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NCT0531xxxx/NCT05311293.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/NCT05311293</url>
</required_header>
<id_info>
<org_study_id>irritable bowel syndrome</org_study_id>
<nct_id>NCT05311293</nct_id>
</id_info>
<brief_title>Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis</brief_title>
<official_title>Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis</official_title>
<sponsors>
<lead_sponsor>
<agency>Tang-Du Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Tang-Du Hospital</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 research group intends to carry out a case-control study to recruit IBS-D patients with
anxiety and depression symptoms, by collecting intestinal mucosa for single-cell
transcriptome sequencing, collecting peripheral blood for proteomic analysis, the two groups
and patient symptoms are associated, and then discover the characteristics of molecular level
changes associated with brain-gut axis dysfunction, explore the pathophysiological mechanism
of comorbid anxiety and depression and IBS, and discover potential targets for effective
treatment. This project can help to construct the colonic single-cell map of IBS-D patients
and explore the differentially expressed genes in the colon of IBS patients and their
signaling pathways related to neuroregulation, providing an effective therapeutic target for
the treatment of comorbid anxiety and depression and IBS.
</textblock>
</brief_summary>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Actual">November 1, 2021</start_date>
<completion_date type="Anticipated">December 2023</completion_date>
<primary_completion_date type="Anticipated">December 2023</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Cross-Sectional</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Anxiety and Depression Score</measure>
<time_frame>up to 100 weeks</time_frame>
<description>To evaluate the extent to which a disease affects a mental condition</description>
</primary_outcome>
<number_of_groups>3</number_of_groups>
<enrollment type="Anticipated">15</enrollment>
<condition>Irritable Bowel Syndrome With Diarrhea</condition>
<arm_group>
<arm_group_label>Patients with simple diarrhea-predominant irritable bowel syndrome</arm_group_label>
</arm_group>
<arm_group>
<arm_group_label>Patients with irritable bowel syndrome accompanied by anxiety and depression</arm_group_label>
</arm_group>
<arm_group>
<arm_group_label>Healthy Volunteers</arm_group_label>
</arm_group>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Endoscopy</intervention_name>
<description>Observe the extent of colonic lesions and obtain intestinal mucosal samples</description>
<arm_group_label>Healthy Volunteers</arm_group_label>
<arm_group_label>Patients with irritable bowel syndrome accompanied by anxiety and depression</arm_group_label>
<arm_group_label>Patients with simple diarrhea-predominant irritable bowel syndrome</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel syndrome
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. Meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel
syndrome;

2. Aged between 18 and 65 years old (inclusive), male or female;

3. HAMA assessment ≥ 14 points or HAMD assessment ≥ 17 points

Exclusion Criteria:

1. Patients with severe cardiovascular and cerebrovascular diseases (such as myocardial
infarction, cerebral infarction, coronary heart disease, etc.);

2. Abnormal liver and kidney function (ALT or AST > 1.5 times the upper limit of normal,
or T-Bil > 1.5 times the upper limit of normal, or Cr more than the upper limit of
normal), hematopoietic system diseases and tumors;

3. Patients with a history of abdominal surgery (except appendectomy and
cholecystectomy);

4. Previous diagnosis of organic diseases of the digestive system, such as inflammatory
bowel disease, intestinal tuberculosis, etc., or still associated with peptic ulcer,
infectious diarrhea, etc.;

5. Previous diagnosis of diseases similar to irritable bowel syndrome symptoms, such as
eosinophilic enteritis, microscopic colitis (including collagen colitis and
lymphocytic colitis), lactose intolerance, malabsorption syndrome;

6. Previous diagnosis of non-intestinal digestive system diseases, such as tuberculous
peritonitis, gallstones, cirrhosis, chronic pancreatitis;

7. Previous diagnosis of diseases affecting the digestive tract function, such as
hyperthyroidism or hypothyroidism, endometriosis, autoimmune diseases, diabetes, etc.;

8. 4. Patients who have taken drugs with bleeding risk or increased bleeding risk before
treatment;

9. 4. Patients who have taken antidepressant drugs and psychotropic drugs before
treatment;

10. 4. Use drugs that affect gastrointestinal motility and function, such as prokinetic
drugs, anticholinergic drugs, calcium channel blockers, 5-HT receptor
agonists/antagonists, antidiarrheal agents, antacids, intestinal bacteria modulators
and antibiotics;

11. Allergic constitution;

12. Pregnant and lactating women; Others that may affect study compliance or adversely
affect the results as judged by the investigator.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Tang-Du Hospital</name>
<address>
<city>Xi'an</city>
<zip>712000</zip>
<country>China</country>
</address>
</facility>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 9, 2022</study_first_submitted>
<study_first_submitted_qc>April 2, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>April 2, 2022</last_update_submitted>
<last_update_submitted_qc>April 2, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 5, 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>Irritable Bowel Syndrome</mesh_term>
<mesh_term>Syndrome</mesh_term>
<mesh_term>Diarrhea</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The research group intends to carry out a case-control study to recruit IBS-D patients with
anxiety and depression symptoms, by collecting intestinal mucosa for single-cell
transcriptome sequencing, collecting peripheral blood for proteomic analysis, the two groups
and patient symptoms are associated, and then discover the characteristics of molecular level
changes associated with brain-gut axis dysfunction, explore the pathophysiological mechanism
of comorbid anxiety and depression and IBS, and discover potential targets for effective
treatment. This project can help to construct the colonic single-cell map of IBS-D patients
and explore the differentially expressed genes in the colon of IBS patients and their
signaling pathways related to neuroregulation, providing an effective therapeutic target for
the treatment of comorbid anxiety and depression and IBS.
Meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel syndrome
Inclusion Criteria:
1. Meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel
syndrome;
2. Aged between 18 and 65 years old (inclusive), male or female;
3. HAMA assessment ≥ 14 points or HAMD assessment ≥ 17 points
Exclusion Criteria:
1. Patients with severe cardiovascular and cerebrovascular diseases (such as myocardial
infarction, cerebral infarction, coronary heart disease, etc.);
2. Abnormal liver and kidney function (ALT or AST > 1.5 times the upper limit of normal,
or T-Bil > 1.5 times the upper limit of normal, or Cr more than the upper limit of
normal), hematopoietic system diseases and tumors;
3. Patients with a history of abdominal surgery (except appendectomy and
cholecystectomy);
4. Previous diagnosis of organic diseases of the digestive system, such as inflammatory
bowel disease, intestinal tuberculosis, etc., or still associated with peptic ulcer,
infectious diarrhea, etc.;
5. Previous diagnosis of diseases similar to irritable bowel syndrome symptoms, such as
eosinophilic enteritis, microscopic colitis (including collagen colitis and
lymphocytic colitis), lactose intolerance, malabsorption syndrome;
6. Previous diagnosis of non-intestinal digestive system diseases, such as tuberculous
peritonitis, gallstones, cirrhosis, chronic pancreatitis;
7. Previous diagnosis of diseases affecting the digestive tract function, such as
hyperthyroidism or hypothyroidism, endometriosis, autoimmune diseases, diabetes, etc.;
8. 4. Patients who have taken drugs with bleeding risk or increased bleeding risk before
treatment;
9. 4. Patients who have taken antidepressant drugs and psychotropic drugs before
treatment;
10. 4. Use drugs that affect gastrointestinal motility and function, such as prokinetic
drugs, anticholinergic drugs, calcium channel blockers, 5-HT receptor
agonists/antagonists, antidiarrheal agents, antacids, intestinal bacteria modulators
and antibiotics;
11. Allergic constitution;
12. Pregnant and lactating women; Others that may affect study compliance or adversely
affect the results as judged by the investigator.
|
NCT0531xxxx/NCT05311306.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/NCT05311306</url>
</required_header>
<id_info>
<org_study_id>D5980R00037</org_study_id>
<nct_id>NCT05311306</nct_id>
</id_info>
<brief_title>REported Outcomes in COPD With Trixeo in Real worlD in Germany</brief_title>
<acronym>RECORD</acronym>
<official_title>A Non-interventional, Multi-centre Study to Investigate the Change in Clinical and Patient-reported Outcomes in Moderate to Severe COPD Patients Treated With TRIXEO (Budesonide / Glycopyrronium / Formoterol) Under Real-life Conditions</official_title>
<sponsors>
<lead_sponsor>
<agency>AstraZeneca</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>AstraZeneca</source>
<brief_summary>
<textblock>
Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory
symptoms (including breathlessness, cough, and sputum production), which has a substantial
impact on health-related quality of life (HRQoL). Medical treatment of COPD aims to reduce
these symptoms, reduce exacerbations, and improve patients' ability to perform exercise and
daily activities. TRIXEO is a triple therapy indicated as a maintenance treatment in adult
patients with moderate-to-severe COPD who are not adequately treated by a combination of an
inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting
beta2-agonist and a long-acting muscarinic antagonist.

The RECORD study is a prospective, non-interventional study to be conducted in the United
Kingdom (UK) and Germany. The study aims to generate data to describe the real world
effectiveness of TRIXEO for patients with COPD who receive TRIXEO in routine clinical
practice. It also aims describe patients HRQoL, physical activity and treatment satisfaction,
and will explore patients' sleep quality and adherence to inhalers in the real-world. This
data may provide important information for practicing physicians.

The study will include approximately 500 patients with moderate to severe COPD from
approximately 50 sites (including hospitals and GP practices) in Germany. Patients eligible
for TRIXEO therapy may be enrolled by their treating physicians. The decision to treat with
TRIXEO must be independent of the study and made by the treating physician according to the
patients' medical need and local routine clinical practice. Patients' data will be collected
for 12 months after starting therapy with TRIXEO.

Demographic and clinical data will be extracted from patients' health care records. Patient
reported outcomes will be collected remotely by asking patients to answer questionnaires on
health status and HRQoL, physical activity, sleep quality, treatment satisfaction, and
inhaled medication adherence through electronic surveys.
</textblock>
</brief_summary>
<overall_status>Active, not recruiting</overall_status>
<start_date type="Actual">March 15, 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>Change from baseline in COPD Assessment Test (CAT) score after 3 months treatment</measure>
<time_frame>3 months</time_frame>
<description>To describe the change in COPD health status after 3 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment</description>
</primary_outcome>
<secondary_outcome>
<measure>Change from baseline in CAT score after 1, 6 and 12 months treatment</measure>
<time_frame>12 months</time_frame>
<description>Describe change in COPD health status after 1, 6 and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline in St George's Respiratory Questionnaire (SGRQ) score after 3 and 12 months treatment</measure>
<time_frame>12 months</time_frame>
<description>Describe change in health-related quality of life (HRQL) after 3 and 12 months vs baseline in eligible COPD patients initiated with TRIXEO treatment</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline in activity limitations, measured by CAT activity question/domain, after 1, 3 and 12 months of treatment</measure>
<time_frame>12 months</time_frame>
<description>Describe change in physical activity and activity limitation at 1, 3, and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline in activity limitations, measured by SGRQ activity question/domain, after 3 and 12 months of treatment</measure>
<time_frame>12 months</time_frame>
<description>Describe change in physical activity and activity limitation at 1, 3, and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment</description>
</secondary_outcome>
<secondary_outcome>
<measure>IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)© scores at baseline, 3 and 12 months</measure>
<time_frame>12 months</time_frame>
<description>Describe change in patient satisfaction with their inhalation device after 3 and 12 months vs baseline in eligible COPD patients initiated with TRIXEO treatment</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline in exacerbation rate (moderate, severe) after 6 and 12 months of treatment</measure>
<time_frame>12 months</time_frame>
<description>Describe change in physician-reported exacerbation rate (moderate and severe exacerbations) after 6 and 12 months vs baseline in eligible COPD patients initiated with TRIXEO treatment</description>
</secondary_outcome>
<enrollment type="Actual">466</enrollment>
<condition>Chronic Obstructive Pulmonary Disease</condition>
<eligibility>
<study_pop>
<textblock>
The source population for this study is patients with moderate to severe COPD and who have
been prescribed TRIXEO therapy in the primary care or hospital care setting may be enrolled
in this study. Patients meeting all the inclusion criteria and none of the exclusion
criteria may be enrolled by their physician.

The decision to start treatment with TRIXEO has to be made by the treating physician
according to the subjects' medical need and a positive benefit/risk balance. The decision
is not part of the study, lies with the treating physician and is taken according to the
standard of current best medical practice and national guidelines.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Physician-diagnosed COPD

- Having been prescribed treatment with TRIXEO according to label and local market
reimbursement criteria

- Patients must be able and willing to read and to comprehend written instructions, and
to comprehend and complete the questionnaires required by the protocol

- After full explanation, patients must have signed an informed consent document
indicating that they understand the purpose of and the procedures required for the
study and are willing to participate in the study.

Exclusion Criteria:

- COPD due to α-1 antitrypsin deficiency

- Previous treatment with any other triple fixed-dose combination during screening

- Hospitalisation due to COPD exacerbation within the last 4 weeks prior to enrolment

- Pregnancy or lactation period

- Participation in an observational trial that might, in the investigator's opinion,
influence the assessment for the current study, or participation in a randomised
clinical trial in the last 30 days.

- Patient still recovering from Covid-19 infection
</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>Research Site</name>
<address>
<city>Auerbach</city>
<zip>08209</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Augsburg</city>
<zip>86150</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Bad Neustadt a.d. Saale</city>
<zip>97616</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Bayreuth</city>
<zip>95445</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Beelitz</city>
<zip>14547</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Berlin</city>
<zip>10711</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Berlin</city>
<zip>10969</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Berlin</city>
<zip>12099</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Berlin</city>
<zip>12203</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Berlin</city>
<zip>12627</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Berlin</city>
<zip>13465</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Biberach</city>
<zip>88400</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Boeblingen</city>
<zip>71032</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Bremen</city>
<zip>28215</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Bremen</city>
<zip>28259</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Cottbus</city>
<zip>03050</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Darmstadt</city>
<zip>64283</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Doerfles-Esbach</city>
<zip>96487</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Dresden</city>
<zip>01324</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Duesseldorf</city>
<zip>40489</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Echterdingen</city>
<zip>70771</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Ehringshausen</city>
<zip>35630</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Filderstadt</city>
<zip>70794</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Flensburg</city>
<zip>24937</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Frankfurt</city>
<zip>60389</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Freiburg</city>
<zip>79104</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Fuerstenwalde</city>
<zip>15517</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Fuerth</city>
<zip>90762</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Halle</city>
<zip>06108</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Hamburg</city>
<zip>20354</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Hamburg</city>
<zip>22041</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Hattingen</city>
<zip>45525</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Ibbenbueren</city>
<zip>49477</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Kronach</city>
<zip>96317</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Laage</city>
<zip>18299</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Leipzig</city>
<zip>04103</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Marburg</city>
<zip>35037</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Marburrg</city>
<zip>35037</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Markkleeberg</city>
<zip>04416</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Nuernberg</city>
<zip>90408</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Nuernberg</city>
<zip>90478</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Nuernberg</city>
<zip>90489</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Peißenberg</city>
<zip>82380</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Potsdam</city>
<zip>14467</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Potsdam</city>
<zip>14478</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Rathenow</city>
<zip>14712</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Rendsburg</city>
<zip>24768</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Rosenheim</city>
<zip>83022</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Rostock</city>
<zip>18055</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Roth</city>
<zip>91154</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Saalfeld</city>
<zip>07318</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Saarlouis</city>
<zip>66740</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Schleswig</city>
<zip>24837</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Teuchern</city>
<zip>06682</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Treuchtlingen</city>
<zip>91757</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Ulm</city>
<zip>89073</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Weißenburg</city>
<zip>91781</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Wiesbaden</city>
<zip>65183</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Wilhelmshaven</city>
<zip>26388</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Witten</city>
<zip>58452</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Wuerzburg</city>
<zip>97070</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Research Site</name>
<address>
<city>Zirndorf</city>
<zip>90513</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location_countries>
<country>Germany</country>
</location_countries>
<verification_date>July 2023</verification_date>
<study_first_submitted>March 28, 2022</study_first_submitted>
<study_first_submitted_qc>March 28, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>July 27, 2023</last_update_submitted>
<last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">July 28, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Lung Diseases, Obstructive</keyword>
<keyword>Pulmonary Disease, Chronic Obstructive</keyword>
<keyword>Lung Diseases</keyword>
<keyword>Respiratory Tract Diseases</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Lung Diseases</mesh_term>
<mesh_term>Lung Diseases, Obstructive</mesh_term>
<mesh_term>Pulmonary Disease, Chronic Obstructive</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 are 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 de-identified 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.</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>
|
Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory
symptoms (including breathlessness, cough, and sputum production), which has a substantial
impact on health-related quality of life (HRQoL). Medical treatment of COPD aims to reduce
these symptoms, reduce exacerbations, and improve patients' ability to perform exercise and
daily activities. TRIXEO is a triple therapy indicated as a maintenance treatment in adult
patients with moderate-to-severe COPD who are not adequately treated by a combination of an
inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting
beta2-agonist and a long-acting muscarinic antagonist.
The RECORD study is a prospective, non-interventional study to be conducted in the United
Kingdom (UK) and Germany. The study aims to generate data to describe the real world
effectiveness of TRIXEO for patients with COPD who receive TRIXEO in routine clinical
practice. It also aims describe patients HRQoL, physical activity and treatment satisfaction,
and will explore patients' sleep quality and adherence to inhalers in the real-world. This
data may provide important information for practicing physicians.
The study will include approximately 500 patients with moderate to severe COPD from
approximately 50 sites (including hospitals and GP practices) in Germany. Patients eligible
for TRIXEO therapy may be enrolled by their treating physicians. The decision to treat with
TRIXEO must be independent of the study and made by the treating physician according to the
patients' medical need and local routine clinical practice. Patients' data will be collected
for 12 months after starting therapy with TRIXEO.
Demographic and clinical data will be extracted from patients' health care records. Patient
reported outcomes will be collected remotely by asking patients to answer questionnaires on
health status and HRQoL, physical activity, sleep quality, treatment satisfaction, and
inhaled medication adherence through electronic surveys.
The source population for this study is patients with moderate to severe COPD and who have
been prescribed TRIXEO therapy in the primary care or hospital care setting may be enrolled
in this study. Patients meeting all the inclusion criteria and none of the exclusion
criteria may be enrolled by their physician.
The decision to start treatment with TRIXEO has to be made by the treating physician
according to the subjects' medical need and a positive benefit/risk balance. The decision
is not part of the study, lies with the treating physician and is taken according to the
standard of current best medical practice and national guidelines.
Inclusion Criteria:
- Physician-diagnosed COPD
- Having been prescribed treatment with TRIXEO according to label and local market
reimbursement criteria
- Patients must be able and willing to read and to comprehend written instructions, and
to comprehend and complete the questionnaires required by the protocol
- After full explanation, patients must have signed an informed consent document
indicating that they understand the purpose of and the procedures required for the
study and are willing to participate in the study.
Exclusion Criteria:
- COPD due to α-1 antitrypsin deficiency
- Previous treatment with any other triple fixed-dose combination during screening
- Hospitalisation due to COPD exacerbation within the last 4 weeks prior to enrolment
- Pregnancy or lactation period
- Participation in an observational trial that might, in the investigator's opinion,
influence the assessment for the current study, or participation in a randomised
clinical trial in the last 30 days.
- Patient still recovering from Covid-19 infection
|
NCT0531xxxx/NCT05311319.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/NCT05311319</url>
</required_header>
<id_info>
<org_study_id>2021-GZWK-03</org_study_id>
<nct_id>NCT05311319</nct_id>
</id_info>
<brief_title>HAIC Combined With Anlotinib and TQB2450 as Adjuvant Therapy in HCC Patients With High Risk of Recurrence After Resection</brief_title>
<official_title>Hepatic Artery Infusion Chemotherapy(HAIC) Combined With Anlotinib and TQB2450 as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Resection</official_title>
<sponsors>
<lead_sponsor>
<agency>Fudan University</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>
This is a single center, non-randomized, open, multi-cohort clinical, exploratory Phase II
study, to evaluate the efficacy and safety of HAIC combined with TQB2450 and anlotinib as
adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after
resection.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The high incidence of HCC recurrence following liver resection is a serious issue. However,
no adjuvant therapy has been widely recognized at present. Interventional therapy and
systemic drug therapy are common treatment methods and effective treatment for liver cancer.
The combination of multiple drugs may reduce the recurrence in HCC patients with high-risk
recurrence. TQB2450 is a humanized monoclonal antibody of programmed death-ligand1 (PD-L1),
enabling T cells to restore immune activity and thus enhance the immune response. Anlotinib
is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and
proliferative signaling.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">January 11, 2022</start_date>
<completion_date type="Anticipated">December 2023</completion_date>
<primary_completion_date type="Anticipated">December 2022</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>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Disease Free Survival (DFS)</measure>
<time_frame>24 months</time_frame>
<description>DFS defined as the time from date of randomization until the date of recurrence or death due to any cause</description>
</primary_outcome>
<secondary_outcome>
<measure>Overall survival (OS)</measure>
<time_frame>24 months</time_frame>
<description>OS defined as the time from date of randomization until the date of death due to any cause</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time to recurrence (TTR)</measure>
<time_frame>24 months</time_frame>
<description>TTR defined as the time from date of randomization until the date of recurrence.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Safety: adverse events</measure>
<time_frame>24 months</time_frame>
<description>adverse events (AEs) categorized by severity in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">70</enrollment>
<condition>Hepatocarcinoma</condition>
<arm_group>
<arm_group_label>HAIC+Anlotinib (4 Cycles) +TQB2450 (4 Cycles)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>HAIC treatment was performed one month after surgery, and Anlotinib and TQB2450 for 4 cycles.</description>
</arm_group>
<arm_group>
<arm_group_label>HAIC+Anlotinib (8 Cycles) +TQB2450 (4 Cycles)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>HAIC treatment was performed one month after surgery, and Anlotinib for 8 cycles and TQB2450 for 4 cycles.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>HAIC+TQB2450+Anlotinib</intervention_name>
<description>HAIC: FOLFOX for 24hour perfusion chemotherapy. Anlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. TQB2450: 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle.</description>
<arm_group_label>HAIC+Anlotinib (4 Cycles) +TQB2450 (4 Cycles)</arm_group_label>
<arm_group_label>HAIC+Anlotinib (8 Cycles) +TQB2450 (4 Cycles)</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-1;

2. The expected survival is more than 3 months;

3. Histologically or cytologically diagnosed as HCC;

4. After hepatectomy, satisfy any of the following recurrence factors: a) microvascular
invasion (MVI); b) Single tumor diameter ≥ 8cm; c) The tumor grew infiltratively,
unclear boundary and no complete capsule; d) Multiple tumor nodules ≥3, or nodules<3
but the diameter of a single tumor is > 3cm; e) With portal vein, hepatic vein or
cholangiocarcinoma thrombus; f) tumor ruptured or invaded adjacent organs before
surgery.

5. hepatitis B virus (HBV) DNA<2000IU/mL;

6. Liver function status Child-Pugh grade A (≤6);

7. The main organs function well.

8. Laboratory inspection met the following criteria: Hemoglobin (Hb) ≥8.0 g/L,
Neutrophils (ANC) ≥ 1.5×10^9/L, Platelet count (PLT) ≥ 60×10^9/L, Total bilirubin
(TBIL) ≤3.0 mg/dL, albumin≥28 g/L, Aspartate aminotransferase (AST), alanine
aminotransferase (ALT) and alkaline phosphatase≤ 5.0 ×upper limit of normal,
International Prothrombin Standardization Ratio (INR) ≤ 2.3, Thyroid-stimulating
hormone (TSH) ≤upper limit of normal;

9. The woman patients of childbearing age who must agree to take contraceptive methods
during the research and within another 6 months after it; who are not in the lactation
period and examined as negative in blood serum test or urine pregnancy test within 7
days before the research; The man patients who must agree to take contraceptive
methods during the research and within another 6 months after it.

10. Voluntary participation and written informed consent;

Exclusion Criteria:

1. History of another malignancy tumor , except for the cured skin basal cell carcinoma
and cervical carcinoma in situ)

2. Other adjuvant therapy after surgery, such as targeted drugs, programmed death-1
(PD-1) antibody and other immunotherapy, FOLFOX systemic chemotherapy;

3. The imaging examination showed residual tumor after the surgical resection;

4. Patients with previous liver transplantation or preparation for liver transplantation.

5. Patients who are allergic to components of TQB2450 and anlotinib or pharmaceutical
excipients;

6. Received any live attenuated vaccine within 4 weeks of admission or during the study
period;

7. Patients with a history of immunodeficiency (or autoimmune disease), or other acquired
congenital immunodeficiency diseases.

8. Hypertension which cannot be well controlled by antihypertensive drugs (systolic blood
pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg).

9. A history of gastrointestinal bleeding within 3 months before enrollment;

10. A history of arterial and venous thrombotic events within 6 months before enrollment,
such as cerebrovascular accidents (including transient ischemic attack, cerebral
hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;

11. Hereditary or acquired hemorrhagic and thrombotic tendencies, such as hemophilia,
coagulation dysfunction, thrombocytopenia, hypersplenism, etc.

12. Pts need to long-term anticoagulant therapy;

13. Participated in any other drug clinical studies within 3 months before enrollment;

14. A history of psychotropic substance abuse or drug abuse;

15. Patients with concomitant diseases which could seriously endanger their own safety or
could affect the completion of the study according to investigators' judgment;
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Lu Wang, PhD</last_name>
<phone>+86-18121299357</phone>
<email>w.lr@hotmail.com</email>
</overall_contact>
<location>
<facility>
<name>Fudan University Shanghai Cancer Center</name>
<address>
<city>Shanghai</city>
<zip>200062</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Lu Wang, M.D.</last_name>
<phone>+86-18121299357</phone>
<email>w.lr@hotmail.com</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 27, 2022</study_first_submitted>
<study_first_submitted_qc>March 27, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>March 27, 2022</last_update_submitted>
<last_update_submitted_qc>March 27, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 5, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Fudan University</investigator_affiliation>
<investigator_full_name>Lu Wang, MD, PhD</investigator_full_name>
<investigator_title>Head of liver surgery department</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Carcinoma, Hepatocellular</mesh_term>
<mesh_term>Recurrence</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This is a single center, non-randomized, open, multi-cohort clinical, exploratory Phase II
study, to evaluate the efficacy and safety of HAIC combined with TQB2450 and anlotinib as
adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after
resection.
The high incidence of HCC recurrence following liver resection is a serious issue. However,
no adjuvant therapy has been widely recognized at present. Interventional therapy and
systemic drug therapy are common treatment methods and effective treatment for liver cancer.
The combination of multiple drugs may reduce the recurrence in HCC patients with high-risk
recurrence. TQB2450 is a humanized monoclonal antibody of programmed death-ligand1 (PD-L1),
enabling T cells to restore immune activity and thus enhance the immune response. Anlotinib
is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and
proliferative signaling.
Inclusion Criteria:
1. Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-1;
2. The expected survival is more than 3 months;
3. Histologically or cytologically diagnosed as HCC;
4. After hepatectomy, satisfy any of the following recurrence factors: a) microvascular
invasion (MVI); b) Single tumor diameter ≥ 8cm; c) The tumor grew infiltratively,
unclear boundary and no complete capsule; d) Multiple tumor nodules ≥3, or nodules<3
but the diameter of a single tumor is > 3cm; e) With portal vein, hepatic vein or
cholangiocarcinoma thrombus; f) tumor ruptured or invaded adjacent organs before
surgery.
5. hepatitis B virus (HBV) DNA<2000IU/mL;
6. Liver function status Child-Pugh grade A (≤6);
7. The main organs function well.
8. Laboratory inspection met the following criteria: Hemoglobin (Hb) ≥8.0 g/L,
Neutrophils (ANC) ≥ 1.5×10^9/L, Platelet count (PLT) ≥ 60×10^9/L, Total bilirubin
(TBIL) ≤3.0 mg/dL, albumin≥28 g/L, Aspartate aminotransferase (AST), alanine
aminotransferase (ALT) and alkaline phosphatase≤ 5.0 ×upper limit of normal,
International Prothrombin Standardization Ratio (INR) ≤ 2.3, Thyroid-stimulating
hormone (TSH) ≤upper limit of normal;
9. The woman patients of childbearing age who must agree to take contraceptive methods
during the research and within another 6 months after it; who are not in the lactation
period and examined as negative in blood serum test or urine pregnancy test within 7
days before the research; The man patients who must agree to take contraceptive
methods during the research and within another 6 months after it.
10. Voluntary participation and written informed consent;
Exclusion Criteria:
1. History of another malignancy tumor , except for the cured skin basal cell carcinoma
and cervical carcinoma in situ)
2. Other adjuvant therapy after surgery, such as targeted drugs, programmed death-1
(PD-1) antibody and other immunotherapy, FOLFOX systemic chemotherapy;
3. The imaging examination showed residual tumor after the surgical resection;
4. Patients with previous liver transplantation or preparation for liver transplantation.
5. Patients who are allergic to components of TQB2450 and anlotinib or pharmaceutical
excipients;
6. Received any live attenuated vaccine within 4 weeks of admission or during the study
period;
7. Patients with a history of immunodeficiency (or autoimmune disease), or other acquired
congenital immunodeficiency diseases.
8. Hypertension which cannot be well controlled by antihypertensive drugs (systolic blood
pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg).
9. A history of gastrointestinal bleeding within 3 months before enrollment;
10. A history of arterial and venous thrombotic events within 6 months before enrollment,
such as cerebrovascular accidents (including transient ischemic attack, cerebral
hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
11. Hereditary or acquired hemorrhagic and thrombotic tendencies, such as hemophilia,
coagulation dysfunction, thrombocytopenia, hypersplenism, etc.
12. Pts need to long-term anticoagulant therapy;
13. Participated in any other drug clinical studies within 3 months before enrollment;
14. A history of psychotropic substance abuse or drug abuse;
15. Patients with concomitant diseases which could seriously endanger their own safety or
could affect the completion of the study according to investigators' judgment;
|
NCT0531xxxx/NCT05311332.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/NCT05311332</url>
</required_header>
<id_info>
<org_study_id>FUE.REC (23)\11-2021</org_study_id>
<nct_id>NCT05311332</nct_id>
</id_info>
<brief_title>Computer-guided vs. Conventional Cortical Shell Technique for Horizontal Augmentation</brief_title>
<official_title>Assessment of Horizontal Bone Gain Using Computer-guided vs. Conventional Cortical Shell Technique for Horizontal Maxillary Alveolar Ridge Augmentation</official_title>
<sponsors>
<lead_sponsor>
<agency>Future University in Egypt</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Future University in Egypt</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 aims to evaluate horizontal bone augmentation achieved at the anterior maxilla
using computer-guided cortical shell bone technique and accuracy of fixation of the bone
shell away from the atrophic ridge by a calculated distance which is always a challenging
step for inexperienced surgeons to fix a cortical shell at the ideal position in the
conventional protocol it was never guided to be precisely fixed at the proper position and
angulation the problem is if it fixed with insufficient distance with proposed volume loss
leads to totally insufficient volume gain for future implant placement also to evaluate the
efficacy of the CAD/CAM surgical guide during chin harvesting procedures in reducing the risk
of anatomical structure damage and patient morbidity with more accuracy compared with the
standard technique. this trial versus free hand conventional cortical shell bone technique
both harvested from symphysis area (chin).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Tooth extraction may be due to a variety of causes such as badly decayed, periodontal
disease, and trauma whatever the reason tooth loss is always followed by loss of masticatory
force and muscle stimulation to the alveolar bone so according to Wolff's Law (Wolff, 1892)
loss of mechanical stimulation is followed by the reduction of bone mass.

Several surgical protocols have been used to manage horizontal maxillary alveolar bone
atrophy such as bone splitting and bone spreading techniques with or without filling the
created space, onlay bone graft, guided bone regeneration using resorbable or non-resorbable
membrane, distraction osteogenesis, and shell bone block technique which use a thin cortical
bone shell to reshape the atrophied ridge and protect the particulate bone graft.

Despite the popularity of this technique, it usually requires high surgical skills, prolonged
intra-operative time, and unfortunately has some technical drawbacks. Such as lack of
anatomical guidance during bone harvesting which may lead to injury to the important vital
structure and lack of guidance during fixation may lead to improperly positioned, tilted, or
rotated shell or even leaving an undesired distance between the shell and deficient ridge

With the increasing use of cone-beam computed tomography (CBCT), intra and extra oral scanner
for patient data acquisition, and complete digital workflow in clinical practice and it is
rapidly becoming the standard of care in dentistry. Regarding bone augmentation as
preparation for future implant placement. computer-aided surgery has been an innovation that
enables clinicians to have firm and accurate treatment planning. Also, milling or 3D printing
methods allow variable techniques for the fabrication of surgical templates.

This study aims to fully digitalize such technique using patient-specific surgical guides to
allow for accurate graft harvesting and positioning and to minimize intraoperative time and
complications associated with this procedure
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">October 13, 2021</start_date>
<completion_date type="Actual">November 1, 2022</completion_date>
<primary_completion_date type="Actual">August 20, 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>Alveolar ridge horizontal net bone gain</measure>
<time_frame>4 months</time_frame>
<description>volumetric change of deficient alveolar ridge after augmentation</description>
</primary_outcome>
<secondary_outcome>
<measure>surgical procedure accuracy</measure>
<time_frame>immediate post operative</time_frame>
<description>depening on the superimposition between immediate postoperative CBCT scan over planning</description>
</secondary_outcome>
<secondary_outcome>
<measure>intraoperation time</measure>
<time_frame>at time of surgery</time_frame>
<description>duration of surgery</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">14</enrollment>
<condition>Alveolar Bone Resorption</condition>
<condition>Horizontal Ridge Deficiency</condition>
<arm_group>
<arm_group_label>Anterior maxillary bone augmentation using computer guided autogenous cortical shell technique.</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>a patient-specific guide was used to harvest a chin cortical shell which was also prepared and positioned at the (anterior horizontally atrophied maxilla) recipient site using another patient-specific positioning guide.</description>
</arm_group>
<arm_group>
<arm_group_label>Anterior maxilla bone augmentation using free hand autogenous cortical shell technique.</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>the horizontally atrophic anterior maxilla was augmented with a cortical shell technique the bone was harvested from the chin without a patient-specific guide.</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin</intervention_name>
<description>Augmentation of horizontal deficient anterior maxilla using the conventional protocol of cortical shell technique</description>
<arm_group_label>Anterior maxilla bone augmentation using free hand autogenous cortical shell technique.</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guide</intervention_name>
<description>using a patient-specific surgical guide to harvest bone cortical shell from the chin and another patient-specific surgical guide to fix it in the atrophied maxillary anterior area</description>
<arm_group_label>Anterior maxillary bone augmentation using computer guided autogenous cortical shell technique.</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- patient free from any systemic condition.

- Edentulous anterior maxilla with a horizontal deficient alveolar ridge that is less
than 4 mm measured from outer buccal cortices to outer palatal cortices.

- Highly motivated patients are willing for the surgical procedure and follow-up, with
informed consent.

Exclusion Criteria:

- Intra bony lesions (e.g. Cysts) or infections(e.g.abcess) that may retard the
osteotomy healing.

- Medically compromised patients.

- Uncooperative patients.

- Patients with any diseases or taking any medications that compromise bone healing
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>20 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Dina Ayman Fayek, BDS</last_name>
<role>Principal Investigator</role>
<affiliation>teaching assistant oral and maxillofacial department future university in Egypt</affiliation>
</overall_official>
<location>
<facility>
<name>future university in Egypt, faculty of dentistry</name>
<address>
<city>Cairo</city>
<country>Egypt</country>
</address>
</facility>
</location>
<location_countries>
<country>Egypt</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 27, 2022</study_first_submitted>
<study_first_submitted_qc>March 27, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 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>Future University in Egypt</investigator_affiliation>
<investigator_full_name>Dina Ayman</investigator_full_name>
<investigator_title>assistant lecturer</investigator_title>
</responsible_party>
<keyword>alveolar ridge deficiency</keyword>
<keyword>computer guided surgery</keyword>
<keyword>chin graft</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Bone Resorption</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
<ipd_description>the data will be available from the corresponding author upon resonable request.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
this study aims to evaluate horizontal bone augmentation achieved at the anterior maxilla
using computer-guided cortical shell bone technique and accuracy of fixation of the bone
shell away from the atrophic ridge by a calculated distance which is always a challenging
step for inexperienced surgeons to fix a cortical shell at the ideal position in the
conventional protocol it was never guided to be precisely fixed at the proper position and
angulation the problem is if it fixed with insufficient distance with proposed volume loss
leads to totally insufficient volume gain for future implant placement also to evaluate the
efficacy of the CAD/CAM surgical guide during chin harvesting procedures in reducing the risk
of anatomical structure damage and patient morbidity with more accuracy compared with the
standard technique. this trial versus free hand conventional cortical shell bone technique
both harvested from symphysis area (chin).
Tooth extraction may be due to a variety of causes such as badly decayed, periodontal
disease, and trauma whatever the reason tooth loss is always followed by loss of masticatory
force and muscle stimulation to the alveolar bone so according to Wolff's Law (Wolff, 1892)
loss of mechanical stimulation is followed by the reduction of bone mass.
Several surgical protocols have been used to manage horizontal maxillary alveolar bone
atrophy such as bone splitting and bone spreading techniques with or without filling the
created space, onlay bone graft, guided bone regeneration using resorbable or non-resorbable
membrane, distraction osteogenesis, and shell bone block technique which use a thin cortical
bone shell to reshape the atrophied ridge and protect the particulate bone graft.
Despite the popularity of this technique, it usually requires high surgical skills, prolonged
intra-operative time, and unfortunately has some technical drawbacks. Such as lack of
anatomical guidance during bone harvesting which may lead to injury to the important vital
structure and lack of guidance during fixation may lead to improperly positioned, tilted, or
rotated shell or even leaving an undesired distance between the shell and deficient ridge
With the increasing use of cone-beam computed tomography (CBCT), intra and extra oral scanner
for patient data acquisition, and complete digital workflow in clinical practice and it is
rapidly becoming the standard of care in dentistry. Regarding bone augmentation as
preparation for future implant placement. computer-aided surgery has been an innovation that
enables clinicians to have firm and accurate treatment planning. Also, milling or 3D printing
methods allow variable techniques for the fabrication of surgical templates.
This study aims to fully digitalize such technique using patient-specific surgical guides to
allow for accurate graft harvesting and positioning and to minimize intraoperative time and
complications associated with this procedure
Inclusion Criteria:
- patient free from any systemic condition.
- Edentulous anterior maxilla with a horizontal deficient alveolar ridge that is less
than 4 mm measured from outer buccal cortices to outer palatal cortices.
- Highly motivated patients are willing for the surgical procedure and follow-up, with
informed consent.
Exclusion Criteria:
- Intra bony lesions (e.g. Cysts) or infections(e.g.abcess) that may retard the
osteotomy healing.
- Medically compromised patients.
- Uncooperative patients.
- Patients with any diseases or taking any medications that compromise bone healing
|
NCT0531xxxx/NCT05311345.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/NCT05311345</url>
</required_header>
<id_info>
<org_study_id>Cryobiopsy 250</org_study_id>
<nct_id>NCT05311345</nct_id>
</id_info>
<brief_title>Integration of Cryobiopsies for ILD Diagnoses- Experience Based on 250 Biopsy Procedures.</brief_title>
<official_title>Integration of Cryobiopsies for ILD Diagnoses- Experience Based on 250 Biopsy Procedures.</official_title>
<sponsors>
<lead_sponsor>
<agency>Aarhus University Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Aarhus</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>
A retrospective study on safety and Diagnostic yield in using cryobiopsies as a Diagnostic
tool in diagnosing patients under investigation for Interstitial lung diseases. This includes
a registration of procedural techniques, complications ( pneumthorax, hemorrhage,
exacerbation and mortalt), days admitted at the hospital, diagnoses and diagnostic yield.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">November 6, 2015</start_date>
<completion_date type="Actual">April 1, 2020</completion_date>
<primary_completion_date type="Actual">September 10, 2019</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>Retrospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Pneumothorax</measure>
<time_frame>2 weeks</time_frame>
<description>Pneumothorax, hemorrhage, acute exacerbation and death</description>
</primary_outcome>
<primary_outcome>
<measure>Hemorrhage</measure>
<time_frame>3 days</time_frame>
<description>Hemorrhage during the procedure</description>
</primary_outcome>
<primary_outcome>
<measure>Acute exacerbation</measure>
<time_frame>100 days</time_frame>
<description>Acute exacerbation after the procedure</description>
</primary_outcome>
<primary_outcome>
<measure>Mortality</measure>
<time_frame>100 days</time_frame>
<description>Mortality after the procedure</description>
</primary_outcome>
<secondary_outcome>
<measure>Diagnostic yield</measure>
<time_frame>1 month</time_frame>
<description>Diagnostic yield is discussed at multidisciplinary team meetings i.e, adequate biopsies (>50% alveolated biopsies), histologic pattern, kontribution to the diagnosis.</description>
</secondary_outcome>
<enrollment type="Actual">250</enrollment>
<condition>Interstitial Lung Disease</condition>
<eligibility>
<study_pop>
<textblock>
Patients under investigation for Interstitial lung diseases that were having cryobiopsies
performed.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- >18years of age

- suspected of Interstitial lung Disease

- cryobiopsies performed.

Exclusion Criteria:

- FVC below 50% of predicted

- DLCO below 35%

- Body Mass Index (BMI) above 35

- pulmonary hypertension with a tricuspidal gradient above 40 mmHg

- other cardiac or other comorbidities that would increase the risk of complications
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<verification_date>March 2022</verification_date>
<study_first_submitted>April 17, 2020</study_first_submitted>
<study_first_submitted_qc>March 27, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>March 27, 2022</last_update_submitted>
<last_update_submitted_qc>March 27, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 5, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
<investigator_full_name>Sissel Kronborg-White</investigator_full_name>
<investigator_title>MD, principal investigator</investigator_title>
</responsible_party>
<keyword>Cryobiopsy</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Lung Diseases</mesh_term>
<mesh_term>Lung Diseases, Interstitial</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
<ipd_description>Participant data and study Protocol can be shared with other researcher upon reasonable request.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
A retrospective study on safety and Diagnostic yield in using cryobiopsies as a Diagnostic
tool in diagnosing patients under investigation for Interstitial lung diseases. This includes
a registration of procedural techniques, complications ( pneumthorax, hemorrhage,
exacerbation and mortalt), days admitted at the hospital, diagnoses and diagnostic yield.
Patients under investigation for Interstitial lung diseases that were having cryobiopsies
performed.
Inclusion Criteria:
- >18years of age
- suspected of Interstitial lung Disease
- cryobiopsies performed.
Exclusion Criteria:
- FVC below 50% of predicted
- DLCO below 35%
- Body Mass Index (BMI) above 35
- pulmonary hypertension with a tricuspidal gradient above 40 mmHg
- other cardiac or other comorbidities that would increase the risk of complications
|
NCT0531xxxx/NCT05311358.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/NCT05311358</url>
</required_header>
<id_info>
<org_study_id>MURA2021/768</org_study_id>
<nct_id>NCT05311358</nct_id>
</id_info>
<brief_title>The Engineer-Built System, Video-Game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children</brief_title>
<official_title>The Engineer-Built System, Video-Game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children</official_title>
<sponsors>
<lead_sponsor>
<agency>Mahidol University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Warakorn Charoensuk</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Apiphan Iamchaimongkol</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Tulyapruek Tawonsawatruk</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Mahidol 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>
There are 3 phases of this project. First phase is to study the satisfaction in healthy
children aged 10-15 years old when they are playing our computer games. The sample size of
this phase was 10. In addition, we will ask the occupational therapist to play and comment
our game for further development.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">May 10, 2022</start_date>
<completion_date type="Actual">June 21, 2022</completion_date>
<primary_completion_date type="Actual">June 21, 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>In the first phase, we will test our video-game based Kinect sensor in healthy children aged 10-12 years old. The healthy children and the occupational therapists have to reply the satisfaction form and comment our game for further improvement. The sample size of this phase is 10.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>satisfaction form</measure>
<time_frame>immediately after playing game</time_frame>
<description>The satisfaction form will be evaluated by healthy children. The satisfaction form will ask the children to rate the games in the following subjects: the presentation of game, the contents of game, the convenience for users the feeling after playing and the further suggestion about the games. There are 5-likert-scale in the satisfaction form: totally disagree, disagree, neutral, agree and totally agree.</description>
</primary_outcome>
<secondary_outcome>
<measure>Satisfaction form</measure>
<time_frame>immediately after playing game</time_frame>
<description>The satisfaction form will be evaluated by occupational therapists. The satisfaction form will ask the therapist to rate the games in the following subjects: the presentation of game, the contents of game, the convenience for users the feeling after playing and the further suggestion about the games. There are 5-likert-scale in the satisfaction form: totally disagree, disagree, neutral, agree and totally agree.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">10</enrollment>
<condition>Cerebral Palsy</condition>
<arm_group>
<arm_group_label>Normal children</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Normal children aged 10-15 years play the game and comment on the satisfaction form</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>The engineer-built system, video-game based Kinect sensor</intervention_name>
<description>There are 3 computer games using Kinect sensor to detect movement of trunk and upper extremities of the children.</description>
<arm_group_label>Normal children</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Normal children aged 10-15 years

- Sufficient cognitive/attention capacity

- Give the informed consent

Exclusion Criteria:

- Inability to understand the instruction and follow the task

- Has severe visual or auditory impairment

- Has limb deformities that interfere with video game playing

- Got an epilepsy or convulsive condition

- Denied to give the informed consent
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>10 Years</minimum_age>
<maximum_age>15 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Faculty of Medicine Ramathibodi Hospital Mahidol University</name>
<address>
<city>Bangkok</city>
<zip>10400</zip>
<country>Thailand</country>
</address>
</facility>
</location>
<location_countries>
<country>Thailand</country>
</location_countries>
<reference>
<citation>Arneson CL, Durkin MS, Benedict RE, Kirby RS, Yeargin-Allsopp M, Van Naarden Braun K, Doernberg NS. Prevalence of cerebral palsy: Autism and Developmental Disabilities Monitoring Network, three sites, United States, 2004. Disabil Health J. 2009 Jan;2(1):45-8. doi: 10.1016/j.dhjo.2008.08.001.</citation>
<PMID>21122742</PMID>
</reference>
<reference>
<citation>Bhasin TK, Brocksen S, Avchen RN, Van Naarden Braun K. Prevalence of four developmental disabilities among children aged 8 years--Metropolitan Atlanta Developmental Disabilities Surveillance Program, 1996 and 2000. MMWR Surveill Summ. 2006 Jan 27;55(1):1-9. Erratum In: MMWR Morb Mortal Wkly Rep. 2006 Feb 3;55(4):105-6.</citation>
<PMID>16437058</PMID>
</reference>
<reference>
<citation>Paneth N, Hong T, Korzeniewski S. The descriptive epidemiology of cerebral palsy. Clin Perinatol. 2006 Jun;33(2):251-67. doi: 10.1016/j.clp.2006.03.011.</citation>
<PMID>16765723</PMID>
</reference>
<reference>
<citation>Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40.</citation>
<PMID>12227618</PMID>
</reference>
<reference>
<citation>Chen YP, Lee SY, Howard AM. Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. Pediatr Phys Ther. 2014 Fall;26(3):289-300. doi: 10.1097/PEP.0000000000000046.</citation>
<PMID>24819682</PMID>
</reference>
<reference>
<citation>7. Samia Abdel Rahman, Abdel Rahman, Afaf A. Shaheen. Virtual Reality Use in Motor Rehabilitation of Neurological Disorders: A Systematic Review. Middle-East Journal of Scientific Research; 7 (1): 63-70.</citation>
</reference>
<reference>
<citation>Chen YP, Kang LJ, Chuang TY, Doong JL, Lee SJ, Tsai MW, Jeng SF, Sung WH. Use of virtual reality to improve upper-extremity control in children with cerebral palsy: a single-subject design. Phys Ther. 2007 Nov;87(11):1441-57. doi: 10.2522/ptj.20060062. Epub 2007 Sep 25.</citation>
<PMID>17895352</PMID>
</reference>
<reference>
<citation>Green D, Wilson PH. Use of virtual reality in rehabilitation of movement in children with hemiplegia--a multiple case study evaluation. Disabil Rehabil. 2012;34(7):593-604. doi: 10.3109/09638288.2011.613520. Epub 2011 Oct 6.</citation>
<PMID>21978233</PMID>
</reference>
<reference>
<citation>Pruksananonda C. Cerebral palsy. In: Prasongjean P, editor. Cerebral Palsy. Bangkok: Chulolongkorn University Printing House; 2010. p. 1-3.</citation>
</reference>
<verification_date>June 2022</verification_date>
<study_first_submitted>March 8, 2022</study_first_submitted>
<study_first_submitted_qc>April 3, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>June 21, 2022</last_update_submitted>
<last_update_submitted_qc>June 21, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">June 24, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Mahidol University</investigator_affiliation>
<investigator_full_name>Sivaporn Vongpipatana</investigator_full_name>
<investigator_title>Assistant Professor</investigator_title>
</responsible_party>
<keyword>video-game based Kinect sensor</keyword>
<keyword>upper extremities</keyword>
<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>Yes</sharing_ipd>
<ipd_description>I will share the information on satisfaction form with the engineers who developed game for game improvement.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
<ipd_time_frame>The study protocol will be share among the researcher team during study period. The statistical analysis plan will be share with the statistician during the analysis and summarize period.</ipd_time_frame>
<ipd_access_criteria>using code number of the participants</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
There are 3 phases of this project. First phase is to study the satisfaction in healthy
children aged 10-15 years old when they are playing our computer games. The sample size of
this phase was 10. In addition, we will ask the occupational therapist to play and comment
our game for further development.
Inclusion Criteria:
- Normal children aged 10-15 years
- Sufficient cognitive/attention capacity
- Give the informed consent
Exclusion Criteria:
- Inability to understand the instruction and follow the task
- Has severe visual or auditory impairment
- Has limb deformities that interfere with video game playing
- Got an epilepsy or convulsive condition
- Denied to give the informed consent
|
NCT0531xxxx/NCT05311371.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/NCT05311371</url>
</required_header>
<id_info>
<org_study_id>2022.065.IRB1.034</org_study_id>
<nct_id>NCT05311371</nct_id>
</id_info>
<brief_title>The Effect of Breathing Exercise on Chemotherapy-induced Nausea and Vomiting in With Autologous Hematopoietic Stem Cell Transplantation Patients</brief_title>
<official_title>The Effect of Breathing Exercise on Chemotherapy-induced Nausea and Vomiting in With Autologous Hematopoietic Stem Cell Transplantation Patients</official_title>
<sponsors>
<lead_sponsor>
<agency>Istanbul University - Cerrahpasa (IUC)</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Koc University Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Istanbul University - Cerrahpasa (IUC)</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>
Nausea and vomiting are serious problems in patients undergoing autologous stem cell
transplantation. It is stated that the incidence of acute and delayed nausea and vomiting is
more than 50%, even if the patient has been given antiemetic prophylaxis during the treatment
process.

Breathing is the easiest relaxation exercise applied during the flow in everyday life and
also one of the most important and essential parts of other relaxation exercise. The
handbooks prepared for the patients undergoing chemotherapy recommend deep breathing
exercises in order to prevent their nausea and vomiting.

The aim of this study is to determine the effect of respiratory exercise on
chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell
transplantation.

Research Hypotheses Ho: Respiratory exercise is not effective in preventing
chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant
patients.

H1: Respiratory exercise is effective in preventing chemotherapy-associated nausea and
vomiting in autologous hematopoietic stem cell transplant patients.

In the literature, no study has been found investigating the effect of breathing exercises on
chemotherapy-induced nausea and vomiting for autologous hematopoietic stem cell
transplantation patients.

The aim of this study is to determine the effect of respiratory exercise on
chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell
transplantation.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 1, 2022</start_date>
<completion_date type="Anticipated">May 1, 2023</completion_date>
<primary_completion_date type="Anticipated">March 3, 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>Randomized controlled trial</intervention_model_description>
<primary_purpose>Prevention</primary_purpose>
<masking>Single (Participant)</masking>
<masking_description>All of the participants were blinded to the randomization procedure.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Patient Information Form</measure>
<time_frame>Baseline</time_frame>
<description>Patient Information Form is a form prepared to determine the sociodemographic and disease-related characteristics of the patients. Sociodemographic characteristics of patient are composed of height, age, weight, educational status, social security, occupation, marital status, nutritional habits, smoking and alcohol use. Patient Information Form have general information about the patients such as diagnosis, duration, stage, and metastasis status of the disease, antiemetic drugs and treatment history. Disease history of cancer is , nausea-vomiting complaints before chemotherapy, the presence of any non-pharmacological method used to reduce nausea and vomiting induced by chemotherapy drugs.</description>
</primary_outcome>
<secondary_outcome>
<measure>Rhodes Index of Nausea, Vomiting ve Retching</measure>
<time_frame>Baseline and 14 days</time_frame>
<description>Responses to each item are classified by using expressions appropriate to the item and scoring the severity of the nausea-vomiting-retching experience from 0 to 4. There are eight items in this scale that evaluate the experience, frequency and distress of nausea-vomiting and retching. The increase in score reflects worsening of the complaint experienced.</description>
</secondary_outcome>
<other_outcome>
<measure>Daily Nutritional Consumption Amount Form</measure>
<time_frame>Baseline and 14 days</time_frame>
<description>The amount of consumption of the patient in the morning, lunch, evening and snacks will be recorded before the treatment and throughout the study. The patient's antiemetic treatment, enteral and parenteral nutrition will be recorded daily in the follow-up form.</description>
</other_outcome>
<other_outcome>
<measure>Patient Nausea And Vomiting Episode Follow-Up Form</measure>
<time_frame>Baseline and 14 days</time_frame>
<description>This follow-up chart was created by the researcher in order to evaluate the severity and episode of nausea and vomiting symptom during chemotherapy treatment and post-transplantation in patients with autologous hematopoietic stem cell transplantation. The scale consists of a 100 mm/10 cm long horizontal line. On the left end of the line, there is 0 "No nausea" statement, while on the right end there is 10 "Nausea is very severe" statement.
The patient will be asked to mark the point on the line that will accurately reflect his or her nausea state. In addition, the patient will be asked to write down the number of nausea and vomiting numerically.</description>
</other_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">60</enrollment>
<condition>Chemotherapy-induced Nausea and Vomiting</condition>
<arm_group>
<arm_group_label>Breathing exercise group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The researcher will collect the data using Patient Information Form, Rhodes Index of Nausea, Vomiting and Retching Scale, Patient Diary for determining the number of nausea, vomiting, and retching episodes and the hours of breathing exercise of the patient, and Daily Nutritional Consumption Amount Form through face-to-face interview technique on the first day and for 14 days.
During chemotherapy and stem cell transplantation, antiemetic treatment included in the treatment protocol will be applied to the patients.
The patients will train about the application of breathing exercise by the researcher. They will be asked to do this breathing exercise with the guideline for at least 5 min in case of sensation of nausea and vomiting for 14 days.</description>
</arm_group>
<arm_group>
<arm_group_label>Control group</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>The researcher will collect the data using Patient Information Form, Rhodes Index of Nausea, Vomiting and Retching Scale, Patient Diary for determining the number of nausea, vomiting, and retching episodes and the hours of breathing exercise of the patient, and Daily Nutritional Consumption Amount Form through face-to-face interview technique on the first day. The researcher will continue to fill out Rhodes Index of Nausea, Vomiting and Retching Scale, Patient Diary for determining the number of nausea, vomiting, and retching episodes and the hours of breathing exercise of the patient, and Daily Nutritional Consumption Amount Form for 14 days.
During chemotherapy and stem cell transplantation, antiemetic treatment included in the treatment protocol will be applied to the patients.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Breathing exercise group</intervention_name>
<description>The exercise was applied in accordance with the "Guideline on Breathing Exercise for Reducing Nausea and Vomiting" prepared by the researcher in accordance with the literature. In addition, the researcher has a breath coaching certificate. The guideline include the application steps of breathing exercise. First, the researcher will demonstrate to the patients the practice of breathing exercise in accordance with the guideline. In the next step, patients they will be asked to do this application on themselves. The training is planned to take about 15-20 minutes for each patient. This guide will be given to patients after the training. They will be asked to do this breathing exercise correctly and effectively in accordance with the guideline for at least 5 min in case of sensation of nausea and vomiting for 14 days. The researcher will follow up the patients for 14 days by visiting room them every day.</description>
<arm_group_label>Breathing exercise group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Control group</intervention_name>
<description>No intervention</description>
<arm_group_label>Control group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Least 18-years-old,

- Autologous hematopoietic stem cell transplantation and take high-dose chemotherapy,

- not have any communicative problems,

- not have Coronavirus disease (COVID-19) disease or respiratory disease,

- Hb value of 10 and above and

- knowing how to read, write, and speak Turkish

Exclusion Criteria:

- have respiratory disease and Coronavirus disease (COVID-19),

- having any communication and psychiatric problem,

- not knowing how to read, write, and speak Turkish,

- not wanting to participate in the study and have anemia.
</textblock>
</criteria>
<gender>All</gender>
<gender_based>Yes</gender_based>
<gender_description>least 18-years-old</gender_description>
<minimum_age>18 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Koç University Hospital</name>
<address>
<city>Istanbul</city>
<zip>34025</zip>
<country>Turkey</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Zeliha GENÇ</last_name>
<phone>90-554-376-10-53</phone>
<email>zakbulut@ku.edu.tr</email>
</contact>
<investigator>
<last_name>Zeliha Genç</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<results_reference>
<citation>Cohen L, de Moor CA, Eisenberg P, Ming EE, Hu H. Chemotherapy-induced nausea and vomiting: incidence and impact on patient quality of life at community oncology settings. Support Care Cancer. 2007 May;15(5):497-503. doi: 10.1007/s00520-006-0173-z. Epub 2006 Nov 14.</citation>
<PMID>17103197</PMID>
</results_reference>
<results_reference>
<citation>Haiderali A, Menditto L, Good M, Teitelbaum A, Wegner J. Impact on daily functioning and indirect/direct costs associated with chemotherapy-induced nausea and vomiting (CINV) in a U.S. population. Support Care Cancer. 2011 Jun;19(6):843-51. doi: 10.1007/s00520-010-0915-9. Epub 2010 Jun 9.</citation>
<PMID>20532923</PMID>
</results_reference>
<results_reference>
<citation>Roila F, Molassiotis A, Herrstedt J, Aapro M, Gralla RJ, Bruera E, Clark-Snow RA, Dupuis LL, Einhorn LH, Feyer P, Hesketh PJ, Jordan K, Olver I, Rapoport BL, Roscoe J, Ruhlmann CH, Walsh D, Warr D, van der Wetering M; participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol. 2016 Sep;27(suppl 5):v119-v133. doi: 10.1093/annonc/mdw270. No abstract available.</citation>
<PMID>27664248</PMID>
</results_reference>
<results_reference>
<citation>Rapoport BL. Delayed Chemotherapy-Induced Nausea and Vomiting: Pathogenesis, Incidence, and Current Management. Front Pharmacol. 2017 Jan 30;8:19. doi: 10.3389/fphar.2017.00019. eCollection 2017.</citation>
<PMID>28194109</PMID>
</results_reference>
<results_reference>
<citation>Aybar DO, Kilic SP, Cinkir HY. The effect of breathing exercise on nausea, vomiting and functional status in breast cancer patients undergoing chemotherapy. Complement Ther Clin Pract. 2020 Aug;40:101213. doi: 10.1016/j.ctcp.2020.101213. Epub 2020 Jun 14.</citation>
<PMID>32891289</PMID>
</results_reference>
<results_reference>
<citation>Suryono A., Akbar F., Nugraha F.S., Armiyati Y. Combination of of deep breathing relaxation and murottal reducing post chemotherapy nausea intensity in nasopharyngeal cancer (NPC) patients, Media Keperawatan Indonesia. 2020; 3: 24-31.</citation>
</results_reference>
<results_reference>
<citation>Yoo HJ, Ahn SH, Kim SB, Kim WK, Han OS. Efficacy of progressive muscle relaxation training and guided imagery in reducing chemotherapy side effects in patients with breast cancer and in improving their quality of life. Support Care Cancer. 2005 Oct;13(10):826-33. doi: 10.1007/s00520-005-0806-7. Epub 2005 Apr 23.</citation>
<PMID>15856335</PMID>
</results_reference>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 25, 2022</study_first_submitted>
<study_first_submitted_qc>April 3, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 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>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
<investigator_full_name>ZELİHA GENÇ</investigator_full_name>
<investigator_title>Principal Investigator and PhD thesis student</investigator_title>
</responsible_party>
<keyword>Nausea</keyword>
<keyword>Vomiting</keyword>
<keyword>Breathing exercise</keyword>
<keyword>Autologous Hematopoietic Stem Cell Transplantation</keyword>
<keyword>Chemotherapy</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Nausea</mesh_term>
<mesh_term>Vomiting</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Nausea and vomiting are serious problems in patients undergoing autologous stem cell
transplantation. It is stated that the incidence of acute and delayed nausea and vomiting is
more than 50%, even if the patient has been given antiemetic prophylaxis during the treatment
process.
Breathing is the easiest relaxation exercise applied during the flow in everyday life and
also one of the most important and essential parts of other relaxation exercise. The
handbooks prepared for the patients undergoing chemotherapy recommend deep breathing
exercises in order to prevent their nausea and vomiting.
The aim of this study is to determine the effect of respiratory exercise on
chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell
transplantation.
Research Hypotheses Ho: Respiratory exercise is not effective in preventing
chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant
patients.
H1: Respiratory exercise is effective in preventing chemotherapy-associated nausea and
vomiting in autologous hematopoietic stem cell transplant patients.
In the literature, no study has been found investigating the effect of breathing exercises on
chemotherapy-induced nausea and vomiting for autologous hematopoietic stem cell
transplantation patients.
The aim of this study is to determine the effect of respiratory exercise on
chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell
transplantation.
Inclusion Criteria:
- Least 18-years-old,
- Autologous hematopoietic stem cell transplantation and take high-dose chemotherapy,
- not have any communicative problems,
- not have Coronavirus disease (COVID-19) disease or respiratory disease,
- Hb value of 10 and above and
- knowing how to read, write, and speak Turkish
Exclusion Criteria:
- have respiratory disease and Coronavirus disease (COVID-19),
- having any communication and psychiatric problem,
- not knowing how to read, write, and speak Turkish,
- not wanting to participate in the study and have anemia.
|
NCT0531xxxx/NCT05311384.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/NCT05311384</url>
</required_header>
<id_info>
<org_study_id>IRB-300008977</org_study_id>
<nct_id>NCT05311384</nct_id>
</id_info>
<brief_title>Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity</brief_title>
<official_title>Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity Recovery Following Stroke: A Pilot Study</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Alabama at Birmingham</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Alabama at Birmingham</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>
CI therapy is a family of techniques that has systematically applied intensive treatment
daily over consecutive days, supervised motor training using a technique called shaping,
behavioral strategies to improve the use of the more- affected limb in real life situations
called a Transfer Package (TP), and strategies to remind participants to use the
more-affected extremity; including restraint of the less-affected arm in the upper extremity
(UE) protocol. Numerous studies examining use of CI therapy with UE rehabilitation have
demonstrated robust evidence for increasing the amount and the quality of the paretic UE
functional use in daily situations of individuals recovering from stroke.

Previous studies have explored the barriers for clinical implementation of the approach,
including the amount of time needed by therapists, other resources required and lack of
payment for the services. With regards to therapists' time/resources, in the signature CI
therapy protocol, therapists supervised movement training for 3 hours daily (except for
weekends) for a 12 consecutive-day period. This level of supervision in highly unusual for
traditional rehabilitation clinical settings. The treatment schedule is also incompatible
with most insurance reimbursement policies in the US. As such, most CI therapy clinics
require patients to pay privately with little or no insurance reimbursement. Such practices
severely limit the number of patients who can afford to receive CI therapy. Two lines of
evidence have suggested that an alternative CI therapy protocol may allow for the essential
(or "Key") CI therapy elements to be delivered in a schedule that better utilizes therapist
time/resources and is compatible with payment policies of many US insurance companies. One
line of evidence comes from findings that indicate that the original 6-hour supervised
training schedule could be shortened to as little as 2-hours/daily without a reduction in
outcomes. Additional evidence comes from a study exploring the systematic addition and
deletion of the signature CI therapy protocol elements indicated that when the transfer
package was omitted, outcomes related to functional use were reduced by 50%. These findings
were also verified by brain imaging studies conducted concurrently that revealed a
much-reduced level of brain remodeling in those not receiving the transfer package. These
findings highlight the potential effectiveness of the transfer package and continued movement
training by the patient while away from clinical supervision. The hypothesis of this study is
that the amount of supervised training could be reduced further and delivered in a
distributed schedule (1 to 4 times/ week over an 8-week period) instead of consecutively over
a 12-day treatment period. This modification could be possible by adapting and strengthening
the transfer package component of the protocol. In order to investigate if all of the Keys
intervention protocol is necessary for producing optimal outcomes, the delivery of specific
protocol elements will be also explored. Additionally, another round of testing at the 4-week
point of the 8-week intervention will be administered to investigate the need for the final 4
weeks of the intervention.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 20, 2022</start_date>
<completion_date type="Anticipated">April 1, 2024</completion_date>
<primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Motor Activity Log (MAL)</measure>
<time_frame>4 weeks after starting the intervention (middle of the protocol)</time_frame>
<description>The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment. The assessment is scored from 0-10, and higher scores denote more frequent spontaneous use and quality of movement of the affected arm.</description>
</primary_outcome>
<primary_outcome>
<measure>Motor Activity Log (MAL)</measure>
<time_frame>after the intervention (8 weeks after starting the protocol)</time_frame>
<description>The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment.The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity before and after the treatment. The assessment is scored from 0-10, and higher scores denote more frequent spontaneous use and quality of movement of the affected arm.</description>
</primary_outcome>
<primary_outcome>
<measure>Motor Activity Log (MAL)</measure>
<time_frame>3 months after the end of the treatment.</time_frame>
<description>The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change and retention of spontaneous use of the affected upper extremity right after the treatment and 3 months after the end of the treatment. The assessment is scored from 0-10, and higher scores denote more frequent spontaneous use and quality of movement of the affected arm.</description>
</primary_outcome>
<primary_outcome>
<measure>Canadian Occupational Performance Measure (COPM)</measure>
<time_frame>4 weeks after starting the intervention (middle of the protocol)</time_frame>
<description>The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before and in the middle of the treatment. The assessment is scored from 0-10, and higher scores denote higher satisfaction, importance, and quality of performance.</description>
</primary_outcome>
<primary_outcome>
<measure>Canadian Occupational Performance Measure (COPM)</measure>
<time_frame>after the intervention (8 weeks after starting the protocol)</time_frame>
<description>The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before and after the treatment. The assessment is scored from 0-10, and higher scores denote higher satisfaction, importance, and quality of performance.</description>
</primary_outcome>
<primary_outcome>
<measure>Canadian Occupational Performance Measure (COPM)</measure>
<time_frame>3 months after the end of the treatment.</time_frame>
<description>The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes and retention of occupational performance right after the treatment and 3 months after the end of the treatment. The assessment is scored from 0-10, and higher scores denote higher satisfaction, importance, and quality of performance.</description>
</primary_outcome>
<primary_outcome>
<measure>Wolf Motor Function Test (WMFT)</measure>
<time_frame>4 weeks after starting the intervention (middle of the protocol)</time_frame>
<description>The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The functional scale ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.</description>
</primary_outcome>
<primary_outcome>
<measure>Wolf Motor Function Test (WMFT)</measure>
<time_frame>after the intervention (8 weeks after starting the protocol)</time_frame>
<description>The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and after the treatment. The functional scale ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.</description>
</primary_outcome>
<primary_outcome>
<measure>Wolf Motor Function Test (WMFT)</measure>
<time_frame>3 months after the end of the treatment.</time_frame>
<description>The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected right after the treatment and 3 months after the end of the treatment. The functional scale ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.</description>
</primary_outcome>
<secondary_outcome>
<measure>Stroke Impact Scale (SIS)</measure>
<time_frame>4 weeks after starting the intervention (middle of the protocol)</time_frame>
<description>The SIS is a self-reported measure of disability and quality of life after stroke. The score ranges from 0-100, where lower score mean more difficulty in doing and remembering things. The SIS will be administered to investigate changes in quality of life comparing the scores collected before and in the middle of the treatment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Stroke Impact Scale (SIS)</measure>
<time_frame>after the intervention (8 weeks after starting the protocol)</time_frame>
<description>The SIS is a self-reported measure of disability and quality of life after stroke. The score ranges from 0-100, where lower score mean more difficulty in doing and remembering things. The SIS will be administered to investigate changes in quality of life comparing the scores collected before and after the treatment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Stroke Impact Scale (SIS)</measure>
<time_frame>3 months after the end of the treatment.</time_frame>
<description>The SIS is a self-reported measure of disability and quality of life after stroke. The score ranges from 0-100, where lower score mean more difficulty in doing and remembering things. The SIS will will be administered to investigate changes and retention of quality of life comparing the scores collected right after of the treatment and 3 months after the end of the treatment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Zung Self-Rating Depression Scale</measure>
<time_frame>4 weeks after starting the intervention (middle of the protocol)</time_frame>
<description>The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected before and in the middle of the treatment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Zung Self-Rating Depression Scale</measure>
<time_frame>after the intervention (8 weeks after starting the protocol)</time_frame>
<description>The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected before and after the treatment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Zung Self-Rating Depression Scale</measure>
<time_frame>3 months after the end of the treatment.</time_frame>
<description>The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected right after of the treatment and 3 months after the end of the treatment.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">16</enrollment>
<condition>CVA (Cerebrovascular Accident)</condition>
<condition>Stroke</condition>
<condition>Upper Extremity Paresis</condition>
<arm_group>
<arm_group_label>Keys intervention</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Keys Constraint-induced Movement Therapy protocol</intervention_name>
<description>All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.</description>
<arm_group_label>Keys intervention</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- At least 6 months after stroke

- Ability to demonstrate minimum movement criteria of more-affected UE including 10
degrees of wrist extension (starting from a fully flexed position), 10 degrees of
thumb abduction, and 10 degrees of extension of two additional fingers at all joints

- Score <2.5 on the MAL indicating significant functional deficits of the more-affected
UE

Exclusion Criteria:

- Inability to answer the MAL questions and/or provide informed consent

- Score <24 on the Mini-Mental State Examination

- No availability to come to the clinic for the sessions.
</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>University of Alabama at Birmingham</name>
<address>
<city>Birmingham</city>
<state>Alabama</state>
<zip>35233</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Sarah M dos Anjos, PhD, MS, OT</last_name>
<phone>205-934-7323</phone>
<email>smanjos@uab.edu</email>
</contact>
<investigator>
<last_name>Sarah M dos Anjos, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3;141(9):e139-e596. doi: 10.1161/CIR.0000000000000757. Epub 2020 Jan 29.</citation>
<PMID>31992061</PMID>
</reference>
<reference>
<citation>Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.</citation>
<PMID>8466415</PMID>
</reference>
<reference>
<citation>Morris DM, Taub E, Mark VW. Constraint-induced movement therapy: characterizing the intervention protocol. Eura Medicophys. 2006 Sep;42(3):257-68.</citation>
<PMID>17039224</PMID>
</reference>
<reference>
<citation>Pedlow K, Lennon S, Wilson C. Application of constraint-induced movement therapy in clinical practice: an online survey. Arch Phys Med Rehabil. 2014 Feb;95(2):276-82. doi: 10.1016/j.apmr.2013.08.240. Epub 2013 Sep 8.</citation>
<PMID>24025659</PMID>
</reference>
<reference>
<citation>Viana R, Teasell R. Barriers to the implementation of constraint-induced movement therapy into practice. Top Stroke Rehabil. 2012 Mar-Apr;19(2):104-14. doi: 10.1310/tsr1902-104.</citation>
<PMID>22436358</PMID>
</reference>
<reference>
<citation>Fleet A, Che M, Mackay-Lyons M, Mackenzie D, Page S, Eskes G, McDonald A, Boyce J, Boe S. Examining the use of constraint-induced movement therapy in canadian neurological occupational and physical therapy. Physiother Can. 2014 Winter;66(1):60-71. doi: 10.3138/ptc.2012-61.</citation>
<PMID>24719511</PMID>
</reference>
<reference>
<citation>Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006 Oct 10;67(7):1189-94. doi: 10.1212/01.wnl.0000238164.90657.c2.</citation>
<PMID>17030751</PMID>
</reference>
<reference>
<citation>Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.</citation>
<PMID>11387578</PMID>
</reference>
<reference>
<citation>Duncan PW, Wallace D, Lai SM, Johnson D, Embretson S, Laster LJ. The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. Stroke. 1999 Oct;30(10):2131-40. doi: 10.1161/01.str.30.10.2131.</citation>
<PMID>10512918</PMID>
</reference>
<reference>
<citation>ZUNG WW. A SELF-RATING DEPRESSION SCALE. Arch Gen Psychiatry. 1965 Jan;12:63-70. doi: 10.1001/archpsyc.1965.01720310065008. No abstract available.</citation>
<PMID>14221692</PMID>
</reference>
<reference>
<citation>Toomey M, Nicholson D, Carswell A. The clinical utility of the Canadian Occupational Performance Measure. Can J Occup Ther. 1995 Dec;62(5):242-9. doi: 10.1177/000841749506200503.</citation>
<PMID>10152880</PMID>
</reference>
<reference>
<citation>Wolf SL, Winstein CJ, Miller JP, Thompson PA, Taub E, Uswatte G, Morris D, Blanton S, Nichols-Larsen D, Clark PC. Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial. Lancet Neurol. 2008 Jan;7(1):33-40. doi: 10.1016/S1474-4422(07)70294-6.</citation>
<PMID>18077218</PMID>
</reference>
<reference>
<citation>Morris DM, Taub E, Macrina DM, Cook EW, Geiger BF. A method for standardizing procedures in rehabilitation: use in the extremity constraint induced therapy evaluation multisite randomized controlled trial. Arch Phys Med Rehabil. 2009 Apr;90(4):663-8. doi: 10.1016/j.apmr.2008.09.576.</citation>
<PMID>19345784</PMID>
</reference>
<reference>
<citation>Andrabi M, Taub E, Mckay Bishop S, Morris D, Uswatte G. Acceptability of constraint induced movement therapy: influence of perceived difficulty and expected treatment outcome. Top Stroke Rehabil. 2022 Oct;29(7):507-515. doi: 10.1080/10749357.2021.1956046. Epub 2021 Aug 23.</citation>
<PMID>34425065</PMID>
</reference>
<reference>
<citation>Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56.</citation>
<PMID>17039223</PMID>
</reference>
<reference>
<citation>Uswatte G, Taub E, Morris D, Barman J, Crago J. Contribution of the shaping and restraint components of Constraint-Induced Movement therapy to treatment outcome. NeuroRehabilitation. 2006;21(2):147-56.</citation>
<PMID>16917161</PMID>
</reference>
<reference>
<citation>Shi YX, Tian JH, Yang KH, Zhao Y. Modified constraint-induced movement therapy versus traditional rehabilitation in patients with upper-extremity dysfunction after stroke: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2011 Jun;92(6):972-82. doi: 10.1016/j.apmr.2010.12.036.</citation>
<PMID>21621674</PMID>
</reference>
<reference>
<citation>Taub E, Uswatte G, Mark VW, Morris DM, Barman J, Bowman MH, Bryson C, Delgado A, Bishop-McKay S. Method for enhancing real-world use of a more affected arm in chronic stroke: transfer package of constraint-induced movement therapy. Stroke. 2013 May;44(5):1383-8. doi: 10.1161/STROKEAHA.111.000559. Epub 2013 Mar 21.</citation>
<PMID>23520237</PMID>
</reference>
<verification_date>April 2023</verification_date>
<study_first_submitted>March 4, 2022</study_first_submitted>
<study_first_submitted_qc>March 27, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>April 27, 2023</last_update_submitted>
<last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 1, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
<investigator_full_name>Sarah Monteiro Dos Anjos, PhD</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>Stroke</mesh_term>
<mesh_term>Paresis</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
CI therapy is a family of techniques that has systematically applied intensive treatment
daily over consecutive days, supervised motor training using a technique called shaping,
behavioral strategies to improve the use of the more- affected limb in real life situations
called a Transfer Package (TP), and strategies to remind participants to use the
more-affected extremity; including restraint of the less-affected arm in the upper extremity
(UE) protocol. Numerous studies examining use of CI therapy with UE rehabilitation have
demonstrated robust evidence for increasing the amount and the quality of the paretic UE
functional use in daily situations of individuals recovering from stroke.
Previous studies have explored the barriers for clinical implementation of the approach,
including the amount of time needed by therapists, other resources required and lack of
payment for the services. With regards to therapists' time/resources, in the signature CI
therapy protocol, therapists supervised movement training for 3 hours daily (except for
weekends) for a 12 consecutive-day period. This level of supervision in highly unusual for
traditional rehabilitation clinical settings. The treatment schedule is also incompatible
with most insurance reimbursement policies in the US. As such, most CI therapy clinics
require patients to pay privately with little or no insurance reimbursement. Such practices
severely limit the number of patients who can afford to receive CI therapy. Two lines of
evidence have suggested that an alternative CI therapy protocol may allow for the essential
(or "Key") CI therapy elements to be delivered in a schedule that better utilizes therapist
time/resources and is compatible with payment policies of many US insurance companies. One
line of evidence comes from findings that indicate that the original 6-hour supervised
training schedule could be shortened to as little as 2-hours/daily without a reduction in
outcomes. Additional evidence comes from a study exploring the systematic addition and
deletion of the signature CI therapy protocol elements indicated that when the transfer
package was omitted, outcomes related to functional use were reduced by 50%. These findings
were also verified by brain imaging studies conducted concurrently that revealed a
much-reduced level of brain remodeling in those not receiving the transfer package. These
findings highlight the potential effectiveness of the transfer package and continued movement
training by the patient while away from clinical supervision. The hypothesis of this study is
that the amount of supervised training could be reduced further and delivered in a
distributed schedule (1 to 4 times/ week over an 8-week period) instead of consecutively over
a 12-day treatment period. This modification could be possible by adapting and strengthening
the transfer package component of the protocol. In order to investigate if all of the Keys
intervention protocol is necessary for producing optimal outcomes, the delivery of specific
protocol elements will be also explored. Additionally, another round of testing at the 4-week
point of the 8-week intervention will be administered to investigate the need for the final 4
weeks of the intervention.
Inclusion Criteria:
- At least 6 months after stroke
- Ability to demonstrate minimum movement criteria of more-affected UE including 10
degrees of wrist extension (starting from a fully flexed position), 10 degrees of
thumb abduction, and 10 degrees of extension of two additional fingers at all joints
- Score <2.5 on the MAL indicating significant functional deficits of the more-affected
UE
Exclusion Criteria:
- Inability to answer the MAL questions and/or provide informed consent
- Score <24 on the Mini-Mental State Examination
- No availability to come to the clinic for the sessions.
|
NCT0531xxxx/NCT05311397.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/NCT05311397</url>
</required_header>
<id_info>
<org_study_id>KL166-I-01-CTP</org_study_id>
<nct_id>NCT05311397</nct_id>
</id_info>
<brief_title>A Study of A166 in Patients With Advanced Solid Malignant Tumors</brief_title>
<official_title>A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of A166 in Patients With Unresectable, Locally Advanced or Metastatic HER2-expressing Solid Tumors (KL166-I-01-CTP)</official_title>
<sponsors>
<lead_sponsor>
<agency>Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This is a single arm, open-label, dose-escalation and dose-expansion phase I study evaluating
A166 in patients with HER2-expressing locally advanced or metastatic solid tumors.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The first stage will determine the recommended stage 2 dose (RS2D) in patients with
unresectable, locally advanced or metastatic HER2-expressing solid tumors based on safety,
tolerability, pharmacokinetic characteristics and antitumor activity. The second stage will
assess the safety, tolerability, pharmacokinetic characteristics and antitumor activity in
dose-expansion cohorts (RS2D:3.6 mg/kg, 4.8 mg/kg and 6.0 mg/kg dose groups).
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">August 9, 2018</start_date>
<completion_date type="Anticipated">December 31, 2023</completion_date>
<primary_completion_date type="Anticipated">June 30, 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>
<intervention_model_description>This 2-part, open-label, PhaseⅠstudy will administer A166 by IV infusion once every 3 weeks. Sequential dose-escalation cohorts are planned using a 3+3 design. An expansion study will be conducted based on the RS2D with comprehensive analysis of safety, tolerability, and pharmacokinetic data in the first phase</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Objective Response Rate (ORR)</measure>
<time_frame>up to 24 month</time_frame>
<description>The percentage of patients with CR and PR assessed by investigators according to RECIST v 1.1</description>
</primary_outcome>
<secondary_outcome>
<measure>Duration of Response (DOR)</measure>
<time_frame>up to 24 month</time_frame>
<description>From the date that response criteria are first met to the first occurrence of PD as determined by the investigators according to RECIST v1.1 or death from any cause, whichever occurs first</description>
</secondary_outcome>
<secondary_outcome>
<measure>Progression-free survival(PFS)</measure>
<time_frame>up to 24 month</time_frame>
<description>PFS, defined as the active comparator arm frist dosing of A166 injection to the first occurrence of disease progression as determined by the investigators according to RECIST v1.1 or death from any cause, whichever occurs first</description>
</secondary_outcome>
<secondary_outcome>
<measure>Overall Survival (OS)</measure>
<time_frame>up to 24 month</time_frame>
<description>OS, defined as the time from randomization to death or lose of follow, whichever occurs first</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">120</enrollment>
<condition>Breast Cancer</condition>
<arm_group>
<arm_group_label>The first stage（Dose-escalation）</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>According to the initial dose, the highest dose and the modified Fibonacci method, the dose escalation of A166 for injection is designed as: 0.1 mg/kg, 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.8 mg/kg (the highest dose is tentatively set at 4.8 mg/kg).</description>
</arm_group>
<arm_group>
<arm_group_label>The second stage（Dose-expansion）</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The administered dose of A166 for injection is RS2D obtained in the first stage .</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>A166</intervention_name>
<description>A166 is an Antibody Drug Conjugate (ADC) targeting HER2 expressing cancer cells.</description>
<arm_group_label>The first stage（Dose-escalation）</arm_group_label>
<arm_group_label>The second stage（Dose-expansion）</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Voluntarily sign informed consent form;

2. Age ≥ 18 years old, no gender limit;

3. Patients had a histologically confirmed incurable locally advanced or metastatic solid
tumors;

4. Determined HER2-positive disease (detected by ISH or NGS) or HER2-expressing disease
by evaluation or detection. Definition of HER2 expression in this study:
Immunohistochemistry [IHC] ≥ 1＋;

5. Patients unable to benefit from the available standard treatment according to the
judgment of the investigator;

6. White blood cell count (WBC) ≥ 4.0×109/L or ≥ lower limit of normal value; Neutrophil
count (NEUT) ≥ 1.5×109/L; Platelet count (PLT) ≥ 100×109/L; Hemoglobin concentration ≥
9.0 g/dL;

7. Total bilirubin (TBIL) ≤ 1.5×ULN. Aspartate aminotransferase (AST), alanine
aminotransferase (ALT) and alkaline phosphatase ≤ 2.5 times the upper limit of normal
(ULN). For patients with liver metastases, ALT and AST ≤ 5 times ULN, and for patients
with liver and/or bone metastases, alkaline phosphatase ≤ 5 times ULN;

8. Creatinine clearance rate ≥ 50 ml/min;

9. Patients had an Eastern Cooperative Oncology Group (ECOG)performance status of 0 or 1,
the expected survival time is ≥ 3 months;

10. During the study period and within 7 months after the final administration of A166,
patients with fertility (regardless of male and female) must receive effective medical
contraceptive measures;

11. The patients must recover from all acute toxicities of the previous treatment
(relieved to grade 1 or baseline), except for hair loss and vitiligo;

Exclusion Criteria:

1. Severe or uncontrollable heart disease requiring treatment, or grade 3 or 4 congestive
heart failure according to the New York Society of Cardiology (NYHA), or unstable
angina pectoris that cannot be controlled by drugs, or history of myocardial
infarction within 6 months prior to enrollment, or severe arrhythmia requiring medical
treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia);

2. History of ≥ Grade 3 allergic reaction to trastuzumab;

3. Permanent with drawal of trastuzumab due to any previous toxicity;

4. Patients with brain metastases who have symptoms or who have received the radiotherapy
or surgery within 3 months before the first administration;

5. Patients requiring oxygen therapy in daily activities;

6. Grade 2 or higher peripheral neuropathy;

7. Any chemotherapy, hormone therapy (except dexamethasone), radiotherapy, immunotherapy
or biological therapy received within 4 weeks before the first administration;

8. Prior-treatment with other clinical research drugs within 4 weeks before the first
administration;

9. Patients who have undergone major surgery within 4 weeks before the first
administration;

10. Active hepatitis B (hepatitis B surface antigen positive and HBV-DNA higher than the
upper limit of reference value) or hepatitis C (positive hepatitis C virus antibody
and HCV-RNA higher than the upper limit of reference value); current or past
alcoholics ; Liver cirrhosis;

11. Known active human immunodeficiency virus (HIV);

12. Systemic diseases that cannot be controlled, including diabetes, hypertension,
pulmonary fibrosis, acute lung disease, interstitial lung disease, glaucoma, etc
according to investigator's judgment;

13. Current pregnancy or lactation;

14. QTc interval> 470 ms according to the baseline measurement:;

15. Left ventricular ejection fraction (LVEF) <45% according to the echocardiogram (ECHO)
or multi-gate circuit controlled acquisition (MUGA) ;

16. Previous cumulative doxorubicin accumulation > 360 mg/m2 or its equivalent dose;
</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>Fudan University Shanghai Cancer Center</name>
<address>
<city>Shanghai</city>
<state>Shanghai</state>
<zip>200032</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Xichun Hu</last_name>
<phone>021-64175590</phone>
<email>xchu2009@hotmail.com</email>
</contact>
<investigator>
<last_name>Xichun Hu, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 7, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 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>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 is a single arm, open-label, dose-escalation and dose-expansion phase I study evaluating
A166 in patients with HER2-expressing locally advanced or metastatic solid tumors.
The first stage will determine the recommended stage 2 dose (RS2D) in patients with
unresectable, locally advanced or metastatic HER2-expressing solid tumors based on safety,
tolerability, pharmacokinetic characteristics and antitumor activity. The second stage will
assess the safety, tolerability, pharmacokinetic characteristics and antitumor activity in
dose-expansion cohorts (RS2D:3.6 mg/kg, 4.8 mg/kg and 6.0 mg/kg dose groups).
Inclusion Criteria:
1. Voluntarily sign informed consent form;
2. Age ≥ 18 years old, no gender limit;
3. Patients had a histologically confirmed incurable locally advanced or metastatic solid
tumors;
4. Determined HER2-positive disease (detected by ISH or NGS) or HER2-expressing disease
by evaluation or detection. Definition of HER2 expression in this study:
Immunohistochemistry [IHC] ≥ 1＋;
5. Patients unable to benefit from the available standard treatment according to the
judgment of the investigator;
6. White blood cell count (WBC) ≥ 4.0×109/L or ≥ lower limit of normal value; Neutrophil
count (NEUT) ≥ 1.5×109/L; Platelet count (PLT) ≥ 100×109/L; Hemoglobin concentration ≥
9.0 g/dL;
7. Total bilirubin (TBIL) ≤ 1.5×ULN. Aspartate aminotransferase (AST), alanine
aminotransferase (ALT) and alkaline phosphatase ≤ 2.5 times the upper limit of normal
(ULN). For patients with liver metastases, ALT and AST ≤ 5 times ULN, and for patients
with liver and/or bone metastases, alkaline phosphatase ≤ 5 times ULN;
8. Creatinine clearance rate ≥ 50 ml/min;
9. Patients had an Eastern Cooperative Oncology Group (ECOG)performance status of 0 or 1,
the expected survival time is ≥ 3 months;
10. During the study period and within 7 months after the final administration of A166,
patients with fertility (regardless of male and female) must receive effective medical
contraceptive measures;
11. The patients must recover from all acute toxicities of the previous treatment
(relieved to grade 1 or baseline), except for hair loss and vitiligo;
Exclusion Criteria:
1. Severe or uncontrollable heart disease requiring treatment, or grade 3 or 4 congestive
heart failure according to the New York Society of Cardiology (NYHA), or unstable
angina pectoris that cannot be controlled by drugs, or history of myocardial
infarction within 6 months prior to enrollment, or severe arrhythmia requiring medical
treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia);
2. History of ≥ Grade 3 allergic reaction to trastuzumab;
3. Permanent with drawal of trastuzumab due to any previous toxicity;
4. Patients with brain metastases who have symptoms or who have received the radiotherapy
or surgery within 3 months before the first administration;
5. Patients requiring oxygen therapy in daily activities;
6. Grade 2 or higher peripheral neuropathy;
7. Any chemotherapy, hormone therapy (except dexamethasone), radiotherapy, immunotherapy
or biological therapy received within 4 weeks before the first administration;
8. Prior-treatment with other clinical research drugs within 4 weeks before the first
administration;
9. Patients who have undergone major surgery within 4 weeks before the first
administration;
10. Active hepatitis B (hepatitis B surface antigen positive and HBV-DNA higher than the
upper limit of reference value) or hepatitis C (positive hepatitis C virus antibody
and HCV-RNA higher than the upper limit of reference value); current or past
alcoholics ; Liver cirrhosis;
11. Known active human immunodeficiency virus (HIV);
12. Systemic diseases that cannot be controlled, including diabetes, hypertension,
pulmonary fibrosis, acute lung disease, interstitial lung disease, glaucoma, etc
according to investigator's judgment;
13. Current pregnancy or lactation;
14. QTc interval> 470 ms according to the baseline measurement:;
15. Left ventricular ejection fraction (LVEF) <45% according to the echocardiogram (ECHO)
or multi-gate circuit controlled acquisition (MUGA) ;
16. Previous cumulative doxorubicin accumulation > 360 mg/m2 or its equivalent dose;
|
NCT0531xxxx/NCT05311410.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/NCT05311410</url>
</required_header>
<id_info>
<org_study_id>COVID-Dentistry</org_study_id>
<nct_id>NCT05311410</nct_id>
</id_info>
<brief_title>Viral Kinetics of SARS-CoV-2 in Patients With COVID-19 in the Intensive Care Unit Undergoing Dental Procedures</brief_title>
<acronym>VKSPCICUDP</acronym>
<official_title>Viral Kinetics of SARS-CoV-2 in Patients in the Intensive Care Unit Undergoing Dental Procedures</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Sao Paulo General Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Sao Paulo General 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>
The prevalence and clinical relevance of viremia in patients with COVID-19 have not been well
investigated. Seeking to understand the need for dentistry to perform bloody procedures in
critically ill patients with COVID-19 admitted to the ICU, the quantification of the
magnitude of viral replication may play a fundamental role in this scenario. For this, it is
necessary to study the viremia kinetics of SARS-CoV-2, seeking to assess whether there is any
characteristic pattern that may be associated with a worse clinical outcome of the patient
with COVID-19 after undergoing bloody dental procedures, therefore, the objective of this
research will be to investigate the occurrence of viral kinetics produced by dental
procedures in patients with SARS-CoV-2 in Intensive Care Units, where, in addition to
analyzing the oral health condition, the viral kinetics of SARS-CoV-2 will also be
investigated by means of reverse transcription polymerase chain reaction (RT-PCR) examination
of blood samples from patients with COVID-19 undergoing bloody dental treatment. This
research is expected to identify risks and consequences regarding the possibility of
performing bloody dental treatment in patients with COVID-19 in serious condition, in
addition to verifying the association of the impact of oral infection foci on this profile of
patients.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">September 20, 2021</start_date>
<completion_date type="Anticipated">October 20, 2025</completion_date>
<primary_completion_date type="Anticipated">December 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>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Increased quantification of viral replication</measure>
<time_frame>Through three collections of blood samples, in the following moments: (T0) 15 minutes before the beginning of the dental procedure; (T1) 10 minutes after the start of the procedure; and (T3) 10 minutes after the end of the procedure.</time_frame>
<description>The performance of bloody dental procedures hospitalized critically ill patients with COVID-19 causes an increase in the quantification of viral replication, causing changes in the patient's clinical outcome</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">60</enrollment>
<condition>SARS-CoV2 Infection</condition>
<condition>Viral Load</condition>
<condition>Oral Diseases</condition>
<condition>Dental Treatment</condition>
<arm_group>
<arm_group_label>Control group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Study group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Non-bloody dental procedures (control group)</intervention_name>
<description>Control group composed of 30 positive patients for SARS-CoV-2, from the same ICU, submitted to non-bloody procedures.</description>
<arm_group_label>Control group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Bloody dental procedures (study group)</intervention_name>
<description>Study group consisting of 30 patients who require open dental treatment and with a positive PCR test for SARS-CoV-2 prior and admitted to the Intensive Care Unit.</description>
<arm_group_label>Study group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria: Patients between 16 and 90 years old who describe subgingival scaling
of at least one dental sextant or a tooth extraction.

Exclusion Criteria: Patients who cannot perform clinical examination and/or open dental
procedure.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>16 Years</minimum_age>
<maximum_age>90 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Dentistry Unit, Heart Institute, Clinical Hospital of the Faculty of Medicine of the University of São Paulo.</name>
<address>
<city>São Paulo</city>
<zip>05403-900</zip>
<country>Brazil</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Itamara LI Neves</last_name>
<phone>+55 (11)26614142</phone>
<email>itamara@incor.usp.br</email>
</contact>
<contact_backup>
<last_name>Elói F Matias</last_name>
<phone>+55 (11)956626714</phone>
<email>eloifmatias@usp.br</email>
</contact_backup>
</location>
<location_countries>
<country>Brazil</country>
</location_countries>
<reference>
<citation>Clerkin KJ, Fried JA, Raikhelkar J, Sayer G, Griffin JM, Masoumi A, Jain SS, Burkhoff D, Kumaraiah D, Rabbani L, Schwartz A, Uriel N. COVID-19 and Cardiovascular Disease. Circulation. 2020 May 19;141(20):1648-1655. doi: 10.1161/CIRCULATIONAHA.120.046941. Epub 2020 Mar 21.</citation>
<PMID>32200663</PMID>
</reference>
<reference>
<citation>Lai CC, Liu YH, Wang CY, Wang YH, Hsueh SC, Yen MY, Ko WC, Hsueh PR. Asymptomatic carrier state, acute respiratory disease, and pneumonia due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): Facts and myths. J Microbiol Immunol Infect. 2020 Jun;53(3):404-412. doi: 10.1016/j.jmii.2020.02.012. Epub 2020 Mar 4.</citation>
<PMID>32173241</PMID>
</reference>
<reference>
<citation>Backer JA, Klinkenberg D, Wallinga J. Incubation period of 2019 novel coronavirus (2019-nCoV) infections among travellers from Wuhan, China, 20-28 January 2020. Euro Surveill. 2020 Feb;25(5):2000062. doi: 10.2807/1560-7917.ES.2020.25.5.2000062.</citation>
<PMID>32046819</PMID>
</reference>
<reference>
<citation>Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:</citation>
<PMID>31986264</PMID>
</reference>
<reference>
<citation>Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.</citation>
<PMID>32113704</PMID>
</reference>
<reference>
<citation>Kinross P, Suetens C, Dias JG, Alexakis L, Wijermans A, Colzani E, Monnet DL; European Centre for Disease Prevention and Control (ECDC) Public Health Emergency Team; ECDC Public Health Emergency Team. Rapidly increasing cumulative incidence of coronavirus disease (COVID-19) in the European Union/European Economic Area and the United Kingdom, 1 January to 15 March 2020. Euro Surveill. 2020 Mar;25(11):2000285. doi: 10.2807/1560-7917.ES.2020.25.11.2000285. Epub 2020 Mar 16.</citation>
<PMID>32186277</PMID>
</reference>
<reference>
<citation>CDC COVID-19 Response Team. Preliminary Estimates of the Prevalence of Selected Underlying Health Conditions Among Patients with Coronavirus Disease 2019 - United States, February 12-March 28, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):382-386. doi: 10.15585/mmwr.mm6913e2.</citation>
<PMID>32240123</PMID>
</reference>
<reference>
<citation>Nguyen H, Manolova G, Daskalopoulou C, Vitoratou S, Prince M, Prina AM. Prevalence of multimorbidity in community settings: A systematic review and meta-analysis of observational studies. J Comorb. 2019 Aug 22;9:2235042X19870934. doi: 10.1177/2235042X19870934. eCollection 2019 Jan-Dec.</citation>
<PMID>31489279</PMID>
</reference>
<reference>
<citation>Dietz W, Santos-Burgoa C. Obesity and its Implications for COVID-19 Mortality. Obesity (Silver Spring). 2020 Jun;28(6):1005. doi: 10.1002/oby.22818. Epub 2020 Apr 18. No abstract available.</citation>
<PMID>32237206</PMID>
</reference>
<reference>
<citation>Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017. Erratum In: JAMA Cardiol. 2020 Jul 1;5(7):848.</citation>
<PMID>32219356</PMID>
</reference>
<reference>
<citation>Radzikowska U, Ding M, Tan G, Zhakparov D, Peng Y, Wawrzyniak P, Wang M, Li S, Morita H, Altunbulakli C, Reiger M, Neumann AU, Lunjani N, Traidl-Hoffmann C, Nadeau KC, O'Mahony L, Akdis C, Sokolowska M. Distribution of ACE2, CD147, CD26, and other SARS-CoV-2 associated molecules in tissues and immune cells in health and in asthma, COPD, obesity, hypertension, and COVID-19 risk factors. Allergy. 2020 Nov;75(11):2829-2845. doi: 10.1111/all.14429. Epub 2020 Aug 24.</citation>
<PMID>32496587</PMID>
</reference>
<reference>
<citation>Amorim Dos Santos J, Normando AGC, Carvalho da Silva RL, Acevedo AC, De Luca Canto G, Sugaya N, Santos-Silva AR, Guerra ENS. Oral Manifestations in Patients with COVID-19: A Living Systematic Review. J Dent Res. 2021 Feb;100(2):141-154. doi: 10.1177/0022034520957289. Epub 2020 Sep 11.</citation>
<PMID>32914677</PMID>
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<citation>Ahmed QA, Niederman MS. Respiratory infection in the chronically critically ill patient. Ventilator-associated pneumonia and tracheobronchitis. Clin Chest Med. 2001 Mar;22(1):71-85. doi: 10.1016/s0272-5231(05)70026-5.</citation>
<PMID>11315460</PMID>
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<citation>Paju S, Scannapieco FA. Oral biofilms, periodontitis, and pulmonary infections. Oral Dis. 2007 Nov;13(6):508-12. doi: 10.1111/j.1601-0825.2007.01410a.x.</citation>
<PMID>17944664</PMID>
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<citation>Marouf N, Cai W, Said KN, Daas H, Diab H, Chinta VR, Hssain AA, Nicolau B, Sanz M, Tamimi F. Association between periodontitis and severity of COVID-19 infection: A case-control study. J Clin Periodontol. 2021 Apr;48(4):483-491. doi: 10.1111/jcpe.13435. Epub 2021 Feb 15.</citation>
<PMID>33527378</PMID>
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<citation>Holmgren CJ. CPITN--interpretations and limitations. Int Dent J. 1994 Oct;44(5 Suppl 1):533-46.</citation>
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<citation>Chen L, Wang G, Long X, Hou H, Wei J, Cao Y, Tan J, Liu W, Huang L, Meng F, Huang L, Wang N, Zhao J, Huang G, Sun Z, Wang W, Zhou J. Dynamics of Blood Viral Load Is Strongly Associated with Clinical Outcomes in Coronavirus Disease 2019 (COVID-19) Patients: A Prospective Cohort Study. J Mol Diagn. 2021 Jan;23(1):10-18. doi: 10.1016/j.jmoldx.2020.10.007. Epub 2020 Oct 26.</citation>
<PMID>33122141</PMID>
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<citation>Moreira MS, Neves ILI, de Bernoche CYSM, Sarra G, Dos Santos-Paul MA, Campos Neves da Silva F, Schroter GT, Montano TCP, de Carvalho CMA, Neves RS. Bilateral paresthesia associated with cardiovascular disease and COVID-19. Oral Dis. 2022 Apr;28 Suppl 1(Suppl 1):912-915. doi: 10.1111/odi.13539. Epub 2020 Aug 1. No abstract available.</citation>
<PMID>32640483</PMID>
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<citation>Natoli S, Oliveira V, Calabresi P, Maia LF, Pisani A. Does SARS-Cov-2 invade the brain? Translational lessons from animal models. Eur J Neurol. 2020 Sep;27(9):1764-1773. doi: 10.1111/ene.14277. Epub 2020 May 22.</citation>
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<citation>GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.</citation>
<PMID>14076341</PMID>
</reference>
<reference>
<citation>Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DK, Bleicker T, Brunink S, Schneider J, Schmidt ML, Mulders DG, Haagmans BL, van der Veer B, van den Brink S, Wijsman L, Goderski G, Romette JL, Ellis J, Zambon M, Peiris M, Goossens H, Reusken C, Koopmans MP, Drosten C. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020 Jan;25(3):2000045. doi: 10.2807/1560-7917.ES.2020.25.3.2000045. Erratum In: Euro Surveill. 2020 Apr;25(14): Euro Surveill. 2020 Jul;25(30): Euro Surveill. 2021 Feb;26(5):</citation>
<PMID>31992387</PMID>
</reference>
<verification_date>August 2023</verification_date>
<study_first_submitted>December 15, 2021</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>August 2, 2023</last_update_submitted>
<last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">August 7, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
<investigator_full_name>Itamara Lucia Itagiba Neves</investigator_full_name>
<investigator_title>itamara@incor.usp.br</investigator_title>
</responsible_party>
<keyword>COVID-19</keyword>
<keyword>Viral load</keyword>
<keyword>Dental treatment</keyword>
<keyword>Intensive care unit</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>COVID-19</mesh_term>
<mesh_term>Mouth Diseases</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>After the defense of the thesis, the digital file available on the Portal Digital Library of Theses and Dissertations of the University of São Paulo, in portable document format (PDF) file.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The prevalence and clinical relevance of viremia in patients with COVID-19 have not been well
investigated. Seeking to understand the need for dentistry to perform bloody procedures in
critically ill patients with COVID-19 admitted to the ICU, the quantification of the
magnitude of viral replication may play a fundamental role in this scenario. For this, it is
necessary to study the viremia kinetics of SARS-CoV-2, seeking to assess whether there is any
characteristic pattern that may be associated with a worse clinical outcome of the patient
with COVID-19 after undergoing bloody dental procedures, therefore, the objective of this
research will be to investigate the occurrence of viral kinetics produced by dental
procedures in patients with SARS-CoV-2 in Intensive Care Units, where, in addition to
analyzing the oral health condition, the viral kinetics of SARS-CoV-2 will also be
investigated by means of reverse transcription polymerase chain reaction (RT-PCR) examination
of blood samples from patients with COVID-19 undergoing bloody dental treatment. This
research is expected to identify risks and consequences regarding the possibility of
performing bloody dental treatment in patients with COVID-19 in serious condition, in
addition to verifying the association of the impact of oral infection foci on this profile of
patients.
Inclusion Criteria: Patients between 16 and 90 years old who describe subgingival scaling
of at least one dental sextant or a tooth extraction.
Exclusion Criteria: Patients who cannot perform clinical examination and/or open dental
procedure.
|
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