>
</location>
<location_countries>
<country>France</country>
</location_countries>
<verification_date>July 2023</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>July 31, 2023</last_update_submitted>
<last_update_submitted_qc>July 31, 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>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Stroke</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Several studies have recently tested the use of muscle vibration for the rehabilitation of
patients after a stroke. When applied in a repeated and focused manner, this vibration
appears to promote the recovery of functional capacities through the mechanisms of
neuromuscular plasticity. These results are encouraging, showing in particular a significant
decrease in spasticity in post-stroke patients in the chronic phase (> 6 months after
stroke), on the upper and/or lower limbs. However, very few studies have been done on this
type of early intervention. Muscle vibration may therefore be an innovative therapy to
complement the care that is currently offered in the acute and subacute phase of post-stroke
rehabilitation.
Moreover, brain plasticity after a stroke is particularly high in the 3 months after the
accident, but the vast majority of studies having evaluated the impact of vibration in a
chronic phase (> 12 months post-stroke). It is likely, however, that the influence of
vibration, particularly on brain plasticity, is increased in the acute or subacute phase
(first 6 months). To date, the effect of vibration on spinal cord or cortical plasticity has
not been quantified in the acute or subacute phase. This is why the second part of this
project (phase 2) aims to systematically evaluate and quantify the neuroplastic and
functional effects of post-stroke vibration in the early phase.
Phase 1 (duration 2 weeks) - Validation of a method for measuring spasticity (upper limb)
with an isokinetic dynamometer 32 patients with ischemic and/or hemorrhagic stroke (> 3
months after stroke)
Phase 2 (duration 6 months): Use of this objective technique to measure the effect of a
muscle vibration protocol to limit the onset of spasticity in a population of 100 patients
following a stroke, in the acute or subacute phase (< 6 weeks post-stroke) in a randomized
trial:
- intervention group: usual rehabilitation + muscle vibrations
- control group: usual rehabilitation + placebo vibrations
Inclusion Criteria:
Phase 1:
- Adult patient,
- Medically stable on medical assessment, with no contraindications to stroke
rehabilitation management management (no medical problems or acute intercurrent
medical events),
- Have had an ischemic and/or hemorrhagic stroke (> 3 months post-stroke), impacting the
motor skills of the upper limbs,
- 1 ≤ MAS < 4 on elbow or wrist flexors,
- Having given oral consent.
Phase 2:
- Adult patient,
- Medically stable on medical evaluation, with no contraindications to stroke
rehabilitation (no medical issues or acute intercurrent medical events),
- With a first stroke < 6 weeks previously, confirmed by imaging,
- Altered motor skills in the upper limb (contralateral to the lesion) (Fugl and Meyer
score), particularly in the wrist and elbow flexors,
- Requiring inpatient or outpatient hospitalization in a rehabilitation center,
- Having given oral consent.
Exclusion Criteria:
- Phases 1 and 2:
- Significant pain on mobilization of the elbow or wrist (visual analog scale > 5/10),
- Presence of other neurological, muscular or osteoarticular conditions altering the
functioning of the upper limb,
- Apparent wound, which may defer inclusion, or very fragile skin,
- Significant cognitive impairment: inability to understand simple instructions or give
consent of any kind (not included if: LAST scores < 5/7 in comprehension, and if
YES/NO answers are unreliable),
- Not covered by national health insurance,
- Pregnant or breastfeeding,
- Being under guardianship or curatorship.
- Person subject to a measure of legal protection
|
NCT0531xxxx/NCT05315739.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/NCT05315739</url>
</required_header>
<id_info>
<org_study_id>SLE-VNS-1.0</org_study_id>
<nct_id>NCT05315739</nct_id>
</id_info>
<brief_title>Vagus Nerve Stimulation for Systemic Lupus Erythematous</brief_title>
<acronym>SLE-VNS</acronym>
<official_title>Vagus Nerve Stimulation as a Novel Treatment for Systemic Lupus Erythematous: A Double Blinded Randomized Controlled Trail</official_title>
<sponsors>
<lead_sponsor>
<agency>Rigshospitalet, Denmark</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Aalborg University 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>Yes</is_fda_regulated_device>
<is_us_export>Yes</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
This trial uses a double blinded, randomized 1:1 (active:sham) placebo controlled, parallel
group design, investigating the effects of transcutaneous vagus nerve stimulation (tVNS) in
patients with systemic lupus erythematosus (SLE).

The main objective is to evaluate whether adjuvant treatment with tVNS in SLE patients with
signs of autonomic dysfunction and fatigue improves patient perceived levels of fatigue.
Secondary outcomes include tVNS induced changes to: patient reported outcomes, autonomic
nervous system function, SLE disease activity, immunologic profile, tolerability of pain and
organ (cardiac, vascular and kidney) functions.

Participants are randomized to received either active non-invasive transcutaneous vagus nerve
stimulation (tVNS) or inactive sham stimulation. The study period is divided in two periods.
The first period investigates the effects of short-term, high-intensity tVNS treatment. The
second phase investigates the effects of long-term, middle-intensity tVNS treatment.
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">May 2022</start_date>
<completion_date type="Anticipated">September 2023</completion_date>
<primary_completion_date type="Anticipated">September 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Fatigue (changes during period 1 and 2)</measure>
<time_frame>During period 1: At baseline, daily (day 2-6) until- and at follow-up (day 7). During period 2: At baseline, at day 7-visit, weekly (week 3-7) until- and at follow-up (week 8).</time_frame>
<description>The FACIT-Fatigue Scale is a short, 13-item, tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point scale for each item. The theoretical maximum value is 52 (maximal fatigue) and minimum 0 (no fatigue).</description>
</primary_outcome>
<secondary_outcome>
<measure>Questionnaire on autonomic symptoms: Composite Autonomic Symptoms Score 31 (COMPASS-31)</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>The COMPASS-31 is a validated questionnaire of 31 questions providing a quantitative measure of autonomic nervous system dysfunction symptoms. The score ranges from 0 (no symptoms) to 100 (most severe autonomic symptoms).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Questionnaire on SLE disease activity: Patient Global Assessment (PtGA)</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit, weekly (week 3-7) until- and at follow-up (week 8).</time_frame>
<description>The participants rate their subjectively perceived disease activity on a scale from 0 to 10, in which 0 = no disease activity and 10 = worst imaginable disease activity.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Questionnaire on SLE disease activity: Systemic Lupus Activity Questionnaire (SLAQ)</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit, and at follow-up (week 8).</time_frame>
<description>In the SLAQ the participants rate their perceived disease activity by rating the severity of 24 disease activity related symptoms by either "no problem", "mild", "moderate" or "severe" In the SLAQ the participants rate their perceived disease activity by rating the severity of 24 disease activity related symptoms by either "no problem", "mild", "moderate" or "severe" and a Patient Global Disease Activity measure as mentioned in (3).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Questionnaire on quality of life: Short form-12 (SF-12)</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit, and at follow-up (week 8).</time_frame>
<description>From the validated 12-item SF-12 a physical and mental component score of patient-reported health related quality of life is calculated. Component scores range from 0-100 (lowest to highest level of self-reported health) and are calculated by giving specific weights to each of the 12 individual items/questions, calculating a weighted sum, and finally adding the sum to a component specific constant.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Questionnaire on pain: Visual analog rating scale (VAS)</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit, weekly (week 3-7) until- and at follow-up (week 8).</time_frame>
<description>Participants will assess the level of musculoskeletal pain within the previous 7 days by scoring the level on the VAS (0 to 10, where 0 = no pain and 10 = worst imaginable pain).</description>
</secondary_outcome>
<secondary_outcome>
<measure>SLE disease activity: SLE Disease Activity Index 2000 (SLEDAI-2K)</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>The validated SLEDAI-2K entails 24 weighted descriptors of disease activity across 9 organ systems. The SLEDAI-2K-score ranges from 0 (no activity) to a theoretical maximum score of 105 and reports on manifestations occurring up to 10 days before the examination.</description>
</secondary_outcome>
<secondary_outcome>
<measure>SLE disease activity: SLEDAI Responder Index 50% (SRI-50)</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>The SRI-50 is a validated derivation of SLEDAI-2K that considers clinically significant improvements (≥ 50%) between visits.</description>
</secondary_outcome>
<secondary_outcome>
<measure>SLE disease activity: SLE Disease Activity Score (SLE-DAS)</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>The SLE-DAS is a validated index containing 17 clinical and laboratory descriptors and is a global measure of SLE disease activity suggested to have improved sensitivity to change and specificity as compared with the SLEDAI-2K.</description>
</secondary_outcome>
<secondary_outcome>
<measure>SLE disease activity: Physician Global Assessment (PGA)</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>The PGA measures disease activity in SLE is determined by the physician's judgement of overall disease activity. It is scored by answering "How do you rate your patient's current disease activity?" with 1=mild, 2=moderate or 3=most active disease imaginable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>SLE disease activity: Painful and swollen joints</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>The number of painful and swollen joints are assessed according to the Disease Activity Score-28 (Swollen joints: 0 = no, and 28 = 28 swollen. Painful joints: 0 = n, and 28 = 28 painful joints).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Autonomic function: Resting heart rate variability (HRV)</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>With the VagusTM device, 5 minutes of resting HRV is measured. Classical time (SDNN, RMSSD) and frequency (LF, HF, total and LF/HF) domain heart rate variability parameters will be assessed.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Autonomic function: Resting Cardiac Vagal Tone (CVT)</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>Cardiac vagal tone reflecting parasympathetic activity is measured through three chest electrocardiography electrodes. A cardiac monitor, the eMotion Faros device is attached to the electrodes and the electrocardiogram is sampled at 8 kHz for 5 minutes, from which the cardiac vagal tone is derived.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Autonomic function: Cardiovascular autonomic reflex tests - heart rate response</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>The heart rate response to three cardiovascular autonomic reflex tests are assessed with the VagusTM-device for estimation of the degree of autonomic dysfunction: The ratio of the maximum and minimum heart rate in relation to a) standing, b) deep breathing and, c) a Valsalva maneuver. By comparing results of the cardiovascular reflex tests with age-dependent cut-off levels, the degree of autonomic dysfunction is divided into categories: no, early (one) and manifest (two or three abnormal tests).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Autonomic function: Cardiovascular autonomic reflex tests - blood pressure response</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>The blood pressure response to one cardiovascular autonomic reflex test is assessed. After a supine 5-min rest, the orthostatic blood pressure is measured. The participant stands for 5 minutes while the blood pressure is measured each minute. Blood pressure drops (systolic 20 mmHg or diastolic 10 mmHg) indicate impaired, especially, sympathetic function.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Autonomic function: Continuous heart rate and HRV monitoring</measure>
<time_frame>During period 1: From baseline to follow-up (day 7). During period 2: From baseline to day 7-visit.</time_frame>
<description>A small patch sensor (ePatch) will be used to monitor the heart rate variability during a period of 7 days. Classical time (RR-interval, SDNN, SDNNi, SDANN, RMSSD) and frequency (VLF, LF, HF and LF/HF) domain heart rate variability parameters will be assessed.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Autonomic function: Sweat secretion</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>The Sudoscan® provides a quick, non-invasive and reproducible assessment of sympathetically controlled sudomotor function, and is based on a reaction between electrodes and chloride ions after a low-voltage sweat gland stimulation as the patient is situated with their hands and feet on two different measure pads for 3 minutes.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Pain tolerability: Cold pressor test</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>The left hand is immersed in circulated ice-chilled water (2.0°C). The subject will be instructed to tolerate to hold the hand in the water for up to 120 seconds or when intolerable pain is reached. At different timepoints throughout the stimulation, the participants are asked to rate the sensation on a numerical rating scale from 0 to 10, where 0 = no pain and 10 = worst pain.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Pain tolerability: Conditioned pain modulation (CMP)</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>The CPM-capacity response can be quantified by applying a "test-pain" (muscle pressure on right quadriceps) before and after the conditioning stimulus. The difference in pressure stimulus intensity before, during, and after induction of cold pressor pain provides a quantitative index of CPM capacity in the individual participant. The techniques used for pressure stimulation and cold pressor test described above will be combined to measure CPM.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cardiac function</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>Cardiac function is assessed with echocardiography, which is a non-invasive ultrasound examination elapsing from 15 -30 minutes, performed with the patient in supine position. A transducer is run across the thorax for visualization of cardiac diastolic and systolic function, anatomical structures, arterial stiffness as well as muscle and chamber sizes to describe systolic and diastolic cardiac function.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Vascular function: Microvascular function</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>Nailfold video capillaroscopy is a non-invasive diagnostic technique that evaluates the morphology of the capillaries in the nailfold through direct visualization. It can reveal both the architecture of capillary rows and fine details of each vessel.</description>
</secondary_outcome>
<secondary_outcome>
<measure>SLE routine status</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>SLE clinical status is assessed by performing routine blood-based analyses of hematological, serological and urinary markers for different organ-specific and SLE-specific characteristics.</description>
</secondary_outcome>
<secondary_outcome>
<measure>SLE inflammatory status - Multiplex plasma cytokine analysis</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>SLE inflammatory status is assessed by analyzing the blood plasma for especially activation markers: TNF, IL-1b, sIL-2Ra, IL-6, IL-8, IL-17, IFN-g, IFN-alfa and Inhibition markers: sTNFr, IL-1RA, IL-10, TGF-b.</description>
</secondary_outcome>
<secondary_outcome>
<measure>SLE inflammatory status - Interferon-regulated gene expression</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>SLE inflammatory status is assessed by analyzing interferon-regulated gene expression in whole blood (nCounter platform, NanoString Technologies, Seattle, WA).</description>
</secondary_outcome>
<secondary_outcome>
<measure>SLE inflammatory status - Immune cell population distribution in whole blood</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>SLE inflammatory status is assessed by analyzing the immune cell population distribution in whole blood (fluorescence-activated cell sorting).</description>
</secondary_outcome>
<secondary_outcome>
<measure>SLE inflammatory status - Functional immune cell stimulation</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>SLE inflammatory status is assessed by analyzing immune cell stimulation in whole blood (TruCulture).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Kidney function</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>Kidney function is assessed by analyzing urine (3*24 hours) for kidney specific markers such as urine albumin- and protein/creatinine-ratio.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Metabolic control</measure>
<time_frame>During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).</time_frame>
<description>Metabolic control is assessed at the hospital by analyzing blood plasma for lipid and glucose profiles</description>
</secondary_outcome>
<secondary_outcome>
<measure>Medication usage</measure>
<time_frame>Medication status is reported at all visits (period 1: baseline and follow-up (day 7); period 2: baseline, day 7 and follow-up (week 8)) and three months after completing the study</time_frame>
<description>Changes in medication status within the time frame of the study and 3 months after study completion is recorded by accessing the participants medication file.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">84</enrollment>
<condition>Systemic Lupus Erythematosus</condition>
<condition>Autonomic Dysfunction</condition>
<condition>Autonomic Neuropathy</condition>
<condition>Fatigue</condition>
<arm_group>
<arm_group_label>Active treatment</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Non-invasive transcutaneous vagus nerve stimulation applied by the gammaCore device (electroCore)</description>
</arm_group>
<arm_group>
<arm_group_label>Sham treatment</arm_group_label>
<arm_group_type>Sham Comparator</arm_group_type>
<description>Inactive sham vagus nerve stimulation applied by the gammaCore sham device (electroCore)</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Non-invasive transcutaneous vagus nerve stimulation (tVNS)</intervention_name>
<description>tVNS delivers an electrical current to the cervical branch of the vagus nerve. Four minutes of bilateral stimulation 4 times per day for 7 days (period 1) and 2 times per day for 8 weeks (period 2) are performed. The two periods are separated by a 2 weeks wash-out period.</description>
<arm_group_label>Active treatment</arm_group_label>
<other_name>GammaCore Sapphire device</other_name>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Sham vagus nerve stimulation</intervention_name>
<description>The sham device produces a slight vibrating sound, but does not produce an electical current and hence, does not activate the vagus nerve.
Four minutes of bilateral stimulation 4 times per day for 7 days (period 1) and 2 times per day for 8 weeks (period 2). The two periods are separated by a 2 weeks wash-out period.</description>
<arm_group_label>Sham treatment</arm_group_label>
<other_name>GammaCore Sapphire sham device</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion criteria

- Reading and understanding Danish.

- SLE diagnosis based on SLE disease classification criteria for at least 1 year.

- Stable disease and medication the past 28 days as defined by:

- No change in disease modifying antirheumatic drugs or biological therapy,

- Receiving maximally 10 mg prednisone daily.

- Having signs of fatigue, as assessed by scoring ≤ 40 in the FACIT-Fatigue
questionnaire.

- Having signs of autonomic dysfunction, as assessed by scoring one or more of:

1. VAGUS score ≥1

2. SUDOSCAN score < 50µS for hands or < 70µS for feet

3. COMPASS-31 score > 12

- Patients willing and able to comply with the scheduled visits, treatment plan,
laboratory tests and other trial procedures.

- Sign the dated informed consent documents

Exclusion criteria

- Significant cardiovascular disease, including congenital cardiac disease, congestive
heart failure, known severe coronary artery disease, or recent myocardial infarction
(within 5 years), as assessed by a physician at the screening.

- Blood pressure < 100/60 or > 160/105

- Clinically significant bradycardia or tachycardia

- History of abnormal baseline ECG, prolonged QT interval or arrhythmia

- Previous surgery on the vagus nerve or abnormal cervical anatomy

- Implanted or portable electro-mechanical medical devices, e.g. pacemaker,
defibrillator, cochlear implant and infusion pump

- Metallic device such as a stent, bone plate or bone screw implanted at or near the
neck

- Receiving active laser treatment for proliferative retinopathy

- Active cancer or cancer in remission

- History of brain tumor, aneurysm, bleed, head trauma, clinically significant syncope
or seizures

- Any clinical abnormalities that, in the opinion of the investigator, may increase the
risk associated with trial participation or may interfere with the interpretation of
the trial results.

- Participation in other clinical trials less than three months prior to inclusion,
unless such a participation is judged to have no influence on the recordings

- Female pregnancy (positive urine-HCG), ongoing lactation or intended pregnancy during
the study period.

- A pregnancy test is conducted at first and last visit to ensure that fertile
female patients are not pregnant during the study period.

- Further, the investigator ensures that fertile female patients use a safe
contraception method during the study and for at least 15 hours after termination
of the study period. Safe contraception: The combined oral contraceptive pill;
intra uterine device; gestagen injection; subdermal implantation; hormone vaginal
ring; and transdermal plaster.

- Male patients who intend to father a child during the course of 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>Søren Jacobsen, DMSc</last_name>
<role>Principal Investigator</role>
<affiliation>Rigshospitalet, Denmark</affiliation>
</overall_official>
<overall_contact>
<last_name>Søren Jacobsen, DMSc</last_name>
<phone>+45 3545 0545</phone>
<email>soeren.jacobsen.01@regionh.dk</email>
</overall_contact>
<overall_contact_backup>
<last_name>Amanda H Zinglersen, MD</last_name>
<phone>+45 3545 1292</phone>
<email>amanda.hempel.zinglersen.01@regionh.dk</email>
</overall_contact_backup>
<verification_date>May 2022</verification_date>
<study_first_submitted>February 25, 2022</study_first_submitted>
<study_first_submitted_qc>April 6, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>May 2, 2022</last_update_submitted>
<last_update_submitted_qc>May 2, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">May 3, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
<investigator_full_name>Søren Jacobsen</investigator_full_name>
<investigator_title>Professor, MD, DMSc</investigator_title>
</responsible_party>
<keyword>Vagus Nerve Stimulation</keyword>
<keyword>Fatigue</keyword>
<keyword>Pain</keyword>
<keyword>Health-Related Quality Of Life</keyword>
<keyword>Autonomic Nervous System Disorders</keyword>
<keyword>Inflammation</keyword>
<keyword>Autoimmunity</keyword>
<keyword>Kidney Diseases</keyword>
<keyword>Vascular Diseases</keyword>
<keyword>Heart Diseases</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Autonomic Nervous System Diseases</mesh_term>
<mesh_term>Primary Dysautonomias</mesh_term>
<mesh_term>Lupus Erythematosus, Systemic</mesh_term>
<mesh_term>Fatigue</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>Data can be provided upon request.</ipd_description>
<ipd_time_frame>From study end.</ipd_time_frame>
<ipd_access_criteria>Researchers who provide a methodological sound proposal</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This trial uses a double blinded, randomized 1:1 (active:sham) placebo controlled, parallel
group design, investigating the effects of transcutaneous vagus nerve stimulation (tVNS) in
patients with systemic lupus erythematosus (SLE).
The main objective is to evaluate whether adjuvant treatment with tVNS in SLE patients with
signs of autonomic dysfunction and fatigue improves patient perceived levels of fatigue.
Secondary outcomes include tVNS induced changes to: patient reported outcomes, autonomic
nervous system function, SLE disease activity, immunologic profile, tolerability of pain and
organ (cardiac, vascular and kidney) functions.
Participants are randomized to received either active non-invasive transcutaneous vagus nerve
stimulation (tVNS) or inactive sham stimulation. The study period is divided in two periods.
The first period investigates the effects of short-term, high-intensity tVNS treatment. The
second phase investigates the effects of long-term, middle-intensity tVNS treatment.
Inclusion criteria
- Reading and understanding Danish.
- SLE diagnosis based on SLE disease classification criteria for at least 1 year.
- Stable disease and medication the past 28 days as defined by:
- No change in disease modifying antirheumatic drugs or biological therapy,
- Receiving maximally 10 mg prednisone daily.
- Having signs of fatigue, as assessed by scoring ≤ 40 in the FACIT-Fatigue
questionnaire.
- Having signs of autonomic dysfunction, as assessed by scoring one or more of:
1. VAGUS score ≥1
2. SUDOSCAN score < 50µS for hands or < 70µS for feet
3. COMPASS-31 score > 12
- Patients willing and able to comply with the scheduled visits, treatment plan,
laboratory tests and other trial procedures.
- Sign the dated informed consent documents
Exclusion criteria
- Significant cardiovascular disease, including congenital cardiac disease, congestive
heart failure, known severe coronary artery disease, or recent myocardial infarction
(within 5 years), as assessed by a physician at the screening.
- Blood pressure < 100/60 or > 160/105
- Clinically significant bradycardia or tachycardia
- History of abnormal baseline ECG, prolonged QT interval or arrhythmia
- Previous surgery on the vagus nerve or abnormal cervical anatomy
- Implanted or portable electro-mechanical medical devices, e.g. pacemaker,
defibrillator, cochlear implant and infusion pump
- Metallic device such as a stent, bone plate or bone screw implanted at or near the
neck
- Receiving active laser treatment for proliferative retinopathy
- Active cancer or cancer in remission
- History of brain tumor, aneurysm, bleed, head trauma, clinically significant syncope
or seizures
- Any clinical abnormalities that, in the opinion of the investigator, may increase the
risk associated with trial participation or may interfere with the interpretation of
the trial results.
- Participation in other clinical trials less than three months prior to inclusion,
unless such a participation is judged to have no influence on the recordings
- Female pregnancy (positive urine-HCG), ongoing lactation or intended pregnancy during
the study period.
- A pregnancy test is conducted at first and last visit to ensure that fertile
female patients are not pregnant during the study period.
- Further, the investigator ensures that fertile female patients use a safe
contraception method during the study and for at least 15 hours after termination
of the study period. Safe contraception: The combined oral contraceptive pill;
intra uterine device; gestagen injection; subdermal implantation; hormone vaginal
ring; and transdermal plaster.
- Male patients who intend to father a child during the course of the study
|
NCT0531xxxx/NCT05315752.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/NCT05315752</url>
</required_header>
<id_info>
<org_study_id>IO-BRUY-CE/220209</org_study_id>
<nct_id>NCT05315752</nct_id>
</id_info>
<brief_title>Changes in Body Fat and Morphologic Characteristics Associated With OSA Resolution After Bariatric Surgery</brief_title>
<official_title>Changes in Body Fat and Morphologic Characteristics Associated With Obstructive Sleep Apnea (OSA) Resolution After Bariatric Surgery</official_title>
<sponsors>
<lead_sponsor>
<agency>Centre Hospitalier Universitaire Saint Pierre</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Centre Hospitalier Universitaire Saint Pierre</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>
Prospective study with inclusion of bariatric surgery candidates with diagnosed Obstructive
Sleep Apnea and requiring treatment with Continuous Positive Air Pressure, aiming to evaluate
at 2-6-12 months after bariatric surgery whether the relationship between biometric changes
(reduction in neck circumference, height, waist/hip ratio, and fat and lean mass) and the
resolution of OSA is better than the relationship between these biometric changes and BMI
reduction.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Investigators are concerned about the high prevalence of Obstructive Sleep Apnoea syndrome
(OSA) in the bariatric population. Postoperatively, there is a high rate of recovery from
OSA. Indeed, investigators know from previous reports that weight loss is a very effective,
but time consuming, strategy for treating OSA. Patients are therefore treated with CPAP
(Continuous Positive Airway Pressure) while waiting for weight loss. In a recent
meta-analysis, which focused on the effect of weight loss achieved through lifestyle
interventions in 618 overweight and obese patients, the apnea-hypopnea index (AHI) decreased
by an amount of 16/h for an average weight loss of 14 kg (1). However, the majority of
patients are not able to maintain weight loss in the long term, and weight gain is associated
with recurrence/aggravation of OSAS (2). Nowadays, bariatric surgery is a common strategy to
achieve sustained and significant weight loss in obese patients. Sarkhosh et al. examined the
impact of bariatric surgery (restrictive procedures, with a mild malabsorption component, or
largely malabsorptive procedures) on sleep apnoea in 13,900 patients. Depending on the
procedure, improvement or resolution of OSAS was achieved in 78-90% of patients (3).

Prospective longitudinal postoperative follow-up study : inclusion of patients who had
scheduled bariatric surgery, diagnosed with OSA, AHI > 15 (polysomnography), treated with
self-controlled CPAP (APAP), under remote monitoring;

Baseline measures:

1. Anthropometric characteristics: body mass index (BMI), neck circumference, waist/hip
ratio, fat mass + lean mass (bioelectrical impedance measurements),

2. APAP treatment characteristics, mean APAP pressure, 95th percentile APAP pressure, APAP
adherence.

Follow-up:

1. The 2-month follow-up: body mass index (BMI), neck circumference, waist/hip ratio, fat
mass + fat-free mass (bioelectrical impedance measurements), mean APAP pressure, 95th
percentile APAP pressure, APAP adherence. To assess potential regression of OSA with
weight loss: home polygraphy after 4 nights off APAP (4).

2. Six-month and 12-month follow-up: same as at 2 months. Follow-up stops in case of a
polygraph showing an AHI <10, allowing APAP treatment to be stopped.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 22, 2022</start_date>
<completion_date type="Anticipated">December 31, 2024</completion_date>
<primary_completion_date type="Anticipated">December 31, 2024</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>12 Months</target_duration>
<primary_outcome>
<measure>Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI</measure>
<time_frame>2 months</time_frame>
<description>Comparison of (1) the correlation between waist circumference reduction and resolution of OAS (AHI<10/hour on polysomnography) and (2) the correlation between waist circumference reduction and BMI reduction</description>
</primary_outcome>
<primary_outcome>
<measure>Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI</measure>
<time_frame>6 months</time_frame>
<description>Comparison of (1) the correlation between waist circumference reduction and resolution of OAS (AHI<10/hour on polysomnography) and (2) the correlation between waist circumference reduction and BMI reduction</description>
</primary_outcome>
<primary_outcome>
<measure>Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI</measure>
<time_frame>12 months</time_frame>
<description>Comparison of (1) the correlation between waist circumference reduction and resolution of OAS (AHI<10/hour on polysomnography) and (2) the correlation between waist circumference reduction and BMI reduction</description>
</primary_outcome>
<secondary_outcome>
<measure>Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction</measure>
<time_frame>2 months</time_frame>
<description>Comparison of (1) the correlation between neck circumference reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between neck circumference reduction and BMI reduction</description>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction</measure>
<time_frame>6 months</time_frame>
<description>Comparison of (1) the correlation between neck circumference reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between neck circumference reduction and BMI reduction</description>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction</measure>
<time_frame>12 months</time_frame>
<description>Comparison of (1) the correlation between neck circumference reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between neck circumference reduction and BMI reduction</description>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of (1) the correlation between hip circumference reduction and OAS resolution and (2) the correlation between hip circumference reduction and BMI reduction</measure>
<time_frame>2 months</time_frame>
<description>Comparison of (1) the correlation between hip circumference reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between hip circumference reduction and BMI reduction</description>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of (1) the correlation between hip circumference reduction and OAS resolution and (2) the correlation between hip circumference reduction and BMI reduction</measure>
<time_frame>6 months</time_frame>
<description>Comparison of (1) the correlation between hip circumference reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between hip circumference reduction and BMI reduction</description>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of (1) the correlation between hip circumference reduction and OAS resolution and (2) the correlation between hip circumference reduction and BMI reduction</measure>
<time_frame>12 months</time_frame>
<description>Comparison of (1) the correlation between hip circumference reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between hip circumference reduction and BMI reduction</description>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of (1) the correlation between lean mass reduction and OAS resolution and (2) the correlation between lean mass reduction and BMI reduction</measure>
<time_frame>2 months</time_frame>
<description>Comparison of (1) the correlation between lean mass reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between lean mass reduction and BMI reduction</description>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of (1) the correlation between lean mass reduction and OAS resolution and (2) the correlation between lean mass reduction and BMI reduction</measure>
<time_frame>6 months</time_frame>
<description>Comparison of (1) the correlation between lean mass reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between lean mass reduction and BMI reduction</description>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of (1) the correlation between lean mass reduction and OAS resolution and (2) the correlation between lean mass reduction and BMI reduction</measure>
<time_frame>9 months</time_frame>
<description>Comparison of (1) the correlation between lean mass reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between lean mass reduction and BMI reduction</description>
</secondary_outcome>
<enrollment type="Anticipated">60</enrollment>
<condition>Obesity</condition>
<condition>Obstructive Sleep Apnea</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Bariatric surgery</intervention_name>
<description>Bariatric surgery includes (but is not limited to)
Gastric bypass: surgical bypass of the entire stomach, duodenum and approximately 1 m of the proximal small intestine
Sleeve: a large part of the stomach is removed laparoscopically, the open vertical edges are put back in place to leave a sleeve-like tube.
Bariatric surgery is considered a treatment option
for patients with a BMI >40 kg/m 2 , assuming the patient has previously participated successfully in a group weight management programme (weight loss >7%) or
for patients with a BMI of 35-40 kg/m 2 when the obesity is associated with type 2 diabetes or hypertension, or OAS (with CPAP therapy) or severe musculoskeletal disease</description>
</intervention>
<eligibility>
<study_pop>
<textblock>
Eligible patients from CHU St Pierre hospital setting
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

Any informed person who is

- eligible for bariatric surgery: with severe obesity (BMI≥35-40) or morbid obesity
(BMI≥40), with co-morbidities, who have not lost enough weight with prior lifestyle
adaptations (balanced diet, physical activity) AND

- with diagnosed obstructive sleep apnoea (OSA) (AHI > 15/hr on polysomnography) AND

- requiring treatment with Continuous Positive Air Pressure (CPAP)

Exclusion Criteria:

- Cognitive impairment - language barrier
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>99 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Marie BRUYNEEL, Prof.</last_name>
<phone>+3225353686</phone>
<email>marie.bruyneel@stpierre-bru.be</email>
</overall_contact>
<overall_contact_backup>
<last_name>Ionela BOLD, MD</last_name>
<phone>+3225353686</phone>
<email>ionela.bold@stpierre-bru.be</email>
</overall_contact_backup>
<location>
<facility>
<name>CHU St Pierre</name>
<address>
<city>Brussels</city>
<zip>1000</zip>
<country>Belgium</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Ionela Bold, MD</last_name>
<phone>+3225353686</phone>
<email>ionela.bold@stpierre-bru.be</email>
</contact>
<contact_backup>
<last_name>Nathalie Y Pauwen, MSc</last_name>
<phone>+32460955869</phone>
<email>nathalie.pauwen@ulb.be</email>
</contact_backup>
</location>
<location>
<facility>
<name>Ionela Bold</name>
<address>
<city>Brussels</city>
<zip>1000</zip>
<country>Belgium</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Ionela Bold</last_name>
<phone>+3225353686</phone>
<email>ionela.bold@stpierre-bru.be</email>
</contact>
<contact_backup>
<last_name>Nathalie Y Pauwen</last_name>
<phone>+32460955869</phone>
<email>nathalie.pauwen@ulb.be</email>
</contact_backup>
</location>
<location_countries>
<country>Belgium</country>
</location_countries>
<verification_date>September 2023</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 7, 2022</study_first_posted>
<last_update_submitted>September 12, 2023</last_update_submitted>
<last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">September 13, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Centre Hospitalier Universitaire Saint Pierre</investigator_affiliation>
<investigator_full_name>Marie Bruyneel</investigator_full_name>
<investigator_title>Head of pneumology department</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Sleep Apnea Syndromes</mesh_term>
<mesh_term>Sleep Apnea, Obstructive</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Prospective study with inclusion of bariatric surgery candidates with diagnosed Obstructive
Sleep Apnea and requiring treatment with Continuous Positive Air Pressure, aiming to evaluate
at 2-6-12 months after bariatric surgery whether the relationship between biometric changes
(reduction in neck circumference, height, waist/hip ratio, and fat and lean mass) and the
resolution of OSA is better than the relationship between these biometric changes and BMI
reduction.
Investigators are concerned about the high prevalence of Obstructive Sleep Apnoea syndrome
(OSA) in the bariatric population. Postoperatively, there is a high rate of recovery from
OSA. Indeed, investigators know from previous reports that weight loss is a very effective,
but time consuming, strategy for treating OSA. Patients are therefore treated with CPAP
(Continuous Positive Airway Pressure) while waiting for weight loss. In a recent
meta-analysis, which focused on the effect of weight loss achieved through lifestyle
interventions in 618 overweight and obese patients, the apnea-hypopnea index (AHI) decreased
by an amount of 16/h for an average weight loss of 14 kg (1). However, the majority of
patients are not able to maintain weight loss in the long term, and weight gain is associated
with recurrence/aggravation of OSAS (2). Nowadays, bariatric surgery is a common strategy to
achieve sustained and significant weight loss in obese patients. Sarkhosh et al. examined the
impact of bariatric surgery (restrictive procedures, with a mild malabsorption component, or
largely malabsorptive procedures) on sleep apnoea in 13,900 patients. Depending on the
procedure, improvement or resolution of OSAS was achieved in 78-90% of patients (3).
Prospective longitudinal postoperative follow-up study : inclusion of patients who had
scheduled bariatric surgery, diagnosed with OSA, AHI > 15 (polysomnography), treated with
self-controlled CPAP (APAP), under remote monitoring;
Baseline measures:
1. Anthropometric characteristics: body mass index (BMI), neck circumference, waist/hip
ratio, fat mass + lean mass (bioelectrical impedance measurements),
2. APAP treatment characteristics, mean APAP pressure, 95th percentile APAP pressure, APAP
adherence.
Follow-up:
1. The 2-month follow-up: body mass index (BMI), neck circumference, waist/hip ratio, fat
mass + fat-free mass (bioelectrical impedance measurements), mean APAP pressure, 95th
percentile APAP pressure, APAP adherence. To assess potential regression of OSA with
weight loss: home polygraphy after 4 nights off APAP (4).
2. Six-month and 12-month follow-up: same as at 2 months. Follow-up stops in case of a
polygraph showing an AHI <10, allowing APAP treatment to be stopped.
Eligible patients from CHU St Pierre hospital setting
Inclusion Criteria:
Any informed person who is
- eligible for bariatric surgery: with severe obesity (BMI≥35-40) or morbid obesity
(BMI≥40), with co-morbidities, who have not lost enough weight with prior lifestyle
adaptations (balanced diet, physical activity) AND
- with diagnosed obstructive sleep apnoea (OSA) (AHI > 15/hr on polysomnography) AND
- requiring treatment with Continuous Positive Air Pressure (CPAP)
Exclusion Criteria:
- Cognitive impairment - language barrier
|
NCT0531xxxx/NCT05315765.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/NCT05315765</url>
</required_header>
<id_info>
<org_study_id>STH20670</org_study_id>
<secondary_id>NIHR 201492</secondary_id>
<nct_id>NCT05315765</nct_id>
</id_info>
<brief_title>Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery</brief_title>
<acronym>PRO-diGI</acronym>
<official_title>Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery</official_title>
<sponsors>
<lead_sponsor>
<agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>University of Sheffield</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Sheffield Teaching Hospitals NHS Foundation Trust</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>
People who undergo surgery, or develop intestinal obstruction will spend a period of time
without normal bowel function. This might extend beyond the normal measures of passage of
flatus or tolerance of diet. This study will take a three stage approach to develop a patient
reported outcome measure for gastrointestinal recovery.

Stage 1: Qualitative interviews with 20-40 patients who have undergone major abdominal
surgery, or conservatively managed intestinal obstruction. These interviews will identify key
themes and ideas to develop the questionnaire.

Stage 2: Face validity testing of questionnaire with 20 patients, using the QQ-10
questionnaire to aid assessment. The questionnaire may be edited after this.

Stage 3: 250-500 patients will be asked to complete the questionnaire following surgery or
treatment for intestinal obstruction. Basic demographics will also be collated. Item
reduction and scale refinement will be undertaken using this dataset. This will provide a
PROM of gastrointestinal recovery which is ready for validation.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Gastrointestinal dysfunction is commonly seen after surgery, and also manifests itself in
intestinal obstruction. During this time, the patient may experience a range of symptoms of
acute intestinal failure, including loss of motility and absorption. These may resolve at
different rates during the period of gastrointestinal recovery. Trials in the area have
conflicting results, partly due to the selection of clinician reported unidimensional
outcomes. There is a clear need for a patient reported outcome measure (PROM) to record
gastrointestinal recovery.

Aims and Objectives

- To develop a PROM for gastrointestinal recovery.

- To identify a candidate long-list of items for inclusion in a PROM through
semi-structured patient interviews, and test face validity with patients and an expert
panel

- To develop a PROM using the approved long list

Methods This study will be conducted in three stages with reference to FDA (Food and Drug
Administration) and ISOQoL (International Society for Quality of Life Research) guidelines.

Stage 1: Five centres will undertake purposive sampling to identify patients who have
undergone major intraabdominal surgery (including gastrointestinal, urological, and
gynaecological) and patients treated for intestinal obstruction. It is expected that 40-60
participants will undergo a semi-structured interview to identify important items related to
recovery of gastrointestinal function in order to reach thematic saturation. Interviews will
be transcribed and coded using a framework methodology. This will generate allow us to
construct a prototype questionnaire with an initial pool of items.

Stage 2: The prototype questionnaire will be shown to a group of international experts in
gastrointestinal recovery for assessment of face validity, using the QQ-10 (Questionnaire
quality-10 item) questionnaire. This will then be tested with 20 patients treated for
eligible conditions at five participating centres using the QQ-10.

Stage 3: Upto 500 participants (depending on number of items on the questionnaire) will be
recruited from 10 centres which offer gastrointestinal, urological, and gynaecological
surgery. Participants will rate items on a Likert scale. Items will undergo factor analysis
to reduce the number of items. This will present a shorter questionnaire with finalised
scales.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">October 28, 2021</start_date>
<completion_date type="Anticipated">March 30, 2023</completion_date>
<primary_completion_date type="Anticipated">January 30, 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>Completion of interviews (stage one)</measure>
<time_frame>Within one month of treatment</time_frame>
<description>completions of interview by group 1</description>
</primary_outcome>
<primary_outcome>
<measure>Completion of questionnaire (stage three)</measure>
<time_frame>Within two weeks of treatment</time_frame>
<description>completion of questionnaire by group 3</description>
</primary_outcome>
<primary_outcome>
<measure>Completion of face validity assessment (stage two)</measure>
<time_frame>Within one month of treatment</time_frame>
<description>Assessment of face validity using the QQ-10 (Questionnaire quality-10 item) questionnaire by group 2</description>
</primary_outcome>
<number_of_groups>3</number_of_groups>
<enrollment type="Anticipated">560</enrollment>
<condition>Ileus</condition>
<condition>Small Bowel Obstruction</condition>
<condition>Intestinal Failure</condition>
<arm_group>
<arm_group_label>Phase 1</arm_group_label>
<description>Qualitative interviews with patients to generate thematic framework and questionnaire</description>
</arm_group>
<arm_group>
<arm_group_label>Phase 2</arm_group_label>
<description>Face validity assessment of questionnaire</description>
</arm_group>
<arm_group>
<arm_group_label>Phase 3</arm_group_label>
<description>Completion of questionnaire to refine scale and item list</description>
</arm_group>
<eligibility>
<study_pop>
<textblock>
Adult patients undergoing major abdominal surgery for gastrointestinal, urological, or
gynaecological indications OR patients being treated for intestinal obstruction regardelss
of aetiology.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

Adult patients (aged 18+) admitted to hospital for one of the following reasons will be
eligible to participate:

- Undergoing major elective gastrointestinal surgery (e.g. colorectal resection, gastric
resection, liver or pancreatic resection)

- Emergency laparotomy for non-trauma indication

- Patients undergoing intra-abdominal surgery for non-gastrointestinal indications
e.g.cystoprostatectomy, prostatectomy, nephrectomy, hysterectomy, or oophorectomy.

- With a diagnosis of intestinal obstruction (small or large bowel).

- Participants are permitted to participate in another study or trial in addition to
PRO-DIGI

Exclusion Criteria:

- Non conversationaI standard of English

- Unable to provide 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>Matthew Lee, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Sheffied and Sheffield Teaching Hospitals</affiliation>
</overall_official>
<overall_contact>
<last_name>Debby Hawkins, PhD</last_name>
<phone>01142434343</phone>
<email>debby.hawkins@nhs.net</email>
</overall_contact>
<location>
<facility>
<name>Sheffield Teaching Hospitals NHS Foundation Trust</name>
<address>
<city>Sheffield</city>
<state>South Yorkshire</state>
<zip>S5 7AU</zip>
<country>United Kingdom</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Debby Hawkins, PhD</last_name>
<phone>+44 0114 2434343</phone>
<email>debby.hawkins@sth.nhs.uk</email>
</contact>
<investigator>
<last_name>Matthew J Lee, MBChB PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United Kingdom</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>October 7, 2021</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 30, 2022</last_update_submitted>
<last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>PROM</keyword>
<keyword>surgery</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Intestinal Obstruction</mesh_term>
<mesh_term>Intestinal Failure</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>Anonymised transcriptions of phase one interviews will be made available on our institution open access data repository. Other data relates to refinement of the PROM and is not relevant outside of this study.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
People who undergo surgery, or develop intestinal obstruction will spend a period of time
without normal bowel function. This might extend beyond the normal measures of passage of
flatus or tolerance of diet. This study will take a three stage approach to develop a patient
reported outcome measure for gastrointestinal recovery.
Stage 1: Qualitative interviews with 20-40 patients who have undergone major abdominal
surgery, or conservatively managed intestinal obstruction. These interviews will identify key
themes and ideas to develop the questionnaire.
Stage 2: Face validity testing of questionnaire with 20 patients, using the QQ-10
questionnaire to aid assessment. The questionnaire may be edited after this.
Stage 3: 250-500 patients will be asked to complete the questionnaire following surgery or
treatment for intestinal obstruction. Basic demographics will also be collated. Item
reduction and scale refinement will be undertaken using this dataset. This will provide a
PROM of gastrointestinal recovery which is ready for validation.
Gastrointestinal dysfunction is commonly seen after surgery, and also manifests itself in
intestinal obstruction. During this time, the patient may experience a range of symptoms of
acute intestinal failure, including loss of motility and absorption. These may resolve at
different rates during the period of gastrointestinal recovery. Trials in the area have
conflicting results, partly due to the selection of clinician reported unidimensional
outcomes. There is a clear need for a patient reported outcome measure (PROM) to record
gastrointestinal recovery.
Aims and Objectives
- To develop a PROM for gastrointestinal recovery.
- To identify a candidate long-list of items for inclusion in a PROM through
semi-structured patient interviews, and test face validity with patients and an expert
panel
- To develop a PROM using the approved long list
Methods This study will be conducted in three stages with reference to FDA (Food and Drug
Administration) and ISOQoL (International Society for Quality of Life Research) guidelines.
Stage 1: Five centres will undertake purposive sampling to identify patients who have
undergone major intraabdominal surgery (including gastrointestinal, urological, and
gynaecological) and patients treated for intestinal obstruction. It is expected that 40-60
participants will undergo a semi-structured interview to identify important items related to
recovery of gastrointestinal function in order to reach thematic saturation. Interviews will
be transcribed and coded using a framework methodology. This will generate allow us to
construct a prototype questionnaire with an initial pool of items.
Stage 2: The prototype questionnaire will be shown to a group of international experts in
gastrointestinal recovery for assessment of face validity, using the QQ-10 (Questionnaire
quality-10 item) questionnaire. This will then be tested with 20 patients treated for
eligible conditions at five participating centres using the QQ-10.
Stage 3: Upto 500 participants (depending on number of items on the questionnaire) will be
recruited from 10 centres which offer gastrointestinal, urological, and gynaecological
surgery. Participants will rate items on a Likert scale. Items will undergo factor analysis
to reduce the number of items. This will present a shorter questionnaire with finalised
scales.
Adult patients undergoing major abdominal surgery for gastrointestinal, urological, or
gynaecological indications OR patients being treated for intestinal obstruction regardelss
of aetiology.
Inclusion Criteria:
Adult patients (aged 18+) admitted to hospital for one of the following reasons will be
eligible to participate:
- Undergoing major elective gastrointestinal surgery (e.g. colorectal resection, gastric
resection, liver or pancreatic resection)
- Emergency laparotomy for non-trauma indication
- Patients undergoing intra-abdominal surgery for non-gastrointestinal indications
e.g.cystoprostatectomy, prostatectomy, nephrectomy, hysterectomy, or oophorectomy.
- With a diagnosis of intestinal obstruction (small or large bowel).
- Participants are permitted to participate in another study or trial in addition to
PRO-DIGI
Exclusion Criteria:
- Non conversationaI standard of English
- Unable to provide informed consent
|
NCT0531xxxx/NCT05315778.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/NCT05315778</url>
</required_header>
<id_info>
<org_study_id>BCRITP</org_study_id>
<nct_id>NCT05315778</nct_id>
</id_info>
<brief_title>Anti-BCMA CAR T-Cell Therapy for R/R ITP</brief_title>
<official_title>Anti-BCMA CAR T-Cell Therapy for Relapsed/Refractory Immune Thrombocytopenia</official_title>
<sponsors>
<lead_sponsor>
<agency>The First Affiliated Hospital of Soochow University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>The First Affiliated Hospital of Soochow 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 is a prospective, single-center, open-label, single-arm study, to evaluate the efficacy
and safety of Anti-BCMA chimeric antigen receptor T cell therapy（BCMA CAR-T）for patients with
relapse/refractory Immune thrombocytopenia(R/R ITP).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Immune thrombocytopenia (ITP) is a disorder that can lead to easy or excessive bruising and
bleeding. Approximately two-thirds of patients achieve remission after/during first-line
therapies. However, the other part of patients could not achieve durable remission or even
refractory to initial treatments. Those cases, known as relapse/refractory Immune
thrombocytopenia (R/R ITP), undergo the heavy burden of disease which decreases the quality
of life. Lots of pathogeneses take part in the occurrence of R/R ITP, and the most important
one of them is antibody-mediated immune platelet destruction. As far as it is known，human
platelet autoantibodies are mainly secreted by plasma cells, especially long-lived plasma
cells. Researchers want to explore that can BCMA CAR-T help R/R ITP patients increase
platelet count, reduce bleeding episodes and the dose of concomitant medications.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">January 1, 2022</start_date>
<completion_date type="Anticipated">June 30, 2023</completion_date>
<primary_completion_date type="Anticipated">December 31, 2022</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</measure>
<time_frame>6-months</time_frame>
<description>The number of participants who achieved CR (defined as platelet count≥100x10e9/L) and PR (defined as platelet count ≥30x10e9/L and at least a 2-fold increase the baseline count and absence of bleeding) at follow-up.</description>
</primary_outcome>
<secondary_outcome>
<measure>Time to response</measure>
<time_frame>6-months</time_frame>
<description>Time since infusion of CAR T-cells to the time to achieve the response.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of response</measure>
<time_frame>6-months</time_frame>
<description>Period from the achievement of response to the loss of response.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of adverse events</measure>
<time_frame>6-months</time_frame>
<description>Adverse events will be assessed daily during the first 2 weeks after the BCMA CAR-T treatment, and monthly thereafter. Adverse events will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluation of bleeding events</measure>
<time_frame>6-months</time_frame>
<description>Bleeding events will be evaluated according to Bleeding rating system of ITP('Chinese guideline on the diagnosis and management of adult primary immune thrombocytopenia (version 2020)').</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluation of concomitant therapy</measure>
<time_frame>6-months</time_frame>
<description>Duration of discontinuation or dose reduction of concomitant treatment，and the degree of decrease of combined treatment from the baseline in patients.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluation of health-related quality of life</measure>
<time_frame>6-months</time_frame>
<description>Health-related quality of life will be evaluated according to ITP-PAQ (Primary Immune Thrombocytopenia Patient Assessment Questionnaire).</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">5</enrollment>
<condition>ITP</condition>
<arm_group>
<arm_group_label>Anti-BCMA CAR T-cells infusion</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>R/R ITP patients will accept infusion of autologous anti-BCMA CAR T-cells with a total of 1.0-2.0×10e7/Kg. The patients will be follow-up for 6 months post CAR T-cell therapy.</description>
</arm_group>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>autologous anti-BCMA chimeric antigen receptor T cells</intervention_name>
<description>Lymphoadenodepletion chemotherapy with FC (fludarabine 30mg/ m2 for 3 consecutive days and cyclophosphamide 300mg/m2 for 3 consecutive days) will be given at day -5, -4 and -3 before CAR T-cells infusion. A total of 1.0-2.0×10e7/Kg autologous anti-BCMA CAR T-cells will be infused by dose-escalation after the lymphoadenodepletion chemotherapy. Dose of CAR T-cells are allowed to be adjusted according to the severity of cytokine release syndrome.</description>
<arm_group_label>Anti-BCMA CAR T-cells infusion</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Refractory ITP defined according to the recent consensual criteria ( 'Chinese
guideline on the diagnosis and management of adult primary immune thrombocytopenia
(version 2020)'), or relapse ITP defined as ITP patients who have responded to
first-line therapy (glucocorticoids or immunoglobulins) and anti-CD20 monoclonal
antibody, but cannot maintain the response.

- Ages 18-65 years inclusive.

- Adequate venous access for apheresis or venous blood and no other contraindications
for leukocytosis.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

- Subjects should have full capacity for civil conduct, understand necessary
information，sign the informed consent form voluntarily，and have good corporation with
the content of this research protocol.

Exclusion Criteria:

- Secondary ITP.

- Patients with a known history or prior diagnosis of arterial thrombosis (such as
cerebral thrombosis, myocardial infarction, etc.), or comorbidity of venous thrombosis
(such as deep vein thrombosis, pulmonary embolism), or are using
anticoagulant/antiplatelet drug at the beginning of trial.

- Patients with a known history or prior diagnosis of serious cardiovascular disease.

- Patients with uncontrolled infection, organ dysfunction or any uncontrolled active
medical disorder that would preclude participation as outlined.

- Patients with malignancy or history of malignancy.

- Failed T cell expansion test.

- During screening, hemoglobin <100g/L; absolute value of neutrophil count <1.5×10^9/L.

- During screening, serum creatinine concentration > 1.5x the upper limit of the normal
range, total bilirubin > 1.5x the upper limit of the normal range, alanine
aminotransferase and aspartate aminotransferase > 3x the upper limit of the normal
range, Left ventricular ejection fraction ≤ 50% by echocardiography, Pulmonary
function ≥ grade 1 dyspnea (CTCAE v5.0), blood oxygen saturation<91% without oxygen
inhalation.

- Prothrombin time (PT) or prothrombin time-international normalized ratio (PT-INR) or
activated partial thromboplastin time (APTT) exceeding 20% of the normal reference
range; or a history of coagulation abnormalities other than ITP.

- Either HIV antibody or syphilis antibody is positive; hepatitis C antibody is positive
and the detection of HCV-RNA exceeds the laboratory test upper reference limit;
hepatitis B surface antigen is positive and the detection of HBV-DNA exceeds the
laboratory test upper reference limit.

- Participated in other clinical studies within 3 months before this CAR-T cell
infusion.

- Patients is pregnant or breastfeeding, or planning pregnancy.

- Patients is fertile and the investigator determines the case is inappropriate to
participate.

- History of severe drug allergy or known allergy to CAR-T treatment related drugs.

- Suspected or established alcohol, drug or drug abuse.

- The investigator judges that it is not suitable to participate in this trial.
</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>The First Affiliated Hospital of Soochow University</name>
<address>
<city>Suzhou</city>
<state>Jiangsu</state>
<zip>215006</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Xiaowen Tang, Ph.D</last_name>
<phone>86-512677801856</phone>
<email>xwtang1020@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 7, 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 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>CAR-T</keyword>
<keyword>BCMA</keyword>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This is a prospective, single-center, open-label, single-arm study, to evaluate the efficacy
and safety of Anti-BCMA chimeric antigen receptor T cell therapy（BCMA CAR-T）for patients with
relapse/refractory Immune thrombocytopenia(R/R ITP).
Immune thrombocytopenia (ITP) is a disorder that can lead to easy or excessive bruising and
bleeding. Approximately two-thirds of patients achieve remission after/during first-line
therapies. However, the other part of patients could not achieve durable remission or even
refractory to initial treatments. Those cases, known as relapse/refractory Immune
thrombocytopenia (R/R ITP), undergo the heavy burden of disease which decreases the quality
of life. Lots of pathogeneses take part in the occurrence of R/R ITP, and the most important
one of them is antibody-mediated immune platelet destruction. As far as it is known，human
platelet autoantibodies are mainly secreted by plasma cells, especially long-lived plasma
cells. Researchers want to explore that can BCMA CAR-T help R/R ITP patients increase
platelet count, reduce bleeding episodes and the dose of concomitant medications.
Inclusion Criteria:
- Refractory ITP defined according to the recent consensual criteria ( 'Chinese
guideline on the diagnosis and management of adult primary immune thrombocytopenia
(version 2020)'), or relapse ITP defined as ITP patients who have responded to
first-line therapy (glucocorticoids or immunoglobulins) and anti-CD20 monoclonal
antibody, but cannot maintain the response.
- Ages 18-65 years inclusive.
- Adequate venous access for apheresis or venous blood and no other contraindications
for leukocytosis.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Subjects should have full capacity for civil conduct, understand necessary
information，sign the informed consent form voluntarily，and have good corporation with
the content of this research protocol.
Exclusion Criteria:
- Secondary ITP.
- Patients with a known history or prior diagnosis of arterial thrombosis (such as
cerebral thrombosis, myocardial infarction, etc.), or comorbidity of venous thrombosis
(such as deep vein thrombosis, pulmonary embolism), or are using
anticoagulant/antiplatelet drug at the beginning of trial.
- Patients with a known history or prior diagnosis of serious cardiovascular disease.
- Patients with uncontrolled infection, organ dysfunction or any uncontrolled active
medical disorder that would preclude participation as outlined.
- Patients with malignancy or history of malignancy.
- Failed T cell expansion test.
- During screening, hemoglobin <100g/L; absolute value of neutrophil count <1.5×10^9/L.
- During screening, serum creatinine concentration > 1.5x the upper limit of the normal
range, total bilirubin > 1.5x the upper limit of the normal range, alanine
aminotransferase and aspartate aminotransferase > 3x the upper limit of the normal
range, Left ventricular ejection fraction ≤ 50% by echocardiography, Pulmonary
function ≥ grade 1 dyspnea (CTCAE v5.0), blood oxygen saturation<91% without oxygen
inhalation.
- Prothrombin time (PT) or prothrombin time-international normalized ratio (PT-INR) or
activated partial thromboplastin time (APTT) exceeding 20% of the normal reference
range; or a history of coagulation abnormalities other than ITP.
- Either HIV antibody or syphilis antibody is positive; hepatitis C antibody is positive
and the detection of HCV-RNA exceeds the laboratory test upper reference limit;
hepatitis B surface antigen is positive and the detection of HBV-DNA exceeds the
laboratory test upper reference limit.
- Participated in other clinical studies within 3 months before this CAR-T cell
infusion.
- Patients is pregnant or breastfeeding, or planning pregnancy.
- Patients is fertile and the investigator determines the case is inappropriate to
participate.
- History of severe drug allergy or known allergy to CAR-T treatment related drugs.
- Suspected or established alcohol, drug or drug abuse.
- The investigator judges that it is not suitable to participate in this trial.
|
NCT0531xxxx/NCT05315791.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/NCT05315791</url>
</required_header>
<id_info>
<org_study_id>2021-126</org_study_id>
<nct_id>NCT05315791</nct_id>
</id_info>
<brief_title>Clinical Application Strategies of Maxillary Sinus Buccal Bony Window</brief_title>
<official_title>Clinical Application Strategies of Maxillary Sinus Buccal Bony Window With Different Residual Bone Heights in Lateral Maxillary Sinus Floor Elevation</official_title>
<sponsors>
<lead_sponsor>
<agency>The Dental Hospital of Zhejiang University School of Medicine</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>The Dental Hospital of Zhejiang University School of Medicine</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>
Through randomized controlled trials, investigators will recruit participants who need
maxillary sinus floor elevation with different residual bone height, and utilize the
maxillary sinus buccal bony window during the surgery. Then investigators will gather the
related information of participants, collect and analyze their CBCT data, in order to help
surgeons select the best operating method for different patients.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Through randomized controlled trials, investigators will recruit 60 participants who need
maxillary sinus floor elevation with different residual bone height (0~3mm; 3~5mm), and
utilize the maxillary sinus buccal bony window during the surgery (A: ground into pieces; B:
replace the bone; C: turn inward to hold up the membrane). Then investigators will gather the
related information of participants, collect and analyze their CBCT data, in order to help
surgeons select the best operating method for different patients.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 10, 2022</start_date>
<completion_date type="Anticipated">December 31, 2032</completion_date>
<primary_completion_date type="Anticipated">March 2, 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>ABH change</measure>
<time_frame>baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery</time_frame>
<description>Apical bone height (ABH): Represented the grafted height at baseline and the grafted height with neo-formed bone at follow-ups.</description>
</primary_outcome>
<primary_outcome>
<measure>ESBG change</measure>
<time_frame>baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery</time_frame>
<description>Endo-sinus bone gain (ESBG): ESBG = ABH + implant protrusion length at baseline; ESBG represented the grafted height and neo-formed bone, and described the height difference of radiopaque area in the sinus cavity at different times.</description>
</primary_outcome>
<primary_outcome>
<measure>RBH</measure>
<time_frame>baseline</time_frame>
<description>Residual bone height (RBH): Only assessed at baseline</description>
</primary_outcome>
<number_of_arms>6</number_of_arms>
<enrollment type="Anticipated">60</enrollment>
<condition>Sinus Floor Augmentation</condition>
<condition>Maxillary Sinus</condition>
<arm_group>
<arm_group_label>a: ground into pieces</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>0~3mm</description>
</arm_group>
<arm_group>
<arm_group_label>b: replace the bone</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>0~3mm</description>
</arm_group>
<arm_group>
<arm_group_label>c: turn inward</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>0~3mm</description>
</arm_group>
<arm_group>
<arm_group_label>d: ground into pieces</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>3~5mm</description>
</arm_group>
<arm_group>
<arm_group_label>e: replace the bone</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>3~5mm</description>
</arm_group>
<arm_group>
<arm_group_label>f: turn inward</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>3~5mm</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>different methods for maxillary sinus floor elevation</intervention_name>
<description>a: 0~3mm+ground into pieces; b: 0~3mm+replace the bone; c: 0~3mm+turn inward to hold up the membrane; d: 3~5mm+ground into pieces; e: 3~5mm+replace the bone; f: 3~5mm+turn inward to hold up the membrane</description>
<arm_group_label>a: ground into pieces</arm_group_label>
<arm_group_label>b: replace the bone</arm_group_label>
<arm_group_label>c: turn inward</arm_group_label>
<arm_group_label>d: ground into pieces</arm_group_label>
<arm_group_label>e: replace the bone</arm_group_label>
<arm_group_label>f: turn inward</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- A single maxillary posterior tooth was missing, and the missing time was ≥ 3 months

- Gingival distance ≥ 4mm

- Residual bone height ≤ 5mm and residual bone width ≥ 6mm

- Good systemic health

- CBCT image was complete and clear, and there was no obvious artifact affecting the
measurement

- Informed consent.

Exclusion Criteria:

- Untreated diabetes or other serious systemic diseases

- Untreated periodontal disease

- Uncontrolled periapical lesions of adjacent teeth

- Certain bone diseases such as osteoporosis and osteosclerosis

- Severe night bruxism

- Mental illness

- Pregnant or breast-feeding patients.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine</name>
<address>
<city>Hangzhou</city>
<state>Zhejiang</state>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jinxing Hu</last_name>
<phone>18867155632</phone>
<email>jxhu@zju.edu.cn</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<results_reference>
<citation>Starch-Jensen T, Jensen JD. Maxillary Sinus Floor Augmentation: a Review of Selected Treatment Modalities. J Oral Maxillofac Res. 2017 Sep 30;8(3):e3. doi: 10.5037/jomr.2017.8303. eCollection 2017 Jul-Sep.</citation>
<PMID>29142655</PMID>
</results_reference>
<results_reference>
<citation>Niu L, Wang J, Yu H, Qiu L. New classification of maxillary sinus contours and its relation to sinus floor elevation surgery. Clin Implant Dent Relat Res. 2018 Aug;20(4):493-500. doi: 10.1111/cid.12606. Epub 2018 Apr 25.</citation>
<PMID>29691967</PMID>
</results_reference>
<results_reference>
<citation>Zhou Y, Shi Y, Si M, Wu M, Xie Z. The comparative evaluation of transcrestal and lateral sinus floor elevation in sites with residual bone height </=6 mm: A two-year prospective randomized study. Clin Oral Implants Res. 2021 Feb;32(2):180-191. doi: 10.1111/clr.13688. Epub 2020 Dec 26.</citation>
<PMID>33220090</PMID>
</results_reference>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 12, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 30, 2022</last_update_submitted>
<last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>The Dental Hospital of Zhejiang University School of Medicine</investigator_affiliation>
<investigator_full_name>Guoli Yang</investigator_full_name>
<investigator_title>Director</investigator_title>
</responsible_party>
<keyword>maxillary sinus floor elevation</keyword>
<keyword>CBCT</keyword>
<keyword>RCT</keyword>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Through randomized controlled trials, investigators will recruit participants who need
maxillary sinus floor elevation with different residual bone height, and utilize the
maxillary sinus buccal bony window during the surgery. Then investigators will gather the
related information of participants, collect and analyze their CBCT data, in order to help
surgeons select the best operating method for different patients.
Through randomized controlled trials, investigators will recruit 60 participants who need
maxillary sinus floor elevation with different residual bone height (0~3mm; 3~5mm), and
utilize the maxillary sinus buccal bony window during the surgery (A: ground into pieces; B:
replace the bone; C: turn inward to hold up the membrane). Then investigators will gather the
related information of participants, collect and analyze their CBCT data, in order to help
surgeons select the best operating method for different patients.
Inclusion Criteria:
- A single maxillary posterior tooth was missing, and the missing time was ≥ 3 months
- Gingival distance ≥ 4mm
- Residual bone height ≤ 5mm and residual bone width ≥ 6mm
- Good systemic health
- CBCT image was complete and clear, and there was no obvious artifact affecting the
measurement
- Informed consent.
Exclusion Criteria:
- Untreated diabetes or other serious systemic diseases
- Untreated periodontal disease
- Uncontrolled periapical lesions of adjacent teeth
- Certain bone diseases such as osteoporosis and osteosclerosis
- Severe night bruxism
- Mental illness
- Pregnant or breast-feeding patients.
|
NCT0531xxxx/NCT05315804.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/NCT05315804</url>
</required_header>
<id_info>
<org_study_id>477/21</org_study_id>
<nct_id>NCT05315804</nct_id>
</id_info>
<brief_title>Treatment of Intraosseous Periodontal Defects With Amelogenins</brief_title>
<official_title>Treatment of Intraosseous Periodontal Pockets by Non-surgical Therapy With Micro-instruments and Application of Amelogenins. A Randomized-controlled Clinical Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Federico II University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Federico II 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>
The aim of the present investigation will be evaluate the healing of periodontal intraosseous
defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of
amelogenins, compared to MINSD alone.

A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and
randomly divided in two groups: amelogenin (A) and no-amelogenin group (B).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The objective of the study will be compare the healing of periodontal intraosseous defects
following treatment with Minimally Invasive Non Surgical Debridement (MINSD) and application
of amelogenins compared to MINSD alone.

Twenty-two patients with intraosseous periodontal defects will be randomly assigned to
treatment with MINSD and application of amelogenins (A Group) or MINSD alone (B Group).

Primary outcome will be "Clinical Attachment Level" (CAL) gain, while the secondary outcomes
will be "Probing Depth" (PD), "Gingival Recession" (GR) and "Radiographic Defect Angle"
(RDA).

After local anesthesia, in A group MINSD will be performed using an ultrasonic scaler with
fine tips and micro-curette; then, amelogenins in gel will be applied in the intraosseous
periodontal pockets using a sterile syringe with plasticized needle.

In the B group, only subgingival mechanical debridement (MINSD) will be performed with an
ultrasonic scaler with fine tips and micro-curette.

Finally, a polishing paste will be applied to the supra-gingival level in both groups using a
rubber cup. Patients of both groups will be recalled every month for professional oral
hygiene and, after 6 months, all measurements will be repeated and the final evaluation will
be carried out.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">February 1, 2023</start_date>
<completion_date type="Anticipated">January 1, 2024</completion_date>
<primary_completion_date type="Anticipated">October 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>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>The study will be designed as a double-arm randomized controlled clinical trial. The intraosseous defects of subjects allocated in A group will be treated with MINSD and application of amelogenins in gel, while in B Group only MINSD will be performed. The null hypothesis of no statistically significant differences between the two modalities for the treatment of intraosseous defects will be tested.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Participant)</masking>
<masking_description>Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization</masking_description>
</study_design_info>
<primary_outcome>
<measure>Change of Clinical Attachment Level (CAL) gain (millimeters)</measure>
<time_frame>baseline and 6 months after periodontal therapy</time_frame>
<description>Distance from the cementoenamel junction to the bottom of the pocket</description>
</primary_outcome>
<secondary_outcome>
<measure>Change of Probing Depth (PD) (millimeters)</measure>
<time_frame>baseline and 6 months after periodontal therapy</time_frame>
<description>Distance from the gingival margin to the bottom of the pocket</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of Gingival Recession (GR) (millimeters)</measure>
<time_frame>baseline and 6 months after periodontal therapy</time_frame>
<description>Distance from gingival margin to the cementoenamel junction</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of Radiographic Defect Angle (RDA) (grade °)</measure>
<time_frame>baseline and 6 months after periodontal therapy</time_frame>
<description>Radiographic intraosseous angle</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">22</enrollment>
<condition>Periodontal Bone Loss</condition>
<condition>Periodontal Pocket</condition>
<arm_group>
<arm_group_label>Amelogenin Group (A)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Amelogenins in gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD)</description>
</arm_group>
<arm_group>
<arm_group_label>No-amelogenin Group (B)</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>MINSD and amelogenins</intervention_name>
<description>After local anesthesia, MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied to the intraosseous periodontal pockets using a sterile syringe with plasticized needle.</description>
<arm_group_label>Amelogenin Group (A)</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>MINSD</intervention_name>
<description>Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.</description>
<arm_group_label>No-amelogenin Group (B)</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Patients diagnosed with periodontitis;

- Age ≥ 18 years old;

- Presence of at least 10 teeth per arch;

- Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant;

- Presence of at least one intraosseous pocket;

- Single-rooted and multi-rooted teeth.

Exclusion Criteria:

- Patients with systemic diseases;

- Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to
periodontal therapy;

- Pregnant or lactating;

- Tobacco smokers (≥ 10 cigarettes per day);

- Multi-rooted teeth with furcation involvement;

- Third molars.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Luca Ramaglia</last_name>
<role>Principal Investigator</role>
<affiliation>Federico II University</affiliation>
</overall_official>
<overall_contact>
<last_name>Luca Ramaglia</last_name>
<phone>+393476912911</phone>
<email>luca.ramaglia@unina.it</email>
</overall_contact>
<location>
<facility>
<name>University of Naples Federico II</name>
<address>
<city>Naples</city>
<zip>80131</zip>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Luca Ramaglia</last_name>
<phone>+393476912911</phone>
<email>luca.ramaglia@unina.it</email>
</contact>
</location>
<location_countries>
<country>Italy</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>February 14, 2023</last_update_submitted>
<last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 15, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Federico II University</investigator_affiliation>
<investigator_full_name>Luca Ramaglia</investigator_full_name>
<investigator_title>Clinical Professor</investigator_title>
</responsible_party>
<keyword>Amelogenin</keyword>
<keyword>Periodontal Therapy</keyword>
<keyword>Periodontal Bone Loss</keyword>
<keyword>Intraosseous Bone Defect</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Alveolar Bone Loss</mesh_term>
<mesh_term>Periodontal Pocket</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 the present investigation will be evaluate the healing of periodontal intraosseous
defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of
amelogenins, compared to MINSD alone.
A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and
randomly divided in two groups: amelogenin (A) and no-amelogenin group (B).
The objective of the study will be compare the healing of periodontal intraosseous defects
following treatment with Minimally Invasive Non Surgical Debridement (MINSD) and application
of amelogenins compared to MINSD alone.
Twenty-two patients with intraosseous periodontal defects will be randomly assigned to
treatment with MINSD and application of amelogenins (A Group) or MINSD alone (B Group).
Primary outcome will be "Clinical Attachment Level" (CAL) gain, while the secondary outcomes
will be "Probing Depth" (PD), "Gingival Recession" (GR) and "Radiographic Defect Angle"
(RDA).
After local anesthesia, in A group MINSD will be performed using an ultrasonic scaler with
fine tips and micro-curette; then, amelogenins in gel will be applied in the intraosseous
periodontal pockets using a sterile syringe with plasticized needle.
In the B group, only subgingival mechanical debridement (MINSD) will be performed with an
ultrasonic scaler with fine tips and micro-curette.
Finally, a polishing paste will be applied to the supra-gingival level in both groups using a
rubber cup. Patients of both groups will be recalled every month for professional oral
hygiene and, after 6 months, all measurements will be repeated and the final evaluation will
be carried out.
Inclusion Criteria:
- Patients diagnosed with periodontitis;
- Age ≥ 18 years old;
- Presence of at least 10 teeth per arch;
- Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant;
- Presence of at least one intraosseous pocket;
- Single-rooted and multi-rooted teeth.
Exclusion Criteria:
- Patients with systemic diseases;
- Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to
periodontal therapy;
- Pregnant or lactating;
- Tobacco smokers (≥ 10 cigarettes per day);
- Multi-rooted teeth with furcation involvement;
- Third molars.
|
NCT0531xxxx/NCT05315817.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/NCT05315817</url>
</required_header>
<id_info>
<org_study_id>CRRT-CVVHD(F)/MP-01-D</org_study_id>
<nct_id>NCT05315817</nct_id>
</id_info>
<brief_title>Safety and Performance Evaluation of multiPlus Dialysate During CRRT</brief_title>
<acronym>multiPlus</acronym>
<official_title>Safety and Performance Evaluation of multiPlus Dialysate During CRRT</official_title>
<sponsors>
<lead_sponsor>
<agency>Fresenius Medical Care Deutschland GmbH</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
<collaborator>
<agency>Winicker Norimed GmbH</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>Fresenius Medical Care Deutschland GmbH</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>
Assessment of the performance of multiPlus dialysate based on the serum creatinine removal 6
hours (360 min) after start of continuous veno-venous haemodialysis/ haemodiafiltration
[CVVHD(F)].

multiPlus is a phosphate-containing dialysis solution for the use in continuous renal
replacement therapy (CRRT) during acute kidney injury (AKI).
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">July 27, 2022</start_date>
<completion_date type="Anticipated">December 2022</completion_date>
<primary_completion_date type="Anticipated">December 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>
<intervention_model_description>Prospective, non-comparative, multi-centre, open-label, interventional, post market clinical follow-up (PMCF) study</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Serum creatinine removal</measure>
<time_frame>360 min after start</time_frame>
<description>The primary variable of this clinical investigation is serum creatinine removal (arterial pre-filter sample taking) assessed 6 hours (360 min) after start of CVVHD(F).</description>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">40</enrollment>
<condition>Acute Kidney Injury</condition>
<arm_group>
<arm_group_label>multiPlus dialysate</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>multiPlus dialysate</intervention_name>
<description>Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate.</description>
<arm_group_label>multiPlus dialysate</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Signed and dated informed consent form by investigator and by

- a) the study patient: if patient is able to consent

- b) the legal representative: if patient is unable to consent:

- c) an independent consultant: in case of emergency

- if c) either legal representative or study patient, whichever can be done sooner,
should be informed by the investigator as soon as possible. If the informed consent
has been obtained by the legal representative (b or emergency scenario) informed
consent to continue the participation in the clinical investigation shall be obtained
from the subject as soon as he or she is capable of giving informed consent (According
to the MDR - Article 68 - Clinical investigations in emergency situations)

- Minimum age of 18 years

- Ability to understand the nature and requirements of the study (if patient is
conscious)

Study specific:

- Body weight greater than 40 kg

- Acute Kidney Injury (AKI) with clinical indication for CVVHD/CVVHDF

- Vascular access allowing blood flow of min 50mL/min

- Estimated life expectancy greater than 3 days

Exclusion Criteria:

- Any conditions which could interfere with the patient's ability to comply with the
study

- In case of female patients: pregnancy (negative pregnancy test for women below 55
years) or lactation period

- Participation in an interventional clinical study during the preceding 30 days

- Previous participation in the same study

- SARS-CoV 2 positive

Study specific

- Hyperphosphataemia (>4.5 mg/dL)

- Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT
Type II)

- Uncontrolled bleeding and coagulation disorders

- Decision to limit therapeutic interventions

- Advanced malignancy (not including myeloma)

- Dementia (if definitely not an acute confusional state from uraemia or other acute
illness)

- Advanced cirrhosis with encephalopathy in the absence of possible liver
transplantation
</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>Michael A. Borger, Prof Dr</last_name>
<role>Principal Investigator</role>
<affiliation>Helios Health Institute GmbH</affiliation>
</overall_official>
<overall_contact>
<last_name>Manuela Stauss-Grabo, Dr</last_name>
<phone>+4961726085248</phone>
<email>Manuela.Stauss-Grabo@fmc-ag.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Christoph Schwarzkopf</last_name>
<phone>+49 6172 608 945 62</phone>
<email>Christoph.schwarzkopf@fmc-ag.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Leipzig Heart Institute GmbH</name>
<address>
<city>Leipzig</city>
<state>Sachsen</state>
<zip>04289</zip>
<country>Germany</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Michael A. Borger, Prof Dr</last_name>
<phone>+49 341 865 1421</phone>
<email>michael.borger@helios-gesundheit.de</email>
</contact>
</location>
<location_countries>
<country>Germany</country>
</location_countries>
<verification_date>July 2022</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>August 1, 2022</last_update_submitted>
<last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">August 2, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Renal replacement therapy</keyword>
<keyword>Acute kidney injury</keyword>
<keyword>Haemodialysis</keyword>
<keyword>Haemodiafiltration</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Acute Kidney Injury</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Dialysis 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>
|
Assessment of the performance of multiPlus dialysate based on the serum creatinine removal 6
hours (360 min) after start of continuous veno-venous haemodialysis/ haemodiafiltration
[CVVHD(F)].
multiPlus is a phosphate-containing dialysis solution for the use in continuous renal
replacement therapy (CRRT) during acute kidney injury (AKI).
Inclusion Criteria:
- Signed and dated informed consent form by investigator and by
- a) the study patient: if patient is able to consent
- b) the legal representative: if patient is unable to consent:
- c) an independent consultant: in case of emergency
- if c) either legal representative or study patient, whichever can be done sooner,
should be informed by the investigator as soon as possible. If the informed consent
has been obtained by the legal representative (b or emergency scenario) informed
consent to continue the participation in the clinical investigation shall be obtained
from the subject as soon as he or she is capable of giving informed consent (According
to the MDR - Article 68 - Clinical investigations in emergency situations)
- Minimum age of 18 years
- Ability to understand the nature and requirements of the study (if patient is
conscious)
Study specific:
- Body weight greater than 40 kg
- Acute Kidney Injury (AKI) with clinical indication for CVVHD/CVVHDF
- Vascular access allowing blood flow of min 50mL/min
- Estimated life expectancy greater than 3 days
Exclusion Criteria:
- Any conditions which could interfere with the patient's ability to comply with the
study
- In case of female patients: pregnancy (negative pregnancy test for women below 55
years) or lactation period
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
- SARS-CoV 2 positive
Study specific
- Hyperphosphataemia (>4.5 mg/dL)
- Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT
Type II)
- Uncontrolled bleeding and coagulation disorders
- Decision to limit therapeutic interventions
- Advanced malignancy (not including myeloma)
- Dementia (if definitely not an acute confusional state from uraemia or other acute
illness)
- Advanced cirrhosis with encephalopathy in the absence of possible liver
transplantation
|
NCT0531xxxx/NCT05315830.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/NCT05315830</url>
</required_header>
<id_info>
<org_study_id>LWY22003CBY</org_study_id>
<nct_id>NCT05315830</nct_id>
</id_info>
<brief_title>A Study of HER2 Tumor Vaccine in Patients With Her-2 Positive Gastric/GEJ Adenocarcinoma Esophagogastric</brief_title>
<official_title>A Single-Arm, Open-Label, Exploratory Study to Evaluate the Safety of HER2 Tumor Vaccine Injection Alone/in Combination With Standard of Care Chemotherapy in Patients With her2/Neu Overexpressing Metastatic or Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction</official_title>
<sponsors>
<lead_sponsor>
<agency>First Affiliated Hospital Bengbu Medical College</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>First Affiliated Hospital Bengbu Medical College</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 is a single-arm, open-label, clinical study to evaluate the safety of HER2 tumor vaccine
injection alone/in combination with standard of care chemotherapy in patients with HER2/neu
overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The
immunoreactivity, pharmacokinetics and of HER2 tumor vaccine.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 7, 2022</start_date>
<completion_date type="Anticipated">March 1, 2024</completion_date>
<primary_completion_date type="Anticipated">March 1, 2023</primary_completion_date>
<phase>Phase 1</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>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Incidence of adverse events</measure>
<time_frame>Up to 6 months</time_frame>
<description>Graded according to the NCI CTCAE version 5.0.</description>
</primary_outcome>
<secondary_outcome>
<measure>To evaluate the antitumor activity</measure>
<time_frame>Up to 2 years</time_frame>
<description>To assess per RECIST and iRECIST</description>
</secondary_outcome>
<secondary_outcome>
<measure>Humoral and cellular immunogenicity of HER2 Tumor Vaccine</measure>
<time_frame>Up to 6 months</time_frame>
<description>Values and changes from randomization in humoral and cellular immunogenicity data including P467-specific antibodies (IgG), Her-2-specific antibodies (IgG), vaccine-specific cytokine levels and regulatory and effector T and B cells.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">10</enrollment>
<condition>Adenocarcinoma - GEJ</condition>
<condition>Adenocarcinoma of the Stomach</condition>
<arm_group>
<arm_group_label>HER2 Vaccine alone</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>0.6 μg HER2 Vaccine</description>
</arm_group>
<arm_group>
<arm_group_label>HER2 Vaccine plus Standard of Care Chemotherapy</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>0.6 μg HER2 Vaccine plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine or other Standard of Care Chemotherapy</description>
</arm_group>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>HER2 Tumor Vaccine</intervention_name>
<description>B-cell epitope vaccine HER2 Tumor Vaccine 0.6 μg，Intramuscular injection on D1, D14 and D28</description>
<arm_group_label>HER2 Vaccine alone</arm_group_label>
</intervention>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>HER2 Tumor Vaccine+ Standard of Care chemotherapy</intervention_name>
<description>B-cell epitope vaccine HER2 Tumor Vaccine 0.6 μg，Intramuscular injection on D1, D14 and D28 Standard of Care Chemotherapy cisplatin by intravenous administration at 80 mg/m2 on the first day of each cycle and either 5-FU, 4000 mg/m2 CIV (administered as 1000 mg/m2/day as continuous infusion for 96 hours on days 1 to 4 of each cycle) or capecitabine for 14 days at 2000 mg/m2/day, orally (administered as 1000 mg/m2 twice daily morning and evening for a total of 2000 mg/m2/day on days 1 to 14 of each cycle) or other standard of care chemotherapy</description>
<arm_group_label>HER2 Vaccine plus Standard of Care Chemotherapy</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Male or female aged ≥ 18 years;

- Metastatic gastric or GEJ adenocarcinoma, or locally advanced disease not amenable to
surgical resection;

- HER2/neu overexpression (3+ by immunohistochemistry (IHC) or if IHC 2+ confirmed by
fluorescent in situ hybridization [FISH];

- ECOG score of 0 ~ 2;

- Adequate bone marrow, hepatic and renal and coagulation function;

- Women of childbearing age who have a negative pregnancy test within 7 days before
treatment. Female patients of childbearing age, and male patients with partners of
childbearing age must agree to use at least one medically recognized contraceptive
method during study treatment and within at least 6 months after the last dose of
investigational drug;

- Voluntarily participated in this study, signed the informed；

Exclusion Criteria:

- Continuous systemic treatment with either corticosteroids (>10 mg daily prednisone
equivalents) or other immunosuppressive medications within 4 weeks prior to first dose
of study treatment. Inhaled or topical steroids and physiological replacement doses of
up to 10 mg daily prednisone equivalents are permitted in the absence of active
auto-immune disease；

- Subjects who have had major surgery within 4 weeks before HER2 tumor vaccine
administration

- Subjects who have received anti-tumor therapy such as chemotherapy, radiotherapy,
biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc within 5
elimination half-life prior first dose of HER2 tumor vaccine treatment;

- Subjects with known brain metastasis and/or clinically history tumor brain of
metastasis；

- Patients with uncontrollable pleural effusion, abdominal effusion and pericardial
effusion;

- Active infection requiring treatment. HIV, HCV, syphilis, CMV, EBV infected patients;
Patients with active HBV replication

- Other conditions that the investigator assessed as ineligible for inclusion.
</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>Zishu Wang, MD</last_name>
<role>Principal Investigator</role>
<affiliation>First Affiliated Hospital Bengbu Medical College</affiliation>
</overall_official>
<overall_contact>
<last_name>Huan Zhou, MD</last_name>
<phone>+86 13665527160</phone>
<email>zhouhuanbest@163.com</email>
</overall_contact>
<location>
<facility>
<name>First Affiliated Hospital Bengbu Medical College</name>
<address>
<city>Bengbu</city>
<state>Anhui</state>
<zip>233030</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Huan Zhou</last_name>
<phone>13665527160</phone>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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 14, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>First Affiliated Hospital Bengbu Medical College</investigator_affiliation>
<investigator_full_name>Wang Zishu</investigator_full_name>
<investigator_title>MD，Head of Oncology Department, Principal Investigator</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Adenocarcinoma</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Vaccines</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This is a single-arm, open-label, clinical study to evaluate the safety of HER2 tumor vaccine
injection alone/in combination with standard of care chemotherapy in patients with HER2/neu
overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The
immunoreactivity, pharmacokinetics and of HER2 tumor vaccine.
Inclusion Criteria:
- Male or female aged ≥ 18 years;
- Metastatic gastric or GEJ adenocarcinoma, or locally advanced disease not amenable to
surgical resection;
- HER2/neu overexpression (3+ by immunohistochemistry (IHC) or if IHC 2+ confirmed by
fluorescent in situ hybridization [FISH];
- ECOG score of 0 ~ 2;
- Adequate bone marrow, hepatic and renal and coagulation function;
- Women of childbearing age who have a negative pregnancy test within 7 days before
treatment. Female patients of childbearing age, and male patients with partners of
childbearing age must agree to use at least one medically recognized contraceptive
method during study treatment and within at least 6 months after the last dose of
investigational drug;
- Voluntarily participated in this study, signed the informed；
Exclusion Criteria:
- Continuous systemic treatment with either corticosteroids (>10 mg daily prednisone
equivalents) or other immunosuppressive medications within 4 weeks prior to first dose
of study treatment. Inhaled or topical steroids and physiological replacement doses of
up to 10 mg daily prednisone equivalents are permitted in the absence of active
auto-immune disease；
- Subjects who have had major surgery within 4 weeks before HER2 tumor vaccine
administration
- Subjects who have received anti-tumor therapy such as chemotherapy, radiotherapy,
biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc within 5
elimination half-life prior first dose of HER2 tumor vaccine treatment;
- Subjects with known brain metastasis and/or clinically history tumor brain of
metastasis；
- Patients with uncontrollable pleural effusion, abdominal effusion and pericardial
effusion;
- Active infection requiring treatment. HIV, HCV, syphilis, CMV, EBV infected patients;
Patients with active HBV replication
- Other conditions that the investigator assessed as ineligible for inclusion.
|
NCT0531xxxx/NCT05315843.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/NCT05315843</url>
</required_header>
<id_info>
<org_study_id>Cbl_Neo</org_study_id>
<nct_id>NCT05315843</nct_id>
</id_info>
<brief_title>Cobalamin Supply and Metabolism in Healthy Children From Birth to the Age of 12 Months and in Their Mothers (Cbl_Neo)</brief_title>
<acronym>Cbl_Neo</acronym>
<official_title>Cobalamin Supply and Metabolism in Healthy Children From Birth to the Age of 12 Months and in Their Mothers (Cbl_Neo)</official_title>
<sponsors>
<lead_sponsor>
<agency>University Children's Hospital, Zurich</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University Children's Hospital, Zurich</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: Infants with severe vitamin B12 (cobalamin, Cbl) deficiency can develop severe,
sometimes irreparable neurological damage in the first months of life. Neonatal Cbl
deficiency is usually secondary and due to low maternal Cbl stores, e.g. in vegan diets or
pernicious anaemia. This Cbl deficiency is then often also found in breast milk. In the
Austrian newborn screening (NBS) for congenital diseases of the Cbl metabolism, newborns with
secondary Cbl deficiency are also frequently discovered. For these, the risk-benefit
assessment of the invasive work-up and treatment that follows is complex. Little is known
about how Cbl levels in maternal blood relate to those in breast milk and the corresponding
levels in the child.

Objective: To investigate the effects of maternal nutrition and maternal Cbl status on
neonatal Cbl levels. In the breastfeeding period, the effects of maternal nutrition on breast
milk and infant Cbl status will be investigated, as well as their relationship to the
maternal and infant microbiome. We hypothesise that adequate Cbl supply in early life is not
determined by diet alone, but also by the interactions between diet and microbiome.

Design and methods: Prospective cohort studies of 100 women and their children with
measurement of Cbl, methylmalonic acid, homocysteine and other metabolites of Cbl metabolism
in umbilical cord blood, maternal blood, dried blood spots and urine from the child at birth.
The same parameters are measured in the mother's blood and breast milk after 3 and 9 months;
in the child, only measurements of methylmalonic acid in the urine are carried out. A 3-day
dietary record is taken from the mother at all measurement times, and from the child at the
measurement times of 3 and 9 months. Stool is collected from mother and child at all
measurement time points to examine the microbiome relevant to Cbl metabolism. A child
development interview will be conducted with mothers by telephone at 12 months of age of
their child.

Schedule: The study lasts 2 years with pre- and post-processing. The LKH Bregenz has about
1200 births per year. Assuming a willingness to participate in the study and an enrolment
rate of about 20% of the women, a recruitment period of 6 months is planned (enrolment of
first participant day 1, last participant end of study month 6; last laboratory parameter
measurement end of study month 15; last child development interview study month 18).
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">November 7, 2022</start_date>
<completion_date type="Anticipated">September 2024</completion_date>
<primary_completion_date type="Anticipated">November 2023</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>Homocysteine</measure>
<time_frame>9 months</time_frame>
<description>Plasma total Homocysteine higher in B12 deficient children</description>
</primary_outcome>
<enrollment type="Anticipated">200</enrollment>
<condition>Vitamin B 12 Deficiency</condition>
<eligibility>
<study_pop>
<textblock>
Pregnant females and their children
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Pregnant women

- their newborns

Exclusion Criteria:

- children: preterm birth

- children: neonatal disease

- women: disease around birth

- women: multiples pregnancy
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Martina Huemer, Prof</last_name>
<phone>0043 5574 4010</phone>
<email>martina.huemer@lkhb.at</email>
</overall_contact>
<location>
<facility>
<name>LKH Bregenz</name>
<address>
<city>Bregenz</city>
<zip>6900</zip>
<country>Austria</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Martina Huemer, MD</last_name>
</contact>
</location>
<location>
<facility>
<name>University Childrens Hospital Freiburg</name>
<address>
<city>Freiburg</city>
<country>Germany</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Luciana Hannibal</last_name>
</contact>
</location>
<location_countries>
<country>Austria</country>
<country>Germany</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 7, 2022</study_first_posted>
<last_update_submitted>November 9, 2022</last_update_submitted>
<last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">November 10, 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>Vitamin B 12 Deficiency</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: Infants with severe vitamin B12 (cobalamin, Cbl) deficiency can develop severe,
sometimes irreparable neurological damage in the first months of life. Neonatal Cbl
deficiency is usually secondary and due to low maternal Cbl stores, e.g. in vegan diets or
pernicious anaemia. This Cbl deficiency is then often also found in breast milk. In the
Austrian newborn screening (NBS) for congenital diseases of the Cbl metabolism, newborns with
secondary Cbl deficiency are also frequently discovered. For these, the risk-benefit
assessment of the invasive work-up and treatment that follows is complex. Little is known
about how Cbl levels in maternal blood relate to those in breast milk and the corresponding
levels in the child.
Objective: To investigate the effects of maternal nutrition and maternal Cbl status on
neonatal Cbl levels. In the breastfeeding period, the effects of maternal nutrition on breast
milk and infant Cbl status will be investigated, as well as their relationship to the
maternal and infant microbiome. We hypothesise that adequate Cbl supply in early life is not
determined by diet alone, but also by the interactions between diet and microbiome.
Design and methods: Prospective cohort studies of 100 women and their children with
measurement of Cbl, methylmalonic acid, homocysteine and other metabolites of Cbl metabolism
in umbilical cord blood, maternal blood, dried blood spots and urine from the child at birth.
The same parameters are measured in the mother's blood and breast milk after 3 and 9 months;
in the child, only measurements of methylmalonic acid in the urine are carried out. A 3-day
dietary record is taken from the mother at all measurement times, and from the child at the
measurement times of 3 and 9 months. Stool is collected from mother and child at all
measurement time points to examine the microbiome relevant to Cbl metabolism. A child
development interview will be conducted with mothers by telephone at 12 months of age of
their child.
Schedule: The study lasts 2 years with pre- and post-processing. The LKH Bregenz has about
1200 births per year. Assuming a willingness to participate in the study and an enrolment
rate of about 20% of the women, a recruitment period of 6 months is planned (enrolment of
first participant day 1, last participant end of study month 6; last laboratory parameter
measurement end of study month 15; last child development interview study month 18).
Pregnant females and their children
Inclusion Criteria:
- Pregnant women
- their newborns
Exclusion Criteria:
- children: preterm birth
- children: neonatal disease
- women: disease around birth
- women: multiples pregnancy
|
NCT0531xxxx/NCT05315856.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/NCT05315856</url>
</required_header>
<id_info>
<org_study_id>2021GR0099</org_study_id>
<nct_id>NCT05315856</nct_id>
</id_info>
<brief_title>Reactogenicity, Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms</brief_title>
<official_title>Different Significance of Reactogenicity in Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms: BNT162b2 mRNA Versus ChAdOx1 nCoV19 Vaccine</official_title>
<sponsors>
<lead_sponsor>
<agency>Korea University Guro Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Ajou University School of Medicine</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hallym University Kangnam Sacred Heart Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Korean Center for Disease Control and Prevention</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Korea University Guro 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>
<is_us_export>Yes</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
Analysis of humoral antibody and cytokine kinetics after vaccination with either BNT162b2 or
ChAdOx1 nCoV-19 vaccine and factors influencing the vaccine immunogenicity
</textblock>
</brief_summary>
<detailed_description>
<textblock>
There is a different aspect of reactogenicity between BNT162b2 and ChAdOx1 nCoV-19 vaccine.
Both new platform vaccines were concerned if they would elicit more significant local or
systemic reactogenicity compared to the conventional vaccines. Previous studies had reported
that immune cells such as mast cells and macrophages are activated just after vaccination,
and release proinflammatory cytokines such as interleukin (IL)-6 and tumor necrosis factor
(TNF)-α. The post-vaccination kinetics of inflammatory cytokines would be variable by each
vaccine platform, and might be associated with reactogenicity. It is an interesting issue to
be investigated whether the reactogenicity following newly developed BNT162b2 and ChAdOx1
would be associated with immunogenicity and inflammatory response or not. To better clarify
these uncertainties, we evaluated the change of antibody response between BNT162b2 and
ChAdOx1 over three months post-vaccination, in relation to the kinetics of inflammatory
cytokines and reactogenicity.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 1, 2021</start_date>
<completion_date type="Anticipated">December 31, 2022</completion_date>
<primary_completion_date type="Anticipated">May 31, 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>Prospective</time_perspective>
</study_design_info>
<target_duration>24 Months</target_duration>
<primary_outcome>
<measure>Immunoglobulin G (IgG) anti-S antibodies</measure>
<time_frame>At 3 weeks after the first-dose vaccination (T1)</time_frame>
<description>measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)</description>
</primary_outcome>
<primary_outcome>
<measure>Immunoglobulin G (IgG) anti-S antibodies</measure>
<time_frame>At 3 weeks after the second-dose vaccination (T2)</time_frame>
<description>measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)</description>
</primary_outcome>
<primary_outcome>
<measure>Neutralizing antibodies</measure>
<time_frame>At 3 weeks after the first-dose vaccination (T1)</time_frame>
<description>Reduction in plaque count of 50% (PRNT50) was calculated for the median neutralizing titer (ND50) using the Spearman-Karber formula</description>
</primary_outcome>
<primary_outcome>
<measure>Neutralizing antibodies</measure>
<time_frame>At 3 weeks after the second-dose vaccination (T2)</time_frame>
<description>Reduction in plaque count of 50% (PRNT50) was calculated for the median neutralizing titer (ND50) using the Spearman-Karber formula</description>
</primary_outcome>
<primary_outcome>
<measure>IL-6, TNF-α, and IL-1ß</measure>
<time_frame>At 3 days after the first dose</time_frame>
<description>measured by flexible customized bead-based multiplex panels for Luminex assays (Human Premixed Multi-Analyte Kit, R&D Systems Inc., Minneapolis, MN, USA).</description>
</primary_outcome>
<primary_outcome>
<measure>IL-6, TNF-α, and IL-1ß</measure>
<time_frame>At 3 days after the second-dose</time_frame>
<description>measured by flexible customized bead-based multiplex panels for Luminex assays (Human Premixed Multi-Analyte Kit, R&D Systems Inc., Minneapolis, MN, USA).</description>
</primary_outcome>
<primary_outcome>
<measure>reactogenicity after vaccination</measure>
<time_frame>Until post-vaccination day 7</time_frame>
<description>Local erythema/swelling was regarded as positive sign if larger than 2.5 cm in diameter. Systemic adverse events were graded as follows: grade 0, no systemic adverse event; grade 1, any adverse event that did not interfere with activity; grade 2, any adverse event that interfered with daily activity. Fever was classified as grade 1 (from 37.5℃ to 38.4℃) and grade 2 (>38.5℃). Systemic adverse events were classified into two ways: (i) the highest level of severity of any adverse event reported by the participants and (ii) with or without specific adverse event.</description>
</primary_outcome>
<secondary_outcome>
<measure>The correlation between humoral immune response and reactogenicity after vaccination</measure>
<time_frame>The correlation between reactogenicity after the first dose and immunogenicity at T1 (3 weeks after dose 1 prior to dose 2) and T2 (3 weeks after dose 2);the correlation between reactogenicity after vaccine dose 2 and immunogenicity at T2</time_frame>
<description>The correlation between humoral immune response and reactogenicity after vaccination</description>
</secondary_outcome>
<secondary_outcome>
<measure>The correlation between cytokine response and reactogenicity after vaccination</measure>
<time_frame>At 3 days after each dose</time_frame>
<description>The correlation between cytokine response and reactogenicity after vaccination</description>
</secondary_outcome>
<secondary_outcome>
<measure>Long-term immunogenicity: Immunoglobulin G (IgG) anti-S antibodies</measure>
<time_frame>At 3 months after the second vaccination (T3)</time_frame>
<description>measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">120</enrollment>
<condition>COVID-19 Vaccination</condition>
<condition>Inflammation</condition>
<condition>Vaccine Immune Response</condition>
<condition>Vaccine Adverse Reaction</condition>
<arm_group>
<arm_group_label>ChAdOx1 vaccine group</arm_group_label>
<description>AstraZeneca vaccine (chimpanzee adenovirus-vectored vaccine, 0.5 mL [5 × 1010 viral particles] per dose)</description>
</arm_group>
<arm_group>
<arm_group_label>BNT162b2 vaccine group</arm_group_label>
<description>Pfizer-BioNTech vaccine (mRNA vaccine; 0.3 mL [30 μg] per dose)</description>
</arm_group>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>either BNT162b2 or ChAdOx1 vaccine</intervention_name>
<description>Either BNT162b2 or ChAdOx1 was assigned to each participant by the Korean governmental policy, not allowing personal choice. Sixty participants were vaccinated with two doses of the ChAdOx1 (AstraZeneca) at 12-week intervals, and the remaining sixty were immunized with the BNT162b2 (Pfizer-BioNTech) vaccine at 3-week interval.</description>
<arm_group_label>BNT162b2 vaccine group</arm_group_label>
<arm_group_label>ChAdOx1 vaccine group</arm_group_label>
</intervention>
<biospec_retention>Samples Without DNA</biospec_retention>
<biospec_descr>
<textblock>
blood sample
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
Healthy young adults between the ages of 19 and 55 years who were willing to receive either
BNT162b2 or ChAdOx1 were enrolled in the study and provided written informed consent
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Volunteers who provide the informed consent after either BNT162b2 or ChAdOx1
vaccination

- healthy adults without underlying medical condition

Exclusion Criteria:

- Volunteers who had ever infected with SARS-CoV2 were excluded.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>19 Years</minimum_age>
<maximum_age>59 Years</maximum_age>
</eligibility>
<overall_official>
<last_name>Joon Young Song, MD</last_name>
<role>Study Chair</role>
<affiliation>Korea University Guro Hospital</affiliation>
</overall_official>
<overall_official>
<last_name>Jung Yeon Heo, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Ajou University School of Medicine</affiliation>
</overall_official>
<overall_official>
<last_name>Yu Bin Seo, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Hallym University Kangnam Sacred Heart Hospital</affiliation>
</overall_official>
<overall_contact>
<last_name>Joon Young Song, MD</last_name>
<phone>+82226263052</phone>
<email>infection@korea.ac.kr</email>
</overall_contact>
<overall_contact_backup>
<last_name>Jung Yeon Heo, MD</last_name>
<phone>+82312197818</phone>
<email>jyeon78@naver.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Ajou University School of Medicine</name>
<address>
<city>Suwon</city>
<state>Gyeonggi-do</state>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jung Yeon Heo</last_name>
<email>jyeon78@naver.com</email>
</contact>
</location>
<location>
<facility>
<name>Kangnam Sacred Heart Hospital</name>
<address>
<city>Seoul</city>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Yu Bin Seo</last_name>
</contact>
</location>
<location>
<facility>
<name>Korea University Guro Hospital</name>
<address>
<city>Seoul</city>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Joon Young Song</last_name>
<email>infection@korea.ac.kr</email>
</contact>
</location>
<location_countries>
<country>Korea, Republic of</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 29, 2022</study_first_submitted>
<study_first_submitted_qc>April 6, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Korea University Guro Hospital</investigator_affiliation>
<investigator_full_name>Joon Young Song</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>reactogenicity; immunogenicity</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>COVID-19</mesh_term>
<mesh_term>Inflammation</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
<ipd_description>We will make a decision after discussion with the staff of other hospitals. We will share data on adverse events and immunogenicity.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Analysis of humoral antibody and cytokine kinetics after vaccination with either BNT162b2 or
ChAdOx1 nCoV-19 vaccine and factors influencing the vaccine immunogenicity
There is a different aspect of reactogenicity between BNT162b2 and ChAdOx1 nCoV-19 vaccine.
Both new platform vaccines were concerned if they would elicit more significant local or
systemic reactogenicity compared to the conventional vaccines. Previous studies had reported
that immune cells such as mast cells and macrophages are activated just after vaccination,
and release proinflammatory cytokines such as interleukin (IL)-6 and tumor necrosis factor
(TNF)-α. The post-vaccination kinetics of inflammatory cytokines would be variable by each
vaccine platform, and might be associated with reactogenicity. It is an interesting issue to
be investigated whether the reactogenicity following newly developed BNT162b2 and ChAdOx1
would be associated with immunogenicity and inflammatory response or not. To better clarify
these uncertainties, we evaluated the change of antibody response between BNT162b2 and
ChAdOx1 over three months post-vaccination, in relation to the kinetics of inflammatory
cytokines and reactogenicity.
blood sample
Healthy young adults between the ages of 19 and 55 years who were willing to receive either
BNT162b2 or ChAdOx1 were enrolled in the study and provided written informed consent
Inclusion Criteria:
- Volunteers who provide the informed consent after either BNT162b2 or ChAdOx1
vaccination
- healthy adults without underlying medical condition
Exclusion Criteria:
- Volunteers who had ever infected with SARS-CoV2 were excluded.
|
NCT0531xxxx/NCT05315869.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/NCT05315869</url>
</required_header>
<id_info>
<org_study_id>AppendicitisFNKV</org_study_id>
<nct_id>NCT05315869</nct_id>
</id_info>
<brief_title>a Retrospective Observational Study Comparing Outcomes of Retrocaecal Appendicitis With Non-retrocaecal Appendicitis</brief_title>
<official_title>Retrocaecal Appendicitis: Risk Factor for Perioperative Complications?</official_title>
<sponsors>
<lead_sponsor>
<agency>Faculty Hospital Kralovske Vinohrady</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Faculty Hospital Kralovske Vinohrady</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 retrospective observational study investigating whether retrocecal appendicitis associated
with worse operative and postoperative outcomes than non-retrocecal appendicitis.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Acute appendicitis is the most common cause of acute abdomen requiring acute surgery. The
prevalence of the retrocaecal position of the appendix varies significantly between studies
from 14 to 36%. Appendectomy of a retrocecal appendix is generally considered to be more
demanding procedure than appendectomy of appendices in other positions. The aim of this study
is to investigate whether retrocaecal appendicitis is associated with a higher rate of
perioperative complications and delayed diagnosis when compared with the other positions.

A retrospective analysis of prospectively collected data of patients undergoing surgery for
signs of acute appendicitis from January 2015 to April 2020 at the University Hospital
Kralovske Vinohrady. Two groups of patients were be formed: the retrocaecal group and the
non-retrocaecal group.

The following data were recorded: sex, age, body mass index, length of hospital stay,
abdominal drain placement, length of surgery, surgical approach (laparoscopic, open or
converted), operative finding (normal appendix or catarrhal, phlegmonous, gangrenous, or
perforated appendicitis), position of the appendix (retrocaecal or non-retrocaecal
positions), histopathological findings (acute inflammation, chronic inflammation, appendiceal
tumour or normal appendix), 30-day postoperative complications, 30-day postoperative
mortality, symptoms (abdominal pain, nausea, vomiting, diarrhoea, body temperature above 37
degrees celsius, urological complaints and gynaecological complaints), duration of symptoms
(from onset to surgery), serious comorbidities and diabetes mellitus.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">January 1, 2015</start_date>
<completion_date type="Actual">May 1, 2020</completion_date>
<primary_completion_date type="Actual">April 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>Retrospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Number of patient with postoperative complications</measure>
<time_frame>30 days after intervention (appendectomy)</time_frame>
<description>surgical site infections, postoperative ileus, bleeding, internal complications,</description>
</primary_outcome>
<primary_outcome>
<measure>Number of patient who undergo converted appendectomy</measure>
<time_frame>during the surgery</time_frame>
<description>Conversion from laparoscopic to open appendectomy</description>
</primary_outcome>
<primary_outcome>
<measure>Length of hospital stay</measure>
<time_frame>30 days after intervention (appendectomy)</time_frame>
<description>Length of hospital stay after the procedure in days</description>
</primary_outcome>
<primary_outcome>
<measure>Duration of procedure</measure>
<time_frame>Throughout the study period (1/2015-4/2020)</time_frame>
<description>Duration of appendectomy in minutes</description>
</primary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Actual">754</enrollment>
<condition>Appendicitis</condition>
<condition>Appendicitis Acute</condition>
<condition>Retrocecal Appendicitis</condition>
<arm_group>
<arm_group_label>Retrocaecal group</arm_group_label>
<description>Patients who underwent surgery for signs of acute appendicitis and had intraoperative finding of the appendix located in the retrocaecal position.</description>
</arm_group>
<arm_group>
<arm_group_label>Non-retrocaecal group</arm_group_label>
<description>Patients who underwent surgery for signs of acute appendicitis and had intraoperative finding of the appendix not located in the retrocaecal position.</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Appendectomy</intervention_name>
<description>Surgical procedure for removal of the appendix</description>
<arm_group_label>Non-retrocaecal group</arm_group_label>
<arm_group_label>Retrocaecal group</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
All patients of the treated at the department of surgery of the University Hospital
Kralovske Vinohrady
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- All patients undergoing surgery for signs of acute appendicitis at the department of
surgery of the University Hospital Kralovske Vinohrady between January 2015 to April
2020

Exclusion Criteria:

- Patients under 18 years of age
</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>Adam Whitley, MUDr.</last_name>
<role>Study Chair</role>
<affiliation>University Hospital Kralovske Vinohrady</affiliation>
</overall_official>
<location>
<facility>
<name>Adam Whitley</name>
<address>
<city>Praha 3</city>
<state>Prague</state>
<zip>13000</zip>
<country>Czechia</country>
</address>
</facility>
</location>
<location_countries>
<country>Czechia</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 20, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 30, 2022</last_update_submitted>
<last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Faculty Hospital Kralovske Vinohrady</investigator_affiliation>
<investigator_full_name>Adam Whitley</investigator_full_name>
<investigator_title>MUDr.</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Appendicitis</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
A retrospective observational study investigating whether retrocecal appendicitis associated
with worse operative and postoperative outcomes than non-retrocecal appendicitis.
Acute appendicitis is the most common cause of acute abdomen requiring acute surgery. The
prevalence of the retrocaecal position of the appendix varies significantly between studies
from 14 to 36%. Appendectomy of a retrocecal appendix is generally considered to be more
demanding procedure than appendectomy of appendices in other positions. The aim of this study
is to investigate whether retrocaecal appendicitis is associated with a higher rate of
perioperative complications and delayed diagnosis when compared with the other positions.
A retrospective analysis of prospectively collected data of patients undergoing surgery for
signs of acute appendicitis from January 2015 to April 2020 at the University Hospital
Kralovske Vinohrady. Two groups of patients were be formed: the retrocaecal group and the
non-retrocaecal group.
The following data were recorded: sex, age, body mass index, length of hospital stay,
abdominal drain placement, length of surgery, surgical approach (laparoscopic, open or
converted), operative finding (normal appendix or catarrhal, phlegmonous, gangrenous, or
perforated appendicitis), position of the appendix (retrocaecal or non-retrocaecal
positions), histopathological findings (acute inflammation, chronic inflammation, appendiceal
tumour or normal appendix), 30-day postoperative complications, 30-day postoperative
mortality, symptoms (abdominal pain, nausea, vomiting, diarrhoea, body temperature above 37
degrees celsius, urological complaints and gynaecological complaints), duration of symptoms
(from onset to surgery), serious comorbidities and diabetes mellitus.
All patients of the treated at the department of surgery of the University Hospital
Kralovske Vinohrady
Inclusion Criteria:
- All patients undergoing surgery for signs of acute appendicitis at the department of
surgery of the University Hospital Kralovske Vinohrady between January 2015 to April
2020
Exclusion Criteria:
- Patients under 18 years of age
|
NCT0531xxxx/NCT05315882.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/NCT05315882</url>
</required_header>
<id_info>
<org_study_id>FIM-CIC-2020-01</org_study_id>
<nct_id>NCT05315882</nct_id>
</id_info>
<brief_title>Cytomegalovirus Infection After HSCT and PT-CY as GVHD Prophylaxis >> GVHD PROPHYLAXIS ERA</brief_title>
<acronym>CY-CMV-2020</acronym>
<official_title>Cytomegalovirus Infection, Indirect Effects and Mortality in Hematopoietic Stem Cell Transplantation With Cyclophosphamide Post-transplant</official_title>
<sponsors>
<lead_sponsor>
<agency>Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Merck Sharp & Dohme LLC</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud</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>
Multicentre, observational, retrospective study to analyze the differences in CMVi pattern
and recurrences between two groups of allogeneic HSCT patients (haplo vs no haplo HSCT), with
intervention both postransplant cyclophosphamide as GvHD prophylaxis, using a database with
information from historical clinic data.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The overall aim of the study is to to analize CMVi after PTCy for GVHD prophylaxis, with a
detailed description of CMVi and recurrences, direct and indirect consequences, in a HSCT
population comparing two cohorts: haploidentical HSCT vs no haploidentical HSCT
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 14, 2020</start_date>
<completion_date type="Actual">December 17, 2020</completion_date>
<primary_completion_date type="Actual">March 17, 2020</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>Incidence of CMVi in HSCT with PT-Cy and CMVi requiring pre-emptive therapy (significant CMVi)</measure>
<time_frame>1 year</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Median time to CMVi</measure>
<time_frame>1 year</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Cumulative incidence of PET-CMVi by day +100, +180 and +365.</measure>
<time_frame>1 year</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Overall survival by day +100, +180 and +365</measure>
<time_frame>1 year</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Overall mortality by day +100, +180 and +365</measure>
<time_frame>1 year</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Non-relapse mortality by day +100, +180 and +365</measure>
<time_frame>1 year</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>CMV indirect effects incidence</measure>
<time_frame>1 year</time_frame>
<description>Hospital admissions, secondary infections, secondary toxicity.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of CMVi recurrent episodes</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>CMV disease</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>CMV direct mortality</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Cumulative incidence of II-IV aGvHD</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Cumulative incidence of moderate-severe cGvHD</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Actual">300</enrollment>
<condition>CMV Infection</condition>
<arm_group>
<arm_group_label>Allogeneic stem cell transplantation</arm_group_label>
<description>Observational, no interventional</description>
</arm_group>
<eligibility>
<study_pop>
<textblock>
300 patients with hematological malignancies under HSCT from matched sibling donors,
unrelated matched and mistmatched donor and haploidentical family donor using PT-CY and CNI
as GVHD prophylaxis
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. Age > 18 years.

2. Period of HSCT: January 1st 2013 to December 31th 2018.

3. GvHD prophylaxis: Post-transplantation Cyclophosphamide (50 mg/Kg on days +3 and +4 or
+3 and +5) and calcineurine inhibitors as GvHD prophylaxis.

4. Conditioning chemotherapy regimen and source of stem cells: myeloablative or reduced
intensity TBF (Thiotepa 5 mg/Kg D -7-6, Fludarabine 50 mg/m2 D -5-4-3, Busulfan 3,2
mg/Kg D -4-3-2) starting on D-7 followed by peripheral blood or bone marrow infusion
on day 0.

Exclusion Criteria:

1. Cord blood HSCT.

2. Antilymphocytic or anti thymocytic thymoglobulin as GvHD prophylaxis.

3. Alentuzumab as GvHD prophylaxis.

3. Sirolimus as GvHD prophylaxis.

4. HIV positive, HVC, HVB active or latent at HSCT.

5. CMV prophylaxis with letermovir.

-
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<overall_official>
<last_name>MARIA JESUS PASCUAL, MD</last_name>
<role>Principal Investigator</role>
<affiliation>HOSPITAL REGIONAL MALAGA / BMT UNIT</affiliation>
</overall_official>
<location>
<facility>
<name>Maria Jesus Pascual</name>
<address>
<city>Malaga</city>
<zip>29010</zip>
<country>Spain</country>
</address>
</facility>
</location>
<location_countries>
<country>Spain</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 8, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 30, 2022</last_update_submitted>
<last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>CMV</keyword>
<keyword>PT-CY</keyword>
<keyword>allogeneic stem cell transplantation</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>Cytomegalovirus Infections</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>Communication at the EBMT 2022 Prague congress</ipd_description>
<ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
<ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
<ipd_time_frame>19 March 2022</ipd_time_frame>
<ipd_url>https://www.ebmt.org/annual-meeting</ipd_url>
</patient_data>
<pending_results>
<submitted>July 28, 2022</submitted>
<returned>June 29, 2023</returned>
</pending_results>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Multicentre, observational, retrospective study to analyze the differences in CMVi pattern
and recurrences between two groups of allogeneic HSCT patients (haplo vs no haplo HSCT), with
intervention both postransplant cyclophosphamide as GvHD prophylaxis, using a database with
information from historical clinic data.
The overall aim of the study is to to analize CMVi after PTCy for GVHD prophylaxis, with a
detailed description of CMVi and recurrences, direct and indirect consequences, in a HSCT
population comparing two cohorts: haploidentical HSCT vs no haploidentical HSCT
300 patients with hematological malignancies under HSCT from matched sibling donors,
unrelated matched and mistmatched donor and haploidentical family donor using PT-CY and CNI
as GVHD prophylaxis
Inclusion Criteria:
1. Age > 18 years.
2. Period of HSCT: January 1st 2013 to December 31th 2018.
3. GvHD prophylaxis: Post-transplantation Cyclophosphamide (50 mg/Kg on days +3 and +4 or
+3 and +5) and calcineurine inhibitors as GvHD prophylaxis.
4. Conditioning chemotherapy regimen and source of stem cells: myeloablative or reduced
intensity TBF (Thiotepa 5 mg/Kg D -7-6, Fludarabine 50 mg/m2 D -5-4-3, Busulfan 3,2
mg/Kg D -4-3-2) starting on D-7 followed by peripheral blood or bone marrow infusion
on day 0.
Exclusion Criteria:
1. Cord blood HSCT.
2. Antilymphocytic or anti thymocytic thymoglobulin as GvHD prophylaxis.
3. Alentuzumab as GvHD prophylaxis.
3. Sirolimus as GvHD prophylaxis.
4. HIV positive, HVC, HVB active or latent at HSCT.
5. CMV prophylaxis with letermovir.
-
|
NCT0531xxxx/NCT05315895.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/NCT05315895</url>
</required_header>
<id_info>
<org_study_id>SZ2021ZZ06</org_study_id>
<nct_id>NCT05315895</nct_id>
</id_info>
<brief_title>The Dampness Syndrome of Chinese Medicine Cohort Study</brief_title>
<acronym>DACOS</acronym>
<official_title>A Multi-Center Prospective Cohort Study of Dampness Syndrome in China</official_title>
<sponsors>
<lead_sponsor>
<agency>Guangzhou University of Traditional Chinese Medicine</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>State Key Laboratory of Dampness Syndrome of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Guangzhou University of Traditional Chinese Medicine</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 researchers plain to build a large-scale, longitudinal, prospective cohort characterized
by TCM dampness syndrome. With the biobank of this cohort the investigators want to find the
causality between TCM dampness syndrome and clinical chronic diseases and a new way to treat
clinical disease.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
DACOS is a national large- scale, longitudinal, multi-center, prospective, cohort study of
natural person aged 35 to 75. The baseline survey and the follow-up surveys will be conducted
in 5 areas covering the eastern, northern, western, southern and middle parts of China. In
this study 100,000 natural person will be regularly followed up for 5 years(visited once a
year), with the loss rate ≤15%. Three parts will be carried in the form of interview,
physical examination and biological sample collection. During the interview, the
investigators plan to do some questionnaires to learn participants' demographic
characteristics, life style, disease history, healthy condition(EQ-5D-5L, SDS,), cognition
state(AD-8, MMSE, MoCA) and the results of TCM syndrome differentiation(Score of Dampness
syndrome and TCM constitution scale). All biological specimens (including blood, feces,
urine, saliva and tongue coating) will be collected and stored in the biological resource
center until researchers request their use. With the building up of this cohort, the
researchers will analyze the causality between dampness syndrome and specific chronic
diseases such as diabetes, coronary heart disease, cancer, dementia and so on.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 6, 2022</start_date>
<completion_date type="Anticipated">March 30, 2028</completion_date>
<primary_completion_date type="Anticipated">December 30, 2027</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>5 Years</target_duration>
<primary_outcome>
<measure>emerging diseases</measure>
<time_frame>through study completion, an average of 1 year</time_frame>
<description>This study will pay attention to the emerging situation of clinical chronic diseases, such as cancer, diabetes, hypertension, coronary heart disease, dementia, etc. Each follow-up the researchers will record the incidence of the emerging diseases of interviewees' by questionnaire including the name of the disease, time of onset and treatments.</description>
</primary_outcome>
<secondary_outcome>
<measure>Montreal Cognitive Assessment(MoCA)</measure>
<time_frame>through study completion, an average of 1 year</time_frame>
<description>MoCA is a brief, 30-question test that helps healthcare professionals detect cognitive impairments very early on, allowing for faster diagnosis and patient care. MoCA is the most sensitive test available for detecting Alzheimer's disease, measuring executive functions and multiple cognitive domains. The value range 0-30: higher scores mean a better Cognitine. The score above 26 is considered the normal congnitive level</description>
</secondary_outcome>
<secondary_outcome>
<measure>European Quality of Life 5-dimensional questionnaire (EQ-5D-5L)</measure>
<time_frame>through study completion, an average of 1 year</time_frame>
<description>The EQ-5D comprises five dimensions of health: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, and anxiety and depression. . EQ-5D-5L, includes five levels of severity for each dimension (no problems, slight problems, moderate problems, severe problems, and extreme problems). The value range 0-100: higher scores mean a worse outcome.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Mini-Mental State Exam (MMSE)</measure>
<time_frame>through study completion, an average of 1 year</time_frame>
<description>MMSE is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The value range 0-30: higher scores mean a better Cognitine.</description>
</secondary_outcome>
<secondary_outcome>
<measure>interview questionnaire</measure>
<time_frame>through study completion, an average of 1 year</time_frame>
<description>Demographic characteristic, life style. disease history, allergies will be involoved.</description>
</secondary_outcome>
<secondary_outcome>
<measure>change of the blood routine results</measure>
<time_frame>through study completion, an average of 1 year</time_frame>
<description>WBC, RBC, PLT , HB, NEUT% and LYM% will be tested and recorded. Above or below each mormal value will be considered as abnormal.</description>
</secondary_outcome>
<secondary_outcome>
<measure>urine routine</measure>
<time_frame>through study completion, an average of 1 year</time_frame>
<description>urinary WBC and urinary RBC will be observed. negative or below 5/HP is normal.
BLO and GLU and PRO in urine will also be test. Negative is normal.</description>
</secondary_outcome>
<secondary_outcome>
<measure>change of faeces routine</measure>
<time_frame>through study completion, an average of 1 year</time_frame>
<description>cells in faeces will be tested such as RBC and WBC. Negative occult blood（FOB) is difined normal.</description>
</secondary_outcome>
<secondary_outcome>
<measure>change of hepatic function</measure>
<time_frame>an average of 1 year</time_frame>
<description>The researchers will check the results of ALT and AST. TBil, DBIL, TBA and TP, ALB. Any indices above or below the criteria range is defined as abnormal. Every time point investigators will record the change of these indices.</description>
</secondary_outcome>
<secondary_outcome>
<measure>change of renal function</measure>
<time_frame>an average of 1 year</time_frame>
<description>The researchers will check the results of Cr， BUN, TC， LDL， HDL,UA and fasting blood glucose，glycosylanted. Any indices above or below the criteria range is defined as abnormal. Every time point investigators will record the change of these indices.</description>
</secondary_outcome>
<secondary_outcome>
<measure>change of CRP</measure>
<time_frame>an average of 1 year</time_frame>
<description>change of CPP</description>
</secondary_outcome>
<secondary_outcome>
<measure>change of Hcy</measure>
<time_frame>an average of 1 year</time_frame>
<description>change of Hcy</description>
</secondary_outcome>
<secondary_outcome>
<measure>change of thyroid function</measure>
<time_frame>an average of 1 year</time_frame>
<description>change of TSH ,FT3, FT4</description>
</secondary_outcome>
<secondary_outcome>
<measure>change of Vit B12 and folic acid</measure>
<time_frame>an average of 1 year</time_frame>
<description>change of Vit B12</description>
</secondary_outcome>
<secondary_outcome>
<measure>change of coagulation function</measure>
<time_frame>an average of 1 year</time_frame>
<description>change of PT, INR,TT,APTT，FIB</description>
</secondary_outcome>
<secondary_outcome>
<measure>change of abdominal ultrasound</measure>
<time_frame>an average of 1 year</time_frame>
<description>change of abdominal ultrasound</description>
</secondary_outcome>
<secondary_outcome>
<measure>change of gynecologic ultrasound</measure>
<time_frame>an average of 1 year</time_frame>
<description>change of gynecologic ultrasound</description>
</secondary_outcome>
<secondary_outcome>
<measure>change of ECG</measure>
<time_frame>an average of 1 year</time_frame>
<description>The researchers will check the change of P, QRS and ST segments separately in electrocardiogram.</description>
</secondary_outcome>
<secondary_outcome>
<measure>change of brain MRI</measure>
<time_frame>an average of 1 year</time_frame>
<description>change of brain MRI. The investigators will focus on the change of hippocampal volume and the spacing of temporal sulcus gyrus.</description>
</secondary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Anticipated">100000</enrollment>
<condition>Chronic Disease</condition>
<condition>Cancer</condition>
<condition>Dementia Alzheimers</condition>
<condition>Metabolic Disease</condition>
<condition>Aging</condition>
<condition>Alzheimer Disease, Early Onset</condition>
<arm_group>
<arm_group_label>general population</arm_group_label>
<description>general population in a specific area and specifc time range.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>natural aging process</intervention_name>
<description>To observe the relationship between new cases of diseases and health status of people exposed to different factors such as life style, alcohol consumption, eating habits, etc.</description>
<arm_group_label>general population</arm_group_label>
</intervention>
<biospec_retention>Samples With DNA</biospec_retention>
<biospec_descr>
<textblock>
All biological specimens (including blood, feces, urine, saliva and tongue coating) will be
stored in the biological resource center of the our research centers after written informed
consent obtained from all subjects who voluntarily participated in this clinical study.
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
general population in a specific area and specifc time range. Such as civil servants of
Guangdong Province. Medical workers in Xinjiang.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. Residents aged 30 to 79, whose residence is consistent with their registered permanent
residence location;

2. Residents who voluntarily participate in the project, agree to the collection of their
biological information, and sign the informed consent form;

3. Residents who have no mental illness and other related diseases, and display a normal
ability of expression and understanding;

Exclusion Criteria:

1. Residents who reject collaboration;

2. Residents who allow no follow-up visits.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>35 Years</minimum_age>
<maximum_age>79 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Jianwen Guo, MD</last_name>
<phone>+86-13724899379</phone>
<email>1308251832@qq.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Bin Zhang, PhD</last_name>
<phone>+86 18511308217</phone>
<email>dochedy@163.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Guangdong Province Hospital of Tradtional Chinese Medicine</name>
<address>
<city>Guangzhou</city>
<state>Guangdong</state>
<zip>510120</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>jianwen Guo, Dr</last_name>
<phone>020-81887233</phone>
<phone_ext>34530</phone_ext>
<email>jianwen_guo@msn.com</email>
</contact>
<investigator>
<last_name>Jianwen Guo, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>November 2022</verification_date>
<study_first_submitted>March 11, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>November 14, 2022</last_update_submitted>
<last_update_submitted_qc>November 14, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">November 15, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Dampness Syndrome</keyword>
<keyword>multi-center study</keyword>
<keyword>prospective cohort study</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Alzheimer Disease</mesh_term>
<mesh_term>Metabolic Diseases</mesh_term>
<mesh_term>Chronic Disease</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>If you need to access or use the population information database and biological sample database, you must go through strict application and approval processes at first</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_info_type>Analytic Code</ipd_info_type>
<ipd_time_frame>After half year of the baseline and follow-ups data completing.</ipd_time_frame>
<ipd_access_criteria>A professional qualification panel determines whether the visitor is qualified to view and use the repository.</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The researchers plain to build a large-scale, longitudinal, prospective cohort characterized
by TCM dampness syndrome. With the biobank of this cohort the investigators want to find the
causality between TCM dampness syndrome and clinical chronic diseases and a new way to treat
clinical disease.
DACOS is a national large- scale, longitudinal, multi-center, prospective, cohort study of
natural person aged 35 to 75. The baseline survey and the follow-up surveys will be conducted
in 5 areas covering the eastern, northern, western, southern and middle parts of China. In
this study 100,000 natural person will be regularly followed up for 5 years(visited once a
year), with the loss rate ≤15%. Three parts will be carried in the form of interview,
physical examination and biological sample collection. During the interview, the
investigators plan to do some questionnaires to learn participants' demographic
characteristics, life style, disease history, healthy condition(EQ-5D-5L, SDS,), cognition
state(AD-8, MMSE, MoCA) and the results of TCM syndrome differentiation(Score of Dampness
syndrome and TCM constitution scale). All biological specimens (including blood, feces,
urine, saliva and tongue coating) will be collected and stored in the biological resource
center until researchers request their use. With the building up of this cohort, the
researchers will analyze the causality between dampness syndrome and specific chronic
diseases such as diabetes, coronary heart disease, cancer, dementia and so on.
All biological specimens (including blood, feces, urine, saliva and tongue coating) will be
stored in the biological resource center of the our research centers after written informed
consent obtained from all subjects who voluntarily participated in this clinical study.
general population in a specific area and specifc time range. Such as civil servants of
Guangdong Province. Medical workers in Xinjiang.
Inclusion Criteria:
1. Residents aged 30 to 79, whose residence is consistent with their registered permanent
residence location;
2. Residents who voluntarily participate in the project, agree to the collection of their
biological information, and sign the informed consent form;
3. Residents who have no mental illness and other related diseases, and display a normal
ability of expression and understanding;
Exclusion Criteria:
1. Residents who reject collaboration;
2. Residents who allow no follow-up visits.
|
NCT0531xxxx/NCT05315908.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/NCT05315908</url>
</required_header>
<id_info>
<org_study_id>201505</org_study_id>
<nct_id>NCT05315908</nct_id>
</id_info>
<brief_title>COVID-19 Testing in Underserved and Vulnerable Populations</brief_title>
<official_title>COVID-19 Testing in Underserved and Vulnerable Populations Receiving Care in San Diego Community Health Centers</official_title>
<sponsors>
<lead_sponsor>
<agency>Jesse Nodora</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of California, San Diego</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>
As part of National Institutes of Health Rapid Acceleration of Diagnostics-Underserved
Populations (RADx-UP) program, the goal of the RADxUP study is to develop, test, and evaluate
a rapid, scalable capacity building project to enhance COVID-19 testing in three regional
community health centers (CHCs) in San Diego County, California. In collaboration with CHC
partners, their consortium organization, Health Quality Partners (HQP), investigators are
pursuing the following Specific Aims: 1) Compare the effectiveness of automated calls vs text
messaging for uptake of COVID-19 testing among asymptomatic adult patients with select
medical conditions and those 65 years of age and older receiving care at participating CHCs.
Secondarily, investigators will invite all study participants to receive flu vaccination and
will assess feasibility and acceptability of study participants to refer adult family
household members who are essential workers for COVID-19 testing. 2) Gather patient,
provider, CHC leadership, and community stakeholder insights to establish best practices for
future scale-up of COVID-19 testing sustainability and vaccination.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Pronounced inequities and disparities in coronavirus disease (COVID-19)COVID-19 morbidity and
mortality have been reported, largely due to comorbid conditions and social determinants of
health. Approximately 95% of COVID-19 related deaths occur among individuals with underlying
medical conditions. Of all racial/ethnic groups, Hispanic/Latino communities in San Diego
County have experienced the greatest burden of COVID-19 disease and deaths. Furthermore,
testing challenges to date are evident, including long turnaround of test results and longer
waiting times for African American and Hispanics compared to whites. The goal of this
community-engaged proposal is to develop, test, and evaluate a rapid, scalable capacity
building project to enhance COVID-19 testing in three regional community health centers
(CHCs) in San Diego County. In collaboration with CHC partners, their consortium organization
(Health Quality Partners), and community stakeholders, investigators propose the following
Specific Aims: 1) Compare the effectiveness of automated and live prompts and reminders and
their combination for uptake of COVID-19 testing among adult patients with select medical
conditions or those 65 years of age and older receiving care at participating CHCs.
Secondarily, investigators will invite all study participants to receive flu vaccination and
will assess feasibility and acceptability of study participants to refer adult family
household members who are essential workers for COVID-19 testing. 2) Gather patient,
provider, CHC leadership, and community stakeholder insights to establish best practices for
future scale-up of COVID-19 testing sustainability and vaccination. This community-engaged
project includes underserved (socioeconomically disadvantaged and large proportion of
Hispanic/Latinos) as well as COVID-19 vulnerable individuals (patients with medical
comorbidities and 65 years of age and older). The approach considers regional COVID-19
morbidity and mortality disparities to identify strategies to address disproportionate
infection rates and follow-up. By working in partnership with health care providers, health
care system leaders, and community stakeholders, the research team has the potential to build
the evidence-base approaches and identify sustainable solutions to understand and address the
current and future pandemics in underserved and vulnerable populations.
</textblock>
</detailed_description>
<overall_status>Terminated</overall_status>
<why_stopped>
Because of low testing uptake, slow accrual at participating health centers and continuously
changing COVID pandemic, research investigators had to terminate the original study and
consider alternate strategies.
</why_stopped>
<start_date type="Actual">November 1, 2020</start_date>
<completion_date type="Actual">November 15, 2021</completion_date>
<primary_completion_date type="Actual">November 15, 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>
<intervention_model_description>Eligible patients who don't opt out will be randomized to one of two arms (automated call vs text messaging)</intervention_model_description>
<primary_purpose>Other</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Proportion of tested patients</measure>
<time_frame>1 year</time_frame>
<description>The proportion of patients who undergo testing within one month of initial contact (automated call vs text messaging) and by the end of the study period (to consider individuals who could not come to the clinic within one month)</description>
</primary_outcome>
<primary_outcome>
<measure>Number (%) tested (total and by clinic)</measure>
<time_frame>1 year</time_frame>
<description>Number (%) of patients who complete COVID-19 test (total and by clinic)</description>
</primary_outcome>
<primary_outcome>
<measure>Number (%) infected (total and by clinic)</measure>
<time_frame>1 year</time_frame>
<description>Number (%) of patients with positive COVID-19 test (total and by clinic)</description>
</primary_outcome>
<primary_outcome>
<measure>Timeliness of testing</measure>
<time_frame>1 year</time_frame>
<description>From time of contact to testing</description>
</primary_outcome>
<secondary_outcome>
<measure>Number vaccinated with flu vaccine</measure>
<time_frame>1 year</time_frame>
<description>Number of patients who receive flu vaccine</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of patients who refer for testing</measure>
<time_frame>1 year</time_frame>
<description>The proportion of study participants with eligible household members who refer household member(s) for COVID-19 testing</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of household members referred for testing</measure>
<time_frame>1 year</time_frame>
<description>The number of household members referred for COVID-19 testing</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">37</enrollment>
<condition>Heart Failure</condition>
<condition>Coronary Artery Disease</condition>
<condition>Cancer</condition>
<condition>Chronic Kidney Diseases</condition>
<condition>COPD</condition>
<condition>Obesity</condition>
<condition>Sickle Cell Disease</condition>
<condition>Diabetes Mellitus, Type 2</condition>
<arm_group>
<arm_group_label>Automated call</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Patients receive up to two automated phone calls in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday.</description>
</arm_group>
<arm_group>
<arm_group_label>Text messaging</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Patients receive up to two text messages in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Community outreach method</intervention_name>
<description>The method includes automated call and text messaging to increase testing for COVID-19</description>
<arm_group_label>Automated call</arm_group_label>
<arm_group_label>Text messaging</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Eligible participants will include asymptomatic men and women receiving care at
participating community health centers with at least one clinic visit in the last
year, age 21 years and over, with co-morbid conditions deemed by the Centers for
Disease Control and Prevention to increase risk for severe COVID-19 illness, including
heart failure, coronary artery disease, cancer, chronic kidney diseases, COPD,
obesity, sickle cell disease and type 2 diabetes mellitus, and those 65 years of age
and older.

Exclusion Criteria:

- Under age 21, inability to communicate in English and other study languages, inability
to complete anterior nasal swab sampling for COVID-19
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Elena Martinez, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Moores Cancer Center, University of California, San Diego</affiliation>
</overall_official>
<location>
<facility>
<name>University of California, San Diego</name>
<address>
<city>La Jolla</city>
<state>California</state>
<zip>92093</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>January 22, 2022</study_first_submitted>
<study_first_submitted_qc>April 5, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>April 5, 2022</last_update_submitted>
<last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>University of California, San Diego</investigator_affiliation>
<investigator_full_name>Jesse Nodora</investigator_full_name>
<investigator_title>Assoc Adjt Professor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Kidney Diseases</mesh_term>
<mesh_term>Renal Insufficiency, Chronic</mesh_term>
<mesh_term>Coronary Artery Disease</mesh_term>
<mesh_term>Anemia, Sickle Cell</mesh_term>
<mesh_term>Diabetes Mellitus, Type 2</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<pending_results>
<submitted>May 11, 2023</submitted>
</pending_results>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
As part of National Institutes of Health Rapid Acceleration of Diagnostics-Underserved
Populations (RADx-UP) program, the goal of the RADxUP study is to develop, test, and evaluate
a rapid, scalable capacity building project to enhance COVID-19 testing in three regional
community health centers (CHCs) in San Diego County, California. In collaboration with CHC
partners, their consortium organization, Health Quality Partners (HQP), investigators are
pursuing the following Specific Aims: 1) Compare the effectiveness of automated calls vs text
messaging for uptake of COVID-19 testing among asymptomatic adult patients with select
medical conditions and those 65 years of age and older receiving care at participating CHCs.
Secondarily, investigators will invite all study participants to receive flu vaccination and
will assess feasibility and acceptability of study participants to refer adult family
household members who are essential workers for COVID-19 testing. 2) Gather patient,
provider, CHC leadership, and community stakeholder insights to establish best practices for
future scale-up of COVID-19 testing sustainability and vaccination.
Pronounced inequities and disparities in coronavirus disease (COVID-19)COVID-19 morbidity and
mortality have been reported, largely due to comorbid conditions and social determinants of
health. Approximately 95% of COVID-19 related deaths occur among individuals with underlying
medical conditions. Of all racial/ethnic groups, Hispanic/Latino communities in San Diego
County have experienced the greatest burden of COVID-19 disease and deaths. Furthermore,
testing challenges to date are evident, including long turnaround of test results and longer
waiting times for African American and Hispanics compared to whites. The goal of this
community-engaged proposal is to develop, test, and evaluate a rapid, scalable capacity
building project to enhance COVID-19 testing in three regional community health centers
(CHCs) in San Diego County. In collaboration with CHC partners, their consortium organization
(Health Quality Partners), and community stakeholders, investigators propose the following
Specific Aims: 1) Compare the effectiveness of automated and live prompts and reminders and
their combination for uptake of COVID-19 testing among adult patients with select medical
conditions or those 65 years of age and older receiving care at participating CHCs.
Secondarily, investigators will invite all study participants to receive flu vaccination and
will assess feasibility and acceptability of study participants to refer adult family
household members who are essential workers for COVID-19 testing. 2) Gather patient,
provider, CHC leadership, and community stakeholder insights to establish best practices for
future scale-up of COVID-19 testing sustainability and vaccination. This community-engaged
project includes underserved (socioeconomically disadvantaged and large proportion of
Hispanic/Latinos) as well as COVID-19 vulnerable individuals (patients with medical
comorbidities and 65 years of age and older). The approach considers regional COVID-19
morbidity and mortality disparities to identify strategies to address disproportionate
infection rates and follow-up. By working in partnership with health care providers, health
care system leaders, and community stakeholders, the research team has the potential to build
the evidence-base approaches and identify sustainable solutions to understand and address the
current and future pandemics in underserved and vulnerable populations.
Inclusion Criteria:
- Eligible participants will include asymptomatic men and women receiving care at
participating community health centers with at least one clinic visit in the last
year, age 21 years and over, with co-morbid conditions deemed by the Centers for
Disease Control and Prevention to increase risk for severe COVID-19 illness, including
heart failure, coronary artery disease, cancer, chronic kidney diseases, COPD,
obesity, sickle cell disease and type 2 diabetes mellitus, and those 65 years of age
and older.
Exclusion Criteria:
- Under age 21, inability to communicate in English and other study languages, inability
to complete anterior nasal swab sampling for COVID-19
|
NCT0531xxxx/NCT05315921.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/NCT05315921</url>
</required_header>
<id_info>
<org_study_id>HY1003-2021-P1</org_study_id>
<nct_id>NCT05315921</nct_id>
</id_info>
<brief_title>Study of OsrhAAT or Placebo in Healthy Volunteers</brief_title>
<official_title>A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Single Ascending Doses of OsrhAAT in Healthy Volunteers</official_title>
<sponsors>
<lead_sponsor>
<agency>Healthgen Biotechnology Corp.</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Healthgen Biotechnology Corp.</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>
A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety,
Tolerability, Pharmacokinetics and Immunogenicity of Single Ascending Doses of OsrhAAT in
Healthy Volunteers
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 22, 2022</start_date>
<completion_date type="Anticipated">June 30, 2023</completion_date>
<primary_completion_date type="Anticipated">March 31, 2023</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>Sequential Assignment</intervention_model>
<intervention_model_description>This is a phase 1, single-center, placebo-controlled, double-blind, randomized study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of OsrhAAT by a single ascending dose (SAD) design in healthy adults.</intervention_model_description>
<primary_purpose>Other</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Safety and tolerability: Incidence of adverse events (AEs), serious adverse events (SAEs), and infusion site reactions</measure>
<time_frame>Adverse events (AE) will be collected from the time of informed consent until EOS. SAE will be collected by the Investigator from the informed consent through 180 days.</time_frame>
</primary_outcome>
<number_of_arms>6</number_of_arms>
<enrollment type="Anticipated">48</enrollment>
<condition>Emphysema Secondary to Congenital AATD</condition>
<arm_group>
<arm_group_label>OsrhAAT 1 mg/kg IV</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>OsrhAAT 3 mg/kg IV</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>OsrhAAT 10 mg/kg IV</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>OsrhAAT 20 mg/kg IV</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>OsrhAAT 40 mg/kg IV</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>OsrhAAT 60 mg/kg IV</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>OsrhAAT 1 mg/kg IV</intervention_name>
<description>Drug: OsrhAAT 1 mg/kg IV A single dose of OsrhAAT 1 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg.
Placebo: Normal Saline (0.9% Sodium Chloride)</description>
<arm_group_label>OsrhAAT 1 mg/kg IV</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>OsrhAAT 3 mg/kg IV</intervention_name>
<description>Drug: OsrhAAT 3 mg/kg IV A single dose of OsrhAAT 3 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg.
Placebo: Normal Saline (0.9% Sodium Chloride)</description>
<arm_group_label>OsrhAAT 3 mg/kg IV</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>OsrhAAT 10 mg/kg IV</intervention_name>
<description>Drug: : OsrhAAT 10 mg/kg IV A single dose of OsrhAAT 10 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg.
Placebo: Normal Saline (0.9% Sodium Chloride)</description>
<arm_group_label>OsrhAAT 10 mg/kg IV</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>OsrhAAT 20 mg/kg IV</intervention_name>
<description>Drug: OsrhAAT 20 mg/kg IV A single dose of OsrhAAT 20 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg.
Placebo: Normal Saline (0.9% Sodium Chloride)</description>
<arm_group_label>OsrhAAT 20 mg/kg IV</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>OsrhAAT 40 mg/kg IV</intervention_name>
<description>Drug: OsrhAAT 40 mg/kg IV A single dose of OsrhAAT 40 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg.
Placebo: Normal Saline (0.9% Sodium Chloride)</description>
<arm_group_label>OsrhAAT 40 mg/kg IV</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>OsrhAAT 60 mg/kg IV</intervention_name>
<description>Drug: OsrhAAT 60 mg/kg IV A single dose of OsrhAAT 60 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg.
Placebo: Normal Saline (0.9% Sodium Chloride)</description>
<arm_group_label>OsrhAAT 60 mg/kg IV</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

Subjects must meet all the following criteria to be enrolled in the trial:

1. Able to understand and willing to sign the ICF

2. Healthy subjects, male or female, non-smokers, 18-55 years of age

3. No significant medical history, and in good health as determined by detailed medical
history (neurological, endocrinal, cardiovascular, pulmonary, hematological,
immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease),
full physical examination, vital signs, 12-lead electrocardiogram (ECG), urinalysis
and laboratory tests at screening. For eligibility purposes, abnormal laboratory or
vital signs results may be repeated once if abnormal result is observed at the initial
reading. Moreover, abnormalities found in the ECG may need to be confirmed by repeated
measurements.

4. Adequate organ function according to the following laboratory values:

- Bone marrow function (absolute neutrophil count ≥1500/mm3 and platelet count
≥100,000/mm3).

- Alanine aminotransferase (ALT) 7-56 units per liter of serum ( or institutional
equivalent), AST 5-40 units per liter of serum (or institutional equivalent),
alkaline phosphatase 20-140 units per liter of serum (or institutional
equivalent), total bilirubin 0.1-1.0 mg/dL (or institutional equivalent) and
creatinine clearance (Cockcroft-Gault equation) ≥90mL/min.

5. Female of non-childbearing potential (i.e., physiologically incapable of becoming
pregnant, including any female who is 1 year of post-menopausal with a FSH > 40mIU/mL,
or surgically sterile [defined as having a bilateral oophorectomy, hysterectomy or
tubal ligation]) or agree to one of the following to prevent pregnancy and, if a woman
of childbearing potential, have a negative pregnancy test at screening:

- Practicing abstinence which is the preferred and usual lifestyle of the subject

- If a sexually active woman of childbearing potential (sexually active with a
non-sterile male partner) agrees to prevent pregnancy by using double methods of
contraception as follow until 180 days after the administration of the
investigational product:

1. Simultaneous use of intra-uterine contraceptive device, placed at least 4
weeks prior to study drug administration, and condom for the male partner.

2. Simultaneous use of hormonal contraceptives, starting at least 4 weeks prior
to study drug administration and must agree to use the same hormonal
contraceptive throughout the study, and condom for the male partner.

3. Simultaneous use of diaphragm with intravaginally applied spermicide and
male condom for the male partner, starting at least 21 days prior to study
drug administration. Male subjects who are not vasectomized for at least 6
months and who are sexually active with a non-sterile female partner must
agree to use double methods of contraception below from the first dose of
randomized study drug until 120 days after their dose and must not donate
sperm during their study participation period:

1. Simultaneous use of a male condom and, for the female partner, hormonal
contraceptives (used since at least 4 weeks) or intra-uterine contraceptive
device (placed since at least 4 weeks)

2. Simultaneous use of a male condom and, for the female partner, a diaphragm
with intravaginally applied spermicide

6. Body mass index (BMI) 18.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and

- 45.0 kg for females

7. Blood pressure ≤ 139/89 mm Hg

8. Able to follow the study protocol and complete the trial

Exclusion Criteria:

Subjects who meet any of the following criteria cannot be enrolled:

1. History of severe infection within 4 weeks prior to administration; signs and symptoms
of any active infection regardless of severity within 2 weeks prior to administration.

2. History of hypersensitivity to OsrhAAT or any excipient or similar drugs

3. Known History of hypersensitivity to rice

4. Use of any prescription drugs, herbal supplements, or nonprescription drugs, including
oral antihistamines (for seasonal allergies), within 1 month or 5 half-lives
(whichever is longer) prior to study drug administration, or dietary supplements
within 1 week prior to study drug administration, unless, in the opinion of the
Investigator and the Sponsor, the medication will not interfere with the study.
Over-the-counter multivitamins will be permitted. If needed, paracetamol/acetaminophen
may be used, but must be documented in the Concomitant medications/Significant
non-drug therapies page of the source data. Any questions of concomitant medications
should be directed to the Sponsor.

5. Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days prior to the first dosing,
administration of a biological product in the context of a clinical research study
within 90 days prior to the first dosing, or concomitant participation in an
investigational study involving no drug or device administration.

6. Donation of blood 12 week prior to dosing

7. Pregnant, or nursing females

8. A history of psychiatric and psychological condition that, in the judgment of the
Investigator, may interfere with the planned treatment and follow-up, affect subject
compliance or place the subject at high risk from treatment-related complications

9. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
QTc interval >450 milliseconds [ms], Bazett Formula: QTc=QT/RR0.5）

10. Active hepatitis B or C. HBV carriers without active disease (HBV DNA titer< 1000
cps/mL or 200 IU/mL), or cured Hepatitis C (negative HCV RNA test) may be enrolled, in
the judgement of the Investigator.

11. Known infection with human immunodeficiency virus (HIV) and a cluster of
differentiation 4 (CD4) count that is unknown or documented to be < 350 cells/mm3
within 12 months, or an Acquired Immune Deficiency Syndrome (AIDS)-defining illness

12. Known history of severe IgA deficiency

13. Immunization with a live or attenuated vaccine is prohibited within 4 weeks prior to
study drug administration. Seasonal influenza vaccines for injection are generally
killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g.,
FluMist®) are live attenuated vaccines and are not allowed

14. Receipt of an immunoglobulin or blood product 90 days prior to dosing

15. History of consuming more than 14 units of alcoholic beverages per week or of
alcoholism or drug/chemical/substance abuse within past 2 years prior to screening
(Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits). Consumed
> 3 (male) or 2 (female) units of alcohol as determined by blood alcohol testing at
screening

16. History of significant drug abuse within one year prior to screening

17. Positive urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabinoids,
cocaine, cotinine and opiates)

18. Any reason which, in the opinion of the Investigator, would prevent the subject from
participating in 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_contact>
<last_name>Yongjun David Kim, MD</last_name>
<phone>714-252-0700</phone>
<phone_ext>1482</phone_ext>
<email>YKim@altasciences.com</email>
</overall_contact>
<location>
<facility>
<name>Altasciences</name>
<address>
<city>Cypress</city>
<state>California</state>
<zip>90630</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Yongjun David Kim, MD</last_name>
<phone>714-252-0700</phone>
<phone_ext>1482</phone_ext>
<email>YKim@altasciences.com</email>
</contact>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>December 8, 2022</last_update_submitted>
<last_update_submitted_qc>December 8, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">December 12, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>OsrhAAT</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Emphysema</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety,
Tolerability, Pharmacokinetics and Immunogenicity of Single Ascending Doses of OsrhAAT in
Healthy Volunteers
Inclusion Criteria:
Subjects must meet all the following criteria to be enrolled in the trial:
1. Able to understand and willing to sign the ICF
2. Healthy subjects, male or female, non-smokers, 18-55 years of age
3. No significant medical history, and in good health as determined by detailed medical
history (neurological, endocrinal, cardiovascular, pulmonary, hematological,
immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease),
full physical examination, vital signs, 12-lead electrocardiogram (ECG), urinalysis
and laboratory tests at screening. For eligibility purposes, abnormal laboratory or
vital signs results may be repeated once if abnormal result is observed at the initial
reading. Moreover, abnormalities found in the ECG may need to be confirmed by repeated
measurements.
4. Adequate organ function according to the following laboratory values:
- Bone marrow function (absolute neutrophil count ≥1500/mm3 and platelet count
≥100,000/mm3).
- Alanine aminotransferase (ALT) 7-56 units per liter of serum ( or institutional
equivalent), AST 5-40 units per liter of serum (or institutional equivalent),
alkaline phosphatase 20-140 units per liter of serum (or institutional
equivalent), total bilirubin 0.1-1.0 mg/dL (or institutional equivalent) and
creatinine clearance (Cockcroft-Gault equation) ≥90mL/min.
5. Female of non-childbearing potential (i.e., physiologically incapable of becoming
pregnant, including any female who is 1 year of post-menopausal with a FSH > 40mIU/mL,
or surgically sterile [defined as having a bilateral oophorectomy, hysterectomy or
tubal ligation]) or agree to one of the following to prevent pregnancy and, if a woman
of childbearing potential, have a negative pregnancy test at screening:
- Practicing abstinence which is the preferred and usual lifestyle of the subject
- If a sexually active woman of childbearing potential (sexually active with a
non-sterile male partner) agrees to prevent pregnancy by using double methods of
contraception as follow until 180 days after the administration of the
investigational product:
1. Simultaneous use of intra-uterine contraceptive device, placed at least 4
weeks prior to study drug administration, and condom for the male partner.
2. Simultaneous use of hormonal contraceptives, starting at least 4 weeks prior
to study drug administration and must agree to use the same hormonal
contraceptive throughout the study, and condom for the male partner.
3. Simultaneous use of diaphragm with intravaginally applied spermicide and
male condom for the male partner, starting at least 21 days prior to study
drug administration. Male subjects who are not vasectomized for at least 6
months and who are sexually active with a non-sterile female partner must
agree to use double methods of contraception below from the first dose of
randomized study drug until 120 days after their dose and must not donate
sperm during their study participation period:
1. Simultaneous use of a male condom and, for the female partner, hormonal
contraceptives (used since at least 4 weeks) or intra-uterine contraceptive
device (placed since at least 4 weeks)
2. Simultaneous use of a male condom and, for the female partner, a diaphragm
with intravaginally applied spermicide
6. Body mass index (BMI) 18.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and
- 45.0 kg for females
7. Blood pressure ≤ 139/89 mm Hg
8. Able to follow the study protocol and complete the trial
Exclusion Criteria:
Subjects who meet any of the following criteria cannot be enrolled:
1. History of severe infection within 4 weeks prior to administration; signs and symptoms
of any active infection regardless of severity within 2 weeks prior to administration.
2. History of hypersensitivity to OsrhAAT or any excipient or similar drugs
3. Known History of hypersensitivity to rice
4. Use of any prescription drugs, herbal supplements, or nonprescription drugs, including
oral antihistamines (for seasonal allergies), within 1 month or 5 half-lives
(whichever is longer) prior to study drug administration, or dietary supplements
within 1 week prior to study drug administration, unless, in the opinion of the
Investigator and the Sponsor, the medication will not interfere with the study.
Over-the-counter multivitamins will be permitted. If needed, paracetamol/acetaminophen
may be used, but must be documented in the Concomitant medications/Significant
non-drug therapies page of the source data. Any questions of concomitant medications
should be directed to the Sponsor.
5. Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days prior to the first dosing,
administration of a biological product in the context of a clinical research study
within 90 days prior to the first dosing, or concomitant participation in an
investigational study involving no drug or device administration.
6. Donation of blood 12 week prior to dosing
7. Pregnant, or nursing females
8. A history of psychiatric and psychological condition that, in the judgment of the
Investigator, may interfere with the planned treatment and follow-up, affect subject
compliance or place the subject at high risk from treatment-related complications
9. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
QTc interval >450 milliseconds [ms], Bazett Formula: QTc=QT/RR0.5）
10. Active hepatitis B or C. HBV carriers without active disease (HBV DNA titer< 1000
cps/mL or 200 IU/mL), or cured Hepatitis C (negative HCV RNA test) may be enrolled, in
the judgement of the Investigator.
11. Known infection with human immunodeficiency virus (HIV) and a cluster of
differentiation 4 (CD4) count that is unknown or documented to be < 350 cells/mm3
within 12 months, or an Acquired Immune Deficiency Syndrome (AIDS)-defining illness
12. Known history of severe IgA deficiency
13. Immunization with a live or attenuated vaccine is prohibited within 4 weeks prior to
study drug administration. Seasonal influenza vaccines for injection are generally
killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g.,
FluMist®) are live attenuated vaccines and are not allowed
14. Receipt of an immunoglobulin or blood product 90 days prior to dosing
15. History of consuming more than 14 units of alcoholic beverages per week or of
alcoholism or drug/chemical/substance abuse within past 2 years prior to screening
(Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits). Consumed
> 3 (male) or 2 (female) units of alcohol as determined by blood alcohol testing at
screening
16. History of significant drug abuse within one year prior to screening
17. Positive urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabinoids,
cocaine, cotinine and opiates)
18. Any reason which, in the opinion of the Investigator, would prevent the subject from
participating in the study
|
NCT0531xxxx/NCT05315934.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/NCT05315934</url>
</required_header>
<id_info>
<org_study_id>EP 18/19 088</org_study_id>
<nct_id>NCT05315934</nct_id>
</id_info>
<brief_title>Comparing the Effects of Upper and Lower Body Aerobic Exercise on Pain in Individuals With Chronic Knee Pain</brief_title>
<official_title>A Comparison of the Effects of Upper Versus Lower Body Aerobic Exercise on the Experience of Pain in Individuals With Chronic Knee Pain</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Bath</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Bath</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 investigators want to compare the effects of upper versus lower body moderate aerobic
exercise on the experience of pain in individuals with chronic knee pain. Participants will
attend the laboratory on 4 separate occasions to complete a series of exercise tests and
experimental pain tests.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Pain has a multifaceted nature encompassing peripheral drivers (i.e. loading), peripheral and
central nervous systems (peripheral and central sensitisation) and cognition (i.e. fear).
Most recently, evidence supports that chronic pain in OA may cause alterations to the
peripheral and central nervous systems. Despite this, current research has mainly targeted
peripheral drivers (usually weight reduction) and cognition (educational programmes) with
results highlighting that such methods are not always effective in reducing pain. It would be
useful to provide a wider range of choice when prescribing exercise for OA for those which
the current prescription is ineffective or un-desirable.

Acutely, both localised and generalised exercise involving the knee joint in individuals with
KOA is known to increase symptomatic pain in some. However, research suggests that diverting
exercise away from the affected joint may improve pain perception and pain experience in a
subset of individuals by targeting cognition (attention away from the joint) and alleviating
peripheral drivers of pain (reduced loading) while still presenting systemic physiological
benefits that come with acute aerobic exercise which target peripheral and central
sensitisation. Currently, there is only one study (Burrows et al, 2014) which has compared
the effects of acute upper vs. lower body exercise on pain perception in KOA patients and
this was employing resistance exercise. Although this study found positive effects of upper
body exercise on pain, this pain was experimentally induced, and symptomatic pain was not
measured.

The investigators aim is to determine the effects of a single bout of upper body aerobic
exercise on experimentally induced and symptomatic pain in individuals with chronic knee pain
in comparison with lower body aerobic exercise.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 4, 2020</start_date>
<completion_date type="Actual">January 2, 2022</completion_date>
<primary_completion_date type="Actual">January 2, 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>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Acute Symptomatic Pain</measure>
<time_frame>Immediately pre and immediately-post exercise</time_frame>
<description>Change in symptomatic pain measured via Visual Analogue Scale (VAS) from pre- to post-exercise on a 0-10 scale where 0 is no pain at all and 10 is the worst pain imaginable</description>
</primary_outcome>
<secondary_outcome>
<measure>Acute Experimental Pain</measure>
<time_frame>Immediately pre and immediately-post exercise</time_frame>
<description>Change in experimental pain via Pressure pain threshold and Mechanical detection threshold from pre- to post- exercise</description>
</secondary_outcome>
<secondary_outcome>
<measure>Follow up Symptomatic Pain</measure>
<time_frame>1-7 days post exercise</time_frame>
<description>Average symptomatic pain in the 7 days following each trial visit measured on a 0-10 Visual Analogue Scale (VAS) where 0 indicates no pain at all and 10 indicates worst pain imaginable</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">19</enrollment>
<condition>Chronic Knee Pain</condition>
<arm_group>
<arm_group_label>Upper Body Aerobic Exercise</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will perform 30 minutes of arm-crank cycling at a moderate exercise intensity based off the participants perceived RPE13</description>
</arm_group>
<arm_group>
<arm_group_label>Lower Body Aerobic Exercise</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will perform 30 minutes of static cycling at a moderate exercise intensity based off the participants perceived RPE13</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Upper body aerobic exercise</intervention_name>
<description>Participants will perform 30 minutes of continuous exercise on the arm-crank ergometer.</description>
<arm_group_label>Upper Body Aerobic Exercise</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Lower body aerobic exercise</intervention_name>
<description>Participants will perform 30 minutes of continuous exercise on the cycle ergometer.</description>
<arm_group_label>Lower Body Aerobic Exercise</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Aged ≥45 years

- Male or female

- Knee pain for ≥3 months

- Activity related joint pain

- No joint related morning stiffness, or morning stiffness lasting less than 30 minutes.

Exclusion Criteria:

- Specific joint injury within the last 6 months

- Inability to undertake cycling exercise

- Use of anti-inflammatory medication

- Smoker (or having quit <6 months ago)

- Osteoarthritis at any upper body sites that would affect ability to complete
arm-cycling exercise.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>45 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>University of Bath</name>
<address>
<city>Bath</city>
<zip>BA27AY</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>May 17, 2020</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>July 26, 2022</last_update_submitted>
<last_update_submitted_qc>July 26, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">July 29, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Bath</investigator_affiliation>
<investigator_full_name>James Bilzon</investigator_full_name>
<investigator_title>Professor James Bilzon</investigator_title>
</responsible_party>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>Anonymous individual data for all outcomes may be made available.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The investigators want to compare the effects of upper versus lower body moderate aerobic
exercise on the experience of pain in individuals with chronic knee pain. Participants will
attend the laboratory on 4 separate occasions to complete a series of exercise tests and
experimental pain tests.
Pain has a multifaceted nature encompassing peripheral drivers (i.e. loading), peripheral and
central nervous systems (peripheral and central sensitisation) and cognition (i.e. fear).
Most recently, evidence supports that chronic pain in OA may cause alterations to the
peripheral and central nervous systems. Despite this, current research has mainly targeted
peripheral drivers (usually weight reduction) and cognition (educational programmes) with
results highlighting that such methods are not always effective in reducing pain. It would be
useful to provide a wider range of choice when prescribing exercise for OA for those which
the current prescription is ineffective or un-desirable.
Acutely, both localised and generalised exercise involving the knee joint in individuals with
KOA is known to increase symptomatic pain in some. However, research suggests that diverting
exercise away from the affected joint may improve pain perception and pain experience in a
subset of individuals by targeting cognition (attention away from the joint) and alleviating
peripheral drivers of pain (reduced loading) while still presenting systemic physiological
benefits that come with acute aerobic exercise which target peripheral and central
sensitisation. Currently, there is only one study (Burrows et al, 2014) which has compared
the effects of acute upper vs. lower body exercise on pain perception in KOA patients and
this was employing resistance exercise. Although this study found positive effects of upper
body exercise on pain, this pain was experimentally induced, and symptomatic pain was not
measured.
The investigators aim is to determine the effects of a single bout of upper body aerobic
exercise on experimentally induced and symptomatic pain in individuals with chronic knee pain
in comparison with lower body aerobic exercise.
Inclusion Criteria:
- Aged ≥45 years
- Male or female
- Knee pain for ≥3 months
- Activity related joint pain
- No joint related morning stiffness, or morning stiffness lasting less than 30 minutes.
Exclusion Criteria:
- Specific joint injury within the last 6 months
- Inability to undertake cycling exercise
- Use of anti-inflammatory medication
- Smoker (or having quit <6 months ago)
- Osteoarthritis at any upper body sites that would affect ability to complete
arm-cycling exercise.
|
NCT0531xxxx/NCT05315947.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/NCT05315947</url>
</required_header>
<id_info>
<org_study_id>EP0110</org_study_id>
<nct_id>NCT05315947</nct_id>
</id_info>
<brief_title>A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants</brief_title>
<official_title>A Single-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants</official_title>
<sponsors>
<lead_sponsor>
<agency>UCB Biopharma SRL</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>UCB Pharma</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 purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV
as dry syrup after a single oral dose in healthy Japanese male study participants.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 4, 2022</start_date>
<completion_date type="Actual">May 13, 2022</completion_date>
<primary_completion_date type="Actual">May 13, 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>Crossover Assignment</intervention_model>
<primary_purpose>Basic Science</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Maximum plasma concentration (Cmax) for a single dose of brivaracetam</measure>
<time_frame>Blood samples for this analysis are collected on Day 1 at 0 (predose), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose</time_frame>
<description>Cmax=maximum concentration</description>
</primary_outcome>
<primary_outcome>
<measure>Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) for a single dose of brivaracetam</measure>
<time_frame>Blood samples for this analysis are collected on Day 1 at 0 (predose), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose</time_frame>
<description>AUC(0-t)=area under the curve from 0 to the time of the last quantifiable concentration;</description>
</primary_outcome>
<secondary_outcome>
<measure>Percentage of participants with at least one treatment-emergent adverse event (TEAE)</measure>
<time_frame>From Baseline to end of Safety Follow-Up, up to 20 days</time_frame>
<description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Percentage of participants with at least one treatment-emergent serious adverse event (SAE)</measure>
<time_frame>From Baseline to end of Safety Follow-Up, up to 20 days</time_frame>
<description>A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalization or prolongation of existing hospitalization
Is a congenital anomaly or birth defect
Is an infection that requires treatment parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">24</enrollment>
<condition>Healthy Study Participants</condition>
<arm_group>
<arm_group_label>Treatment A-B</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Study participants randomized to this arm will receive a single dose of brivaracetam tablet (Treatment A) as reference and single dose of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints.</description>
</arm_group>
<arm_group>
<arm_group_label>Treatment B-A</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Study participants randomized to this arm will receive a single dose of brivaracetam tablet (Treatment A) as reference and single dose of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>brivaracetam</intervention_name>
<description>Study participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally.</description>
<arm_group_label>Treatment A-B</arm_group_label>
<arm_group_label>Treatment B-A</arm_group_label>
<other_name>BRV</other_name>
<other_name>Briviact</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>brivaracetam</intervention_name>
<description>Study participants will receive a single-dose of brivaractam dry syrup (test - Treatment B) administered orally.</description>
<arm_group_label>Treatment A-B</arm_group_label>
<arm_group_label>Treatment B-A</arm_group_label>
<other_name>BRV</other_name>
<other_name>Briviact</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion criteria:

- Study participant must be between 20 to 50 years of age (inclusive) at the time of
signing the Informed Consent Form (ICF)

- Study participant is overtly healthy as determined by medical evaluation including
medical history, physical examination, laboratory tests, and cardiac monitoring

- Study participant is of Japanese descent as evidenced by appearance and verbal
confirmation of familial heritage (a study participant has all 4 Japanese grandparents
born in Japan)

Exclusion criteria:

- Study participant has used other drugs, including over-the-counter medications,
herbal/traditional medicines, or dietary supplements (excluding medicines for external
use),with the exception of paracetamol, within 14 days before first administration of
IMP or has received a coronavirus disease 2019 (COVID-19) vaccine within 7 days of
initiating IMP

- Study participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids,
phenobarbital, isoniazid, phenytoin, rifampicin) within 2 months before the first
administration of Investigational Medicinal Product (IMP)

- Study participant has a positive result for hepatitis B surface antigen, hepatitis C
virus antibody test, human immunodeficiency virus antibody test, or syphilis at
Screening Visit

- Study participant has donated blood or plasma or has experienced blood loss ≥400 mL
within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14
days before first administration of IMP

- Study participant is a current smoker or has used nicotine-containing products (eg,
tobacco, patches, gum) within 30 days before the first administration of IMP

- Consumption of more than 600 mg of caffeine/day (1 cup of coffee contains
approximately 100mg of caffeine, 1 cup of tea approximately 30 mg, and 1 glass of cola
approximately 20 mg)
</textblock>
</criteria>
<gender>Male</gender>
<gender_based>Yes</gender_based>
<minimum_age>20 Years</minimum_age>
<maximum_age>50 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>UCB Cares</last_name>
<role>Study Director</role>
<affiliation>001 844 599 2273 (UCB)</affiliation>
</overall_official>
<location>
<facility>
<name>EP0110 1</name>
<address>
<city>Sumida</city>
<state>Tokyo</state>
<country>Japan</country>
</address>
</facility>
</location>
<location_countries>
<country>Japan</country>
</location_countries>
<verification_date>July 2022</verification_date>
<study_first_submitted>March 14, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>July 7, 2022</last_update_submitted>
<last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">July 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>brivaracetam</keyword>
<keyword>Healthy Study Participants</keyword>
<keyword>Phase 1</keyword>
<keyword>BRV</keyword>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Brivaracetam</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.</ipd_description>
</patient_data>
<pending_results>
<submitted>March 27, 2023</submitted>
</pending_results>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV
as dry syrup after a single oral dose in healthy Japanese male study participants.
Inclusion criteria:
- Study participant must be between 20 to 50 years of age (inclusive) at the time of
signing the Informed Consent Form (ICF)
- Study participant is overtly healthy as determined by medical evaluation including
medical history, physical examination, laboratory tests, and cardiac monitoring
- Study participant is of Japanese descent as evidenced by appearance and verbal
confirmation of familial heritage (a study participant has all 4 Japanese grandparents
born in Japan)
Exclusion criteria:
- Study participant has used other drugs, including over-the-counter medications,
herbal/traditional medicines, or dietary supplements (excluding medicines for external
use),with the exception of paracetamol, within 14 days before first administration of
IMP or has received a coronavirus disease 2019 (COVID-19) vaccine within 7 days of
initiating IMP
- Study participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids,
phenobarbital, isoniazid, phenytoin, rifampicin) within 2 months before the first
administration of Investigational Medicinal Product (IMP)
- Study participant has a positive result for hepatitis B surface antigen, hepatitis C
virus antibody test, human immunodeficiency virus antibody test, or syphilis at
Screening Visit
- Study participant has donated blood or plasma or has experienced blood loss ≥400 mL
within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14
days before first administration of IMP
- Study participant is a current smoker or has used nicotine-containing products (eg,
tobacco, patches, gum) within 30 days before the first administration of IMP
- Consumption of more than 600 mg of caffeine/day (1 cup of coffee contains
approximately 100mg of caffeine, 1 cup of tea approximately 30 mg, and 1 glass of cola
approximately 20 mg)
|
NCT0531xxxx/NCT05315960.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/NCT05315960</url>
</required_header>
<id_info>
<org_study_id>146256</org_study_id>
<nct_id>NCT05315960</nct_id>
</id_info>
<brief_title>SOcial coNNEction in Long-Term Care Home Residents</brief_title>
<acronym>SONNET</acronym>
<official_title>SOcial coNNEction in Long-Term Care Home Residents</official_title>
<sponsors>
<lead_sponsor>
<agency>University College, London</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>University Health Network, Toronto</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>University College, London</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 a new measure which can accurately assess social connection for
people with dementia living in long-term care homes. The Social Connection in Long-term Care
home residents (SONNET) study will use interviews and focus groups with people affected by
dementia and long-term care residents to establish what aspects of social connection are
important for people living in care homes. These findings and a review of other studies and
measures will be used to develop a new measure or measures of social connection which will
then be tested in a study based in care homes in Canada and the UK.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Research Question:

Can a new measure reliably and validly assess social connection for people with dementia in
care homes?

Background:

Social connection, including objective and subjective constructs relating to human
relationships, is a fundamental human need, but is impaired in people with dementia,
particularly in those living in long-term care (LTC) settings due to cognitive impairment,
complex health needs, and separation from previous social networks and community activities.
Measurement instruments therefore need to be tailored to the distinct characteristics of this
population and be tested in this setting, but there is no current evidence-based consensus on
the best approaches to measurement.

Objectives:

1. Appraise existing measures of social connection used in LTC homes

2. Evaluate which aspects of social connection are considered important by people affected
by dementia and professional staff

3. Develop a new measure informed by our appraisal of previous measures and the priorities
of key stakeholders and test its preliminary psychometric properties

Methods:

A systematic review of measurement instruments assessing social connection in LTC residents,
including dementia-specific measures will be conducted and measures will be appraised using
COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments)
methodology. Focus groups and qualitative interviews will then be conducted with 50-70 people
living with dementia, LTC residents, families, clinicians, care staff, and researchers in the
UK and Canada to establish the important aspects of social connection and its measurement,
including considerations for LTC residents with dementia and those with different stages of
dementia severity. Findings from the systematic review and qualitative study will be used to
inform the development of a measure or measures which will be iteratively refined during
interviews. Finally, the new measure(s) will be tested for psychometric properties in 150
people with dementia living in LTC homes in the UK and Canada to establish acceptability,
reliability, and validity.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 16, 2022</start_date>
<completion_date type="Anticipated">February 29, 2024</completion_date>
<primary_completion_date type="Anticipated">January 1, 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>Cross-Sectional</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Resident Assessment Instrument-Minimum Data Set (RAI-MDS) Index of Social Engagement</measure>
<time_frame>10 minutes</time_frame>
<description>Minimum 0, Maximum 6. Higher scores indicate a higher level of social engagement.</description>
</primary_outcome>
<secondary_outcome>
<measure>Clinical Dementia Rating Scale</measure>
<time_frame>10 minutes</time_frame>
<description>Minimum 0, Maximum 5. Higher scores indicate a more severe dementia.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Neuropsychiatric Inventory</measure>
<time_frame>10 minutes</time_frame>
<description>Minimum 0, Maximum 144. Higher scores indicate a more severe neuropsychiatric symptoms.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Katz Index of Independence in activities of Daily Living</measure>
<time_frame>10 minutes</time_frame>
<description>Minimum 0, Maximum 6. Higher scores indicate more independence in activities in daily living.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Dementia-specific quality of life (DEMQOL-Proxy)</measure>
<time_frame>10 minutes</time_frame>
<description>Minimum 31, Maximum 124. Higher scores indicate better health-related quality of life.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Family caregiver proxy-raters only will also be asked to completed the EQ5D</measure>
<time_frame>5 minutes</time_frame>
<description>Minimum 0, Maximum 1. Higher scores indicate better quality of life.</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">220</enrollment>
<condition>Dementia</condition>
<arm_group>
<arm_group_label>Qualitative study</arm_group_label>
<description>Consenting participants will complete a form asking about basic characteristics including age, sex, ethnicity, marital status etc. People living in long-term care and family carers will participate in an individual interview and professional staff will participate in an individual interview or focus group (between 5 and 10 participants) depending on their preference. The interview or focus group is expected to last 30-60 minutes. Sessions will be conducted in-person or online (using MS Teams), depending on preference and COVID-19-related restrictions. All sessions will be audio-recorded and transcribed.</description>
</arm_group>
<arm_group>
<arm_group_label>Cross-sectional study</arm_group_label>
<description>Procedures:
Consent will be obtained from residents, for those who have mental capacity to give informed consent, or from a nearest relative or caregiver as consultee, for those who lack capacity. Once consent is obtained, the LTC resident will be asked to complete a form asking about their characteristics and a questionnaire about their social connections which is expected to take approximately 15 minutes. The proxy will be asked to complete a sociodemographic form about themselves along with a number of questionnaires regarding the LTC resident's dementia severity, neuropsychiatric symptoms, activities of daily living and quality of life for comparison. Data collection for the proxy is expected to take approximately 30-60 minutes. Anticipated sample size 150 between Canada and the UK.</description>
</arm_group>
<eligibility>
<study_pop>
<textblock>
The study will purposively sample participants for diverse representation, including with
respect to age, sex, gender identity, sexual orientation, socioeconomic status, race,
ethnicity, and, marital status. To ensure a range of demographic characteristics and to
include traditionally under-represented groups, English language proficiency for people
living with dementia, LTC residents and caregivers (e.g. family, friend) is not a
requirement. Interpreters will be used for those not fluent in English and arranged through
the institution's interpreter services.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Qualitative study

Inclusion criteria:

- LTC residents with or without dementia: Able to provide consent for research.

- Caregivers: Visit the resident at least monthly (not including when COVID-related
visitor restrictions are in place).

- Clinicians/care staff: Whose role currently includes working in LTC home or has done
in past 2 years.

- Academic researchers: Have expertise in social functioning in dementia.

- All participants must be over the age of 18 years old to participate in the study.

Cross-sectional study Inclusion criteria

- LTC residents: Have a confirmed diagnosis of dementia OR Scoring ≥2 on the Noticeable
Problems Checklist

- Proxy: Visit or care for the resident at least once monthly.

- All participants must be over the age of 18 years old and have adequate English
language proficiency to participate in the study.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>110 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Andrew Sommerlad</last_name>
<phone>+442076799248</phone>
<email>a.sommerlad@ucl.ac.uk</email>
</overall_contact>
<overall_contact_backup>
<last_name>Jennifer Bethell</last_name>
<email>jennifer.bethell@uhn.ca</email>
</overall_contact_backup>
<location>
<facility>
<name>University Health Network</name>
<address>
<city>Toronto</city>
<state>Ontario</state>
<zip>M5G 2A2</zip>
<country>Canada</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Jennifer Bethell</last_name>
<email>jennifer.bethell@uhn.ca</email>
</contact>
</location>
<location>
<facility>
<name>Division of Psychiatry, University College London</name>
<address>
<city>London</city>
<zip>W1T 7NF</zip>
<country>United Kingdom</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Andrew Sommerlad</last_name>
<email>a.sommerlad@ucl.ac.uk</email>
</contact>
</location>
<location_countries>
<country>Canada</country>
<country>United Kingdom</country>
</location_countries>
<verification_date>May 2022</verification_date>
<study_first_submitted>March 18, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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 23, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Dementia</keyword>
<keyword>Long-term care</keyword>
<keyword>Outcome measurement</keyword>
<keyword>PROM</keyword>
<keyword>Psychometric</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Dementia</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 study aims to develop a new measure which can accurately assess social connection for
people with dementia living in long-term care homes. The Social Connection in Long-term Care
home residents (SONNET) study will use interviews and focus groups with people affected by
dementia and long-term care residents to establish what aspects of social connection are
important for people living in care homes. These findings and a review of other studies and
measures will be used to develop a new measure or measures of social connection which will
then be tested in a study based in care homes in Canada and the UK.
Research Question:
Can a new measure reliably and validly assess social connection for people with dementia in
care homes?
Background:
Social connection, including objective and subjective constructs relating to human
relationships, is a fundamental human need, but is impaired in people with dementia,
particularly in those living in long-term care (LTC) settings due to cognitive impairment,
complex health needs, and separation from previous social networks and community activities.
Measurement instruments therefore need to be tailored to the distinct characteristics of this
population and be tested in this setting, but there is no current evidence-based consensus on
the best approaches to measurement.
Objectives:
1. Appraise existing measures of social connection used in LTC homes
2. Evaluate which aspects of social connection are considered important by people affected
by dementia and professional staff
3. Develop a new measure informed by our appraisal of previous measures and the priorities
of key stakeholders and test its preliminary psychometric properties
Methods:
A systematic review of measurement instruments assessing social connection in LTC residents,
including dementia-specific measures will be conducted and measures will be appraised using
COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments)
methodology. Focus groups and qualitative interviews will then be conducted with 50-70 people
living with dementia, LTC residents, families, clinicians, care staff, and researchers in the
UK and Canada to establish the important aspects of social connection and its measurement,
including considerations for LTC residents with dementia and those with different stages of
dementia severity. Findings from the systematic review and qualitative study will be used to
inform the development of a measure or measures which will be iteratively refined during
interviews. Finally, the new measure(s) will be tested for psychometric properties in 150
people with dementia living in LTC homes in the UK and Canada to establish acceptability,
reliability, and validity.
The study will purposively sample participants for diverse representation, including with
respect to age, sex, gender identity, sexual orientation, socioeconomic status, race,
ethnicity, and, marital status. To ensure a range of demographic characteristics and to
include traditionally under-represented groups, English language proficiency for people
living with dementia, LTC residents and caregivers (e.g. family, friend) is not a
requirement. Interpreters will be used for those not fluent in English and arranged through
the institution's interpreter services.
Qualitative study
Inclusion criteria:
- LTC residents with or without dementia: Able to provide consent for research.
- Caregivers: Visit the resident at least monthly (not including when COVID-related
visitor restrictions are in place).
- Clinicians/care staff: Whose role currently includes working in LTC home or has done
in past 2 years.
- Academic researchers: Have expertise in social functioning in dementia.
- All participants must be over the age of 18 years old to participate in the study.
Cross-sectional study Inclusion criteria
- LTC residents: Have a confirmed diagnosis of dementia OR Scoring ≥2 on the Noticeable
Problems Checklist
- Proxy: Visit or care for the resident at least once monthly.
- All participants must be over the age of 18 years old and have adequate English
language proficiency to participate in the study.
|
NCT0531xxxx/NCT05315973.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/NCT05315973</url>
</required_header>
<id_info>
<org_study_id>801468</org_study_id>
<nct_id>NCT05315973</nct_id>
</id_info>
<brief_title>Personalized Fingertip Glucose Measurement With a Touch Sensor</brief_title>
<official_title>Personalized Fingertip Glucose Measurement With a Touch Sensor</official_title>
<sponsors>
<lead_sponsor>
<agency>University of California, San Diego</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of California, San Diego</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>
Self-testing of glucose by patients living with diabetes mellitus (DM) involves needles,
which causes discomfort or inconvenience eventually lead to decreased willingness to perform
such needle-based check-ups that are vital to DM management. While technology has evolved,
currently there is no glucose monitoring device that is needle-free. The investigators are
studying a glucose sensor that detects glucose non-invasively, from sweat on an individual's
fingertip. As it has not yet been tested in individuals with DM, the team will examine its
accuracy and acceptability in these patients. Results from this clinical trial could serve as
the basis for further development of a non-invasive glucose sensor.
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">June 1, 2022</start_date>
<completion_date type="Anticipated">July 1, 2023</completion_date>
<primary_completion_date type="Anticipated">June 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>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>Accuracy: glucose readings in mg/dL</measure>
<time_frame>1 day</time_frame>
<description>Correlation of touch sensor glucose readings compared with glucometer measurements</description>
</primary_outcome>
<secondary_outcome>
<measure>Acceptability: questionnaire ratings on a scale of 1-5, with 5 being the highest</measure>
<time_frame>1 day</time_frame>
<description>ease of use, and any other comments to optimize the design and function of this sensor, as reported by the participants</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">25</enrollment>
<condition>Diabetes Mellitus</condition>
<arm_group>
<arm_group_label>Sensor group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Testing sensor vs glucometer</intervention_name>
<description>Will test accuracy of this sensor; there will be no intervention.</description>
<arm_group_label>Sensor group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- An existing diagnosis of diabetes mellitus, either T1DM or T2DM, or any other type or
etiology of diabetes

- Having a hemoglobin A1c < 9.0%, and taking medication for diabetes. Individuals will
bring their own lab report.

- Ability to provide informed consent for participation.

Exclusion Criteria:

- Individuals without diabetes

- Uncontrolled medical conditions, including diabetes with a hemoglobin A1c > 9.0%,
hypertension, heart, kidney, or liver failure.

- Those who cannot speak or read English. Participation will be limited to those who
read and speak English, as this is a pilot study of a small number of participants,
that will very unlikely offer the prospect of direct benefit from participating.

- Individuals who have frequent hypoglycemia, hypoglycemia unawareness, or who are at
high risk for hypoglycemia.
</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>Edward C Chao, DO</last_name>
<role>Principal Investigator</role>
<affiliation>University of California, San Diego</affiliation>
</overall_official>
<overall_contact>
<last_name>Marielys Padilla-Martinez</last_name>
<phone>858-534-4449</phone>
<email>mpadillamartinez@health.ucsd.edu</email>
</overall_contact>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 15, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 29, 2022</last_update_submitted>
<last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of California, San Diego</investigator_affiliation>
<investigator_full_name>Edward Chao</investigator_full_name>
<investigator_title>Clinical Professor of Medicine</investigator_title>
</responsible_party>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>This will include all data collected in the study, sensor glucose readings, as well as glucometer measurements.</ipd_description>
<ipd_info_type>Study Protocol</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>approximately 10 yrs</ipd_time_frame>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Self-testing of glucose by patients living with diabetes mellitus (DM) involves needles,
which causes discomfort or inconvenience eventually lead to decreased willingness to perform
such needle-based check-ups that are vital to DM management. While technology has evolved,
currently there is no glucose monitoring device that is needle-free. The investigators are
studying a glucose sensor that detects glucose non-invasively, from sweat on an individual's
fingertip. As it has not yet been tested in individuals with DM, the team will examine its
accuracy and acceptability in these patients. Results from this clinical trial could serve as
the basis for further development of a non-invasive glucose sensor.
Inclusion Criteria:
- An existing diagnosis of diabetes mellitus, either T1DM or T2DM, or any other type or
etiology of diabetes
- Having a hemoglobin A1c < 9.0%, and taking medication for diabetes. Individuals will
bring their own lab report.
- Ability to provide informed consent for participation.
Exclusion Criteria:
- Individuals without diabetes
- Uncontrolled medical conditions, including diabetes with a hemoglobin A1c > 9.0%,
hypertension, heart, kidney, or liver failure.
- Those who cannot speak or read English. Participation will be limited to those who
read and speak English, as this is a pilot study of a small number of participants,
that will very unlikely offer the prospect of direct benefit from participating.
- Individuals who have frequent hypoglycemia, hypoglycemia unawareness, or who are at
high risk for hypoglycemia.
|
NCT0531xxxx/NCT05315986.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/NCT05315986</url>
</required_header>
<id_info>
<org_study_id>R210281</org_study_id>
<nct_id>NCT05315986</nct_id>
</id_info>
<brief_title>Exploration of Relationships Between Sleep, Gut Health and Cognition</brief_title>
<official_title>The Gut-sleep-brain Axis: Targeting the Gut Microbiota and Sleep Quality by Individualized Non-pharmaceutical Approaches to Promote Healthy Ageing.</official_title>
<sponsors>
<lead_sponsor>
<agency>University of East Anglia</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of East Anglia</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>
Our study aims to build on emerging evidence showing relationships between gut health, sleep
and brain functions. To achieve this, our study aims to test the feasibility of using
non-pharmacological interventions: a psychoeducation-based intervention (enhanced sleep
education - ESE) and a dietary supplement (Saffron extract), to improve sleep in older adults
with insomnia complaints. Our study also aims to test the feasibility of using wearable and
commercially available EEG headband technology to measure objective sleep quality in the
home, which will allow for a reliable and ecologically more valid sleep research.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
One-third of the UK adult population presents with disordered sleep, and the prevalence
further increases with ageing. Disordered sleep has also been identified as a risk factor for
dementia, which is alarming given that cases of dementia are predicted to triple across the
world by 2050.

Our study aims to build on emerging evidence showing relationships between gut health, sleep,
and brain functions. To achieve this, our study aims to test the feasibility of using
non-pharmacological interventions: a psychoeducation-based intervention (enhanced sleep
education - ESE) and a dietary supplement (Saffron extract), to improve sleep in older adults
with insomnia. The study aims to test the feasibility of using wearable sleep tracking EEG
technology (DREEM3 device) to measure sleep quality in the home environment, which could
contribute to a reliable but naturalistic and accessible future sleep research.

The study is split into 4 phases:

Screening phase: Participants will be asked to complete an online screening assessment to
check for eligibility.

Baseline assessment phase (1 week): Participants will complete in-person testing in the Sleep
and Brain Research Unit (SBRU) located at the University of East Anglia, to assess their
cognitive functions, psychological well-being, and postural control. They will be asked to
provide a faecal sample to profile the baseline gut microbiota, a urine sample to gain a
baseline measure for testing supplement adherence and wear the DREEM3 headband device and
complete a sleep diary to track their sleep quality with a high accuracy in their habitual
home environment.

Intervention phase (4 weeks): Participants will be randomly assigned to 1 of 4 groups
following a factorial design: Group 1: Food supplement & ESE; Group 2: Food supplement & No
ESE (control); Group 3: Placebo (control) & ESE, and Group 4: Placebo (control) & No ESE
(control). These groups will allow us to test the effectiveness of each non-pharmacological
intervention for feasibility.

Follow-up assessment (1 week - overlap with the last week of intervention): Participants will
be asked to measure their sleep at home using the DREEM3 EEG device and complete a sleep
diary, and finally will be re-tested for cognitive performance, psychological wellbeing, and
postural control. A follow-up faecal sample and urine sample will be collected as well.

This research predicts that it is feasible for sleep difficulties in older adults to be
objectively assessed in the home environment and non-pharmacologically treated using food
supplements and behavioural techniques. It endeavours to provide pilot evidence for the
effectiveness of future individualized non-pharmaceutical sleep treatments in older people at
risk of dementia.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 29, 2022</start_date>
<completion_date type="Anticipated">December 15, 2022</completion_date>
<primary_completion_date type="Anticipated">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>Randomized</allocation>
<intervention_model>Factorial Assignment</intervention_model>
<intervention_model_description>Forty-eight (i.e. n=12 per group; 4 groups) healthy older adults aged 55 and over with subjective sleep complaints will be recruited for this 4-week double blinded placebo controlled feasibility study. This project will adopt a 2 x 2 Factorial design.</intervention_model_description>
<primary_purpose>Other</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
<masking_description>Participant's and Investigators will be blinded to which participants are receiving the dietary saffron supplement and placebo. Random allocation will be conducted by an independent researcher.
Participants and investigators will not be blinded to which participants have been allocated ot the ESE intervention.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Number of nights on which participants used the Dreem headband over a 14 day period</measure>
<time_frame>2 weeks</time_frame>
<description>Frequency of Dreem headband usage over a 14 day period will be used to measure device adherence rates. Higher adherence rates will indicate higher levels of acceptability of the device as a method of measuring electrical activity (electroencephalogram) within the home environment</description>
</primary_outcome>
<primary_outcome>
<measure>Mean percentage of Dreem device signal quality over a 14 day period</measure>
<time_frame>2 weeks</time_frame>
<description>Signal quality will range from 0-100%, with percentages >80% indicating good signal quality. Higher signal quality will indicate higher levels of feasibility of the device as a method of measuring objective sleep quality based on electrical activity of the brain (electroencephalogram) within the home environment.</description>
</primary_outcome>
<primary_outcome>
<measure>Number of Participants who report that they made changes to their sleeping habits following engagement in Enhanced Sleep Education (ESE).</measure>
<time_frame>4 weeks</time_frame>
<description>Frequency of participants who make self-reported changed to their sleeping habits will be used to measure adherence rates to the Enhanced Sleep Education (ESE) intervention. Higher adherence to the intervention will indicate higher acceptability of this method for treating sleep complaints.</description>
</primary_outcome>
<primary_outcome>
<measure>Changes in scores on the self-reported sleep quality measure using the Pittsburgh Sleep Quality Index (PSQI) pre/post treatment conditions compared to a placebo.</measure>
<time_frame>4 weeks</time_frame>
<description>Changes in scores on the Pittsburgh Sleep Quality Index (PSQI) pre/post treatment conditions compared to a placebo will be used to measure feasibility of using proposed treatment conditions to treat sleep difficulties. Treatment conditions include: Enhanced Sleep Education (ESE) intervention X Dietary Supplement (Saffr'Inside), ESE X Placebo, No ESE (control) X Dietary Supplement (Saffr'Inside), No ESE (control) X Placebo. A decrease in scores on the PSQI would indicate improved sleep and suggest feasibility of using the described treatment conditions to improve subjective sleep complaints. (Highest score = 21, Lowest score = 0)</description>
</primary_outcome>
<primary_outcome>
<measure>Changes in scores on the Insomnia Severity Index (ISI) pre/post treatment conditions compared to a placebo.</measure>
<time_frame>4 weeks</time_frame>
<description>Changes in Insomnia Severity Index (ISI) pre/post treatment conditions compared to a placebo will be used to measure feasibility of using proposed treatment conditions to treat sleep difficulties. Treatment conditions include: Enhanced Sleep Education (ESE) intervention X Dietary Supplement (Saffr'Inside), ESE X Placebo, No ESE (control) X Dietary Supplement (Saffr'Inside), No ESE (control) X Placebo. A decrease in scores on the ISI would indicate improved sleep and suggest feasibility of using the proposed treatment conditions to improve subjective sleep complaints. (Highest score = 28, Lowest score= 0)</description>
</primary_outcome>
<primary_outcome>
<measure>Changes in objective sleep quality as measured by the sleep efficiency index based on the Dreem electroencephalogram headband pre/post treatment conditions compared to a placebo.</measure>
<time_frame>4 weeks</time_frame>
<description>Sleep efficiency index will be measured using percentage (sleep efficiency = total sleep time / time in bed x 100).
Changes in sleep efficiency index of sleep will be used to measure the feasibility of the proposed treatment conditions on improving objective sleep quality. Higher percentages of sleep efficiency suggest improved sleep.</description>
</primary_outcome>
<primary_outcome>
<measure>Changes in the time spent awake following initial sleep onset (in minutes) as measured by the Dreem electroencephalogram headband pre/post treatment conditions compared to a placebo.</measure>
<time_frame>4 weeks</time_frame>
<description>Changes in the time spent awake following initial sleep onset (in minutes) will be used to measure objective sleep quality. Decreases in time spent awake following initial sleep onset (in minutes) will suggest feasibility of proposed treatment conditions for improving objective sleep quality.</description>
</primary_outcome>
<primary_outcome>
<measure>Mean number of days on which participants ingested the dietary supplements (Saffr'Inside) per subject over a 4 week period</measure>
<time_frame>4 weeks</time_frame>
<description>Frequency (mean number of days per subject) of ingestion of the dietary supplement will be used to measure the adherence rate of the supplement. Higher adherence rates will indicate higher levels of acceptability of using a supplement to improve sleep complaints.</description>
</primary_outcome>
<secondary_outcome>
<measure>Changes in scores on the Patient Health Questionnaire (PHQ-9) pre/post treatment conditions compared to a placebo.</measure>
<time_frame>4 weeks</time_frame>
<description>Changes in scores on the Patient Health Questionnaire (PHQ-9) pre/post treatment conditions compared to a placebo will be used to measure the feasibility of proposed treatment conditions to improve Psychological wellbeing. A decrease in scores indicates a decrease in experiences of low mood and improved psychological wellbeing. (highest score = 27, lowest score = 0)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in the time to complete (in seconds) on the Trail Making Task B pre/post treatment conditions compared to a placebo.</measure>
<time_frame>4 weeks</time_frame>
<description>Changes in completion time (in seconds) on the Trail Making Task B pre/post treatment conditions compared to a placebo will be used measure changes in participants cognitive functioning. Decreases in completion time would suggest improve cognitive functioning.</description>
</secondary_outcome>
<other_outcome>
<measure>Changes in gut microbiome composition following a period of ingesting a dietary supplement (Saffr'Inside)</measure>
<time_frame>4 weeks</time_frame>
<description>To examine species composition, we will perform community analysis via 16S rRNA sequencing. DNA will be extracted from faecal samples and a 250bp region from the V3-V4 hyper-variable region amplified and sequenced on the Illumina MiSeq platform. Principle coordinates analysis (PCoA) of UniFrac/Bray-Curtis distances and ANOSIM/PERMANOVA tests will be used to identify differences in microbial community structure between control and treatment groups pre/post intervention.</description>
</other_outcome>
<number_of_arms>4</number_of_arms>
<enrollment type="Anticipated">48</enrollment>
<condition>Insomnia</condition>
<condition>Sleep Disturbance</condition>
<arm_group>
<arm_group_label>Group 1: Sleep intervention (ESE) & Saffron (food supplement)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Saffron: Dietary supplement consists of a gummy sweet (Saffr'Inside; 30mg). Ingest one gummy per day for a duration of 4 weeks total.
Enhanced Sleep Education (ESE): Receive a psycho-education based multi-component sleep intervention consisting of: Sleep education, Sleep hygiene, mindfulness and sleep behavioural recommendations adapted from the validated Brief Behaviour Treatment for Insomnia (BBTi) intervention.The intervention is presented to participants via a pre-recorded presentation, lasting approximately 15 minutes. Participants will also receive some personalized feedback from their objective sleep measurements, collected from their EEG data to help them better understand their sleep patterns.</description>
</arm_group>
<arm_group>
<arm_group_label>Group 2: Sleep intervention (ESE) & No Saffron (placebo food supplement)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Placebo (no Saffron): Placebo food supplement identical looking (gummy sweet) to experimental food supplement. Ingestion of one gummy per day for a duration of 4 weeks total.
Enhanced Sleep Education (ESE): Receive a psycho-education based multi-component sleep intervention consisting of: Sleep education, Sleep hygiene, mindfulness and sleep behavioural recommendations adapted from the validated Brief Behaviour Treatment for Insomnia (BBTi) intervention.The intervention is presented to participants via a pre-recorded presentation, lasting approximately 15 minutes. Participants will also receive some personalized feedback from their objective sleep measurements, collected from their EEG data to help them better understand their sleep patterns.</description>
</arm_group>
<arm_group>
<arm_group_label>Group 3: No sleep intervention (Control ESE) & Saffron (food supplement)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Saffron: Dietary supplement consists of a gummy sweet (Saffr'Inside; 30mg). Ingest one gummy per day for a duration of 4 weeks total.
No Psycho-education (ESE) intervention. Control.</description>
</arm_group>
<arm_group>
<arm_group_label>Group 4: No sleep intervention (Control ESE) & No Saffron (placebo food supplement)</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Placebo (no Saffron): Placebo food supplement identical looking (gummy sweet) to experimental food supplement. Ingestion of one gummy per day for a duration of 4 weeks total.
No Psycho-education (ESE) intervention. Control.</description>
</arm_group>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Saffr'Inside; 30mg</intervention_name>
<description>Ingestion of one gummy sweet of Saffr'Inside; 30mg, on a daily basis for 4 weeks.</description>
<arm_group_label>Group 1: Sleep intervention (ESE) & Saffron (food supplement)</arm_group_label>
<arm_group_label>Group 3: No sleep intervention (Control ESE) & Saffron (food supplement)</arm_group_label>
</intervention>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Enhanced Sleep Education</intervention_name>
<description>Psycho-education based multi-component sleep intervention</description>
<arm_group_label>Group 1: Sleep intervention (ESE) & Saffron (food supplement)</arm_group_label>
<arm_group_label>Group 2: Sleep intervention (ESE) & No Saffron (placebo food supplement)</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Placebo food supplement</intervention_name>
<description>Placebo food supplement identical to the active gummy sweet of Saffr'Inside; 30mg, on a daily basis for 4 weeks.</description>
<arm_group_label>Group 2: Sleep intervention (ESE) & No Saffron (placebo food supplement)</arm_group_label>
<arm_group_label>Group 4: No sleep intervention (Control ESE) & No Saffron (placebo food supplement)</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Aged over 55 years

2. Conversational English and capacity to consent

3. Availability to take part in the study

4. Subjective sleep complaints of impaired sleep quality or insufficient sleep

5. Participants with no clinical diagnosis or signs of dementia (m-ACE-III score above
21)

6. Potential for sleep complications such as insomnia before the study

7. A body mass index between 20 and 35 for men, and 18.5 and 35 for women

8. High Score on Pittsburgh Sleep Quality Index (PSQI; > 5) OR The Insomnia Severity
Index (ISI; > 10)

Exclusion Criteria:

1. Acute infections or diseases

2. Psychiatric disorders or chronic neurological conditions include a diagnosis of
dementia, mild cognitive impairment (MCI)/ prodromal AD.

3. Learning, sensory, or motor impairment/ disabilities that would pose an unfair
disadvantage in the cognitive tests

4. Chronic pain conditions

5. Currently taking blood thinning medications

6. Current diagnosis of malignant tumours/ cancers

7. Worked as a shift worker or travelled across more than three time zones in the past
two months

8. Alcohol consumption above 14 units/week and/ use or dependency of illicit
substances/alcohol

9. Consume more than 5 cups of caffeinated beverages (e.g., coffee/tea/coke, etc) per
day.

10. Smokers (tobacco, e-cigarettes, or vapes)

11. Taking antibiotics, or any dietary supplements that may interfere with study outcomes.

12. Self-quarantined or presumed positive status for COVID-19 (see considerations for
COVID-19 in safety and comfort section).

13. Currently enrolled or enrolled previously (within the last 2 months) in a drug trial.

14. Participants who show signs or symptoms of having dementia.

15. Participants with high scores (>10) on the Patient Heath Questionnaire-9 (PHQ-9)
depression scale and/ or who indicate that they have suicidal thoughts

16. A diagnosis of untreated sleep apnoea or another sleep-related disorder excluding
insomnia
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>55 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Alpar S Lazar, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>University of East Anglia</affiliation>
</overall_official>
<overall_contact>
<last_name>Alpar S Lazar, PhD</last_name>
<phone>01603 592605</phone>
<email>a.lazar@uea.ac.uk</email>
</overall_contact>
<overall_contact_backup>
<last_name>David Vauzour, PhD</last_name>
<phone>01603 591732</phone>
<email>d.vauzour@uea.ac.uk</email>
</overall_contact_backup>
<verification_date>February 2022</verification_date>
<study_first_submitted>February 21, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 29, 2022</last_update_submitted>
<last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>sleep</keyword>
<keyword>polysomonography</keyword>
<keyword>food supplement</keyword>
<keyword>gut health</keyword>
<keyword>microbiome</keyword>
<keyword>cognition</keyword>
<keyword>EEG</keyword>
<keyword>Dreem3</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>Yes</sharing_ipd>
<ipd_description>IPD may include: Participant contact details, Participant demographic information, Participant scores on screening questionnaires and DNA extracted from urine/fecal samples.
Data will be shared with other researchers within the University of East Anglia (UEA) if Participants consent to this, so that individuals can be contacted of similar research studies going on at the UEA that they may be eligible to be enrolled in.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
<ipd_time_frame>Data will become available following completion of the study for a minimum of 10 years.</ipd_time_frame>
<ipd_access_criteria>Data will only be shared with researchers at the UEA.</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Our study aims to build on emerging evidence showing relationships between gut health, sleep
and brain functions. To achieve this, our study aims to test the feasibility of using
non-pharmacological interventions: a psychoeducation-based intervention (enhanced sleep
education - ESE) and a dietary supplement (Saffron extract), to improve sleep in older adults
with insomnia complaints. Our study also aims to test the feasibility of using wearable and
commercially available EEG headband technology to measure objective sleep quality in the
home, which will allow for a reliable and ecologically more valid sleep research.
One-third of the UK adult population presents with disordered sleep, and the prevalence
further increases with ageing. Disordered sleep has also been identified as a risk factor for
dementia, which is alarming given that cases of dementia are predicted to triple across the
world by 2050.
Our study aims to build on emerging evidence showing relationships between gut health, sleep,
and brain functions. To achieve this, our study aims to test the feasibility of using
non-pharmacological interventions: a psychoeducation-based intervention (enhanced sleep
education - ESE) and a dietary supplement (Saffron extract), to improve sleep in older adults
with insomnia. The study aims to test the feasibility of using wearable sleep tracking EEG
technology (DREEM3 device) to measure sleep quality in the home environment, which could
contribute to a reliable but naturalistic and accessible future sleep research.
The study is split into 4 phases:
Screening phase: Participants will be asked to complete an online screening assessment to
check for eligibility.
Baseline assessment phase (1 week): Participants will complete in-person testing in the Sleep
and Brain Research Unit (SBRU) located at the University of East Anglia, to assess their
cognitive functions, psychological well-being, and postural control. They will be asked to
provide a faecal sample to profile the baseline gut microbiota, a urine sample to gain a
baseline measure for testing supplement adherence and wear the DREEM3 headband device and
complete a sleep diary to track their sleep quality with a high accuracy in their habitual
home environment.
Intervention phase (4 weeks): Participants will be randomly assigned to 1 of 4 groups
following a factorial design: Group 1: Food supplement & ESE; Group 2: Food supplement & No
ESE (control); Group 3: Placebo (control) & ESE, and Group 4: Placebo (control) & No ESE
(control). These groups will allow us to test the effectiveness of each non-pharmacological
intervention for feasibility.
Follow-up assessment (1 week - overlap with the last week of intervention): Participants will
be asked to measure their sleep at home using the DREEM3 EEG device and complete a sleep
diary, and finally will be re-tested for cognitive performance, psychological wellbeing, and
postural control. A follow-up faecal sample and urine sample will be collected as well.
This research predicts that it is feasible for sleep difficulties in older adults to be
objectively assessed in the home environment and non-pharmacologically treated using food
supplements and behavioural techniques. It endeavours to provide pilot evidence for the
effectiveness of future individualized non-pharmaceutical sleep treatments in older people at
risk of dementia.
Inclusion Criteria:
1. Aged over 55 years
2. Conversational English and capacity to consent
3. Availability to take part in the study
4. Subjective sleep complaints of impaired sleep quality or insufficient sleep
5. Participants with no clinical diagnosis or signs of dementia (m-ACE-III score above
21)
6. Potential for sleep complications such as insomnia before the study
7. A body mass index between 20 and 35 for men, and 18.5 and 35 for women
8. High Score on Pittsburgh Sleep Quality Index (PSQI; > 5) OR The Insomnia Severity
Index (ISI; > 10)
Exclusion Criteria:
1. Acute infections or diseases
2. Psychiatric disorders or chronic neurological conditions include a diagnosis of
dementia, mild cognitive impairment (MCI)/ prodromal AD.
3. Learning, sensory, or motor impairment/ disabilities that would pose an unfair
disadvantage in the cognitive tests
4. Chronic pain conditions
5. Currently taking blood thinning medications
6. Current diagnosis of malignant tumours/ cancers
7. Worked as a shift worker or travelled across more than three time zones in the past
two months
8. Alcohol consumption above 14 units/week and/ use or dependency of illicit
substances/alcohol
9. Consume more than 5 cups of caffeinated beverages (e.g., coffee/tea/coke, etc) per
day.
10. Smokers (tobacco, e-cigarettes, or vapes)
11. Taking antibiotics, or any dietary supplements that may interfere with study outcomes.
12. Self-quarantined or presumed positive status for COVID-19 (see considerations for
COVID-19 in safety and comfort section).
13. Currently enrolled or enrolled previously (within the last 2 months) in a drug trial.
14. Participants who show signs or symptoms of having dementia.
15. Participants with high scores (>10) on the Patient Heath Questionnaire-9 (PHQ-9)
depression scale and/ or who indicate that they have suicidal thoughts
16. A diagnosis of untreated sleep apnoea or another sleep-related disorder excluding
insomnia
|
NCT0531xxxx/NCT05315999.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/NCT05315999</url>
</required_header>
<id_info>
<org_study_id>P003161</org_study_id>
<nct_id>NCT05315999</nct_id>
</id_info>
<brief_title>Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care</brief_title>
<acronym>ProTreat</acronym>
<official_title>Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care: A Randomized Controlled Phase II Feasibility Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Gerhild Becker</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University Hospital Freiburg</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>
Palliative cancer patients with tumor pain often suffer from nausea and vomiting when
starting pain therapy with opioids. The objective of the clinical pilot trial is to evaluate
the efficacy and tolerability of palonosetron in the prophylactic treatment of opioid-induced
nausea and vomiting.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Pain is one of the most common and debilitating symptoms in patients with advanced cancer and
opioids are the main stay of treatment for cancer pain. However, initiation of opioid-therapy
is frequently hindered by OINV. OINV is a highly distressing symptom and can affect
medication compliance, enteral absorption, and quality of life.This Phase II feasibility
study is conducted to assess the feasibility of the prophylactic antiemetic treatment of OINV
with palonosetron in comparison to placebo. The objective is to investigate the feasibility
of patient recruitment and implementation of the study design as well as to obtain an initial
estimate of the antiemetic efficacy and safety of prophylactic treatment of OINV with
palonosetron compared to placebo. A total of 30 palliative patients starting an
opioid-therapy (WHO III) for cancer pain will be randomly assigned to receive either a single
dose of placebo or palonosetron. Safety and efficiency assessment are based on patient
reports regarding OINV, pain and safety parameters during the following 6 days.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">May 2022</start_date>
<completion_date type="Anticipated">May 2023</completion_date>
<primary_completion_date type="Anticipated">May 2023</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>Treatment</primary_purpose>
<masking>Triple (Participant, Care Provider, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Feasibility of the study design</measure>
<time_frame>12 months</time_frame>
<description>Rates of patient recruitment per month, screening failures, drop-out from the trial.</description>
</primary_outcome>
<primary_outcome>
<measure>Number of patients who show no relevant increase of nausea</measure>
<time_frame>day 1 to day 6</time_frame>
<description>Number of patients who show no relevant increase of nausea after starting opioid therapy at any of the following 6 days. Nausea scores are assessed on an increasing 11-point numeric rating scale (NRS) from 0 to 10, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity according to the Edmonton Symptom Assessment Schedule (ESAS). Relevant is an increase on this NRS ≥1, which reflects the minimal clinically important difference (MCID) for nausea</description>
</primary_outcome>
<secondary_outcome>
<measure>Complete response of OINV</measure>
<time_frame>day 1 to day 6</time_frame>
<description>Complete response defined as no emetic episodes, no nausea, no rescue anti-emetic. Comparing Palonosetron treatment with placebo</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time to OINV</measure>
<time_frame>day 1 to day 6</time_frame>
<description>Time to emetic episodes or nausea or rescue antiemetic after randomisation, comparing Palonosetron treatment with placebo</description>
</secondary_outcome>
<secondary_outcome>
<measure>Nausea</measure>
<time_frame>day 1 to day 6</time_frame>
<description>Occurrence and severity of nausea rated by the participants on a 11-point numeric rating scale (NRS), comparing Palonosetron treatment with placebo. Nausea scores are assessed on an increasing 11-point numerical scale from 0 to 10, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity according to the Edmonton Symptom Assessment Schedule (ESAS).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Vomiting</measure>
<time_frame>day 1 to day 6</time_frame>
<description>Occurrence of vomiting, comparing Palonosetron treatment with placebo</description>
</secondary_outcome>
<secondary_outcome>
<measure>Pain control</measure>
<time_frame>day 1 to day 6</time_frame>
<description>Daily opioid intake and pain score rated by the participants on a 11-point numeric rating scale (NRS). Pain scores are assessed on an increasing 11-point numerical scale from 0 to 10, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity according to the Edmonton Symptom Assessment Schedule (ESAS)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Rescue anti-emetics</measure>
<time_frame>day 1 to day 6</time_frame>
<description>The use of rescue anti-emetics, comparing Palonosetron treatment with placebo</description>
</secondary_outcome>
<secondary_outcome>
<measure>Participant's burden by nausea, pain, constipation and headache</measure>
<time_frame>day 1 to day 6</time_frame>
<description>Assessed by a questionnaire: Patients are asked to assign the burden of their symptoms to one of 4 categories: not at all, a little, strongly, extremely strongly</description>
</secondary_outcome>
<secondary_outcome>
<measure>Severity of constipation</measure>
<time_frame>day1 and day 6</time_frame>
<description>Stool consistency and frequency, bowel function index (BFI)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Symptom preferences</measure>
<time_frame>day1 and day 6</time_frame>
<description>Patients were asked to rank 5 possible symptoms (tumor pain, nausea, vomiting, constipation, headache) from their most undesired to their most acceptable symptom. Rated by the participants at day 6 and compared to baseline.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Percentage of participants reporting any grade 3 adverse event (AE) or any serious adverse event (SAE) from patients from the time of the signed ICF to the end of the study.</measure>
<time_frame>day 1 to day 6</time_frame>
<description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Patient satisfaction with the study drug</measure>
<time_frame>day 6</time_frame>
<description>Patients are asked to rate speed of action of the study drug received, the satisfaction with the overall control of nausea and emesis using 4 categories (very satisfied, satisfied, dissatisfied, very dissatisfied) and the and willingness to use the study drug again (yes, no, unknown). Rated by the participants at day 6.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">30</enrollment>
<condition>Nausea</condition>
<condition>Vomiting</condition>
<condition>Pain</condition>
<condition>Advanced Cancer</condition>
<arm_group>
<arm_group_label>Palonosetron Hydrochloride</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Palonosetron (500µg): single dose per os 1-2 hours before the start of opioid-therapy (WHO III)</description>
</arm_group>
<arm_group>
<arm_group_label>Placebo</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Placebo: single dose per os 1-2 hours before the start of opioid-therapy (WHO III)</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Palonosetron Hydrochloride</intervention_name>
<description>Palonosetron (500µg): single dose per os 1-2 hours before the start of opioid-therapy (WHO III)</description>
<arm_group_label>Palonosetron Hydrochloride</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>Placebo: single dose per os 1-2 hours before the start of opioid-therapy (WHO III)</description>
<arm_group_label>Placebo</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Patients aged ≥18 years

2. Opioid naïve (no opioids intake within last 72 hours) patients in whom opioid therapy
(WHO III) is started to treat cancer pain;

3. Palliative (not curable) cancer pain patients;

4. The latest laboratory values before registration meet the following criteria:
Potassium within normal range: 3,5 - 5,1 mmol/l;

5. Patients must have a score for nausea on a 0-10 numeric rating scale (NRS) < 3 at
screening visit;

6. Patients under risk for QT prolongation (e.g. history of cardiac disease, receiving
concomitant medication known to cause QT-prolongation, electrolyte abnormalities must
show an Electrocardiogram with no QTc prolongation (QTc men> 460 msec; women
>440msec);

7. Written informed consent obtained according to international guidelines and local
laws;

8. Ability of patient to understand nature, importance, and individual consequences of
clinical trial;

9. Patients must be able to adhere to the study visit schedule and other protocol
requirements.

Exclusion Criteria:

1. Patient's death is imminent (judged by the "surprise" question of the treating
physician or nurse: "Would you be surprised if this patient died within the next 7
days?"); If the answer is "no", trial subject cannot participate;

2. Participation in the trial considered inappropriate based on the patient's physical,
social, psychological, or spiritual condition (judgement of treating physician or
nurse);

3. Patients if they had other known acute reasons for nausea and/or emesis, e.g.:

1. were undergoing chemotherapy < 72 h before or during the study treatment period;

2. were undergoing radiotherapy to the skull or abdomen < 72 h before or during the
study treatment period;

3. were undergoing surgical procedures or non-invasive procedures under general
anaesthesia < 72 h before or during the study treatment period;

4. a score for nausea on a 0-10 numeric rating scale ≥ 3 at screening visit;

5. other reason;

4. Patients with contraindications or hypersensitivity to opioids or palonosetron,
fructose, soya, lactose or peanut intolerance;

5. Patients unable to take oral medications;

6. Patients undergoing dialyses treatment;

7. Known or persistent abuse of medication, drugs, or alcohol;

8. Current or planned pregnancy, nursing period;

9. Patients who are sexually active and unwilling to use highly effective contraceptive
methods. The following contraceptive methods with a Pearl Index lower than 1% are
regarded as highly effective:

1. Oral hormonal contraception ('pill')

2. Dermal hormonal contraception

3. Vaginal hormonal contraception (NuvaRing®)

4. Contraceptive plaster

5. Long-acting injectable contraceptives

6. Implants that release progesterone (Implanon®)

7. Tubal ligation (female sterilisation)

8. Intrauterine devices that release hormones (hormone spiral)

9. Double barrier methods

This means that the following are not regarded as safe: condom plus spermicide, simple
barrier methods (vaginal pessaries, condom, and female condoms), copper spirals, the
rhythm method, basal temperature method, and the withdrawal method (coitus
interruptus).

Except: Female patients who are surgically sterilised by hysterectomy or who are
expected to be postmenopausal are eligible for this trial. A lack of menstruation of
at least 12 months will be considered as a proof to be postmenopausal.

Men must agree to use a latex condom during sexual contact with females of
childbearing potential while participating in this study even if they have undergone a
successful vasectomy.

Patients must abstain from donating blood, semen, or sperm during participation in the
study.

10. Simultaneous participation in any other interventional clinical trial within the last
14 days before the start of this trial; simultaneous participation in registry and
diagnostic trials is allowed;

11. Patients without legal German language capacity who are unable to understand the
nature, significance and consequences of the trial or any other co-existing medical or
psychological condition that will preclude participation in the study;

12. Persons who are in a relationship of dependence/employment with the sponsor or the
investigator will be excluded.
</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>Gerhild Becker, Prof. Dr. med.</last_name>
<role>Study Chair</role>
<affiliation>Clinic for Palliative Care, Medical Center, University of Freiburg, Germany</affiliation>
</overall_official>
<overall_contact>
<last_name>Arlette Tais, Dr.</last_name>
<phone>+49 761 270-34438</phone>
<email>arlette.tais@uniklinik-freiburg.de</email>
</overall_contact>
<location>
<facility>
<name>Clinic for Palliative Care, Medical Center, University of Freiburg</name>
<address>
<city>Freiburg</city>
<zip>D-79106</zip>
<country>Germany</country>
</address>
</facility>
<contact>
<last_name>Gerhild Becker, Prof.</last_name>
<phone>+49 761 270 - 95412</phone>
<email>gerhild.becker@uniklinik-freiburg.de</email>
</contact>
</location>
<location_countries>
<country>Germany</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 2, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 29, 2022</last_update_submitted>
<last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>University Hospital Freiburg</investigator_affiliation>
<investigator_full_name>Gerhild Becker</investigator_full_name>
<investigator_title>Prof. Dr. med.</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>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Palonosetron</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Palliative cancer patients with tumor pain often suffer from nausea and vomiting when
starting pain therapy with opioids. The objective of the clinical pilot trial is to evaluate
the efficacy and tolerability of palonosetron in the prophylactic treatment of opioid-induced
nausea and vomiting.
Pain is one of the most common and debilitating symptoms in patients with advanced cancer and
opioids are the main stay of treatment for cancer pain. However, initiation of opioid-therapy
is frequently hindered by OINV. OINV is a highly distressing symptom and can affect
medication compliance, enteral absorption, and quality of life.This Phase II feasibility
study is conducted to assess the feasibility of the prophylactic antiemetic treatment of OINV
with palonosetron in comparison to placebo. The objective is to investigate the feasibility
of patient recruitment and implementation of the study design as well as to obtain an initial
estimate of the antiemetic efficacy and safety of prophylactic treatment of OINV with
palonosetron compared to placebo. A total of 30 palliative patients starting an
opioid-therapy (WHO III) for cancer pain will be randomly assigned to receive either a single
dose of placebo or palonosetron. Safety and efficiency assessment are based on patient
reports regarding OINV, pain and safety parameters during the following 6 days.
Inclusion Criteria:
1. Patients aged ≥18 years
2. Opioid naïve (no opioids intake within last 72 hours) patients in whom opioid therapy
(WHO III) is started to treat cancer pain;
3. Palliative (not curable) cancer pain patients;
4. The latest laboratory values before registration meet the following criteria:
Potassium within normal range: 3,5 - 5,1 mmol/l;
5. Patients must have a score for nausea on a 0-10 numeric rating scale (NRS) < 3 at
screening visit;
6. Patients under risk for QT prolongation (e.g. history of cardiac disease, receiving
concomitant medication known to cause QT-prolongation, electrolyte abnormalities must
show an Electrocardiogram with no QTc prolongation (QTc men> 460 msec; women
>440msec);
7. Written informed consent obtained according to international guidelines and local
laws;
8. Ability of patient to understand nature, importance, and individual consequences of
clinical trial;
9. Patients must be able to adhere to the study visit schedule and other protocol
requirements.
Exclusion Criteria:
1. Patient's death is imminent (judged by the "surprise" question of the treating
physician or nurse: "Would you be surprised if this patient died within the next 7
days?"); If the answer is "no", trial subject cannot participate;
2. Participation in the trial considered inappropriate based on the patient's physical,
social, psychological, or spiritual condition (judgement of treating physician or
nurse);
3. Patients if they had other known acute reasons for nausea and/or emesis, e.g.:
1. were undergoing chemotherapy < 72 h before or during the study treatment period;
2. were undergoing radiotherapy to the skull or abdomen < 72 h before or during the
study treatment period;
3. were undergoing surgical procedures or non-invasive procedures under general
anaesthesia < 72 h before or during the study treatment period;
4. a score for nausea on a 0-10 numeric rating scale ≥ 3 at screening visit;
5. other reason;
4. Patients with contraindications or hypersensitivity to opioids or palonosetron,
fructose, soya, lactose or peanut intolerance;
5. Patients unable to take oral medications;
6. Patients undergoing dialyses treatment;
7. Known or persistent abuse of medication, drugs, or alcohol;
8. Current or planned pregnancy, nursing period;
9. Patients who are sexually active and unwilling to use highly effective contraceptive
methods. The following contraceptive methods with a Pearl Index lower than 1% are
regarded as highly effective:
1. Oral hormonal contraception ('pill')
2. Dermal hormonal contraception
3. Vaginal hormonal contraception (NuvaRing®)
4. Contraceptive plaster
5. Long-acting injectable contraceptives
6. Implants that release progesterone (Implanon®)
7. Tubal ligation (female sterilisation)
8. Intrauterine devices that release hormones (hormone spiral)
9. Double barrier methods
This means that the following are not regarded as safe: condom plus spermicide, simple
barrier methods (vaginal pessaries, condom, and female condoms), copper spirals, the
rhythm method, basal temperature method, and the withdrawal method (coitus
interruptus).
Except: Female patients who are surgically sterilised by hysterectomy or who are
expected to be postmenopausal are eligible for this trial. A lack of menstruation of
at least 12 months will be considered as a proof to be postmenopausal.
Men must agree to use a latex condom during sexual contact with females of
childbearing potential while participating in this study even if they have undergone a
successful vasectomy.
Patients must abstain from donating blood, semen, or sperm during participation in the
study.
10. Simultaneous participation in any other interventional clinical trial within the last
14 days before the start of this trial; simultaneous participation in registry and
diagnostic trials is allowed;
11. Patients without legal German language capacity who are unable to understand the
nature, significance and consequences of the trial or any other co-existing medical or
psychological condition that will preclude participation in the study;
12. Persons who are in a relationship of dependence/employment with the sponsor or the
investigator will be excluded.
|
NCT0531xxxx/NCT05316012.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/NCT05316012</url>
</required_header>
<id_info>
<org_study_id>BC-09902</org_study_id>
<nct_id>NCT05316012</nct_id>
</id_info>
<brief_title>The Integration of Sensor Technology Into Incontinence Materials: a Single-group Pretest-posttest Study in a Nursing Home Environment</brief_title>
<acronym>Smart Diapers</acronym>
<official_title>The Integration of Sensor Technology Into Incontinence Materials: a Single-group Pretest-posttest Study in a Nursing Home Environment</official_title>
<sponsors>
<lead_sponsor>
<agency>University Ghent</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University Ghent</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>
The smart diaper aims to (1) detect humidity, (2) be capable of sending real-time indication
of the saturation to the healthcare workers when urine loss occurs and (3) generate alerts
when the diaper requires changing. Potential benefits of the smart diaper compared to
incontinence management products without sensor technology include: workload reduction,
increased comfort for residents and staff, more person-centred care, increased quality of
care, less skin damage and economic (e.g. less costs due to less excessive diaper changes),
and/or environmental (e.g. less waste) gains.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">June 20, 2022</start_date>
<completion_date type="Actual">November 27, 2022</completion_date>
<primary_completion_date type="Actual">October 27, 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>Mean percentage saturation</measure>
<time_frame>10 days</time_frame>
<description>The difference between the percentage saturation determined by the smart diaper and the percentage saturation based on the data registered in the frequency volume urine charts (FVUCs) (during each study period* for each diaper change)</description>
</primary_outcome>
<primary_outcome>
<measure>The % of correct warnings</measure>
<time_frame>10 days</time_frame>
<description>= warning on saturation of the incontinence material) generated by the sensor.
a. Each warning generated by the sensor will be assessed by the nurse (correct/incorrect warning)</description>
</primary_outcome>
<primary_outcome>
<measure>Frequency of skin irritations</measure>
<time_frame>10 days</time_frame>
<description>3. The frequency of skin irritations related to incontinence (Incontinence-Associated Dermatitis or IAD) in the gluteal/sacral area (assessed daily during each study period*).</description>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">13</enrollment>
<condition>Incontinence</condition>
<arm_group>
<arm_group_label>Residents</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>5 residents - fase 1 Intervention device: smart diaper (diaper, sensor and strips, without alerting system).
15 residents -fase 2, of which 5 residents of study phase 1 Intervention device: smart diaper (diaper, sensor and strips, with alerting system)</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Smart diapers</intervention_name>
<description>Residents receive standard continence care while using the smart diaper (without the alerting system) - fase 1
Diapers are changed as usual, e.g., after morning care, visual soiling, unpleasant odor, saturation, leakage.
Residents receive continence care while using the smart diaper with the alerting system - fase 2</description>
<arm_group_label>Residents</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Resident of nursing home

- Urinary incontinence or double incontinence (Katz score incontinence ≥ 3) by day and
night. (Score assessed in one week interval before start study period 1 and 2 "D1")

- Wearing adult diapers as incontinence material, size M.

- Unable to change diaper independently when saturated or leaking (Katz score toileting
≥ 3). (Score assessed in one week interval before start study period 1 and 2 "D1")

- Written informed consent from resident or resident's legal representative.

- Dutch speaking

Exclusion Criteria:

- Residents who are receiving end-of-life care

- Residents with a Mini-Mental State Examination (MMSE)-score of < 24

- Residents with a dominant belly sleeping position
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>WZC Heilig Hart vzw</name>
<address>
<city>Oudenaarde</city>
<zip>9700</zip>
<country>Belgium</country>
</address>
</facility>
</location>
<location_countries>
<country>Belgium</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>February 22, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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>incontinence</keyword>
<keyword>sensor technology</keyword>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The smart diaper aims to (1) detect humidity, (2) be capable of sending real-time indication
of the saturation to the healthcare workers when urine loss occurs and (3) generate alerts
when the diaper requires changing. Potential benefits of the smart diaper compared to
incontinence management products without sensor technology include: workload reduction,
increased comfort for residents and staff, more person-centred care, increased quality of
care, less skin damage and economic (e.g. less costs due to less excessive diaper changes),
and/or environmental (e.g. less waste) gains.
Inclusion Criteria:
- Resident of nursing home
- Urinary incontinence or double incontinence (Katz score incontinence ≥ 3) by day and
night. (Score assessed in one week interval before start study period 1 and 2 "D1")
- Wearing adult diapers as incontinence material, size M.
- Unable to change diaper independently when saturated or leaking (Katz score toileting
≥ 3). (Score assessed in one week interval before start study period 1 and 2 "D1")
- Written informed consent from resident or resident's legal representative.
- Dutch speaking
Exclusion Criteria:
- Residents who are receiving end-of-life care
- Residents with a Mini-Mental State Examination (MMSE)-score of < 24
- Residents with a dominant belly sleeping position
|
NCT0531xxxx/NCT05316025.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/NCT05316025</url>
</required_header>
<id_info>
<org_study_id>38RC21.197</org_study_id>
<nct_id>NCT05316025</nct_id>
</id_info>
<brief_title>Cardiovascular Digital Health Data Observatory</brief_title>
<acronym>CADHO</acronym>
<official_title>Grenoble Cardiovascular Digital Health Data Observatory</official_title>
<sponsors>
<lead_sponsor>
<agency>University Hospital, Grenoble</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University Hospital, Grenoble</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 COVID-19 health crisis has led to a drastic decrease in the rate of myocardial infarction
without the causes being completely identified. They are probably multiple, but this crisis
has confirmed the need for massive health data from different horizons to better assess
coronary disease in order to develop precision medicine. This objective is now achievable
thanks to the use of tools such as big data and artificial intelligence (AI). Our team is
developing algorithms to analyze medical images and identify people at risk of major
cardiovascular events. These algorithms which are developed with retrospective data must be
validated on prospective data, which is the objective of the Grenoble cardiovascular digital
health data observatory.

The algorithm that will be validated is currently being created as part of a RIPH 3 study
"AIDECORO" (NCT: 04598997). It is being developed from clinical, biological and imaging data
from 600 patients with ST+ infarction and 1000 "control" patients who have undergone coronary
angiography (these data are exported and stored in the PREDIMED health data warehouse via the
hospital information system).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This a type 3 study of the Jardé law, involving the human person, It is a study :
observational study, prospective, descriptive, monocentric

The main objective of the study is to prospectively validate cardiovascular medical image
analysis algorithms capable of identifying patients with poor prognostic criteria using
artificial intelligence and big data methods.

The primary endpoint is the rate of occurrence of death or hospitalization for heart failure
during follow-up.

The predictive accuracy of the algorithms will be assessed by calculating the sensitivity,
specificity, positive predictive value, and negative predictive value on the prospective
cohort.

Patients who are to undergo coronary angiography during a hospitalization in the cardiology
department are prospectively recruited after obtaining their non opposition. The data were
collected using the CARDIO Datamart developed by the PREDIMED health data host. The
collection of the primary endpoint (death from any cause and hospitalization for heart
failure) will be performed by telephone follow-up.

The number of subjects needed for this study is 5000 patients.

The prospective validation of the algorithm developed retrospectively in the AIDECORO project
(coronary image) will make it possible to move towards the last stage of the project, which
will consist of evaluating in a randomized study the superiority of precision medicine using
this algorithm, allowing for therapeutic escalation or de-escalation according to the
predictive risk evaluated by the algorithm in relation to usual management.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">May 2022</start_date>
<completion_date type="Anticipated">January 2025</completion_date>
<primary_completion_date type="Anticipated">January 2025</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>1 Year</target_duration>
<primary_outcome>
<measure>Prospectively validate cardiovascular medical image analysis algorithms capable of identifying patients with poor prognostic criteria using artificial intelligence and big data methods.</measure>
<time_frame>Through study completion, an average of 1 year</time_frame>
<description>The rate of occurrence of death or hospitalization for heart failure during follow-up.</description>
</primary_outcome>
<secondary_outcome>
<measure>Evaluate the predictive performance of algorithms to identify patients with persistent anginal symptoms.</measure>
<time_frame>12 months</time_frame>
<description>Seattle Angina Questionnaire summary score to 12 months</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluate the predictive performance of algorithms to identify patients with persistent dyspnea symptoms.</measure>
<time_frame>12 months</time_frame>
<description>Rose Angina Questionnaire to 12 months</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluate the predictive performance of algorithms to identify patients with good disease perception.</measure>
<time_frame>12 months</time_frame>
<description>Seattle Angina Questionnaire to 12 months</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluate the predictive performance of algorithms to identify patients satisfied with their care.</measure>
<time_frame>12 months</time_frame>
<description>Seattle Angina Questionnaire to 12 months</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluate the predictive performance of the algorithms for quality of life at one year.</measure>
<time_frame>12 months</time_frame>
<description>EuroQOL (EQ-5D-5L) to 12 months</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluate the predictive performance of algorithms for healthcare consumption</measure>
<time_frame>12 months</time_frame>
<description>Average annual cost of care to 12 months</description>
</secondary_outcome>
<secondary_outcome>
<measure>Assessing the prognostic value of frailty in coronary artery disease</measure>
<time_frame>Day one</time_frame>
<description>Dynanometry</description>
</secondary_outcome>
<secondary_outcome>
<measure>Assessing the prognostic value of environmental influence in coronary artery disease</measure>
<time_frame>Day one</time_frame>
<description>Measurement of air pollutants from the SIRANE dispersion model</description>
</secondary_outcome>
<enrollment type="Anticipated">5000</enrollment>
<condition>Cardiovascular Diseases</condition>
<condition>Digital</condition>
<condition>Health Data</condition>
<condition>Observatory</condition>
<condition>Coronarography</condition>
<condition>Heart Failure</condition>
<condition>Cardiovascular</condition>
<eligibility>
<study_pop>
<textblock>
All patients receiving coronary angiography during hospitalization for suspected or managed
coronary artery disease at CHUGA.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Adult patients who have undergone coronary angiography at CHUGA for whom images are
usable.

- No opposition to participation

Exclusion Criteria:

- Coronary image not usable

- Persons referred to in articles L1121-5 to L-1121-8 of the CSP

- Patients living outside the Rhône Alpes region.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<overall_official>
<last_name>Gilles Barone-Rochette</last_name>
<role>Principal Investigator</role>
<affiliation>CHU Grenoble Alpes</affiliation>
</overall_official>
<overall_contact>
<last_name>Gilles Barone-Rochette</last_name>
<phone>0476765172</phone>
<email>gbarone@chu-grenoble.fr</email>
</overall_contact>
<overall_contact_backup>
<last_name>Clémence Charlon</last_name>
<phone>0476766652</phone>
<email>ccharlon@chu-grenoble.fr</email>
</overall_contact_backup>
<reference>
<citation>Skrede OJ, De Raedt S, Kleppe A, Hveem TS, Liestol K, Maddison J, Askautrud HA, Pradhan M, Nesheim JA, Albregtsen F, Farstad IN, Domingo E, Church DN, Nesbakken A, Shepherd NA, Tomlinson I, Kerr R, Novelli M, Kerr DJ, Danielsen HE. Deep learning for prediction of colorectal cancer outcome: a discovery and validation study. Lancet. 2020 Feb 1;395(10221):350-360. doi: 10.1016/S0140-6736(19)32998-8.</citation>
<PMID>32007170</PMID>
</reference>
<reference>
<citation>Gonzalez G, Ash SY, Vegas-Sanchez-Ferrero G, Onieva Onieva J, Rahaghi FN, Ross JC, Diaz A, San Jose Estepar R, Washko GR; COPDGene and ECLIPSE Investigators. Disease Staging and Prognosis in Smokers Using Deep Learning in Chest Computed Tomography. Am J Respir Crit Care Med. 2018 Jan 15;197(2):193-203. doi: 10.1164/rccm.201705-0860OC.</citation>
<PMID>28892454</PMID>
</reference>
<reference>
<citation>Lu MT, Ivanov A, Mayrhofer T, Hosny A, Aerts HJWL, Hoffmann U. Deep Learning to Assess Long-term Mortality From Chest Radiographs. JAMA Netw Open. 2019 Jul 3;2(7):e197416. doi: 10.1001/jamanetworkopen.2019.7416.</citation>
<PMID>31322692</PMID>
</reference>
<reference>
<citation>Betancur J, Hu LH, Commandeur F, Sharir T, Einstein AJ, Fish MB, Ruddy TD, Kaufmann PA, Sinusas AJ, Miller EJ, Bateman TM, Dorbala S, Di Carli M, Germano G, Otaki Y, Liang JX, Tamarappoo BK, Dey D, Berman DS, Slomka PJ. Deep Learning Analysis of Upright-Supine High-Efficiency SPECT Myocardial Perfusion Imaging for Prediction of Obstructive Coronary Artery Disease: A Multicenter Study. J Nucl Med. 2019 May;60(5):664-670. doi: 10.2967/jnumed.118.213538. Epub 2018 Sep 27.</citation>
<PMID>30262516</PMID>
</reference>
<reference>
<citation>Slama R, Morgenstern V, Cyrys J, Zutavern A, Herbarth O, Wichmann HE, Heinrich J; LISA Study Group. Traffic-related atmospheric pollutants levels during pregnancy and offspring's term birth weight: a study relying on a land-use regression exposure model. Environ Health Perspect. 2007 Sep;115(9):1283-92. doi: 10.1289/ehp.10047.</citation>
<PMID>17805417</PMID>
</reference>
<reference>
<citation>Krittanawong C, Johnson KW, Rosenson RS, Wang Z, Aydar M, Baber U, Min JK, Tang WHW, Halperin JL, Narayan SM. Deep learning for cardiovascular medicine: a practical primer. Eur Heart J. 2019 Jul 1;40(25):2058-2073. doi: 10.1093/eurheartj/ehz056.</citation>
<PMID>30815669</PMID>
</reference>
<reference>
<citation>Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.</citation>
<PMID>23681066</PMID>
</reference>
<verification_date>January 2022</verification_date>
<study_first_submitted>February 3, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 29, 2022</last_update_submitted>
<last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Deep learning</keyword>
<keyword>Observatory</keyword>
<keyword>Cardiovascular</keyword>
<keyword>Health data</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cardiovascular Diseases</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The COVID-19 health crisis has led to a drastic decrease in the rate of myocardial infarction
without the causes being completely identified. They are probably multiple, but this crisis
has confirmed the need for massive health data from different horizons to better assess
coronary disease in order to develop precision medicine. This objective is now achievable
thanks to the use of tools such as big data and artificial intelligence (AI). Our team is
developing algorithms to analyze medical images and identify people at risk of major
cardiovascular events. These algorithms which are developed with retrospective data must be
validated on prospective data, which is the objective of the Grenoble cardiovascular digital
health data observatory.
The algorithm that will be validated is currently being created as part of a RIPH 3 study
"AIDECORO" (NCT: 04598997). It is being developed from clinical, biological and imaging data
from 600 patients with ST+ infarction and 1000 "control" patients who have undergone coronary
angiography (these data are exported and stored in the PREDIMED health data warehouse via the
hospital information system).
This a type 3 study of the Jardé law, involving the human person, It is a study :
observational study, prospective, descriptive, monocentric
The main objective of the study is to prospectively validate cardiovascular medical image
analysis algorithms capable of identifying patients with poor prognostic criteria using
artificial intelligence and big data methods.
The primary endpoint is the rate of occurrence of death or hospitalization for heart failure
during follow-up.
The predictive accuracy of the algorithms will be assessed by calculating the sensitivity,
specificity, positive predictive value, and negative predictive value on the prospective
cohort.
Patients who are to undergo coronary angiography during a hospitalization in the cardiology
department are prospectively recruited after obtaining their non opposition. The data were
collected using the CARDIO Datamart developed by the PREDIMED health data host. The
collection of the primary endpoint (death from any cause and hospitalization for heart
failure) will be performed by telephone follow-up.
The number of subjects needed for this study is 5000 patients.
The prospective validation of the algorithm developed retrospectively in the AIDECORO project
(coronary image) will make it possible to move towards the last stage of the project, which
will consist of evaluating in a randomized study the superiority of precision medicine using
this algorithm, allowing for therapeutic escalation or de-escalation according to the
predictive risk evaluated by the algorithm in relation to usual management.
All patients receiving coronary angiography during hospitalization for suspected or managed
coronary artery disease at CHUGA.
Inclusion Criteria:
- Adult patients who have undergone coronary angiography at CHUGA for whom images are
usable.
- No opposition to participation
Exclusion Criteria:
- Coronary image not usable
- Persons referred to in articles L1121-5 to L-1121-8 of the CSP
- Patients living outside the Rhône Alpes region.
|
NCT0531xxxx/NCT05316038.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/NCT05316038</url>
</required_header>
<id_info>
<org_study_id>Belaswitch_Grenoble</org_study_id>
<nct_id>NCT05316038</nct_id>
</id_info>
<brief_title>Metabolic and Infectious Complications Post Belatacept Conversion</brief_title>
<acronym>Belaswitch</acronym>
<official_title>Study of the Impact of Belatacept Conversion on Metabolic and Infectious Complications in Kidney Transplant Recipients at Grenoble-Alpes University Hospital</official_title>
<sponsors>
<lead_sponsor>
<agency>University Hospital, Grenoble</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University Hospital, Grenoble</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 BELASWITCH study is a prospective single-centre study including all kidney transplant
patients for whom a conversion from Tacrolimus to Belatacept has been decided by the
transplant clinicians of the Grenoble Alpes University Hospital.

Each patient will be included at the time of conversion (patients stable on Tacrolimus for at
least 6 months) and will be their own control 1 year after conversion to Belatacept.

The study has two components:

- A "Metabolic" benefit arm: the investigators assume that conversion from Tacrolimus to
Belatacept reduces the risk of diabetes by reducing the level of insulin resistance.

- An "Infectious" risk arm: measurement of the viral load of Torque Teno Virus to assess
the state of immunosuppression of patients. In this sense, the investigators hypothesise
that it could serve as a biomarker of immunodepression in this population.
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">June 1, 2022</start_date>
<completion_date type="Anticipated">June 1, 2024</completion_date>
<primary_completion_date type="Anticipated">June 1, 2023</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>Oral glucose tolerance test results in kidney transplant patients on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 1 year</measure>
<time_frame>1 year</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Torque TenoVirus replication (in copies/ml) in kidney transplant patients on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year.</measure>
<time_frame>1 year</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Comparison of weight and height (combined to report BMI in kg/m^2) on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of blood pressure in mmHg on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of abdominal perimeter of kidney transplant recipients in centimeters on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of HbA1c measurment in percentage on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of LDL measurment in g/l on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of HDL measurment in g/l on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of triglycerides measurment in g/l on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of major cardiovascular events (stroke, coronary syndrome, hospitalization for cardiac decompensation, death from cardiovascular causes)</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Correlation of TorqueTenoVirus replication in copies/ml with the occurrence of opportunistic infections (Cytomegalovirus, Epstein-Barr virus, BKVirus).</measure>
<time_frame>1 year</time_frame>
<description>Opportunistic infections are defined as positive DNAemia in copies/ml</description>
</secondary_outcome>
<secondary_outcome>
<measure>Correlatation of TorqueTenoVirus replication (in copies/ml) with immunosuppressant assays: Tacrolimus (µg/l) at M-1 and D0 and Belatacept (µg/l) at M3, M6 and M12</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Correlation of TorqueTenoVirus in copies/ml and the risk of biopsy-proven renal transplant rejection up to M12 after conversion to Belatacept.</measure>
<time_frame>1 year</time_frame>
<description>Rejection are defined according to the more recent histological Banff classification</description>
</secondary_outcome>
<secondary_outcome>
<measure>Compare the performance of TorqueTenoVirus quantitative polymerase chain reaction in copies/ml performed on plasma and whole blood samples</measure>
<time_frame>3 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Trough Plasma Concentration of Belatacept</measure>
<time_frame>3 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Area under the plasma concentration versus time curve (AUC) of Belatacept</measure>
<time_frame>3 months</time_frame>
</secondary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Anticipated">100</enrollment>
<condition>Kidney Transplant Infection</condition>
<condition>Cardiovascular Diseases</condition>
<condition>Immunosuppression</condition>
<condition>Kidney Transplant; Complications</condition>
<arm_group>
<arm_group_label>Belatacept cohort</arm_group_label>
<description>Kidney transplanted patients for whom a conversion from Tacrolimus to belatacept has been decided will be included in this cohort.</description>
</arm_group>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Oral glucose tolerance test</intervention_name>
<description>The test is performed on an empty stomach for at least 10 hours. The first blood sugar level is taken on an empty stomach. Then ingestion of 75g of sugar. A second blood test takes place 1 hour after the sugar intake and the third blood sugar test takes place 2 hours after the sugar intake.</description>
<arm_group_label>Belatacept cohort</arm_group_label>
</intervention>
<biospec_retention>Samples Without DNA</biospec_retention>
<biospec_descr>
<textblock>
peripheral blood mononucleated cell Plasma
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
The BELASWITCH study cohort is a prospective single-centre study including all adult kidney
transplant recipients for whom a conversion from Tacrolimus to Belatacept has been decided
by the transplant clinicians of the Grenoble Alpes University Hospital.

Each patient will be included at the time of conversion (patients stable on Tacrolimus for
at least 6 months) and will be their own control 1 year after conversion to Belatacept.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Adult patients who have had a kidney transplant more than 6 months ago.

- Whose immunosuppression includes stable Tacrolimus (change in dose or dosage form
allowed) for at least 3 months.

- Therapeutic plan to change Tacrolimus-based immunosuppression to Belatacept

- Having signed the consent of collection CRB04 - Nephrology Collection (last
authorization number: AC-2019-3627) and the BELASWITCH protocol consent.

Exclusion Criteria:

- Subjects under guardianship or deprived of liberty

- Patients who object to the use of their data and/or samples in the research

- Patients having received an immunosuppressive treatment different from the standard
one (Tacrolimus, mycophenolate mofetil or Everolimus, corticosteroids)

- ABO and/or HLA incompatible kidney transplantation
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
</eligibility>
<overall_contact>
<last_name>Johan Noble, M.D.</last_name>
<phone>+33 4 76 76 74 73</phone>
<email>jnoble@chu-grenoble.fr</email>
</overall_contact>
<overall_contact_backup>
<last_name>Claire Bollart</last_name>
<phone>+33 4 76 76 68 14</phone>
<email>CBollart@chu-grenoble.fr</email>
</overall_contact_backup>
<results_reference>
<citation>Collins AJ, Foley RN, Gilbertson DT, Chen SC. United States Renal Data System public health surveillance of chronic kidney disease and end-stage renal disease. Kidney Int Suppl (2011). 2015 Jun;5(1):2-7. doi: 10.1038/kisup.2015.2.</citation>
<PMID>26097778</PMID>
</results_reference>
<results_reference>
<citation>Dharnidharka VR. Costimulation blockade with belatacept in renal transplantation. N Engl J Med. 2005 Nov 10;353(19):2085-6; author reply 2085-6. doi: 10.1056/NEJM200511103531919. No abstract available.</citation>
<PMID>16282187</PMID>
</results_reference>
<results_reference>
<citation>Vincenti F, Rostaing L, Grinyo J, Rice K, Steinberg S, Gaite L, Moal MC, Mondragon-Ramirez GA, Kothari J, Polinsky MS, Meier-Kriesche HU, Munier S, Larsen CP. Belatacept and Long-Term Outcomes in Kidney Transplantation. N Engl J Med. 2016 Jan 28;374(4):333-43. doi: 10.1056/NEJMoa1506027. Erratum In: N Engl J Med. 2016 Feb 18;374(7):698.</citation>
<PMID>26816011</PMID>
</results_reference>
<results_reference>
<citation>Durrbach A, Pestana JM, Florman S, Del Carmen Rial M, Rostaing L, Kuypers D, Matas A, Wekerle T, Polinsky M, Meier-Kriesche HU, Munier S, Grinyo JM. Long-Term Outcomes in Belatacept- Versus Cyclosporine-Treated Recipients of Extended Criteria Donor Kidneys: Final Results From BENEFIT-EXT, a Phase III Randomized Study. Am J Transplant. 2016 Nov;16(11):3192-3201. doi: 10.1111/ajt.13830. Epub 2016 Jun 9.</citation>
<PMID>27130868</PMID>
</results_reference>
<results_reference>
<citation>Baron PW, Infante S, Peters R, Tilahun J, Weissman J, Delgado L, Kore AH, Beeson WL, de Vera ME. Post-Transplant Diabetes Mellitus After Kidney Transplant in Hispanics and Caucasians Treated with Tacrolimus-Based Immunosuppression. Ann Transplant. 2017 May 23;22:309-314. doi: 10.12659/aot.903079.</citation>
<PMID>28533501</PMID>
</results_reference>
<results_reference>
<citation>Iida S, Ishida H, Tokumoto T, Omoto K, Shirakawa H, Shimizu T, Amano H, Setoguchi K, Nozaki T, Toki D, Tokita D, Tanabe K. New-onset diabetes after transplantation in tacrolimus-treated, living kidney transplantation: long-term impact and utility of the pre-transplant OGTT. Int Urol Nephrol. 2010 Dec;42(4):935-45. doi: 10.1007/s11255-010-9712-0. Epub 2010 Feb 19.</citation>
<PMID>20169408</PMID>
</results_reference>
<results_reference>
<citation>Drachenberg CB, Klassen DK, Weir MR, Wiland A, Fink JC, Bartlett ST, Cangro CB, Blahut S, Papadimitriou JC. Islet cell damage associated with tacrolimus and cyclosporine: morphological features in pancreas allograft biopsies and clinical correlation. Transplantation. 1999 Aug 15;68(3):396-402. doi: 10.1097/00007890-199908150-00012.</citation>
<PMID>10459544</PMID>
</results_reference>
<results_reference>
<citation>Terrec F, Jouve T, Naciri-Bennani H, Benhamou PY, Malvezzi P, Janbon B, Giovannini D, Rostaing L, Noble J. Late Conversion From Calcineurin Inhibitors to Belatacept in Kidney-Transplant Recipients Has a Significant Beneficial Impact on Glycemic Parameters. Transplant Direct. 2019 Dec 24;6(1):e517. doi: 10.1097/TXD.0000000000000964. eCollection 2020 Jan.</citation>
<PMID>32047845</PMID>
</results_reference>
<results_reference>
<citation>Rangaswami J, Mathew RO, Parasuraman R, Tantisattamo E, Lubetzky M, Rao S, Yaqub MS, Birdwell KA, Bennett W, Dalal P, Kapoor R, Lerma EV, Lerman M, McCormick N, Bangalore S, McCullough PA, Dadhania DM. Cardiovascular disease in the kidney transplant recipient: epidemiology, diagnosis and management strategies. Nephrol Dial Transplant. 2019 May 1;34(5):760-773. doi: 10.1093/ndt/gfz053.</citation>
<PMID>30984976</PMID>
</results_reference>
<results_reference>
<citation>Anavekar NS, McMurray JJ, Velazquez EJ, Solomon SD, Kober L, Rouleau JL, White HD, Nordlander R, Maggioni A, Dickstein K, Zelenkofske S, Leimberger JD, Califf RM, Pfeffer MA. Relation between renal dysfunction and cardiovascular outcomes after myocardial infarction. N Engl J Med. 2004 Sep 23;351(13):1285-95. doi: 10.1056/NEJMoa041365.</citation>
<PMID>15385655</PMID>
</results_reference>
<results_reference>
<citation>Nankivell BJ, P'Ng CH, O'Connell PJ, Chapman JR. Calcineurin Inhibitor Nephrotoxicity Through the Lens of Longitudinal Histology: Comparison of Cyclosporine and Tacrolimus Eras. Transplantation. 2016 Aug;100(8):1723-31. doi: 10.1097/TP.0000000000001243.</citation>
<PMID>27306529</PMID>
</results_reference>
<results_reference>
<citation>Bertrand D, Terrec F, Etienne I, Chavarot N, Sberro R, Gatault P, Garrouste C, Bouvier N, Grall-Jezequel A, Jaureguy M, Caillard S, Thervet E, Colosio C, Golbin L, Rerolle JP, Thierry A, Sayegh J, Janbon B, Malvezzi P, Jouve T, Rostaing L, Noble J. Opportunistic Infections and Efficacy Following Conversion to Belatacept-Based Therapy after Kidney Transplantation: A French Multicenter Cohort. J Clin Med. 2020 Oct 28;9(11):3479. doi: 10.3390/jcm9113479.</citation>
<PMID>33126667</PMID>
</results_reference>
<results_reference>
<citation>Everly MJ, Roberts M, Townsend R, Bray RA, Gebel HM. Comparison of de novo IgM and IgG anti-HLA DSAs between belatacept- and calcineurin-treated patients: An analysis of the BENEFIT and BENEFIT-EXT trial cohorts. Am J Transplant. 2018 Sep;18(9):2305-2313. doi: 10.1111/ajt.14939. Epub 2018 Jun 16.</citation>
<PMID>29767445</PMID>
</results_reference>
<results_reference>
<citation>Bertrand D, Chavarot N, Gatault P, Garrouste C, Bouvier N, Grall-Jezequel A, Jaureguy M, Caillard S, Lemoine M, Colosio C, Golbin L, Rerolle JP, Thierry A, Sayegh J, Etienne I, Lebourg L, Sberro R, Guerrot D. Opportunistic infections after conversion to belatacept in kidney transplantation. Nephrol Dial Transplant. 2020 Feb 1;35(2):336-345. doi: 10.1093/ndt/gfz255.</citation>
<PMID>32030416</PMID>
</results_reference>
<results_reference>
<citation>Noble J, Jouve T, Janbon B, Rostaing L, Malvezzi P. Belatacept in kidney transplantation and its limitations. Expert Rev Clin Immunol. 2019 Apr;15(4):359-367. doi: 10.1080/1744666X.2019.1574570. Epub 2019 Feb 7.</citation>
<PMID>30676815</PMID>
</results_reference>
<results_reference>
<citation>Noble J, Langello A, Bouchut W, Lupo J, Lombardo D, Rostaing L. Immune Response Post-SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients Receiving Belatacept. Transplantation. 2021 Nov 1;105(11):e259-e260. doi: 10.1097/TP.0000000000003923. No abstract available.</citation>
<PMID>34387243</PMID>
</results_reference>
<results_reference>
<citation>Strassl R, Doberer K, Rasoul-Rockenschaub S, Herkner H, Gorzer I, Klager JP, Schmidt R, Haslacher H, Schiemann M, Eskandary FA, Kikic Z, Reindl-Schwaighofer R, Puchhammer-Stockl E, Bohmig GA, Bond G. Torque Teno Virus for Risk Stratification of Acute Biopsy-Proven Alloreactivity in Kidney Transplant Recipients. J Infect Dis. 2019 May 24;219(12):1934-1939. doi: 10.1093/infdis/jiz039.</citation>
<PMID>30668796</PMID>
</results_reference>
<results_reference>
<citation>Doberer K, Haupenthal F, Nackenhorst M, Bauernfeind F, Dermuth F, Eigenschink M, Schiemann M, Klager J, Gorzer I, Eskandary F, Reindl-Schwaighofer R, Kikic Z, Bohmig G, Strassl R, Regele H, Puchhammer-Stockl E, Bond G. Torque Teno Virus Load Is Associated With Subclinical Alloreactivity in Kidney Transplant Recipients: A Prospective Observational Trial. Transplantation. 2021 Sep 1;105(9):2112-2118. doi: 10.1097/TP.0000000000003619.</citation>
<PMID>33587432</PMID>
</results_reference>
<results_reference>
<citation>Sharts-Hopko NC. Hormone replacement therapy and cardiovascular health in midlife women. Medsurg Nurs. 1995 Aug;4(4):314-6. No abstract available.</citation>
<PMID>7627237</PMID>
</results_reference>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 21, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 29, 2022</last_update_submitted>
<last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University Hospital, Grenoble</investigator_affiliation>
<investigator_full_name>EssaiClinique_Belaswitch</investigator_full_name>
<investigator_title>Pincipal investigator</investigator_title>
</responsible_party>
<keyword>transplantation</keyword>
<keyword>Belatacept</keyword>
<keyword>TTV</keyword>
<keyword>Cardio-vascular complications</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cardiovascular 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>
|
The BELASWITCH study is a prospective single-centre study including all kidney transplant
patients for whom a conversion from Tacrolimus to Belatacept has been decided by the
transplant clinicians of the Grenoble Alpes University Hospital.
Each patient will be included at the time of conversion (patients stable on Tacrolimus for at
least 6 months) and will be their own control 1 year after conversion to Belatacept.
The study has two components:
- A "Metabolic" benefit arm: the investigators assume that conversion from Tacrolimus to
Belatacept reduces the risk of diabetes by reducing the level of insulin resistance.
- An "Infectious" risk arm: measurement of the viral load of Torque Teno Virus to assess
the state of immunosuppression of patients. In this sense, the investigators hypothesise
that it could serve as a biomarker of immunodepression in this population.
peripheral blood mononucleated cell Plasma
The BELASWITCH study cohort is a prospective single-centre study including all adult kidney
transplant recipients for whom a conversion from Tacrolimus to Belatacept has been decided
by the transplant clinicians of the Grenoble Alpes University Hospital.
Each patient will be included at the time of conversion (patients stable on Tacrolimus for
at least 6 months) and will be their own control 1 year after conversion to Belatacept.
Inclusion Criteria:
- Adult patients who have had a kidney transplant more than 6 months ago.
- Whose immunosuppression includes stable Tacrolimus (change in dose or dosage form
allowed) for at least 3 months.
- Therapeutic plan to change Tacrolimus-based immunosuppression to Belatacept
- Having signed the consent of collection CRB04 - Nephrology Collection (last
authorization number: AC-2019-3627) and the BELASWITCH protocol consent.
Exclusion Criteria:
- Subjects under guardianship or deprived of liberty
- Patients who object to the use of their data and/or samples in the research
- Patients having received an immunosuppressive treatment different from the standard
one (Tacrolimus, mycophenolate mofetil or Everolimus, corticosteroids)
- ABO and/or HLA incompatible kidney transplantation
|
NCT0531xxxx/NCT05316051.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/NCT05316051</url>
</required_header>
<id_info>
<org_study_id>u20105881</org_study_id>
<nct_id>NCT05316051</nct_id>
</id_info>
<brief_title>Effect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet</brief_title>
<official_title>Effect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet</official_title>
<sponsors>
<lead_sponsor>
<agency>Nour Mustafaalsaafin</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Sharjah</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>
Inverted orthosis is a type of rigid foot orthosis that was designed to aid in controlling
high degrees of foot pronation. It is essential to administer patients foot orthoses with
different inverted angles, with higher angles prescribed when greater reduction of foot
pronation is indicated. However, there is shortage of clinical knowledge regarding the
inverted angle in terms of biomechanical changes. The aim of this study is to investigate the
effect of different inverted angles of foot orthoses on the walking kinematics in females
with flexible flatfeet.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">November 1, 2022</start_date>
<completion_date type="Actual">April 1, 2023</completion_date>
<primary_completion_date type="Actual">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>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Participant)</masking>
</study_design_info>
<primary_outcome>
<measure>Lower limb kinematics</measure>
<time_frame>Through study completion, an average of 1 year.</time_frame>
<description>Lower limb kinematics will be processed and calculated using a motion capture system (SMART-DX, BTS Bioengineering, Milan, Italy). The following kinematic variables will be obtained for each subject : (i) maximum hip extension angle, (ii) maximum hip adduction angle, (iii) maximum hip external rotation angle, (iv) maximum knee flexion angle during loading response, (v) maximum knee extension angle during midstance, (vi) maximum knee flexion angle at toe off, (vii) minimum knee abduction angle, (viii) maximum knee abduction angle, (ix) maximum knee external rotation angle, (x) maximum knee internal rotation angle, (xi) maximum ankle plantarflexion angle during loading response, (xii) maximum ankle dorsiflexion angle during midstance, (xiii) maximum ankle plantarflexion angle at toe off, (xiv) maximum ankle external rotation angle, (xv) maximum ankle internal rotation angle.</description>
</primary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Actual">31</enrollment>
<condition>Flexible Flatfoot</condition>
<arm_group>
<arm_group_label>25° inverted angle foot orthoses</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>15° inverted angle foot orthoses</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Control</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Inverted foot orthoses</intervention_name>
<description>Inverted functional orthoses will be used in this study based on Blake (1986) inverted orthotic technique. Two groups of foot orthosis will be fabricated with two different inverted angles: 25° inverted angle and 15° inverted angle.</description>
<arm_group_label>15° inverted angle foot orthoses</arm_group_label>
<arm_group_label>25° inverted angle foot orthoses</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Females

- Within the age group of 18-35 years

- Asymptomatic flexible flatfeet

- Resting Calcaneal Stance Position angle of ≥ 4° in valgus in both feet (bilateral)

Exclusion Criteria:

- Previous surgery of the lower limbs or spine that might affect the performance of the
study procedures

- Any severe medical or musculoskeletal conditions that may have affected the lower
limbs

- Fixed flatfoot deformity

- Leg length discrepancy (> 1cm)

- Pregnancy
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>35 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Fatma A. Hegazy, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Sharjah</affiliation>
</overall_official>
<location>
<facility>
<name>University of Sharjah</name>
<address>
<city>Sharjah</city>
<country>United Arab Emirates</country>
</address>
</facility>
</location>
<location_countries>
<country>United Arab Emirates</country>
</location_countries>
<verification_date>April 2023</verification_date>
<study_first_submitted>March 19, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>April 13, 2023</last_update_submitted>
<last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">April 18, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>University of Sharjah</investigator_affiliation>
<investigator_full_name>Nour Mustafaalsaafin</investigator_full_name>
<investigator_title>Postgraduate Student</investigator_title>
</responsible_party>
<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>
|
Inverted orthosis is a type of rigid foot orthosis that was designed to aid in controlling
high degrees of foot pronation. It is essential to administer patients foot orthoses with
different inverted angles, with higher angles prescribed when greater reduction of foot
pronation is indicated. However, there is shortage of clinical knowledge regarding the
inverted angle in terms of biomechanical changes. The aim of this study is to investigate the
effect of different inverted angles of foot orthoses on the walking kinematics in females
with flexible flatfeet.
Inclusion Criteria:
- Females
- Within the age group of 18-35 years
- Asymptomatic flexible flatfeet
- Resting Calcaneal Stance Position angle of ≥ 4° in valgus in both feet (bilateral)
Exclusion Criteria:
- Previous surgery of the lower limbs or spine that might affect the performance of the
study procedures
- Any severe medical or musculoskeletal conditions that may have affected the lower
limbs
- Fixed flatfoot deformity
- Leg length discrepancy (> 1cm)
- Pregnancy
|
NCT0531xxxx/NCT05316064.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/NCT05316064</url>
</required_header>
<id_info>
<org_study_id>NMRR-21-1819-61300 (IIR)</org_study_id>
<nct_id>NCT05316064</nct_id>
</id_info>
<brief_title>Reducing Abundance of Human Papilloma Virus in Women by Taking Probiotic</brief_title>
<official_title>The Effects of Probiotic Against Reducing Abundance of Human Papilloma Virus (HPV) in Women</official_title>
<sponsors>
<lead_sponsor>
<agency>Universiti Sains Malaysia</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Universiti Sains Malaysia</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 evaluate the efficacy of oral administration of probiotic at
9 log colony forming unit (CFU)/day to reduce vaginal abundance of HPV in women compared to
placebo via the use of vaginal self-swab.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Probiotics have shown an antiviral activity and several mechanisms have been demonstrated. In
respiratory tract infections (RTIs), the majority of probiotics can inhibit the most
important respiratory viruses by immunomodulatory mechanisms. There are over 200 different
types of viruses, which cause RTIs in humans. Human rhinoviruses (HRV) are the largest group
of respiratory viruses, comprising over 150 serotypes. In humans, the predominant illness
caused by HRV is the acute upper RTI, also known as the common cold. The second most common
viruses infecting humans are the human enteroviruses (HEV), which are associated with
clinical manifestations ranging from mild respiratory symptoms to serious conditions.
Influenza viruses, respiratory syncytial virus (RSV), and adenoviruses are also major
causative agents of both upper and lower RTIs. In addition, many other viruses or virus
groups cause RTIs, e.g., parainfluenza viruses and coronaviruses can cause a broad spectrum
of respiratory diseases, ranging from mild upper RTIs to pneumonia. In recent years, with the
rapid development of high-throughput molecular techniques, several new viruses associated
with respiratory diseases, such as human bocavirus, human metapneumovirus, and the new
coronaviruses HKU1 and NL63, have been identified as well. Recently, COVID-19 had cause huge
effect worldwide. With this, to reduce the burden and severity of this pandemic, the use of
probiotic in preventing of COVID-19 has been ongoing. Probiotics also had given out
significant outcome in gastroenteritis infections where a study suggested that probiotics had
be effective in alleviating the duration and severity of acute rotavirus gastroenteritis.
Apart from this, for viruses that cause hepatitis, skin virus infections, human
immunodeficiency virus (HIV), or HPV, probiotics could directly or indirectly, help reduce
their symptoms or prevent infection.

Probiotics are known as a good natural non-drug, which was widely used to boost immune cells
in host to fight against infection. Generally, probiotic effects are mediated through immune
regulation, particularly through balance control of proinflammatory and anti-inflammatory
cytokines. The immune response is initiated by innate immunity following exposure to foreign
substances or tissue injury. Innate immunity exerts protective roles in host homeostasis in
part by priming adaptive immune responses against persisting insults and inducing
inflammation. However, the unbalanced immune response leads to severe inflammation and
uncontrolled tissue damage and disease. Probiotics have been found to enhance the innate
immunity and modulate pathogen-induced inflammation via toll-like receptor-regulated
signaling pathways.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">December 27, 2021</start_date>
<completion_date type="Anticipated">November 28, 2023</completion_date>
<primary_completion_date type="Anticipated">November 28, 2023</primary_completion_date>
<phase>Phase 2/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>Triple (Participant, Care Provider, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Changes in vaginal abundance of HPV of women upon administration of probiotic.</measure>
<time_frame>12-weeks</time_frame>
<description>Differences in vaginal HPV abundance in women upon administration of probiotic at 9 log CFU/day compared to placebo via real-time PCR quantification of the L1 capsid gene as a conserved region of the HPV genome using consensus primers PGMY09 and PGMY1.</description>
</primary_outcome>
<secondary_outcome>
<measure>Changes in vaginal microbiota of women upon administration of probiotic.</measure>
<time_frame>12-weeks</time_frame>
<description>Differences in vaginal microbiota in women upon administration of probiotic at 9 log CFU/day compared to placebo via microbiota profiling using DNA of vaginal samples amplified for bacterial 16S rRNA and analyzed for high-throughput community sequencing.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in gut microbiota of women upon administration of probiotic.</measure>
<time_frame>12-weeks</time_frame>
<description>Differences in gut microbiota profiles of women on probiotic and placebo via microbiota profiling using DNA of fecal samples amplified for bacterial 16S rRNA and analyzed for high-throughput community sequencing.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in vaginal health of women upon administration of probiotic via the use of questionnaire.</measure>
<time_frame>12-weeks</time_frame>
<description>Differences in total scores of women upon administration of probiotic at 9 log CFU/day compared to placebo via the use of vulvovaginal symptom questionnaire (VSQ) containing 21-items on a two-point scale with higher scores indicating poorer health status.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in immunity of women upon administration of probiotic 9 log CFU/day as assessed via biochemical tests.</measure>
<time_frame>12-weeks</time_frame>
<description>To evaluate differences in immunity of women on probiotic and placebo in terms of blood immunity profiling via measuring concentrations of immunoglobulins such as IgA, IgG and IgM, and cytokines such as interleukin (IL)-1b, IL-4, IL-10, TNF-α and IFN-γ using commercially available ELISA kits.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">126</enrollment>
<condition>Human Papilloma Virus Infection</condition>
<arm_group>
<arm_group_label>probiotic 9 log CFU/day</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Intervention consists of daily oral administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic.</description>
</arm_group>
<arm_group>
<arm_group_label>placebo</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>placebo contains primarily carrier without probiotic and it is identical in taste and appearance and appear as light-yellow powder. It is also taken by the participants for 12 weeks.</description>
</arm_group>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>probiotic</intervention_name>
<description>oral administration of probiotic at 9 log CFU/day for 12 weeks to reduce vaginal abundance of HPV in women compared to placebo via the use of vaginal self-swab.</description>
<arm_group_label>probiotic 9 log CFU/day</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>placebo</intervention_name>
<description>oral administration of primarily carrier without the probiotic for 12 weeks</description>
<arm_group_label>placebo</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Sexually active women

- Age above 26 years old

- Determined as HPV positive against L1 variant

- Willing to commit throughout the experiment

Exclusion Criteria:

- On long term medication (6 months and above) for any illnesses

- Pregnant

- Uterus and/or cervix removed

- Prior HPV vaccination

- Cervical intraepithelial neoplasia
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>26 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>MingTze Liong, Doctor</last_name>
<role>Study Director</role>
<affiliation>School of Industrial Technology USM</affiliation>
</overall_official>
<overall_official>
<last_name>Binti Sany Salina, Doctor</last_name>
<role>Principal Investigator</role>
<affiliation>Institut Perubatan & Pergigian Termaju USM</affiliation>
</overall_official>
<overall_contact>
<last_name>MingTze Liong, PhD</last_name>
<phone>+60175938806</phone>
<email>liongmintze@gmail.com</email>
</overall_contact>
<location>
<facility>
<name>Hospital Seberang Jaya</name>
<address>
<city>Pulau pinang</city>
<state>Penang</state>
<zip>13700</zip>
<country>Malaysia</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<phone>+60-04-3827224</phone>
<email>ppcpenang@moh.gov.my</email>
</contact>
</location>
<location_countries>
<country>Malaysia</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 17, 2022</study_first_submitted>
<study_first_submitted_qc>March 29, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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 10, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Universiti Sains Malaysia</investigator_affiliation>
<investigator_full_name>Min-Tze LIONG</investigator_full_name>
<investigator_title>Professor</investigator_title>
</responsible_party>
<keyword>probiotics</keyword>
<keyword>human papilloma virus</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Papillomavirus Infections</mesh_term>
<mesh_term>Papilloma</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 efficacy of oral administration of probiotic at
9 log colony forming unit (CFU)/day to reduce vaginal abundance of HPV in women compared to
placebo via the use of vaginal self-swab.
Probiotics have shown an antiviral activity and several mechanisms have been demonstrated. In
respiratory tract infections (RTIs), the majority of probiotics can inhibit the most
important respiratory viruses by immunomodulatory mechanisms. There are over 200 different
types of viruses, which cause RTIs in humans. Human rhinoviruses (HRV) are the largest group
of respiratory viruses, comprising over 150 serotypes. In humans, the predominant illness
caused by HRV is the acute upper RTI, also known as the common cold. The second most common
viruses infecting humans are the human enteroviruses (HEV), which are associated with
clinical manifestations ranging from mild respiratory symptoms to serious conditions.
Influenza viruses, respiratory syncytial virus (RSV), and adenoviruses are also major
causative agents of both upper and lower RTIs. In addition, many other viruses or virus
groups cause RTIs, e.g., parainfluenza viruses and coronaviruses can cause a broad spectrum
of respiratory diseases, ranging from mild upper RTIs to pneumonia. In recent years, with the
rapid development of high-throughput molecular techniques, several new viruses associated
with respiratory diseases, such as human bocavirus, human metapneumovirus, and the new
coronaviruses HKU1 and NL63, have been identified as well. Recently, COVID-19 had cause huge
effect worldwide. With this, to reduce the burden and severity of this pandemic, the use of
probiotic in preventing of COVID-19 has been ongoing. Probiotics also had given out
significant outcome in gastroenteritis infections where a study suggested that probiotics had
be effective in alleviating the duration and severity of acute rotavirus gastroenteritis.
Apart from this, for viruses that cause hepatitis, skin virus infections, human
immunodeficiency virus (HIV), or HPV, probiotics could directly or indirectly, help reduce
their symptoms or prevent infection.
Probiotics are known as a good natural non-drug, which was widely used to boost immune cells
in host to fight against infection. Generally, probiotic effects are mediated through immune
regulation, particularly through balance control of proinflammatory and anti-inflammatory
cytokines. The immune response is initiated by innate immunity following exposure to foreign
substances or tissue injury. Innate immunity exerts protective roles in host homeostasis in
part by priming adaptive immune responses against persisting insults and inducing
inflammation. However, the unbalanced immune response leads to severe inflammation and
uncontrolled tissue damage and disease. Probiotics have been found to enhance the innate
immunity and modulate pathogen-induced inflammation via toll-like receptor-regulated
signaling pathways.
Inclusion Criteria:
- Sexually active women
- Age above 26 years old
- Determined as HPV positive against L1 variant
- Willing to commit throughout the experiment
Exclusion Criteria:
- On long term medication (6 months and above) for any illnesses
- Pregnant
- Uterus and/or cervix removed
- Prior HPV vaccination
- Cervical intraepithelial neoplasia
|
NCT0531xxxx/NCT05316077.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/NCT05316077</url>
</required_header>
<id_info>
<org_study_id>VEC-88-001</org_study_id>
<nct_id>NCT05316077</nct_id>
</id_info>
<brief_title>Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up</brief_title>
<official_title>Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up</official_title>
<sponsors>
<lead_sponsor>
<agency>Guerbet</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Guerbet</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 conducted within the frame of the Post-Market Surveillance (PMS) activities, as
described in the Post Market Clinical Follow-up (PMCF) plan of Vectorio®. This study aims at
collecting clinical data, to confirm the General Safety and Performance Requirements of
Vectorio® which is a Lipiodol Resistant Mixing & Injection System for cTACE.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">August 30, 2022</start_date>
<completion_date type="Anticipated">March 31, 2023</completion_date>
<primary_completion_date type="Anticipated">March 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>Rate of leakage/breakage</measure>
<time_frame>During cTACE procedure</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Time necessary to obtain a water in oil emulsion defined as time between the filling of 20 mL-syringe with Lipiodol (T0) and the obtention of water in oil emulsion ready for injection (Te).</measure>
<time_frame>During cTACE procedure</time_frame>
<description>Collection of the time needed to obtain water in oil emulsion (Lipiodol/chemotherapeutic agent)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Ease of emulsion preparation through a rating scale</measure>
<time_frame>During cTACE procedure</time_frame>
<description>Rating scale: 0: Difficult - 1: Easy - 2: Very Easy (if rating is difficult, reason should be specified)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Need to perform remixing during cTACE procedure</measure>
<time_frame>During cTACE procedure</time_frame>
<description>Need to perform remixing : Yes/No - If Yes, how many times: Once, twice, three times, more</description>
</secondary_outcome>
<secondary_outcome>
<measure>Assessment of per procedure Lipiodol tumor uptake rate by angiography and/or Cone Beam CT</measure>
<time_frame>During cTACE procedure</time_frame>
<description>Lipiodol tumor uptake: 0-25%; 25-50%; 50-75%; 75-100%</description>
</secondary_outcome>
<secondary_outcome>
<measure>Collection of Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) /Device Deficiencies (DDs)</measure>
<time_frame>Study period</time_frame>
</secondary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Anticipated">50</enrollment>
<condition>Oncology</condition>
<arm_group>
<arm_group_label>Vectorio® kit</arm_group_label>
</arm_group>
<eligibility>
<study_pop>
<textblock>
Adult patients with confirmed diagnosis of hepatocellular carcinoma (HCC) and eligible for
cTACE procedures
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. Female or male adult patient older than 18 years

2. Patient with confirmed diagnosis of HCC and eligible for cTACE procedure

3. Patient affiliated to national health insurance according to local regulatory
requirements

4. Patient having read the information and having provided his/her consent to participate
in writing by dating and signing the informed consent form

Exclusion Criteria:

1. Patient with contraindications to cTACE procedure

2. Patient with known contra-indication(s) to the use or with known sensitivity to
Lipiodol or chemotherapeutic agent

3. Pregnant or breast-feeding female patient.

4. Patient unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood
of completing 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_contact>
<last_name>Jing Hao</last_name>
<phone>+33 6 47 12 19 57</phone>
<email>jing.hao@guerbet.com</email>
</overall_contact>
<location>
<facility>
<name>Univ.-Klinik für Radiologie</name>
<address>
<city>Graz</city>
<country>Austria</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Rupert Portugaller, Dr</last_name>
</contact>
</location>
<location>
<facility>
<name>CHU-Hôpital François Mitterrand</name>
<address>
<city>Dijon</city>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Romaric Loffroy, Pr</last_name>
</contact>
</location>
<location>
<facility>
<name>CHUV</name>
<address>
<city>Lausanne</city>
<country>Switzerland</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Rafael Duran, Dr</last_name>
</contact>
</location>
<location_countries>
<country>Austria</country>
<country>France</country>
<country>Switzerland</country>
</location_countries>
<verification_date>September 2022</verification_date>
<study_first_submitted>March 18, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_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">September 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>Neoplasms</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study is conducted within the frame of the Post-Market Surveillance (PMS) activities, as
described in the Post Market Clinical Follow-up (PMCF) plan of Vectorio®. This study aims at
collecting clinical data, to confirm the General Safety and Performance Requirements of
Vectorio® which is a Lipiodol Resistant Mixing & Injection System for cTACE.
Adult patients with confirmed diagnosis of hepatocellular carcinoma (HCC) and eligible for
cTACE procedures
Inclusion Criteria:
1. Female or male adult patient older than 18 years
2. Patient with confirmed diagnosis of HCC and eligible for cTACE procedure
3. Patient affiliated to national health insurance according to local regulatory
requirements
4. Patient having read the information and having provided his/her consent to participate
in writing by dating and signing the informed consent form
Exclusion Criteria:
1. Patient with contraindications to cTACE procedure
2. Patient with known contra-indication(s) to the use or with known sensitivity to
Lipiodol or chemotherapeutic agent
3. Pregnant or breast-feeding female patient.
4. Patient unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood
of completing the study
|
NCT0531xxxx/NCT05316090.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/NCT05316090</url>
</required_header>
<id_info>
<org_study_id>P.T.REC/012/003125</org_study_id>
<nct_id>NCT05316090</nct_id>
</id_info>
<brief_title>Effect of Core Stability Excercises Program on Reaching in Children With Cerebral Palsy</brief_title>
<official_title>Effect of Core Stability Excercises Program on Reaching in Children With Cerebral Palsy</official_title>
<sponsors>
<lead_sponsor>
<agency>Cairo University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Cairo 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>
Purpose of the study:

To evaluate effect of core stability exercises program on upper limb reaching in children
with spastic hemiparetic cerebral palsy.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Thirty spastic hemiparetic cerebral palsied children of both sexes will be selected from
General hospitals and private centers in El-Minia government with the following criteria:

1. The age of the selected children ranged from 3 To 6 years old.

2. Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale

3. Children in study group will be treated using core stability exercises program in
addition to traditional program and children in the control group will be treated using
traditional physical therapy program.

4. Trunk control measurement scale and pediatric reach test will be used to evaluate each
child individually before and after 6 successive weeks of treatment, three times per
week.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 8, 2021</start_date>
<completion_date type="Actual">August 8, 2021</completion_date>
<primary_completion_date type="Actual">August 1, 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>
<intervention_model_description>study group and control group</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Pediatric reach test</measure>
<time_frame>assessment after 6 weeks of intervention</time_frame>
<description>Reaching score</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">30</enrollment>
<condition>Cerebral Palsy</condition>
<arm_group>
<arm_group_label>study group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Children in study group treated using core stability exercises program in addition to traditional program</description>
</arm_group>
<arm_group>
<arm_group_label>control group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Children in the control group treated using traditional physical therapy program.</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Core stability exercises program</intervention_name>
<description>Strengthening to the trunk muscles</description>
<arm_group_label>study group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Traditional physical therapy program</intervention_name>
<description>Neurodevelopmental training excercises</description>
<arm_group_label>control group</arm_group_label>
<arm_group_label>study group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. The age of the selected children ranged from 3 To 6 years old.

2. Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth
scale(Bohannon and Smith, 1987).

3. Children with hemiparetic cerebral palsy

Exclusion Criteria:

1. Fructures and fixed deformities
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>3 Years</minimum_age>
<maximum_age>6 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Mai Abbass, Ph.D.</last_name>
<role>Study Director</role>
<affiliation>Cairo University</affiliation>
</overall_official>
<location>
<facility>
<name>Faculty of Physical Therapy, Cairo University</name>
<address>
<city>Cairo</city>
<zip>11432</zip>
<country>Egypt</country>
</address>
</facility>
</location>
<location_countries>
<country>Egypt</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 23, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 30, 2022</last_update_submitted>
<last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Cairo University</investigator_affiliation>
<investigator_full_name>Mai Elsayed Abbass</investigator_full_name>
<investigator_title>Lecturer of pediatric physical therapy</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cerebral Palsy</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Purpose of the study:
To evaluate effect of core stability exercises program on upper limb reaching in children
with spastic hemiparetic cerebral palsy.
Thirty spastic hemiparetic cerebral palsied children of both sexes will be selected from
General hospitals and private centers in El-Minia government with the following criteria:
1. The age of the selected children ranged from 3 To 6 years old.
2. Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale
3. Children in study group will be treated using core stability exercises program in
addition to traditional program and children in the control group will be treated using
traditional physical therapy program.
4. Trunk control measurement scale and pediatric reach test will be used to evaluate each
child individually before and after 6 successive weeks of treatment, three times per
week.
Inclusion Criteria:
1. The age of the selected children ranged from 3 To 6 years old.
2. Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth
scale(Bohannon and Smith, 1987).
3. Children with hemiparetic cerebral palsy
Exclusion Criteria:
1. Fructures and fixed deformities
|
NCT0531xxxx/NCT05316103.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/NCT05316103</url>
</required_header>
<id_info>
<org_study_id>NFEC-2022-063</org_study_id>
<nct_id>NCT05316103</nct_id>
</id_info>
<brief_title>Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy</brief_title>
<official_title>Use of Probe-based Confocal Laser Endomicroscopy to Perform Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy</official_title>
<sponsors>
<lead_sponsor>
<agency>Nanfang Hospital, Southern Medical University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Nanfang Hospital, Southern Medical 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>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
Currently, low concordance (36%) is found between clinical complete response and pathologic
complete response in patients with rectal cancer after neoadjuvant chemoradiotherapy.
Probe-based confocal laser endoscopy (pCLE) provides a promising targeted optical biopsy to
evaluate the response to neoadjuvant chemoradiotherapy. The aim of this study is to
investigate whether pCLE-targeted optical biopsy can improve the accuracy of preoperative
endoscopic biopsy for local rectal scars in rectal cancer patients after neoadjuvant
chemoradiotherapy.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Patients with locally advanced rectal cancer can benefit from neoadjuvant chemoradiotherapy,
and 20%-30% of patients receiving such therapy can attain a pathologic complete response,
defined as the eradication of cancer cells. For those who reach pathologic complete response,
a watch-and-wait strategy is supposed to be the best choice. However, low concordance (36%)
was found between clinical complete response and pathologic complete response in patients
with rectal cancer after neoadjuvant chemoradiotherapy. There is a compelling need to improve
the consistency.

Probed-based confocal laser endoscopy (pCLE) is a novel endoscopic adjunct that allows
real-time in vivo histological examination of mucosal surfaces. By using intravenous
fluorescent agents, pCLE highlights certain mucosal elements that facilitate an optical
biopsy in real time. It provides a promising targeted optical biopsy for local rectal scars
in rectal cancer patients after neoadjuvant chemoradiotherapy.

The investigators perform this study to investigate whether pCLE-targeted optical biopsy
could improve the accuracy of preoperative endoscopic biopsy for local rectal scars in rectal
cancer patients after neoadjuvant chemoradiotherapy. In this study, rectal cancer patients
after neoadjuvant chemoradiotherapy will be successively arranged to accept traditional
endoscopic biopsy and pCLE-based targeted optical biopsy. The consistency rate will be
calculated according to the postoperative pathological results.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">November 4, 2021</start_date>
<completion_date type="Anticipated">November 1, 2026</completion_date>
<primary_completion_date type="Anticipated">November 1, 2026</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>Accuracy of pCLE-targeted optical biopsy</measure>
<time_frame>7 days</time_frame>
<description>The investigators will use pCLE-targeted optical biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy and compare the pathological diagnosis between optical biopsy and surgically resected specimens.</description>
</primary_outcome>
<secondary_outcome>
<measure>Sensitivity,specificity,positive predictive value and negative predictive value of pCLE targeted optical biopsy</measure>
<time_frame>7 days</time_frame>
<description>The investigators will use pCLE-targeted optical biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy and compare the pathological diagnosis between optical biopsy and surgically resected specimens.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Complications of biopsy</measure>
<time_frame>7 days</time_frame>
<description>Complications of biopsy, such as bleeding and drug allergies.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">68</enrollment>
<condition>Rectal Cancer</condition>
<arm_group>
<arm_group_label>Endoscopic biopsy and probe-based confocal laser endomicroscopy biopsy</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>In this study , endoscopic biopsy and pCLE-targeted optical biopsy will be successively performed for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Probe-based confocal laser endomicroscopy targeted optical biopsy</intervention_name>
<description>After intravenous injection of fluorescein sodium, pCLE-based targeted optical biopsy will be performed.</description>
<arm_group_label>Endoscopic biopsy and probe-based confocal laser endomicroscopy biopsy</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Age from over 18 to under 80 years

2. American Society of Anesthesiology(ASA) score class I,II,or III

3. Locally advanced rectal cancer

4. Patient has completed standard neoadjuvant therapy

5. Expected surgical resection

6. Written informed consent

Exclusion Criteria:

1. Pregnant or lactating women

2. Acute renal insufficiency or stage II to IV chronic renal insufficiency

3. Patients with allergic constitution
</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>Jun Yan, M.D., Ph.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Nanfang Hospital, Southern Medical University</affiliation>
</overall_official>
<overall_contact>
<last_name>Jun Yan, M.D., Ph.D.</last_name>
<phone>086-13825066546</phone>
<email>yanjunfudan@163.com</email>
</overall_contact>
<location>
<facility>
<name>Nanfang Hospital, Southern Medical University</name>
<address>
<city>Guangzhou</city>
<state>Guangdong</state>
<zip>510000</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jun Yan, M.D.,Ph.D</last_name>
<phone>086-13825066546</phone>
<email>yanjunfudan@163.com</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<reference>
<citation>Gash KJ, Baser O, Kiran RP. Factors associated with degree of tumour response to neo-adjuvant radiotherapy in rectal cancer and subsequent corresponding outcomes. Eur J Surg Oncol. 2017 Nov;43(11):2052-2059. doi: 10.1016/j.ejso.2017.07.024. Epub 2017 Aug 10.</citation>
<PMID>28943178</PMID>
</reference>
<reference>
<citation>van der Sande ME, Maas M, Melenhorst J, Breukink SO, van Leerdam ME, Beets GL. Predictive Value of Endoscopic Features for a Complete Response After Chemoradiotherapy for Rectal Cancer. Ann Surg. 2021 Dec 1;274(6):e541-e547. doi: 10.1097/SLA.0000000000003718.</citation>
<PMID>31851000</PMID>
</reference>
<reference>
<citation>Ryan JE, Warrier SK, Lynch AC, Heriot AG. Assessing pathological complete response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer: a systematic review. Colorectal Dis. 2015 Oct;17(10):849-61. doi: 10.1111/codi.13081.</citation>
<PMID>26260213</PMID>
</reference>
<reference>
<citation>Glynne-Jones R, Wallace M, Livingstone JI, Meyrick-Thomas J. Complete clinical response after preoperative chemoradiation in rectal cancer: is a "wait and see" policy justified? Dis Colon Rectum. 2008 Jan;51(1):10-9; discussion 19-20. doi: 10.1007/s10350-007-9080-8. Epub 2007 Nov 28.</citation>
<PMID>18043968</PMID>
</reference>
<reference>
<citation>Al-Mansour MR, Caycedo-Marulanda A, Davis BR, Alawashez A, Docimo S, Qureshi A, Tsuda S. SAGES TAVAC safety and efficacy analysis confocal laser endomicroscopy. Surg Endosc. 2021 May;35(5):2091-2103. doi: 10.1007/s00464-020-07607-3. Epub 2020 May 13.</citation>
<PMID>32405892</PMID>
</reference>
<reference>
<citation>Safatle-Ribeiro AV, Marques CFS, Pires C, Arraes L, Baba ER, Meirelles L, Kawaguti FS, da Costa Martins B, Lenz LT, de Lima MS, Gusmon-Oliveira CC, Ribeiro U Jr, Maluf-Filho F, Nahas SC. Diagnosis of Clinical Complete Response by Probe-Based Confocal Laser Endomicroscopy (pCLE) After Chemoradiation for Advanced Rectal Cancer. J Gastrointest Surg. 2021 Feb;25(2):357-368. doi: 10.1007/s11605-020-04878-y. Epub 2021 Jan 14.</citation>
<PMID>33443686</PMID>
</reference>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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>Sponsor</responsible_party_type>
</responsible_party>
<keyword>rectal cancer</keyword>
<keyword>confocal laser endomicroscopy</keyword>
<keyword>optical biopsy</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Rectal 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>
|
Currently, low concordance (36%) is found between clinical complete response and pathologic
complete response in patients with rectal cancer after neoadjuvant chemoradiotherapy.
Probe-based confocal laser endoscopy (pCLE) provides a promising targeted optical biopsy to
evaluate the response to neoadjuvant chemoradiotherapy. The aim of this study is to
investigate whether pCLE-targeted optical biopsy can improve the accuracy of preoperative
endoscopic biopsy for local rectal scars in rectal cancer patients after neoadjuvant
chemoradiotherapy.
Patients with locally advanced rectal cancer can benefit from neoadjuvant chemoradiotherapy,
and 20%-30% of patients receiving such therapy can attain a pathologic complete response,
defined as the eradication of cancer cells. For those who reach pathologic complete response,
a watch-and-wait strategy is supposed to be the best choice. However, low concordance (36%)
was found between clinical complete response and pathologic complete response in patients
with rectal cancer after neoadjuvant chemoradiotherapy. There is a compelling need to improve
the consistency.
Probed-based confocal laser endoscopy (pCLE) is a novel endoscopic adjunct that allows
real-time in vivo histological examination of mucosal surfaces. By using intravenous
fluorescent agents, pCLE highlights certain mucosal elements that facilitate an optical
biopsy in real time. It provides a promising targeted optical biopsy for local rectal scars
in rectal cancer patients after neoadjuvant chemoradiotherapy.
The investigators perform this study to investigate whether pCLE-targeted optical biopsy
could improve the accuracy of preoperative endoscopic biopsy for local rectal scars in rectal
cancer patients after neoadjuvant chemoradiotherapy. In this study, rectal cancer patients
after neoadjuvant chemoradiotherapy will be successively arranged to accept traditional
endoscopic biopsy and pCLE-based targeted optical biopsy. The consistency rate will be
calculated according to the postoperative pathological results.
Inclusion Criteria:
1. Age from over 18 to under 80 years
2. American Society of Anesthesiology(ASA) score class I,II,or III
3. Locally advanced rectal cancer
4. Patient has completed standard neoadjuvant therapy
5. Expected surgical resection
6. Written informed consent
Exclusion Criteria:
1. Pregnant or lactating women
2. Acute renal insufficiency or stage II to IV chronic renal insufficiency
3. Patients with allergic constitution
|
NCT0531xxxx/NCT05316116.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/NCT05316116</url>
</required_header>
<id_info>
<org_study_id>MCC-21035</org_study_id>
<nct_id>NCT05316116</nct_id>
</id_info>
<brief_title>Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)</brief_title>
<official_title>A Pilot Study of Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)</official_title>
<sponsors>
<lead_sponsor>
<agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>EUSA Pharma, Inc.</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>H. Lee Moffitt Cancer Center and Research Institute</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 purpose of the study is to evaluate the safety and effectiveness of siltuximab for
participants being treated for large granular lymphocytic leukemia (LGLL).
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">February 15, 2023</start_date>
<completion_date type="Anticipated">September 1, 2025</completion_date>
<primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
<phase>Early 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>Overall Response Rate</measure>
<time_frame>Up to 30 months</time_frame>
<description>Overall response rate is defined as the rate of achieving best response of CR or PR, and will be summarized for participants who have received any dose of study drug</description>
</primary_outcome>
<secondary_outcome>
<measure>Complete Response Rate (CR)</measure>
<time_frame>Up to 30 months</time_frame>
<description>CR rate is defined as the percentage of patients achieving best response of CR.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time to Response (TTR)</measure>
<time_frame>Up to 30 months</time_frame>
<description>TTR is defined as time from first dose of study drug to time of meeting criteria for CR or PR, whichever comes first.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of Response (DOR)</measure>
<time_frame>Up to 30 months</time_frame>
<description>Duration of Response is defined as time from achieving either CR or PR, whichever comes first, to time of progression or starting another LGLL treatment, whichever comes first.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of Complete Response</measure>
<time_frame>Up to 30 months</time_frame>
<description>Duration of CR is defined as time from achieving CR to time of progression or starting another LGLL treatment, whichever comes first.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time to Complete Response</measure>
<time_frame>Up to 30 months</time_frame>
<description>Time to CR is defined as time from first dose of study drug to time of CR</description>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of Complete Response with Normalization of PB LGL Count</measure>
<time_frame>Up to 30 months</time_frame>
<description>Rate of CR with normalization of PB LGL count is defined as meeting criteria for CR AND a normal PB LGL count ( <400/mm³ CD3+CD57+ cells or <650/mm³ CD8+ T cells in PB).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Progression Free Survival</measure>
<time_frame>Up to 30 months</time_frame>
<description>PFS is defined as time from first dose of study drug to time of disease progression or starting another LGLL treatment, whichever comes first</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">20</enrollment>
<condition>Large Granular Lymphocyte Leukemia</condition>
<arm_group>
<arm_group_label>Siltuximab</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Siltuximab will be given every 3 weeks, for between 18 and 36 weeks</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Siltuximab</intervention_name>
<description>Siltuximab will be given on day 1 of each cycle. The dose will be 11 mg/kg given over 1 hour by intravenous infusion. Each cycle is three weeks (+-3 days).</description>
<arm_group_label>Siltuximab</arm_group_label>
<other_name>Interleukin-6</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Provision of signed and dated informed consent form

- Stated willingness to comply with all study procedures and availability for the
duration of the study.

- Male or female, aged >/= 18.

- Meet the diagnosis criteria of LGLL as below:

- a. For a patient with treatment-naive LGLL, peripheral blood needs to have CD3+ CD57+
cells >400/mm³ or CD8+ cells >650/mm³, and, evidence for clonal T cell receptor gamma
or beta gene rearrangement by PCR needs to be detected in either peripheral blood or
bone marrow.

- b. For patients with an established diagnosis of LGLL who have been previously
treated, multicolor flow cytometry should identify a residual CD3+CD57+CD8+ LGLL
population in peripheral blood or bone marrow, and, evidence for clonal T cell
receptor gamma or beta gene rearrangement by PCR needs to be detected in either
peripheral blood or bone marrow. There is no requirement that peripheral blood
absolute clonal CD3+ CD57+ or CD8+ LGLL populations need to reach predetermined
minimal value for eligibility since immunosuppressive therapy can significantly
decrease LGLL cell count without any impact on neutropenia, anemia or thrombocytopenia
which are major causes of morbidity and mortality

- Has at least one of the indications for treatment:

1. severe neutropenia less than 500/mm³, OR

2. neutropenia associated with recurrent infection, OR

3. symptomatic anemia with Hemoglobin < 9 g/dL, OR

4. transfusion-dependent anemia with transfusion needs >= 1 u per month, OR

5. severe thrombocytopenia <20,000/mm³, OR

6. thrombocytopenia <50,000/mm³ with bleeding.

- Participant can be treatment-naïve or previously treated for LGLL.

- Participant currently receiving therapy must have a wash-out period of ≥ 30 days or 5
elimination half-lives, whichever is longer, prior to study drug administration.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

- Creatinine clearance (CLCr) ≥15 mL/min.

- If a participant has chronic liver disease, Child-Pugh score needs to be either A or
B.

- For females of reproductive potential: use of highly effective contraception for at
least 1 month prior to study drug infusion and agreement to use highly effective
contraception during study participation and for an additional 3 months after the last
dose of study drug.

- For males of reproductive potential: use of condoms or other methods to ensure
effective contraception with partner during study participation and for an additional
3 months after the last dose of study drug. Men must agree to not donate sperm during
the same period.

Exclusion Criteria:

- Any active infection requiring systemic therapy, including viral infections such as
HIV, Hepatitis B, and/or Hepatitis C.

- Current use of methotrexate, cyclophosphamide, or cyclosporine for any medical
conditions.

- Has coexisting myelodysplastic syndrome (MDS).

- Elevated LGL due to viral infection.

- Pregnancy or lactation.

- Known severe allergic reactions to siltuximab.

- At increased risk for Gastrointestinal (GI) perforation, in the opinion of the study
investigator.

- Received live vaccine 30 days prior to study drug administration or Intend to receive
live vaccine during treatment period and within 3 months after last dose of study
drug.

- Rheumatological conditions such as rheumatoid arthritis (RA) are not exclusion
criteria for the study.

- Coexisting hematological conditions such as autoimmune hematological anemia (AIHA) or
immune thrombocytopenia (ITP) are not automatic exclusion criteria but will be at
discretion of study investigator.

- Previous or concurrent malignancies not considered cured, except inactive non-melanoma
skin cancer, in situ carcinoma of the cervix, early-stage prostate cancer, or other
cancer deemed clinically insignificant by the Investigator.

- Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with the participant's
participation for the full duration of the trial, or is not in the best interest of
the participant to participate, in the opinion of the study Investigator.
</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>Ning Dong, MD, MS</last_name>
<role>Principal Investigator</role>
<affiliation>Moffitt Cancer Center</affiliation>
</overall_official>
<overall_contact>
<last_name>Richard Corona</last_name>
<phone>813-745-3465</phone>
<email>Richard.Corona@moffitt.org</email>
</overall_contact>
<overall_contact_backup>
<last_name>Ning Dong, MD, MS</last_name>
<phone>813-745-7673</phone>
<email>ning.dong@moffitt.org</email>
</overall_contact_backup>
<location>
<facility>
<name>Moffitt Cancer Center</name>
<address>
<city>Tampa</city>
<state>Florida</state>
<zip>33612</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Richard Corona</last_name>
<phone>813-745-3465</phone>
<email>Richard.Corona@moffitt.org</email>
</contact>
<investigator>
<last_name>Ning Dong, MD, MS</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>https://moffitt.org/clinicaltrialssearch?DiseaseSite=&q=21035</url>
<description>Moffitt Cancer Center Clinical Trial Search</description>
</link>
<verification_date>June 2023</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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 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, Lymphoid</mesh_term>
<mesh_term>Leukemia, Large Granular Lymphocytic</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Siltuximab</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 study is to evaluate the safety and effectiveness of siltuximab for
participants being treated for large granular lymphocytic leukemia (LGLL).
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the
duration of the study.
- Male or female, aged >/= 18.
- Meet the diagnosis criteria of LGLL as below:
- a. For a patient with treatment-naive LGLL, peripheral blood needs to have CD3+ CD57+
cells >400/mm³ or CD8+ cells >650/mm³, and, evidence for clonal T cell receptor gamma
or beta gene rearrangement by PCR needs to be detected in either peripheral blood or
bone marrow.
- b. For patients with an established diagnosis of LGLL who have been previously
treated, multicolor flow cytometry should identify a residual CD3+CD57+CD8+ LGLL
population in peripheral blood or bone marrow, and, evidence for clonal T cell
receptor gamma or beta gene rearrangement by PCR needs to be detected in either
peripheral blood or bone marrow. There is no requirement that peripheral blood
absolute clonal CD3+ CD57+ or CD8+ LGLL populations need to reach predetermined
minimal value for eligibility since immunosuppressive therapy can significantly
decrease LGLL cell count without any impact on neutropenia, anemia or thrombocytopenia
which are major causes of morbidity and mortality
- Has at least one of the indications for treatment:
1. severe neutropenia less than 500/mm³, OR
2. neutropenia associated with recurrent infection, OR
3. symptomatic anemia with Hemoglobin < 9 g/dL, OR
4. transfusion-dependent anemia with transfusion needs >= 1 u per month, OR
5. severe thrombocytopenia <20,000/mm³, OR
6. thrombocytopenia <50,000/mm³ with bleeding.
- Participant can be treatment-naïve or previously treated for LGLL.
- Participant currently receiving therapy must have a wash-out period of ≥ 30 days or 5
elimination half-lives, whichever is longer, prior to study drug administration.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Creatinine clearance (CLCr) ≥15 mL/min.
- If a participant has chronic liver disease, Child-Pugh score needs to be either A or
B.
- For females of reproductive potential: use of highly effective contraception for at
least 1 month prior to study drug infusion and agreement to use highly effective
contraception during study participation and for an additional 3 months after the last
dose of study drug.
- For males of reproductive potential: use of condoms or other methods to ensure
effective contraception with partner during study participation and for an additional
3 months after the last dose of study drug. Men must agree to not donate sperm during
the same period.
Exclusion Criteria:
- Any active infection requiring systemic therapy, including viral infections such as
HIV, Hepatitis B, and/or Hepatitis C.
- Current use of methotrexate, cyclophosphamide, or cyclosporine for any medical
conditions.
- Has coexisting myelodysplastic syndrome (MDS).
- Elevated LGL due to viral infection.
- Pregnancy or lactation.
- Known severe allergic reactions to siltuximab.
- At increased risk for Gastrointestinal (GI) perforation, in the opinion of the study
investigator.
- Received live vaccine 30 days prior to study drug administration or Intend to receive
live vaccine during treatment period and within 3 months after last dose of study
drug.
- Rheumatological conditions such as rheumatoid arthritis (RA) are not exclusion
criteria for the study.
- Coexisting hematological conditions such as autoimmune hematological anemia (AIHA) or
immune thrombocytopenia (ITP) are not automatic exclusion criteria but will be at
discretion of study investigator.
- Previous or concurrent malignancies not considered cured, except inactive non-melanoma
skin cancer, in situ carcinoma of the cervix, early-stage prostate cancer, or other
cancer deemed clinically insignificant by the Investigator.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with the participant's
participation for the full duration of the trial, or is not in the best interest of
the participant to participate, in the opinion of the study Investigator.
|
NCT0531xxxx/NCT05316129.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/NCT05316129</url>
</required_header>
<id_info>
<org_study_id>MCC-21113</org_study_id>
<nct_id>NCT05316129</nct_id>
</id_info>
<brief_title>Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer</brief_title>
<official_title>A Phase I Clinical Trial of an Infusion of Autologous T Cells Genetically Engineered With a Chimeric Receptor to Target the Follicle-Stimulating Hormone Receptor in Patients With Recurrent Ovarian Cancer</official_title>
<sponsors>
<lead_sponsor>
<agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Anixa Biosciences, Inc.</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>H. Lee Moffitt Cancer Center and Research Institute</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>
The purpose of this first in human study is to evaluate the safety of treatment with
autologous T cells genetically modified to express a CER (chimeric endocrine receptor)
targeting the FSHR (follicle-stimulating hormone receptor) (FSHCER T cells), with or without
conditioning chemotherapy, in participants with recurrent or persistent ovarian, fallopian
tube, or primary peritoneal cancer.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 28, 2022</start_date>
<completion_date type="Anticipated">March 2029</completion_date>
<primary_completion_date type="Anticipated">March 2024</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<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>Maximum Tolerated Dose of FSHCER T Cells</measure>
<time_frame>Day 1</time_frame>
<description>Participants will receive escalating doses of FSHCER T Cells to determine the Maximum Tolerated Dose (MTD). MTD is defined as the the highest dose of t cells that does not cause unacceptable side effects.</description>
</primary_outcome>
<secondary_outcome>
<measure>Duration of Response</measure>
<time_frame>Up to 15 years</time_frame>
<description>The duration of response is measured from the time measurement criteria are met for immune complete response or immune partial response (whichever is first recorded) until the first date that progressive disease (immune related progressive disease -irPD) is objectively documented (taking as reference for PD the smallest measurements recorded [nadir] since the treatment started).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of Stable Disease</measure>
<time_frame>Up to 15 years</time_frame>
<description>Stable Disease is measured from the start of the treatment until the criteria for confirmed progressive disease are met.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Overall Survival</measure>
<time_frame>Up to 15 years</time_frame>
<description>Overall survival defined as the time from initial date of treatment to date of death.</description>
</secondary_outcome>
<number_of_arms>10</number_of_arms>
<enrollment type="Anticipated">48</enrollment>
<condition>Ovarian Cancer</condition>
<arm_group>
<arm_group_label>Intraperitoneal treatment- Dose Level 1</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^5. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.</description>
</arm_group>
<arm_group>
<arm_group_label>Intravenous treatment - Dose Level 1</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^5 by Intravenous (IV).</description>
</arm_group>
<arm_group>
<arm_group_label>Intraperitoneal treatment- Dose Level 2</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^5. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.</description>
</arm_group>
<arm_group>
<arm_group_label>Intravenous treatment - Dose Level 2</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^5 by Intravenous (IV).</description>
</arm_group>
<arm_group>
<arm_group_label>Intraperitoneal treatment- Dose Level 3</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^6. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.</description>
</arm_group>
<arm_group>
<arm_group_label>Intravenous treatment - Dose Level 3</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^6 by Intravenous (IV).</description>
</arm_group>
<arm_group>
<arm_group_label>Intraperitoneal treatment- Dose Level 4</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^6. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.</description>
</arm_group>
<arm_group>
<arm_group_label>Intravenous treatment - Dose Level 4</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^6 by Intravenous (IV).</description>
</arm_group>
<arm_group>
<arm_group_label>Intraperitoneal treatment- Dose Level 5</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^7. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.</description>
</arm_group>
<arm_group>
<arm_group_label>Intravenous treatment - Dose Level 5</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^7 by Intravenous (IV).</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Follicle Stimulating Hormone Receptor T Cells</intervention_name>
<description>Participants will receive an infusion of autologous t cells genetically modified ex vivo to express the FSHR-specific 4-1BB/CD3ζ CER.</description>
<arm_group_label>Intraperitoneal treatment- Dose Level 1</arm_group_label>
<arm_group_label>Intraperitoneal treatment- Dose Level 2</arm_group_label>
<arm_group_label>Intraperitoneal treatment- Dose Level 3</arm_group_label>
<arm_group_label>Intraperitoneal treatment- Dose Level 4</arm_group_label>
<arm_group_label>Intraperitoneal treatment- Dose Level 5</arm_group_label>
<arm_group_label>Intravenous treatment - Dose Level 1</arm_group_label>
<arm_group_label>Intravenous treatment - Dose Level 2</arm_group_label>
<arm_group_label>Intravenous treatment - Dose Level 3</arm_group_label>
<arm_group_label>Intravenous treatment - Dose Level 4</arm_group_label>
<arm_group_label>Intravenous treatment - Dose Level 5</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Pathologically confirmed diagnosis of high-grade (grade 2-3) epithelial ovarian
cancer, primary peritoneal cancer, or fallopian tube carcinoma (EOC), which are
serous, endometrioid, clear cell, mucinous, mixed epithelial, or undifferentiated. The
study does not include pure sarcoma, stromal, or germ-cell tumors. Tumors that are
substantially high-grade carcinoma and have focal elements of lower grade tumors or
sarcomatous elements (e.g., carcinosarcoma) are eligible.

- Have measurable disease or detectable (non-measurable) disease. Measurable disease is
defined as at least 1 lesion that can be accurately measured in at least 1 dimension
(longest diameter to be recorded). Each lesion must be ≥10 mm when measured by CT,
MRI, or caliper measurement at clinical examination or ≥20 mm when measured by chest
x-ray. Lymph nodes must be ≥15 mm in short axis when measured by CT or MRI. Detectable
(non-measurable) disease is defined as not having measurable disease but having:
Baseline values of CA-125 at least 2 × upper limit of normal AND EITHER Ascites and/or
pleural effusion attributed to tumor OR Solid and/or cystic abnormalities on
radiographic imaging consistent with recurrent disease that do not meet response
evaluation criteria in solid tumors (RECIST) version 1.1 definitions for target
lesions.

- Patient's carcinoma should express the FSHR antigen, detectable by PCR analysis of
archival tumor sample

- Patients must have had 1 prior platinum-based chemotherapeutic regimen for the
management of ovarian, primary peritoneal, or fallopian tube carcinoma and at least 2
prior chemotherapy regimens.

- Patients should be considered platinum- refractory (progression while on a prior
platinum chemotherapy) or resistant (persistence or recurrence within 6 months after a
prior platinum chemotherapy) and be deemed unlikely to have significant benefit from
any standard therapies by the treating investigator.

- Patients with a known germline or somatic BRCA pathogenic mutation should have a prior
PARP inhibitor and subsequent progression, unless they have a documented history of
intolerance or inability to swallow oral medications

- Patients are allowed to receive, but are not required to receive, up to 6 additional
prior chemotherapy treatment regimens (including platinum-based chemotherapy). Prior
maintenance therapy with an agent when there has not been progression will not be a
separate treatment regimen. Prior hormonal therapy is allowed, and when used alone,
even as a therapeutic agent, it does not count toward this prior regimen requirement.
Hormonal therapy must be discontinued at least 1 week before T-cell infusion.
Continuation of hormone replacement therapy is permitted

- Patients are allowed to receive, but are not required to receive, biologic/targeted
therapy alone or as part of their treatment regimens. When used as treatment after
progression, these treatments will count as a separate therapy.

- ECOG status of 2 or better (or Karnofsky Performance Status score of ≥60%)

- Life expectancy of at least 3 months.

- Adequate bone marrow, renal, and hepatic function.

- No anticancer therapy (chemotherapy, biologic therapy, or immunotherapy) in the 3
weeks before the T-cell infusion (and all hematologic effects have resolved). No prior
immunotherapy with checkpoint blockade (e.g., PD1 inhibitor, PDL1 inhibitor, or CTL4-
antagonist or similar agent) in the 6 months before the T-cell infusion (and all
clinically significant related side effects must be resolved).

- Patient agrees to undergo placement of either interventional radiologically placed or
surgically placed peritoneal port (may be temporary or subcutaneous).

- Although it is anticipated that patients who are eligible for this study will not have
childbearing potential, any patient the treating doctor or investigator deems to have
childbearing potential must agree to an acceptable means of contraception from the
time of screening to at least 6 months after T-cell infusion.

Exclusion Criteria:

- Known active hepatitis B infection, known history of hepatitis C or HIV infection.

- Clinical or radiographic evidence of bowel obstruction or need for parenteral
hydration and/or nutrition.

- Known or suspected extensive abdominal adhesions that would preclude port placement or
infusion.

- Any of the following cardiac conditions:

Clinically significant heart disease (New York Heart Association class 3 or 4) or
symptomatic congestive heart failure.

Myocardial infarction <6 months before enrollment. History of clinically significant
ventricular arrhythmia or unexplained syncope that is not believed to be vasovagal in
nature or due to dehydration.

History of severe non-ischemic cardiomyopathy with ejection fraction <20%. Findings on
baseline ECG or ECHO that, in the opinion of the patient's treating physician or
investigator, would require medical intervention before anticancer therapy

- Active autoimmune disease (excluding autoimmune thyroid disease on a stable thyroid
regimen). Such conditions include but are not limited to systemic lupus erythematous,
rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis.

- Known or suspected leptomeningeal disease and patients with metastases to the brain
stem, midbrain, pons, or medulla.

- Known or suspected untreated brain metastases. Patients with radiographically stable,
asymptomatic previously irradiated lesions are eligible provided patient is >4 weeks
beyond completion of cranial irradiation and >3 weeks off of corticosteroid therapy at
the time of study intervention.

- Prior history of clinically significant seizure disorder (e.g., not including
childhood febrile seizures).

- Any concurrent active malignancies, defined as malignancies requiring any therapy
other than expectant observation, because adverse events (AEs) resulting from these
malignancies or their treatment may confound our assessment of the safety of adoptive
T-cell therapy for ovarian cancer.

- Prior radiotherapy to any portion of the abdominal cavity or pelvis.

- Current lactation or pregnancy

- Any of the following within 28 days of first date of study treatment:

Serious uncontrolled medical illness or disorder that in the opinion of the treating
physician would make the patient ineligible for the study.

Active uncontrolled infection (with the exception of uncomplicated urinary tract
infection).

Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess. Abdominal
surgery (for reasons other than IP port placement).

- Any other issue which, in the opinion of the treating physician or principal
investigator, would make the patient ineligible for the study.
</textblock>
</criteria>
<gender>Female</gender>
<gender_based>Yes</gender_based>
<gender_description>female participants only</gender_description>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Robert M Wenham, MD, MS, FACOG, FACS</last_name>
<role>Principal Investigator</role>
<affiliation>Moffitt Cancer Center</affiliation>
</overall_official>
<location>
<facility>
<name>Moffitt Cancer Center</name>
<address>
<city>Tampa</city>
<state>Florida</state>
<zip>33612</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Tanner Pearson</last_name>
<phone>813-745-6552</phone>
<email>Tanner.Pearson@moffitt.org</email>
</contact>
<contact_backup>
<last_name>Matthew Scott</last_name>
<email>Matthew.Scott@moffitt.org</email>
</contact_backup>
<investigator>
<last_name>Robert M Wenham, MD, MS, FACOG, FACS</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Daniel Abate-Daga, PhD</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>July 2023</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>July 20, 2023</last_update_submitted>
<last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">July 21, 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>Ovarian Neoplasms</mesh_term>
<mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Hormones</mesh_term>
<mesh_term>Follicle Stimulating Hormone</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this first in human study is to evaluate the safety of treatment with
autologous T cells genetically modified to express a CER (chimeric endocrine receptor)
targeting the FSHR (follicle-stimulating hormone receptor) (FSHCER T cells), with or without
conditioning chemotherapy, in participants with recurrent or persistent ovarian, fallopian
tube, or primary peritoneal cancer.
Inclusion Criteria:
- Pathologically confirmed diagnosis of high-grade (grade 2-3) epithelial ovarian
cancer, primary peritoneal cancer, or fallopian tube carcinoma (EOC), which are
serous, endometrioid, clear cell, mucinous, mixed epithelial, or undifferentiated. The
study does not include pure sarcoma, stromal, or germ-cell tumors. Tumors that are
substantially high-grade carcinoma and have focal elements of lower grade tumors or
sarcomatous elements (e.g., carcinosarcoma) are eligible.
- Have measurable disease or detectable (non-measurable) disease. Measurable disease is
defined as at least 1 lesion that can be accurately measured in at least 1 dimension
(longest diameter to be recorded). Each lesion must be ≥10 mm when measured by CT,
MRI, or caliper measurement at clinical examination or ≥20 mm when measured by chest
x-ray. Lymph nodes must be ≥15 mm in short axis when measured by CT or MRI. Detectable
(non-measurable) disease is defined as not having measurable disease but having:
Baseline values of CA-125 at least 2 × upper limit of normal AND EITHER Ascites and/or
pleural effusion attributed to tumor OR Solid and/or cystic abnormalities on
radiographic imaging consistent with recurrent disease that do not meet response
evaluation criteria in solid tumors (RECIST) version 1.1 definitions for target
lesions.
- Patient's carcinoma should express the FSHR antigen, detectable by PCR analysis of
archival tumor sample
- Patients must have had 1 prior platinum-based chemotherapeutic regimen for the
management of ovarian, primary peritoneal, or fallopian tube carcinoma and at least 2
prior chemotherapy regimens.
- Patients should be considered platinum- refractory (progression while on a prior
platinum chemotherapy) or resistant (persistence or recurrence within 6 months after a
prior platinum chemotherapy) and be deemed unlikely to have significant benefit from
any standard therapies by the treating investigator.
- Patients with a known germline or somatic BRCA pathogenic mutation should have a prior
PARP inhibitor and subsequent progression, unless they have a documented history of
intolerance or inability to swallow oral medications
- Patients are allowed to receive, but are not required to receive, up to 6 additional
prior chemotherapy treatment regimens (including platinum-based chemotherapy). Prior
maintenance therapy with an agent when there has not been progression will not be a
separate treatment regimen. Prior hormonal therapy is allowed, and when used alone,
even as a therapeutic agent, it does not count toward this prior regimen requirement.
Hormonal therapy must be discontinued at least 1 week before T-cell infusion.
Continuation of hormone replacement therapy is permitted
- Patients are allowed to receive, but are not required to receive, biologic/targeted
therapy alone or as part of their treatment regimens. When used as treatment after
progression, these treatments will count as a separate therapy.
- ECOG status of 2 or better (or Karnofsky Performance Status score of ≥60%)
- Life expectancy of at least 3 months.
- Adequate bone marrow, renal, and hepatic function.
- No anticancer therapy (chemotherapy, biologic therapy, or immunotherapy) in the 3
weeks before the T-cell infusion (and all hematologic effects have resolved). No prior
immunotherapy with checkpoint blockade (e.g., PD1 inhibitor, PDL1 inhibitor, or CTL4-
antagonist or similar agent) in the 6 months before the T-cell infusion (and all
clinically significant related side effects must be resolved).
- Patient agrees to undergo placement of either interventional radiologically placed or
surgically placed peritoneal port (may be temporary or subcutaneous).
- Although it is anticipated that patients who are eligible for this study will not have
childbearing potential, any patient the treating doctor or investigator deems to have
childbearing potential must agree to an acceptable means of contraception from the
time of screening to at least 6 months after T-cell infusion.
Exclusion Criteria:
- Known active hepatitis B infection, known history of hepatitis C or HIV infection.
- Clinical or radiographic evidence of bowel obstruction or need for parenteral
hydration and/or nutrition.
- Known or suspected extensive abdominal adhesions that would preclude port placement or
infusion.
- Any of the following cardiac conditions:
Clinically significant heart disease (New York Heart Association class 3 or 4) or
symptomatic congestive heart failure.
Myocardial infarction <6 months before enrollment. History of clinically significant
ventricular arrhythmia or unexplained syncope that is not believed to be vasovagal in
nature or due to dehydration.
History of severe non-ischemic cardiomyopathy with ejection fraction <20%. Findings on
baseline ECG or ECHO that, in the opinion of the patient's treating physician or
investigator, would require medical intervention before anticancer therapy
- Active autoimmune disease (excluding autoimmune thyroid disease on a stable thyroid
regimen). Such conditions include but are not limited to systemic lupus erythematous,
rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis.
- Known or suspected leptomeningeal disease and patients with metastases to the brain
stem, midbrain, pons, or medulla.
- Known or suspected untreated brain metastases. Patients with radiographically stable,
asymptomatic previously irradiated lesions are eligible provided patient is >4 weeks
beyond completion of cranial irradiation and >3 weeks off of corticosteroid therapy at
the time of study intervention.
- Prior history of clinically significant seizure disorder (e.g., not including
childhood febrile seizures).
- Any concurrent active malignancies, defined as malignancies requiring any therapy
other than expectant observation, because adverse events (AEs) resulting from these
malignancies or their treatment may confound our assessment of the safety of adoptive
T-cell therapy for ovarian cancer.
- Prior radiotherapy to any portion of the abdominal cavity or pelvis.
- Current lactation or pregnancy
- Any of the following within 28 days of first date of study treatment:
Serious uncontrolled medical illness or disorder that in the opinion of the treating
physician would make the patient ineligible for the study.
Active uncontrolled infection (with the exception of uncomplicated urinary tract
infection).
Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess. Abdominal
surgery (for reasons other than IP port placement).
- Any other issue which, in the opinion of the treating physician or principal
investigator, would make the patient ineligible for the study.
|
NCT0531xxxx/NCT05316142.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/NCT05316142</url>
</required_header>
<id_info>
<org_study_id>1400-2-86-21845</org_study_id>
<nct_id>NCT05316142</nct_id>
</id_info>
<brief_title>Any Unique Identifier Assigned to the Protocol by the Sponsor</brief_title>
<official_title>Evaluation of the Effect of Subconjunctival 5-fluorouracil on the Outcome of Ahmed Valve in Neovascular Glaucoma: Randomized Clinical Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Iran University of Medical Sciences</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Iran University of Medical Sciences</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>Yes</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
Neovascular glaucoma is a common and severe type of secondary closed-angle glaucoma. Topical
treatments have variable effects and unfortunately often require surgery to control IOP.
Although Glaucoma Drainage Device (GDD) such as Ahmed Glaucoma Valve (AGV) are a surgical
choice in these patients, their effectiveness decreases over time.

One of the main causes of failure in AGV surgery is the formation of scar tissue and fibrosis
around the shunt plate.

So, the aim of this study was to evaluate the effect of using MMC Intraoperative and 5FU
Postoperative with AGV surgery in neovascular glaucoma patients according to a specific
protocol, on the incidence of Hypertensive Phase (HP) and surgical success rate.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
All patients with neovascular glaucoma who need surgery for the first time are included in
the study. Inclusion criteria include patients over 18 years of age with neovascular glaucoma
whose IOP is not controlled by medical treatment. Exclusion criteria Study includes: No Light
Perception patients, age less than 18 years, history of any type of eye surgery including
previous glaucoma and retinal surgeries (except uncomplicated cataract surgery), history of
cyclodestructive procedures, pregnant patients.

Patients after obtaining a history, especially of drugs and underlying diseases, under
complete ophthalmic examination including: visual acuity (VA) and BCVA with Snelln chart,
examination with slit lamp and performing dynamic gonioscopy using, IOP measurement with
Goldmann Applanation Tonometer and corneal thickness measurement (CCT). . Patients are then
randomized using permuted block design computer and placed in two groups of AGV surgery with
anti-fibrotic treatment and AGV surgery alone.

In AGV surgery, the conjunctiva of the superotemporal area is first dissected. The plate
shunt is then threaded 10 mm from the limbus to the sclera with non-absorbable proline
thread. The tube insertion is then performed using a 23g needle, and after fixing the scleral
patch, the conjugate is threaded with 8.0 vicryl thread and the shunt surgery is completed.

In all patients during surgery and before fixing the shunt plate, MMC is used with a sponge
at a dose of 0.2 mg / ml for 2 minutes and then washed with a large amount of BSS. All
patients receive intraviteral bevacizumab at the end of the operation. In the postoperative
anti-fibrotic group during F/U in the first, third and fifth weeks, 5FU subconjunctival
injection is performed after local anesthesia with tetracaine behind the slit lamp for all
patients with a pressure above 6 mm Hg. 5FU with a volume of 0.1 ml containing 5 mg of drug
is injected in the area of the tendon adjacent to the shunt plate.

After surgery, patients undergo regular examinations. Patients at least on the first day,
first week, third week, fifth week, third month, sixth month, twelfth month in terms of
visual acuity, refraction, IOP, various surgical complications, the number of drugs used to
control IOP are evaluated.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">June 1, 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>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Clinical trial study with two parallel groups, randomized using computer permuted block randomization, 35 patients in each group are included and followed up for at least 6 months.</intervention_model_description>
<primary_purpose>Other</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Success Rate (SR)</measure>
<time_frame>Sixth month</time_frame>
<description>1. Reduction of at least 20% IOP after surgery 2. 21> IOP> 6 with or without medication</description>
</primary_outcome>
<primary_outcome>
<measure>Hypertensive Phase (HP)</measure>
<time_frame>Third month</time_frame>
<description>IOP>21 after surgery</description>
</primary_outcome>
<secondary_outcome>
<measure>Number of mediaction</measure>
<time_frame>Sixth month</time_frame>
<description>Number of antiglauocoma medication after surgery</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">70</enrollment>
<condition>Neovascular Glaucoma</condition>
<arm_group>
<arm_group_label>AGV with intraoperation MMC</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Patients with neovascular glaucoma undergoing shunt implant surgery with MMC during surgery. This method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world. First, MMC at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed. The shunt is fixed and then the shunt tube is inserted into the eye and fixed with nylon 10.0 thread. The conjunctiva is also swabbed with 8.0 vicryl sutures. After the operation, patients undergo regular examinations according to a specific protocol to evaluate the effectiveness as well as possible complications.</description>
</arm_group>
<arm_group>
<arm_group_label>AGV with intraoperation MMC and postoperation 5FU</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Patients with neovascular glaucoma undergoing shunt implant surgery with MMC during and 5FU after surgery .This method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world. First, 5FU at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed. The shunt is fixed and then the shunt tube is inserted into the eye and fixed with nylon 10.0 thread. The conjunctiva is also swabbed with 8.0 vicryl sutures. After the operation, patients undergo regular examinations according to a specific protocol to evaluate the effectiveness as well as possible complications. Also in the first, third and fifth weeks, 5FU injections are given as a subconjugate with a volume of 0.1 ml containing 5 mg of the drug.</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>AGV implantation</intervention_name>
<description>This method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world</description>
<arm_group_label>AGV with intraoperation MMC</arm_group_label>
<arm_group_label>AGV with intraoperation MMC and postoperation 5FU</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

• Patients with diagnosis of neovascular glaucoma

Exclusion Criteria:

- Patients with no light perception

- Patients aged less than 18 years old

- History of previous GDD implantation

- History of cyclodestructive procedures

- Pregnant patients
</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>Iran University of Medical Sciences</name>
<address>
<city>Tehran</city>
<zip>1445613131</zip>
<country>Iran, Islamic Republic of</country>
</address>
</facility>
</location>
<location_countries>
<country>Iran, Islamic Republic of</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>February 15, 2023</last_update_submitted>
<last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 16, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Neovascular Glaucoma (NVG)</keyword>
<keyword>Ahmed Glaucoma Valve (AGV)</keyword>
<keyword>5FU</keyword>
<keyword>MMC</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Glaucoma</mesh_term>
<mesh_term>Glaucoma, Neovascular</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Neovascular glaucoma is a common and severe type of secondary closed-angle glaucoma. Topical
treatments have variable effects and unfortunately often require surgery to control IOP.
Although Glaucoma Drainage Device (GDD) such as Ahmed Glaucoma Valve (AGV) are a surgical
choice in these patients, their effectiveness decreases over time.
One of the main causes of failure in AGV surgery is the formation of scar tissue and fibrosis
around the shunt plate.
So, the aim of this study was to evaluate the effect of using MMC Intraoperative and 5FU
Postoperative with AGV surgery in neovascular glaucoma patients according to a specific
protocol, on the incidence of Hypertensive Phase (HP) and surgical success rate.
All patients with neovascular glaucoma who need surgery for the first time are included in
the study. Inclusion criteria include patients over 18 years of age with neovascular glaucoma
whose IOP is not controlled by medical treatment. Exclusion criteria Study includes: No Light
Perception patients, age less than 18 years, history of any type of eye surgery including
previous glaucoma and retinal surgeries (except uncomplicated cataract surgery), history of
cyclodestructive procedures, pregnant patients.
Patients after obtaining a history, especially of drugs and underlying diseases, under
complete ophthalmic examination including: visual acuity (VA) and BCVA with Snelln chart,
examination with slit lamp and performing dynamic gonioscopy using, IOP measurement with
Goldmann Applanation Tonometer and corneal thickness measurement (CCT). . Patients are then
randomized using permuted block design computer and placed in two groups of AGV surgery with
anti-fibrotic treatment and AGV surgery alone.
In AGV surgery, the conjunctiva of the superotemporal area is first dissected. The plate
shunt is then threaded 10 mm from the limbus to the sclera with non-absorbable proline
thread. The tube insertion is then performed using a 23g needle, and after fixing the scleral
patch, the conjugate is threaded with 8.0 vicryl thread and the shunt surgery is completed.
In all patients during surgery and before fixing the shunt plate, MMC is used with a sponge
at a dose of 0.2 mg / ml for 2 minutes and then washed with a large amount of BSS. All
patients receive intraviteral bevacizumab at the end of the operation. In the postoperative
anti-fibrotic group during F/U in the first, third and fifth weeks, 5FU subconjunctival
injection is performed after local anesthesia with tetracaine behind the slit lamp for all
patients with a pressure above 6 mm Hg. 5FU with a volume of 0.1 ml containing 5 mg of drug
is injected in the area of the tendon adjacent to the shunt plate.
After surgery, patients undergo regular examinations. Patients at least on the first day,
first week, third week, fifth week, third month, sixth month, twelfth month in terms of
visual acuity, refraction, IOP, various surgical complications, the number of drugs used to
control IOP are evaluated.
Inclusion Criteria:
• Patients with diagnosis of neovascular glaucoma
Exclusion Criteria:
- Patients with no light perception
- Patients aged less than 18 years old
- History of previous GDD implantation
- History of cyclodestructive procedures
- Pregnant patients
|
NCT0531xxxx/NCT05316155.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/NCT05316155</url>
</required_header>
<id_info>
<org_study_id>CR109115</org_study_id>
<secondary_id>42756493BLC1003</secondary_id>
<secondary_id>2021-004144-22</secondary_id>
<nct_id>NCT05316155</nct_id>
</id_info>
<brief_title>Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer</brief_title>
<official_title>Phase 1 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non- Muscle-Invasive or Muscle-Invasive Bladder Cancer and Selected FGFR Mutations or Fusions</official_title>
<sponsors>
<lead_sponsor>
<agency>Janssen Research & Development, LLC</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Janssen Research & Development, 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>
The purpose of the study in Part 1 (dose escalation) is to determine the recommended Phase 2
dose(s) (RP2D[s]) and in Part 2 (dose expansion) is to determine the safety of Erdafitinib
Intravesical Delivery System administered at the RP2D(s).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Bladder cancer is the most common malignancy worldwide where non-muscle invasive (NMIBC),
requiring intensive regimens of frequent monitoring, local resection (transurethral resection
of bladder [TURBT]). This study enrolls participants with non-muscle invasive or muscle
invasive bladder cancer with activating fibroblast growth factor receptor (FGFR) mutations or
fusions. Erdafitinib is a pan-FGFR inhibitor with demonstrated clinical activity when
administered orally in patients with solid tumors, including bladder cancer, with FGFR
genetic alterations. The Erdafitinib intravesical delivery system is designed to provide
release of Erdafitinib in the bladder to treat localized bladder cancer, while reducing
systemic toxicities. The study consists of a screening phase, a treatment phase, and a
follow-up phase. Total duration of the study is 5 years 3 months.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 11, 2022</start_date>
<completion_date type="Anticipated">April 14, 2027</completion_date>
<primary_completion_date type="Anticipated">April 11, 2025</primary_completion_date>
<phase>Phase 1</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>Number of Participants with Adverse Events (AEs)</measure>
<time_frame>Up to 5 years 3 months</time_frame>
<description>An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
</primary_outcome>
<primary_outcome>
<measure>Number of Participants with AEs by Severity</measure>
<time_frame>Up to 5 years 3 months</time_frame>
<description>Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.</description>
</primary_outcome>
<primary_outcome>
<measure>Number of Participants with Dose-limiting Toxicity (DLT)</measure>
<time_frame>Up to 28 days</time_frame>
<description>Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.</description>
</primary_outcome>
<secondary_outcome>
<measure>Plasma Concentration of Erdafitinib</measure>
<time_frame>Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks</time_frame>
<description>Plasma concentration of Erdafitinib will be reported.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Urine Concentration of Erdafitinib</measure>
<time_frame>Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks</time_frame>
<description>Urine concentration of Erdafitinib will be reported.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cohorts 1 and 2: Recurrence-Free Survival (RFS)</measure>
<time_frame>Up to 5 years 3 months</time_frame>
<description>RFS is defined as the time from start of treatment to the first detection of any new high-grade bladder cancer or upper tract urothelial carcinoma or positive urine cytology.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cohort 3 and 5: Complete Response (CR) Rate</measure>
<time_frame>At 3 months</time_frame>
<description>CR is defined as the absence of urothelial carcinoma by cystoscopy, confirmed pathologically at first assessment, and negative urine cytology.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cohort 3 and 5: Duration of CR</measure>
<time_frame>Up to 5 years 3 months</time_frame>
<description>Duration of CR is defined as the time from first documentation of CR until the date of documented recurrence or progression, or death, whichever comes first.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cohort 4: Pathological Complete Response (pCR) Rate</measure>
<time_frame>Up to 8 weeks</time_frame>
<description>pCR rate is defined as percentage of participants with no pathologic evidence of intravesical disease (pT0) and no pathologic evidence of nodal involvement (pN0).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cohort 4: No Pathologic Evidence of Intravesical Disease (pT0)</measure>
<time_frame>Up to 8 weeks</time_frame>
<description>pT0 rate is defined as percentage of participants with no Pathologic Evidence of Intravesical Disease.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cohort 4: Rate of downstaging to Less than (<) pT2</measure>
<time_frame>Up to 8 weeks</time_frame>
<description>Rate of downstaging to <pT2 is defined as percentage of participants with pT stage <2.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">112</enrollment>
<condition>Urinary Bladder Neoplasms</condition>
<condition>Receptors, Fibroblast Growth Factor</condition>
<arm_group>
<arm_group_label>Part 1: Dose Escalation</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with recurrent, bacillus Calmette-Guerin (BCG)-experienced high risk papillary-only Non-Muscle-Invasive Bladder Cancer (NMIBC), refusing or ineligible for radical cystectomy or with recurrent, intermediate-risk NMIBC will receive Erdafitinib Intravesical Delivery System. The dose will be escalated to determine preliminary recommended phase 2 dose(s) (RP2D[s]) for Part 2.</description>
</arm_group>
<arm_group>
<arm_group_label>Part 2: Dose Expansion</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants in each of 5 disease-specific NMIBC or MIBC cohorts may be enrolled at one or more dose levels that have been determined to be safe in Part 1.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Erdafitinib Intravesical Delivery System</intervention_name>
<description>Erdafitinib intravesical delivery system will be administered.</description>
<arm_group_label>Part 1: Dose Escalation</arm_group_label>
<arm_group_label>Part 2: Dose Expansion</arm_group_label>
<other_name>JNJ-42756493</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Recurrent, non-muscle-invasive or muscle-invasive urothelial carcinoma of the Bladder

- For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR)
mutation or fusion, as determined by local or central testing, approved by the sponsor
prior to the start of study treatment. Local tissue-based results (if already
existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR)
tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or
equivalent laboratories, or results from commercially available PCR or NGS tests

- Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no
BCG experience because BCG was not available as a treatment option in the
participant's location within the previous 2 years and is currently unavailable.
Participants who received an abbreviated course of BCG due to toxicity are still
eligible

- Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)

- Cohorts 2 and 4: Willing and eligible for RC

Exclusion Criteria:

- Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell
carcinoma of the urothelium

- Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor

- Received pelvic radiotherapy <=6 months prior to the planned start of study treatment.
If received pelvic radiotherapy greater than (>)6 months prior to the start of study
treatment, there must be no cystoscopic evidence of radiation cystitis

- Presence of any bladder or urethral anatomic feature that in the opinion of the
investigator may prevent the safe use of Erdafitinib intravesical delivery system

- Indwelling urinary catheter. Intermittent catheterization is acceptable
</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>Janssen Research & Development, LLC Clinical Trial</last_name>
<role>Study Director</role>
<affiliation>Janssen Research & Development, LLC</affiliation>
</overall_official>
<overall_contact>
<last_name>Study Contact</last_name>
<phone>844-434-4210</phone>
<email>Participate-In-This-Study@its.jnj.com</email>
</overall_contact>
<location>
<facility>
<name>University of Southern California</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90033</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>H. Lee Moffitt Cancer Center</name>
<address>
<city>Tampa</city>
<state>Florida</state>
<zip>33612</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Northwestern University</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<zip>60611</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Levine Cancer Institute, Carolinas HealthCare System</name>
<address>
<city>Charlotte</city>
<state>North Carolina</state>
<zip>28204</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Carolina Urologic Research Center</name>
<address>
<city>Myrtle Beach</city>
<state>South Carolina</state>
<zip>29572</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Urology Associates</name>
<address>
<city>Nashville</city>
<state>Tennessee</state>
<zip>37209</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Urology San Antonio Research</name>
<address>
<city>San Antonio</city>
<state>Texas</state>
<zip>78229</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Universitatsklinikum Frankfurt</name>
<address>
<city>Frankfurt am Main</city>
<zip>60590</zip>
<country>Germany</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Marien hospital Herne</name>
<address>
<city>Herne</city>
<zip>44625</zip>
<country>Germany</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Universitätsklinikum Münster</name>
<address>
<city>Münster</city>
<zip>48149</zip>
<country>Germany</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Universitaetsklinikum Ulm</name>
<address>
<city>Ulm</city>
<zip>89081</zip>
<country>Germany</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>National Cancer Center</name>
<address>
<city>Goyang-Si</city>
<zip>10408</zip>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Chonnam National University Hospital</name>
<address>
<city>Gwangju</city>
<zip>61469</zip>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Seoul National University Hospital</name>
<address>
<city>Seoul</city>
<zip>03080</zip>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>The Catholic University of Korea Seoul St. Mary's Hospital</name>
<address>
<city>Seoul</city>
<zip>06591</zip>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Radboud Umcn</name>
<address>
<city>Nijmegen</city>
<zip>6525 GA</zip>
<country>Netherlands</country>
</address>
</facility>
<status>Completed</status>
</location>
<location>
<facility>
<name>UMC Utrecht</name>
<address>
<city>Utrecht</city>
<zip>3584 CX</zip>
<country>Netherlands</country>
</address>
</facility>
<status>Completed</status>
</location>
<location>
<facility>
<name>Fundacion Puigvert</name>
<address>
<city>Barcelona</city>
<zip>08025</zip>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Hosp. Univ. Vall D Hebron</name>
<address>
<city>Barcelona</city>
<zip>08035</zip>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Hosp. Clinic I Provincial de Barcelona</name>
<address>
<city>Barcelona</city>
<zip>08036</zip>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Hosp. Univ. 12 de Octubre</name>
<address>
<city>Madrid</city>
<zip>28041</zip>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location_countries>
<country>Germany</country>
<country>Korea, Republic of</country>
<country>Netherlands</country>
<country>Spain</country>
<country>United States</country>
</location_countries>
<removed_countries>
<country>France</country>
</removed_countries>
<verification_date>September 2023</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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 13, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Non-Muscle-Invasive Bladder Cancer (NIMBC)</keyword>
<keyword>Muscle-Invasive Bladder Cancer (MIBC)</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Urinary Bladder Neoplasms</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu</ipd_description>
<ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of the study in Part 1 (dose escalation) is to determine the recommended Phase 2
dose(s) (RP2D[s]) and in Part 2 (dose expansion) is to determine the safety of Erdafitinib
Intravesical Delivery System administered at the RP2D(s).
Bladder cancer is the most common malignancy worldwide where non-muscle invasive (NMIBC),
requiring intensive regimens of frequent monitoring, local resection (transurethral resection
of bladder [TURBT]). This study enrolls participants with non-muscle invasive or muscle
invasive bladder cancer with activating fibroblast growth factor receptor (FGFR) mutations or
fusions. Erdafitinib is a pan-FGFR inhibitor with demonstrated clinical activity when
administered orally in patients with solid tumors, including bladder cancer, with FGFR
genetic alterations. The Erdafitinib intravesical delivery system is designed to provide
release of Erdafitinib in the bladder to treat localized bladder cancer, while reducing
systemic toxicities. The study consists of a screening phase, a treatment phase, and a
follow-up phase. Total duration of the study is 5 years 3 months.
Inclusion Criteria:
- Recurrent, non-muscle-invasive or muscle-invasive urothelial carcinoma of the Bladder
- For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR)
mutation or fusion, as determined by local or central testing, approved by the sponsor
prior to the start of study treatment. Local tissue-based results (if already
existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR)
tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or
equivalent laboratories, or results from commercially available PCR or NGS tests
- Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no
BCG experience because BCG was not available as a treatment option in the
participant's location within the previous 2 years and is currently unavailable.
Participants who received an abbreviated course of BCG due to toxicity are still
eligible
- Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)
- Cohorts 2 and 4: Willing and eligible for RC
Exclusion Criteria:
- Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell
carcinoma of the urothelium
- Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor
- Received pelvic radiotherapy <=6 months prior to the planned start of study treatment.
If received pelvic radiotherapy greater than (>)6 months prior to the start of study
treatment, there must be no cystoscopic evidence of radiation cystitis
- Presence of any bladder or urethral anatomic feature that in the opinion of the
investigator may prevent the safe use of Erdafitinib intravesical delivery system
- Indwelling urinary catheter. Intermittent catheterization is acceptable
|
NCT0531xxxx/NCT05316168.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/NCT05316168</url>
</required_header>
<id_info>
<org_study_id>ftjo21D.1099</org_study_id>
<nct_id>NCT05316168</nct_id>
</id_info>
<brief_title>Post Operative Pain Management for ACL Reconstruction</brief_title>
<official_title>Isolated Adductor Canal Block vs Adductor Canal Block With IPACK in ACL Reconstruction: A Randomized, Prospective Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Rothman Institute Orthopaedics</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Rothman Institute Orthopaedics</source>
<oversight_info>
<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>
Health care providers are seeking methods to limit post-operative pain and opioid
prescriptions to reduce the burden of the national opioid use epidemic. Adductor canal block
(ACB) is a peripheral nerve block that has been shown to reduce pain and opioid usage with
minimal effect on quadriceps function in patients undergoing arthroscopic knee surgery.
Infiltration between Popliteal Artery and Capsule of the Knee (iPACK) block has also shown
promise in reducing pain and opioid usage, specifically reducing posterior knee pain, which
ACB is not able to achieve. To our knowledge, there is currently no study in the orthopedic
literature comparing post-operative pain and opioid consumption in ACL reconstruction (ACLR)
patients who received isolated ACB versus ACB with IPACK.

The primary aim of this study is to investigate the role of IPACK in combination with ACB in
reducing peri-operative (14-days) pain levels in ACLR patients. The secondary aim is to
determine the effectiveness of IPACK in reducing post-operative opioid use. The tertiary aim
is to determine any effect of IPACK on post-operative functional outcomes.
</textblock>
</brief_summary>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Anticipated">March 30, 2022</start_date>
<completion_date type="Anticipated">December 2, 2022</completion_date>
<primary_completion_date type="Anticipated">December 2, 2022</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>Prevention</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Post operative pain management</measure>
<time_frame>14 days</time_frame>
<description>This will be measured by the participants completing a pain and medication Use questionnaire</description>
</primary_outcome>
<primary_outcome>
<measure>Post operative pain management 2</measure>
<time_frame>6 months</time_frame>
<description>Participants will also complete the International Knee Documentation Committee (IKDC) questionnaires</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">154</enrollment>
<condition>Pain, Postoperative</condition>
<arm_group>
<arm_group_label>isolated adductor canal block (ACB)</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone.</description>
</arm_group>
<arm_group>
<arm_group_label>isolated adductor canal block (ACB) + IPACK</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Bupivacaine HCl 0.5% Injectable Solution</intervention_name>
<description>During adductor canal block participants will receive 20cc of Bupivacaine HCl 0.5%</description>
<arm_group_label>isolated adductor canal block (ACB)</arm_group_label>
<arm_group_label>isolated adductor canal block (ACB) + IPACK</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Dexamethasone</intervention_name>
<description>During adductor canal block participants will receive 2mg Dexamethasone</description>
<arm_group_label>isolated adductor canal block (ACB)</arm_group_label>
<arm_group_label>isolated adductor canal block (ACB) + IPACK</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Infiltration between Popliteal Artery and Capsule of the knee (iPACK)</intervention_name>
<description>Prior to closing the surgical wound participants will receive a local injections of 20cc 0.5% bupivacaine mixed with 2mg dexamethasone</description>
<arm_group_label>isolated adductor canal block (ACB) + IPACK</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Percocet 5Mg-325Mg Tablet</intervention_name>
<description>Participant will receive 20 Percocet 5/325mg tablets post surgery for pain control</description>
<arm_group_label>isolated adductor canal block (ACB)</arm_group_label>
<arm_group_label>isolated adductor canal block (ACB) + IPACK</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- All patients undergoing primary ACLR for ACL tear, including patients with concomitant
meniscectomy or meniscal repair.

Exclusion Criteria:

- Revision ACLR, worker's compensation, pregnancy, age<18 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>
<location>
<facility>
<name>Rothman Orthopaedic Institute</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19107</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2021</verification_date>
<study_first_submitted>December 2, 2021</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 30, 2022</last_update_submitted>
<last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 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>Pain, Postoperative</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Dexamethasone</mesh_term>
<mesh_term>Bupivacaine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Health care providers are seeking methods to limit post-operative pain and opioid
prescriptions to reduce the burden of the national opioid use epidemic. Adductor canal block
(ACB) is a peripheral nerve block that has been shown to reduce pain and opioid usage with
minimal effect on quadriceps function in patients undergoing arthroscopic knee surgery.
Infiltration between Popliteal Artery and Capsule of the Knee (iPACK) block has also shown
promise in reducing pain and opioid usage, specifically reducing posterior knee pain, which
ACB is not able to achieve. To our knowledge, there is currently no study in the orthopedic
literature comparing post-operative pain and opioid consumption in ACL reconstruction (ACLR)
patients who received isolated ACB versus ACB with IPACK.
The primary aim of this study is to investigate the role of IPACK in combination with ACB in
reducing peri-operative (14-days) pain levels in ACLR patients. The secondary aim is to
determine the effectiveness of IPACK in reducing post-operative opioid use. The tertiary aim
is to determine any effect of IPACK on post-operative functional outcomes.
Inclusion Criteria:
- All patients undergoing primary ACLR for ACL tear, including patients with concomitant
meniscectomy or meniscal repair.
Exclusion Criteria:
- Revision ACLR, worker's compensation, pregnancy, age<18 years
|
NCT0531xxxx/NCT05316181.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/NCT05316181</url>
</required_header>
<id_info>
<org_study_id>NCC2021-0334</org_study_id>
<nct_id>NCT05316181</nct_id>
</id_info>
<brief_title>HIPEC for Platinum-Resistant Recurrent Ovarian Cancer</brief_title>
<acronym>KOV-HIPEC-02</acronym>
<official_title>Randomized Phase III Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Platinum-Resistant Recurrent Ovarian Cancer</official_title>
<sponsors>
<lead_sponsor>
<agency>National Cancer Center, Korea</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>National Cancer Center, Korea</source>
<oversight_info>
<is_fda_regulated_drug>Yes</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>
Platinum-resistant recurrent epithelial ovarian cancer randomizing with or without
hyperthermic intraperitoneal chemotherapy (HIPEC)
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The objective of this trial (KOV-HIPEC-02) is to prove the survival benefit of HIPEC with
doxorubicin and mitomycin (trial arm) compared to physician-choice chemotherapy (control arm)
in patients with platinum-resistant recurrent epithelial ovarian cancer.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 7, 2022</start_date>
<completion_date type="Anticipated">December 31, 2029</completion_date>
<primary_completion_date type="Anticipated">December 31, 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>Randomized controlled, open-label, multicenter phase III trial</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Progression-free survival (PFS)</measure>
<time_frame>From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Overall survival (OS)</measure>
<time_frame>From randomization to the date of death from any cause, assessed up to 5 years</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>cancer-specific survival</measure>
<time_frame>From randomization to the date of death due to ovarian cancer, assessed up to 5 years</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Treatment-related adverse events</measure>
<time_frame>From randomization up to the end of treatment plus 6 weeks</time_frame>
<description>assessed by CTCAE ver.5.0</description>
</secondary_outcome>
<secondary_outcome>
<measure>Health-related quality of life (QLQ C30)</measure>
<time_frame>Over the 5 year surveillance period</time_frame>
<description>assessed by EEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Score 30 (QLQ-C30)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Health-related quality of life (QLQ OV28)</measure>
<time_frame>Over the 5 year surveillance period</time_frame>
<description>assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Health-related quality of life (EQ-5D-5L)</measure>
<time_frame>Over the 5 year surveillance period</time_frame>
<description>assessed by the 5-level EQ-5D version (EQ-5D-5L)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cost-effectiveness analysis</measure>
<time_frame>At time of completion of 5-year surveillance period</time_frame>
<description>assessed by Quality-Adjusted Live Years (QALYs)</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">140</enrollment>
<condition>Epithelial Ovarian Cancer</condition>
<arm_group>
<arm_group_label>HIPEC</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) followed by physician-choice chemotherapy until disease progression.</description>
</arm_group>
<arm_group>
<arm_group_label>No HIPEC</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Physician-choice chemotherapy from enrollment until disease progression.</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>HIPEC</intervention_name>
<description>HIPEC perfusion, doxorubicin 35mg/m2 & mitomycin 15 mg/m2, 41.5'C, 90 min.</description>
<arm_group_label>HIPEC</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
- Inclusion Criteria:

- Patients ≥18 years old,

- Patients with Eastern Cooperative Oncology Group (ECOG) Performance status 0-2,

- Patients diagnosed with histologically confirmed epithelial ovarian cancer,
fallopian tube cancer, or primary peritoneal cancer,

- Resistant to platinum-based chemotherapy (Platinum-refractory or resistant
disease)

- Resectable intraperitoneal disease based on previous clinical history and recent
image finding,

- A life expectancy > 3 months as clinically judged,

- Women who are medically unable to conceive or who are of childbearing potential,
agree to follow contraceptive guidelines during treatment,

- Patient can also consent to the provision of clinical information for secondary
use such as future biomedical research. However, in the future, subjects can
participate in the main trial even if they do not intend to participate in
sharing clinical information and,

- Adequate organ function for cytoreductive surgery and HIPEC

- Exclusion criteria:

- Non-epithelial ovarian carcinoma,

- Borderline ovarian tumor,

- Patients who are not appropriate for surgical and HIPEC procedures based on
previous surgery or clinical findings, including severe intestinal adhesions,
obstruction, or abdominal fistula,

- Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with
features suggestive of MDS/AML,

- Patients which extra-abdominal disease is a major disease or is expected to cause
of death,

- Patients with active central nervous system metastasis and carcinoma meningitis
or patients who have been previously treated for brain metastases must be in a
stable state in radiology,

- Patients with antibacterial, antifungal, or antiviral infections requiring
systemic treatment (administration of parenteral antibiotics),

- Active tuberculosis that is not controlled within 1 month of treatment,

- Patient diagnosed with a psychiatric disorder or substance abuse disorder that
would interfere with your ability to cooperate with the trial,

- Patients who have not undergone hysterectomy and have a positive urine pregnancy
test result within 14 days prior to clinical trial assignment, even if the urine
pregnancy test result is negative at screening,

- Pregnant or lactating women,

- Patients with any contraindications to the use of doxorubicin or mitomycin (i.e.,
hypersensitivity to doxorubicin or mitomycin),

- Patients with a history of allogeneic tissue/solid organ transplantation or bone
marrow transplantation or a history of double umbilical cord transplantation or,

- History or current evidence of any condition, therapy, or laboratory abnormality
that may confound the results of the study, interfere with the patient's
participation, in the opinion of the treating investigator.
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Myong Cheol Lim, MD, Ph.D</last_name>
<phone>+820319201760</phone>
<email>mclim@ncc.re.kr</email>
</overall_contact>
<overall_contact_backup>
<last_name>Ji Hyun Kim, MD</last_name>
<phone>+8201026835747</phone>
<email>jihyunkim@ncc.re.kr</email>
</overall_contact_backup>
<location>
<facility>
<name>Myong Cheol Lim</name>
<address>
<city>Goyang-si</city>
<state>Gyeonggi-do</state>
<zip>10408</zip>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Myong Cheol Lim</last_name>
<email>gynlim@gmail.com</email>
</contact>
<investigator>
<last_name>Myong Cheol Lim</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>Korea, Republic of</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 3, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>May 31, 2023</last_update_submitted>
<last_update_submitted_qc>May 31, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 1, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>National Cancer Center, Korea</investigator_affiliation>
<investigator_full_name>Myong Cheol Lim</investigator_full_name>
<investigator_title>Principal investigator</investigator_title>
</responsible_party>
<keyword>Ovarian cancer</keyword>
<keyword>Hyperthermic intraperitoneal chemotherapy</keyword>
<keyword>HIPEC</keyword>
<keyword>Recurrent ovarian cancer</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ovarian Neoplasms</mesh_term>
<mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Platinum-resistant recurrent epithelial ovarian cancer randomizing with or without
hyperthermic intraperitoneal chemotherapy (HIPEC)
The objective of this trial (KOV-HIPEC-02) is to prove the survival benefit of HIPEC with
doxorubicin and mitomycin (trial arm) compared to physician-choice chemotherapy (control arm)
in patients with platinum-resistant recurrent epithelial ovarian cancer.
- Inclusion Criteria:
- Patients ≥18 years old,
- Patients with Eastern Cooperative Oncology Group (ECOG) Performance status 0-2,
- Patients diagnosed with histologically confirmed epithelial ovarian cancer,
fallopian tube cancer, or primary peritoneal cancer,
- Resistant to platinum-based chemotherapy (Platinum-refractory or resistant
disease)
- Resectable intraperitoneal disease based on previous clinical history and recent
image finding,
- A life expectancy > 3 months as clinically judged,
- Women who are medically unable to conceive or who are of childbearing potential,
agree to follow contraceptive guidelines during treatment,
- Patient can also consent to the provision of clinical information for secondary
use such as future biomedical research. However, in the future, subjects can
participate in the main trial even if they do not intend to participate in
sharing clinical information and,
- Adequate organ function for cytoreductive surgery and HIPEC
- Exclusion criteria:
- Non-epithelial ovarian carcinoma,
- Borderline ovarian tumor,
- Patients who are not appropriate for surgical and HIPEC procedures based on
previous surgery or clinical findings, including severe intestinal adhesions,
obstruction, or abdominal fistula,
- Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with
features suggestive of MDS/AML,
- Patients which extra-abdominal disease is a major disease or is expected to cause
of death,
- Patients with active central nervous system metastasis and carcinoma meningitis
or patients who have been previously treated for brain metastases must be in a
stable state in radiology,
- Patients with antibacterial, antifungal, or antiviral infections requiring
systemic treatment (administration of parenteral antibiotics),
- Active tuberculosis that is not controlled within 1 month of treatment,
- Patient diagnosed with a psychiatric disorder or substance abuse disorder that
would interfere with your ability to cooperate with the trial,
- Patients who have not undergone hysterectomy and have a positive urine pregnancy
test result within 14 days prior to clinical trial assignment, even if the urine
pregnancy test result is negative at screening,
- Pregnant or lactating women,
- Patients with any contraindications to the use of doxorubicin or mitomycin (i.e.,
hypersensitivity to doxorubicin or mitomycin),
- Patients with a history of allogeneic tissue/solid organ transplantation or bone
marrow transplantation or a history of double umbilical cord transplantation or,
- History or current evidence of any condition, therapy, or laboratory abnormality
that may confound the results of the study, interfere with the patient's
participation, in the opinion of the treating investigator.
|
NCT0531xxxx/NCT05316194.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/NCT05316194</url>
</required_header>
<id_info>
<org_study_id>MIC in OA</org_study_id>
<nct_id>NCT05316194</nct_id>
</id_info>
<brief_title>Minimal Clinically Important Changes in Osteoarthritis Treatment</brief_title>
<official_title>Minimal Clinically Important Changes in Digitally Delivered Osteoarthritis Treatment</official_title>
<sponsors>
<lead_sponsor>
<agency>Joint Academy</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
<collaborator>
<agency>Lund University</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Joint Academy</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 assess minimal clinically important change, cut-offs for treatment failure and patient
acceptable symptom state for pain and patient-reported function and quality of life in
persons with hip or knee osteoarthritis, participating in digitally delivered first-line
education and exercise treatment.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Patient-reported outcome measures (PROMs) are consistently recommended as the primary
end-point in clinical trials evaluating treatment effects in different medical conditions.
For a meaningful interpretation of the PROMs used, three different approaches have been
proposed; The Minimal Important Change (MIC), which is the smallest change in scores that
represents an important improvement for the patient, i.e., the patient is feeling better, the
Patient Acceptable Symptom State (PASS), which represents patients that consider their
current status as acceptable, i.e., the patient is feeling good and Treatment Failure (TF),
which represents patients that consider their state so unsatisfactory that they think the
treatment has failed, all based on relevant anchor questions. Previous research in patients
with anterior cruciate ligament (ACL) injury and femoroacetabular impingement reveals that
feeling better is not necessarily the same as feeling good and reporting only the MIC (or
mean change) may overestimate the results, stressing the need for including different
measures of improvement to evaluate treatment effects on PROMs. The MIC, PASS and TF for
persons undergoing digital treatment for hip or knee osteoarthritis are not yet determined.
In this retrospective register-based study we will define MIC, PASS and TF in pain and
patient-reported function and quality of life, using anchor-based questions, for persons
participating in digital first-line treatment for hip and knee OA. In addition, we will use
these thresholds to establish the proportion of patients reaching MIC and/or PASS or
reporting TF, separate for persons with hip and knee OA.

Statistical analysis:

For MIC calculations, participants will be categorized as "importantly improved" if they
answered "Better an important improvement" or "Somewhat better but enough to be an important
improvement" to the anchor questions for KOOS/HOOS and NRS. MIC for an important improvement
will then be calculated using the predictive modeling method (MICpred), adjusting for the
proportion of improved patients.

The MICpred method will also be used to calculate the post score (i.e., 3, 6, 9 and 12
months) for KOOS/HOOS-scores and NRS-scores for participants that have responded "Yes" to the
PASS or TF anchor question, respectively. The proportion of participants reaching the
cut-offs of MIC, PASS and TF for the KOOS/HOOS and NRS, will then be calculated separately
for participants with knee and hip OA.

Subgroup analyses on the effect of sex, age and baseline symptoms (depending on data
distribution to ensure we will have an adequated sample size also in subgroups) on MIC, PASS
and TF will also be performed using the MICpred method
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">May 2022</start_date>
<completion_date type="Anticipated">March 2023</completion_date>
<primary_completion_date type="Anticipated">December 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>Joint pain</measure>
<time_frame>3 - 12 months</time_frame>
<description>Joint pain will be measured with the NRS-scale. NRS comprises an 11-point scale where 0 indicates no pain and 10 indicates the worst possible pain during the last week</description>
</primary_outcome>
<primary_outcome>
<measure>KOOS/HOOS-12</measure>
<time_frame>3-12 months</time_frame>
<description>The Knee injury and Osteoarthritis Outcome Score (KOOS-12)(knee OA) and the Hip injury and Outcome Score (HOOS)(hip OA) will be used for evaluating knee/hip function and quality of life. The KOOS/HOOS-12 are short versions of the original KOOS/HOOS questionnaires and includes 12 items measuring knee/hip pain, physical function and knee/hip-related quality of life. All items are scored from 0-4. The scores will then be normalized to a score from 0-100 for each domain (pain, function and quality of life) as well as a total score of all three domains where 0 indicates extreme problems and 100 indicates no problems.</description>
</primary_outcome>
<primary_outcome>
<measure>MIC</measure>
<time_frame>3 - 12 months</time_frame>
<description>The MIC associated with KOOS/HOOS-12/NRS scores will be calculated using domain specific anchor questions; NRS and KOOS/HOOS pain: How is your joint pain now compared with prior to your participation in the treatment? KOOS/HOOS function: How is your ability to perform daily activities now, compared with prior to your participation in the treatment? (sitting, standing, walking, stairs, putting on/taking off socks, household work)? KOOS/HOOS QoL: How is your quality of life in relation to your knee now, compared with prior to your participation in the treatment? (trust in knee, lifestyle, how often you think of your knee)? With the following response option; Better, an important improvement/ Somewhat better but enough to be an important improvement/ Very small change, not enough to be an important improvement/About the same/Very small change, not enough to be an important deterioration/Somewhat worse, but enough to be an important deterioration/Worse, an important deterioration</description>
</primary_outcome>
<primary_outcome>
<measure>Patient acceptable symtom state (PASS)</measure>
<time_frame>3 - 12 months</time_frame>
<description>The following question will be asked (yes/no); Considering your knee/hip function, do you feel that your current state is satisfactory? You should take all activities during your daily life, sport and recreational activities, your level of pain and other symptoms, and also your knee/hip- related quality of life into account.</description>
</primary_outcome>
<primary_outcome>
<measure>Treatment failed (TF)</measure>
<time_frame>3 - 12 months</time_frame>
<description>The following question will be asked (yes/no): If you answered "No" to the previous question, would you consider your current function as being so unsatisfactory that you think the treatment has failed?</description>
</primary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Anticipated">25000</enrollment>
<condition>Osteoarthritis, Knee</condition>
<condition>Osteoarthritis, Hip</condition>
<arm_group>
<arm_group_label>Participation in digital OA treatment</arm_group_label>
<description>All participants that have participated in a digitally delivered first-line treatment program (Joint Academy) for hip or knee OA until May 2022.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Digital treatment for hip and knee osteoarthritis</intervention_name>
<description>The program is an app-based version of the Swedish face-to-face management program for OA "Better management of patients with OsteoArthrits" and includes weekly educational sessions, individualized exercises and a possibility to chat asynchronously with a physical therapist during the entire duration of the program.</description>
<arm_group_label>Participation in digital OA treatment</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Participants join the digital OA treatment program via online advertisements and campaigns
placed on search engines and social networks, or by recommendations by their local care
provider. Radiographic and or clinical diagnosis of hip or knee OA from a physical
therapist or physician (95% of all patients in previously published studies). Individuals
without a prior diagnosis had clinical OA confirmed by an orthopaedic surgeon or
physiotherapist via telephone (diagnosis according to NICE criteria and Swedish National
Guidelines, and confirming the absence of any red flag symptoms), or if deemed necessary
were recommended to seek face-to-face care before inclusion in the programme.

From October 1st 2021, all patients should have undergone a physical examination by doctor
or physiotherapists before being able to enter the treatment.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Data for all participants enrolled in the program until May 2022, and have given their
written informed consent, will be extracted from the digital treatment register.

Inclusion criteria will be; i) diagnosed hip or knee OA ii) provided answer for KOOS/HOOS
questionnaires and/or NRS pain at baseline and any of the follow-ups, i.e., 3, 6, 9 and/or
12 months.

Exclusion criteria: none
</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>Leif E Dahlberg</last_name>
<role>Study Director</role>
<affiliation>Arthro Therapeutics</affiliation>
</overall_official>
<location>
<facility>
<name>Arthro Therapeutics</name>
<address>
<city>Malmö</city>
<zip>21134</zip>
<country>Sweden</country>
</address>
</facility>
</location>
<location_countries>
<country>Sweden</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Osteoarthritis</keyword>
<keyword>Minimal Clinically Important Change</keyword>
<keyword>Responder</keyword>
<keyword>Exercise</keyword>
<keyword>Telehealth</keyword>
<keyword>Digital</keyword>
<keyword>Knee</keyword>
<keyword>Hip</keyword>
<keyword>Treatment failure</keyword>
<keyword>Patient acceptable symptom state</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Osteoarthritis</mesh_term>
<mesh_term>Osteoarthritis, Knee</mesh_term>
<mesh_term>Osteoarthritis, Hip</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>IPD will only be shared between the researchers working with this project. According to the European General Data Protection Regulation (GDPR) we cannot legally share IPD outside of this project.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
To assess minimal clinically important change, cut-offs for treatment failure and patient
acceptable symptom state for pain and patient-reported function and quality of life in
persons with hip or knee osteoarthritis, participating in digitally delivered first-line
education and exercise treatment.
Patient-reported outcome measures (PROMs) are consistently recommended as the primary
end-point in clinical trials evaluating treatment effects in different medical conditions.
For a meaningful interpretation of the PROMs used, three different approaches have been
proposed; The Minimal Important Change (MIC), which is the smallest change in scores that
represents an important improvement for the patient, i.e., the patient is feeling better, the
Patient Acceptable Symptom State (PASS), which represents patients that consider their
current status as acceptable, i.e., the patient is feeling good and Treatment Failure (TF),
which represents patients that consider their state so unsatisfactory that they think the
treatment has failed, all based on relevant anchor questions. Previous research in patients
with anterior cruciate ligament (ACL) injury and femoroacetabular impingement reveals that
feeling better is not necessarily the same as feeling good and reporting only the MIC (or
mean change) may overestimate the results, stressing the need for including different
measures of improvement to evaluate treatment effects on PROMs. The MIC, PASS and TF for
persons undergoing digital treatment for hip or knee osteoarthritis are not yet determined.
In this retrospective register-based study we will define MIC, PASS and TF in pain and
patient-reported function and quality of life, using anchor-based questions, for persons
participating in digital first-line treatment for hip and knee OA. In addition, we will use
these thresholds to establish the proportion of patients reaching MIC and/or PASS or
reporting TF, separate for persons with hip and knee OA.
Statistical analysis:
For MIC calculations, participants will be categorized as "importantly improved" if they
answered "Better an important improvement" or "Somewhat better but enough to be an important
improvement" to the anchor questions for KOOS/HOOS and NRS. MIC for an important improvement
will then be calculated using the predictive modeling method (MICpred), adjusting for the
proportion of improved patients.
The MICpred method will also be used to calculate the post score (i.e., 3, 6, 9 and 12
months) for KOOS/HOOS-scores and NRS-scores for participants that have responded "Yes" to the
PASS or TF anchor question, respectively. The proportion of participants reaching the
cut-offs of MIC, PASS and TF for the KOOS/HOOS and NRS, will then be calculated separately
for participants with knee and hip OA.
Subgroup analyses on the effect of sex, age and baseline symptoms (depending on data
distribution to ensure we will have an adequated sample size also in subgroups) on MIC, PASS
and TF will also be performed using the MICpred method
Participants join the digital OA treatment program via online advertisements and campaigns
placed on search engines and social networks, or by recommendations by their local care
provider. Radiographic and or clinical diagnosis of hip or knee OA from a physical
therapist or physician (95% of all patients in previously published studies). Individuals
without a prior diagnosis had clinical OA confirmed by an orthopaedic surgeon or
physiotherapist via telephone (diagnosis according to NICE criteria and Swedish National
Guidelines, and confirming the absence of any red flag symptoms), or if deemed necessary
were recommended to seek face-to-face care before inclusion in the programme.
From October 1st 2021, all patients should have undergone a physical examination by doctor
or physiotherapists before being able to enter the treatment.
Data for all participants enrolled in the program until May 2022, and have given their
written informed consent, will be extracted from the digital treatment register.
Inclusion criteria will be; i) diagnosed hip or knee OA ii) provided answer for KOOS/HOOS
questionnaires and/or NRS pain at baseline and any of the follow-ups, i.e., 3, 6, 9 and/or
12 months.
Exclusion criteria: none
|
NCT0531xxxx/NCT05316207.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/NCT05316207</url>
</required_header>
<id_info>
<org_study_id>TelenursingOHS</org_study_id>
<nct_id>NCT05316207</nct_id>
</id_info>
<brief_title>Tele-Nursing Follow-Up After Open Heart Surgery</brief_title>
<official_title>Investigation of the Effect of Tele-Nursing on Anxiety And Complications in Patients With Open Heart Surgery</official_title>
<sponsors>
<lead_sponsor>
<agency>Hasan Kalyoncu University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Hasan Kalyoncu 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: Failure to follow-up patients by healthcare professionals after discharge may
increase the development of anxiety and complications in patients.

Aim: The aim of this study is to determine the effects of tele-nursing method to patients who
have undergone Open Heart Surgery (OHS) after discharge on anxiety and some other
complications.

Material and Methods:This quasi-experimental randomized controlled study, which was conducted
in a private hospital between November 2020 and April 2021, included 75 patients, 38 from the
Intervention (IG) and 37 from the Control Group (KG). IG and CG patients were provided
routine treatment and care. In addition to the IG, training and counselling were provided at
least four times by phone calls between the first week after discharge and the end of the
first month. Descriptive Form and State-Trait Anxiety Inventory (STAI-S and T) were
administered to all patients before discharge, and STAI-S was administered at the end of the
first month after discharge. Post-discharge complications were evaluated by medical doctor in
both groups. These data, number of hospitalization and readmission rates were obtained from
hospital records.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">November 1, 2020</start_date>
<completion_date type="Actual">April 21, 2021</completion_date>
<primary_completion_date type="Actual">April 21, 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>Prevention</primary_purpose>
<masking>Single (Participant)</masking>
<masking_description>Intervention group and control group</masking_description>
</study_design_info>
<primary_outcome>
<measure>Determination of change in anxiety levels between groups before discharge and one month after discharge</measure>
<time_frame>State and trait anxiety levels were measured 72 hours before discharge for all participants who met the inclusion criteria.State anxiety levels of all participants were measured one month after discharge.</time_frame>
<description>Anxiety levels of all participants who met the inclusion criteria were measured using the state and trait anxiety scale in the pre-test. At the end of the first week after discharge, the intervention was started for the patients in the study group and the intervention was completed at the end of the first month after discharge. One month after discharge, the state anxiety levels were measured again with the state anxiety scale.</description>
</primary_outcome>
<secondary_outcome>
<measure>Rates of Complication Development</measure>
<time_frame>Complications developed in both groups were recorded at the end of the first week and the end of the fourth week after discharge.</time_frame>
<description>The rate of total hospitalization before and after the intervention, the rate of admission to the hospital for examination, leg incision infection, effusion, chest incision infection and other complications that may occur within one month after discharge, according to the groups</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">75</enrollment>
<condition>Open Heart Surgery</condition>
<condition>Tele-nursing</condition>
<arm_group>
<arm_group_label>Intervention Group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>IG was formed from 40 patients who received routine care, treatment and education services of the clinic after open heart surgery, and whose routine controls were determined by the randomization method. The patients in the IG would call by the researcher at least four times, at the end of the first, second, third and fourth weeks after discharge, to provide education and counseling via tele-nursing. In these phone calls, the current problems of the patient, if any, and the issues that should be paid attention to during the home care process after open heart surgery were explained.It was stated that, unlike the patients in CG, patients in IG would be called by the researcher at least four times at the end of the first, second, third and fourth weeks after discharge to provide education and counseling via tele-nursing.</description>
</arm_group>
<arm_group>
<arm_group_label>Control Group</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>The patients in the CG were formed from 40 patients who received routine care, treatment and education services of the clinic after open heart surgery, and who were determined by the randomization method, whose routine controls were made after discharge. No application was made to the patients in the CG by the researcher within the scope of the study. However, the researcher gave the phone number to the patients in the CG in terms of their right to receive ethical and professional care, and it was stated that they could call between 10:00 and 22:00 if needed. The reasons for calling the investigator from the CG were recorded .</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Telenursing</intervention_name>
<description>From the end of the first week after discharge to the end of the first month, patients were counseled over the phone during the home process. Complications were followed up.</description>
<arm_group_label>Intervention Group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Eighteen years and older,

- Able to speak and understand Turkish,

- Without hearing, comprehension, vision and speech problems,

- Open heart surgery for the first time,

- Those who were not diagnosed with depression or anxiety disorder before surgery and
didn't use medication for this purpose,

- Having a mobile phone that can take photos by herself/himself or her/his attendants,

- No serious complications to delay hospital discharge,

- Patients who volunteered to participate were included in the study.

Exclusion Criteria:

Patients who wished to withdraw from the study after volunteering were excluded from 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>Kadiriye Pehlivan, MSc RN</last_name>
<role>Principal Investigator</role>
<affiliation>Hasan Kalyoncu University</affiliation>
</overall_official>
<overall_official>
<last_name>Ayla Yava, Prof, RN</last_name>
<role>Study Director</role>
<affiliation>Hasan Kalyoncu Üni̇versi̇tesi̇ University</affiliation>
</overall_official>
<location>
<facility>
<name>Medical Park Hospital</name>
<address>
<city>Gaziantep</city>
<state>Şahinbey</state>
<zip>27027</zip>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 14, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 30, 2022</last_update_submitted>
<last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Hasan Kalyoncu University</investigator_affiliation>
<investigator_full_name>Kadiriye Pehlivan</investigator_full_name>
<investigator_title>Principal Investigator, Research Assistant</investigator_title>
</responsible_party>
<keyword>Anxiety</keyword>
<keyword>Complication</keyword>
<keyword>Readmission</keyword>
<keyword>Hospitalization</keyword>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Introduction: Failure to follow-up patients by healthcare professionals after discharge may
increase the development of anxiety and complications in patients.
Aim: The aim of this study is to determine the effects of tele-nursing method to patients who
have undergone Open Heart Surgery (OHS) after discharge on anxiety and some other
complications.
Material and Methods:This quasi-experimental randomized controlled study, which was conducted
in a private hospital between November 2020 and April 2021, included 75 patients, 38 from the
Intervention (IG) and 37 from the Control Group (KG). IG and CG patients were provided
routine treatment and care. In addition to the IG, training and counselling were provided at
least four times by phone calls between the first week after discharge and the end of the
first month. Descriptive Form and State-Trait Anxiety Inventory (STAI-S and T) were
administered to all patients before discharge, and STAI-S was administered at the end of the
first month after discharge. Post-discharge complications were evaluated by medical doctor in
both groups. These data, number of hospitalization and readmission rates were obtained from
hospital records.
Inclusion Criteria:
- Eighteen years and older,
- Able to speak and understand Turkish,
- Without hearing, comprehension, vision and speech problems,
- Open heart surgery for the first time,
- Those who were not diagnosed with depression or anxiety disorder before surgery and
didn't use medication for this purpose,
- Having a mobile phone that can take photos by herself/himself or her/his attendants,
- No serious complications to delay hospital discharge,
- Patients who volunteered to participate were included in the study.
Exclusion Criteria:
Patients who wished to withdraw from the study after volunteering were excluded from the
study.
|
NCT0531xxxx/NCT05316220.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/NCT05316220</url>
</required_header>
<id_info>
<org_study_id>M21-517</org_study_id>
<nct_id>NCT05316220</nct_id>
</id_info>
<brief_title>A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis</brief_title>
<official_title>A Randomized, Double-blind Study to Assess the Safety and Efficacy of Mesalamine Delayed-release Capsules in Children Aged 5 to 17 Years for the Maintenance of Remission of Ulcerative Colitis</official_title>
<sponsors>
<lead_sponsor>
<agency>AbbVie</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>AbbVie</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>
Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) characterized by
diffuse, continuous inflammation of the colon. This study will assess how safe and effective
mesalamine delayed-release capsules are in treating pediatric participants with UC. Adverse
events and change in disease activity will be assessed.

Delzicol (Mesalamine) is an approved drug being developed for the treatment of Ulcerative
Colitis (UC). Study doctors put the participants in 1 of 2 groups, called treatment arms.
Each group receives a different treatment. Around 80 Pediatric participants aged 5 to 17
years with a diagnosis of UC will be enrolled in approximately 45 sites in the United States.

Participants will receive oral mesalamine capsules twice daily for 26 weeks and followed for
30 days.

There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and completing questionnaires.
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">December 31, 2022</start_date>
<completion_date type="Anticipated">September 14, 2024</completion_date>
<primary_completion_date type="Anticipated">September 14, 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>
<primary_purpose>Treatment</primary_purpose>
<masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Percentage of Participants Maintaining Clinical Remission Responder Status Based on the modified Mayo Score (mMS)</measure>
<time_frame>Week 26</time_frame>
<description>Clinical remission responder based on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore <= 1.</description>
</primary_outcome>
<secondary_outcome>
<measure>Percentage of Participants Maintaining Endoscopic Remission Responder Status Based on the mMS</measure>
<time_frame>Week 26</time_frame>
<description>Endoscopic remission responder based on the mMS is defined as Endoscopy subscore = 0 or 1.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Percentage of Participants Maintaining Symptomatic Remission Responder Status Based on the mMS</measure>
<time_frame>Week 26</time_frame>
<description>Symptomatic remission responder based on the mMS s defined as Rectal bleeding subscore = 0 AND Stool frequency subscore <= 1.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">80</enrollment>
<condition>Ulcerative Colitis (UC)</condition>
<arm_group>
<arm_group_label>Mesalamine Dose A</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive mesalamine Dose A twice daily for 26 weeks.</description>
</arm_group>
<arm_group>
<arm_group_label>Mesalamine Dose B</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive mesalamine Dose B twice daily for 26 weeks.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Mesalamine</intervention_name>
<description>Oral Capsules</description>
<arm_group_label>Mesalamine Dose A</arm_group_label>
<arm_group_label>Mesalamine Dose B</arm_group_label>
<other_name>Delzicol</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>Oral Capsule</description>
<arm_group_label>Mesalamine Dose B</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Documented history of Ulcerative Colitis (UC) who have been successfully maintained in
remission for at least 30 days prior to the screening visit and are on a stable dose of
mesalamine or 5-aminosalicylic acid equivalent.

Exclusion Criteria:

- Abnormal and clinically significant results according to the investigator or designee, on
physical examination, medical history, electrocardiogram (ECG), hematology, clinical
chemistry, or urinalysis.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>5 Years</minimum_age>
<maximum_age>17 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>ABBVIE INC.</last_name>
<role>Study Director</role>
<affiliation>AbbVie</affiliation>
</overall_official>
<overall_contact>
<last_name>ABBVIE CALL CENTER</last_name>
<phone>844-663-3742</phone>
<email>abbvieclinicaltrials@abbvie.com</email>
</overall_contact>
<location>
<facility>
<name>Childrens National /ID# 243379</name>
<address>
<city>Washington</city>
<state>District of Columbia</state>
<zip>20010-2916</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Angel Kids Pediatrics /ID# 244874</name>
<address>
<city>Jacksonville</city>
<state>Florida</state>
<zip>32225-3131</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Treken Primary Care /ID# 241302</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<zip>30315</zip>
<country>United States</country>
</address>
</facility>
<contact>
<last_name>Site Coordinator</last_name>
<phone>4043050004</phone>
</contact>
</location>
<location>
<facility>
<name>Eagle Clinical Research /ID# 242045</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<zip>60621</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Virgo Carter Pediatrics /ID# 241556</name>
<address>
<city>Silver Spring</city>
<state>Maryland</state>
<zip>20910</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>UH Cleveland Medical Center /ID# 243375</name>
<address>
<city>Cleveland</city>
<state>Ohio</state>
<zip>44106</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Children's Hospital Oklahoma /ID# 242614</name>
<address>
<city>Oklahoma City</city>
<state>Oklahoma</state>
<zip>73104</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Carilion Medical Center /ID# 244398</name>
<address>
<city>Roanoke</city>
<state>Virginia</state>
<zip>24014</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>San Juan Bautista School of Medicine /ID# 243377</name>
<address>
<city>Caguas</city>
<zip>726</zip>
<country>Puerto Rico</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Centro de Investigaciones Clinicas San Jorge Children's and Women's Hospital /ID# 244595</name>
<address>
<city>San Juan</city>
<zip>912</zip>
<country>Puerto Rico</country>
</address>
</facility>
</location>
<location_countries>
<country>Puerto Rico</country>
<country>United States</country>
</location_countries>
<link>
<url>https://www.abbvieclinicaltrials.com</url>
<description>Related Info</description>
</link>
<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 7, 2022</study_first_posted>
<last_update_submitted>November 21, 2022</last_update_submitted>
<last_update_submitted_qc>November 21, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">November 22, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Ulcerative Colitis (UC)</keyword>
<keyword>Mesalamine</keyword>
<keyword>Delzicol</keyword>
<keyword>AGN-226474</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Colitis</mesh_term>
<mesh_term>Colitis, Ulcerative</mesh_term>
<mesh_term>Ulcer</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Mesalamine</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</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>
<ipd_time_frame>For details on when studies are available for sharing, please refer to the link below.</ipd_time_frame>
<ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.</ipd_access_criteria>
<ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) characterized by
diffuse, continuous inflammation of the colon. This study will assess how safe and effective
mesalamine delayed-release capsules are in treating pediatric participants with UC. Adverse
events and change in disease activity will be assessed.
Delzicol (Mesalamine) is an approved drug being developed for the treatment of Ulcerative
Colitis (UC). Study doctors put the participants in 1 of 2 groups, called treatment arms.
Each group receives a different treatment. Around 80 Pediatric participants aged 5 to 17
years with a diagnosis of UC will be enrolled in approximately 45 sites in the United States.
Participants will receive oral mesalamine capsules twice daily for 26 weeks and followed for
30 days.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and completing questionnaires.
Inclusion Criteria:
- Documented history of Ulcerative Colitis (UC) who have been successfully maintained in
remission for at least 30 days prior to the screening visit and are on a stable dose of
mesalamine or 5-aminosalicylic acid equivalent.
Exclusion Criteria:
- Abnormal and clinically significant results according to the investigator or designee, on
physical examination, medical history, electrocardiogram (ECG), hematology, clinical
chemistry, or urinalysis.
|
NCT0531xxxx/NCT05316233.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/NCT05316233</url>
</required_header>
<id_info>
<org_study_id>2029-701-008</org_study_id>
<nct_id>NCT05316233</nct_id>
</id_info>
<brief_title>A Study to Assess Adverse Events and Change in Disease Activity of JUVÉDERM® VOLITE™ XC Injectable Gel for Change in Neck Appearance in Adult Participants</brief_title>
<official_title>Multicenter, Evaluator-blinded, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLITE™ XC Injectable Gel for Improvement in Neck Appearance</official_title>
<sponsors>
<lead_sponsor>
<agency>AbbVie</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>AbbVie</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 cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and
visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and
roughness of sun exposed skin. The neck is a frequently mentioned area by patients
complaining about its crepey texture and deep lines. VOLITE XC is a crosslinked HA gel
implant formulated with lidocaine that was developed to provide a safe, minimally invasive
method of treating fine lines and improving skin quality. The purpose of this study is to
assess adverse events and effectiveness of VOLITE XC in adults seeking improvement in neck
appearance.

VOLITE XC is an investigational product being developed for the improvement of horizontal
neck lines. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in
3 chance that participants will be assigned to the control group. Around 212 adult
participants with transverse neck lines will be enrolled in the study at approximately 20
sites.

Participants in the treatment group will receive VOLITE XC at Day 1 and followed for up to 14
Months. Participants will have the opportunity to receive optional touch-up and optional
repeat treatment of VOLITE XC during the follow-up duration period. The control group
received no treatment and will be followed for up to 6 months after randomization.
Participants can then opt to receive VOLITE XC and followed for 6 Months.

There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, checking for side
effects and completing questionnaires.
</textblock>
</brief_summary>
<overall_status>Active, not recruiting</overall_status>
<start_date type="Actual">May 2, 2022</start_date>
<completion_date type="Anticipated">December 31, 2024</completion_date>
<primary_completion_date type="Anticipated">December 31, 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>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Percentage of Participants Achieving "Responder" status based on Evaluating Investigator's (EI) live assessment of transverse neck lines using the Allergan Transverse Neck Lines Scale (ATNLS)</measure>
<time_frame>Month 1</time_frame>
<description>A "responder" is a participant with at least 1-grade improvement on the ATNLS. ATNLS is a 5-point photonumeric scale to grade the severity of transverse neck lines (0=None, 4=Extreme)</description>
</primary_outcome>
<primary_outcome>
<measure>Number of Participants with Adverse Events</measure>
<time_frame>Up to 14 Months</time_frame>
<description>An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.</description>
</primary_outcome>
<secondary_outcome>
<measure>Percentage of Participants Achieving "Responder" Status for EI's Assessment of global aesthetic improvement on the neck using the Global Aesthetic Improvement Scale (GAIS)</measure>
<time_frame>Month 1</time_frame>
<description>A "responder" is a participant who shows improvement in the overall aesthetic assessment on the neck using GAIS. GAIS is a 5-point ordinal scale (2=Much Improved, -2=Much Worse).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Percentage of Participants Achieving "Responder" Status for Participant's Assessment of global aesthetic improvement on the Neck using GAIS</measure>
<time_frame>Month 1</time_frame>
<description>A "responder" is a participant who shows improvement in the overall aesthetic assessment in the neck using GAIS. GAIS is a 5-point ordinal scale (2=Much Improved, -2=Much Worse).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline to Month 1 on FACE-Q Appraisal of Neck Lines questionnaire</measure>
<time_frame>Baseline to Month 1</time_frame>
<description>FACE-Q is a 10-item questionnaire assessing various aspects of the neck appearance. In the FACE-Q Appraisal of Neck Lines questionnaire, the responses will be summed and converted to a Rasch-transformed score that ranges from 0 to 100.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">159</enrollment>
<condition>Neck Lines</condition>
<arm_group>
<arm_group_label>VOLITE XC</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive VOLITE XC for initial treatment and followed for up to 14 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of VOLITE XC during the follow-up duration period.</description>
</arm_group>
<arm_group>
<arm_group_label>Control Group</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>The control group received no treatment and will be followed for up to 6 months after randomization. Participants can then opt to receive VOLITE XC and followed for 6 Months.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>VOLITE XC</intervention_name>
<description>Intradermal Injection</description>
<arm_group_label>Control Group</arm_group_label>
<arm_group_label>VOLITE XC</arm_group_label>
<other_name>JUVÉDERM® VOLITE™ XC</other_name>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>VOLITE XC</intervention_name>
<description>Subdermal Injection</description>
<arm_group_label>Control Group</arm_group_label>
<arm_group_label>VOLITE XC</arm_group_label>
<other_name>JUVÉDERM® VOLITE™ XC</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Participants in general good health as determined by Treating Investigator's judgment,
including no known active pandemic infection.

- Participants seeking improvement of transverse neck lines.

- Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live
assessment.

Exclusion Criteria:

- Neck deformity or significant skin laxity with severe redundant folds.

- Significant skin pigmentation disorders or discoloration in the neck area that would
interfere with the visual assessment of the neck area.

- Current cutaneous inflammatory or infectious processes (eg. acne, herpes), abscess, an
unhealed wound, or a cancerous or precancerous lesion on the neck.

- Tendency to develop hypertrophic scarring.

- History of thyroid cancer, skin cancer of the neck, radiation of the treatment area,
or de novo cancer in the treatment area.

- Permanent soft tissue fillers in the neck area.

- Semi-permanent soft tissue fillers in the neck area within 2 years before enrollment.

- HA fillers or autologous fat in the neck area within 12 months before enrollment.

- Mesotherapy, photomodulation, intense pulsed light, radiofrequency, dermabrasion,
chemical peel, microneedling, laser, or other cosmetic procedures in the neck area
within 12 months before enrollment.

- Botulinum toxin in the neck area within 6 months before enrollment.

- Deoxycholic acid injections or cryolipolysis in the submentum area within 6 months
before enrollment.

- Neck surgeries and procedures.

- Neck tattoos, piercings, pigmentation, hair, or past trauma that would interfere with
the visualization of the neck area for the effectiveness assessments.

- Pregnant, nursing or planning a pregnancy.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>22 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>ABBVIE INC.</last_name>
<role>Study Director</role>
<affiliation>AbbVie</affiliation>
</overall_official>
<location>
<facility>
<name>Steve Yoelin MD Medical Associate Inc /ID# 239072</name>
<address>
<city>Newport Beach</city>
<state>California</state>
<zip>92663</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Laser & Skin surgery Medical group, Inc /ID# 241999</name>
<address>
<city>Sacramento</city>
<state>California</state>
<zip>95816-5520</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Cosmetic Laser Dermatology /ID# 239121</name>
<address>
<city>San Diego</city>
<state>California</state>
<zip>92121-2119</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Art of Skin MD /ID# 239071</name>
<address>
<city>Solana Beach</city>
<state>California</state>
<zip>92075-2228</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Center for Dermatology and Dermatologic Surgery /ID# 239137</name>
<address>
<city>Washington</city>
<state>District of Columbia</state>
<zip>20037-1445</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hevia Cosmetic Dermatology /ID# 239118</name>
<address>
<city>Coral Gables</city>
<state>Florida</state>
<zip>33134</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Skin Research Institute LLC /ID# 239109</name>
<address>
<city>Coral Gables</city>
<state>Florida</state>
<zip>33146-1837</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Institute of the Southeast, LLC /ID# 239070</name>
<address>
<city>West Palm Beach</city>
<state>Florida</state>
<zip>33401-2712</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Delricht Research /ID# 242001</name>
<address>
<city>New Orleans</city>
<state>Louisiana</state>
<zip>70115</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Rkmd, Llc /Id# 239075</name>
<address>
<city>North Bethesda</city>
<state>Maryland</state>
<zip>20852-3093</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Image Dermatology, P.C. /ID# 239136</name>
<address>
<city>Montclair</city>
<state>New Jersey</state>
<zip>07042</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mariwalla Dermatology /ID# 239102</name>
<address>
<city>West Islip</city>
<state>New York</state>
<zip>11795-4916</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Aesthetic Solutions /ID# 239074</name>
<address>
<city>Chapel Hill</city>
<state>North Carolina</state>
<zip>27517-9901</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Bellaire Dermatology Associates /ID# 239133</name>
<address>
<city>Bellaire</city>
<state>Texas</state>
<zip>77401</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>https://www.abbvieclinicaltrials.com/study/?id=2029-701-008</url>
<description>Related Info</description>
</link>
<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 7, 2022</study_first_posted>
<last_update_submitted>August 28, 2023</last_update_submitted>
<last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">August 30, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Hyaluronic Acid</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</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>
<ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
<ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
<ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and
visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and
roughness of sun exposed skin. The neck is a frequently mentioned area by patients
complaining about its crepey texture and deep lines. VOLITE XC is a crosslinked HA gel
implant formulated with lidocaine that was developed to provide a safe, minimally invasive
method of treating fine lines and improving skin quality. The purpose of this study is to
assess adverse events and effectiveness of VOLITE XC in adults seeking improvement in neck
appearance.
VOLITE XC is an investigational product being developed for the improvement of horizontal
neck lines. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in
3 chance that participants will be assigned to the control group. Around 212 adult
participants with transverse neck lines will be enrolled in the study at approximately 20
sites.
Participants in the treatment group will receive VOLITE XC at Day 1 and followed for up to 14
Months. Participants will have the opportunity to receive optional touch-up and optional
repeat treatment of VOLITE XC during the follow-up duration period. The control group
received no treatment and will be followed for up to 6 months after randomization.
Participants can then opt to receive VOLITE XC and followed for 6 Months.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, checking for side
effects and completing questionnaires.
Inclusion Criteria:
- Participants in general good health as determined by Treating Investigator's judgment,
including no known active pandemic infection.
- Participants seeking improvement of transverse neck lines.
- Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live
assessment.
Exclusion Criteria:
- Neck deformity or significant skin laxity with severe redundant folds.
- Significant skin pigmentation disorders or discoloration in the neck area that would
interfere with the visual assessment of the neck area.
- Current cutaneous inflammatory or infectious processes (eg. acne, herpes), abscess, an
unhealed wound, or a cancerous or precancerous lesion on the neck.
- Tendency to develop hypertrophic scarring.
- History of thyroid cancer, skin cancer of the neck, radiation of the treatment area,
or de novo cancer in the treatment area.
- Permanent soft tissue fillers in the neck area.
- Semi-permanent soft tissue fillers in the neck area within 2 years before enrollment.
- HA fillers or autologous fat in the neck area within 12 months before enrollment.
- Mesotherapy, photomodulation, intense pulsed light, radiofrequency, dermabrasion,
chemical peel, microneedling, laser, or other cosmetic procedures in the neck area
within 12 months before enrollment.
- Botulinum toxin in the neck area within 6 months before enrollment.
- Deoxycholic acid injections or cryolipolysis in the submentum area within 6 months
before enrollment.
- Neck surgeries and procedures.
- Neck tattoos, piercings, pigmentation, hair, or past trauma that would interfere with
the visualization of the neck area for the effectiveness assessments.
- Pregnant, nursing or planning a pregnancy.
|
NCT0531xxxx/NCT05316246.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/NCT05316246</url>
</required_header>
<id_info>
<org_study_id>ZSXY-NKT-01</org_study_id>
<nct_id>NCT05316246</nct_id>
</id_info>
<brief_title>Efficacy and Safety of BV With Tislelizumab for the Treatment of CD30+ Relapsed/Refractory NK/T-cell Lymphoma</brief_title>
<official_title>Efficacy and Safety of Brentuximab Vedotin in Combination With Tislelizumab for the Treatment of CD30-positive Relapsed/Refractory NK/T-cell Lymphoma</official_title>
<sponsors>
<lead_sponsor>
<agency>Shanghai Zhongshan Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Takeda</agency>
<agency_class>Industry</agency_class>
</collaborator>
<collaborator>
<agency>BeiGene</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>Shanghai Zhongshan 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>
<is_us_export>Yes</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
This is a single-arm, open-label, multicenter, phase 2 study designed to evaluate the
efficacy and safety of brentuximab vedotin combined with PD-1 inhibitor tislelizumab in
Chinese patients with relapsed/refractory CD30+ NK/CL. Brentuximab vedotin will be
administered as 1.8 mg/kg IV infusion on Day 1 of each 3-week cycle. PD-1 inhibitor
tislelizumab will be administered as 200 mg on Day 1 of each 3-week cycle. Patients will
receive maximum of 8 cycles if they do not meet the criteria for removal from the study.
Patients will be assessed for overall response using the Revised Response Criteria for
Malignant Lymphoma (Lugano 2014). Dedicated computed tomography (CT) scans (neck, chest,
abdomen, and pelvis) will be performed at Baseline and at Cycles 2, 4 and 8, and positron
emission tomography (PET) scans will be performed at Baseline and at Cycles 4 and 8. No
additional PET scanning is required beyond Cycle 8 unless clinically indicated (for example,
suspected of disease progression). The disease symptoms will be assessed at Baseline and on
Day 1 of each cycle. Patients may continue study treatment until the sooner of disease
progression, unacceptable toxicity, or completion of 8 cycles. Patients who discontinue study
treatment for any reason other than withdrawal of consent will have safety follow-up
assessments through 30 days after the last dose of 、study drug (end of treatment [EOT]).
Patients who discontinue study treatment with stable disease (SD), responses and progression
disease (PD) will be followed for 1-year PFS rate and 1-year OS rate. The CT scan, PET-CT and
laboratory examination will be followed based on clinical practice. The study will be closed
when all patients enrolled have completed the required follow-up.Toxicity will be evaluated
according to the National Cancer Institute Common Terminology Criteria for Adverse Events
(NCI CTCAE), version 5.0 Laboratory values, vital signs, and electrocardiograms (ECGs) will
be obtained to evaluate the safety and tolerability of study treatment.
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">June 1, 2022</start_date>
<completion_date type="Anticipated">December 31, 2024</completion_date>
<primary_completion_date type="Anticipated">June 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>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 response (CR) rate</measure>
<time_frame>1 year after treatment completion</time_frame>
<description>complete response (CR) rate, evaluated by PET-CT and CT/MRI, according to Lugano 2014 criteria</description>
</primary_outcome>
<secondary_outcome>
<measure>overall response rate (ORR)</measure>
<time_frame>1 year after treatment completion</time_frame>
<description>overall response rate (ORR), evaluated by PET-CT and MRI, according to Lugano 2014 criteria</description>
</secondary_outcome>
<secondary_outcome>
<measure>1-year progression free survival rate (PFS)</measure>
<time_frame>1 year after treatment completion</time_frame>
<description>1-year progression free survival rate (PFS), time from date of enrolment to date of disease progression, death of any reason, whichever comes first</description>
</secondary_outcome>
<secondary_outcome>
<measure>1-year overall survival rate (OS)</measure>
<time_frame>1 year after treatment completion</time_frame>
<description>1-year overall survival rate (OS), time from date of enrolment to date of death of any reason.</description>
</secondary_outcome>
<secondary_outcome>
<measure>adverse events according to CTCAE 5.0</measure>
<time_frame>1 year after treatment completion</time_frame>
<description>safety profiles, evaluated by adverse events according to CTCAE 5.0</description>
</secondary_outcome>
<secondary_outcome>
<measure>disease control rate (DCR)</measure>
<time_frame>1 year after treatment completion</time_frame>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">40</enrollment>
<condition>NK/T Cell Lymphoma Nos</condition>
<arm_group>
<arm_group_label>CD30-positive Relapsed/Refractory NK/T-cell Lymphoma</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Brentuximab vedotin will be administered as 1.8 mg/kg IV infusion on Day 1 of each 3-week cycle. PD-1 inhibitor tislelizumab will be administered as 200 mg on Day 1 of each 3-week cycle. Patients will receive maximum of 8 cycles if they do not meet the criteria for removal from the study. Patients will be assessed for overall response using the Revised Response Criteria for Malignant Lymphoma (Lugano 2014). Dedicated computed tomography (CT) scans (neck, chest, abdomen, and pelvis) will be performed at Baseline and at Cycles 2, 4 and 8, and positron emission tomography (PET) scans will be performed at Baseline and at Cycles 4 and 8.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Brentuximab Vedotin in Combination with Tislelizumab</intervention_name>
<description>Brentuximab vedotin will be administered after diluted with 100 ml normal saline as an IV infusion over approximately 30 minutes on Day 1 of each 21-day cycle at a dose of 1.8 mg/kg. Tislelizumab will be administered after diluted with 100 ml normal saline as an IV infusion over approximately 30 minutes on Day 1 of each 21-day cycle at a fixed dose of 200 mg. The rationale of fixed dose of Tislelizumab is according to the drug description, which is based on previous I/II phase clinical trial results of Tislelizumab. The time interval between administration of tislelizumab and brentuximab vedotin should be not less than 2 hours, and thereafter, the dosing cycle of tislelizumab is synchronized with that of brentuximab vedotin.</description>
<arm_group_label>CD30-positive Relapsed/Refractory NK/T-cell Lymphoma</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Adults aged 18~75 years

- Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma
according to WHO 2016 criteria

- ≥10% CD30 positive for tumor tissue immunohistochemistry

- Previously treated with asparaginase-based regimens (refractory or relapsed after
initial remission)

- PET/CT or CT/MRI with at least one objectively measurable or evaluable lesion

- ECOG Performance score 0-2

- The laboratory test within 1 week before enrollment meets the following conditions:

- Blood routine: absolute neutrophil count≥1,500/uL, Leukocytes≥3,000/mm3, Hb>8.0g/dL,
PLT>100 ×10*9/L. Liver function: ALT, AST≤ 2.5 times the upper limit of normal, TBIL
≤1.5 times the upper limit of normal. Renal function: Cr >2.0 mg/dL and/or creatinine
clearance or calculated creatinine clearance > 40 mL/minute , Amylase and/or lipase
≤1.5 x ULN, Coagulation : plasma fibrinogen ≥ 1.0g/L. Cardiac function: LVEF≥50%, ECG
does not suggest any acute myocardial infarction, arrhythmia or atrioventricular
conduction above I Blocking,

- Sign the informed consent form,

- Female patient is either post-menopausal for at least 1 year before the screening
visit or surgically sterile or if of childbearing potential, agree to practice 2
effective methods of contraception, at the same time from the time of signing informed
consent through six months after the last dose of study drug

- Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to
practice effective barrier contraception during the entire study period and through 6
months during entire study treatment period and through 6 months after the last dose
of study drug,

- Voluntary compliance with research protocols, follow-up plans, laboratory and
auxiliary examinations.

Exclusion Criteria:

- Serious active infection requiring ICU treatment.

- Patients with any active viral, bacterial, or fungal infections that require
intravenous antibiotics within 2 weeks before the first dose of the study drug

- Known HIV infection or active infection with HBV, HCV. Patients who are infected with
HBV but not active hepatitis at the same time are not excluded.

- Serious complications such as fulminant DIC.

- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient
contained in the drug formulation of brentuximab vedotin.

- Peripheral neuropathy ≥ Grade 2 (NCI-CTCAE version 5.0 ).

- Symptomatic neurologic disease compromising normal activities of daily living or
requiring medications

- Known cerebral or meningeal disease (HL or any other etiology), including signs or
symptoms of PML

- Significant organ dysfunction: such as respiratory failure, NYHA classification Class
III or IV, chronic congestive heart failure, decompensation Hepatic or renal
insufficiency, high blood pressure and diabetes that cannot be controlled despite
active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past
6 months.

- Pregnant and lactating women.

- Had a history of autoimmune diseases, and disease was active in the last 6 months, and
was still taking oral immunosuppressant in the past three months, with daily
prednisone dose greater than 10 mg

- Patients who are known to be seriously allergic to any of the drugs in the study
regimen (e.g. life-threatening allergic symptoms such as anaphylactic shock).

- Patients combined with other tumors who require surgery or chemotherapy within 6
months.

- Other experimental drugs are being used.

- Diagnosed or treated for another malignancy within 3 years before the first dose or
previously diagnosed with another malignancy and have evidence of residual disease.
Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not
excluded if they have undergone complete resection
</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>Peng Liu, Ph.D</last_name>
<role>Principal Investigator</role>
<affiliation>Fudan University</affiliation>
</overall_official>
<overall_contact>
<last_name>Peng Liu, Ph.D</last_name>
<phone>862164041990</phone>
<phone_ext>2925</phone_ext>
<email>liu.peng@zs-hospital.sh.cn</email>
</overall_contact>
<overall_contact_backup>
<last_name>Yian Zhang, M.D</last_name>
<phone>02164041990</phone>
<phone_ext>13010</phone_ext>
<email>zhang.yi_an@zs-hospital.sh.cn</email>
</overall_contact_backup>
<results_reference>
<citation>Feng Y, Rao H, Lei Y, Huang Y, Wang F, Zhang Y, Xi S, Wu Q, Shao J. CD30 expression in extranodal natural killer/T-cell lymphoma, nasal type among 622 cases of mature T-cell and natural killer-cell lymphoma at a single institution in South China. Chin J Cancer. 2017 May 10;36(1):43. doi: 10.1186/s40880-017-0212-9.</citation>
<PMID>28486951</PMID>
</results_reference>
<results_reference>
<citation>Kwong YL, Kim WS, Lim ST, Kim SJ, Tang T, Tse E, Leung AY, Chim CS. SMILE for natural killer/T-cell lymphoma: analysis of safety and efficacy from the Asia Lymphoma Study Group. Blood. 2012 Oct 11;120(15):2973-80. doi: 10.1182/blood-2012-05-431460. Epub 2012 Aug 23.</citation>
<PMID>22919026</PMID>
</results_reference>
<results_reference>
<citation>Kwong YL, Chan TSY, Tan D, Kim SJ, Poon LM, Mow B, Khong PL, Loong F, Au-Yeung R, Iqbal J, Phipps C, Tse E. PD1 blockade with pembrolizumab is highly effective in relapsed or refractory NK/T-cell lymphoma failing l-asparaginase. Blood. 2017 Apr 27;129(17):2437-2442. doi: 10.1182/blood-2016-12-756841. Epub 2017 Feb 10.</citation>
<PMID>28188133</PMID>
</results_reference>
<results_reference>
<citation>Li X, Cheng Y, Zhang M, Yan J, Li L, Fu X, Zhang X, Chang Y, Sun Z, Yu H, Zhang L, Wang X, Wu J, Li Z, Nan F, Tian L, Li W, Young KH. Activity of pembrolizumab in relapsed/refractory NK/T-cell lymphoma. J Hematol Oncol. 2018 Jan 31;11(1):15. doi: 10.1186/s13045-018-0559-7.</citation>
<PMID>29386072</PMID>
</results_reference>
<results_reference>
<citation>Chan TSY, Li J, Loong F, Khong PL, Tse E, Kwong YL. PD1 blockade with low-dose nivolumab in NK/T cell lymphoma failing L-asparaginase: efficacy and safety. Ann Hematol. 2018 Jan;97(1):193-196. doi: 10.1007/s00277-017-3127-2. Epub 2017 Sep 6. No abstract available.</citation>
<PMID>28879531</PMID>
</results_reference>
<results_reference>
<citation>Tao R, Fan L, Song Y, Hu Y, Zhang W, Wang Y, Xu W, Li J. Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4). Signal Transduct Target Ther. 2021 Oct 27;6(1):365. doi: 10.1038/s41392-021-00768-0.</citation>
<PMID>34702811</PMID>
</results_reference>
<results_reference>
<citation>Kim HK, Moon SM, Moon JH, Park JE, Byeon S, Kim WS. Complete remission in CD30-positive refractory extranodal NK/T-cell lymphoma with brentuximab vedotin. Blood Res. 2015 Dec;50(4):254-6. doi: 10.5045/br.2015.50.4.254. Epub 2015 Dec 21. No abstract available.</citation>
<PMID>26770954</PMID>
</results_reference>
<results_reference>
<citation>Advani RH, Moskowitz AJ, Bartlett NL, Vose JM, Ramchandren R, Feldman TA, LaCasce AS, Christian BA, Ansell SM, Moskowitz CH, Brown L, Zhang C, Taft D, Ansari S, Sacchi M, Ho L, Herrera AF. Brentuximab vedotin in combination with nivolumab in relapsed or refractory Hodgkin lymphoma: 3-year study results. Blood. 2021 Aug 12;138(6):427-438. doi: 10.1182/blood.2020009178.</citation>
<PMID>33827139</PMID>
</results_reference>
<results_reference>
<citation>Yamaguchi M, Suzuki R, Oguchi M, Asano N, Amaki J, Akiba T, Maeda T, Itasaka S, Kubota N, Saito Y, Kobayashi Y, Itami J, Ueda K, Miyazaki K, Ii N, Tomita N, Sekiguchi N, Takizawa J, Saito B, Murayama T, Ando T, Wada H, Hyo R, Ejima Y, Hasegawa M, Katayama N. Treatments and Outcomes of Patients With Extranodal Natural Killer/T-Cell Lymphoma Diagnosed Between 2000 and 2013: A Cooperative Study in Japan. J Clin Oncol. 2017 Jan;35(1):32-39. doi: 10.1200/JCO.2016.68.1619. Epub 2016 Oct 31.</citation>
<PMID>28034070</PMID>
</results_reference>
<results_reference>
<citation>Lim SH, Hong JY, Lim ST, Hong H, Arnoud J, Zhao W, Yoon DH, Tang T, Cho J, Park S, Ko YH, Kim SJ, Suh C, Lin T, Kim WS. Beyond first-line non-anthracycline-based chemotherapy for extranodal NK/T-cell lymphoma: clinical outcome and current perspectives on salvage therapy for patients after first relapse and progression of disease. Ann Oncol. 2017 Sep 1;28(9):2199-2205. doi: 10.1093/annonc/mdx316.</citation>
<PMID>28911074</PMID>
</results_reference>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>April 6, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Shanghai Zhongshan Hospital</investigator_affiliation>
<investigator_full_name>Peng Liu</investigator_full_name>
<investigator_title>Chief of hematology department</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Lymphoma</mesh_term>
<mesh_term>Lymphoma, T-Cell</mesh_term>
<mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Tislelizumab</mesh_term>
<mesh_term>Brentuximab Vedotin</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 single-arm, open-label, multicenter, phase 2 study designed to evaluate the
efficacy and safety of brentuximab vedotin combined with PD-1 inhibitor tislelizumab in
Chinese patients with relapsed/refractory CD30+ NK/CL. Brentuximab vedotin will be
administered as 1.8 mg/kg IV infusion on Day 1 of each 3-week cycle. PD-1 inhibitor
tislelizumab will be administered as 200 mg on Day 1 of each 3-week cycle. Patients will
receive maximum of 8 cycles if they do not meet the criteria for removal from the study.
Patients will be assessed for overall response using the Revised Response Criteria for
Malignant Lymphoma (Lugano 2014). Dedicated computed tomography (CT) scans (neck, chest,
abdomen, and pelvis) will be performed at Baseline and at Cycles 2, 4 and 8, and positron
emission tomography (PET) scans will be performed at Baseline and at Cycles 4 and 8. No
additional PET scanning is required beyond Cycle 8 unless clinically indicated (for example,
suspected of disease progression). The disease symptoms will be assessed at Baseline and on
Day 1 of each cycle. Patients may continue study treatment until the sooner of disease
progression, unacceptable toxicity, or completion of 8 cycles. Patients who discontinue study
treatment for any reason other than withdrawal of consent will have safety follow-up
assessments through 30 days after the last dose of 、study drug (end of treatment [EOT]).
Patients who discontinue study treatment with stable disease (SD), responses and progression
disease (PD) will be followed for 1-year PFS rate and 1-year OS rate. The CT scan, PET-CT and
laboratory examination will be followed based on clinical practice. The study will be closed
when all patients enrolled have completed the required follow-up.Toxicity will be evaluated
according to the National Cancer Institute Common Terminology Criteria for Adverse Events
(NCI CTCAE), version 5.0 Laboratory values, vital signs, and electrocardiograms (ECGs) will
be obtained to evaluate the safety and tolerability of study treatment.
Inclusion Criteria:
- Adults aged 18~75 years
- Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma
according to WHO 2016 criteria
- ≥10% CD30 positive for tumor tissue immunohistochemistry
- Previously treated with asparaginase-based regimens (refractory or relapsed after
initial remission)
- PET/CT or CT/MRI with at least one objectively measurable or evaluable lesion
- ECOG Performance score 0-2
- The laboratory test within 1 week before enrollment meets the following conditions:
- Blood routine: absolute neutrophil count≥1,500/uL, Leukocytes≥3,000/mm3, Hb>8.0g/dL,
PLT>100 ×10*9/L. Liver function: ALT, AST≤ 2.5 times the upper limit of normal, TBIL
≤1.5 times the upper limit of normal. Renal function: Cr >2.0 mg/dL and/or creatinine
clearance or calculated creatinine clearance > 40 mL/minute , Amylase and/or lipase
≤1.5 x ULN, Coagulation : plasma fibrinogen ≥ 1.0g/L. Cardiac function: LVEF≥50%, ECG
does not suggest any acute myocardial infarction, arrhythmia or atrioventricular
conduction above I Blocking,
- Sign the informed consent form,
- Female patient is either post-menopausal for at least 1 year before the screening
visit or surgically sterile or if of childbearing potential, agree to practice 2
effective methods of contraception, at the same time from the time of signing informed
consent through six months after the last dose of study drug
- Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to
practice effective barrier contraception during the entire study period and through 6
months during entire study treatment period and through 6 months after the last dose
of study drug,
- Voluntary compliance with research protocols, follow-up plans, laboratory and
auxiliary examinations.
Exclusion Criteria:
- Serious active infection requiring ICU treatment.
- Patients with any active viral, bacterial, or fungal infections that require
intravenous antibiotics within 2 weeks before the first dose of the study drug
- Known HIV infection or active infection with HBV, HCV. Patients who are infected with
HBV but not active hepatitis at the same time are not excluded.
- Serious complications such as fulminant DIC.
- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient
contained in the drug formulation of brentuximab vedotin.
- Peripheral neuropathy ≥ Grade 2 (NCI-CTCAE version 5.0 ).
- Symptomatic neurologic disease compromising normal activities of daily living or
requiring medications
- Known cerebral or meningeal disease (HL or any other etiology), including signs or
symptoms of PML
- Significant organ dysfunction: such as respiratory failure, NYHA classification Class
III or IV, chronic congestive heart failure, decompensation Hepatic or renal
insufficiency, high blood pressure and diabetes that cannot be controlled despite
active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past
6 months.
- Pregnant and lactating women.
- Had a history of autoimmune diseases, and disease was active in the last 6 months, and
was still taking oral immunosuppressant in the past three months, with daily
prednisone dose greater than 10 mg
- Patients who are known to be seriously allergic to any of the drugs in the study
regimen (e.g. life-threatening allergic symptoms such as anaphylactic shock).
- Patients combined with other tumors who require surgery or chemotherapy within 6
months.
- Other experimental drugs are being used.
- Diagnosed or treated for another malignancy within 3 years before the first dose or
previously diagnosed with another malignancy and have evidence of residual disease.
Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not
excluded if they have undergone complete resection
|
NCT0531xxxx/NCT05316259.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/NCT05316259</url>
</required_header>
<id_info>
<org_study_id>BTP-66732FE</org_study_id>
<nct_id>NCT05316259</nct_id>
</id_info>
<brief_title>A Food-Effect Study of BPI-16350 in Healthy Subjects</brief_title>
<official_title>A Phase 1, Single-center, Open-Label, Randomized, 2 Period Crossover Study to Estimate the Effect of Food on the Pharmacokinetics of BPI-16350 in Chinese Healthy Volunteers After a Single Oral Administration</official_title>
<sponsors>
<lead_sponsor>
<agency>Betta Pharmaceuticals Co., Ltd.</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Betta Pharmaceuticals 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>
This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350.

Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose
of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting
conditions(Treatment A) or with a high-fat meal(Treatment B).
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 15, 2022</start_date>
<completion_date type="Actual">August 30, 2022</completion_date>
<primary_completion_date type="Actual">August 30, 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>Crossover Assignment</intervention_model>
<primary_purpose>Basic Science</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Cmax</measure>
<time_frame>from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose</time_frame>
<description>Maximum observed concentration</description>
</primary_outcome>
<primary_outcome>
<measure>AUC0-t</measure>
<time_frame>from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose</time_frame>
<description>Area under the concentration-time curve from time 0 to time t</description>
</primary_outcome>
<primary_outcome>
<measure>AUC0-∞</measure>
<time_frame>from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose</time_frame>
<description>Area under the concentration-time curve from time 0 to infinity</description>
</primary_outcome>
<secondary_outcome>
<measure>Tmax</measure>
<time_frame>from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose</time_frame>
<description>Time to reach maximum observed plasma concentration</description>
</secondary_outcome>
<secondary_outcome>
<measure>t1/2</measure>
<time_frame>from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose</time_frame>
<description>Half-life time</description>
</secondary_outcome>
<secondary_outcome>
<measure>λz</measure>
<time_frame>from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose</time_frame>
<description>Elimination rate constant</description>
</secondary_outcome>
<secondary_outcome>
<measure>tlag</measure>
<time_frame>from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose</time_frame>
<description>Lag Time</description>
</secondary_outcome>
<secondary_outcome>
<measure>AUC %Extrap</measure>
<time_frame>from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose</time_frame>
<description>Percentage of AUCinf due to extrapolation from Tlast to infinity</description>
</secondary_outcome>
<secondary_outcome>
<measure>CL/F</measure>
<time_frame>from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose</time_frame>
<description>Apparent Oral Clearance</description>
</secondary_outcome>
<secondary_outcome>
<measure>V/F</measure>
<time_frame>from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose</time_frame>
<description>Apparent Volume of Distribution</description>
</secondary_outcome>
<secondary_outcome>
<measure>Characterize the safety of BPI-16350</measure>
<time_frame>from Day 1 to Day 23</time_frame>
<description>Number of subjects with treatment related adverse events</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">24</enrollment>
<condition>Healthy</condition>
<arm_group>
<arm_group_label>Group A（Dosing in the fasted state followed by fed dosing）</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Dosing in the fasted state followed by fed dosing.A washout period of 14 days will be maintained between the 2 treatment periods.</description>
</arm_group>
<arm_group>
<arm_group_label>Group B（Dosing in the fed state followed by fasted dosing）</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Dosing in the fed state followed by fasted dosing.A washout period of 14 days will be maintained between the 2 treatment periods.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>BPI-16350</intervention_name>
<description>Administered orally</description>
<arm_group_label>Group A（Dosing in the fasted state followed by fed dosing）</arm_group_label>
<arm_group_label>Group B（Dosing in the fed state followed by fasted dosing）</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Healthy subjects aged 18~45 (including 18 and 45 years old);

- Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the
range of 19 ~ 26kg /m2;

- Clinical laboratory evaluations within the reference range for the test laboratory,
unless deemed not clinically significant by the Investigator;

- The subjects should took effective contraceptive measures voluntarily from informed
consent until 3 months after Study Completion；

- Able to comprehend and willing to sign an informed consent form.

Exclusion Criteria:

- History of significant hypersensitivity to any drug compound or food；

- Significant history or clinical manifestation of any significant cardiovascular,
hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic,
musculoskeletal,hematological disorder；

- Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum
antibody or human immunodeficiency virus antibody is positive；

- Family history of long QTc syndrome; History or presence of an abnormal ECG；

- Drug abusers, smokers or alcoholics；

- Use of any medications within 14 days prior to the first administration；

- Donation of blood ≥ 200 mL or receipt of blood products within 3 months before
enrollment, or plan on blood donation during the study period；

- Participation in any other investigational drug study or receive any vaccine within 3
months before enrollment；

- Female subjects who are pregnant or lactating；the serum HCG test of women with
fertility is postive at Screening.
</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>
<overall_official>
<last_name>Haibin Yu, Ph.D</last_name>
<role>Principal Investigator</role>
<affiliation>Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University</affiliation>
</overall_official>
<location>
<facility>
<name>Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University</name>
<address>
<city>Beijing</city>
<state>Beijing</state>
<zip>100069</zip>
<country>China</country>
</address>
</facility>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>April 2023</verification_date>
<study_first_submitted>March 14, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>May 7, 2023</last_update_submitted>
<last_update_submitted_qc>May 7, 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>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350.
Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose
of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting
conditions(Treatment A) or with a high-fat meal(Treatment B).
Inclusion Criteria:
- Healthy subjects aged 18~45 (including 18 and 45 years old);
- Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the
range of 19 ~ 26kg /m2;
- Clinical laboratory evaluations within the reference range for the test laboratory,
unless deemed not clinically significant by the Investigator;
- The subjects should took effective contraceptive measures voluntarily from informed
consent until 3 months after Study Completion；
- Able to comprehend and willing to sign an informed consent form.
Exclusion Criteria:
- History of significant hypersensitivity to any drug compound or food；
- Significant history or clinical manifestation of any significant cardiovascular,
hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic,
musculoskeletal,hematological disorder；
- Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum
antibody or human immunodeficiency virus antibody is positive；
- Family history of long QTc syndrome; History or presence of an abnormal ECG；
- Drug abusers, smokers or alcoholics；
- Use of any medications within 14 days prior to the first administration；
- Donation of blood ≥ 200 mL or receipt of blood products within 3 months before
enrollment, or plan on blood donation during the study period；
- Participation in any other investigational drug study or receive any vaccine within 3
months before enrollment；
- Female subjects who are pregnant or lactating；the serum HCG test of women with
fertility is postive at Screening.
|
NCT0531xxxx/NCT05316272.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/NCT05316272</url>
</required_header>
<id_info>
<org_study_id>162427a</org_study_id>
<nct_id>NCT05316272</nct_id>
</id_info>
<brief_title>Effects of DHEA and Exercise on Bone Marrow Fat in Postmenopausal Women</brief_title>
<official_title>Effects of DHEA and Exercise on Bone Marrow Fat in Postmenopausal Women</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Colorado, Denver</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Colorado, Denver</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>
Bone strength -the main determinant of bone fracture- is a function not only of bone mineral
density (BMD) and microstructure, but also of its microenvironment, including bone marrow fat
(BMF). The adrenal steroid dehydroepiandrosterone (DHEA) -the main precursor for estrogens
and androgens in postmenopausal women- as well as bone-loading exercise, increase BMD in
older women, however, their effects on BMF are largely unknown. This study has high potential
to unveil the hormonal and mechanical effects of DHEA and exercise on BMF, respectively, and
to elucidate longitudinal associations of BMF with bone strength in older women with bone
loss.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The proportion of the U.S. population older than 65 years will increase from 12.7% in 2000 to
20.3% in 2050, and the number of fractures is expected to exceed 3 million by 2025 with
associated costs in the order of $25.3 billion per year. DAMES is an ongoing clinical trial
(NCT03227458) that aims to assess -for the first time- changes in areal bone mineral density
(aBMD) and fat-free mass (FFM) in response to therapy with the adrenal steroid
dehydroepiandrosterone (DHEA) alone and combined with bone-loading exercise (EX) in older
women with bone loss. The hormonal and mechanical strategies proposed in DAMES represent a
low-cost alternative treatment to improve bone quantity with a number of other health
benefits not afforded by typical pharmacological approaches. However, bone strength -the main
determinant of bone fracture- is a function of not only BMD and microstructure, but also of
its microenvironment, including bone marrow fat (BMF). This in an ancillary study to the
DAMES clinical trial. Here, the investigators propose to leverage the well-characterized
cohort of subjects, exercise training, clinical, laboratory and imaging data from DAMES, and
add a small group of controls to its three existing arms (DHEA only, EX+Placebo, and EX+DHEA)
to investigate the effects of DHEA therapy and EX on BMF in older women using advanced
imaging, numerical engineering, and image analysis techniques. In particular, the
investigators aim to determine in the lumbar spine and hip of older women with low bone mass
or moderate osteoporosis: 1) whether DHEA or EX leads to changes in BMF content; 2) whether
BMF content is associated with bone strength at baseline, and whether changes in BMF content
are associated with changes in bone strength, evaluating the impact of DHEA or EX on these
associations; and 3) the spatial distribution of changes in BMF content in response to DHEA
or EX. BMF will be measured with chemical shift-based water-fat separation magnetic resonance
imaging, bone strength will be estimated with finite element modeling from quantitative
computed tomography scans, and differences in the spatial distribution of BMF changes between
groups will be assessed using voxel-based morphometry. Ultimately, the investigators will
leverage the DAMES clinical trial to unveil new information to improve our understanding of
DHEA and EX on bone quantity and quality. The longitudinal assessments of bone quality in
this ancillary proposal, with those of bone quantity in the parent study, in women who have
already lost bone mass is unprecedented. Understanding how osteoporosis treatments -including
exercise- act on BMF could lead to the generation of novel approaches for fracture risk
assessment, procedures for therapy monitoring, and treatments for bone loss.
</textblock>
</detailed_description>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Actual">March 11, 2022</start_date>
<completion_date type="Anticipated">January 2024</completion_date>
<primary_completion_date type="Anticipated">January 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>Two-by-two crossed design of DHEA versus control and exercise versus no exercise control.</intervention_model_description>
<primary_purpose>Prevention</primary_purpose>
<masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
<masking_description>Masking of the study pill (DHEA or placebo) is described as noted above. Exercise cannot be masked.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Changes in spine bone marrow fat content</measure>
<time_frame>36 weeks</time_frame>
<description>changes in bone marrow fat content of the lumbar spine</description>
</primary_outcome>
<primary_outcome>
<measure>Changes in hip bone marrow fat content</measure>
<time_frame>36 weeks</time_frame>
<description>changes in bone marrow fat content of the proximal femur</description>
</primary_outcome>
<primary_outcome>
<measure>Correlation of lumbar spine bone marrow fat content with bone strength at baseline</measure>
<time_frame>baseline - 0 weeks of intervention</time_frame>
<description>Correlation of lumbar bone marrow fat content (%) with strength (N) of the lumbar spine at baseline</description>
</primary_outcome>
<primary_outcome>
<measure>Correlation of hip bone marrow fat content with hip strength at baseline</measure>
<time_frame>baseline - 0 weeks of intervention</time_frame>
<description>Correlation of proximal femur spine bone marrow fat content (%) with strength (N) of the proximal femur at baseline</description>
</primary_outcome>
<primary_outcome>
<measure>Correlation of the changes in spine bone marrow fat content with changes in spine bone strength</measure>
<time_frame>36 weeks</time_frame>
<description>Correlation of the changes in lumbar spine bone marrow fat content (%) with changes in lumbar spine strength (N)</description>
</primary_outcome>
<primary_outcome>
<measure>Correlation of the changes in hip bone marrow fat content (%) with changes in hip bone strength (N)</measure>
<time_frame>36 weeks</time_frame>
<description>Correlation of the changes in proximal femur bone marrow fat content (%) with changes in proximal femur bone strength (N)</description>
</primary_outcome>
<other_outcome>
<measure>spatial distribution of the changes in bone marrow fat content of the spine</measure>
<time_frame>36 weeks</time_frame>
<description>spatial distribution of the changes in bone marrow fat content of the lumbar spine</description>
</other_outcome>
<other_outcome>
<measure>spatial distribution of the changes in bone marrow fat content of the hip</measure>
<time_frame>36 weeks</time_frame>
<description>spatial distribution of the changes in bone marrow fat content of the proximal femur</description>
</other_outcome>
<number_of_arms>4</number_of_arms>
<enrollment type="Anticipated">52</enrollment>
<condition>Low Bone Density</condition>
<condition>Osteoporosis</condition>
<arm_group>
<arm_group_label>Exercise and placebo</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>supervised bone-loading exercise 3 days per week and one placebo pill per day for 36 weeks</description>
</arm_group>
<arm_group>
<arm_group_label>Exercise and DHEA</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>supervised bone-loading exercise 3 days per week and one dose of DHEA (50 milligrams) per day for 36 weeks</description>
</arm_group>
<arm_group>
<arm_group_label>no exercise and DHEA</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>no supervised bone exercise and one dose of DHEA (50 milligrams) per day for 36 weeks</description>
</arm_group>
<arm_group>
<arm_group_label>no exercise and placebo</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>no supervised bone-loading exercise and one placebo pill per day for 36 weeks</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Exercise</intervention_name>
<description>Supervised bone-loading exercise on 3 days per week for 36 weeks</description>
<arm_group_label>Exercise and DHEA</arm_group_label>
<arm_group_label>Exercise and placebo</arm_group_label>
<arm_group_label>no exercise and DHEA</arm_group_label>
<arm_group_label>no exercise and placebo</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>DHEA</intervention_name>
<description>DHEA in pill form 50 milligrams taken daily for 36 weeks</description>
<arm_group_label>Exercise and DHEA</arm_group_label>
<arm_group_label>Exercise and placebo</arm_group_label>
<arm_group_label>no exercise and DHEA</arm_group_label>
<arm_group_label>no exercise and placebo</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- women aged 55 to 85 years

- non-frail, as determined by Short Physical Performance Battery score > 9 (0-12 scale)

- 5 years or longer since menopause (defined as last menstrual period)

- willing to participate in a 36-week exercise program that will start at a moderate
intensity and gradually progress to a higher intensity

- willing to take DHEA (50mg/d) or a placebo pill daily and remain blinded for up to 36
weeks

- not performing resistance exercise training or high impact weight-bearing exercise
(e.g., jogging) ≥ 2 days per week in the past 6 months

- ambulatory without assistive devices

- serum DHEAS < 140 μg/dL (3.8 μmol/L)

- low bone mass or moderate osteoporosis indicated by lumbar spine, total hip, or
femoral neck aBMD t-scores < -1.0 and ≥ -3.0

- refusal of standard osteoporosis treatment in women with moderate osteoporosis (BMD
≥-3.0 and ≤ -2.5)

- evidence of a negative (no findings suspicious for breast cancer) mammogram within the
past 12 months

- planning to reside in the Denver area for the duration of the study

- willing to provide evidence of completed COVID-19 vaccination

- no implanted metal or electronic devices

- no metallic foreign body in the eye

- no "triggerfish" contact lenses

- no gastric reflux device

- no insulin pumps

- no temporary transvenous pacing leads

- no aneurysm clips

- no cardiac pacemakers

- no implanted cardioverter defibrillator

- no magnetically-activated implant or device

- no neurostimulation system

- no spinal cord stimulator

- no cochlear implant

- no bone growth/bone fusion stimulator

- no known claustrophobia

Exclusion Criteria:

- history of hospitalization for Corona Virus Disease 2019 (COVID-19)

- does not meet Centers for Disease Control and Prevention (CDC) recommendations for
home isolation because has had a positive severe acute respiratory syndrome
coronavirus 2 (SARS-COV-2) test less than 10 days before study entry; or has had fever
within the past 3 days and respiratory symptoms have not improved; or symptoms first
appeared less than 10 days before study entry.

- not willing to provide evidence of completed COVID-19 vaccination.

- uncontrolled hypertension defined as resting systolic BP >150 mmHg or diastolic BP >90
mmHg; participants who do not meet these criteria at first screening will be
re-evaluated, including follow-up evaluation by their primary care provider (PCP) with
initiation or adjustment of anti-hypertensive medications.

- diagnosed ischemic heart disease or indicators of unstable ischemic heart disease
(e.g., angina) or arrhythmias at rest or during the graded exercise test (GXT) without
negative follow-up evaluation will be cause for exclusion; follow-up evaluation must
include diagnostic testing (e.g., thallium stress test) with interpretation by a
cardiologist

- diagnosis of heart failure, clinically significant aortic stenosis, uncontrolled
angina, or uncontrolled arrhythmia.

- pulmonary disease requiring use of oral steroids within the previous 6 months or the
use of supplemental oxygen ≥ 4 liters with physical exertion

- orthopedic problems (e.g., severe osteoarthritis, rheumatoid arthritis) that greatly
limit the ability to perform moderate to high intensity resistance exercise (e.g.,
unable to be properly positioned in exercise equipment or to have severely restricted
range of motion even after modifications have been made)

- hip fracture, hip or knee replacement, or spinal surgery in the past 6 months

- undergoing physical therapy involving the lower extremities

- hematocrit > 54%

- thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) <
0.4 or > 10 micro units/mL, without signs or symptoms of clinical hypo- or
hyperthyroidism.volunteers with abnormal TSH values will be re-considered for
participation in the study after follow-up evaluation by their PCP with initiation or
adjustment of thyroid hormone replacement

- acute liver disease indicated by liver function tests (ALT, aspartate
aminotransferase, alkaline phosphatase) ≥ 1.5 times the upper limits of normal

- estimated glomerular filtration rate (eGFR) < 45, using Modification of Diet in Renal
Disease Study (MDRD) equation

- poorly controlled diabetes mellitus based on HbA1c > 8.5% or use of insulin.

- fasted serum triglycerides > 400 mg/dL

- serum 25-hydroxy vitamin D < 20 ng/mL; volunteers will be re-considered for
participation in the study after initiation or adjustment of vitamin D
supplementation, per the study's vitamin D repletion protocol.

- use of DHEA supplementation or sex hormones in the past 6 months. Use of prescription
low dose vaginal estrogen creams (Premarin or Estrace) 3 days per week or less will
not be exclusionary.

- use in the past 6 months of any medications known to alter bone metabolism (e.g., oral
glucocorticoids, bone anti- resorptive agents)

- lumbar spine, total hip, or femoral neck aBMD t-scores < -3.0.

- confirmed history of osteoporotic fracture

- secondary osteoporosis

- documented history of cognitive impairment or dementia or Mini-Cog < 4.

- current smoker

- personal history of breast, ovarian, metastatic endometrial, or cervical cancer

- any cancer requiring treatment in the past 3 years except non-melanoma skin cancers

- undiagnosed vaginal bleeding

- women who, in the judgment of the study physician, appear incapable of safely
participating in the exercise (e.g., neuromuscular/musculoskeletal impairment).

- Known claustrophobia if participating in the optional MRI study

- No metal implants (detailed above) if participating in the optional MRI study
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>55 Years</minimum_age>
<maximum_age>85 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Catherine Jankowski, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Colorado, Denver</affiliation>
</overall_official>
<overall_official>
<last_name>Julio Carballido-Gamio, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Colorado, Denver</affiliation>
</overall_official>
<location>
<facility>
<name>University of Colorado Anschutz Medical Campus</name>
<address>
<city>Aurora</city>
<state>Colorado</state>
<zip>80045</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>April 2023</verification_date>
<study_first_submitted>March 17, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>April 24, 2023</last_update_submitted>
<last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">April 25, 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>Osteoporosis</mesh_term>
<mesh_term>Bone Diseases, Metabolic</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Bone strength -the main determinant of bone fracture- is a function not only of bone mineral
density (BMD) and microstructure, but also of its microenvironment, including bone marrow fat
(BMF). The adrenal steroid dehydroepiandrosterone (DHEA) -the main precursor for estrogens
and androgens in postmenopausal women- as well as bone-loading exercise, increase BMD in
older women, however, their effects on BMF are largely unknown. This study has high potential
to unveil the hormonal and mechanical effects of DHEA and exercise on BMF, respectively, and
to elucidate longitudinal associations of BMF with bone strength in older women with bone
loss.
The proportion of the U.S. population older than 65 years will increase from 12.7% in 2000 to
20.3% in 2050, and the number of fractures is expected to exceed 3 million by 2025 with
associated costs in the order of $25.3 billion per year. DAMES is an ongoing clinical trial
(NCT03227458) that aims to assess -for the first time- changes in areal bone mineral density
(aBMD) and fat-free mass (FFM) in response to therapy with the adrenal steroid
dehydroepiandrosterone (DHEA) alone and combined with bone-loading exercise (EX) in older
women with bone loss. The hormonal and mechanical strategies proposed in DAMES represent a
low-cost alternative treatment to improve bone quantity with a number of other health
benefits not afforded by typical pharmacological approaches. However, bone strength -the main
determinant of bone fracture- is a function of not only BMD and microstructure, but also of
its microenvironment, including bone marrow fat (BMF). This in an ancillary study to the
DAMES clinical trial. Here, the investigators propose to leverage the well-characterized
cohort of subjects, exercise training, clinical, laboratory and imaging data from DAMES, and
add a small group of controls to its three existing arms (DHEA only, EX+Placebo, and EX+DHEA)
to investigate the effects of DHEA therapy and EX on BMF in older women using advanced
imaging, numerical engineering, and image analysis techniques. In particular, the
investigators aim to determine in the lumbar spine and hip of older women with low bone mass
or moderate osteoporosis: 1) whether DHEA or EX leads to changes in BMF content; 2) whether
BMF content is associated with bone strength at baseline, and whether changes in BMF content
are associated with changes in bone strength, evaluating the impact of DHEA or EX on these
associations; and 3) the spatial distribution of changes in BMF content in response to DHEA
or EX. BMF will be measured with chemical shift-based water-fat separation magnetic resonance
imaging, bone strength will be estimated with finite element modeling from quantitative
computed tomography scans, and differences in the spatial distribution of BMF changes between
groups will be assessed using voxel-based morphometry. Ultimately, the investigators will
leverage the DAMES clinical trial to unveil new information to improve our understanding of
DHEA and EX on bone quantity and quality. The longitudinal assessments of bone quality in
this ancillary proposal, with those of bone quantity in the parent study, in women who have
already lost bone mass is unprecedented. Understanding how osteoporosis treatments -including
exercise- act on BMF could lead to the generation of novel approaches for fracture risk
assessment, procedures for therapy monitoring, and treatments for bone loss.
Inclusion Criteria:
- women aged 55 to 85 years
- non-frail, as determined by Short Physical Performance Battery score > 9 (0-12 scale)
- 5 years or longer since menopause (defined as last menstrual period)
- willing to participate in a 36-week exercise program that will start at a moderate
intensity and gradually progress to a higher intensity
- willing to take DHEA (50mg/d) or a placebo pill daily and remain blinded for up to 36
weeks
- not performing resistance exercise training or high impact weight-bearing exercise
(e.g., jogging) ≥ 2 days per week in the past 6 months
- ambulatory without assistive devices
- serum DHEAS < 140 μg/dL (3.8 μmol/L)
- low bone mass or moderate osteoporosis indicated by lumbar spine, total hip, or
femoral neck aBMD t-scores < -1.0 and ≥ -3.0
- refusal of standard osteoporosis treatment in women with moderate osteoporosis (BMD
≥-3.0 and ≤ -2.5)
- evidence of a negative (no findings suspicious for breast cancer) mammogram within the
past 12 months
- planning to reside in the Denver area for the duration of the study
- willing to provide evidence of completed COVID-19 vaccination
- no implanted metal or electronic devices
- no metallic foreign body in the eye
- no "triggerfish" contact lenses
- no gastric reflux device
- no insulin pumps
- no temporary transvenous pacing leads
- no aneurysm clips
- no cardiac pacemakers
- no implanted cardioverter defibrillator
- no magnetically-activated implant or device
- no neurostimulation system
- no spinal cord stimulator
- no cochlear implant
- no bone growth/bone fusion stimulator
- no known claustrophobia
Exclusion Criteria:
- history of hospitalization for Corona Virus Disease 2019 (COVID-19)
- does not meet Centers for Disease Control and Prevention (CDC) recommendations for
home isolation because has had a positive severe acute respiratory syndrome
coronavirus 2 (SARS-COV-2) test less than 10 days before study entry; or has had fever
within the past 3 days and respiratory symptoms have not improved; or symptoms first
appeared less than 10 days before study entry.
- not willing to provide evidence of completed COVID-19 vaccination.
- uncontrolled hypertension defined as resting systolic BP >150 mmHg or diastolic BP >90
mmHg; participants who do not meet these criteria at first screening will be
re-evaluated, including follow-up evaluation by their primary care provider (PCP) with
initiation or adjustment of anti-hypertensive medications.
- diagnosed ischemic heart disease or indicators of unstable ischemic heart disease
(e.g., angina) or arrhythmias at rest or during the graded exercise test (GXT) without
negative follow-up evaluation will be cause for exclusion; follow-up evaluation must
include diagnostic testing (e.g., thallium stress test) with interpretation by a
cardiologist
- diagnosis of heart failure, clinically significant aortic stenosis, uncontrolled
angina, or uncontrolled arrhythmia.
- pulmonary disease requiring use of oral steroids within the previous 6 months or the
use of supplemental oxygen ≥ 4 liters with physical exertion
- orthopedic problems (e.g., severe osteoarthritis, rheumatoid arthritis) that greatly
limit the ability to perform moderate to high intensity resistance exercise (e.g.,
unable to be properly positioned in exercise equipment or to have severely restricted
range of motion even after modifications have been made)
- hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
- undergoing physical therapy involving the lower extremities
- hematocrit > 54%
- thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) <
0.4 or > 10 micro units/mL, without signs or symptoms of clinical hypo- or
hyperthyroidism.volunteers with abnormal TSH values will be re-considered for
participation in the study after follow-up evaluation by their PCP with initiation or
adjustment of thyroid hormone replacement
- acute liver disease indicated by liver function tests (ALT, aspartate
aminotransferase, alkaline phosphatase) ≥ 1.5 times the upper limits of normal
- estimated glomerular filtration rate (eGFR) < 45, using Modification of Diet in Renal
Disease Study (MDRD) equation
- poorly controlled diabetes mellitus based on HbA1c > 8.5% or use of insulin.
- fasted serum triglycerides > 400 mg/dL
- serum 25-hydroxy vitamin D < 20 ng/mL; volunteers will be re-considered for
participation in the study after initiation or adjustment of vitamin D
supplementation, per the study's vitamin D repletion protocol.
- use of DHEA supplementation or sex hormones in the past 6 months. Use of prescription
low dose vaginal estrogen creams (Premarin or Estrace) 3 days per week or less will
not be exclusionary.
- use in the past 6 months of any medications known to alter bone metabolism (e.g., oral
glucocorticoids, bone anti- resorptive agents)
- lumbar spine, total hip, or femoral neck aBMD t-scores < -3.0.
- confirmed history of osteoporotic fracture
- secondary osteoporosis
- documented history of cognitive impairment or dementia or Mini-Cog < 4.
- current smoker
- personal history of breast, ovarian, metastatic endometrial, or cervical cancer
- any cancer requiring treatment in the past 3 years except non-melanoma skin cancers
- undiagnosed vaginal bleeding
- women who, in the judgment of the study physician, appear incapable of safely
participating in the exercise (e.g., neuromuscular/musculoskeletal impairment).
- Known claustrophobia if participating in the optional MRI study
- No metal implants (detailed above) if participating in the optional MRI study
|
NCT0531xxxx/NCT05316285.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/NCT05316285</url>
</required_header>
<id_info>
<org_study_id>E-10840098-772.02-1950</org_study_id>
<nct_id>NCT05316285</nct_id>
</id_info>
<brief_title>Effects of School-based Yoga Program on University Students</brief_title>
<official_title>Effects of School-based Yoga Program on University Students on Physical, Emotional and Psychosocial Health</official_title>
<sponsors>
<lead_sponsor>
<agency>Medipol University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Medipol 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>
Focusing on emotions is valuable because "how a person feels, reacts, and expresses emotions
can have both short-term and long-term effects on physical and mental health". This is
explained by mechanisms such as reappraisal, attention regulation, self-monitoring,
self-awareness, and regulation of the autonomic nervous system. Because yoga reduces negative
emotions such as anxiety, anger, and depression, teens are likely to result in less conflict
and stress in their lives. It is thought that it is also important for young people to accept
difficult feelings and to be able to accept and approve these feelings. When negative
emotions are acknowledged and witnessed, they often dissolve or transform, and the process
allows the individual to learn about their limits, preferences, and needs. Processing
emotions in this way allows a person to be honest with oneself and can contribute to
healthier development. Therefore, yoga appears to be a useful well-being tool and practice
that schools should adopt, as it can increase life skills for students such as concentration,
memory, relational skills, and decision-making that are affected by emotions. Emotional
well-being is important for learning in life and school. As noted earlier, research supports
such a view, but more research is needed to understand how and why yoga should be offered to
young people in their schools. However, it is suggested that researchers further explore the
role of yoga in the management of emotions, both in terms of emotional processing and
regulation of emotions. The role of yogic breathing (pranayama) as part of a holistic
perspective on yoga, and specifically the role of yoga in the relationship between being with
emotions, regulating emotions, and how it relates to change, should be further explored.

It has been described in the literature that care should be taken to avoid possible harm to
individuals associated with the use of unhealthy weight control behaviors among young adults
and women with obesity. Yoga's intent to strengthen and support a positive sense of self
makes it a particularly viable strategy for healthy weight management for women and those at
high risk for poor body image. Finally, it has been reported that reductions in perceived
stress may mediate the effects of participation in a yoga program on negative emotional and
behavioral problems. It has been suggested that future studies may also assess the extent to
which exposure to stress and trauma may affect youth's participation in and benefit from
mindfulness and yoga interventions.

Considering all the suggestions and research needs in the literature, this study was planned
to examine the improvement in self-esteem, life satisfaction, body image, anxiety, depression
and cognitive emotion regulation levels of university students after their participation in
the yoga program provided to them in the school environment and to compare them with students
who do not do yoga. In the study, it is planned to investigate the pre-exam anxiety levels of
university youth who regularly practice yoga.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Adolescence is often described as a period of hypersensitivity that includes increased
risk-taking and reward seeking. Such a period of high emotionality will often affect the
well-being and mental health of young people, as some experiences can be like emotional
roller coasters. Adolescence is not only a period of increased emotionality, but also a
psychopathology related to affect. Therefore, how teens relate to their emotions is important
to their overall well-being. Young individuals face many internal and external changes that
can make them overly emotional. In general, the teenage years are characterized by emotional
turmoil, as there is more activation in the emotional part of the brain (limbic system)
during adolescence. It has been reported that adolescents are highly emotional, therefore
they are often "captured by their emotions" and that the emotional life of adolescents is
quite complex both internally and externally. On the inside, teens experience both hormonal
changes and "fine-tuning of the neural networks that both generate and govern their
emotions". From the outside, young people often experience dramatic changes in their social
relationships (parents, peers, romantic relationships, etc.) with the increasing demands of
school and society. Because of this high level of emotionality, the adolescence years are
characterized by "increased psychopathological levels of dysfunctional affect". Learning to
manage emotional responses is an important developmental task for young people's
socio-cognitive development. Their development in these areas will affect their emotional
decision-making and self-regulation skills.

Miller et al. in their review confirm that yoga is a promising intervention for children and
youth. Researchers have also reported that "yoga has positive effects on a range of outcomes
in psychological/behavioral, cognitive, and physiological/physical functioning." Researchers
have reported that practicing yoga can improve mental health and well-being in school
settings and beyond, and that yoga facilitates learning among young people. While schools are
highlighted as ideal environments for promoting healthy lifestyle skills from an early age,
there is less clarity about yoga styles, advice on frequency, and how it works. Still,
scholars seem to agree on the value of teaching yoga as a holistic system of practice,
including asanas or physical postures, pranayama or breathing exercises, relaxation
techniques, and meditation or mindfulness practices.

Young people's mental health and well-being includes the ability to self-regulate
emotionally, mentally, behaviorally and develop healthy relationships with peers and
teachers. Better mood, coping with emotions and coping with stress are important for
adolescents' development of life mastery skills and well-being. "Emotional regulation" as a
method of communicating with emotions, as a well-known concept, refers to the way individuals
manage an experience and express their emotions. In other words, emotional regulation
describes the ability to both adapt emotional responses to socially accepted expressions and
also allow flexibility in an individual's responses.

It has been stated that doing yoga can improve emotional regulation and the ability of
individuals to give more adaptive responses. Miller et al. found that practicing yoga
increases the ability to regulate emotional, cognitive, and somatic impulses and experiences.
Similarly, in a review article on yoga and emotion regulation, Menezes et al. concluded:
"Emerging evidence suggests that yoga may help promote healthier psychological responses,
demonstrating its potential as an emotion regulation strategy". Other researchers have found
that yoga in schools leads students to improve their mood and self-regulation skills and thus
have better resilience. Yoga promotes awareness and acceptance and is a method for teaching
young people to be more aware and aware of their own breath, body and mind. Studies have
shown that yoga can reduce anxiety and improve emotion regulation skills among children and
adolescents. Practicing yoga improves the mental health and well-being of teenagers and young
adults, as well as increases their awareness of their bodies, minds, emotions, and response
patterns. They suggest that "it occurs through interaction between activities that can lead
to the development or enhancement of emotion regulation skills".

These authors found that attention regulation (via the prefrontal cortex), acceptance,
regulation of autonomic activity (reduced anxiety and arousal), and endocrine responses
underlie the relationship between yoga and emotion regulation. Increased awareness of
themselves and their emotions can be valuable for teens to build resilience and improve their
mental health and well-being.

Focusing on emotions is valuable because "how a person feels, reacts, and expresses emotions
can have both short-term and long-term effects on physical and mental health" (13). This is
explained by mechanisms such as reappraisal, attention regulation, self-monitoring,
self-awareness, and regulation of the autonomic nervous system. Because yoga reduces negative
emotions such as anxiety, anger, and depression, teens are likely to result in less conflict
and stress in their lives. It is thought that it is also important for young people to accept
difficult feelings and to be able to accept and approve these feelings. When negative
emotions are acknowledged and witnessed, they often dissolve or transform, and the process
allows the individual to learn about their limits, preferences, and needs. Processing
emotions in this way allows a person to be honest with oneself and can contribute to
healthier development. Therefore, yoga appears to be a useful well-being tool and practice
that schools should adopt, as it can increase life skills for students such as concentration,
memory, relational skills, and decision-making that are affected by emotions. Emotional
well-being is important for learning in life and school. As noted earlier, research supports
such a view, but more research is needed to understand how and why yoga should be offered to
young people in their schools. However, it is suggested that researchers further explore the
role of yoga in the management of emotions, both in terms of emotional processing and
regulation of emotions. The role of yogic breathing (pranayama) as part of a holistic
perspective on yoga, and specifically the role of yoga in the relationship between being with
emotions, regulating emotions, and how it relates to change, should be further explored.

It has been described in the literature that care should be taken to avoid possible harm to
individuals associated with the use of unhealthy weight control behaviors among young adults
and women with obesity. Yoga's intent to strengthen and support a positive sense of self
makes it a particularly viable strategy for healthy weight management for women and those at
high risk for poor body image. Finally, it has been reported that reductions in perceived
stress may mediate the effects of participation in a yoga program on negative emotional and
behavioral problems. It has been suggested that future studies may also assess the extent to
which exposure to stress and trauma may affect youth's participation in and benefit from
mindfulness and yoga interventions.

Considering all the suggestions and research needs in the literature, this study was planned
to examine the improvement in self-esteem, life satisfaction, body image, anxiety, depression
and cognitive emotion regulation levels of university students after their participation in
the yoga program provided to them in the school environment and to compare them with students
who do not do yoga. In the study, it is planned to investigate the pre-exam anxiety levels of
university youth who regularly practice yoga.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">February 11, 2023</start_date>
<completion_date type="Anticipated">August 1, 2023</completion_date>
<primary_completion_date type="Anticipated">February 20, 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>Supportive Care</primary_purpose>
<masking>Single (Participant)</masking>
</study_design_info>
<primary_outcome>
<measure>Cognitive Emotion Regulation Questionnaire</measure>
<time_frame>up to 14 weeks</time_frame>
<description>Consisting of 36 items, the scale has nine subscales. Each subscale consists of four items. The five-point Likert-type scale is evaluated between 1 (never) and 5 (always). The score of each subscale varies between 4 and 20 and scoring is done accordingly. High scores obtained from the subscales indicate that the strategy determined by that subscale is used more.</description>
</primary_outcome>
<primary_outcome>
<measure>The State-Trait Anxiety Inventory (STAI)</measure>
<time_frame>up to 14 weeks</time_frame>
<description>The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress. Form Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level.</description>
</primary_outcome>
<primary_outcome>
<measure>Body Cathexis Scale (BCS)</measure>
<time_frame>up to 14 weeks</time_frame>
<description>The form includes 40 items, each of which is related with an organ or a body zone (arm, leg, face, etc.) or with a function. Each item is rated between 1 and 5 points ("don't like at all," "don't like," "undecided," "like," and "like very much"), resulting in a total score between 40 and 200. The total score corresponds to the level of satisfaction with one's own body.</description>
</primary_outcome>
<primary_outcome>
<measure>Satisfaction with Life Scale (SWLS)</measure>
<time_frame>up to 14 weeks</time_frame>
<description>Subjective well-being is conceptualised as consisting of two major components: the emotional or affective component and the judgment or cognitive component. The SWLS was designed to measure the judgment component. Scores consist of a raw score (between 5 and 35). Higher scores represent higher life satisfaction. Scorers can be assigned into six well-being categories and interpretative text in provided for each.</description>
</primary_outcome>
<primary_outcome>
<measure>Rosenberg Self-Esteem Scale (RSES):</measure>
<time_frame>up to 14 weeks</time_frame>
<description>It consists of 10 items in total, 5 of which are positive expressions and 5 negative. Scores are given from "strongly disagree" (0) to "strongly agree" (3). A high total score demonstrated high self-esteem, a low score low self-esteem.</description>
</primary_outcome>
<primary_outcome>
<measure>Test Anxiety Inventory</measure>
<time_frame>up to 14 weeks</time_frame>
<description>TAI was designed to measure anxiety in high school and university students. It consists of two subgroups: measurement of worry (TAI-W) and measurement of emotional distress (TAI-E). There are eight items in TAI-W, the inventory for measuring worry, eight items in TAI-E, the subscale focusing emotionality, and four items in TAI-T, a subscale for measuring total anxiety score. The respondents choose from the following options in Likert's four point scale: (1) almost never, (2) sometimes, (3) often, or (4) almost always. The values of the Cronbach Alpha coefficient of the original TAI were as follows: 0.96 for TAI-T, 0.91 for TAI-W, and 0.91 for TAI-E.</description>
</primary_outcome>
<primary_outcome>
<measure>Three-factor Eating Questionnaire (TFEQ-R21)</measure>
<time_frame>up to 14 weeks</time_frame>
<description>The TFEQ-R21 (see Appendix) asks participants to respond to 21 questions on a four-point Likert scale for items 1-20 and on an eight-point numerical rating scale for item 21. Responses to each of the items are given a score between
1 and 4. Before calculating domain scores, items 1-16 were reverse coded and item 21 was recoded as follows: 1-2 scores as 1; 3-4 as 2; 5-6 as 3; 7-8 as 4. Domain scores were then calculated as a mean of all items within each domain; hence, domain scores also ranged from 1 to 4 (CR (six items), UE (nine items) and EE (six items)), with higher scores being indicative of greater CR, UE and EE.</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">60</enrollment>
<condition>Yoga</condition>
<condition>Adolescent Behavior</condition>
<condition>Emotional Regulation</condition>
<condition>Mental Health</condition>
<condition>Eating Behaviors</condition>
<condition>Well-being</condition>
<arm_group>
<arm_group_label>Yoga Group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>It will consist of students who choose the Yoga for a Healthy Life lesson. For 14 weeks, one day a week and 60 minutes a day, theoretical and practical yoga training will be applied.</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 consist of students who chose the Fashion and Beauty lesson.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Yoga exercise</intervention_name>
<description>Yoga lesson practices will be designed and implemented by instructors physiotherapists who have completed 200 hours of yoga instructor training (RYT-200). The yoga program, which will consist of one-hour sessions once a week, is planned to last 14 weeks. 4 weeks of classes will be theoretical lessons related to yoga philosophy, 10 weeks of yoga sessions will be applied every week on different concepts such as upper extremity and / or lower extremity focused strengthening and / or flexibility and breathing exercises. In addition to this training, students will be advised to repeat the practices once a week. Sessions will begin with breathing practices called pranayama, followed by yoga postures called asanas, and the sequence will be finished with savasana pose. In this pose, guided meditations will be performed on subjects such as body awareness and self-compassion.</description>
<arm_group_label>Yoga Group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- students of Istanbul Medipol University,

- filling out all the scale questions

- agree to participate in the study

Exclusion Criteria:

- pregnancy

- having mental problems perceiving verbal commands

- having a concomitant disease that will hinder exercise and physical activity
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>19 Years</minimum_age>
<maximum_age>24 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<verification_date>January 2023</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>January 3, 2023</last_update_submitted>
<last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">January 5, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Medipol University</investigator_affiliation>
<investigator_full_name>Pınar Ciddi</investigator_full_name>
<investigator_title>Assistant Professor</investigator_title>
</responsible_party>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Focusing on emotions is valuable because "how a person feels, reacts, and expresses emotions
can have both short-term and long-term effects on physical and mental health". This is
explained by mechanisms such as reappraisal, attention regulation, self-monitoring,
self-awareness, and regulation of the autonomic nervous system. Because yoga reduces negative
emotions such as anxiety, anger, and depression, teens are likely to result in less conflict
and stress in their lives. It is thought that it is also important for young people to accept
difficult feelings and to be able to accept and approve these feelings. When negative
emotions are acknowledged and witnessed, they often dissolve or transform, and the process
allows the individual to learn about their limits, preferences, and needs. Processing
emotions in this way allows a person to be honest with oneself and can contribute to
healthier development. Therefore, yoga appears to be a useful well-being tool and practice
that schools should adopt, as it can increase life skills for students such as concentration,
memory, relational skills, and decision-making that are affected by emotions. Emotional
well-being is important for learning in life and school. As noted earlier, research supports
such a view, but more research is needed to understand how and why yoga should be offered to
young people in their schools. However, it is suggested that researchers further explore the
role of yoga in the management of emotions, both in terms of emotional processing and
regulation of emotions. The role of yogic breathing (pranayama) as part of a holistic
perspective on yoga, and specifically the role of yoga in the relationship between being with
emotions, regulating emotions, and how it relates to change, should be further explored.
It has been described in the literature that care should be taken to avoid possible harm to
individuals associated with the use of unhealthy weight control behaviors among young adults
and women with obesity. Yoga's intent to strengthen and support a positive sense of self
makes it a particularly viable strategy for healthy weight management for women and those at
high risk for poor body image. Finally, it has been reported that reductions in perceived
stress may mediate the effects of participation in a yoga program on negative emotional and
behavioral problems. It has been suggested that future studies may also assess the extent to
which exposure to stress and trauma may affect youth's participation in and benefit from
mindfulness and yoga interventions.
Considering all the suggestions and research needs in the literature, this study was planned
to examine the improvement in self-esteem, life satisfaction, body image, anxiety, depression
and cognitive emotion regulation levels of university students after their participation in
the yoga program provided to them in the school environment and to compare them with students
who do not do yoga. In the study, it is planned to investigate the pre-exam anxiety levels of
university youth who regularly practice yoga.
Adolescence is often described as a period of hypersensitivity that includes increased
risk-taking and reward seeking. Such a period of high emotionality will often affect the
well-being and mental health of young people, as some experiences can be like emotional
roller coasters. Adolescence is not only a period of increased emotionality, but also a
psychopathology related to affect. Therefore, how teens relate to their emotions is important
to their overall well-being. Young individuals face many internal and external changes that
can make them overly emotional. In general, the teenage years are characterized by emotional
turmoil, as there is more activation in the emotional part of the brain (limbic system)
during adolescence. It has been reported that adolescents are highly emotional, therefore
they are often "captured by their emotions" and that the emotional life of adolescents is
quite complex both internally and externally. On the inside, teens experience both hormonal
changes and "fine-tuning of the neural networks that both generate and govern their
emotions". From the outside, young people often experience dramatic changes in their social
relationships (parents, peers, romantic relationships, etc.) with the increasing demands of
school and society. Because of this high level of emotionality, the adolescence years are
characterized by "increased psychopathological levels of dysfunctional affect". Learning to
manage emotional responses is an important developmental task for young people's
socio-cognitive development. Their development in these areas will affect their emotional
decision-making and self-regulation skills.
Miller et al. in their review confirm that yoga is a promising intervention for children and
youth. Researchers have also reported that "yoga has positive effects on a range of outcomes
in psychological/behavioral, cognitive, and physiological/physical functioning." Researchers
have reported that practicing yoga can improve mental health and well-being in school
settings and beyond, and that yoga facilitates learning among young people. While schools are
highlighted as ideal environments for promoting healthy lifestyle skills from an early age,
there is less clarity about yoga styles, advice on frequency, and how it works. Still,
scholars seem to agree on the value of teaching yoga as a holistic system of practice,
including asanas or physical postures, pranayama or breathing exercises, relaxation
techniques, and meditation or mindfulness practices.
Young people's mental health and well-being includes the ability to self-regulate
emotionally, mentally, behaviorally and develop healthy relationships with peers and
teachers. Better mood, coping with emotions and coping with stress are important for
adolescents' development of life mastery skills and well-being. "Emotional regulation" as a
method of communicating with emotions, as a well-known concept, refers to the way individuals
manage an experience and express their emotions. In other words, emotional regulation
describes the ability to both adapt emotional responses to socially accepted expressions and
also allow flexibility in an individual's responses.
It has been stated that doing yoga can improve emotional regulation and the ability of
individuals to give more adaptive responses. Miller et al. found that practicing yoga
increases the ability to regulate emotional, cognitive, and somatic impulses and experiences.
Similarly, in a review article on yoga and emotion regulation, Menezes et al. concluded:
"Emerging evidence suggests that yoga may help promote healthier psychological responses,
demonstrating its potential as an emotion regulation strategy". Other researchers have found
that yoga in schools leads students to improve their mood and self-regulation skills and thus
have better resilience. Yoga promotes awareness and acceptance and is a method for teaching
young people to be more aware and aware of their own breath, body and mind. Studies have
shown that yoga can reduce anxiety and improve emotion regulation skills among children and
adolescents. Practicing yoga improves the mental health and well-being of teenagers and young
adults, as well as increases their awareness of their bodies, minds, emotions, and response
patterns. They suggest that "it occurs through interaction between activities that can lead
to the development or enhancement of emotion regulation skills".
These authors found that attention regulation (via the prefrontal cortex), acceptance,
regulation of autonomic activity (reduced anxiety and arousal), and endocrine responses
underlie the relationship between yoga and emotion regulation. Increased awareness of
themselves and their emotions can be valuable for teens to build resilience and improve their
mental health and well-being.
Focusing on emotions is valuable because "how a person feels, reacts, and expresses emotions
can have both short-term and long-term effects on physical and mental health" (13). This is
explained by mechanisms such as reappraisal, attention regulation, self-monitoring,
self-awareness, and regulation of the autonomic nervous system. Because yoga reduces negative
emotions such as anxiety, anger, and depression, teens are likely to result in less conflict
and stress in their lives. It is thought that it is also important for young people to accept
difficult feelings and to be able to accept and approve these feelings. When negative
emotions are acknowledged and witnessed, they often dissolve or transform, and the process
allows the individual to learn about their limits, preferences, and needs. Processing
emotions in this way allows a person to be honest with oneself and can contribute to
healthier development. Therefore, yoga appears to be a useful well-being tool and practice
that schools should adopt, as it can increase life skills for students such as concentration,
memory, relational skills, and decision-making that are affected by emotions. Emotional
well-being is important for learning in life and school. As noted earlier, research supports
such a view, but more research is needed to understand how and why yoga should be offered to
young people in their schools. However, it is suggested that researchers further explore the
role of yoga in the management of emotions, both in terms of emotional processing and
regulation of emotions. The role of yogic breathing (pranayama) as part of a holistic
perspective on yoga, and specifically the role of yoga in the relationship between being with
emotions, regulating emotions, and how it relates to change, should be further explored.
It has been described in the literature that care should be taken to avoid possible harm to
individuals associated with the use of unhealthy weight control behaviors among young adults
and women with obesity. Yoga's intent to strengthen and support a positive sense of self
makes it a particularly viable strategy for healthy weight management for women and those at
high risk for poor body image. Finally, it has been reported that reductions in perceived
stress may mediate the effects of participation in a yoga program on negative emotional and
behavioral problems. It has been suggested that future studies may also assess the extent to
which exposure to stress and trauma may affect youth's participation in and benefit from
mindfulness and yoga interventions.
Considering all the suggestions and research needs in the literature, this study was planned
to examine the improvement in self-esteem, life satisfaction, body image, anxiety, depression
and cognitive emotion regulation levels of university students after their participation in
the yoga program provided to them in the school environment and to compare them with students
who do not do yoga. In the study, it is planned to investigate the pre-exam anxiety levels of
university youth who regularly practice yoga.
Inclusion Criteria:
- students of Istanbul Medipol University,
- filling out all the scale questions
- agree to participate in the study
Exclusion Criteria:
- pregnancy
- having mental problems perceiving verbal commands
- having a concomitant disease that will hinder exercise and physical activity
|
NCT0531xxxx/NCT05316298.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/NCT05316298</url>
</required_header>
<id_info>
<org_study_id>202200240</org_study_id>
<nct_id>NCT05316298</nct_id>
</id_info>
<brief_title>Diabetic Foot Osteomyelitis Treatment Using Gentamicin-loaded Calcium Sulfate-hydroxyapatite Biocomposite</brief_title>
<acronym>PRESERVE</acronym>
<official_title>Gentamicin-loaded Calcium Sulfate-hydroxyaPatite Biocomposite to tREat Diabetic Foot Ulcers Complicated by oSteomyElitis: a pRospectiVE Cohort Study</official_title>
<sponsors>
<lead_sponsor>
<agency>University Medical Center Groningen</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Ziekenhuisgroep Twente</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Slingeland Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Franciscus Gasthuis</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>UMC Utrecht</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Rijnstate Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Jeroen Bosch Ziekenhuis</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Reinier de Graaf Groep</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>St. Antonius Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>St Jansdal Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Maasstad Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>University Medical Center Groningen</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 amputation risk is high when diabetic foot ulcers, complicated by osteomyelitis, fail to
heal after non-surgical standard-of-care treatment. A new treatment regimen has been
developed recently and has been proven feasible. This treatment regimen consists of surgical
debridement, followed by bone void filling with gentamicin-loaded calcium
sulfate-hydroxyapatite biocomposite and closure of soft tissues and skin, in combination with
antibiotic therapy and offloading. This treatment regimen has not been investigated
prospectively.

Therefore, this multicenter prospective cohort study was designed, with the primary objective
of investigating postoperative wound healing. Patients with diabetic forefoot ulcers,
complicated by osteomyelitis, will be included. The most relevant exclusion criteria are:
Severe diabetic foot infection, severe limb ischemia, and foot deformity causing high
pressure and friction on the diabetic foot ulcer. After inclusion, subjects will undergo
study phase 1, which is observation of the standard-of-care non-surgical treatment. When
standard-of-care non-surgical treatment is unsuccessful, subjects will be included in study
phase 2, which consists of treatment by surgical debridement of the diabetic foot ulcer and
underlying osteomyelitis, followed by bone void filling with gentamicin-loaded calcium
sulfate-hydroxyapatite biocomposite and closure of soft tissues and skin, followed by a
postoperatieve treatment regimen which involves wound care, 10 days of antibiotic therapy and
offloading.

The primary outcome measure of this study is the proportion of subjects with post-operative
wound healing, which will be investigated clinically and will be objectified by a review
panel of blinded, independent experts based on digital photographs. Follow-up will be
performed until wound healing or for a maximum of 20 weeks. The primary outcome measure is
the proportion of subjects with postoperative wound healing during 20 weeks of follow-up.
Secondary outcome measures are: days until postoperative wound healing, proportion of
subjects with persistent osteomyelitis post-operatively, proportion of subjects undergoing
amputations during follow-up, foot function index scores at inclusion and after 20 weeks
follow-up.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Anticipated">December 1, 2022</start_date>
<completion_date type="Anticipated">January 1, 2025</completion_date>
<primary_completion_date type="Anticipated">January 1, 2025</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>Postoperative wound healing</measure>
<time_frame>20 weeks</time_frame>
<description>Macroscopic complete epithelialization of all surgical wounds after removal of sutures and/or staples without drainage for a minimum of 2 weeks.</description>
</primary_outcome>
<secondary_outcome>
<measure>Duration to postoperative wound healing</measure>
<time_frame>20 weeks</time_frame>
<description>Duration to postoperative wound healing, expressed in days postoperatively.</description>
</secondary_outcome>
<secondary_outcome>
<measure>persistent osteomyelitis postoperatively</measure>
<time_frame>20 weeks</time_frame>
<description>The proportion of subjects without postoperative wound healing and with persistent osteomyelitis, diagnosis based on clinical findings (signs of inflammation) in combination with suggestive findings of osteomyelitis on imaging (X-ray, MRI) or a positive probe-to-bone test.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Amputations during follow-up</measure>
<time_frame>20 weeks</time_frame>
<description>Proportion of patients undergoing amputations (minor = distal to the ankle joint, major = proximal to the ankle joint)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Foot Function Index (FFI) scores</measure>
<time_frame>20 weeks</time_frame>
<description>Pre-operatively and at final follow-up, subjects will fill-in FFI-5pt questionnaires. These consist of 15 questions regarding pain in the foot and functional problems due to foot problems. These are translated in Dutch and have previously been validated. We will calculate the overall FFI scores and those or the domains of 'pain' and 'disability'. Per patient, we will also calculate the changes in mean or median FFI-5pt scores overall and separately for the domains of 'pain' and 'disability', by subtracting the FFI-5pt score measured at final follow-up from the FFI-5pt score measured at inclusion.</description>
</secondary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Anticipated">182</enrollment>
<condition>Diabetic Foot Ulcer</condition>
<condition>Osteomyelitis</condition>
<condition>Diabetes Mellitus</condition>
<arm_group>
<arm_group_label>PRESERVE protocol</arm_group_label>
<description>Treatment according to the PRESERVE protocol consists of 2 study phases. Phase 1 consists of standard-of-care non-surgical treatment, performed in accordance with current treatment guidelines, during which the research team performs observations.
After failed standard-of care non surgical treatment, subjects will be included in study phase 2 and undergo treatment by surgical debridement of the diabetic foot ulcer and underlying osteomyelitis, followed by bone void filling with gentamicin-loaded calcium sulfate-hydroxyapatite biocomposite and closure of soft tissues and skin, followed by postoperative treatment regimen including woundcare, 10 days of antibiotics and offloading.</description>
</arm_group>
<eligibility>
<study_pop>
<textblock>
In this study, patients will be included who present in one of the 10 participating Dutch
hospitals with forefoot diabetic foot ulcers complicated by osteomyelitis and sufficient
skin and soft tissues around the ulcer for surgical closure.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- 18 years of age or older.

- One or multiple forefoot diabetic foot ulcers complicated by osteomyelitis. The
treating physician will diagnose osteomyelitis, based on either positive culture
results or histopathologic findings of a bone sample, or on the combination of
clinical findings of inflammation and a positive probe-to-bone test or imaging
findings (X-ray, MRI) A patient with multiple forefoot DFOs can be included as long as
all ulcers are related to osteomyelitis on one location.

- Sufficient soft tissues and skin for primary closure or closure by local tissue
transposition after surgical debridement, as judged by the treating physician.

- Written declaration of informed consent

Exclusion Criteria:

- Acute Charcot neuroarthropathy, which will be diagnosed by the treating physician
based on clinical examination and MRI.

- Adequate surgical debridement is possible by performing an amputation, as judged
clinically by the treating physician (e.g. DFO on the 4th or 5th digit).

- Contra-indications for the use of gentamicin-loaded calcium sulfate-hydroxyapatite
biocomposite, as mentioned by the producer: hypersensitivity to any aminoglycoside
antibiotics, myasthenia gravis, severe renal impairment, pre-existing calcium
metabolism disorders, pregnancy, and breastfeeding. This information will be
investigated using the patient's electronic health record file and verbal
verification. Severe renal impairment is defined as chronic kidney disease with an
estimated glomerular filtration rate <30 ml/min/1.73m2 or renal replacement therapy.

- Foot deformities that lead to increased pressure and friction on the site of the
ulcer, which can only be adequately managed by surgical correction, as judged
clinically by the treating physician.

- Implants in bone affected by osteomyelitis

- Inadequate quality and / or volume of soft tissues and skin for primary closure or
closure by local tissue transposition after surgical debridement, as judged by the
treating physician.

- No written declaration of informed consent.

- Osteomyelitis on ≥1 separate locations.

- Other infected diabetic foot ulcers.

- Severe chronic limb Ischemia, defined in accordance with the Wound-, Ischemia-, Foot
Infection classification as signs and / or symptoms of peripheral artery disease and a
systolic toe pressure < 30 mmHg and/or a transcutaneous oxygen pressure < 30 mmHg in
the forefoot.Previous revascularisation is no exclusion criterion.

- Severe communication disabilities as judged by the treating physician, which would
interfere with adherence to instructions.

- Severe diabetic foot infection, defined as infection-grade 4 according to the
International Working Group on the Diabetic Foot classification.

- Severely immunocompromised state as judged by the treating physician (e.g.,
neutropenia due to chemotherapy, high doses of corticosteroids, HIV infection with CD4
count <200 / µl).
</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>Kor H. Hutting, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>University Medical Center Groningen</affiliation>
</overall_official>
<overall_contact>
<last_name>Kor H. Hutting, M.D.</last_name>
<phone>0031887084232</phone>
<email>k.h.hutting@umcg.nl</email>
</overall_contact>
<location>
<facility>
<name>Jeroen Bosch Hospital</name>
<address>
<city>'s-Hertogenbosch</city>
<country>Netherlands</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Bart Verhoeven, M.D.</last_name>
</contact>
</location>
<location>
<facility>
<name>Hospitalgroup Twente</name>
<address>
<city>Almelo</city>
<country>Netherlands</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Wouter ten Cate, M.D.</last_name>
</contact>
</location>
<location>
<facility>
<name>Rijnstate Hospital</name>
<address>
<city>Arnhem</city>
<country>Netherlands</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Luuk Smeets, M.D.</last_name>
</contact>
</location>
<location>
<facility>
<name>Reinier de Graaf Hospital</name>
<address>
<city>Delft</city>
<country>Netherlands</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Casper Smit, M.D.</last_name>
</contact>
</location>
<location>
<facility>
<name>Slingeland Hospital</name>
<address>
<city>Doetinchem</city>
<country>Netherlands</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Dick Scharn, M.D.</last_name>
</contact>
</location>
<location>
<facility>
<name>St. Jansdal Hospital</name>
<address>
<city>Harderwijk</city>
<country>Netherlands</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Vincent Scholtes, M.D.</last_name>
</contact>
</location>
<location>
<facility>
<name>St. Antonius Hospital</name>
<address>
<city>Nieuwegein</city>
<country>Netherlands</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Olaf Bakker, M.D.</last_name>
</contact>
</location>
<location>
<facility>
<name>Franciscus Gasthuis & Vlietland</name>
<address>
<city>Rotterdam</city>
<country>Netherlands</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Gijs Welten, M.D.</last_name>
</contact>
</location>
<location>
<facility>
<name>Maasstad Hospital</name>
<address>
<city>Rotterdam</city>
<country>Netherlands</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>George Akkersdijk</last_name>
</contact>
</location>
<location>
<facility>
<name>University Medical Center Utrecht</name>
<address>
<city>Utrecht</city>
<country>Netherlands</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Bart-Jeroen Petri, M.D.</last_name>
</contact>
</location>
<location_countries>
<country>Netherlands</country>
</location_countries>
<verification_date>November 2022</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>November 11, 2022</last_update_submitted>
<last_update_submitted_qc>November 11, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">November 16, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Surgical treatment</keyword>
<keyword>antibiotic-loaded bone graft substitute</keyword>
<keyword>Cerament G</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Osteomyelitis</mesh_term>
<mesh_term>Diabetic Foot</mesh_term>
<mesh_term>Foot Ulcer</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>After completion of the study the data will be made publically available</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_info_type>Analytic Code</ipd_info_type>
<ipd_time_frame>Expected to become available in june 2024 for 10 years.</ipd_time_frame>
<ipd_access_criteria>Upon requrest by a professional researcher with a valid research plan.</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The amputation risk is high when diabetic foot ulcers, complicated by osteomyelitis, fail to
heal after non-surgical standard-of-care treatment. A new treatment regimen has been
developed recently and has been proven feasible. This treatment regimen consists of surgical
debridement, followed by bone void filling with gentamicin-loaded calcium
sulfate-hydroxyapatite biocomposite and closure of soft tissues and skin, in combination with
antibiotic therapy and offloading. This treatment regimen has not been investigated
prospectively.
Therefore, this multicenter prospective cohort study was designed, with the primary objective
of investigating postoperative wound healing. Patients with diabetic forefoot ulcers,
complicated by osteomyelitis, will be included. The most relevant exclusion criteria are:
Severe diabetic foot infection, severe limb ischemia, and foot deformity causing high
pressure and friction on the diabetic foot ulcer. After inclusion, subjects will undergo
study phase 1, which is observation of the standard-of-care non-surgical treatment. When
standard-of-care non-surgical treatment is unsuccessful, subjects will be included in study
phase 2, which consists of treatment by surgical debridement of the diabetic foot ulcer and
underlying osteomyelitis, followed by bone void filling with gentamicin-loaded calcium
sulfate-hydroxyapatite biocomposite and closure of soft tissues and skin, followed by a
postoperatieve treatment regimen which involves wound care, 10 days of antibiotic therapy and
offloading.
The primary outcome measure of this study is the proportion of subjects with post-operative
wound healing, which will be investigated clinically and will be objectified by a review
panel of blinded, independent experts based on digital photographs. Follow-up will be
performed until wound healing or for a maximum of 20 weeks. The primary outcome measure is
the proportion of subjects with postoperative wound healing during 20 weeks of follow-up.
Secondary outcome measures are: days until postoperative wound healing, proportion of
subjects with persistent osteomyelitis post-operatively, proportion of subjects undergoing
amputations during follow-up, foot function index scores at inclusion and after 20 weeks
follow-up.
In this study, patients will be included who present in one of the 10 participating Dutch
hospitals with forefoot diabetic foot ulcers complicated by osteomyelitis and sufficient
skin and soft tissues around the ulcer for surgical closure.
Inclusion Criteria:
- 18 years of age or older.
- One or multiple forefoot diabetic foot ulcers complicated by osteomyelitis. The
treating physician will diagnose osteomyelitis, based on either positive culture
results or histopathologic findings of a bone sample, or on the combination of
clinical findings of inflammation and a positive probe-to-bone test or imaging
findings (X-ray, MRI) A patient with multiple forefoot DFOs can be included as long as
all ulcers are related to osteomyelitis on one location.
- Sufficient soft tissues and skin for primary closure or closure by local tissue
transposition after surgical debridement, as judged by the treating physician.
- Written declaration of informed consent
Exclusion Criteria:
- Acute Charcot neuroarthropathy, which will be diagnosed by the treating physician
based on clinical examination and MRI.
- Adequate surgical debridement is possible by performing an amputation, as judged
clinically by the treating physician (e.g. DFO on the 4th or 5th digit).
- Contra-indications for the use of gentamicin-loaded calcium sulfate-hydroxyapatite
biocomposite, as mentioned by the producer: hypersensitivity to any aminoglycoside
antibiotics, myasthenia gravis, severe renal impairment, pre-existing calcium
metabolism disorders, pregnancy, and breastfeeding. This information will be
investigated using the patient's electronic health record file and verbal
verification. Severe renal impairment is defined as chronic kidney disease with an
estimated glomerular filtration rate <30 ml/min/1.73m2 or renal replacement therapy.
- Foot deformities that lead to increased pressure and friction on the site of the
ulcer, which can only be adequately managed by surgical correction, as judged
clinically by the treating physician.
- Implants in bone affected by osteomyelitis
- Inadequate quality and / or volume of soft tissues and skin for primary closure or
closure by local tissue transposition after surgical debridement, as judged by the
treating physician.
- No written declaration of informed consent.
- Osteomyelitis on ≥1 separate locations.
- Other infected diabetic foot ulcers.
- Severe chronic limb Ischemia, defined in accordance with the Wound-, Ischemia-, Foot
Infection classification as signs and / or symptoms of peripheral artery disease and a
systolic toe pressure < 30 mmHg and/or a transcutaneous oxygen pressure < 30 mmHg in
the forefoot.Previous revascularisation is no exclusion criterion.
- Severe communication disabilities as judged by the treating physician, which would
interfere with adherence to instructions.
- Severe diabetic foot infection, defined as infection-grade 4 according to the
International Working Group on the Diabetic Foot classification.
- Severely immunocompromised state as judged by the treating physician (e.g.,
neutropenia due to chemotherapy, high doses of corticosteroids, HIV infection with CD4
count <200 / µl).
|
NCT0531xxxx/NCT05316311.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/NCT05316311</url>
</required_header>
<id_info>
<org_study_id>CNV202003</org_study_id>
<secondary_id>CNV202003</secondary_id>
<nct_id>NCT05316311</nct_id>
</id_info>
<brief_title>A Study of Implantation of CRENEOUS ENTERPRISE 2 Intracranial Stent in Participants With Severe Symptomatic Intracranial Atherosclerotic Stenosis</brief_title>
<official_title>Implantation of CERENOVUS ENTERPRISE 2 Intracranial Stent in Patients With Severe Symptomatic Intracranial Atherosclerotic Stenosis: A Multicenter, Prospective and Single-Arm Study in China</official_title>
<sponsors>
<lead_sponsor>
<agency>Medos International SARL</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Medos International SARL</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>
The purpose of this study is to evaluate the safety and effectiveness of CERENOVUS ENTERPRISE
2 intracranial stent implantation in treatment of participants with severe symptomatic
intracranial atherosclerotic stenosis.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 24, 2022</start_date>
<completion_date type="Anticipated">November 3, 2025</completion_date>
<primary_completion_date type="Anticipated">September 3, 2025</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>Percentage of Participants with In-Stent Restenosis</measure>
<time_frame>At 12 months post-procedure</time_frame>
<description>In-stent restenosis greater than (>) 50 percent (%) at 12 months post-procedure as assessed by an independent Imaging Core Lab will be reported. The percent stenosis of an intracranial artery is calculated according to the warfarin-aspirin symptomatic intracranial disease (WASID) criteria: percent stenosis= ([1-{Dstenosis/Dnormal}]) * 100, where Dstenosis = the diameter of the artery at the site of the most severe stenosis and Dnormal = the diameter of the proximal normal artery.</description>
</primary_outcome>
<secondary_outcome>
<measure>Number of Participants with Technical Success</measure>
<time_frame>Immediately post-procedure (Day 0)</time_frame>
<description>Technical success immediately post-procedure is defined as complete stent coverage and residual stenosis less than or equal to (<=) 50% as assessed by an independent Imaging Core Lab.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of Participants with In-Stent Restenosis</measure>
<time_frame>At 6 months post-procedure</time_frame>
<description>In-stent restenosis (>50%) at 6 months post-procedure as assessed by an independent Imaging Core Lab will be reported. The percent stenosis of an intracranial artery is calculated according to the warfarin-aspirin symptomatic intracranial disease (WASID) criteria: percent stenosis=([1-{Dstenosis/Dnormal}]) * 100, where Dstenosis = the diameter of the artery at the site of the most severe stenosis and Dnormal = the diameter of the proximal normal artery.</description>
</secondary_outcome>
<secondary_outcome>
<measure>National Institutes of Health Stroke Scale (NIHSS) Scores</measure>
<time_frame>At 6 months and 12 months post-procedure</time_frame>
<description>NIHSS scores at 6 months and 12 months post-procedure will be reported. NIHSS score is a tool used to objectively quantify the impairment caused by a stroke and to evaluate stroke severity. It ranges from 0 to 42, with 42 being the highest and 0 being the lowest. The higher the NIHSS score, the worse the neurological function.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Modified Rankin Scale (mRS) Scores</measure>
<time_frame>At 30 days, 6 months and 12 months post-procedure</time_frame>
<description>mRS scores at 30 days, 6 months and 12 months post-procedure will be reported. mRS score is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. It ranges from 0 to 5. The higher the mRS score, the worse the prognosis.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of Participants Free of Ischemic Stroke within the Territory of Stented Vessel</measure>
<time_frame>From 30 days to 12 months post-procedure</time_frame>
<description>Ischemic stroke within the territory of stented vessel from 30 days to 12 months post-procedure as assessed by the independent clinical events committee will be reported.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">194</enrollment>
<condition>Intracranial Atherosclerosis</condition>
<arm_group>
<arm_group_label>CERENOVUS ENTERPRISE 2 Intracranial Stent</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with severe symptomatic intracranial artery stenosis will be treated with CERENOVUS ENTERPRISE 2 Intracranial Stent.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>CERENOVUS ENTERPRISE 2 Intracranial Stent</intervention_name>
<description>CERENOVUS ENTERPRISE 2 Intracranial Stent will be used to treat severe symptomatic intracranial artery stenosis.</description>
<arm_group_label>CERENOVUS ENTERPRISE 2 Intracranial Stent</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

Pre-procedure inclusion criteria

- Participants aged 22-80 years old

- All participants are required to meet at least one additional criteria (a-f) provided
below to qualify for the study; (a) insulin dependent diabetes for at least 15 years;
(b) at least 2 of the following atherosclerotic risk factors: hypertension (blood
pressure [BP] greater than or equal to [>=] 140/90 or on antihypertensive therapy);
dyslipidemia (low density lipoprotein [LDL] 130 milligrams per deciliter [mg/dl] or
high density lipoprotein [HDL] less than [<] 40 mg/dl or fasting triglycerides >= 150
mg/dl or on lipid lowering therapy); smoking; abnormal glucose metabolism (fasting
blood glucose >= 6.2 millimole per liter (mmol/L) or 2 hours postprandial blood
glucose >= 7.8mmol/L); family history of any of the following: myocardial infarction,
coronary artery bypass, coronary angioplasty or stenting, stroke, carotid
endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was
<55 years of age for men or <65 for women at the time of the event ; (c) history of
any of the following: myocardial infarction, coronary artery bypass, coronary
angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular
surgery for atherosclerotic disease ; (d) any stenosis of an extracranial carotid or
vertebral artery, another intracranial artery, subclavian artery, coronary artery,
iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or
renal artery that was documented by non-invasive vascular imaging or catheter
angiography and is considered atherosclerotic ; (e) Aortic arch atheroma or
atherosclerotic aortic aneurysm documented by non-invasive vascular imaging or
catheter angiography ; (f) High resolution magnetic resonance imaging (MRI) imaging
confirmed the presence of atherosclerotic plaques in the target arterial stenosis

- Participants with symptomatic intracranial atherosclerotic stenosis who is receiving
medical treatment (that is, receiving at least one antithrombotic medication and
vascular risk factor management) but still had recurrent (2 or more) ischemic strokes
during the medical treatment period within past year

- Vascular diameter proximal to the stenosis must be measured at 2.0-4.0 millimeters
(mm)

- Modified Rankin Scale (mRS) <= 2

- Stenosis of 70%-99% on non-invasive vascular imaging or digital subtraction
angiography (DSA), with normal distal vessel

- Participant is willing and able to return for all follow-up visits required by the
protocol

- Participants understand the purpose and requirements of the study and have signed an
informed consent form Intra procedure

- Stenosis of 70 percent (%) -99% on digital subtraction angiography (DSA), with normal
distal vessel

Exclusion Criteria:

- Participant underwent an acute ischemic stroke within 2 weeks

- Participants in whom one stent can't cover the lesion length or the use of multiple
stents is required

- Greater than (>) 50% stenosis proximal or distal to the target intracranial lesion

- Intracranial arterial stenosis related to non-atherosclerotic factors, such as:
arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella
zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection;
any intracranial stenosis associated with cerebrospinal fluid pleocytosis;
radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease;
neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy;
suspected vasospastic process, and developmental or genetic abnormalities

- Participants with symptoms of cerebral ischemia caused by cardiac embolism

- Severe vascular tortuosity, highly calcified or anatomy that would preclude the safe
introduction of a guiding catheter, guiding sheath or stent placement

- Myocardial infarction within previous 30 days

- Permanent atrial fibrillation, persistent atrial fibrillation, any episode of
paroxysmal atrial fibrillation within the past six months, or history of paroxysmal
atrial fibrillation requiring chronic anticoagulation

- Intolerance or allergic reaction to any of antithrombotic therapy or medicine used
during the procedure

- History of life-threatening allergy to contrast medium. If not life threatening and
can be effectively pre-treated, participant can be enrolled at investigators'
discretion

- Surgery within previous 30 days or planned in the next 90 days after enrollment

- Intracranial hemorrhage within 3 months

- Concomitant intracranial tumor, aneurysm or arteriovenous malformation

- Haemoglobin <10 grams per deciliter (g/dL), blood platelet count <80000 per
milliliters (/ml), international normalization ratio >1.5, or other uncorrectable
coagulopathies.

- Life expectancy of <3 years due to the concomitant illness.

- Pregnant or lactating women

- Participants judged unsuitable for stenting and angioplasty by the investigator
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>22 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Medos International SARL Clinical Trial</last_name>
<role>Study Director</role>
<affiliation>Medos International SARL</affiliation>
</overall_official>
<overall_contact>
<last_name>Jie ZHOU</last_name>
<phone>86 18600551010</phone>
<email>jzhou138@its.jnj.com</email>
</overall_contact>
<location>
<facility>
<name>Xuanwu Hospital, Capital Medical University</name>
<address>
<city>Beijing</city>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Liqun Jiao</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>West China Hospital of Sichuan University</name>
<address>
<city>Chengdu</city>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Hongbo Zheng</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>First Affiliated Hospital, Harbin Medical University</name>
<address>
<city>Harbin</city>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Huaizhang Shi</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Qilu Hospital of Shandong University</name>
<address>
<city>Jinan</city>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Wei Wu</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Shandong Provincial Hospital</name>
<address>
<city>Jinan</city>
<country>China</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>Nanjing Drum Tower Hospital</name>
<address>
<city>Nanjing</city>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Yun Xu</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Ningbo First Hospital</name>
<address>
<city>Ningbo</city>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Zhiqing Lin</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Huashan Hospital Fudan University</name>
<address>
<city>Shanghai</city>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Yuxiang Gu</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Wenzhou Central Hospital</name>
<address>
<city>Wenzhou</city>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Jun Sun</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
<address>
<city>Xi'an</city>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Jianfeng Han</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>The Second Affiliated Hospital of Xi'an Jiaotong University</name>
<address>
<city>Xi'an</city>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Guilian Zhang</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>China</country>
</location_countries>
<reference>
<citation>Redon J, Olsen MH, Cooper RS, Zurriaga O, Martinez-Beneito MA, Laurent S, Cifkova R, Coca A, Mancia G. Stroke mortality and trends from 1990 to 2006 in 39 countries from Europe and Central Asia: implications for control of high blood pressure. Eur Heart J. 2011 Jun;32(11):1424-31. doi: 10.1093/eurheartj/ehr045. Epub 2011 Apr 12.</citation>
<PMID>21487117</PMID>
</reference>
<reference>
<citation>Wong KS, Li H, Lam WW, Chan YL, Kay R. Progression of middle cerebral artery occlusive disease and its relationship with further vascular events after stroke. Stroke. 2002 Feb;33(2):532-6. doi: 10.1161/hs0202.102602.</citation>
<PMID>11823665</PMID>
</reference>
<reference>
<citation>Kasner SE, Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Benesch CG, Sila CA, Jovin TG, Romano JG, Cloft HJ; Warfarin Aspirin Symptomatic Intracranial Disease Trial Investigators. Predictors of ischemic stroke in the territory of a symptomatic intracranial arterial stenosis. Circulation. 2006 Jan 31;113(4):555-63. doi: 10.1161/CIRCULATIONAHA.105.578229. Epub 2006 Jan 23.</citation>
<PMID>16432056</PMID>
</reference>
<reference>
<citation>Famakin BM, Chimowitz MI, Lynn MJ, Stern BJ, George MG; WASID Trial Investigators. Causes and severity of ischemic stroke in patients with symptomatic intracranial arterial stenosis. Stroke. 2009 Jun;40(6):1999-2003. doi: 10.1161/STROKEAHA.108.546150. Epub 2009 Apr 30.</citation>
<PMID>19407228</PMID>
</reference>
<reference>
<citation>Fiorella D. Endovascular treatment of intracranial stenosis. World Neurosurg. 2011 Dec;76(6 Suppl):S66-70. doi: 10.1016/j.wneu.2011.07.024.</citation>
<PMID>22182273</PMID>
</reference>
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<PMID>17395864</PMID>
</reference>
<reference>
<citation>Zaidat OO, Klucznik R, Alexander MJ, Chaloupka J, Lutsep H, Barnwell S, Mawad M, Lane B, Lynn MJ, Chimowitz M; NIH Multi-center Wingspan Intracranial Stent Registry Study Group. The NIH registry on use of the Wingspan stent for symptomatic 70-99% intracranial arterial stenosis. Neurology. 2008 Apr 22;70(17):1518-24. doi: 10.1212/01.wnl.0000306308.08229.a3. Epub 2008 Jan 30.</citation>
<PMID>18235078</PMID>
</reference>
<reference>
<citation>Fiorella DJ, Turk AS, Levy EI, Pride GL Jr, Woo HH, Albuquerque FC, Welch BG, Niemann DB, Aagaard-Kienitz B, Rasmussen PA, Hopkins LN, Masaryk TJ, McDougall CG. U.S. Wingspan Registry: 12-month follow-up results. Stroke. 2011 Jul;42(7):1976-81. doi: 10.1161/STROKEAHA.111.613877. Epub 2011 Jun 2.</citation>
<PMID>21636812</PMID>
</reference>
<reference>
<citation>Barnard ZR, Alexander MJ. Update in the treatment of intracranial atherosclerotic disease. Stroke Vasc Neurol. 2019 Oct 16;5(1):59-64. doi: 10.1136/svn-2019-000279. eCollection 2020.</citation>
<PMID>32411409</PMID>
</reference>
<reference>
<citation>Nordmeyer H, Chapot R, Haage P. Endovascular Treatment of Intracranial Atherosclerotic Stenosis. Rofo. 2019 Jul;191(7):643-652. doi: 10.1055/a-0855-4298. Epub 2019 Apr 4. English, German.</citation>
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</reference>
<reference>
<citation>Tarabishy (2019). Counseling and Management of Patients with Intracranial Atherosclerosis Disease. In: Spiotta A., Turner R., Chaudry M., Turk A. (eds) Management of Cerebrovascular Disorders.</citation>
</reference>
<reference>
<citation>Hurford R, Wolters FJ, Li L, Lau KK, Kuker W, Rothwell PM. Prognosis of Asymptomatic Intracranial Stenosis in Patients With Transient Ischemic Attack and Minor Stroke. JAMA Neurol. 2020 Aug 1;77(8):947-954. doi: 10.1001/jamaneurol.2020.1326.</citation>
<PMID>32453401</PMID>
</reference>
<reference>
<citation>Zhang Q, Dong K, Song H. Comparison of stent versus medical therapy for symptomatic patients with intracranial atherosclerotic stenosis: A meta-analysis. J Neurol Sci. 2017 Jan 15;372:272-278. doi: 10.1016/j.jns.2016.11.064. Epub 2016 Nov 25.</citation>
<PMID>28017227</PMID>
</reference>
<reference>
<citation>Krasteva MP, Lau KK, Mordasini P, Tsang ACO, Heldner MR. Intracranial Atherosclerotic Stenoses: Pathophysiology, Epidemiology, Risk Factors and Current Therapy Options. Adv Ther. 2020 May;37(5):1829-1865. doi: 10.1007/s12325-020-01291-4. Epub 2020 Apr 8.</citation>
<PMID>32270364</PMID>
</reference>
<reference>
<citation>Samuels OB, Joseph GJ, Lynn MJ, Smith HA, Chimowitz MI. A standardized method for measuring intracranial arterial stenosis. AJNR Am J Neuroradiol. 2000 Apr;21(4):643-6.</citation>
<PMID>10782772</PMID>
</reference>
<reference>
<citation>Chimowitz MI, Lynn MJ, Turan TN, Fiorella D, Lane BF, Janis S, Derdeyn CP; SAMMPRIS Investigators. Design of the stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis trial. J Stroke Cerebrovasc Dis. 2011 Jul-Aug;20(4):357-68. doi: 10.1016/j.jstrokecerebrovasdis.2011.05.001.</citation>
<PMID>21729789</PMID>
</reference>
<reference>
<citation>Bai WX, Gao BL, Li TX, Wang ZL, Cai DY, Zhu LF, Xue JY, Li ZS. Wingspan stenting can effectively prevent long-term strokes for patients with severe symptomatic atherosclerotic basilar stenosis. Interv Neuroradiol. 2016 Jun;22(3):318-24. doi: 10.1177/1591019915623797. Epub 2016 Jan 27.</citation>
<PMID>26823331</PMID>
</reference>
<reference>
<citation>Zhang Y, Rajah GB, Liu P, Sun Y, Liu T, Li X, Miao Z, Li G. Balloon-mounted versus self-expanding stents for symptomatic intracranial vertebrobasilar artery stenosis combined with poor collaterals. Neurol Res. 2019 Aug;41(8):704-713. doi: 10.1080/01616412.2019.1610837. Epub 2019 Apr 28.</citation>
<PMID>31030623</PMID>
</reference>
<reference>
<citation>Wang ZL, Gao BL, Li TX, Cai DY, Zhu LF, Xue JY, Bai WX, Li ZS. Outcomes of middle cerebral artery angioplasty and stenting with Wingspan at a high-volume center. Neuroradiology. 2016 Feb;58(2):161-9. doi: 10.1007/s00234-015-1611-8. Epub 2015 Oct 29.</citation>
<PMID>26515072</PMID>
</reference>
<reference>
<citation>Wang ZL, Gao BL, Li TX, Cai DY, Zhu LF, Bai WX, Xue JY, Li ZS. Symptomatic intracranial vertebral artery atherosclerotic stenosis (>/=70%) with concurrent contralateral vertebral atherosclerotic diseases in 88 patients treated with the intracranial stenting. Eur J Radiol. 2015 Sep;84(9):1801-4. doi: 10.1016/j.ejrad.2015.05.033. Epub 2015 Jun 5.</citation>
<PMID>26119803</PMID>
</reference>
<reference>
<citation>Gruber P, Garcia-Esperon C, Berberat J, Kahles T, Hlavica M, Anon J, Diepers M, Nedeltchev K, Remonda L. Neuro Elutax SV drug-eluting balloon versus Wingspan stent system in symptomatic intracranial high-grade stenosis: a single-center experience. J Neurointerv Surg. 2018 Dec;10(12):e32. doi: 10.1136/neurintsurg-2017-013699. Epub 2018 Apr 7.</citation>
<PMID>29627786</PMID>
</reference>
<reference>
<citation>Li TX, Gao BL, Cai DY, Wang ZL, Zhu LF, Xue JY, Bai WX, He YK, Li L. Wingspan Stenting for Severe Symptomatic Intracranial Atherosclerotic Stenosis in 433 Patients Treated at a Single Medical Center. PLoS One. 2015 Sep 30;10(9):e0139377. doi: 10.1371/journal.pone.0139377. eCollection 2015.</citation>
<PMID>26422692</PMID>
</reference>
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<citation>Ma N, Zhang Y, Shuai J, Jiang C, Zhu Q, Chen K, Liu L, Li B, Shi X, Gao L, Liu Y, Wang F, Li Y, Liu T, Zheng H, Mo D, Gao F, Wang Y, Wang Y, Feng L, Miao Z. Stenting for symptomatic intracranial arterial stenosis in China: 1-year outcome of a multicentre registry study. Stroke Vasc Neurol. 2018 May 7;3(3):176-184. doi: 10.1136/svn-2017-000137. eCollection 2018 Sep.</citation>
<PMID>30294474</PMID>
</reference>
<reference>
<citation>Lee KY, Chen DY, Hsu HL, Chen CJ, Tseng YC. Undersized angioplasty and stenting of symptomatic intracranial tight stenosis with Enterprise: Evaluation of clinical and vascular outcome. Interv Neuroradiol. 2016 Apr;22(2):187-95. doi: 10.1177/1591019915609165. Epub 2015 Nov 4.</citation>
<PMID>26542728</PMID>
</reference>
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<citation>Vajda Z, Schmid E, Guthe T, Klotzsch C, Lindner A, Niehaus L, Sperber W, Peters J, Arnold G, Bazner H, Henkes H. The modified Bose method for the endovascular treatment of intracranial atherosclerotic arterial stenoses using the Enterprise stent. Neurosurgery. 2012 Jan;70(1):91-101; discussion 101. doi: 10.1227/NEU.0b013e31822dff0f.</citation>
<PMID>21778921</PMID>
</reference>
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<citation>Wang X, Wang Z, Ji Y, Ding X, Zang Y, Wang C. Enterprise stent in recanalizing non-acute atherosclerotic intracranial internal carotid artery occlusion. Clin Neurol Neurosurg. 2017 Nov;162:47-52. doi: 10.1016/j.clineuro.2017.06.015. Epub 2017 Jun 27.</citation>
<PMID>28926782</PMID>
</reference>
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<citation>Salik AE, Selcuk HH, Zalov H, Kilinc F, Cirak M, Kara B. Medium-term results of undersized angioplasty and stenting for symptomatic high-grade intracranial atherosclerotic stenosis with Enterprise. Interv Neuroradiol. 2019 Oct;25(5):484-490. doi: 10.1177/1591019919832244. Epub 2019 Apr 16.</citation>
<PMID>30991867</PMID>
</reference>
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<citation>Qiu, X.,Ding, Y.,Xia, S.,Li, W.,Chen, L.,Xia, X.,Ke, S.,Wei, J.,Li, Q.,Peng, Z.. Effect evaluation of Enterprise stents in the treatment of complex and severe symptomatic intracranial atherosclerotic stenosis. Chinese Journal of Cerebrovascular Diseases. 2019. 16 (5):257-262</citation>
</reference>
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<citation>Rubin, D.B., Multiple Imputation after 18+ Years. Journal of the American Statistical Association, 1996. 91(434): p. 473-489.</citation>
</reference>
<verification_date>September 2023</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>September 12, 2023</last_update_submitted>
<last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">September 14, 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>Intracranial Arteriosclerosis</mesh_term>
<mesh_term>Atherosclerosis</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu</ipd_description>
<ipd_url>http://yoda.yale.edu</ipd_url>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to evaluate the safety and effectiveness of CERENOVUS ENTERPRISE
2 intracranial stent implantation in treatment of participants with severe symptomatic
intracranial atherosclerotic stenosis.
Inclusion Criteria:
Pre-procedure inclusion criteria
- Participants aged 22-80 years old
- All participants are required to meet at least one additional criteria (a-f) provided
below to qualify for the study; (a) insulin dependent diabetes for at least 15 years;
(b) at least 2 of the following atherosclerotic risk factors: hypertension (blood
pressure [BP] greater than or equal to [>=] 140/90 or on antihypertensive therapy);
dyslipidemia (low density lipoprotein [LDL] 130 milligrams per deciliter [mg/dl] or
high density lipoprotein [HDL] less than [<] 40 mg/dl or fasting triglycerides >= 150
mg/dl or on lipid lowering therapy); smoking; abnormal glucose metabolism (fasting
blood glucose >= 6.2 millimole per liter (mmol/L) or 2 hours postprandial blood
glucose >= 7.8mmol/L); family history of any of the following: myocardial infarction,
coronary artery bypass, coronary angioplasty or stenting, stroke, carotid
endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was
<55 years of age for men or <65 for women at the time of the event ; (c) history of
any of the following: myocardial infarction, coronary artery bypass, coronary
angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular
surgery for atherosclerotic disease ; (d) any stenosis of an extracranial carotid or
vertebral artery, another intracranial artery, subclavian artery, coronary artery,
iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or
renal artery that was documented by non-invasive vascular imaging or catheter
angiography and is considered atherosclerotic ; (e) Aortic arch atheroma or
atherosclerotic aortic aneurysm documented by non-invasive vascular imaging or
catheter angiography ; (f) High resolution magnetic resonance imaging (MRI) imaging
confirmed the presence of atherosclerotic plaques in the target arterial stenosis
- Participants with symptomatic intracranial atherosclerotic stenosis who is receiving
medical treatment (that is, receiving at least one antithrombotic medication and
vascular risk factor management) but still had recurrent (2 or more) ischemic strokes
during the medical treatment period within past year
- Vascular diameter proximal to the stenosis must be measured at 2.0-4.0 millimeters
(mm)
- Modified Rankin Scale (mRS) <= 2
- Stenosis of 70%-99% on non-invasive vascular imaging or digital subtraction
angiography (DSA), with normal distal vessel
- Participant is willing and able to return for all follow-up visits required by the
protocol
- Participants understand the purpose and requirements of the study and have signed an
informed consent form Intra procedure
- Stenosis of 70 percent (%) -99% on digital subtraction angiography (DSA), with normal
distal vessel
Exclusion Criteria:
- Participant underwent an acute ischemic stroke within 2 weeks
- Participants in whom one stent can't cover the lesion length or the use of multiple
stents is required
- Greater than (>) 50% stenosis proximal or distal to the target intracranial lesion
- Intracranial arterial stenosis related to non-atherosclerotic factors, such as:
arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella
zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection;
any intracranial stenosis associated with cerebrospinal fluid pleocytosis;
radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease;
neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy;
suspected vasospastic process, and developmental or genetic abnormalities
- Participants with symptoms of cerebral ischemia caused by cardiac embolism
- Severe vascular tortuosity, highly calcified or anatomy that would preclude the safe
introduction of a guiding catheter, guiding sheath or stent placement
- Myocardial infarction within previous 30 days
- Permanent atrial fibrillation, persistent atrial fibrillation, any episode of
paroxysmal atrial fibrillation within the past six months, or history of paroxysmal
atrial fibrillation requiring chronic anticoagulation
- Intolerance or allergic reaction to any of antithrombotic therapy or medicine used
during the procedure
- History of life-threatening allergy to contrast medium. If not life threatening and
can be effectively pre-treated, participant can be enrolled at investigators'
discretion
- Surgery within previous 30 days or planned in the next 90 days after enrollment
- Intracranial hemorrhage within 3 months
- Concomitant intracranial tumor, aneurysm or arteriovenous malformation
- Haemoglobin <10 grams per deciliter (g/dL), blood platelet count <80000 per
milliliters (/ml), international normalization ratio >1.5, or other uncorrectable
coagulopathies.
- Life expectancy of <3 years due to the concomitant illness.
- Pregnant or lactating women
- Participants judged unsuitable for stenting and angioplasty by the investigator
|
NCT0531xxxx/NCT05316324.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/NCT05316324</url>
</required_header>
<id_info>
<org_study_id>22-071</org_study_id>
<nct_id>NCT05316324</nct_id>
</id_info>
<brief_title>A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction</brief_title>
<official_title>A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Acellular Dermal Matrix</official_title>
<sponsors>
<lead_sponsor>
<agency>Memorial Sloan Kettering Cancer Center</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>The Plastic Surgery Foundation</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Memorial Sloan Kettering Cancer 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>
The researchers are doing this study to look at the number of complications that occur
immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is
used compared to when ADM is not used. These complications include infections, the need for
Tissue Expander (TE) or implant removal, and other conditions that lead to additional
surgery.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 23, 2022</start_date>
<completion_date type="Anticipated">March 2024</completion_date>
<primary_completion_date type="Anticipated">March 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>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Percentage of patients who experience major complications</measure>
<time_frame>90 days</time_frame>
<description>Listed below are definitions for 90-day major complications for TEs (i.e., infection, explantation, and reoperation for any cause, including mastectomy flap necrosis):
Infection defined as:
Any event requiring the restart of antibiotics (oral or intravenous) after completion of initial perioperative antibiotics
Admission to the hospital for signs and symptoms of cellulitis (redness on breast mound) requiring antibiotics
Purulent drainage from the surgical site or incision
Explantation defined as the need for removal of a TE for any cause
Reoperation defined as skin excision performed in either the clinic or the operating room for mastectomy skin flap necrosis, surgical incision dehiscence, pending skin breakdown or another surgical complication</description>
</primary_outcome>
<secondary_outcome>
<measure>Estimate rates of minor complications (specifically seroma)</measure>
<time_frame>90 days</time_frame>
<description>Minor complication for (Tissue Expanders) TEs are defined as:
o Seroma: Clinically significant noninfected fluid collection requiring either needle aspiration or drain replacement</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">352</enrollment>
<condition>Breast Cancer</condition>
<arm_group>
<arm_group_label>Prepectoral Breast Reconstruction with ADM</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Prepectoral Breast Reconstruction without ADM</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)</intervention_name>
<description>Prepectoral Breast Reconstruction with (ADM)</description>
<arm_group_label>Prepectoral Breast Reconstruction with ADM</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)</intervention_name>
<description>Prepectoral Breast Reconstruction without ADM</description>
<arm_group_label>Prepectoral Breast Reconstruction without ADM</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Females aged 21-60 years

- Planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat
breast cancer

- Planning to undergo immediate two-stage prosthetic breast reconstruction with TE
placement as the first stage

- Planning to undergo nipple-sparing or skin-sparing mastectomy

- Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin
that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion

- Intraoperative confirmation of prepectoral plane viability by operating physician

Exclusion Criteria:

- History of radiotherapy to the operative breast

- Current smoker

- Non-English speaking patients

- Planning to undergo direct-to-implant reconstruction

- Prior sternotomy
</textblock>
</criteria>
<gender>Female</gender>
<gender_based>Yes</gender_based>
<gender_description>Breast Cancer</gender_description>
<minimum_age>21 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Evan Matros, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
</overall_official>
<overall_contact>
<last_name>Evan Matros, MD</last_name>
<phone>646-608-8044</phone>
<email>matrose@mskcc.org</email>
</overall_contact>
<overall_contact_backup>
<last_name>Jonas Nelson, MD</last_name>
<phone>646-608-8040</phone>
</overall_contact_backup>
<location>
<facility>
<name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10065</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Evan Matros, MD</last_name>
<phone>646-608-8044</phone>
</contact>
<contact_backup>
<last_name>Jonas Nelson, MD</last_name>
<phone>646-608-8040</phone>
</contact_backup>
</location>
<location>
<facility>
<name>Memorial Sloan Kettering Nassau (Limited Protocol Activities)</name>
<address>
<city>Rockville Centre</city>
<state>New York</state>
<zip>11553</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Evan Matros, MD</last_name>
<phone>646-608-8044</phone>
</contact>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.mskcc.org/mskcc/html/44.cfm</url>
<description>Memorial Sloan Kettering Cancer Center</description>
</link>
<verification_date>July 2023</verification_date>
<study_first_submitted>March 23, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>July 26, 2023</last_update_submitted>
<last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">July 27, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Acellular Dermal Matrix</keyword>
<keyword>Breast Reconstruction</keyword>
<keyword>Mastectomy</keyword>
<keyword>22-071</keyword>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The researchers are doing this study to look at the number of complications that occur
immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is
used compared to when ADM is not used. These complications include infections, the need for
Tissue Expander (TE) or implant removal, and other conditions that lead to additional
surgery.
Inclusion Criteria:
- Females aged 21-60 years
- Planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat
breast cancer
- Planning to undergo immediate two-stage prosthetic breast reconstruction with TE
placement as the first stage
- Planning to undergo nipple-sparing or skin-sparing mastectomy
- Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin
that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion
- Intraoperative confirmation of prepectoral plane viability by operating physician
Exclusion Criteria:
- History of radiotherapy to the operative breast
- Current smoker
- Non-English speaking patients
- Planning to undergo direct-to-implant reconstruction
- Prior sternotomy
|
NCT0531xxxx/NCT05316337.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/NCT05316337</url>
</required_header>
<id_info>
<org_study_id>WBS08-ECG</org_study_id>
<nct_id>NCT05316337</nct_id>
</id_info>
<brief_title>Withings ECG-Monitor Study</brief_title>
<official_title>Validation of WBS08 With Withings ECG Monitor for the Detection of Atrial Fibrillation</official_title>
<sponsors>
<lead_sponsor>
<agency>Withings</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
<collaborator>
<agency>Syntactx</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Withings</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 aim of the study is to evaluate the performance of Withings WBS08 with embedded Withings
ECG Monitor in the automatic detection of atrial fibrillation
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">July 15, 2022</start_date>
<completion_date type="Anticipated">September 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>Non-Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Basic Science</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Co-primary outcomes</measure>
<time_frame>4 months</time_frame>
<description>Sensitivity (percentage of true positives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the SUT, compared to the reference 12-lead ECG.</description>
</primary_outcome>
<primary_outcome>
<measure>Co-primary outcomes</measure>
<time_frame>4 months</time_frame>
<description>Specificity (percentage of true negatives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the SUT, compared to the reference 12-lead ECG.</description>
</primary_outcome>
<secondary_outcome>
<measure>Evaluation of the classification into heart rate subgroups</measure>
<time_frame>4 months</time_frame>
<description>The classification into heart rate subgroups will be evaluated for the pairs of strips such that the rhythm classification of the 12-lead ECG is either SR or AF and such that the strip generated by the SUT is classified as either SR or AF. The evaluation will be assessed with the concordance of classifications, i.e. the percentage P of identical classifications by the SUT and the reference method, into each of the four following subgroups:
SR with a HR between 50 and 99 bpm
SR with a HR between 100 and 150 bpm
AF with a HR between 50 and 99 bpm
AF with a HR between 100 and 150 bpm</description>
</secondary_outcome>
<secondary_outcome>
<measure>Clinical Equivalence of ECG waveforms</measure>
<time_frame>4 months</time_frame>
<description>Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 6-leads generated by the SUT and the leads I, II, III, aVR, aVL, aVF of the 12-lead ECG by a board of certified cardiologists:
The visibility and polarity of the P waves, QRS complexes and T waves will be determined by cardiologists and according to a set of predetermined rules. For each type of wave (P, QRS and T),</description>
</secondary_outcome>
<secondary_outcome>
<measure>Clinical Equivalence of ECG waveforms</measure>
<time_frame>4 months</time_frame>
<description>The durations of the QT intervals, QRS complex widths, and PR intervals will be measured by cardiologists with a caliper and according to a set of predetermined rules for each of the 6 leads of the strips generated by the SUT and the leads I, II, III, aVR, aVL, aVF of the 12-lead ECG.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Heart Rate equivalence</measure>
<time_frame>4 months</time_frame>
<description>heart rate will be determined by independent cardiologists, or cardiac technicians supervised by cardiologists, from each six-channel strip recorded with the SUT and from each lead I, II, III, aVR, aVL, aVF of the 12-lead reference ECG</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">632</enrollment>
<condition>Atrial Fibrillation</condition>
<arm_group>
<arm_group_label>Atrial fibrillation</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Normal Sinus Rhythm</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Electrocardiogram recording</intervention_name>
<description>ECG recording with investigational device</description>
<arm_group_label>Atrial fibrillation</arm_group_label>
<arm_group_label>Normal Sinus Rhythm</arm_group_label>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Electrocardiogram recording</intervention_name>
<description>ECG recording with reference device</description>
<arm_group_label>Atrial fibrillation</arm_group_label>
<arm_group_label>Normal Sinus Rhythm</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Male or female who are 22 years of age or older,

- Subject able to read, understand, and provide written informed consent,

- Subject willing and able to participate in the study procedures as described in the
consent form,

- Subject able to communicate effectively with and willing to follow instructions from
the study staff.

Exclusion Criteria:

- Vulnerable subject with regard to regulations in force

- Subject who is deprived of liberty by judicial, medical or administrative
decision,

- Underage subject,

- Legally protected subject, or subject who is unable, linguistic or psychic
incapacity, to sign the written informed consent form.

- Subject within several of the above categories,

- Subject who refused to participate in the study,

- Subject mentally impaired resulting in limited ability to cooperate

- Subject with electrical stimulation by pacemaker

- Patient with pathologic disorder that may affect motricity resulting in significant
tremor that prevents subject from being able to hold still (e.g Parkinson disease)

- Patient unable to stay in an upright position for the duration of study measures

- Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular
disease that, in the opinion of the Investigator, may increase the risk to the subject
or renders data uninterpretable (e.g., recent or ongoing unstable angina,
decompensated heart failure, active myocarditis or pericarditis)

- Acute pulmonary embolism or pulmonary infarction, within 90 days of screening

- Stroke or transient ischemic attack within 90 days of screening

- Active life-threatening rhythms as determined by the investigator (ventricular
tachycardia, ventricular fibrillation, 3 rd -degree heart block).

- History of life-threatening rhythms as determined by the investigator (ventricular
tachycardia, ventricular fibrillation, 3 rd -degree heart block)

- Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo,
dermatomyositis or allergic contact dermatitis over electrode attachment sites

- Known sensitivity to medical adhesives, isopropyl alcohol, or electrocardiogram (ECG)
electrodes including known allergy or sensitivity to fluoroelastomer bands

- Weight more than 180 kg
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>22 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Jeffrey Wessler, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Heartbeat Health</affiliation>
</overall_official>
<overall_contact>
<last_name>David Campo, PhD</last_name>
<phone>+33 1.41.46.04.60</phone>
<email>david.campo@withings.com</email>
</overall_contact>
<location>
<facility>
<name>FWD Clinical Research</name>
<address>
<city>Boca Raton</city>
<state>Florida</state>
<zip>33486</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Esthefany Jabbour</last_name>
<email>esthefany@fwdclinical.com</email>
</contact>
<investigator>
<last_name>Michael Cammarata, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Florida Cardiovascular Research</name>
<address>
<city>Hialeah</city>
<state>Florida</state>
<zip>33012</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<email>ketia@floridavresearch.com</email>
</contact>
<investigator>
<last_name>Pablo Guala, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>The Angel Medical Research</name>
<address>
<city>Miami Lakes</city>
<state>Florida</state>
<zip>33016</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordiator</last_name>
<email>leadcoordinator@theangelresearch.com</email>
</contact>
<investigator>
<last_name>John Dylewski, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Diverse Clinical Research</name>
<address>
<city>Miami</city>
<state>Florida</state>
<zip>33175</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>S Cuba</last_name>
</contact>
<investigator>
<last_name>Mireya Garcia, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>American Institute of Therapeutics</name>
<address>
<city>Lake Bluff</city>
<state>Illinois</state>
<zip>60044</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>John Somberg, MD</last_name>
<email>johnsomberg1@comcast.net</email>
</contact>
<investigator>
<last_name>John Somberg, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Cambridge Medical Trials</name>
<address>
<city>Alexandria</city>
<state>Louisiana</state>
<zip>71301</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Naseem Jaffrani, MD</last_name>
</contact>
<investigator>
<last_name>Naseem Jaffrani, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Heartbeat Health</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10019</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jeffrey Wessler, MD</last_name>
</contact>
<contact_backup>
<last_name>Study Coordinator</last_name>
<email>clinical@heartbeathealth.com</email>
</contact_backup>
<investigator>
<last_name>Jeffrey Wessler, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Texas Heart Institute</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77030</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<email>hpetaway@texasheart.org</email>
</contact>
<investigator>
<last_name>Alex Postilian, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>LINQ Research LLC</name>
<address>
<city>Pearland</city>
<state>Texas</state>
<zip>77584</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator, MD</last_name>
<phone>281-984-4358</phone>
</contact>
<investigator>
<last_name>Andres Vasquez, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Henri-Mondor Hospital</name>
<address>
<city>Créteil</city>
<state>Île De France</state>
<zip>94000</zip>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jean-Pascal Lefaucheur, Pr</last_name>
<phone>+ 33 (0)1 49 81 26 77</phone>
<email>jean-pascal.lefaucheur@aphp.fr</email>
</contact>
</location>
<location_countries>
<country>France</country>
<country>United States</country>
</location_countries>
<verification_date>August 2023</verification_date>
<study_first_submitted>March 18, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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>Sponsor</responsible_party_type>
</responsible_party>
<keyword>mHealth</keyword>
<keyword>Atrial fibrillation</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Atrial Fibrillation</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 the study is to evaluate the performance of Withings WBS08 with embedded Withings
ECG Monitor in the automatic detection of atrial fibrillation
Inclusion Criteria:
- Male or female who are 22 years of age or older,
- Subject able to read, understand, and provide written informed consent,
- Subject willing and able to participate in the study procedures as described in the
consent form,
- Subject able to communicate effectively with and willing to follow instructions from
the study staff.
Exclusion Criteria:
- Vulnerable subject with regard to regulations in force
- Subject who is deprived of liberty by judicial, medical or administrative
decision,
- Underage subject,
- Legally protected subject, or subject who is unable, linguistic or psychic
incapacity, to sign the written informed consent form.
- Subject within several of the above categories,
- Subject who refused to participate in the study,
- Subject mentally impaired resulting in limited ability to cooperate
- Subject with electrical stimulation by pacemaker
- Patient with pathologic disorder that may affect motricity resulting in significant
tremor that prevents subject from being able to hold still (e.g Parkinson disease)
- Patient unable to stay in an upright position for the duration of study measures
- Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular
disease that, in the opinion of the Investigator, may increase the risk to the subject
or renders data uninterpretable (e.g., recent or ongoing unstable angina,
decompensated heart failure, active myocarditis or pericarditis)
- Acute pulmonary embolism or pulmonary infarction, within 90 days of screening
- Stroke or transient ischemic attack within 90 days of screening
- Active life-threatening rhythms as determined by the investigator (ventricular
tachycardia, ventricular fibrillation, 3 rd -degree heart block).
- History of life-threatening rhythms as determined by the investigator (ventricular
tachycardia, ventricular fibrillation, 3 rd -degree heart block)
- Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo,
dermatomyositis or allergic contact dermatitis over electrode attachment sites
- Known sensitivity to medical adhesives, isopropyl alcohol, or electrocardiogram (ECG)
electrodes including known allergy or sensitivity to fluoroelastomer bands
- Weight more than 180 kg
|
NCT0531xxxx/NCT05316350.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/NCT05316350</url>
</required_header>
<id_info>
<org_study_id>HWA10-ECG</org_study_id>
<nct_id>NCT05316350</nct_id>
</id_info>
<brief_title>Withings ECG-app Study</brief_title>
<official_title>Validation of HWA10 With Withings ECG-app for the Detection of Atrial Fibrillation</official_title>
<sponsors>
<lead_sponsor>
<agency>Withings</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
<collaborator>
<agency>Syntactx</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Withings</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 aim of the study is to evaluate the performance of Withings HWA10 with embedded Withings
ECG-app in the automatic detection of atrial fibrillation
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">July 15, 2022</start_date>
<completion_date type="Anticipated">September 2023</completion_date>
<primary_completion_date type="Anticipated">September 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>Basic Science</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Co-primary outcomes</measure>
<time_frame>4 months</time_frame>
<description>Sensitivity (percentage of true positives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the SUT, compared to the reference 12-lead ECG.</description>
</primary_outcome>
<primary_outcome>
<measure>Co-primary outcomes</measure>
<time_frame>4 months</time_frame>
<description>Specificity (percentage of true negatives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the SUT, compared to the reference 12-lead ECG.</description>
</primary_outcome>
<secondary_outcome>
<measure>Evaluation of the classification into heart rate subgroups</measure>
<time_frame>4 months</time_frame>
<description>The classification into heart rate subgroups will be evaluated for the pairs of strips such that the rhythm classification of the 12-lead ECG is either SR or AF and such that the strip generated by the SUT is classified as either SR or AF. The evaluation will be assessed with the concordance of classifications, i.e. the percentage P of identical classifications by the SUT and the reference method, into each of the four following subgroups:
SR with a HR between 50 and 99 bpm
SR with a HR between 100 and 150 bpm
AF with a HR between 50 and 99 bpm
AF with a HR between 100 and 150 bpm</description>
</secondary_outcome>
<secondary_outcome>
<measure>Clinical Equivalence of ECG waveforms</measure>
<time_frame>4 months</time_frame>
<description>Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 6-leads generated by the SUT and the leads I, II, III, aVR, aVL, aVF of the 12-lead ECG by a board of certified cardiologists:
The visibility and polarity of the P waves, QRS complexes and T waves will be determined by cardiologists and according to a set of predetermined rules. For each type of wave (P, QRS and T),</description>
</secondary_outcome>
<secondary_outcome>
<measure>Clinical Equivalence of ECG waveforms</measure>
<time_frame>4 months</time_frame>
<description>The durations of the QT intervals, QRS complex widths, and PR intervals will be measured by cardiologists with a caliper and according to a set of predetermined rules for each of the 6 leads of the strips generated by the SUT and the leads I, II, III, aVR, aVL, aVF of the 12-lead ECG.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Heart Rate equivalence</measure>
<time_frame>4 months</time_frame>
<description>heart rate will be determined by independent cardiologists, or cardiac technicians supervised by cardiologists, from each six-channel strip recorded with the SUT and from each lead I, II, III, aVR, aVL, aVF of the 12-lead reference ECG</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">632</enrollment>
<condition>Atrial Fibrillation</condition>
<arm_group>
<arm_group_label>Atrial Fibrillation</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Normal Sinus Rhythm</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Electrocardiogram recording</intervention_name>
<description>ECG recording with investigational device</description>
<arm_group_label>Atrial Fibrillation</arm_group_label>
<arm_group_label>Normal Sinus Rhythm</arm_group_label>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Electrocardiogram recording</intervention_name>
<description>ECG recording with reference device</description>
<arm_group_label>Atrial Fibrillation</arm_group_label>
<arm_group_label>Normal Sinus Rhythm</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Male or female who are 22 years of age or older

- Subject able to read, understand, and provide written informed consent

- Subject willing and able to participate in the study procedures as described in the
consent form

- Subject able to communicate effectively with and willing to follow instructions from
the study staff

- Have a wrist circumference between 140 mm and 210 mm (measured at "band center" on the
preferred wrist, 1cm from the bone. This location is determined by asking the
volunteer to put on a normal wrist-watch and marking the skin with a pen/marker to
outline the edges of the band.)

Exclusion Criteria:

- Vulnerable subject with regard to regulations in force

- Subject who is deprived of liberty by judicial, medical or administrative
decision,

- Underage subject,

- Legally protected subject, or subject who is unable, linguistic or psychic
incapacity, to sign the written informed consent form,

- Subject within several of the above categories,

- Subject who refused to participate in the study,

- Subject mentally impaired resulting in limited ability to cooperate

- Subject in physical incapacity to wear a watch on one wrist and place the other hand
on top of the watch

- Subject with electrical stimulation by pacemaker

- Patient with pathologic disorder that may affect motricity resulting in significant
tremor that prevents subject from being able to hold still (e.g Parkinson disease)

- Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular
disease that, in the opinion of the Investigator, may increase the risk to the subject
or renders data uninterpretable (e.g., recent or ongoing unstable angina,
decompensated heart failure, active myocarditis or pericarditis)

- Acute pulmonary embolism or pulmonary infarction, within 90 days of screening

- Stroke or transient ischemic attack within 90 days of screening

- Active life-threatening rhythms as determined by the investigator (ventricular
tachycardia, ventricular fibrillation, 3 rd -degree heart block).

- History of abnormal life-threatening rhythms (ventricular tachycardia, ventricular
fibrillation, 3 rd -degree heart block)

- Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo,
dermatomyositis or allergic contact dermatitis on both wrists or over electrode
attachment sites

- Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or
electrocardiogram (ECG) electrodes including known allergy or sensitivity to
fluoroelastomer bands primarily used in wrist worn fitness devices
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>22 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Jeffrey Wessler, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Heartbeat Health</affiliation>
</overall_official>
<overall_contact>
<last_name>David Campo, PhD</last_name>
<phone>+33 1.41.46.04.60</phone>
<email>david.campo@withings.com</email>
</overall_contact>
<location>
<facility>
<name>FWD Clinical Research</name>
<address>
<city>Boca Raton</city>
<state>Florida</state>
<zip>33486</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Esthefany Jabbour</last_name>
<email>esthefany@fwdclinical.com</email>
</contact>
<investigator>
<last_name>Michael Cammarata, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Florida Cardiovascular Research</name>
<address>
<city>Hialeah</city>
<state>Florida</state>
<zip>33012</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<email>ketia@floridavresearch.com</email>
</contact>
<investigator>
<last_name>Pablo Guala, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>The Angel Medical Research</name>
<address>
<city>Miami Lakes</city>
<state>Florida</state>
<zip>33016</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordiator</last_name>
<email>leadcoordinator@theangelresearch.com</email>
</contact>
<investigator>
<last_name>John Dylewski, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Diverse Clinical Research</name>
<address>
<city>Miami</city>
<state>Florida</state>
<zip>33175</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>S Cuba</last_name>
</contact>
<investigator>
<last_name>Mireya Garcia, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>American Institute of Therapeutics</name>
<address>
<city>Lake Bluff</city>
<state>Illinois</state>
<zip>60044</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>John Somberg, MD</last_name>
<email>johnsomberg1@comcast.net</email>
</contact>
<investigator>
<last_name>John Somberg, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Cambridge Medical Trials</name>
<address>
<city>Alexandria</city>
<state>Louisiana</state>
<zip>71301</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Naseem Jaffrani, MD</last_name>
</contact>
<investigator>
<last_name>Naseem Jaffrani, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Heartbeat Health</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10019</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jeffrey Wessler, MD</last_name>
</contact>
<contact_backup>
<last_name>Study Coordinator</last_name>
<email>clinical@heartbeathealth.com</email>
</contact_backup>
<investigator>
<last_name>Jeffrey Wessler, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Texas Heart Institute</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77030</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<email>hpetaway@texasheart.org</email>
</contact>
<investigator>
<last_name>Brianna Costello, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>LINQ Research LLC</name>
<address>
<city>Pearland</city>
<state>Texas</state>
<zip>77584</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator, MD</last_name>
<phone>281-984-4358</phone>
</contact>
<investigator>
<last_name>Andres Vasquez, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Henri-Mondor Hospital</name>
<address>
<city>Créteil</city>
<state>Île De France</state>
<zip>94000</zip>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jean-Pascal Lefaucheur, Pr</last_name>
<phone>+ 33 (0)1 49 81 26 77</phone>
<email>jean-pascal.lefaucheur@aphp.fr</email>
</contact>
</location>
<location_countries>
<country>France</country>
<country>United States</country>
</location_countries>
<verification_date>August 2023</verification_date>
<study_first_submitted>March 18, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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>Sponsor</responsible_party_type>
</responsible_party>
<keyword>mhealth</keyword>
<keyword>Atrial Fibrillation</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Atrial Fibrillation</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 the study is to evaluate the performance of Withings HWA10 with embedded Withings
ECG-app in the automatic detection of atrial fibrillation
Inclusion Criteria:
- Male or female who are 22 years of age or older
- Subject able to read, understand, and provide written informed consent
- Subject willing and able to participate in the study procedures as described in the
consent form
- Subject able to communicate effectively with and willing to follow instructions from
the study staff
- Have a wrist circumference between 140 mm and 210 mm (measured at "band center" on the
preferred wrist, 1cm from the bone. This location is determined by asking the
volunteer to put on a normal wrist-watch and marking the skin with a pen/marker to
outline the edges of the band.)
Exclusion Criteria:
- Vulnerable subject with regard to regulations in force
- Subject who is deprived of liberty by judicial, medical or administrative
decision,
- Underage subject,
- Legally protected subject, or subject who is unable, linguistic or psychic
incapacity, to sign the written informed consent form,
- Subject within several of the above categories,
- Subject who refused to participate in the study,
- Subject mentally impaired resulting in limited ability to cooperate
- Subject in physical incapacity to wear a watch on one wrist and place the other hand
on top of the watch
- Subject with electrical stimulation by pacemaker
- Patient with pathologic disorder that may affect motricity resulting in significant
tremor that prevents subject from being able to hold still (e.g Parkinson disease)
- Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular
disease that, in the opinion of the Investigator, may increase the risk to the subject
or renders data uninterpretable (e.g., recent or ongoing unstable angina,
decompensated heart failure, active myocarditis or pericarditis)
- Acute pulmonary embolism or pulmonary infarction, within 90 days of screening
- Stroke or transient ischemic attack within 90 days of screening
- Active life-threatening rhythms as determined by the investigator (ventricular
tachycardia, ventricular fibrillation, 3 rd -degree heart block).
- History of abnormal life-threatening rhythms (ventricular tachycardia, ventricular
fibrillation, 3 rd -degree heart block)
- Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo,
dermatomyositis or allergic contact dermatitis on both wrists or over electrode
attachment sites
- Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or
electrocardiogram (ECG) electrodes including known allergy or sensitivity to
fluoroelastomer bands primarily used in wrist worn fitness devices
|
NCT0531xxxx/NCT05316363.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/NCT05316363</url>
</required_header>
<id_info>
<org_study_id>11/IRB/090</org_study_id>
<nct_id>NCT05316363</nct_id>
</id_info>
<brief_title>Efficacy and Safety of OMT on Asthmatics</brief_title>
<official_title>Efficacy and Safety of Osteopathic Manipulative Treatment on Asthmatics</official_title>
<sponsors>
<lead_sponsor>
<agency>Western University of Health Sciences</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Western University of Health 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>
This is a pilot study in which the objective is to determine the feasibility of a randomized
clinical trial investigating the safety and efficacy of OMT as an adjunctive treatment for
patients with mild to moderate asthma compared to the same patient population without the use
of OMT. OMT may be able to correct anatomical dysfunctions that contribute to increased
symptoms in asthmatic patients. OMT's effect on asthma will be demonstrated by symptomatology
reporting, frequency of medication use, and pulmonary function tests.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Asthma is a leading cause of activity limitation and healthcare burden in the United States
of America. The asthmatic population is in need of treatments that target reducing asthma
symptoms, reduce the need for medication, and improve lung functionality. As of today, there
are not many studies investigating the efficacy and safety of osteopathic manipulative
treatment (OMT) on asthmatic patients. This is a pilot study in which the objective is to
determine the feasibility of a randomized clinical trial investigating the safety and
efficacy of OMT as an adjunctive treatment for patients with mild to moderate asthma compared
to the same patient population without the use of OMT. Subjects will be randomized into
either a control group or an intervention group where OMT will be used in conjunction with
standard asthmatic treatment. Subjective and objective measurements will be taken including
the Asthma Control Test (ACT) questionnaire, peak flow, spirometry, pulse oximetry, and
chest/diaphragmatic excursion measurements. Measurements will be compared from baseline,
before the first treatment and at the follow-up visit after the final treatment.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">December 11, 2012</start_date>
<completion_date type="Actual">January 8, 2015</completion_date>
<primary_completion_date type="Actual">January 8, 2015</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 into two groups: Standard asthmatic care with OMT intervention and standard asthmatic care with no OMT.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Care Provider, Investigator)</masking>
<masking_description>Care providers were not involved in any data analysis and the investigator was also blind to the assignment and outcomes assessment.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Asthma Control Test (ACT) Score</measure>
<time_frame>Between baseline and 5 weeks</time_frame>
<description>Determine the efficacy of adjunctive OMT treatment when compared to standard care in the reduction of symptomatology of dyspnea, wheezing and bronchoconstriction and decrease medication use as measured by the Expert Panel Report 3 and Global Initiative for Asthma Monitoring Asthma Control Test (ACT) questionnaire which is scored on a range from 5 to 25 with higher scores indicating better control of asthma symptoms.</description>
</primary_outcome>
<secondary_outcome>
<measure>Morphological Measurements of Chest and Diaphragm Excursion</measure>
<time_frame>Between baseline and 5 weeks</time_frame>
<description>Chest wall and diaphragm excursion measurements were obtained to assess wall and diaphragm motion during respiration at three different levels: The anterior landmarks were the third intercostal space, xiphoid process and superior aspect of umbilicus which corresponded with the posterior landmarks of the transverse processes of T5, T10 and T12 vertebrae, respectively for participants with and without OMT.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Pulse Oximetry (Pulse Rate)</measure>
<time_frame>Between baseline and 5 weeks</time_frame>
<description>Pulse rate in beats per minute (BPM) was compared between subjects who received OMT as compared to subjects who only received standard care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Pulse Oximetry (Blood O2 Saturation Levels)</measure>
<time_frame>Between baseline and 5 weeks</time_frame>
<description>Blood O2 Saturation levels as measured by a pulse oximeter as a percentage was compared between subjects that received OMT versus those treated with only standard care.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Spirometry Readings: Forced Expiratory Volume in One Second (FEV1)</measure>
<time_frame>Between baseline and 5 weeks</time_frame>
<description>Forced expiratory volume in one second was reported as volume of air expired in one second in subjects who received OMT as compared to subjects who only received standard care.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">32</enrollment>
<condition>Asthma</condition>
<arm_group>
<arm_group_label>OMT Intervention Arm</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients treated with 4 techniques for 8 minutes in the supine position. OMT systematically administered to address the 4 body regions - cervical spine, thoracic spine, ribs and diaphragm. The techniques utilized for this study include: suboccipital release, diaphragmatic release, rib raising and paraspinal inhibition of the thoracic spine. Each technique administered for approximately 2 minutes.</description>
</arm_group>
<arm_group>
<arm_group_label>Control</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Patients lie supine on the treatment table and rested quietly for a total of 8 minutes.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>OMT</intervention_name>
<description>Suboccipital Release - Finger pads are placed onto suboccipital musculature and a smooth, gentle, and rhythmic laterocephalad traction is applied to reduce muscle tension.
Paraspinal Inhibition - Hands are placed under the patient's thoracolumbar spine and contract the erector spinae tissue to draw the thoracolumbar spine into extension and hold until relaxation is felt.
Rib Raising - Hands are placed under the subject's thorax and contact the rib angles with finger pads. Fingers are flexed while adding an anteriolateral traction directed at the rib angle while maintaining neutral wrists. Arms are used as a lever by leaning forward thus creating a fulcrum with the treatment table with a smooth, rhythmic motion. This motion is repeated several times throughout the entire thoracic region, unilaterally and then switch sides.
Diaphragm Release - Hands apply a gentle pressure until a barrier or point of ease of the fascia is felt and hold that position until tissue response is felt.</description>
<arm_group_label>OMT Intervention Arm</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Clinically diagnosed with mild to moderate asthma (Episodic symptoms included were
airflow obstruction or airway hyper-responsiveness, and airflow obstruction that was
at least partially reversible (based upon an increase in FEV1 or greater than or equal
to 12% from baseline or by an increase of at least 10% of predicted FEV1 after
inhalation of a short-acting bronchodilator)

Exclusion Criteria:

- pneumonia

- COPD as a primary diagnosis

- pulmonary fibrosis

- smoking history

- inability to perform pulmonary function tests

- history of recent myocardial infarction or heart disease

- unable to respond to the questionnaire

- unable to provide informed consent

- pregnant

- using muscle relaxants

- Any contraindications to OMT such as: known bone metastases, severe osteoporosis,
osteomyelitis, or fracture
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>55 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 18, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 30, 2022</last_update_submitted>
<last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Western University of Health Sciences</investigator_affiliation>
<investigator_full_name>Jesus Sanchez</investigator_full_name>
<investigator_title>Assistant Dean of Academic Affairs, Professor of NMM/OMM & Family Medicine</investigator_title>
</responsible_party>
<keyword>OMT</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Asthma</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 is a pilot study in which the objective is to determine the feasibility of a randomized
clinical trial investigating the safety and efficacy of OMT as an adjunctive treatment for
patients with mild to moderate asthma compared to the same patient population without the use
of OMT. OMT may be able to correct anatomical dysfunctions that contribute to increased
symptoms in asthmatic patients. OMT's effect on asthma will be demonstrated by symptomatology
reporting, frequency of medication use, and pulmonary function tests.
Asthma is a leading cause of activity limitation and healthcare burden in the United States
of America. The asthmatic population is in need of treatments that target reducing asthma
symptoms, reduce the need for medication, and improve lung functionality. As of today, there
are not many studies investigating the efficacy and safety of osteopathic manipulative
treatment (OMT) on asthmatic patients. This is a pilot study in which the objective is to
determine the feasibility of a randomized clinical trial investigating the safety and
efficacy of OMT as an adjunctive treatment for patients with mild to moderate asthma compared
to the same patient population without the use of OMT. Subjects will be randomized into
either a control group or an intervention group where OMT will be used in conjunction with
standard asthmatic treatment. Subjective and objective measurements will be taken including
the Asthma Control Test (ACT) questionnaire, peak flow, spirometry, pulse oximetry, and
chest/diaphragmatic excursion measurements. Measurements will be compared from baseline,
before the first treatment and at the follow-up visit after the final treatment.
Inclusion Criteria:
- Clinically diagnosed with mild to moderate asthma (Episodic symptoms included were
airflow obstruction or airway hyper-responsiveness, and airflow obstruction that was
at least partially reversible (based upon an increase in FEV1 or greater than or equal
to 12% from baseline or by an increase of at least 10% of predicted FEV1 after
inhalation of a short-acting bronchodilator)
Exclusion Criteria:
- pneumonia
- COPD as a primary diagnosis
- pulmonary fibrosis
- smoking history
- inability to perform pulmonary function tests
- history of recent myocardial infarction or heart disease
- unable to respond to the questionnaire
- unable to provide informed consent
- pregnant
- using muscle relaxants
- Any contraindications to OMT such as: known bone metastases, severe osteoporosis,
osteomyelitis, or fracture
|
NCT0531xxxx/NCT05316376.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/NCT05316376</url>
</required_header>
<id_info>
<org_study_id>2020-KY-036</org_study_id>
<nct_id>NCT05316376</nct_id>
</id_info>
<brief_title>Effect of Albumin-bound Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Patients Receiving Neoadjuvant Chemotherapy for Advanced Ovarian, Fallopian Tube or Peritoneal Cancer: A Phase 2 Single Center Clinical Trial</brief_title>
<official_title>Effect of Albumin-bound Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Patients Receiving Neoadjuvant Chemotherapy for Advanced Ovarian, Fallopian Tube or Peritoneal Cancer: A Phase 2 Single Center Clinical Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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>
Neoadjuvant chemotherapy (NACT) is an important option for patients with advanced ovarian
cancer. Paclitaxel plus carboplatin is the first-line regimen for ovarian cancer NACT
patients. However, the efficacy of NACT is controversial, how to improve the efficacy become
an urgent problem to be solved in the treatment of ovarian cancer. It has been confirmed that
the dose-intensive paclitaxel combined carboplatin regimen can improve the prognosis in Asian
patients with advanced ovarian cancer. However, this protocol has a low rate of complete
tumor remission after NACT (4%) with toxicities and high probability of severe
hypersensitivity reactions. Albumin-bound paclitaxel has the characteristics of tumor
targeting, low allergenicity. We propose that dose-dense albumin-bound paclitaxel
(ddnab-paclitaxel) (100 mg/m2, days 1, 8, and 15) combined with carboplatin (AUC = 5 days 1,
4 weeks) regimen may be superior to the paclitaxel plus carboplatin regimen. We conducted
this Phase II randomized controlled study to testify the efficacy of dd-nab paclitaxel. 57
stage IIIC-IV patients with high-grade epithelial, fallopian tube, and peritoneal cancer who
are unable to undergo optimal cytoreduction and receive NACT after tumor biopsy will be
recruited. The regimen for the study group is albumin-bound paclitaxel (100 mg/m2, days 1, 8,
and 15 doses) combined with carboplatin (AUC = 5 day 1, 4 weeks), while patients in the
control group use paclitaxel (175 mg/m2, day 1) combined with carboplatin (AUC=6, day1).
Interval debulking surgery(IDS) will be performed within 3-4 weeks after 3 cycles of NACT.
The primary endpoint is the proportion of Chemotherapy Response Score (CRS) of 3 according to
the CRS system. The secondary endpoints are progression-free survival(PFS), overall
survival(OS) and the rates of complete resection and adverse events(AEs).
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">May 1, 2022</start_date>
<completion_date type="Anticipated">April 30, 2025</completion_date>
<primary_completion_date type="Anticipated">October 30, 2023</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>Dd-nab-paclitaxel (100 mg/m2, days 1, 8, and 15, every 4 weeks), combined with carboplatin (AUC = 5, days 1), dd-nab TC regimen every 4 weeks will be given to the patients in study group, while for the patients in control group, paclitaxel (175 mg/m2, day 1) combined with carboplatin (AUC=6, day1) will administered.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Investigator)</masking>
<masking_description>Pathological slides of omentum will be independently reviewed by two pathologists who will be blinded to the randomization to determine the CRS.</masking_description>
</study_design_info>
<primary_outcome>
<measure>chemotherapy response score(CRS) 3</measure>
<time_frame>At the end of cycle 3 NACT (each cycle is 21 days)</time_frame>
<description>the proportion of chemotherapy response score 3</description>
</primary_outcome>
<secondary_outcome>
<measure>PFS</measure>
<time_frame>From date of randomization until the date of first documented progression, assessed up to 3 years</time_frame>
<description>progression-free survival</description>
</secondary_outcome>
<secondary_outcome>
<measure>OS</measure>
<time_frame>From date of randomization until the time of death from any cause, assessed up to 3 years</time_frame>
<description>overall survival</description>
</secondary_outcome>
<secondary_outcome>
<measure>AEs</measure>
<time_frame>during the treatment procedure</time_frame>
<description>adverse effects of chemotherapy</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">78</enrollment>
<condition>Ovarian Cancer</condition>
<arm_group>
<arm_group_label>dd-nabTC</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>albumin-bound paclitaxel (100 mg/m2, days 1, 8, and 15, every 4 weeks) combined with carboplatin (AUC = 5, day 1, every 4 weeks)</description>
</arm_group>
<arm_group>
<arm_group_label>CONTROL</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>paclitaxel (175 mg/m2, day 1, every 4 weeks) combined with carboplatin (AUC=6, day1, every 4 weeks)</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>albumin-bound paclitaxel</intervention_name>
<description>albumin-bound paclitaxel (100 mg/m2, days 1, 8, and 15, every 4 weeks) combined with carboplatin (AUC = 5 day 1, every 4 weeks)</description>
<arm_group_label>dd-nabTC</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>paclitaxel</intervention_name>
<description>paclitaxel (175 mg/m2, day 1, every 3 weeks) combined with carboplatin (AUC=6, day1, every 3 weeks)</description>
<arm_group_label>CONTROL</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- International Federation of Gynecology and Obstetrics(FIGO) stage IIIC-IVA, HGSOC
Patients with Fagotti score ≥8

- Adequate kidney function (blood creatinine 58-96 µmol/L)

- Adequate haematological function (haemoglobin ≥110g/L, leucocytes ≥4.0×109/L,
neutrophils ≥2.0×109/L, platelets≥100×109/L)

- Adequate liver function (serum total bilirubin 3.4-22.2µmol/L, alanine
aminotransferase (ALT) 7-40U/L, aspartate aminotransferase (AST) 13-35U/L, AST/ALT
≤1.5)

- World Health Organization(WHO) score 0-2

- expected lifespan>12 weeks

Exclusion Criteria:

- Patients who had received chemotherapy, radiotherapy or any kind of targeted therapy

- Complicated with any other known malignancies

- Patients with poor cardiopulmonary function, which would limit compliance with study
requirements
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Jing Li, Doctor</last_name>
<phone>86-15915893493</phone>
<email>lijing228@mail.sysu.edu.cn</email>
</overall_contact>
<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 7, 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 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Paclitaxel</mesh_term>
<mesh_term>Albumin-Bound Paclitaxel</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Neoadjuvant chemotherapy (NACT) is an important option for patients with advanced ovarian
cancer. Paclitaxel plus carboplatin is the first-line regimen for ovarian cancer NACT
patients. However, the efficacy of NACT is controversial, how to improve the efficacy become
an urgent problem to be solved in the treatment of ovarian cancer. It has been confirmed that
the dose-intensive paclitaxel combined carboplatin regimen can improve the prognosis in Asian
patients with advanced ovarian cancer. However, this protocol has a low rate of complete
tumor remission after NACT (4%) with toxicities and high probability of severe
hypersensitivity reactions. Albumin-bound paclitaxel has the characteristics of tumor
targeting, low allergenicity. We propose that dose-dense albumin-bound paclitaxel
(ddnab-paclitaxel) (100 mg/m2, days 1, 8, and 15) combined with carboplatin (AUC = 5 days 1,
4 weeks) regimen may be superior to the paclitaxel plus carboplatin regimen. We conducted
this Phase II randomized controlled study to testify the efficacy of dd-nab paclitaxel. 57
stage IIIC-IV patients with high-grade epithelial, fallopian tube, and peritoneal cancer who
are unable to undergo optimal cytoreduction and receive NACT after tumor biopsy will be
recruited. The regimen for the study group is albumin-bound paclitaxel (100 mg/m2, days 1, 8,
and 15 doses) combined with carboplatin (AUC = 5 day 1, 4 weeks), while patients in the
control group use paclitaxel (175 mg/m2, day 1) combined with carboplatin (AUC=6, day1).
Interval debulking surgery(IDS) will be performed within 3-4 weeks after 3 cycles of NACT.
The primary endpoint is the proportion of Chemotherapy Response Score (CRS) of 3 according to
the CRS system. The secondary endpoints are progression-free survival(PFS), overall
survival(OS) and the rates of complete resection and adverse events(AEs).
Inclusion Criteria:
- International Federation of Gynecology and Obstetrics(FIGO) stage IIIC-IVA, HGSOC
Patients with Fagotti score ≥8
- Adequate kidney function (blood creatinine 58-96 µmol/L)
- Adequate haematological function (haemoglobin ≥110g/L, leucocytes ≥4.0×109/L,
neutrophils ≥2.0×109/L, platelets≥100×109/L)
- Adequate liver function (serum total bilirubin 3.4-22.2µmol/L, alanine
aminotransferase (ALT) 7-40U/L, aspartate aminotransferase (AST) 13-35U/L, AST/ALT
≤1.5)
- World Health Organization(WHO) score 0-2
- expected lifespan>12 weeks
Exclusion Criteria:
- Patients who had received chemotherapy, radiotherapy or any kind of targeted therapy
- Complicated with any other known malignancies
- Patients with poor cardiopulmonary function, which would limit compliance with study
requirements
|
NCT0531xxxx/NCT05316389.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/NCT05316389</url>
</required_header>
<id_info>
<org_study_id>ICO-2021-05</org_study_id>
<nct_id>NCT05316389</nct_id>
</id_info>
<brief_title>Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life</brief_title>
<acronym>QUARLAMI</acronym>
<official_title>Minimal Harvest Dorsalis Major Flap Breast Reconstruction: Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life</official_title>
<sponsors>
<lead_sponsor>
<agency>Institut Cancerologie de l'Ouest</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Institut Cancerologie de l'Ouest</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 dorsalis major flap is an interesting therapeutic option in breast reconstruction because
of reliability and reproducibility.

In recent years, the minimal flap technique has been developed, which consists of removing
only a portion of the of the large dorsal muscle to reduce the painful and functional
sequelae of this surgery.

The objective of this prospective study is to evaluate the functional and aesthetic results
in patients who have undergone who have undergone this procedure (prospective cohort) or who
will undergo this procedure or prosthetic reconstruction (prospective cohort).

The investigators also wish to evaluate the quality of life of patients after reconstruction
with a minimal harvest dorsalis flap or a prosthesis or prosthesis in the prospective cohort.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Retrospective Cohort :

- Clinical data reconstruction and follow-up up to 1 year

- DASH questionnaire

- Breast Q

- aesthetic evaluation (patient and surgeon and other health professional)

Prospective Cohort :

- Clinical data reconstruction and follow-up up to 1 year

- DASH questionnaire (pre-op, at 6 month and at 12 month)

- Breast Q(pre-op, at 6 month and at 12 month)

- aesthetic evaluation (patient and surgeon and other health professional) (at 6 month and
at 12 month)
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">February 21, 2022</start_date>
<completion_date type="Anticipated">February 21, 2025</completion_date>
<primary_completion_date type="Anticipated">February 21, 2025</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>functional evaluation of the shoulder and upper limb (mobility and pain)</measure>
<time_frame>6 month</time_frame>
<description>Disabilities of the Arm, Shoulder and Hand (DASH) (0 = no disability to 100 = maximum disability)</description>
</primary_outcome>
<secondary_outcome>
<measure>satisfaction of aesthetic by the patient and by the surgeon</measure>
<time_frame>6 month</time_frame>
<description>5 numerical scales (from 0 to 5) measuring overall satisfaction with the reconstruction, general appearance of the breast, breast shape, breast consistency and breast volume</description>
</secondary_outcome>
<secondary_outcome>
<measure>occurrence of postoperative complications</measure>
<time_frame>6 month</time_frame>
<description>complications</description>
</secondary_outcome>
<secondary_outcome>
<measure>quality of life through the Breast-Q questionnaire</measure>
<time_frame>6 months</time_frame>
<description>Breast-Q questionnaire</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">200</enrollment>
<condition>Breast Cancer</condition>
<arm_group>
<arm_group_label>A Retrospective</arm_group_label>
<description>A = retrospective cohort including all patients treated at the ICO Angers between January 2017 and September 2021</description>
</arm_group>
<arm_group>
<arm_group_label>B Prospective</arm_group_label>
<description>B = prospective including all patients treated at the ICO from February 2022 (2 years of recruitment)</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Breast reconstruction</intervention_name>
<description>Muscle sparing Latissimus Dorsi Flap or prothesis</description>
<arm_group_label>A Retrospective</arm_group_label>
<arm_group_label>B Prospective</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Patients at the ICO Angers site with an indication for immediate or deferred breast
reconstruction for their breast cancer
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. Patients with a desire for breast reconstruction

2. Indication for mastectomy or with a history of mastectomy, with or without
preservation of the skin skin,

3. Breast reconstruction procedure by LDPM performed between January 2017 and
September2021, (retrospective cohort )

4. Breast reconstruction procedure by LDPM or by prosthesis performed from February 2022
(prospective cohort)

5. Information to the patient and collection of her non-opposition

6. Affiliation to a social security system, or beneficiary of such a system

Exclusion Criteria:

1. Performance of a breast reconstruction by a technique other than LDPM or prosthesis

2. Patient opposed to the use of her data for research

3. Person in an emergency situation, adult subject to a legal protection measure (adult
under guardianship, curatorship or safeguard of justice), or unable to express his
consent,

4. Impossibility to submit to the medical follow-up of the trial for geographical, social
or psychological psychological reasons.
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<overall_official>
<last_name>Julia DE FREITAS</last_name>
<role>Principal Investigator</role>
<affiliation>ICO</affiliation>
</overall_official>
<overall_contact>
<last_name>Laëtitia HIMPE, MD</last_name>
<phone>0240679747</phone>
<email>promotionrc@ico.unicancer.fr</email>
</overall_contact>
<overall_contact_backup>
<last_name>Julia DE FREITAS, MD</last_name>
<email>julia.defreitas@ico.unicancer.fr</email>
</overall_contact_backup>
<location>
<facility>
<name>Institut de Cancerologie de L'Ouest (Ico)</name>
<address>
<city>Angers</city>
<zip>49055</zip>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Julia DE FREITAS, MD</last_name>
<email>julia.defreitas@ico.unicancer.fr</email>
</contact>
<contact_backup>
<last_name>Augustin REYNARD, MD</last_name>
<email>augustin.reynard@ico.unicancer.fr</email>
</contact_backup>
</location>
<location_countries>
<country>France</country>
</location_countries>
<verification_date>August 2023</verification_date>
<study_first_submitted>March 11, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>August 31, 2023</last_update_submitted>
<last_update_submitted_qc>August 31, 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>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The dorsalis major flap is an interesting therapeutic option in breast reconstruction because
of reliability and reproducibility.
In recent years, the minimal flap technique has been developed, which consists of removing
only a portion of the of the large dorsal muscle to reduce the painful and functional
sequelae of this surgery.
The objective of this prospective study is to evaluate the functional and aesthetic results
in patients who have undergone who have undergone this procedure (prospective cohort) or who
will undergo this procedure or prosthetic reconstruction (prospective cohort).
The investigators also wish to evaluate the quality of life of patients after reconstruction
with a minimal harvest dorsalis flap or a prosthesis or prosthesis in the prospective cohort.
Retrospective Cohort :
- Clinical data reconstruction and follow-up up to 1 year
- DASH questionnaire
- Breast Q
- aesthetic evaluation (patient and surgeon and other health professional)
Prospective Cohort :
- Clinical data reconstruction and follow-up up to 1 year
- DASH questionnaire (pre-op, at 6 month and at 12 month)
- Breast Q(pre-op, at 6 month and at 12 month)
- aesthetic evaluation (patient and surgeon and other health professional) (at 6 month and
at 12 month)
Patients at the ICO Angers site with an indication for immediate or deferred breast
reconstruction for their breast cancer
Inclusion Criteria:
1. Patients with a desire for breast reconstruction
2. Indication for mastectomy or with a history of mastectomy, with or without
preservation of the skin skin,
3. Breast reconstruction procedure by LDPM performed between January 2017 and
September2021, (retrospective cohort )
4. Breast reconstruction procedure by LDPM or by prosthesis performed from February 2022
(prospective cohort)
5. Information to the patient and collection of her non-opposition
6. Affiliation to a social security system, or beneficiary of such a system
Exclusion Criteria:
1. Performance of a breast reconstruction by a technique other than LDPM or prosthesis
2. Patient opposed to the use of her data for research
3. Person in an emergency situation, adult subject to a legal protection measure (adult
under guardianship, curatorship or safeguard of justice), or unable to express his
consent,
4. Impossibility to submit to the medical follow-up of the trial for geographical, social
or psychological psychological reasons.
|
NCT0531xxxx/NCT05316402.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/NCT05316402</url>
</required_header>
<id_info>
<org_study_id>2021/CHU/39</org_study_id>
<nct_id>NCT05316402</nct_id>
</id_info>
<brief_title>Sun Exposure for Outdoor Athletes in Mayotte and Reunion Island</brief_title>
<acronym>EXSPOSOL</acronym>
<official_title>Sun Exposure for Outdoor Athletes in Mayotte and Reunion Island</official_title>
<sponsors>
<lead_sponsor>
<agency>Centre Hospitalier Universitaire de la Réunion</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Centre Hospitalier Universitaire de la Réunion</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 UV index in Mayotte and Reunion is greater than 14, eight months out of 12. This index
decreases linearly over the period from mid-April to mid-August where it can drop to reach an
index of 8 in the month of July. The inhabitants are therefore exposed to a maximum intensity
of UV radiation according to the WHO.

The World Health Organization (WHO) recommends extreme precautions for indices greater than
11 (avoid exposure between 11 a.m. and 3 p.m. (GMT+3 hours), stay in the shade, wear a
t-shirt, sunglasses, hat and sunscreen).

Sun exposure is a major risk factor in the development of skin cancer, basal cell cancer,
squamous cell cancer and cutaneous melanoma. It is also the cause of premature aging of the
skin. Moreover, it causes ocular complications such as the occurrence of cataracts and this
without distinction of skin phenotype.

There is currently no prevention campaign on the risks of sun exposure in Mayotte or Reunion
for adults, while many risky behaviors are observed both in the professional field and during
leisure activities. In order to better understand risk-taking and choose appropriate
awareness-raising tools, it is necessary to identify the knowledge, attitudes and practices
(KAP) of these populations in terms of risk of sun exposure and to measure the impact of
solar prevention education actions.
</textblock>
</brief_summary>
<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">September 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>Improve the knowledge of photo-exposed sportsmen on the risks associated with exposure to the sun</measure>
<time_frame>6 month</time_frame>
<description>knowledge quiz</description>
</primary_outcome>
<secondary_outcome>
<measure>Assess the change in attitudes and practices of photo-exposed sportsmen</measure>
<time_frame>6 month</time_frame>
<description>attitudes and practices of photo-exposed workers quiz</description>
</secondary_outcome>
<secondary_outcome>
<measure>fitzpatrick scale : classification of skin types (phototype I to VI)</measure>
<time_frame>6 month</time_frame>
<description>association between phototype and knowledge level</description>
</secondary_outcome>
<secondary_outcome>
<measure>knowledge questionnaire on the risks of sun exposure</measure>
<time_frame>6 month</time_frame>
<description>association between phototype and knowledge level</description>
</secondary_outcome>
<secondary_outcome>
<measure>Obtain UV dosimetry data by occupation to confirm risk exposure during working hours.</measure>
<time_frame>6 month</time_frame>
<description>dosimetry data</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">400</enrollment>
<condition>Sun Exposure</condition>
<arm_group>
<arm_group_label>training on the risks associated with sun exposure</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>power point on the risks associated with sun exposure</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>training on the risks associated with sun exposure</intervention_name>
<description>15-minute power point and presentation on the risks of sun exposure</description>
<arm_group_label>training on the risks associated with sun exposure</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>dosimetry</intervention_name>
<description>dosimetry</description>
<arm_group_label>training on the risks associated with sun exposure</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Live in Mayotte or Reunion island

- 18 years old,

- Practice outdoor sports > 4 hours per week in one of the identified sports
associations

- Belong to the list of targeted associations

Exclusion Criteria:

- Person deprived of liberty by judicial or administrative decision, minor, and person
subject to a legal protection measure: guardianship or curators

- Person not wishing to participate

- No one speaking any of the following languages: English / French / Shimaore / Kibushi
/ Creole or Comorian

- Person who cannot be followed during the 6 months of the study

- Inability to answer the questionnaire
</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>Lucie AUZANNEAU</last_name>
<phone>0262359949</phone>
<phone_ext>+262</phone_ext>
<email>lucie.auzanneau@chu-reunion.fr</email>
</overall_contact>
<location>
<facility>
<name>Mayotte</name>
<address>
<city>Chirongui</city>
<country>Mayotte</country>
</address>
</facility>
<contact>
<last_name>Lucie AUZANNEAU</last_name>
</contact>
<investigator>
<last_name>Jessica DUMEZ, MD, MSc</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Reunion</name>
<address>
<city>Saint-Pierre</city>
<country>Réunion</country>
</address>
</facility>
<contact>
<last_name>Lucie AUZANNEAU</last_name>
</contact>
<investigator>
<last_name>Antoine BERTOLOTTI, MD, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>Mayotte</country>
<country>Réunion</country>
</location_countries>
<verification_date>February 2022</verification_date>
<study_first_submitted>March 14, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Sun Exposure, sportsmen</keyword>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The UV index in Mayotte and Reunion is greater than 14, eight months out of 12. This index
decreases linearly over the period from mid-April to mid-August where it can drop to reach an
index of 8 in the month of July. The inhabitants are therefore exposed to a maximum intensity
of UV radiation according to the WHO.
The World Health Organization (WHO) recommends extreme precautions for indices greater than
11 (avoid exposure between 11 a.m. and 3 p.m. (GMT+3 hours), stay in the shade, wear a
t-shirt, sunglasses, hat and sunscreen).
Sun exposure is a major risk factor in the development of skin cancer, basal cell cancer,
squamous cell cancer and cutaneous melanoma. It is also the cause of premature aging of the
skin. Moreover, it causes ocular complications such as the occurrence of cataracts and this
without distinction of skin phenotype.
There is currently no prevention campaign on the risks of sun exposure in Mayotte or Reunion
for adults, while many risky behaviors are observed both in the professional field and during
leisure activities. In order to better understand risk-taking and choose appropriate
awareness-raising tools, it is necessary to identify the knowledge, attitudes and practices
(KAP) of these populations in terms of risk of sun exposure and to measure the impact of
solar prevention education actions.
Inclusion Criteria:
- Live in Mayotte or Reunion island
- 18 years old,
- Practice outdoor sports > 4 hours per week in one of the identified sports
associations
- Belong to the list of targeted associations
Exclusion Criteria:
- Person deprived of liberty by judicial or administrative decision, minor, and person
subject to a legal protection measure: guardianship or curators
- Person not wishing to participate
- No one speaking any of the following languages: English / French / Shimaore / Kibushi
/ Creole or Comorian
- Person who cannot be followed during the 6 months of the study
- Inability to answer the questionnaire
|
NCT0531xxxx/NCT05316415.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/NCT05316415</url>
</required_header>
<id_info>
<org_study_id>2017/65</org_study_id>
<nct_id>NCT05316415</nct_id>
</id_info>
<brief_title>The Effects of Music on the Anxiety and Sleep Quality of Pregnant Women on Bed Rest for a High-risk Pregnancy</brief_title>
<official_title>The Effects of Music on the Anxiety and Sleep Quality of Pregnant Women on Bed Rest for a High-risk Pregnancy</official_title>
<sponsors>
<lead_sponsor>
<agency>Cukurova University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Cukurova 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 identify the effects of music on the anxiety and sleep
quality of women with high-risk pregnancy having bed rest in the hospital in Turkey.

This randomized-controlled study involved 80 control and 80 experimental group with a
high-risk pregnant woman .
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The literature review indicates a limited number of studies on the effects of music in
eliminating the anxiety and sleep problems in women with a high-risk pregnancy having bed
rest in the hospital; the existing studies were found to be mainly about anxiety. The purpose
of this study is to identify the effects of music on the anxiety and sleep quality of women
with a high-risk pregnancy having bed rest in the hospital.

This study adopted a pretest-posttest randomized controlled study involved 80 control and 80
experimental group with a high-risk pregnant woman . The women in the experimental group
listened to Acemaşiran music for 40 minutes in successive three days and two times a day.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">September 15, 2017</start_date>
<completion_date type="Actual">November 15, 2019</completion_date>
<primary_completion_date type="Actual">September 15, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>State-trait Anxiety Inventory</measure>
<time_frame>Two hours after the last listening session, the participants were administered the State-trait anxiety inventory to measure</time_frame>
<description>The inventory developed by Spielberger et al. in 1970 consists of two parts that measure two different aspects of anxiety, which are state and trait anxiety. Two inventories are printed on separate pages, and each inventory has 20 questions</description>
</primary_outcome>
<secondary_outcome>
<measure>Pittsburgh Sleep Quality Index</measure>
<time_frame>. Two hours after the last listening session, the participants were administered the Pittsburg Sleep Quality Index to measure their sleep quality.</time_frame>
<description>The PSQI consists of 19 self-rated questions, and 5 questions rated by the bedpartner or roommate. The 19 self-rated questions assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep-related problems. Each subscale is scored between 0 and 3, and the total score to be obtained from the scale ranges between 0 and 21.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">80</enrollment>
<condition>Pregnancy, High Risk</condition>
<condition>Anxiety State</condition>
<condition>Sleep Quality</condition>
<arm_group>
<arm_group_label>Acemaşiran Music Group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Listening to Acemaşiran music for 40 minutes in successive three days and two times a day (noon and evening) Routine clinical care</description>
</arm_group>
<arm_group>
<arm_group_label>Control Group</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Routine clinical care</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Acemaşiran Music Group</intervention_name>
<description>Agreeing to participate in the study Knowing Turkish and being literate Having been hospitalized for bed rest for at least 5 days. Having a gestational age of 28 to 36 weeks Being hospitalized due to at least one of the diagnoses including hypertensive diseases, diabetes mellitus, preterm labor, placenta previa, cervical insufficiency, or premature rupture of the membrane</description>
<arm_group_label>Acemaşiran Music Group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Agreeing to participate in the study

- Knowing Turkish and being literate

- Having been hospitalized for bed rest for at least 5 days.

- Having a gestational age of 28 to 36 weeks

- Being hospitalized due to at least one of the diagnoses including hypertensive
diseases, diabetes mellitus, preterm labor, placenta previa, cervical insufficiency,
or premature rupture of the membrane

Exclusion Criteria:

- Fetal congenital anomalies

- Having a hearing impairment
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Cukurova University Balcalı Hospital</name>
<address>
<city>Adana</city>
<state>Saricam</state>
<zip>01330</zip>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>February 14, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 30, 2022</last_update_submitted>
<last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Cukurova University</investigator_affiliation>
<investigator_full_name>Cemile Onat Koroglu</investigator_full_name>
<investigator_title>Lecturer</investigator_title>
</responsible_party>
<keyword>Anxiety</keyword>
<keyword>bed rest</keyword>
<keyword>high-risk pregnancy</keyword>
<keyword>music</keyword>
<keyword>sleep quality</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 identify the effects of music on the anxiety and sleep
quality of women with high-risk pregnancy having bed rest in the hospital in Turkey.
This randomized-controlled study involved 80 control and 80 experimental group with a
high-risk pregnant woman .
The literature review indicates a limited number of studies on the effects of music in
eliminating the anxiety and sleep problems in women with a high-risk pregnancy having bed
rest in the hospital; the existing studies were found to be mainly about anxiety. The purpose
of this study is to identify the effects of music on the anxiety and sleep quality of women
with a high-risk pregnancy having bed rest in the hospital.
This study adopted a pretest-posttest randomized controlled study involved 80 control and 80
experimental group with a high-risk pregnant woman . The women in the experimental group
listened to Acemaşiran music for 40 minutes in successive three days and two times a day.
Inclusion Criteria:
- Agreeing to participate in the study
- Knowing Turkish and being literate
- Having been hospitalized for bed rest for at least 5 days.
- Having a gestational age of 28 to 36 weeks
- Being hospitalized due to at least one of the diagnoses including hypertensive
diseases, diabetes mellitus, preterm labor, placenta previa, cervical insufficiency,
or premature rupture of the membrane
Exclusion Criteria:
- Fetal congenital anomalies
- Having a hearing impairment
|
NCT0531xxxx/NCT05316428.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/NCT05316428</url>
</required_header>
<id_info>
<org_study_id>TPN171H-08</org_study_id>
<nct_id>NCT05316428</nct_id>
</id_info>
<brief_title>A Study of the Hemodynamic Interactions of TPN171H Tablets & Alcohol in Healthy Male Subjects</brief_title>
<official_title>A Randomized, Blind, Placebo-controlled, Three-way Crossover Study Evaluating the Interaction of TPN171H Tablets and Alcohol in Healthy Chinese Male Subjects</official_title>
<sponsors>
<lead_sponsor>
<agency>Vigonvita Life Sciences</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Vigonvita Life 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>
The purpose of this study is primarily to evaluate the effects of taking TPN171H tablets with
alcohol on blood pressure, pulse,and pharmacokinetic in Chinese healthy male subjects.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This study will be divided into two parts: pre-test and formal test. The pre-trial is an open
design to evaluate the safety and tolerability of TPN171H tablets in combination with alcohol
in healthy male subjects. Two subjects at 5 mg and 10 mg doses will be taken with alcohol,
blood pressure (SBP and DBP), pulse, alcohol breath monitoring and PK blood sample collection
were required, and the time point was the same as the formal test.

The dosage of TPN171H tablets in the formal trial will be determined according to the
preliminary test results.

The formal trial is a single-centre, blind, randomized, placebo-controlled, three-period,
three-way crossover study, in which each subject will be randomized to receive each of the
following three treatments with a washout period of at least 3 days between treatments:

Treatment A: a single oral dose of one10 mg or 5 mg TPN171H tablet plus an oral dose of
alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).

Treatment B: a single oral dose of one placebo tablet plus an oral dose of alcohol drink
mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).

Treatment C: a single oral dose of one10 mg or 5 mg TPN171H tablet plus an oral dose of
placebo drink mixed with fruit juice.

For each treatment period, supine blood pressure and pulse rate will be measured pre-dose and
every 15 minutes for 4 hours post-dose,and at 6h,8h,24h and 48h post-dose. Alcohol levels
using a breathalyzer will be measured at pre-dose and up to 8 hours post dose during all 3
treatments by designated unblinded personnel.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 24, 2022</start_date>
<completion_date type="Actual">April 6, 2022</completion_date>
<primary_completion_date type="Actual">April 2, 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>Crossover Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Maximum change in blood pressure (SBP and DBP)</measure>
<time_frame>48 hours after treatment</time_frame>
<description>Maximum change in decubitus (semi-decubitus) blood pressure (SBP and DBP) from baseline</description>
</primary_outcome>
<primary_outcome>
<measure>Maximum change in pulse</measure>
<time_frame>48 hours after treatment</time_frame>
<description>Maximum change from baseline in decubitus (semi-decubitus) position;</description>
</primary_outcome>
<primary_outcome>
<measure>The area under effect-time curve (AUEC0- 4h) of supine systolic (SBP) and diastolic (DBP) blood pressure, and pulse</measure>
<time_frame>4 hours after treatment</time_frame>
<description>The area under effect-time curve (AUEC0- 4h) of supine systolic (SBP) and diastolic (DBP) blood pressure, and pulse relative to baseline change.</description>
</primary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Actual">19</enrollment>
<condition>Alcohol</condition>
<condition>Phosphodiesterase Inhibitor</condition>
<condition>Erectile Dysfunction</condition>
<arm_group>
<arm_group_label>alcohol plus TPN171H</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>0.5 g/Kg alcohol plus 10 mg TPN171H tablet</description>
</arm_group>
<arm_group>
<arm_group_label>alcohol</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>0.5 g/kg alcohol</description>
</arm_group>
<arm_group>
<arm_group_label>TPN171H</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>10 mg TPN171H tablet</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>TPN171H tablet plus alcohol</intervention_name>
<description>10 mg TPN171H tablet QD plus 0.5 g/kg alcohol</description>
<arm_group_label>alcohol plus TPN171H</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>alcohol</intervention_name>
<description>0.5 g/kg alcohol</description>
<arm_group_label>alcohol</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>TPN171H tablet</intervention_name>
<description>10 mg TPN171H tablet QD</description>
<arm_group_label>TPN171H</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Voluntarily sign and abide by the contents of the informed consent;

2. Adult male subjects, either 21 to 45 years of age,

3. Body weight ≥55 kg; Body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including
the critical value);

4. Subjects must agree to use at least one method of birth control for at least three
months from the time of the first dose to at least the last;

5. Normal or abnormal important indicators of physical examination, vital signs
examination, electrocardiogram examination and laboratory examination have no clinical
significance as judged by the researcher.

Exclusion Criteria:

1. Unable to consume alcohol according to 0.5 g/kg (body weight);

2. After ingestion of 0.5 g/kg alcohol, the instrument showed alcohol concentration ≥120
mg/100 mL after exhalation, or moderate or severe acute alcoholism, which was judged
by the investigator to be unfit to continue to participate in the study (see Appendix
1 for clinical classification of acute alcoholism);

3. Systolic pressure in decubitus (semi-decubitus) position < 90 or ≥140 mmHg; Diastolic
pressure in decubitus (semi-decubitus) position < 60 or ≥90 mmHg；

4. Known allergic history, patients with allergic diseases or allergic predisposition to
the study product or any of its components or related product;

5. May significantly affect drug absorption, distribution, metabolism and excretion of
any surgical situation or condition, or may pose a hazard to participate in research
subjects of any surgical situation or condition, such as the history of
gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal
resection, etc.), gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding
history etc. (except for gallbladder removal);

6. Patients with myocardial infarction, severe/unstable angina pectoris, coronary
artery/peripheral artery bypass graft, congestive heart failure, severe arrhythmias,
and cerebrovascular accidents, including transient ischemic attack, within 6 months
prior to the administration of the study drug;

7. Those who had used any drugs to inhibit or induce drug metabolism in the liver within
4 weeks before enrollment or needed to use any drugs in combination during the study
period; Patients taking nitrates in any form;

8. Known history of the following eye diseases: non-avascular ischemic optic neuropathy
(NAION), abnormal color vision, hereditary retinal degeneration (e.g. Retinitis
pigmentosa), macular degeneration;

9. Known history of sudden hearing loss or loss;

10. A history of postural hypotension;

11. Patients with blood loss >400 mL within 3 months before inclusion;

12. Participated in clinical research of other drugs or medical devices within 3 months
prior to inclusion;

13. Current or previous alcoholics (drinking more than 14 standard units per week. 1
standard unit containing 14 g alcohol, such as 360 mL beer or 45 mL 40% spirits or 150
mL wine), or positive breath test for alcohol;

14. Have a history of drug use or have been screened positive for drug abuse;

15. Smokers who smoked more than 10 cigarettes a day within 6 months prior to inclusion;

16. Human immunodeficiency virus antibody (HIV), hepatitis C virus antibody (anti-HCV),
hepatitis B surface antigen (HBsAg), treponema pallidum antibody (anti-TP) positive;

17. Alcohol sensitivity test positive;

18. There were other factors that the investigator considered inappropriate for the study.
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>45 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Chen Yu</last_name>
<role>Principal Investigator</role>
<affiliation>Shanghai Xuhui Central Hospital</affiliation>
</overall_official>
<location>
<facility>
<name>Shanghai Xuhui Central Hospital</name>
<address>
<city>Shanghai</city>
<country>China</country>
</address>
</facility>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>February 2022</verification_date>
<study_first_submitted>February 8, 2022</study_first_submitted>
<study_first_submitted_qc>March 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>May 20, 2022</last_update_submitted>
<last_update_submitted_qc>May 20, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">May 23, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Phase I</keyword>
<keyword>Crossover Study</keyword>
<keyword>Alcohol</keyword>
<keyword>TPN171H</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Erectile Dysfunction</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ethanol</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is primarily to evaluate the effects of taking TPN171H tablets with
alcohol on blood pressure, pulse,and pharmacokinetic in Chinese healthy male subjects.
This study will be divided into two parts: pre-test and formal test. The pre-trial is an open
design to evaluate the safety and tolerability of TPN171H tablets in combination with alcohol
in healthy male subjects. Two subjects at 5 mg and 10 mg doses will be taken with alcohol,
blood pressure (SBP and DBP), pulse, alcohol breath monitoring and PK blood sample collection
were required, and the time point was the same as the formal test.
The dosage of TPN171H tablets in the formal trial will be determined according to the
preliminary test results.
The formal trial is a single-centre, blind, randomized, placebo-controlled, three-period,
three-way crossover study, in which each subject will be randomized to receive each of the
following three treatments with a washout period of at least 3 days between treatments:
Treatment A: a single oral dose of one10 mg or 5 mg TPN171H tablet plus an oral dose of
alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
Treatment B: a single oral dose of one placebo tablet plus an oral dose of alcohol drink
mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
Treatment C: a single oral dose of one10 mg or 5 mg TPN171H tablet plus an oral dose of
placebo drink mixed with fruit juice.
For each treatment period, supine blood pressure and pulse rate will be measured pre-dose and
every 15 minutes for 4 hours post-dose,and at 6h,8h,24h and 48h post-dose. Alcohol levels
using a breathalyzer will be measured at pre-dose and up to 8 hours post dose during all 3
treatments by designated unblinded personnel.
Inclusion Criteria:
1. Voluntarily sign and abide by the contents of the informed consent;
2. Adult male subjects, either 21 to 45 years of age,
3. Body weight ≥55 kg; Body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including
the critical value);
4. Subjects must agree to use at least one method of birth control for at least three
months from the time of the first dose to at least the last;
5. Normal or abnormal important indicators of physical examination, vital signs
examination, electrocardiogram examination and laboratory examination have no clinical
significance as judged by the researcher.
Exclusion Criteria:
1. Unable to consume alcohol according to 0.5 g/kg (body weight);
2. After ingestion of 0.5 g/kg alcohol, the instrument showed alcohol concentration ≥120
mg/100 mL after exhalation, or moderate or severe acute alcoholism, which was judged
by the investigator to be unfit to continue to participate in the study (see Appendix
1 for clinical classification of acute alcoholism);
3. Systolic pressure in decubitus (semi-decubitus) position < 90 or ≥140 mmHg; Diastolic
pressure in decubitus (semi-decubitus) position < 60 or ≥90 mmHg；
4. Known allergic history, patients with allergic diseases or allergic predisposition to
the study product or any of its components or related product;
5. May significantly affect drug absorption, distribution, metabolism and excretion of
any surgical situation or condition, or may pose a hazard to participate in research
subjects of any surgical situation or condition, such as the history of
gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal
resection, etc.), gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding
history etc. (except for gallbladder removal);
6. Patients with myocardial infarction, severe/unstable angina pectoris, coronary
artery/peripheral artery bypass graft, congestive heart failure, severe arrhythmias,
and cerebrovascular accidents, including transient ischemic attack, within 6 months
prior to the administration of the study drug;
7. Those who had used any drugs to inhibit or induce drug metabolism in the liver within
4 weeks before enrollment or needed to use any drugs in combination during the study
period; Patients taking nitrates in any form;
8. Known history of the following eye diseases: non-avascular ischemic optic neuropathy
(NAION), abnormal color vision, hereditary retinal degeneration (e.g. Retinitis
pigmentosa), macular degeneration;
9. Known history of sudden hearing loss or loss;
10. A history of postural hypotension;
11. Patients with blood loss >400 mL within 3 months before inclusion;
12. Participated in clinical research of other drugs or medical devices within 3 months
prior to inclusion;
13. Current or previous alcoholics (drinking more than 14 standard units per week. 1
standard unit containing 14 g alcohol, such as 360 mL beer or 45 mL 40% spirits or 150
mL wine), or positive breath test for alcohol;
14. Have a history of drug use or have been screened positive for drug abuse;
15. Smokers who smoked more than 10 cigarettes a day within 6 months prior to inclusion;
16. Human immunodeficiency virus antibody (HIV), hepatitis C virus antibody (anti-HCV),
hepatitis B surface antigen (HBsAg), treponema pallidum antibody (anti-TP) positive;
17. Alcohol sensitivity test positive;
18. There were other factors that the investigator considered inappropriate for the study.
|
NCT0531xxxx/NCT05316441.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/NCT05316441</url>
</required_header>
<id_info>
<org_study_id>Erciyes Universty</org_study_id>
<nct_id>NCT05316441</nct_id>
</id_info>
<brief_title>Positive Psychotherapy in Adolescents on Achievement Motivation</brief_title>
<official_title>The Effect of Achievement Skill Development Psychoeducation Based on Positive Psychotherapy in Adolescents on Achievement Motivation</official_title>
<sponsors>
<lead_sponsor>
<agency>TC Erciyes University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>TC Erciyes 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 is to determine the effect of success skill development psychoeducation
based on Positive Psychotherapy on the achievement motivation of adolescents.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The foundation of positive psychotherapy (PPT) Prof. Dr. It was cast by Nossrat Peseschkian.
Psychodynamic approaches, existential-humanistic approaches, cultural therapy approaches and
behavioral approaches are used in therapy. Positive Psychotherapy states that people have two
basic abilities, namely loving and knowing.

In line with the ability to love, primary abilities (love, modeling, relationship/contact,
time, patience, trust, belief/religion, doubt, certainty, sexuality, hope and integrity) are
formed; In line with the ability to know, secondary abilities (punctuality, orderliness,
cleanliness, obedience, courtesy, honesty, loyalty, justice, hard work/success, frugality and
reliability) are formed, which are behavioral categories.

These real abilities develop with family, society, environment and time and become the
character of the person, and the degree of whether or not the real abilities are in the
person plays a decisive role in both the individual's own mental state and interpersonal
relations. The ability to succeed, which is one of the secondary abilities, is extremely
important for people to have goals and passions in life.

The two most important components of a successful learning-teaching process are providing
learner motivation and ensuring the learner's behavioral, sensory and cognitive participation
in this process.

Considering that a significant decrease in achievement motivation is observed especially in
adolescents with advancing age, the achievement motivation levels of learners against course
processes emerge as an important requirement.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 2022</start_date>
<completion_date type="Anticipated">June 2022</completion_date>
<primary_completion_date type="Anticipated">May 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>The research was designed in an experimental model with an intervention-control group. The sample of the research; It consists of 60 students (30 controls, 30 experiments) with 80% power, 95% confidence interval and 0.05 margin of error.</intervention_model_description>
<primary_purpose>Other</primary_purpose>
<masking>Single (Participant)</masking>
</study_design_info>
<primary_outcome>
<measure>Achievement Motivation</measure>
<time_frame>Change = Pre-psychoeducational assessment (Time 1), immediately after psychoeducation (Time 2).</time_frame>
<description>The scale consists of 9 items and two sub-dimensions. Of these dimensions, there are 2 items in the expectation sub-dimension and 6 items in the value sub-dimension. The lowest score that can be obtained from the scale is 8, and the highest score is 40.</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">60</enrollment>
<condition>Adolescent Behavior</condition>
<arm_group>
<arm_group_label>Intervention Group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>A total of 5 sessions of 1.5 hours of group therapy will be applied to the Intervention Group. Group therapies will be carried out over the internet once a week, after appropriate days and times are determined.</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 not be interfered with.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>psychoeducation</intervention_name>
<description>Positive Psychotherapy is a recently emerged therapy method that works on talents. In the study, success skill development psychoeducation based on positive psychotherapy will be applied.</description>
<arm_group_label>Intervention Group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

Being a high school student. Having equipment and internet to attend group sessions.
Volunteer to work.

Exclusion Criteria:

Not having the equipment and internet to attend group sessions. Not being willing to work.
</textblock>
</criteria>
<gender>All</gender>
<gender_based>Yes</gender_based>
<minimum_age>15 Years</minimum_age>
<maximum_age>18 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Eda Albayrak</last_name>
<phone>05397779765</phone>
<email>eda.albayrak@erciyes.edu.tr</email>
</overall_contact>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 15, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>April 14, 2022</last_update_submitted>
<last_update_submitted_qc>April 14, 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>TC Erciyes University</investigator_affiliation>
<investigator_full_name>Eda Albayrak</investigator_full_name>
<investigator_title>Research Assistant</investigator_title>
</responsible_party>
<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 is to determine the effect of success skill development psychoeducation
based on Positive Psychotherapy on the achievement motivation of adolescents.
The foundation of positive psychotherapy (PPT) Prof. Dr. It was cast by Nossrat Peseschkian.
Psychodynamic approaches, existential-humanistic approaches, cultural therapy approaches and
behavioral approaches are used in therapy. Positive Psychotherapy states that people have two
basic abilities, namely loving and knowing.
In line with the ability to love, primary abilities (love, modeling, relationship/contact,
time, patience, trust, belief/religion, doubt, certainty, sexuality, hope and integrity) are
formed; In line with the ability to know, secondary abilities (punctuality, orderliness,
cleanliness, obedience, courtesy, honesty, loyalty, justice, hard work/success, frugality and
reliability) are formed, which are behavioral categories.
These real abilities develop with family, society, environment and time and become the
character of the person, and the degree of whether or not the real abilities are in the
person plays a decisive role in both the individual's own mental state and interpersonal
relations. The ability to succeed, which is one of the secondary abilities, is extremely
important for people to have goals and passions in life.
The two most important components of a successful learning-teaching process are providing
learner motivation and ensuring the learner's behavioral, sensory and cognitive participation
in this process.
Considering that a significant decrease in achievement motivation is observed especially in
adolescents with advancing age, the achievement motivation levels of learners against course
processes emerge as an important requirement.
Inclusion Criteria:
Being a high school student. Having equipment and internet to attend group sessions.
Volunteer to work.
Exclusion Criteria:
Not having the equipment and internet to attend group sessions. Not being willing to work.
|
NCT0531xxxx/NCT05316454.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/NCT05316454</url>
</required_header>
<id_info>
<org_study_id>B.30.2.ATA.. 0.01.00/</org_study_id>
<nct_id>NCT05316454</nct_id>
</id_info>
<brief_title>Self-Efficacy Support on Medication Adherence and Self-Efficacy Levels in Hypertension Patients</brief_title>
<official_title>Effect of Self-Efficacy Support on Medication Adherence and Self-Efficacy Levels in Hypertension Patients: A Randomized Controlled Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Ataturk University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Ataturk 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>
Background:Health professionals are responsible for the education of hypertension patients.

Aim:The aim of this research is to see how self-efficacy support affects hypertension
patients' medication adherence and self-efficacy levels.

Methods: This research is randomized controlled interventional research. The research is
conducted inTurkey June-December2021.The research sample included 63hypertension patients who
met the research's research requirements.According to the sequence of the arrival at the
hospital, data were separated into groups with odd(intervention group)and double(control
group)numbers.The necessary forms for both groups' pre-test data were filled out
face-to-face. The intervention group received hands-on blood pressure measurement training
with the "Hypertension Training Manual",including how to self-measure blood pressure.Over the
course of the research, patients were asked to check their blood pressure twice a day at home
and record the results.The patients in the intervention group were reminded of their blood
pressure measurement three times a week by SMStechnique for three months to avoid forgetting
it.Three months later, the same forms for the post-test data of both groups were filled out
with an online survey method.The data were evaluated using the single-blind study.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Background:Health professionals are responsible for the education of hypertension patients.

Aim:The aim of this research is to see how self-efficacy support affects hypertension
patients' medication adherence and self-efficacy levels.

The Research's Population and Sample Hypertension patients who applied to the cardiology
outpatient clinics at a Hospital in Turkey between June and December 2021 formed the target
population of the research. The research sample included 63 hypertension patients over the
age of 18 who met the research requirements and agreed to participate.

A priori power analysis was used to determine the sample size, and it was determined that
each of the intervention and control groups needed at least 30 hypertension patients for the
research's power to exceed 80% at the 95% confidence interval, 0.05 significance level, and
medium effect size. Given the possibility of data loss owing to a variety of factors, it was
decided to include 100 hypertension patients in the research sample. Because 12 patients
wished to withdraw from the research and 25 patients did not complete the final applications,
the research sample consisted of 63 hypertension patients, 31 in the intervention group and
32 in the control group.

Criteria for Research Inclusion All intervention and control groups were required to meet the
inclusion criteria below.

- With a diagnosis of essential hypertension, follow up for at least 6 months,

- Using antihypertensive drugs,

- Not changing the antihypertensive medication in the last 1 month,

- Not having mental or communication problems,

- Being the age of 18 or older,

- Having at least primary education level,

- Not being a pregnant or nursing mother. Data Collection Data Collection Tools To Be Used
in the Research The research data were collected using the "Patient Descriptive
Information Form", "Self-Efficacy-Efficacy Scale", and "Medication Adherence
Self-Efficacy-Efficacy Scale in Hypertensive Patients." Patient Introductory Information
Form This form, which has been developed by the researchers based on the literature and
has 19 questions, includes the socio-demographic characteristics of the patients and
their disease-related features.

Self-Efficacy - Efficacy Scale The scale evaluates generic self-efficacy-efficacy perception
and does not belong to any subjective category. The Self-Efficacy-Efficacy Scale is a
23-item, 5-point Likert-type scale with a minimum of 23 points and a maximum of 115 points.

Medication Adherence Self-Efficacy Scale in Hypertensive Patients The scale consists of 13
items and is in a four-point Likert type. The scale can be used to determine the lowest 13
and highest 52 points. The increase in the scale score shows that the individuals' compliance
with the antihypertensive medication is above average.

Used Materials for Self-Efficacy Support Hypertension Education Booklet The Hypertension
Education Booklet, which was created by the researchers based on the literature review,
contains information about the disease and its treatment, treatment methods, lifestyle
changes that are effective in the management of hypertension, the importance of treatment
compliance, and blood pressure measurement at home.

For the booklet, 1 internal medicine specialist, 3 nurse faculty members, and 1 specialist
nurse provided expert opinions. In addition, three hypertension patients were given the
booklet to assess its comprehension, and arrangements were made based on their ideas. The
survey was completed after Item and Content validity analyses were performed.

Blood Pressure Monitor Given the uncertainty of measurement by auscultation, the Hypertension
Guidelines in the 2015 Canadian Education Program advocate using an automatic
sphygmomanometer for office blood pressure measurement.Blood pressure is now measured at home
using an upper arm blood pressure monitor. As a result, an appropriate blood pressure
monitor, which enables self-measured blood pressure monitoring at home, with the BAP project
number TSA-2021-8985 was delivered within the scope of the project. The device complies with
the European Norm EN 60601-1-2.

Phone "Don't forget to measure your blood pressure in the morning and evening!" message sent
3 times a week by SMS method to the patients in the intervention group. In addition, the
patients were contacted by phone at the end of the first, second, and third months to acquire
information regarding the research process.

Research Implementation The objective of the research and the manner of application was
explained to all patients in the intervention and control groups who met the eligibility
requirements. Patients who agreed to take part in the research were required to complete an
"Informed Consent Form for Volunteers." As a pre-test, both groups were given the "Patient
Introductory Information Form","Self-Efficacy-Efficacy Scale", and "Medication Adherence
Self-Efficacy Scale in Hypertensive Patients" through a face-to-face interview.

Separation of Groups Patients were sorted into odd and even numbers according to the order in
which they arrived at the hospital in the research, regardless of their age or gender, as
long as the number of participants in the intervention and control groups was equal. The
method was repeated until a total of 100 data points were collected, with odd numbers
representing the intervention group and even numbers representing the control group.

Intervention Group Patient education and blood pressure measurement training took place in
the ECG room of the outpatient clinic which is equipped to instruct patients. The
"Hypertension Education Booklet" was used to instruct the patients. Following that, the
patient received blood pressure measurement training, including a demonstration of how to
self-measure blood pressure. The patient was instructed to repeat the same process. The
researcher provided retraining in the event of errors or shortcomings. The training continued
until the patient performed the accurate measurement. It took around half an hour. The
patients were given a blood pressure monitor to use at home to test their blood pressure.
Patients were asked to take their blood pressure at home twice a day and record the results
during the research. Patients in the intervention group were texted three times a week for
three months to remind them to take their blood pressure.

The patients were called by phone after the first month to control the procedure and acquire
information about the research process. In addition, the patients' queries were answered and
information on the various events that occurred was acquired. Similarly, patients were also
reached by phone after the second month to control the process and acquire information about
the research process. The same forms were given to the patients in the intervention group as
a post-test at the end of the third month, utilizing an online survey method.

Control Group The control group received no intervention after the pre-test data of the
control group were gathered face to face. The same forms were collected as post-test data via
an online survey method at the end of the third month.

Pre-Application The researcher invited two patients who applied to the outpatient clinic to
read and answer the survey questions before the research to assess the intelligibility of the
questions in the data collection form. All of the questions were found to be clear and of
adequate scope. The data of the patients, taken to the pre-application, were not included in
the research data.

Data Evaluation The statistics were evaluated using the single-blind study. The data were
analyzed in the SPSS 20 Package Program. To establish their distribution among the groups,
frequency and percentage distributions were utilized. The intervention and control groups
were compared using the chi-square test. To compare two independent groups, an "independent
sample t-test" was utilized. To compare two dependent groups, a "Paired t-test" was
performed. Descriptive statistics (mean and standard deviation) were used. The statistical
significance cut-off value was set at 0.05.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">June 1, 2021</start_date>
<completion_date type="Actual">February 1, 2022</completion_date>
<primary_completion_date type="Actual">September 1, 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>Supportive Care</primary_purpose>
<masking>Single (Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Self-Efficacy - Efficacy Scale</measure>
<time_frame>3months</time_frame>
<description>The scale evaluates generic self-efficacy-efficacy perception and does not belong to any subjective category. The Self-Efficacy-Efficacy Scale is a 23-item, 5-point Likert-type scale with a minimum of 23 points and a maximum of 115 points.</description>
</primary_outcome>
<primary_outcome>
<measure>Medication Adherence Self-Efficacy Scale in Hypertensive Patients</measure>
<time_frame>3months</time_frame>
<description>The scale consists of 13 items and is in a four-point Likert type. The scale can be used to determine the lowest 13 and highest 52 points. The increase in the scale score shows that the individuals' compliance with the antihypertensive medication is above average.</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">63</enrollment>
<condition>Hypertension</condition>
<arm_group>
<arm_group_label>Experimental</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients with hypertension benefit from self-efficacy support in terms of medication adherence and self-efficacy.</description>
</arm_group>
<arm_group>
<arm_group_label>Control</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>No change.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>self-efficacy support</intervention_name>
<description>self-efficacy support</description>
<arm_group_label>Experimental</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

All intervention and control groups were required to meet the inclusion criteria below.

- With a diagnosis of essential hypertension, follow up for at least 6 months,

- Using antihypertensive drugs,

- Not changing the antihypertensive medication in the last 1 month,

- Not having mental or communication problems,

- Being the age of 18 or older,

- Having at least primary education level,

- Not being a pregnant or nursing mother.

Exclusion Criteria:

All intervention and control groups were required to meet the inclusion criteria below.

- With a diagnosis of essential hypertension, follow up for at least 6 months,

- Using antihypertensive drugs,

- Not changing the antihypertensive medication in the last 1 month,

- Not having mental or communication problems,

- Being the age of 18 or older,

- Having at least primary education level,

- Not being a pregnant or nursing mother.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>50 Years</minimum_age>
<maximum_age>72 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>BAHAR Çiftçi, phd</last_name>
<role>Study Director</role>
<affiliation>Atatürk University</affiliation>
</overall_official>
<location>
<facility>
<name>Atatürk University Faculty of Nursing</name>
<address>
<city>Erzurum</city>
<state>Center</state>
<zip>25242</zip>
<country>Turkey</country>
</address>
</facility>
</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 30, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>March 30, 2022</last_update_submitted>
<last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Ataturk University</investigator_affiliation>
<investigator_full_name>Bahar Ciftci</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>Nursing, hypertension, self-efficacy, self-efficacy support</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>
<ipd_description>The article is intented to be shared after it is published.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Background:Health professionals are responsible for the education of hypertension patients.
Aim:The aim of this research is to see how self-efficacy support affects hypertension
patients' medication adherence and self-efficacy levels.
Methods: This research is randomized controlled interventional research. The research is
conducted inTurkey June-December2021.The research sample included 63hypertension patients who
met the research's research requirements.According to the sequence of the arrival at the
hospital, data were separated into groups with odd(intervention group)and double(control
group)numbers.The necessary forms for both groups' pre-test data were filled out
face-to-face. The intervention group received hands-on blood pressure measurement training
with the "Hypertension Training Manual",including how to self-measure blood pressure.Over the
course of the research, patients were asked to check their blood pressure twice a day at home
and record the results.The patients in the intervention group were reminded of their blood
pressure measurement three times a week by SMStechnique for three months to avoid forgetting
it.Three months later, the same forms for the post-test data of both groups were filled out
with an online survey method.The data were evaluated using the single-blind study.
Background:Health professionals are responsible for the education of hypertension patients.
Aim:The aim of this research is to see how self-efficacy support affects hypertension
patients' medication adherence and self-efficacy levels.
The Research's Population and Sample Hypertension patients who applied to the cardiology
outpatient clinics at a Hospital in Turkey between June and December 2021 formed the target
population of the research. The research sample included 63 hypertension patients over the
age of 18 who met the research requirements and agreed to participate.
A priori power analysis was used to determine the sample size, and it was determined that
each of the intervention and control groups needed at least 30 hypertension patients for the
research's power to exceed 80% at the 95% confidence interval, 0.05 significance level, and
medium effect size. Given the possibility of data loss owing to a variety of factors, it was
decided to include 100 hypertension patients in the research sample. Because 12 patients
wished to withdraw from the research and 25 patients did not complete the final applications,
the research sample consisted of 63 hypertension patients, 31 in the intervention group and
32 in the control group.
Criteria for Research Inclusion All intervention and control groups were required to meet the
inclusion criteria below.
- With a diagnosis of essential hypertension, follow up for at least 6 months,
- Using antihypertensive drugs,
- Not changing the antihypertensive medication in the last 1 month,
- Not having mental or communication problems,
- Being the age of 18 or older,
- Having at least primary education level,
- Not being a pregnant or nursing mother. Data Collection Data Collection Tools To Be Used
in the Research The research data were collected using the "Patient Descriptive
Information Form", "Self-Efficacy-Efficacy Scale", and "Medication Adherence
Self-Efficacy-Efficacy Scale in Hypertensive Patients." Patient Introductory Information
Form This form, which has been developed by the researchers based on the literature and
has 19 questions, includes the socio-demographic characteristics of the patients and
their disease-related features.
Self-Efficacy - Efficacy Scale The scale evaluates generic self-efficacy-efficacy perception
and does not belong to any subjective category. The Self-Efficacy-Efficacy Scale is a
23-item, 5-point Likert-type scale with a minimum of 23 points and a maximum of 115 points.
Medication Adherence Self-Efficacy Scale in Hypertensive Patients The scale consists of 13
items and is in a four-point Likert type. The scale can be used to determine the lowest 13
and highest 52 points. The increase in the scale score shows that the individuals' compliance
with the antihypertensive medication is above average.
Used Materials for Self-Efficacy Support Hypertension Education Booklet The Hypertension
Education Booklet, which was created by the researchers based on the literature review,
contains information about the disease and its treatment, treatment methods, lifestyle
changes that are effective in the management of hypertension, the importance of treatment
compliance, and blood pressure measurement at home.
For the booklet, 1 internal medicine specialist, 3 nurse faculty members, and 1 specialist
nurse provided expert opinions. In addition, three hypertension patients were given the
booklet to assess its comprehension, and arrangements were made based on their ideas. The
survey was completed after Item and Content validity analyses were performed.
Blood Pressure Monitor Given the uncertainty of measurement by auscultation, the Hypertension
Guidelines in the 2015 Canadian Education Program advocate using an automatic
sphygmomanometer for office blood pressure measurement.Blood pressure is now measured at home
using an upper arm blood pressure monitor. As a result, an appropriate blood pressure
monitor, which enables self-measured blood pressure monitoring at home, with the BAP project
number TSA-2021-8985 was delivered within the scope of the project. The device complies with
the European Norm EN 60601-1-2.
Phone "Don't forget to measure your blood pressure in the morning and evening!" message sent
3 times a week by SMS method to the patients in the intervention group. In addition, the
patients were contacted by phone at the end of the first, second, and third months to acquire
information regarding the research process.
Research Implementation The objective of the research and the manner of application was
explained to all patients in the intervention and control groups who met the eligibility
requirements. Patients who agreed to take part in the research were required to complete an
"Informed Consent Form for Volunteers." As a pre-test, both groups were given the "Patient
Introductory Information Form","Self-Efficacy-Efficacy Scale", and "Medication Adherence
Self-Efficacy Scale in Hypertensive Patients" through a face-to-face interview.
Separation of Groups Patients were sorted into odd and even numbers according to the order in
which they arrived at the hospital in the research, regardless of their age or gender, as
long as the number of participants in the intervention and control groups was equal. The
method was repeated until a total of 100 data points were collected, with odd numbers
representing the intervention group and even numbers representing the control group.
Intervention Group Patient education and blood pressure measurement training took place in
the ECG room of the outpatient clinic which is equipped to instruct patients. The
"Hypertension Education Booklet" was used to instruct the patients. Following that, the
patient received blood pressure measurement training, including a demonstration of how to
self-measure blood pressure. The patient was instructed to repeat the same process. The
researcher provided retraining in the event of errors or shortcomings. The training continued
until the patient performed the accurate measurement. It took around half an hour. The
patients were given a blood pressure monitor to use at home to test their blood pressure.
Patients were asked to take their blood pressure at home twice a day and record the results
during the research. Patients in the intervention group were texted three times a week for
three months to remind them to take their blood pressure.
The patients were called by phone after the first month to control the procedure and acquire
information about the research process. In addition, the patients' queries were answered and
information on the various events that occurred was acquired. Similarly, patients were also
reached by phone after the second month to control the process and acquire information about
the research process. The same forms were given to the patients in the intervention group as
a post-test at the end of the third month, utilizing an online survey method.
Control Group The control group received no intervention after the pre-test data of the
control group were gathered face to face. The same forms were collected as post-test data via
an online survey method at the end of the third month.
Pre-Application The researcher invited two patients who applied to the outpatient clinic to
read and answer the survey questions before the research to assess the intelligibility of the
questions in the data collection form. All of the questions were found to be clear and of
adequate scope. The data of the patients, taken to the pre-application, were not included in
the research data.
Data Evaluation The statistics were evaluated using the single-blind study. The data were
analyzed in the SPSS 20 Package Program. To establish their distribution among the groups,
frequency and percentage distributions were utilized. The intervention and control groups
were compared using the chi-square test. To compare two independent groups, an "independent
sample t-test" was utilized. To compare two dependent groups, a "Paired t-test" was
performed. Descriptive statistics (mean and standard deviation) were used. The statistical
significance cut-off value was set at 0.05.
Inclusion Criteria:
All intervention and control groups were required to meet the inclusion criteria below.
- With a diagnosis of essential hypertension, follow up for at least 6 months,
- Using antihypertensive drugs,
- Not changing the antihypertensive medication in the last 1 month,
- Not having mental or communication problems,
- Being the age of 18 or older,
- Having at least primary education level,
- Not being a pregnant or nursing mother.
Exclusion Criteria:
All intervention and control groups were required to meet the inclusion criteria below.
- With a diagnosis of essential hypertension, follow up for at least 6 months,
- Using antihypertensive drugs,
- Not changing the antihypertensive medication in the last 1 month,
- Not having mental or communication problems,
- Being the age of 18 or older,
- Having at least primary education level,
- Not being a pregnant or nursing mother.
|
NCT0531xxxx/NCT05316467.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/NCT05316467</url>
</required_header>
<id_info>
<org_study_id>53211036-01</org_study_id>
<nct_id>NCT05316467</nct_id>
</id_info>
<brief_title>Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma</brief_title>
<official_title>Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma: Two Single-arm, Prospective and Open-label Clinical Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Xiaojun Chen</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Fudan 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>
To investigate the efficacy of weight management plus megestrol acetate in obese patients
with early endometrioid carcinoma（EEC）asking for fertility-sparing treatment
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Background:

High-dosage high-efficacy progesterone, such as Megestrol Acetate (MA) and
medroxyprogesterone acetate(MPA), is still the first-line treatment for women with early
endometrioid endometrial cancer (EEC) who want to preserve fertility. Approximately 70% to
80% of females who meet the criteria for conservation treatment are able to achieve CR after
progestin therapy, with a median time of 6-7 months, but about 20% to 30% of patients get no
response or need to take longer time to achieve remission (over one year). Overweight/obesity
is an independent risk factor for fertility-sparing treatment response and pregnant outcomes
in young females with early endometrioid cancer, substantial evidence showed that obesity can
cause relatively lower complete response（CR）rates, longer time to achieve completer remission
and lower birth rates besides metabolic disorders and other adverse effects caused by
obesity. Weight management has been found to improve metabolic disorders, ovarian functions
and pregnant outcomes.The hypothesize is that weight management plus progestin therapy may
raise CR rates and pregnant outcomes in young female EEC patients asking for fertility
conservation. Previous research has shown that metformin plus MA can increase CR rates.
Enhanced lifestyle management (diet control, exercise and daily behavioral guidance) may
improve metabolic conditions, increase CR rates and pregnant outcomes in obese EEC patients
who want to preserve fertility. Till now, no similar studies were found, so the investigators
design this study to explore the efficacy of weight control in EEC fertility-sparing patients
to provide new evidence for improving conservative treatment.

Objective: To investigate whether weight management plus MA improve the efficacy of
preserving fertility when compared to MA alone in obese women with EEC who want fertility
conservation.

Design: This study is two single-arm, prospective, open-label. Patients with early-stage
endometrioid carcinoma requiring conservation treatment with BMI ≥ 24 kg/m2 will be recruited
in this study and they will be divided into two arms, one is overweight group
(24kg/m2≤BMI<28kg/m2) and another is obese group (BMI≥28kg/m2). Each arm and its sample size
was designed according to Simon's Two-Stage Design. All enrolled patients will receive
enhanced lifestyle management to control weight and take MA for treating EEC. Hysteroscopic
examination, metabolic and inflammatory indicators will be performed every 12 to16 weeks
while other indexes will be evaluated every month, including weight, heart rates，blood
pressure and so on.For the progestin efficacy evaluation, CR is defined as the remission of
EEC to proliferative or secretory endometrium; partial response (PR) is defined as regression
to simple or complex hyperplasia with or without atypia; no response (NR) is defined as the
persistence of the disease; and progressive disease (PD) is defined as disease progression in
patients. Two months' maintenance treatment will be recommended for patients with CR, and
participants will be followed up for 2 years.

Outcomes: Primary outcome is the CR rates of the two arms (overweight and obesity group).
Secondary outcomes include pregnancy rates, live birth rates, weight loss, insulin
resistance, chronic inflammation indicators, time to achieve CR and the recurrence rates and
so on. Safety and side events during the whole trial will be monitored in two years.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 1, 2022</start_date>
<completion_date type="Anticipated">February 28, 2026</completion_date>
<primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date>
<phase>Phase 2/Phase 3</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>
<intervention_model_description>All enrolled patients will receive enhanced lifestyle management to control weight and take Megestrol Acetate (MA) for treating EEC.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Pathological complete response (CR) rates</measure>
<time_frame>From date of recruitment until the date of CR, assessed up to 28 weeks.</time_frame>
<description>The 28-week CR rates will be calculated in two arms</description>
</primary_outcome>
<secondary_outcome>
<measure>Pregnancy outcomes</measure>
<time_frame>up to 2 years after complete response of the last participant</time_frame>
<description>For patients have a desire for fertility, pregnancies, births and related outcomes will be counted, and the rate of pregnancy will be counted as number of pregnancies/ number of patients trying to fertility in the following period.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Weight change</measure>
<time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame>
<description>Body weight will be recorded every month and compare its change during the trial in kilograms.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of body composition</measure>
<time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame>
<description>Assess the improvement of body composition, the investigators will detect body composition with InBody machine and calculate changes of the indicated indexes.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of heart rates</measure>
<time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame>
<description>Record heart rates in bpm (beats per minute) every 12-16 weeks and calculate its change during the trial.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of blood pressures</measure>
<time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame>
<description>Record blood pressure (both of systolic and diastolic pressures) every 12-16 weeks and compare its change during the treatment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Blood glucose change</measure>
<time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame>
<description>Assess fasting glucose levels each 3 to 4 months and calculate changes during the trial in mmol/L.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Blood lipids change</measure>
<time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame>
<description>Assess blood lipids levels each 3 to 4 months and compare their change during the treatment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Insulin resistance change</measure>
<time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame>
<description>Assess fasting insulin levels each 3 to 4 months and compare their changes during the trial.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Ovarian reserve function change</measure>
<time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame>
<description>Detect serum Anti-Mullerian Hormone (AMH) levels each 3 or 4 months and calculate its change.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Quality of life change</measure>
<time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame>
<description>Collect quality of life questionnaire (SF-36 and IWQOL-LITE) every 12-16 weeks and count scores.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Physical activities change</measure>
<time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame>
<description>Collect physical activities questionnaire（IPAQ）and compare scores changes through conservative treatment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Chronic inflammatory indexes change</measure>
<time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame>
<description>Detect chronic inflammatory indexes, including TNF-α(tumor necrosis factor), IL-1 and IL-6, and calculate changes through the whole treatment period.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time of pathological complete response (CR)</measure>
<time_frame>From date of recruitment until the date of CR, assessed up to 2 years.</time_frame>
<description>Time of histologic regression from EC to proliferative or secretory endometrium</description>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of adverse events</measure>
<time_frame>From date of recruitment until the date of CR, assessed up to 2 years.</time_frame>
<description>Adverse events related with MA and weight control. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be recorded, as well as incidence of adverse events.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Relapse rates</measure>
<time_frame>up to 2 years after the treatment for each patient</time_frame>
<description>All enrolled patients will be followed up for 2 years. During the following-up period, if patients recur after complete regression, they will be counted and the number of recurrence will be divided by number of patients followed up, then the investigators can get the relapse rates. Comparison will be performed between two groups.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">89</enrollment>
<condition>Endometrial Carcinoma</condition>
<condition>Obese</condition>
<condition>Overweight</condition>
<condition>Fertility Issues</condition>
<arm_group>
<arm_group_label>overweight 24kg/m2≤BMI<28kg/m2</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>MA+ weight management enrolled patients will receive megestrol acetate 160mg po qd plus weight management</description>
</arm_group>
<arm_group>
<arm_group_label>BMI≥28kg/m2</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>MA+ weight management enrolled patients will receive megestrol acetate 160mg po qd plus weight management</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Intensive Lifestyle Intervention (ILI)</intervention_name>
<description>dietary guidance
exercise guidance
lifestyle intervention</description>
<arm_group_label>BMI≥28kg/m2</arm_group_label>
<arm_group_label>overweight 24kg/m2≤BMI<28kg/m2</arm_group_label>
<other_name>Weight Management</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Megestrol Acetate 160 MG Oral Tablet</intervention_name>
<description>enrolled participants will take Megestrol Acetate 160mg daily</description>
<arm_group_label>BMI≥28kg/m2</arm_group_label>
<arm_group_label>overweight 24kg/m2≤BMI<28kg/m2</arm_group_label>
<other_name>yilizhi</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. 18 years≤age≤45years

2. BMI (body mass index) ≥24kg/m2

3. Consent informed and signed

4. Pathologically confirmed as endometrial carcinoma Patients with endometrial specimens
obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed
histologically as endometrioid carcinoma, G1. If specimens are from other hospitals,
they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics
and Gynecology Hospital of Fudan University.

5. Imaging Assessment Enhanced MRI of the pelvis and enhanced CT of the upper abdomen
must be performed in 2 weeks prior to starting treatment to assess the lesions
confined to the endometrial layer without clear myometrial infiltration or
extrauterine involvement.

6. Have a strong desire to reproduce and ask for fertility preservation or those who
insist on keeping the uterus despite no reproductive requirements.

7. Have good compliance and follow-up conditions, and patients are willing to follow up
in Obstetrics and Gynecology Hospital of Fudan University in time.

Exclusion Criteria:

1. Patients with non-endometrioid endometrial carcinoma, endometrioid endometrial
carcinoma G2/G3 or other malignant tumors of the reproductive system; imaging suggests
myometrial invasion, cervical involvement or extra-uterine involvement.

2. Combined with severe medical disease or liver or kidney dysfunction: alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) levels elevate to 3 times
or more of the upper limit of normal, kidney dysfunction (creatinine clearance <30
mL/min)

3. Patients with other types of endometrial cancer or other malignant tumors of the
reproductive system; patients with breast cancer or other hormone-dependent tumors
that cannot be used with progesterone.

4. Those who have received high doses of high potency progestin or oral contraceptives
within the last 3 months (or those on maintenance medication).

5. Those who require hysterectomy or other methods other than conservative treatment.

6. Known or suspected pregnancy.

7. Those who has contraindications to use progestin.

8. Deep vein thrombosis, stroke, myocardial infarction.

9. Severe joint lesions that prevent walking or movement.
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>45 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>XIAOJUN CHEN, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Obstetrics & Gynecology Hospital of Fudan University</affiliation>
</overall_official>
<overall_contact>
<last_name>WEIWEI SHAN, PhD</last_name>
<phone>8613817813106</phone>
<email>danweiwei7468@fckyy.org.cn</email>
</overall_contact>
<overall_contact_backup>
<last_name>XIAOJUN CHEN, PhD</last_name>
<phone>8613601680784</phone>
<email>cxjlhjj@163.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Obstetrics and Gynecology Hospital, Fudan University</name>
<address>
<city>Shanghai</city>
<state>Shanghai</state>
<zip>200011</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Xiaojun Chen, PhD</last_name>
<phone>862163455055</phone>
<email>cxjlhjj@163.com</email>
</contact>
<contact_backup>
<last_name>Weiwei Shan, phd</last_name>
<phone>8613817813106</phone>
<email>fdsww1024@sina.cn</email>
</contact_backup>
<investigator>
<last_name>Weiwei Shan, phd</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>August 2022</verification_date>
<study_first_submitted>March 9, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 2022</study_first_posted>
<last_update_submitted>May 27, 2023</last_update_submitted>
<last_update_submitted_qc>May 27, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 31, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>Fudan University</investigator_affiliation>
<investigator_full_name>Xiaojun Chen</investigator_full_name>
<investigator_title>MD.PhD. Vice president of Obstetrics & Gynecology Hospital of Fudan University</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Carcinoma</mesh_term>
<mesh_term>Endometrial Neoplasms</mesh_term>
<mesh_term>Carcinoma, Endometrioid</mesh_term>
<mesh_term>Infertility</mesh_term>
<mesh_term>Overweight</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Megestrol</mesh_term>
<mesh_term>Megestrol Acetate</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
To investigate the efficacy of weight management plus megestrol acetate in obese patients
with early endometrioid carcinoma（EEC）asking for fertility-sparing treatment
Background:
High-dosage high-efficacy progesterone, such as Megestrol Acetate (MA) and
medroxyprogesterone acetate(MPA), is still the first-line treatment for women with early
endometrioid endometrial cancer (EEC) who want to preserve fertility. Approximately 70% to
80% of females who meet the criteria for conservation treatment are able to achieve CR after
progestin therapy, with a median time of 6-7 months, but about 20% to 30% of patients get no
response or need to take longer time to achieve remission (over one year). Overweight/obesity
is an independent risk factor for fertility-sparing treatment response and pregnant outcomes
in young females with early endometrioid cancer, substantial evidence showed that obesity can
cause relatively lower complete response（CR）rates, longer time to achieve completer remission
and lower birth rates besides metabolic disorders and other adverse effects caused by
obesity. Weight management has been found to improve metabolic disorders, ovarian functions
and pregnant outcomes.The hypothesize is that weight management plus progestin therapy may
raise CR rates and pregnant outcomes in young female EEC patients asking for fertility
conservation. Previous research has shown that metformin plus MA can increase CR rates.
Enhanced lifestyle management (diet control, exercise and daily behavioral guidance) may
improve metabolic conditions, increase CR rates and pregnant outcomes in obese EEC patients
who want to preserve fertility. Till now, no similar studies were found, so the investigators
design this study to explore the efficacy of weight control in EEC fertility-sparing patients
to provide new evidence for improving conservative treatment.
Objective: To investigate whether weight management plus MA improve the efficacy of
preserving fertility when compared to MA alone in obese women with EEC who want fertility
conservation.
Design: This study is two single-arm, prospective, open-label. Patients with early-stage
endometrioid carcinoma requiring conservation treatment with BMI ≥ 24 kg/m2 will be recruited
in this study and they will be divided into two arms, one is overweight group
(24kg/m2≤BMI<28kg/m2) and another is obese group (BMI≥28kg/m2). Each arm and its sample size
was designed according to Simon's Two-Stage Design. All enrolled patients will receive
enhanced lifestyle management to control weight and take MA for treating EEC. Hysteroscopic
examination, metabolic and inflammatory indicators will be performed every 12 to16 weeks
while other indexes will be evaluated every month, including weight, heart rates，blood
pressure and so on.For the progestin efficacy evaluation, CR is defined as the remission of
EEC to proliferative or secretory endometrium; partial response (PR) is defined as regression
to simple or complex hyperplasia with or without atypia; no response (NR) is defined as the
persistence of the disease; and progressive disease (PD) is defined as disease progression in
patients. Two months' maintenance treatment will be recommended for patients with CR, and
participants will be followed up for 2 years.
Outcomes: Primary outcome is the CR rates of the two arms (overweight and obesity group).
Secondary outcomes include pregnancy rates, live birth rates, weight loss, insulin
resistance, chronic inflammation indicators, time to achieve CR and the recurrence rates and
so on. Safety and side events during the whole trial will be monitored in two years.
Inclusion Criteria:
1. 18 years≤age≤45years
2. BMI (body mass index) ≥24kg/m2
3. Consent informed and signed
4. Pathologically confirmed as endometrial carcinoma Patients with endometrial specimens
obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed
histologically as endometrioid carcinoma, G1. If specimens are from other hospitals,
they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics
and Gynecology Hospital of Fudan University.
5. Imaging Assessment Enhanced MRI of the pelvis and enhanced CT of the upper abdomen
must be performed in 2 weeks prior to starting treatment to assess the lesions
confined to the endometrial layer without clear myometrial infiltration or
extrauterine involvement.
6. Have a strong desire to reproduce and ask for fertility preservation or those who
insist on keeping the uterus despite no reproductive requirements.
7. Have good compliance and follow-up conditions, and patients are willing to follow up
in Obstetrics and Gynecology Hospital of Fudan University in time.
Exclusion Criteria:
1. Patients with non-endometrioid endometrial carcinoma, endometrioid endometrial
carcinoma G2/G3 or other malignant tumors of the reproductive system; imaging suggests
myometrial invasion, cervical involvement or extra-uterine involvement.
2. Combined with severe medical disease or liver or kidney dysfunction: alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) levels elevate to 3 times
or more of the upper limit of normal, kidney dysfunction (creatinine clearance <30
mL/min)
3. Patients with other types of endometrial cancer or other malignant tumors of the
reproductive system; patients with breast cancer or other hormone-dependent tumors
that cannot be used with progesterone.
4. Those who have received high doses of high potency progestin or oral contraceptives
within the last 3 months (or those on maintenance medication).
5. Those who require hysterectomy or other methods other than conservative treatment.
6. Known or suspected pregnancy.
7. Those who has contraindications to use progestin.
8. Deep vein thrombosis, stroke, myocardial infarction.
9. Severe joint lesions that prevent walking or movement.
|
NCT0531xxxx/NCT05316480.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/NCT05316480</url>
</required_header>
<id_info>
<org_study_id>PTCA199-1</org_study_id>
<nct_id>NCT05316480</nct_id>
</id_info>
<brief_title>Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms</brief_title>
<official_title>Preliminary Exploration of Therapeutic Efficacy of Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms</official_title>
<sponsors>
<lead_sponsor>
<agency>Fudan University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Fudan 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>
The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients
with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located
in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical
efficacy has been shown in adult with various types of cancer with EGFR overexpression. The
phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with
stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">May 1, 2022</start_date>
<completion_date type="Anticipated">December 30, 2026</completion_date>
<primary_completion_date type="Anticipated">April 30, 2025</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 (ORR)</measure>
<time_frame>Baseline to 6 months</time_frame>
<description>Overall Response rate was defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1.</description>
</primary_outcome>
<secondary_outcome>
<measure>Disease control rate (DCR)</measure>
<time_frame>Baseline to 6 months</time_frame>
<description>Disease control rate was defined as the proportion of patients with a best overall response of Complete Response, Partial response, or Stable disease, based on the investigator's assessment per RECIST version 1.1.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Progression free survival (PFS)</measure>
<time_frame>Patients will be followed until disease progression, estimating around 12months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Overall survival (OS)</measure>
<time_frame>Patients will be followed until disease progression, estimating around 12months</time_frame>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">42</enrollment>
<condition>Pancreatic Neuroendocrine Neoplasm</condition>
<arm_group>
<arm_group_label>Nimotuzumab</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>nimotuzumab 200mg/week</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Nimotuzumab</intervention_name>
<description>nimotuzumab 200mg/week</description>
<arm_group_label>Nimotuzumab</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Histologically or cytologically proven diagnosis of pancreatic neuroendocrine tumors
(pNET) with well and moderately differentiated with evidence of unresectable disease
or metastatic disease. Locally advanced disease must not be amendable to resection or
radiation therapy with curative intent.

2. Overexpression of EGFR in tumor tissue sample from tumor biopsy or prior primary tumor
resection. Therefore availability of paraffin-embedding tumor tissue sample is needed.

3. Documented progression of the disease by CT scan, MRI, or Octreoscan within 12 months
prior to baseline.

4. Measurable disease as per RECIST. Measurable lesions that have been previously
radiated will not be considered target lesions unless increase in size has been
observed following completion of radiation therapy.

5. Male or female, 18 years of age or older.

6. ECOG performance status less than 2.

7. Life expectancy greater than 12 weeks.

8. The definitions of minimum adequacy for organ function required prior to study entry
are as follows.

Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 x upper
limit of normal (ULN), or AST and ALT < 5 x ULN if liver function abnormalities are
due to underlying malignancy Total serum bilirubin < 1.5 x ULN Serum albumin > 3.0
g/dL Absolute neutrophil count (ANC) > 1500/L Hemoglobin > 9.0 g/dL Creatinin
clearance < 40 mL/min

9. Signed and dated informed consent document indicating that the patient (or legally
acceptable representative) has been informed of all the pertinent aspects of the trial
prior to enrollment.

10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures.

Exclusion Criteria:

1. Active second primary malignancy or history of second primary malignancy.

2. Current treatment on another clinical trial.

3. Any of the following within the 12 months prior to starting study treatment:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, congestive heart failure, cerebrovascular accident including transient ischemic
attack, or pulmonary embolus.

4. Pregnancy or breastfeeding. All female patients with reproductive potential must have
a negative pregnancy test (serum or urine) prior to randomization.

5. Pathological confirmed to be poor differentiated tumor of pancreatic neuroendocrine
neoplasms.

6. Patients who are unwilling or unable to comply with study procedures.

7. Prior targeted treatment on EGFR.

8. Low expression or absence of EGFR in tumor tissue sample from tumor biopsy or prior
primary tumor resection.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University</name>
<address>
<city>Shanghai</city>
<state>Shanghai</state>
<zip>200032</zip>
<country>China</country>
</address>
</facility>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 28, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 7, 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 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Fudan University</investigator_affiliation>
<investigator_full_name>Xian-Jun Yu</investigator_full_name>
<investigator_title>Professor</investigator_title>
</responsible_party>
<keyword>EGFR</keyword>
<keyword>nimotuzumab</keyword>
<keyword>Pancreatic Neuroendocrine Neoplasm</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Neoplasms</mesh_term>
<mesh_term>Neuroendocrine Tumors</mesh_term>
<mesh_term>Adenoma, Islet Cell</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Nimotuzumab</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients
with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.
Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located
in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical
efficacy has been shown in adult with various types of cancer with EGFR overexpression. The
phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with
stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.
Inclusion Criteria:
1. Histologically or cytologically proven diagnosis of pancreatic neuroendocrine tumors
(pNET) with well and moderately differentiated with evidence of unresectable disease
or metastatic disease. Locally advanced disease must not be amendable to resection or
radiation therapy with curative intent.
2. Overexpression of EGFR in tumor tissue sample from tumor biopsy or prior primary tumor
resection. Therefore availability of paraffin-embedding tumor tissue sample is needed.
3. Documented progression of the disease by CT scan, MRI, or Octreoscan within 12 months
prior to baseline.
4. Measurable disease as per RECIST. Measurable lesions that have been previously
radiated will not be considered target lesions unless increase in size has been
observed following completion of radiation therapy.
5. Male or female, 18 years of age or older.
6. ECOG performance status less than 2.
7. Life expectancy greater than 12 weeks.
8. The definitions of minimum adequacy for organ function required prior to study entry
are as follows.
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 x upper
limit of normal (ULN), or AST and ALT < 5 x ULN if liver function abnormalities are
due to underlying malignancy Total serum bilirubin < 1.5 x ULN Serum albumin > 3.0
g/dL Absolute neutrophil count (ANC) > 1500/L Hemoglobin > 9.0 g/dL Creatinin
clearance < 40 mL/min
9. Signed and dated informed consent document indicating that the patient (or legally
acceptable representative) has been informed of all the pertinent aspects of the trial
prior to enrollment.
10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures.
Exclusion Criteria:
1. Active second primary malignancy or history of second primary malignancy.
2. Current treatment on another clinical trial.
3. Any of the following within the 12 months prior to starting study treatment:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, congestive heart failure, cerebrovascular accident including transient ischemic
attack, or pulmonary embolus.
4. Pregnancy or breastfeeding. All female patients with reproductive potential must have
a negative pregnancy test (serum or urine) prior to randomization.
5. Pathological confirmed to be poor differentiated tumor of pancreatic neuroendocrine
neoplasms.
6. Patients who are unwilling or unable to comply with study procedures.
7. Prior targeted treatment on EGFR.
8. Low expression or absence of EGFR in tumor tissue sample from tumor biopsy or prior
primary tumor resection.
|