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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>
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<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>
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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>
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<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>
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<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.
|
NCT0531xxxx/NCT05311423.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/NCT05311423</url>
</required_header>
<id_info>
<org_study_id>KY2021-840</org_study_id>
<nct_id>NCT05311423</nct_id>
</id_info>
<brief_title>The Prevalence and Reproductive Outcome of Infertile Women With Genital Tuberculosis</brief_title>
<acronym>TB-PRIME</acronym>
<official_title>The Prevalence of Genital Tuberculosis and the Impact on Reproductive Outcomes in Infertile Women: a National Multicenter Prospective Cohort Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Huashan Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Shanghai First Maternity and Infant Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>General Hospital of Ningxia Medical University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Tang-Du Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>The First Affiliated Hospital of Zhengzhou University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>The 924th Hospital of Joint Logistics Support Force of Chinese People's Liberation</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Shenzhen Zhongshan Urology Hospita</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Northwest Women's and Children's Hospital, Xi'an, Shaanxi</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Jiangxi Maternal and Child Health Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>The First People's Hospital of Yunnan</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Tongji Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>The Second Hospital of Hebei Medical University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>First Affiliated Hospital of Wenzhou Medical University</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Huashan 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>
Female genital tuberculosis infection (FGTB) is an important cause of female infertility in
TB-endemic areas. The pregnancy rate of assisted reproductive treatment (ART) in the
infertile women with FGTB is still unsatisfied even after receiving standard
anti-tuberculosis treatment. Moreover, recent years have witnessed an alarming increase in
reports of FGTB-related maternal and neonatal complications after fertility treatments. These
underscore that timely detection and treatment of FGTB before ART hold benefit for the mother
and child.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This project aims to recruit infertile female with high risk of tuberculosis infecton who
need assisted reproductive treatment in multiple reproductive centers. The
infertility-related medical history and laboratory examination results were recorded
according to clinical routine, and other essential information such as tuberculosis symptoms,
tuberculosis-related history and other health conditions were also recorded, and the
pregnancy outcomes of these patients were followed up.

According to the results of clinical screening, they were divided into four cohorts:
non-tuberculosis (non-TB) group, latent tuberculosis infection (LTBI) group, subclinical
genital tuberculosis infection (SGTB) group and female genital tuberculosis infection (FGTB)
group.

Non-TB group: QuantiFERON-TB test (QFT) negative, continue assisted reproductive treatment;
LTBI group: QFT positive. Excluded active pulmonary tuberculosis, patients have negative
endometrial histopathology, acid-fast bacilli (AFB) microscopy, Mycobacterium tuberculosis
(Mtb) culture, or GeneXpert MTB/RIF Ultra test results. Then assisted reproductive treatment
can be continued, but follow-up for tuberculosis-related symptoms is required; SGTB group:
QFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial
histopathology, AFB microscopy, Mtb culture, but GeneXpert MTB/RIF Ultra positive test
results. They are recommended to receive 6-month first-line standard anti-tuberculosis
treatment (ATT) regimen; FGTB group: QFT positive. Excluded active pulmonary tuberculosis,
regardless of GeneXpert MTB/RIF Ultra results, at least one of these test results, including
endometrial histopathologiy, AFB microscopy, Mtb culture is positive, they will receive
6-month ATT.

Patients diagnosed with SGTB and FGTB will receive 6-month first-line standard ATT before
ART, and follow up their anti-tuberculosis drug-related adverse reactions (TB-ARs) according
to clinical routine to prevent the occurrence of grade 3-4 adverse drug reactions.

All cohorts will be followed up for pregnancy outcomes after entering the assisted
reproduction cycle, and the pregnancy outcomes of all subjects after the first assisted
reproduction after enrollment were recorded. Follow-up nodes included the 2nd, 4th, 10th
weeks and 37th weeks of gestation. Follow-up content includes pregnancy status. Follow-up
subjects will be terminated when adverse pregnancy outcomes such as ectopic pregnancy and
miscarriage occurred; follow-up of pregnant participants will be extended to 2 weeks
postpartum. Participants from the SGTB or FGTB group achieve pregnant naturally after drug
withdrawal, the follow-up of the natural pregnancy outcome will be started as well.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">December 1, 2021</start_date>
<completion_date type="Anticipated">August 1, 2023</completion_date>
<primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date>
<study_type>Observational [Patient Registry]</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<target_duration>18 Months</target_duration>
<primary_outcome>
<measure>Clinical pregnancy rate of ART</measure>
<time_frame>2 years</time_frame>
<description>the number of participants with gestational sacs seen by ultrasound examination 4-6 weeks after transplantation/the number of embryo transfer cycles in this group</description>
</primary_outcome>
<primary_outcome>
<measure>Continued pregnancy rate of ART</measure>
<time_frame>2 years</time_frame>
<description>the number of patients whose pregnancy was confirmed by repeat ultrasonography at 10th week of gestation/the number of embryo transfer cycles in this group</description>
</primary_outcome>
<primary_outcome>
<measure>Prevalence of SGTB among infertile women</measure>
<time_frame>6 months</time_frame>
<description>the number of SGTB participants/the total number of this project</description>
</primary_outcome>
<secondary_outcome>
<measure>Prevalence of FGTB/LTBI among infertile women</measure>
<time_frame>2 years</time_frame>
<description>the number of each group/the total number of this project</description>
</secondary_outcome>
<secondary_outcome>
<measure>Abortion rate</measure>
<time_frame>2 years</time_frame>
<description>number of abortions/number of clinical pregnancy in non-TB or LTBI or SGTB or FGTB group</description>
</secondary_outcome>
<secondary_outcome>
<measure>Ectopic pregnancy rate</measure>
<time_frame>2 years</time_frame>
<description>number of ectopic pregnancy/number of clinical pregnancy in non-TB or LTBI or SGTB or FGTB group</description>
</secondary_outcome>
<secondary_outcome>
<measure>Preterm birth rate</measure>
<time_frame>2 years</time_frame>
<description>the number of premature births/the number of clinical pregnancy in non-TB or LTBI or SGTB or FGTB group</description>
</secondary_outcome>
<secondary_outcome>
<measure>Live birth rate</measure>
<time_frame>2 years</time_frame>
<description>the number of live births/the number of clinical pregnancy in non-TB or LTBI or SGTB or FGTB group</description>
</secondary_outcome>
<secondary_outcome>
<measure>Maternal mortality rate</measure>
<time_frame>2 years</time_frame>
<description>the number of maternal mortality/the number of clinical pregnancy in non-TB or LTBI or SGTB or FGTB group</description>
</secondary_outcome>
<secondary_outcome>
<measure>Neonatal mortality rate</measure>
<time_frame>2 years</time_frame>
<description>the number of neonatal mortality/the number of clinical pregnancy in non-TB or LTBI or SGTB or FGTB group</description>
</secondary_outcome>
<secondary_outcome>
<measure>Spontaneous pregnancy rate</measure>
<time_frame>2 years</time_frame>
<description>number of Spontaneous pregnancy/number of subjects completed ATT in FGTB/SGTB group</description>
</secondary_outcome>
<secondary_outcome>
<measure>The incidence of grade 3-4 adverse events</measure>
<time_frame>2 years</time_frame>
<description>the number of patients with grade 3-4 adverse events during anti-tuberculosis treatment / the total number of in FGTB/SGTB group</description>
</secondary_outcome>
<secondary_outcome>
<measure>The rate of drug discontinuation due to adverse drug reactions</measure>
<time_frame>2 years</time_frame>
<description>the number of patients who discontinued in anti-tuberculosis treatment due to adverse drug reactions / the total number of patients with adverse reactions in FGTB/SGTB group</description>
</secondary_outcome>
<secondary_outcome>
<measure>Treatment completion rate</measure>
<time_frame>2 years</time_frame>
<description>number of patients who completed anti-tuberculosis treatment / total number of patients in this group × 100%</description>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of active tuberculosis of LTBI group during 1 year after enrollment</measure>
<time_frame>1 year</time_frame>
<description>the number of subjects who develop to active tuberculosis during 1 year after enrollment/the number of subjects of LTBI group</description>
</secondary_outcome>
<number_of_groups>4</number_of_groups>
<enrollment type="Anticipated">3000</enrollment>
<condition>Infertility, Female</condition>
<condition>Genital Tuberculoses, Female</condition>
<arm_group>
<arm_group_label>Non-TB Group</arm_group_label>
<description>QuantiFERON-TB test (QFT) negative, continue assisted reproductive treatment</description>
</arm_group>
<arm_group>
<arm_group_label>Latent tuberculosis infection Group</arm_group_label>
<description>QFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial histopathology, acid-fast bacilli (AFB) microscopy, Mycobacterium tuberculosis (Mtb) culture, or GeneXpert MTB/RIF Ultra test results. Then assisted reproductive treatment can be continued, but follow-up for tuberculosis-related symptoms is required</description>
</arm_group>
<arm_group>
<arm_group_label>Subclinical genital tuberculosis Group</arm_group_label>
<description>QFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial histopathology, AFB microscopy, Mtb culture, but GeneXpert MTB/RIF Ultra positive test results. They are recommended to receive 6-month first-line standard anti-tuberculosis treatment (ATT) regimen</description>
</arm_group>
<arm_group>
<arm_group_label>Female genital tuberculosis Group</arm_group_label>
<description>QFT positive. Excluded active pulmonary tuberculosis, regardless of GeneXpert MTB/RIF Ultra results, at least one of these test results, including endometrial histopathologiy, AFB microscopy, Mtb culture is positive, they will receive 6-month ATT</description>
</arm_group>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert Ultra</intervention_name>
<description>Endometrial biopsy is required to diagnose LTBI, SGTB and FGTB, which is an invasive operation and increases patients' economic burden. A screening method has been established that uses the interferon gamma release test as the primary screening test, and those who are positive undergo endometrial biopsy. Therefore, this project will use QFT to screen participants with Mtb infection, and further endometrium biopsy will be performed for QFT positive patients to diagnose LTBI, FGTB and SGTB. For participants with negative results for all diagnostic tests but QFT (defined as LTBI), close follow-up is necessary according to WHO guidelines.</description>
<arm_group_label>Female genital tuberculosis Group</arm_group_label>
<arm_group_label>Latent tuberculosis infection Group</arm_group_label>
<arm_group_label>Non-TB Group</arm_group_label>
<arm_group_label>Subclinical genital tuberculosis Group</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Infertile female patients with high risk factors for tuberculosis infection who intend to
undergo assisted reproduction
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- 1) Female, aged ≥20 years and <43 years old;

- 2) In line with conventional assisted reproduction indications;

- 3) Meet any of the following:

1. with tuberculosis infection history;

2. with a history of close contact to tuberculosis patients;

3. exact positive IGRA results in the past or chest imaging indicated a past history
of pulmonary tuberculosis;

4. suspected symptoms of tuberculosis, including fever, night sweats, fatigue, cough
and sputum;

5. suspected symptoms of genital tuberculosis, including lower abdominal pain,
abnormal menstruation, fallopian tube stenosis, obstruction, thickening, beading
changes, uterine cavity adhesions, deformation, pelvic adhesions, etc.;

- 4) Voluntarily join the study and sign the informed consent

Exclusion Criteria:

- 1) Co-infection with HIV;

- 2) Chromosomal abnormalities;

- 3) suspected genital tuberculosis infection symptoms (participants meet inclusion
criteria 3)e in Inclusion Criteria) known to be caused only by factors part from
tuberculosis, such as endocrine factors, history of ectopic pregnancy, history of
uterine curettage, chronic pelvic inflammatory disease, endometriosis, malignant
tumors, etc.;

- 4) There are other serious physical or mental illnesses that are not suitable for
selection;

- 5) Participate in other clinical studies that would affect this study at the same
time.
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>20 Years</minimum_age>
<maximum_age>43 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Qiaoling Ruan, Dr.</last_name>
<phone>021-52887946</phone>
<email>qlruan07@fudan.edu.cn</email>
</overall_contact>
<overall_contact_backup>
<last_name>Xiaoming Teng, Dr.</last_name>
<phone>021-54035206</phone>
<email>tengxiaoming@51mch.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Shanghai First Maternity and Infant Hospital</name>
<address>
<city>Shanghai</city>
<state>Shanghai</state>
<zip>200051</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Xiaoming Teng, Dr.</last_name>
<phone>021-54035206</phone>
<email>tengxiaoming@51mch.com</email>
</contact>
<investigator>
<last_name>Xiaoming Teng, Dr.</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Zhiqin Chen, Dr.</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>January 21, 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>Huashan Hospital</investigator_affiliation>
<investigator_full_name>Wen-hong Zhang</investigator_full_name>
<investigator_title>director of department of infectious diseases</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Tuberculosis</mesh_term>
<mesh_term>Tuberculosis, Female Genital</mesh_term>
<mesh_term>Infertility</mesh_term>
<mesh_term>Infertility, Female</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Female genital tuberculosis infection (FGTB) is an important cause of female infertility in
TB-endemic areas. The pregnancy rate of assisted reproductive treatment (ART) in the
infertile women with FGTB is still unsatisfied even after receiving standard
anti-tuberculosis treatment. Moreover, recent years have witnessed an alarming increase in
reports of FGTB-related maternal and neonatal complications after fertility treatments. These
underscore that timely detection and treatment of FGTB before ART hold benefit for the mother
and child.
This project aims to recruit infertile female with high risk of tuberculosis infecton who
need assisted reproductive treatment in multiple reproductive centers. The
infertility-related medical history and laboratory examination results were recorded
according to clinical routine, and other essential information such as tuberculosis symptoms,
tuberculosis-related history and other health conditions were also recorded, and the
pregnancy outcomes of these patients were followed up.
According to the results of clinical screening, they were divided into four cohorts:
non-tuberculosis (non-TB) group, latent tuberculosis infection (LTBI) group, subclinical
genital tuberculosis infection (SGTB) group and female genital tuberculosis infection (FGTB)
group.
Non-TB group: QuantiFERON-TB test (QFT) negative, continue assisted reproductive treatment;
LTBI group: QFT positive. Excluded active pulmonary tuberculosis, patients have negative
endometrial histopathology, acid-fast bacilli (AFB) microscopy, Mycobacterium tuberculosis
(Mtb) culture, or GeneXpert MTB/RIF Ultra test results. Then assisted reproductive treatment
can be continued, but follow-up for tuberculosis-related symptoms is required; SGTB group:
QFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial
histopathology, AFB microscopy, Mtb culture, but GeneXpert MTB/RIF Ultra positive test
results. They are recommended to receive 6-month first-line standard anti-tuberculosis
treatment (ATT) regimen; FGTB group: QFT positive. Excluded active pulmonary tuberculosis,
regardless of GeneXpert MTB/RIF Ultra results, at least one of these test results, including
endometrial histopathologiy, AFB microscopy, Mtb culture is positive, they will receive
6-month ATT.
Patients diagnosed with SGTB and FGTB will receive 6-month first-line standard ATT before
ART, and follow up their anti-tuberculosis drug-related adverse reactions (TB-ARs) according
to clinical routine to prevent the occurrence of grade 3-4 adverse drug reactions.
All cohorts will be followed up for pregnancy outcomes after entering the assisted
reproduction cycle, and the pregnancy outcomes of all subjects after the first assisted
reproduction after enrollment were recorded. Follow-up nodes included the 2nd, 4th, 10th
weeks and 37th weeks of gestation. Follow-up content includes pregnancy status. Follow-up
subjects will be terminated when adverse pregnancy outcomes such as ectopic pregnancy and
miscarriage occurred; follow-up of pregnant participants will be extended to 2 weeks
postpartum. Participants from the SGTB or FGTB group achieve pregnant naturally after drug
withdrawal, the follow-up of the natural pregnancy outcome will be started as well.
Infertile female patients with high risk factors for tuberculosis infection who intend to
undergo assisted reproduction
Inclusion Criteria:
- 1) Female, aged ≥20 years and <43 years old;
- 2) In line with conventional assisted reproduction indications;
- 3) Meet any of the following:
1. with tuberculosis infection history;
2. with a history of close contact to tuberculosis patients;
3. exact positive IGRA results in the past or chest imaging indicated a past history
of pulmonary tuberculosis;
4. suspected symptoms of tuberculosis, including fever, night sweats, fatigue, cough
and sputum;
5. suspected symptoms of genital tuberculosis, including lower abdominal pain,
abnormal menstruation, fallopian tube stenosis, obstruction, thickening, beading
changes, uterine cavity adhesions, deformation, pelvic adhesions, etc.;
- 4) Voluntarily join the study and sign the informed consent
Exclusion Criteria:
- 1) Co-infection with HIV;
- 2) Chromosomal abnormalities;
- 3) suspected genital tuberculosis infection symptoms (participants meet inclusion
criteria 3)e in Inclusion Criteria) known to be caused only by factors part from
tuberculosis, such as endocrine factors, history of ectopic pregnancy, history of
uterine curettage, chronic pelvic inflammatory disease, endometriosis, malignant
tumors, etc.;
- 4) There are other serious physical or mental illnesses that are not suitable for
selection;
- 5) Participate in other clinical studies that would affect this study at the same
time.
|
NCT0531xxxx/NCT05311436.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/NCT05311436</url>
</required_header>
<id_info>
<org_study_id>PR-21082</org_study_id>
<nct_id>NCT05311436</nct_id>
</id_info>
<brief_title>Nutri-CAP: Nutrition for Children, Adolescent Girls, and Pregnant Women in Slums of Dhaka City</brief_title>
<official_title>Nutri-CAP: Nutrition for Children, Adolescent Girls, and Pregnant Women in Slums of Dhaka City</official_title>
<sponsors>
<lead_sponsor>
<agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Global Affairs Canada</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>International Centre for Diarrhoeal Disease Research, Bangladesh</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The objective of the research project is to establish an evidence-based sustainable nutrition
service delivery platform for optimizing pregnancy weight gain, increasing dietary diversity
of adolescent girls, and ensuring proper physical growth of under 2 children.

Hypothesis

1. Pregnant Women: Intensive nutrition and WASH counseling, iron-folate, calcium
supplementation during pregnancy, can improve gestational weight gain and improve
hemoglobin status in pregnant women in a slum of Dhaka city

2. Adolescent girl: Iron and zinc supplementation and nutrition counseling on dietary
diversity could improve nutritional status and dietary diversity score in adolescent
girls of slums in Dhaka

3. Children <2 years: Counselling on IYCF, growth monitoring, and promotion, ensuring
six-monthly vitamin A supplementation, counseling on WASH, treatment of acute
malnutrition, and daily 1 egg supplementation for 3 months for severely stunted children
can improve the nutritional status of children

4. Counselling to improve Water, Sanitation and Hygiene (WASH) practice: WASH intervention
can improve EED biomarkers
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Background

1. Burden: The emergence of COVID-19 poses a substantial public health risk to the world.
Our research done at the peak of the lockdown in Dhaka city showed that 90% of more than
200 households surveyed in a slum in Dhaka city and villages of Matlab in rural
Bangladesh suffered from food insecurity, the situation was worse in the slum areas. Our
previous work demonstrated that 50% of under-five children in slums have stunted growth,
half of all children suffer from deficiency of zinc. Our recently completed study
revealed that third-trimester weight gain was poor in general among rural women in
Matlab, Bangladesh, and 54% of the women failed to gain adequate weight (>4 kg) in the
third trimester.

2. Knowledge gap: Although the burden of undernutrition, as well as adverse consequences of
nutritional impairment, is prominent in Bangladesh, there is no platform to implement
sustainable nutrition delivery services in slums, particularly for children, adolescent
girls, and mothers with pregnancy. In addition, there lack of data on the status of
pregnancy weight gain, dietary diversity both in pregnant women and adolescent girls in
slums. Evidence on the role of Infant and Young Child Feeding (IYCF), growth monitoring
and promotion, micronutrient supplementation, and counseling on Water, Sanitation, and
Hygiene (WASH) in improving childhood growth and ameliorating Environmental Enteric
Dysfunction (EED) is also limited.

3. Relevance: Such lack of knowledge limits the success of nutritional programs being done
in slums. Moreover, it is causing obstacles in reducing the nutritional burden among
three vulnerable groups of the population.

Methods

This study will be conducted in the Bauniabadh and the adjacent slum areas of Dhaka city.
This study includes a community survey, formative study, community-based nutrition
intervention, and an evaluation of the programmatic intervention using a quasi-experimental
design.

Bauniabadh slum area has a population of ~150,000. It has five blocks: A, B, C, D, and E.
Blocks B, C, and E will be the intervention area for programmatic intervention and A and D
will be the control area where no intervention will be provided. Blocks A, and D is separated
from other blocks by a road, a school, and a water body.

At first, a community survey will be conducted to identify the total number of beneficiaries
in both the control and intervention areas: under 2 years old children, adolescent girls, and
pregnant women at or before 16 weeks of gestation.

The formative research includes 24-h dietary recalls, in-depth interviews with purposively
selected household heads, women, adolescent girls, and focus group discussions with women and
adolescent girls to explore the locally available foods to prepare nutritious diets for
pregnant women and adolescent girls. Moreover, this formative study will help in tailoring
the messages for group counseling sessions on nutrition and WASH on the perspectives of the
slum dwellers in Dhaka city. All counseling materials for the programmatic intervention will
be developed from data generated from the formative research and using existing materials.

In the intervention area, nutrition intervention will be provided to all pregnant women,
adolescent girls, and children under the age of 2 years. For pregnant women, intensive
dietary counseling will be provided through household visits. The intervention also includes
daily iron-folate and calcium supplementation to the pregnant women for the remaining
pregnancy period till childbirth, and at least four antenatal visits to local ANC service
providers will be ensured. For all adolescent girls, monthly two nutrition education sessions
for six months will be organized to improve dietary diversity. Adolescent girls will also
receive weekly iron and folate supplementation for 3 months and 10 mg of zinc sulfate tablet
daily for 1 month. Training research staff will do monthly growth monitoring and promotion
for all under 2-year-old children. All children suffering from acute malnutrition will be
treated and severely stunted children will be supplemented with one egg daily for 3
consecutive months and multiple micronutrient powders for six months. Additionally,
counseling on water sanitation and hygiene, and food safety will be provided to all
beneficiary households. This program will ensure community participation to improve the
garbage disposal system, water supply and cleaning of drains in the area.

The primary outcome measures will be total pregnancy weight gain (kg) and rate of weight gain
(kg/week) for pregnant women. Change in dietary diversity scores in adolescent girls and
change in length-for-age z-score for children under the age of 2 years.

Evaluation will be done using a quasi-experimental design. Data related to outcome indicators
will be collected from target groups from both the intervention and the controls areas.

At the end of the intervention, based on calculated sample sizes to see the changes in
outcome variables, at a 5% level of significance with 90% power, we will need to enroll at
least 199 pregnant women, 572 adolescent girls, 420 <2 children in each group. Based on
previous data, we assume that the total available sample sizes for the programmatic
intervention will be 400 pregnant women, 1200 adolescent girls, and 1500 for children <2
years. Therefore, our sample size will have more than enough power to test our hypotheses.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">July 1, 2022</start_date>
<completion_date type="Anticipated">August 31, 2024</completion_date>
<primary_completion_date type="Anticipated">February 29, 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Non-Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Prevention</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Gestational weight gain</measure>
<time_frame>From the 16th week of gestation to child birth</time_frame>
<description>Change in gestational weight gain and rate of weight gain in the pregnant woman</description>
</primary_outcome>
<primary_outcome>
<measure>Dietary Diversity</measure>
<time_frame>6 months</time_frame>
<description>Change in Dietary Diversity of Adolescent Girl</description>
</primary_outcome>
<primary_outcome>
<measure>Improve linear growth</measure>
<time_frame>1 year</time_frame>
<description>Change in length for age z-score of children less than 2 years</description>
</primary_outcome>
<secondary_outcome>
<measure>Hemoglobin level of adolescent girl</measure>
<time_frame>6 months</time_frame>
<description>A change in hemoglobin level Adolescent Girl</description>
</secondary_outcome>
<secondary_outcome>
<measure>IYCF indicators</measure>
<time_frame>1 year</time_frame>
<description>A change in WHO's core IYCF indicators for Children <2 years</description>
</secondary_outcome>
<other_outcome>
<measure>Hemoglobin level of Pregnant woman</measure>
<time_frame>16 week of pregnancy to child birth</time_frame>
<description>A change in hemoglobin level of Pregnant woman</description>
</other_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">3260</enrollment>
<condition>Gestational Weight Gain</condition>
<condition>Diet, Food, and Nutrition</condition>
<condition>Undernutrition</condition>
<condition>Health Behavior</condition>
<arm_group>
<arm_group_label>Experimental</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Pregnant women will receive monthly intensive dietary counseling, daily iron-folate, calcium supplementation, and at least four antenatal visits to local ANC service providers from enrollment before 16 weeks of gestation to delivery of the baby will be ensured.
Adolescent girls will receive twice-monthly nutrition education sessions to improve dietary diversity scores from enrolment to 6 months of enrollment.
Under 2y children will receive monthly growth monitoring and promotion, IYCF counseling
Severely stunted children: Daily 1 egg for 3 consecutive months and 1 sachet of multiple micronutrient powder supplementation for 6 months.</description>
</arm_group>
<arm_group>
<arm_group_label>Control</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Participants will receive the standard of care in the area</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Experimental - Intensive nutrition counselling for pregnant, adolescent and under2 children</intervention_name>
<description>Pregnant women: Intensive dietary counseling using diet chart for locally available food, and to attend antenatal care services from local ANC providers, daily Iron, folic acid, and calcium supplementation
Adolescent girls: Behavioral: Group sessions in the nutrition centers with the adolescent girls will be conducted twice monthly for six months. Iron and folic acid (200 mg ferrous fumarate and 200 μg folic acid); once weekly for 3 months; zinc 10 mg daily for 1 month
Children <2 years: Behavioral counseling sessions through monthly home visits on Infant and Young Child feeding, Growth monitoring and promotion, and water sanitation and hygiene, and food safety,
Severely stunted children: 1 egg supplementation for 3 months and 1 sachet of multiple micronutrient powder (1 RDA of vitamin A and C, iron-folic acid, and zinc) daily for 6 months.</description>
<arm_group_label>Experimental</arm_group_label>
<other_name>Iron, folic acid and calcium supplementation for pregnant women</other_name>
<other_name>Zinc and iron-folate supplementation to adolescent gilrs</other_name>
<other_name>Egg supplementation to severely stunted children daily for 3 months to</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Pregnant women:

- Age 18-39 years

- Before 16 weeks of gestation

- BMI 15-24.99 kg/m2 measured on enrolment

- Have the plan to stay in the study area till delivery

- Willing to participate in the study

- Not enrolled in any nutrition project/programme currently

Adolescent girls:

- Aged 11-19 years

- Willing to participate in the study

- Not involved in any nutrition project/programme

- Will stay in the study area for the next 2 years

Children:

- Aged 0-24 months

- Youngest child of the household

- Caregivers have the plan to stay in the study area at least up to two years of age

- Not enrolled in any nutrition project/programme currently

Exclusion Criteria:

- Pregnant women:

- Subject not willing to provide consent

- Subject has the plan to migrate outside of the study area during the study period

- Subject has a plan to go elsewhere ( village/ parents' house) for delivery

- Any reported/diagnosed chronic diseases (such as hypertension, heart disease,
chronic obstructive pulmonary disease, chronic kidney disease, chronic liver
disease, pancreatic diseases, diabetes mellitus, thyroid dysfunction,
immunological diseases, malignancy, or any other diseases which could impede
compliance with the study protocol)

- Extremely obese

- Subject involved in any nutrition programme/ intervention currently

Adolescent girls:

- Subject not willing to give assent/consent

- Subject has the plan to migrate outside the study area during the study period

- Subject involved in any nutrition programme/intervention currently

Children:

- Caregiver/guardian not willing to provide consent

- Have the plan to migrate outside of the study area during the study period

- Child with any congenital anomaly

- Subject involved in any nutrition programme/intervention currently
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>1 Day</minimum_age>
<maximum_age>39 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Mustafa Mahfuz, MBBS, MPH</last_name>
<role>Principal Investigator</role>
<affiliation>International Centre for Diarrhoeal Disease Research, Bangladesh</affiliation>
</overall_official>
<overall_contact>
<last_name>Mustafa Mahfuz, MBBS, MPH</last_name>
<phone>_+880-2-2222277001-10</phone>
<phone_ext>2304</phone_ext>
<email>mustafa@icddrb.org</email>
</overall_contact>
<overall_contact_backup>
<last_name>Fahmida Farzana, MSc, MPH</last_name>
<phone>_+880-2-2222277001-10</phone>
<phone_ext>2280</phone_ext>
<email>fahmidaf@icddrb.org</email>
</overall_contact_backup>
<location>
<facility>
<name>International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)</name>
<address>
<city>Dhaka</city>
<zip>1236</zip>
<country>Bangladesh</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Mustafa Mahfuz, MBBS, MPH</last_name>
<phone>+8802222277001</phone>
<phone_ext>2304</phone_ext>
<email>mustafa@icddrb.org</email>
</contact>
</location>
<location_countries>
<country>Bangladesh</country>
</location_countries>
<verification_date>April 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>August 29, 2022</last_update_submitted>
<last_update_submitted_qc>August 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">August 30, 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>Malnutrition</mesh_term>
<mesh_term>Weight Gain</mesh_term>
<mesh_term>Gestational Weight Gain</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Iron</mesh_term>
<mesh_term>Folic Acid</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The objective of the research project is to establish an evidence-based sustainable nutrition
service delivery platform for optimizing pregnancy weight gain, increasing dietary diversity
of adolescent girls, and ensuring proper physical growth of under 2 children.
Hypothesis
1. Pregnant Women: Intensive nutrition and WASH counseling, iron-folate, calcium
supplementation during pregnancy, can improve gestational weight gain and improve
hemoglobin status in pregnant women in a slum of Dhaka city
2. Adolescent girl: Iron and zinc supplementation and nutrition counseling on dietary
diversity could improve nutritional status and dietary diversity score in adolescent
girls of slums in Dhaka
3. Children <2 years: Counselling on IYCF, growth monitoring, and promotion, ensuring
six-monthly vitamin A supplementation, counseling on WASH, treatment of acute
malnutrition, and daily 1 egg supplementation for 3 months for severely stunted children
can improve the nutritional status of children
4. Counselling to improve Water, Sanitation and Hygiene (WASH) practice: WASH intervention
can improve EED biomarkers
Background
1. Burden: The emergence of COVID-19 poses a substantial public health risk to the world.
Our research done at the peak of the lockdown in Dhaka city showed that 90% of more than
200 households surveyed in a slum in Dhaka city and villages of Matlab in rural
Bangladesh suffered from food insecurity, the situation was worse in the slum areas. Our
previous work demonstrated that 50% of under-five children in slums have stunted growth,
half of all children suffer from deficiency of zinc. Our recently completed study
revealed that third-trimester weight gain was poor in general among rural women in
Matlab, Bangladesh, and 54% of the women failed to gain adequate weight (>4 kg) in the
third trimester.
2. Knowledge gap: Although the burden of undernutrition, as well as adverse consequences of
nutritional impairment, is prominent in Bangladesh, there is no platform to implement
sustainable nutrition delivery services in slums, particularly for children, adolescent
girls, and mothers with pregnancy. In addition, there lack of data on the status of
pregnancy weight gain, dietary diversity both in pregnant women and adolescent girls in
slums. Evidence on the role of Infant and Young Child Feeding (IYCF), growth monitoring
and promotion, micronutrient supplementation, and counseling on Water, Sanitation, and
Hygiene (WASH) in improving childhood growth and ameliorating Environmental Enteric
Dysfunction (EED) is also limited.
3. Relevance: Such lack of knowledge limits the success of nutritional programs being done
in slums. Moreover, it is causing obstacles in reducing the nutritional burden among
three vulnerable groups of the population.
Methods
This study will be conducted in the Bauniabadh and the adjacent slum areas of Dhaka city.
This study includes a community survey, formative study, community-based nutrition
intervention, and an evaluation of the programmatic intervention using a quasi-experimental
design.
Bauniabadh slum area has a population of ~150,000. It has five blocks: A, B, C, D, and E.
Blocks B, C, and E will be the intervention area for programmatic intervention and A and D
will be the control area where no intervention will be provided. Blocks A, and D is separated
from other blocks by a road, a school, and a water body.
At first, a community survey will be conducted to identify the total number of beneficiaries
in both the control and intervention areas: under 2 years old children, adolescent girls, and
pregnant women at or before 16 weeks of gestation.
The formative research includes 24-h dietary recalls, in-depth interviews with purposively
selected household heads, women, adolescent girls, and focus group discussions with women and
adolescent girls to explore the locally available foods to prepare nutritious diets for
pregnant women and adolescent girls. Moreover, this formative study will help in tailoring
the messages for group counseling sessions on nutrition and WASH on the perspectives of the
slum dwellers in Dhaka city. All counseling materials for the programmatic intervention will
be developed from data generated from the formative research and using existing materials.
In the intervention area, nutrition intervention will be provided to all pregnant women,
adolescent girls, and children under the age of 2 years. For pregnant women, intensive
dietary counseling will be provided through household visits. The intervention also includes
daily iron-folate and calcium supplementation to the pregnant women for the remaining
pregnancy period till childbirth, and at least four antenatal visits to local ANC service
providers will be ensured. For all adolescent girls, monthly two nutrition education sessions
for six months will be organized to improve dietary diversity. Adolescent girls will also
receive weekly iron and folate supplementation for 3 months and 10 mg of zinc sulfate tablet
daily for 1 month. Training research staff will do monthly growth monitoring and promotion
for all under 2-year-old children. All children suffering from acute malnutrition will be
treated and severely stunted children will be supplemented with one egg daily for 3
consecutive months and multiple micronutrient powders for six months. Additionally,
counseling on water sanitation and hygiene, and food safety will be provided to all
beneficiary households. This program will ensure community participation to improve the
garbage disposal system, water supply and cleaning of drains in the area.
The primary outcome measures will be total pregnancy weight gain (kg) and rate of weight gain
(kg/week) for pregnant women. Change in dietary diversity scores in adolescent girls and
change in length-for-age z-score for children under the age of 2 years.
Evaluation will be done using a quasi-experimental design. Data related to outcome indicators
will be collected from target groups from both the intervention and the controls areas.
At the end of the intervention, based on calculated sample sizes to see the changes in
outcome variables, at a 5% level of significance with 90% power, we will need to enroll at
least 199 pregnant women, 572 adolescent girls, 420 <2 children in each group. Based on
previous data, we assume that the total available sample sizes for the programmatic
intervention will be 400 pregnant women, 1200 adolescent girls, and 1500 for children <2
years. Therefore, our sample size will have more than enough power to test our hypotheses.
Inclusion Criteria:
- Pregnant women:
- Age 18-39 years
- Before 16 weeks of gestation
- BMI 15-24.99 kg/m2 measured on enrolment
- Have the plan to stay in the study area till delivery
- Willing to participate in the study
- Not enrolled in any nutrition project/programme currently
Adolescent girls:
- Aged 11-19 years
- Willing to participate in the study
- Not involved in any nutrition project/programme
- Will stay in the study area for the next 2 years
Children:
- Aged 0-24 months
- Youngest child of the household
- Caregivers have the plan to stay in the study area at least up to two years of age
- Not enrolled in any nutrition project/programme currently
Exclusion Criteria:
- Pregnant women:
- Subject not willing to provide consent
- Subject has the plan to migrate outside of the study area during the study period
- Subject has a plan to go elsewhere ( village/ parents' house) for delivery
- Any reported/diagnosed chronic diseases (such as hypertension, heart disease,
chronic obstructive pulmonary disease, chronic kidney disease, chronic liver
disease, pancreatic diseases, diabetes mellitus, thyroid dysfunction,
immunological diseases, malignancy, or any other diseases which could impede
compliance with the study protocol)
- Extremely obese
- Subject involved in any nutrition programme/ intervention currently
Adolescent girls:
- Subject not willing to give assent/consent
- Subject has the plan to migrate outside the study area during the study period
- Subject involved in any nutrition programme/intervention currently
Children:
- Caregiver/guardian not willing to provide consent
- Have the plan to migrate outside of the study area during the study period
- Child with any congenital anomaly
- Subject involved in any nutrition programme/intervention currently
|
NCT0531xxxx/NCT05311449.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/NCT05311449</url>
</required_header>
<id_info>
<org_study_id>Mersin Universit</org_study_id>
<nct_id>NCT05311449</nct_id>
</id_info>
<brief_title>The Effect of Post-Cesarean Section Acupressure on the Severity of Pain and First Mobilization Distance</brief_title>
<acronym>Acupress</acronym>
<official_title>The Effect of Acupressure After Cesarean Section on Pain Intensity and First Mobilization Distance: A Double-Blind Randomized Controlled Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Mersin University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Mersin University</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This randomized controlled trial evaluates the effect of acupressure application on
cesareans' pain and the number of steps in the first mobilization. This study hypothesizes
that acupressure reduces pain and improves number of steps.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Methods: In the study, 64 cesareans will randomly assigned to acupressure and placebo
acupressure groups. To the acupressure group (n = 32), an average of 15 minutes will be
applied to the LI4 (liver), P6 (pericardium) and the Sanyinjia points on the splenic meridian
(SP6) located on the inner side of the lower leg, four fingers above the ankle and behind the
tibia. In the placebo acupressure group (n = 32), the points 1.5 cm away from the LI4, P6 and
SP6 points (four points in total) will be applied for an average of 15 minutes. The primary
outcome of the research is the effect of acupressure on the pain of cesareans. The secondary
outcome of the study is to determine the effect of acupressure on the number of steps. The
pain will be collected before and 1 minute, 2nd and 4th hour after acupressure and placebo
acupressure administration. The number of steps will be collected 4th hour after acupressure
and placebo acupressure administration.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">June 26, 2022</start_date>
<completion_date type="Actual">July 22, 2022</completion_date>
<primary_completion_date type="Actual">June 26, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Prospective, parallel, two-arm, randomized controlled clinical trial, double blind</intervention_model_description>
<primary_purpose>Supportive Care</primary_purpose>
<masking>None (Open Label)</masking>
<masking_description>In the study, a researcher (T.Ç.Y.) will determine the acupressure and placebo points to be applied to women. However, the researcher (A.A.) who will apply acupressure and placebo acupressure be blinded without knowing whether these points are acupressure or placebo points. Participants will not know that they are in the acupressure or placebo group. Thus, the research will be carried out as a double-blind randomized controlled trial. When the research is completed, the data of the control and study groups (A or B) will be transferred to the computer environment by a researcher independent of the research, and the data will be analyzed by a statistician and the findings will be reported.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Pain evaluated using the visual analog scale</measure>
<time_frame>Change from before implementation and after 1 minute, 2nd and 4th hour after implementation</time_frame>
<description>The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain.</description>
</primary_outcome>
<secondary_outcome>
<measure>The number of steps using step counter (TNV 3D Pedometer (Model: PM2000, Made in China)</measure>
<time_frame>Change 4th hour after acupressure</time_frame>
<description>The number of steps in the first mobilization will be evaluated with a pedometer.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">64</enrollment>
<condition>Pain</condition>
<condition>Mobilization</condition>
<arm_group>
<arm_group_label>Acupressure Group (experimental)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The experimental group will be given acupressure.</description>
</arm_group>
<arm_group>
<arm_group_label>Placebo Acupressure Group (control)</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>The placebo group will be given placebo acupressure.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Acupressure</intervention_name>
<description>The experimental group will start with LI4 points, and continue with P6 and SP6 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.</description>
<arm_group_label>Acupressure Group (experimental)</arm_group_label>
<other_name>Acupress</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Plasebo acupressure</intervention_name>
<description>In the control group, the application will start with the points 1.5 cm around the LI4, P6 and SP6 points. The application process will continue in the same way with acupressure group and the pressure intensity will be less.</description>
<arm_group_label>Placebo Acupressure Group (control)</arm_group_label>
<other_name>Placebo Acupress</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Being conscious,

- The mother tongue is Turkish,

- To be oriented and cooperative,

- be between 18-45 years old,

- To voluntarily agree to participate in the study (signing the Informed Consent Form),

- Repeated cesarean section,

- Cesarean section under spinal anesthesia,

- Not having a risky pregnancy (preeclampsia, gestational diabetes etc.),

- No health problems of the fetus,

- To have given birth by cesarean section between 37-40 weeks,

- To be in the second hour of the postpartum period,

- Not receiving post-op patient-controlled analgesia,

- Not to have smoked or used alcohol during pregnancy,

- No complications in the mother and/or newborn after cesarean section,

- No sensitivity in the area where acupressure will be applied,

- Absence of any systemic or psychiatric diagnosis,

- Absence of active COVID-19 infection.

Exclusion Criteria:

- Lack of consciousness,

- The mother tongue is not Turkish,

- Not oriented and cooperative,

- Not to be between the ages of 18-45,

- Refusal to voluntarily participate in the study (those who did not sign the Informed
Consent Form),

- Normal birth or cesarean delivery under general anesthesia,

- Cesarean delivery due to the risk of deterioration of maternal or fetal health,

- Not having had a risky pregnancy (preeclampsia, gestational diabetes, etc.),

- Not giving birth outside 37-40 weeks and by cesarean section,

- Not in the second hour of the postpartum period,

- Receiving post-op patient-controlled analgesia,

- To have used cigarettes and alcohol during pregnancy,

- Sensitivity in the area where acupressure will be applied,

- Presence of any systemic or psychiatric diagnosis,

- Active COVID-19 infection.
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>45 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Duygu VEFİKULUÇAY YILMAZ, Doctorate</last_name>
<role>Study Director</role>
<affiliation>Mersin University</affiliation>
</overall_official>
<overall_official>
<last_name>Aslıhan AKSU, master</last_name>
<role>Principal Investigator</role>
<affiliation>Mersin University</affiliation>
</overall_official>
<overall_official>
<last_name>Filiz DEĞİRMENCİ, master</last_name>
<role>Principal Investigator</role>
<affiliation>Mersin University</affiliation>
</overall_official>
<overall_official>
<last_name>Gülay ALTUN UĞRAŞ, doctorate</last_name>
<role>Principal Investigator</role>
<affiliation>Mersin University</affiliation>
</overall_official>
<overall_official>
<last_name>Mürşide ÇEVİKOĞLU KILLI, doctorate</last_name>
<role>Principal Investigator</role>
<affiliation>Mersin City Hospital</affiliation>
</overall_official>
<location>
<facility>
<name>Mersin University</name>
<address>
<city>Mersin</city>
<state>Yenişehir</state>
<zip>33343</zip>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<reference>
<citation>Chen Y, Xiang XY, Chin KHR, Gao J, Wu J, Lao L, Chen H. Acupressure for labor pain management: a systematic review and meta-analysis of randomized controlled trials. Acupunct Med. 2021 Aug;39(4):243-252. doi: 10.1177/0964528420946044. Epub 2020 Aug 18.</citation>
<PMID>32811182</PMID>
</reference>
<results_reference>
<citation>Smith CA, Collins CT, Levett KM, Armour M, Dahlen HG, Tan AL, Mesgarpour B. Acupuncture or acupressure for pain management during labour. Cochrane Database Syst Rev. 2020 Feb 7;2(2):CD009232. doi: 10.1002/14651858.CD009232.pub2.</citation>
<PMID>32032444</PMID>
</results_reference>
<results_reference>
<citation>Akgun M, Boz I. The effects of acupressure on post-cesarean pain and analgesic consumption: a randomized single-blinded placebo-controlled study. Int J Qual Health Care. 2020 Nov 16;32(9):609-617. doi: 10.1093/intqhc/mzaa107.</citation>
<PMID>32877509</PMID>
</results_reference>
<verification_date>September 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>September 23, 2022</last_update_submitted>
<last_update_submitted_qc>September 23, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">September 27, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Mersin University</investigator_affiliation>
<investigator_full_name>Tugba CAM YANIK</investigator_full_name>
<investigator_title>Research Assistant</investigator_title>
</responsible_party>
<keyword>Post-cesarean</keyword>
<keyword>Acupressure</keyword>
<keyword>Pain</keyword>
<keyword>Step</keyword>
<keyword>Mobilization</keyword>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This randomized controlled trial evaluates the effect of acupressure application on
cesareans' pain and the number of steps in the first mobilization. This study hypothesizes
that acupressure reduces pain and improves number of steps.
Methods: In the study, 64 cesareans will randomly assigned to acupressure and placebo
acupressure groups. To the acupressure group (n = 32), an average of 15 minutes will be
applied to the LI4 (liver), P6 (pericardium) and the Sanyinjia points on the splenic meridian
(SP6) located on the inner side of the lower leg, four fingers above the ankle and behind the
tibia. In the placebo acupressure group (n = 32), the points 1.5 cm away from the LI4, P6 and
SP6 points (four points in total) will be applied for an average of 15 minutes. The primary
outcome of the research is the effect of acupressure on the pain of cesareans. The secondary
outcome of the study is to determine the effect of acupressure on the number of steps. The
pain will be collected before and 1 minute, 2nd and 4th hour after acupressure and placebo
acupressure administration. The number of steps will be collected 4th hour after acupressure
and placebo acupressure administration.
Inclusion Criteria:
- Being conscious,
- The mother tongue is Turkish,
- To be oriented and cooperative,
- be between 18-45 years old,
- To voluntarily agree to participate in the study (signing the Informed Consent Form),
- Repeated cesarean section,
- Cesarean section under spinal anesthesia,
- Not having a risky pregnancy (preeclampsia, gestational diabetes etc.),
- No health problems of the fetus,
- To have given birth by cesarean section between 37-40 weeks,
- To be in the second hour of the postpartum period,
- Not receiving post-op patient-controlled analgesia,
- Not to have smoked or used alcohol during pregnancy,
- No complications in the mother and/or newborn after cesarean section,
- No sensitivity in the area where acupressure will be applied,
- Absence of any systemic or psychiatric diagnosis,
- Absence of active COVID-19 infection.
Exclusion Criteria:
- Lack of consciousness,
- The mother tongue is not Turkish,
- Not oriented and cooperative,
- Not to be between the ages of 18-45,
- Refusal to voluntarily participate in the study (those who did not sign the Informed
Consent Form),
- Normal birth or cesarean delivery under general anesthesia,
- Cesarean delivery due to the risk of deterioration of maternal or fetal health,
- Not having had a risky pregnancy (preeclampsia, gestational diabetes, etc.),
- Not giving birth outside 37-40 weeks and by cesarean section,
- Not in the second hour of the postpartum period,
- Receiving post-op patient-controlled analgesia,
- To have used cigarettes and alcohol during pregnancy,
- Sensitivity in the area where acupressure will be applied,
- Presence of any systemic or psychiatric diagnosis,
- Active COVID-19 infection.
|
NCT0531xxxx/NCT05311462.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/NCT05311462</url>
</required_header>
<id_info>
<org_study_id>ZS-3067</org_study_id>
<nct_id>NCT05311462</nct_id>
</id_info>
<brief_title>An Observational Cohort Study to Obese Patients With Weight Cycling</brief_title>
<official_title>Exploration on Prevention and Treatment Mechanism of Obese Patient With Weight Cycling: An Investigator-initiated Single-center Cohort Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Peking Union Medical College Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Peking Union Medical College 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>
Medical nutritional weight loss was effective in reducing body weight and waist circumference
and improving a range of cardiovascular disease risk factors in obese patients, with an
average effective weight loss of 11.1 kg (about 13%) over 4 months in obese adults. However,
it was found through the follow-up visit that these subjects had lost only 5.8kg from
baseline and regained about half of their weight (5.1 kg, 48%) after 21 months of weight-loss
intervention. In this study, intestinal flora analysis was proposed to identify the causes of
individual repeated weight loss failure, structure changes of weight cycling and the
advantage species of flora, and explore different intestinal microbiota（microbial genomics）
in ending weight loss, obesity-related genetic characteristics (SNPs loci and RNA seq),
metabolite（metabolomics）and potential interaction between appetite-related hormones and
weight cycling triggers. This study aimed to provide new insights for implementing
personalized weight loss programs to improve the success rate of weight loss. The obese
patients who failed to lose weight repeatedly were recruited from Peking Union Medical
College Hospital.

Research Contents:(1) Comparison of anthropometric, biochemical, energy consumption, and
intestinal microbiota related indicators between groups; (2) Genotyping to screen out
differential SNPs loci;(3) Analysis of the interaction between genes and environmental
factors in different metabolic types of obesity. (4) A group of healthy volunteers with
normal weight as the healthy control group.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 8, 2022</start_date>
<completion_date type="Anticipated">December 20, 2022</completion_date>
<primary_completion_date type="Anticipated">June 20, 2022</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>BMI changes</measure>
<time_frame>Baseline time; after 1 months; after 45days; after 3 months; after 9 months</time_frame>
<description>Both the height and weight will be measured with a standard instrument and recorded in meters and kilograms respectively，following a requirement of accurating to two decimal places. And the weight and height will be combined to report in a form of BMI in kg/m^2.The changes in BMI before and after the study will be expressed as mean ± SD.</description>
</primary_outcome>
<primary_outcome>
<measure>serum metabolome</measure>
<time_frame>Baseline time; after 9 months</time_frame>
<description>Collection of peripheral blood (PB) serum for metabolomics analysis PB will be collected directly into serum separation tubes. The serum samples from this study will be profiled by a non-targeted LC-MS based metabolomics analysis.Metabolomics will be profiled by reverse-phase LC-MS using C8-pos (reverse-phase C8 chromatography/positive and negative ion mode that detects non-polar and weak-polar compounds) and HILIC-pos (hydrophilic interaction chromatography/positive ion mode that detects polar molecules). This study will compare and observe the type and concentration difference of serum metabolites before and after.</description>
</primary_outcome>
<primary_outcome>
<measure>Faecal metagenomes changes</measure>
<time_frame>Baseline time; after 45 days; after 3 months; after 9 months</time_frame>
<description>Patients will be requested to give stool samples that are collected in a sterile, sealed container and stored at -80 °C for strain-resolved metagenomic sequencing.DNA will be extracted from stool using the TIANamp Stool DNA Kit. We will conduct quality control using agarose gel electrophoresis. Metagenomics library will be constructed by NEXTflex Rapid DNA-Seq Kit (Illumina). The procedures included cluster generation, template hybridization, isothermal amplification, linearization, blocking and denaturation, and hybridization of the sequencing primers. We will observe differences in microbiome characteristics at various time points.</description>
</primary_outcome>
<primary_outcome>
<measure>transcriptome changes</measure>
<time_frame>Baseline time; after 3 months</time_frame>
<description>Peripheral blood of the subjects will be collected and used to extract PBMC.RNA extraction and transcriptome sequencing of the PBMC samples will be used for transcriptome sequencing.Total RNA will be extracted by using the RNAeasy kit according to the manufacturer's instructions. The purity, concentration, and integrity of total RNA will be checked using the NanoPhotometer spectrophotometer, the Qubit RNA Assay Kit in Qubit 2.0 Fluorometer and the RNA Nano 6000 Assay Kit of the Bioanalyzer 2100 System, respectively. Besides, RNA degradation and contamination will be monitored on 1% agarose gels. Sequencing libraries will be generated using the rRNA-depleted RNA by NEBNext UltraTM Directional RNA Library Prep Kit for Illumina and sequenced on an Illumina HiSeq 4000 platform. Transcriptome changes before and after the intervention will be observed to predict the outcome of weight-loss interventions.</description>
</primary_outcome>
<other_outcome>
<measure>insulin resistance index</measure>
<time_frame>Baseline time; after 3 months; after 9 months</time_frame>
</other_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">180</enrollment>
<condition>Weight Cycling</condition>
<condition>Obesity</condition>
<arm_group>
<arm_group_label>Weight-loss success with history of weight cycling</arm_group_label>
<description>High-protein diet for three months</description>
</arm_group>
<arm_group>
<arm_group_label>Weight-loss failure with history of weight cycling</arm_group_label>
<description>High-protein diet for three months</description>
</arm_group>
<eligibility>
<study_pop>
<textblock>
Exposure group: Obese individuals with a history of weight cycling and successful weight
loss with the nutritional intervention program after enrollment Control group: obese people
with a history of previous weight cycle and failure to lose weight with nutritional
intervention programs after enrollment Healthy control group: healthy volunteers of normal
weight as a control population
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Normal weight (18.5 ≤ BMI < 24 kg/m2) or obese (28 ≤ BMI < 35 kg/m2);

- Aged 18 to 50 years old;

- Han nationality;

- Able to follow the weight-loss prescription;

- Able to sign consent independently;

- Definition of Weight cycling: Loss weight more than once in the past 3 years, and
weight regain exceeds 5% or more of the baseline weight of losing weight.

Exclusion Criteria:

- Bodyweight has changed more than ±10% in the past year;

- Taking drugs known to affect body weight (orlistat, GLP-1 receptor agonists, etc.);

- Taking drugs known to affect glucolipid metabolism (such as sulfonylureas, biguanides,
acarbose, or insulin) have been taken in the past 6 months or at present;
Lipid-lowering drugs such as statins, bate, niacin, and ezetimibe; Diuretics, β
-blockers and other antihypertensive drugs; Glucocorticoid, thyroid hormone, etc.);

- Women who are currently pregnant or nearly 3 months breastfeeding;

- With serious eating disorders or vigorous exercise to lose weight;

- Hard physical workers;

- History of serious cardiovascular disease;

- Acute, chronic, or active gastrointestinal diseases;

- Serious systemic diseases;

- History of serious mental disorders;

- Cancer or active tumor;

- Secondary obesity or drug obesity patients: including hypothalamic obesity, pituitary
obesity, hypercortisolism, and hypogonadism obesity;

- Severe liver dysfunction (ALT, AST, ALP, and TBil > the upper limit of 2.5 times
reference value);

- Chronic kidney disease (eGFR < 60 mL/min/1.73 m2 or eGFR < 90 mL/min/1.73 m2 with
proteinuria);

- Those who are considered by the researcher to be poor compliance or unable to complete
this research well.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>50 Years</maximum_age>
</eligibility>
<overall_official>
<last_name>Wei Chen, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Peking Union Medical College Hospital</affiliation>
</overall_official>
<overall_contact>
<last_name>Wei Chen, M.D.</last_name>
<phone>010-69154095</phone>
<email>chenw@pumch.cn</email>
</overall_contact>
<overall_contact_backup>
<last_name>Wanyang Li, M.D.</last_name>
<phone>17692110272</phone>
</overall_contact_backup>
<location>
<facility>
<name>Peking Union Medical College Hospital</name>
<address>
<city>Beijing</city>
<state>Beijing</state>
<zip>100010</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Wei Chen, M.D.</last_name>
<phone>010-69154095</phone>
<email>txchenwei@sina.com</email>
</contact>
<contact_backup>
<last_name>Xiaodong Shi</last_name>
<phone>17888811579</phone>
</contact_backup>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 15, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>April 20, 2022</last_update_submitted>
<last_update_submitted_qc>April 20, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 21, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
<investigator_full_name>Wei Chen</investigator_full_name>
<investigator_title>Professor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Body Weight</mesh_term>
<mesh_term>Weight Cycling</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Medical nutritional weight loss was effective in reducing body weight and waist circumference
and improving a range of cardiovascular disease risk factors in obese patients, with an
average effective weight loss of 11.1 kg (about 13%) over 4 months in obese adults. However,
it was found through the follow-up visit that these subjects had lost only 5.8kg from
baseline and regained about half of their weight (5.1 kg, 48%) after 21 months of weight-loss
intervention. In this study, intestinal flora analysis was proposed to identify the causes of
individual repeated weight loss failure, structure changes of weight cycling and the
advantage species of flora, and explore different intestinal microbiota（microbial genomics）
in ending weight loss, obesity-related genetic characteristics (SNPs loci and RNA seq),
metabolite（metabolomics）and potential interaction between appetite-related hormones and
weight cycling triggers. This study aimed to provide new insights for implementing
personalized weight loss programs to improve the success rate of weight loss. The obese
patients who failed to lose weight repeatedly were recruited from Peking Union Medical
College Hospital.
Research Contents:(1) Comparison of anthropometric, biochemical, energy consumption, and
intestinal microbiota related indicators between groups; (2) Genotyping to screen out
differential SNPs loci;(3) Analysis of the interaction between genes and environmental
factors in different metabolic types of obesity. (4) A group of healthy volunteers with
normal weight as the healthy control group.
Exposure group: Obese individuals with a history of weight cycling and successful weight
loss with the nutritional intervention program after enrollment Control group: obese people
with a history of previous weight cycle and failure to lose weight with nutritional
intervention programs after enrollment Healthy control group: healthy volunteers of normal
weight as a control population
Inclusion Criteria:
- Normal weight (18.5 ≤ BMI < 24 kg/m2) or obese (28 ≤ BMI < 35 kg/m2);
- Aged 18 to 50 years old;
- Han nationality;
- Able to follow the weight-loss prescription;
- Able to sign consent independently;
- Definition of Weight cycling: Loss weight more than once in the past 3 years, and
weight regain exceeds 5% or more of the baseline weight of losing weight.
Exclusion Criteria:
- Bodyweight has changed more than ±10% in the past year;
- Taking drugs known to affect body weight (orlistat, GLP-1 receptor agonists, etc.);
- Taking drugs known to affect glucolipid metabolism (such as sulfonylureas, biguanides,
acarbose, or insulin) have been taken in the past 6 months or at present;
Lipid-lowering drugs such as statins, bate, niacin, and ezetimibe; Diuretics, β
-blockers and other antihypertensive drugs; Glucocorticoid, thyroid hormone, etc.);
- Women who are currently pregnant or nearly 3 months breastfeeding;
- With serious eating disorders or vigorous exercise to lose weight;
- Hard physical workers;
- History of serious cardiovascular disease;
- Acute, chronic, or active gastrointestinal diseases;
- Serious systemic diseases;
- History of serious mental disorders;
- Cancer or active tumor;
- Secondary obesity or drug obesity patients: including hypothalamic obesity, pituitary
obesity, hypercortisolism, and hypogonadism obesity;
- Severe liver dysfunction (ALT, AST, ALP, and TBil > the upper limit of 2.5 times
reference value);
- Chronic kidney disease (eGFR < 60 mL/min/1.73 m2 or eGFR < 90 mL/min/1.73 m2 with
proteinuria);
- Those who are considered by the researcher to be poor compliance or unable to complete
this research well.
|
NCT0531xxxx/NCT05311475.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/NCT05311475</url>
</required_header>
<id_info>
<org_study_id>CLK21001/SAN-0677</org_study_id>
<secondary_id>2021-004050-31</secondary_id>
<nct_id>NCT05311475</nct_id>
</id_info>
<brief_title>Prospective, Randomized, Multinational, Multicenter, Double-blind, Placebo and Active Controlled Trial in 4 Parallel-groups of Patients Suffering From Seasonal Allergic Rhinitis</brief_title>
<official_title>A Multicenter, Randomized, Double-blind, Placebo and Active Controlled Parallel-group Trial to Assess the Efficacy and Safety of the Fixed Combination Medicinal Product Mometasone Furoate + Azelastine Hydrochloride Nasal Spray (50 + 140 mcg) in the Treatment of Seasonal Allergic Rhinitis</official_title>
<sponsors>
<lead_sponsor>
<agency>Sandoz</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Sandoz</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The trial will be conducted as a prospective, randomized, multinational, multicenter,
double-blind, placebo and active controlled trial in 4 parallel-groups of patients suffering
from seasonal allergic rhinitis.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 4, 2022</start_date>
<completion_date type="Actual">June 20, 2023</completion_date>
<primary_completion_date type="Actual">June 20, 2023</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Change from baseline in the daily Total Nasal Symptom Score (TNSS)</measure>
<time_frame>Baseline, Day 7</time_frame>
<description>The benefit of the treatment with the fixed combination medicinal product Momeatsone+Azelastine nasal spray (test product) in comparison to the treatment with the individual medicinal products Mometasone nasal spray and Azelastine nasal spray (comparator products) will be assessed by comparing the change from baseline in the daily Total Nasal Symptom Score (TNSS) during the first seven days of treatment. Total Nasal Symptom Score (TNSS) of 4 symptoms (rhinorrhea, sneezing, nasal itching, and nasal congestion) will be assessed by the patient in a patient's diary. Each symptom will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms, such that the maximum TNSS is 12.</description>
</primary_outcome>
<secondary_outcome>
<measure>Change from baseline in the daily Total Nasal Symptom Score (TNSS)</measure>
<time_frame>Baseline, Day 14</time_frame>
<description>Total Nasal Symptom Score (TNSS) of 4 symptoms (rhinorrhea, sneezing, nasal itching, and nasal congestion) will be assessed by the patient in a patient's diary starting at Visit 1 for the baseline run-in period (3 to 5 days). The mean of the symptom scores during the last 3 days prior to Visit 2 will be used to calculate baseline symptoms. Following randomization at Visit 2, the patient will document the TNSS in the evening retrospectively for each day of treatment until treatment day 14. Each symptom will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms, such that the maximum TNSS is 12.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline in individual daily nasal symptoms</measure>
<time_frame>Baseline, Day 7 and Day 14</time_frame>
<description>Change from baseline in individual daily nasal symptoms (nasal congestion, rhinorrhea, nasal itching and sneezing) during 7 and 14 days of treatment for all four arms will be assessed.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline in individual daily ocular symptoms</measure>
<time_frame>Baseline, Day 7 and Day 14</time_frame>
<description>Ocular itching and Redness and Ocular tearing will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The symptoms will be assessed by the patient in a patient's diary starting at Visit 1. The patient will document the ocular symptoms in the evening retrospectively for each day of treatment until treatment day 14.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Baseline-adjusted differences in nasal obstruction assessed by peak nasal inspiratory flow measurements (PNIF)</measure>
<time_frame>Baseline, Day 7 and Day 14</time_frame>
<description>The PNIF will be performed by means of portable In-Check Nasal flow meter using a face mask which the patient applies over the nose (without touching it) with the mouth closed. The In-Check Nasal is a portable inspiratory flow meter, measuring inspiratory flow between 30-370 L/min.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline in Rhinoscopy score</measure>
<time_frame>Baseline, Day 7 and Day 14</time_frame>
<description>Rhinoscopy score: during the nasal examination the investigator will evaluate the symptoms rhinorrhea, redness and edema using a 4-point scale as follows: absent = 0, mild = 1, moderate = 2, and severe = 3.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Intra-group changes in health-related Quality of Life (RQLQ)</measure>
<time_frame>Baseline, Day 7 and Day 14</time_frame>
<description>Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) has 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). There are 3 'patient-specific' questions in the activity domain which allow patients to select 3 activities in which they are most limited by their rhinoconjunctivitis. Patients recall how bothered they have been by their rhinoconjunctivitis during the previous week and to respond to each question on a 7-point scale (0 = not impaired at all - 6 = severely impaired). The overall RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of responders with an improvement of ≥ 0.5 points in the assessment of overall RQLQ</measure>
<time_frame>Baseline, Day 7 and Day 14</time_frame>
<description>Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) has 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). There are 3 'patient-specific' questions in the activity domain which allow patients to select 3 activities in which they are most limited by their rhinoconjunctivitis. Patients recall how bothered they have been by their rhinoconjunctivitis during the previous week and to respond to each question on a 7-point scale (0 = not impaired at all - 6 = severely impaired). The overall RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Intra-group changes in the Rhinitis Control Assessment Test (RCAT) score</measure>
<time_frame>Baseline, Day 7 and Day 14</time_frame>
<description>Rhinitis Control Assessment Test (RCAT) questionnaire has 6 items that include nasal congestion, sneezing, watery eyes, sleep problems caused by rhinitis, activity avoidance, and nasal or other allergy symptoms control. Responses are measured on a 5-point scales. RCAT scores range from 6 to 30, with higher scores indicating better rhinitis control.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of responders with a RCAT score ≥22</measure>
<time_frame>Baseline, Day 7 and Day 14</time_frame>
<description>Rhinitis Control Assessment Test (RCAT) questionnaire has 6 items that include nasal congestion, sneezing, watery eyes, sleep problems caused by rhinitis, activity avoidance, and nasal or other allergy symptoms control. Responses are measured on a 5-point scales. RCAT scores range from 6 to 30, with higher scores indicating better rhinitis control.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Onset of action: Instantaneous TNSS</measure>
<time_frame>On Day 2 (first day of treatment) from 0 to 8 hours (at 5 minutes, 15 minutes, 30 minutes, 1 h, 2 h, 4 h, 8 h) after the first dose administration</time_frame>
<description>Instantaneous Total Nasal Symptom Score (TNSS) of 4 symptoms (rhinorrhea, sneezing, nasal itching, and nasal congestion) will be assessed by the patient in a patient's diary.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Onset of action: instantaneous ocular symptoms</measure>
<time_frame>On Day 2 (first day of treatment) from 0 to 8 hours (at 5 minutes, 15 minutes, 30 minutes, 1 h, 2 h, 4 h, 8 h) after the first dose administration</time_frame>
<description>Instantaneous Ocular itching and Redness and Ocular tearing will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.</description>
</secondary_outcome>
<number_of_arms>4</number_of_arms>
<enrollment type="Actual">669</enrollment>
<condition>Seasonal Allergic Rhinitis</condition>
<arm_group>
<arm_group_label>Mometasone + Azelastine</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Mometasone + Azelastine (50 + 140 mcg per actuation)</description>
</arm_group>
<arm_group>
<arm_group_label>Mometasone</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Mometasone furoate nasal spray (50 mcg per actuation)</description>
</arm_group>
<arm_group>
<arm_group_label>Azelastine</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Azelastine hydrochloride nasal spray (140 mcg per actuation)</description>
</arm_group>
<arm_group>
<arm_group_label>Placebo</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Placebo nasal spray</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Mometasone</intervention_name>
<description>Mometasone furoate nasal spray (50 mcg per actuation)</description>
<arm_group_label>Mometasone</arm_group_label>
<arm_group_label>Mometasone + Azelastine</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Azelastine</intervention_name>
<description>Azelastine hydrochloride nasal spray (140 mcg per actuation)</description>
<arm_group_label>Azelastine</arm_group_label>
<arm_group_label>Mometasone + Azelastine</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>Placebo nasal spray</description>
<arm_group_label>Placebo</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

Only patients fulfilling all of the following criteria at screening Visit 1 should be
included in the present trial:

- Male or non-pregnant, non-lactating female patient aged between 12 and 65 years (valid
for Poland) OR between 18 and 65 years (valid for Bulgaria, Moldova and Germany)
inclusive on the date of consent.

- Female patient of childbearing potential abstaining from sexual intercourse or using a
reliable method of contraception (e.g., condom with spermicide, intra uterine device,
oral, injected, transdermal or implanted hormonal contraceptives, or had in the past a
female sterilization e.g. tubal ligation, hysterectomy, oophorectomy, salpingectomy)
for 30 days before enrolment and agree to continue its use during the trial.

- A minimum of two seasons of previous history of at least moderate seasonal allergic
rhinitis (SAR) to the pollen/allergens in season at the time the trial is being
conducted.

- Patient must have the following SAR symptoms: (i) nasal congestion, and at least one
of the following; (ii) rhinorrhea; (iii) nasal itching; or (iv) sneezing. Nasal
congestion plus one other nasal symptom score both rated by the patient as at least
moderate in severity (≥2 on a 0-3 scale) and Total Nasal Symptom Score (TNSS) ≥6.0
over the last 24 hours.

- Negative SARS-CoV-2 Rapid Antigen Test result at screening visit.

- For adults (≥18 years): Informed consent to participate in the trial provided in
written form; For adolescents (≥12 - <18 years): own patient informed consent/ assent
to participate in the trial and the informed consent from all parent(s)/ legal
guardian(s) provided in written form.

Inclusion criteria at Visit 2 (selection for randomization):

Only patients fulfilling at Visit 2 the following inclusion criteria will be randomized in
the trial:

- Pollen-specific immunoglobulin E (sIgE) test ≥EAST class 3 (at least 3.5 kU/l).

- Negative serum (hCG) pregnancy test (for female patient only).

- Patient selected for randomization must have the following SAR symptoms over 3 days
during the 3- to 5-day baseline period: (i) nasal congestion, and 1 or more of the
following; (ii) rhinorrhea; (iii) nasal itching; or (iv) sneezing.

- The mean TNSS must be ≥6.0 over 3 days out of the last 3-5 days of the Placebo run-in
period; additionally, the mean nasal congestion score and mean of 1 other nasal
symptom score both must be ≥2 (on a 0-3 scale) over 3 days out of the last 3-5 days of
the Placebo run-in period.

Exclusion Criteria:

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

- Simultaneous participation in other clinical trials.

- Use of any investigational drug within 30 days prior to enrolment (Visit 1).

- Clinically significant medical condition (such as cardiovascular, hepatic,
neurological, hematological, renal, gastrointestinal, endocrine or other major
systemic disease) that, in the judgement of the investigator, would interfere with the
trial, require treatment, or make implementation of the protocol or interpretation of
the trial results difficult.

- Any known hypersensitivity to azelastine or other antihistamines, mometasone or other
steroids, or any of the components of the trial nasal sprays.

- Structural nasal abnormalities symptomatic enough to cause nasal obstruction, as
judged by the investigator, or any recent nasal surgery or trauma that is not
completely healed.

- Any other nasal conditions, including infectious rhinitis, sinusitis, rhinitis
medicamentosa, atrophic rhinitis, and perennial rhinitis (PAR) (coexisting PAR will be
allowed if SAR shows clear exacerbations).

- History of upper respiratory tract or sinus infection that required antibiotic therapy
with the last dose within 14 days prior to screening.

- Treatment for oral candidiasis within 30 days of starting the trial.

- Presence of untreated fungal, bacterial or viral systemic infection, or infection of
the ear, nose, and throat or oral cavity of any character.

- Presence of ocular herpes simplex or cataracts, or a history of glaucoma.

- Vaccination within 14 days prior to screening visit.

- History of habitual abuse of nasal decongestants (rhinitis medicamentosa).

- History of non-response to intranasal steroids.

- History of non-response to antihistamines.

- Recent exposure or being at risk to chicken pox or measles exposure.

- The patient is receiving immunotherapy or has received immunotherapy in the last 24
months.

- Use of anti-immunoglobulin E antibodies within 6 months prior to screening visit.

- Use of any of the following drugs:

1. Systemic corticosteroid therapy within 60 days prior to screening visit.

2. Topical (intranasal, inhaled, ocular) corticosteroid therapy within 30 days prior
to screening visit.

3. Immunosuppressive drugs and immunomodulating drugs (e.g., omalizumab, mepolizumab
or dupilumab) within 30 days prior to screening visit.

4. Cromolyn sodium or nedocromil within 14 days prior to screening visit.

5. Tricyclic antidepressants within 14 days prior to screening visit.

6. Histamine H1 antagonists (any generation of antihistamines) i.e., loratadine,
cetirizine, desloratadine, levocetirizine, fexofenadine, hydroxyzine, etc. within
14 days prior to screening visit.

7. Leukotriene modifiers within 7 days prior to screening visit.

8. Nasal or oral decongestants (including anticholinergic agents, oxymetazoline,
ephedrine or pseudoephedrine, and other vasoconstrictors) and mucolytics (like
guaifenesin), or other medications that could mask the symptoms of rhinitis,
e.g., major tranquilizers, anti-epileptic agents, within 3 days prior to
screening visit. This includes over-the-counter preparations for common cold or
eye drops containing any of the above-mentioned agents.

9. Nasal sprays or washes with any medication, including saline, within 24 hours
prior to screening visit.

- Planned to travel outside of the geographical region (as judged by the investigator
according to regional pollination calendar) for >3 consecutive days during the trial.

- Member of the investigational trial staff or a member of the family of the
investigational trial staff.

- History of alcohol or drug abuse within the last 5 years.

- History of non-compliance with medication regimens or treatment protocols in previous
clinical studies.

- Legal incapacity (for adults only) and/or other circumstances rendering the patient
unable to understand the nature, scope and possible consequences of the trial.

- Patients who are known or suspected to be in custody or submitted to an institution
due to a judicial order.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>12 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Sandoz</last_name>
<role>Study Director</role>
<affiliation>Sandoz</affiliation>
</overall_official>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Burgas</city>
<country>Bulgaria</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Gabrovo</city>
<country>Bulgaria</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Plovdiv</city>
<country>Bulgaria</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Sliven</city>
<country>Bulgaria</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Sofia</city>
<zip>1606</zip>
<country>Bulgaria</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Sofia</city>
<country>Bulgaria</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Varna</city>
<country>Bulgaria</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Aachen</city>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Dreieich</city>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Dresden</city>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Duisburg</city>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Hamburg</city>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Heidelberg</city>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Neuenhagen</city>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Röthenbach</city>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Schorndorf</city>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Viernheim</city>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Chisinau</city>
<country>Moldova, Republic of</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Brzeg Dolny</city>
<country>Poland</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Chodzież</city>
<country>Poland</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Inowrocław</city>
<country>Poland</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Jaksice</city>
<country>Poland</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Lodz</city>
<country>Poland</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Lublin</city>
<country>Poland</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Ostrowiec</city>
<country>Poland</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Poznan</city>
<country>Poland</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Warszawa</city>
<country>Poland</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sandoz Investigative Site</name>
<address>
<city>Wrocław</city>
<country>Poland</country>
</address>
</facility>
</location>
<location_countries>
<country>Bulgaria</country>
<country>Germany</country>
<country>Moldova, Republic of</country>
<country>Poland</country>
</location_countries>
<verification_date>July 2023</verification_date>
<study_first_submitted>March 25, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>July 10, 2023</last_update_submitted>
<last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">July 11, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Rhinitis</mesh_term>
<mesh_term>Rhinitis, Allergic</mesh_term>
<mesh_term>Rhinitis, Allergic, Seasonal</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Mometasone Furoate</mesh_term>
<mesh_term>Azelastine</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The trial will be conducted as a prospective, randomized, multinational, multicenter,
double-blind, placebo and active controlled trial in 4 parallel-groups of patients suffering
from seasonal allergic rhinitis.
Inclusion Criteria:
Only patients fulfilling all of the following criteria at screening Visit 1 should be
included in the present trial:
- Male or non-pregnant, non-lactating female patient aged between 12 and 65 years (valid
for Poland) OR between 18 and 65 years (valid for Bulgaria, Moldova and Germany)
inclusive on the date of consent.
- Female patient of childbearing potential abstaining from sexual intercourse or using a
reliable method of contraception (e.g., condom with spermicide, intra uterine device,
oral, injected, transdermal or implanted hormonal contraceptives, or had in the past a
female sterilization e.g. tubal ligation, hysterectomy, oophorectomy, salpingectomy)
for 30 days before enrolment and agree to continue its use during the trial.
- A minimum of two seasons of previous history of at least moderate seasonal allergic
rhinitis (SAR) to the pollen/allergens in season at the time the trial is being
conducted.
- Patient must have the following SAR symptoms: (i) nasal congestion, and at least one
of the following; (ii) rhinorrhea; (iii) nasal itching; or (iv) sneezing. Nasal
congestion plus one other nasal symptom score both rated by the patient as at least
moderate in severity (≥2 on a 0-3 scale) and Total Nasal Symptom Score (TNSS) ≥6.0
over the last 24 hours.
- Negative SARS-CoV-2 Rapid Antigen Test result at screening visit.
- For adults (≥18 years): Informed consent to participate in the trial provided in
written form; For adolescents (≥12 - <18 years): own patient informed consent/ assent
to participate in the trial and the informed consent from all parent(s)/ legal
guardian(s) provided in written form.
Inclusion criteria at Visit 2 (selection for randomization):
Only patients fulfilling at Visit 2 the following inclusion criteria will be randomized in
the trial:
- Pollen-specific immunoglobulin E (sIgE) test ≥EAST class 3 (at least 3.5 kU/l).
- Negative serum (hCG) pregnancy test (for female patient only).
- Patient selected for randomization must have the following SAR symptoms over 3 days
during the 3- to 5-day baseline period: (i) nasal congestion, and 1 or more of the
following; (ii) rhinorrhea; (iii) nasal itching; or (iv) sneezing.
- The mean TNSS must be ≥6.0 over 3 days out of the last 3-5 days of the Placebo run-in
period; additionally, the mean nasal congestion score and mean of 1 other nasal
symptom score both must be ≥2 (on a 0-3 scale) over 3 days out of the last 3-5 days of
the Placebo run-in period.
Exclusion Criteria:
Patients presenting any of the following criteria will NOT be included in the trial:
- Simultaneous participation in other clinical trials.
- Use of any investigational drug within 30 days prior to enrolment (Visit 1).
- Clinically significant medical condition (such as cardiovascular, hepatic,
neurological, hematological, renal, gastrointestinal, endocrine or other major
systemic disease) that, in the judgement of the investigator, would interfere with the
trial, require treatment, or make implementation of the protocol or interpretation of
the trial results difficult.
- Any known hypersensitivity to azelastine or other antihistamines, mometasone or other
steroids, or any of the components of the trial nasal sprays.
- Structural nasal abnormalities symptomatic enough to cause nasal obstruction, as
judged by the investigator, or any recent nasal surgery or trauma that is not
completely healed.
- Any other nasal conditions, including infectious rhinitis, sinusitis, rhinitis
medicamentosa, atrophic rhinitis, and perennial rhinitis (PAR) (coexisting PAR will be
allowed if SAR shows clear exacerbations).
- History of upper respiratory tract or sinus infection that required antibiotic therapy
with the last dose within 14 days prior to screening.
- Treatment for oral candidiasis within 30 days of starting the trial.
- Presence of untreated fungal, bacterial or viral systemic infection, or infection of
the ear, nose, and throat or oral cavity of any character.
- Presence of ocular herpes simplex or cataracts, or a history of glaucoma.
- Vaccination within 14 days prior to screening visit.
- History of habitual abuse of nasal decongestants (rhinitis medicamentosa).
- History of non-response to intranasal steroids.
- History of non-response to antihistamines.
- Recent exposure or being at risk to chicken pox or measles exposure.
- The patient is receiving immunotherapy or has received immunotherapy in the last 24
months.
- Use of anti-immunoglobulin E antibodies within 6 months prior to screening visit.
- Use of any of the following drugs:
1. Systemic corticosteroid therapy within 60 days prior to screening visit.
2. Topical (intranasal, inhaled, ocular) corticosteroid therapy within 30 days prior
to screening visit.
3. Immunosuppressive drugs and immunomodulating drugs (e.g., omalizumab, mepolizumab
or dupilumab) within 30 days prior to screening visit.
4. Cromolyn sodium or nedocromil within 14 days prior to screening visit.
5. Tricyclic antidepressants within 14 days prior to screening visit.
6. Histamine H1 antagonists (any generation of antihistamines) i.e., loratadine,
cetirizine, desloratadine, levocetirizine, fexofenadine, hydroxyzine, etc. within
14 days prior to screening visit.
7. Leukotriene modifiers within 7 days prior to screening visit.
8. Nasal or oral decongestants (including anticholinergic agents, oxymetazoline,
ephedrine or pseudoephedrine, and other vasoconstrictors) and mucolytics (like
guaifenesin), or other medications that could mask the symptoms of rhinitis,
e.g., major tranquilizers, anti-epileptic agents, within 3 days prior to
screening visit. This includes over-the-counter preparations for common cold or
eye drops containing any of the above-mentioned agents.
9. Nasal sprays or washes with any medication, including saline, within 24 hours
prior to screening visit.
- Planned to travel outside of the geographical region (as judged by the investigator
according to regional pollination calendar) for >3 consecutive days during the trial.
- Member of the investigational trial staff or a member of the family of the
investigational trial staff.
- History of alcohol or drug abuse within the last 5 years.
- History of non-compliance with medication regimens or treatment protocols in previous
clinical studies.
- Legal incapacity (for adults only) and/or other circumstances rendering the patient
unable to understand the nature, scope and possible consequences of the trial.
- Patients who are known or suspected to be in custody or submitted to an institution
due to a judicial order.
|
NCT0531xxxx/NCT05311488.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/NCT05311488</url>
</required_header>
<id_info>
<org_study_id>849579</org_study_id>
<nct_id>NCT05311488</nct_id>
</id_info>
<brief_title>Early Detection of Neuropathy in ATTRv</brief_title>
<acronym>EDONA</acronym>
<official_title>Early Detection of Peripheral Neuropathy in Hereditary Transthyretin Amyloidosis</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Pennsylvania</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Ionis Pharmaceuticals, Inc.</agency>
<agency_class>Industry</agency_class>
</collaborator>
<collaborator>
<agency>Muscle Study Group (MSG)</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>University of Pennsylvania</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of the study is to evaluate and compare different tools that are used to detect
evidence of peripheral neuropathy in patients with TTRv.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Early detection of peripheral neuropathy in patients with TTRv is important to support
initiation of therapy that alters the course of the disease. Current tools used to detect
peripheral neuropathy may not be sensitive, especially in very early and distal peripheral
neuropathy. This study will compare different methods of assessing for peripheral neuropathy
including using in-vivo reflectance confocal microscopy to assess for meissner corpuscles,
serum neurofilament light chain, quantitative sensory testing, neuropathy impairement scores,
nerve conduction studies and quality of life and symptoms questionnaires.
</textblock>
</detailed_description>
<overall_status>Active, not recruiting</overall_status>
<start_date type="Actual">February 14, 2022</start_date>
<completion_date type="Anticipated">February 14, 2029</completion_date>
<primary_completion_date type="Anticipated">February 14, 2024</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Change in Serum neurofilament light chain</measure>
<time_frame>12 months</time_frame>
<description>Change in sesrum neurofilament light chain concentration at 12 months</description>
</primary_outcome>
<primary_outcome>
<measure>Meissner corpuscles</measure>
<time_frame>12 months</time_frame>
<description>Change in Meissner corpuscles density at 12 months</description>
</primary_outcome>
<secondary_outcome>
<measure>Quantitative sensory testing</measure>
<time_frame>12 months</time_frame>
<description>Testing of vibratory sensation using a tuning fork, testing of light touch using neurofilament</description>
</secondary_outcome>
<secondary_outcome>
<measure>Neuropathy symptoms questionnaire</measure>
<time_frame>12 months</time_frame>
<description>Questionnaire that assess symptoms of neuropathy and severity.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Neuropathy impairment score</measure>
<time_frame>12 months</time_frame>
<description>Neurological examination reporting motor strength, reflexes and sensation. Scale ranges from 0 (normal) to 244, with a higher score indicating greater impairment.</description>
</secondary_outcome>
<number_of_groups>3</number_of_groups>
<enrollment type="Actual">47</enrollment>
<condition>Hereditary Amyloidosis, Transthyretin-Related</condition>
<arm_group>
<arm_group_label>Symptomatic TTRv</arm_group_label>
<description>Patients with known TTR mutations and neuropathy</description>
</arm_group>
<arm_group>
<arm_group_label>Asymptomatic TTRv</arm_group_label>
<description>Patients with TTR mutation and no symptoms within less than 10 years of typical onset of disease</description>
</arm_group>
<arm_group>
<arm_group_label>Healthy controls</arm_group_label>
<description>Age and sex matched healthy controls without neuropathy or other neurological disorder.</description>
</arm_group>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>neurofilament light chain</intervention_name>
<description>Blood test</description>
<arm_group_label>Asymptomatic TTRv</arm_group_label>
<arm_group_label>Healthy controls</arm_group_label>
<arm_group_label>Symptomatic TTRv</arm_group_label>
</intervention>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>In-vivo Meissner Corpuscle imaging</intervention_name>
<description>Imaging</description>
<arm_group_label>Asymptomatic TTRv</arm_group_label>
<arm_group_label>Healthy controls</arm_group_label>
<arm_group_label>Symptomatic TTRv</arm_group_label>
</intervention>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Nerve conduction study</intervention_name>
<description>Nerve conduction study</description>
<arm_group_label>Asymptomatic TTRv</arm_group_label>
<arm_group_label>Healthy controls</arm_group_label>
<arm_group_label>Symptomatic TTRv</arm_group_label>
</intervention>
<biospec_retention>Samples Without DNA</biospec_retention>
<biospec_descr>
<textblock>
Blood will be processed, and serum will be stored according to PDMDC GeneticsBiobank
protocol. The serum will be assayed by ultrasensitive single molecule array (Simoa NF-Light®
assay, Quanterix, Lexington, MA) to determine NF-L concentration. Samples will be tested in
duplicate.
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
ATTRv symptomatic, asymptomatic and control.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. Age 30 years or older

2. Patients with known TTR mutations and neuropathy, patients with TTR mutation and no
symptoms within less than 10 years of typical onset of disease., or healthy persons
without neuropathy

Exclusion Criteria:

1. Patients with neuropathy other than TTR amyloid

2. Subjects with risk factors for neuropathy (diabetes, history of neuropathy in the
family, neurotoxic drugs) or with neurological disorder associated with elevated NFL

The following distribution of age ranges will be considered when enrolling healthy
participants:

- 5 patients age 30-40

- 5 patients age 40-50

- 5 patients age 50-60

- 5 patients age 60-70

The following age limitations will be in place for asymptomatic TTR carriers. The idea is
to select patients that are likely to develop evidence of disease within the next 10 years.

- Non V122I mutation> or =30

- V122I> or = 55
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>30 Years</minimum_age>
<maximum_age>90 Years</maximum_age>
</eligibility>
<overall_official>
<last_name>Chafic Karam, MD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Pennsylvania</affiliation>
</overall_official>
<overall_official>
<last_name>Brian Drachman</last_name>
<role>Principal Investigator</role>
<affiliation>University of Pennsylvania</affiliation>
</overall_official>
<overall_official>
<last_name>Sami Khella, MD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Pennsylvania</affiliation>
</overall_official>
<overall_official>
<last_name>Janice Pieretti, MD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Pennsylvania</affiliation>
</overall_official>
<location>
<facility>
<name>University of Pennsylvania</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>April 2023</verification_date>
<study_first_submitted>March 16, 2022</study_first_submitted>
<study_first_submitted_qc>March 25, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>April 3, 2023</last_update_submitted>
<last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">April 5, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>transthryretin</keyword>
<keyword>Hereditary transthyretin amyloidosis</keyword>
<keyword>TTRv</keyword>
<keyword>familial amyloid polyneuropathy</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Amyloidosis, Familial</mesh_term>
<mesh_term>Amyloidosis</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 purpose of the study is to evaluate and compare different tools that are used to detect
evidence of peripheral neuropathy in patients with TTRv.
Early detection of peripheral neuropathy in patients with TTRv is important to support
initiation of therapy that alters the course of the disease. Current tools used to detect
peripheral neuropathy may not be sensitive, especially in very early and distal peripheral
neuropathy. This study will compare different methods of assessing for peripheral neuropathy
including using in-vivo reflectance confocal microscopy to assess for meissner corpuscles,
serum neurofilament light chain, quantitative sensory testing, neuropathy impairement scores,
nerve conduction studies and quality of life and symptoms questionnaires.
Blood will be processed, and serum will be stored according to PDMDC GeneticsBiobank
protocol. The serum will be assayed by ultrasensitive single molecule array (Simoa NF-Light®
assay, Quanterix, Lexington, MA) to determine NF-L concentration. Samples will be tested in
duplicate.
ATTRv symptomatic, asymptomatic and control.
Inclusion Criteria:
1. Age 30 years or older
2. Patients with known TTR mutations and neuropathy, patients with TTR mutation and no
symptoms within less than 10 years of typical onset of disease., or healthy persons
without neuropathy
Exclusion Criteria:
1. Patients with neuropathy other than TTR amyloid
2. Subjects with risk factors for neuropathy (diabetes, history of neuropathy in the
family, neurotoxic drugs) or with neurological disorder associated with elevated NFL
The following distribution of age ranges will be considered when enrolling healthy
participants:
- 5 patients age 30-40
- 5 patients age 40-50
- 5 patients age 50-60
- 5 patients age 60-70
The following age limitations will be in place for asymptomatic TTR carriers. The idea is
to select patients that are likely to develop evidence of disease within the next 10 years.
- Non V122I mutation> or =30
- V122I> or = 55
|
NCT0531xxxx/NCT05311501.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/NCT05311501</url>
</required_header>
<id_info>
<org_study_id>TPSO001</org_study_id>
<nct_id>NCT05311501</nct_id>
</id_info>
<brief_title>Impact of Non-surgical Periodontal Therapy in the Management of Plaque Psoriasis.</brief_title>
<official_title>Impact of Non-surgical Periodontal Therapy in the Management of Plaque Psoriasis. A Randomised Controlled Trial.</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Siena</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Siena</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>
Both periodontitis and plaque psoriasis are non communicable chronic inflammatory diseases.
They share genetic polymorphysms (IL-1, IL-6 e TNFalfa) and risk factors (smoking, diabetes,
obesity), as well as a great resemblance in terms of pathophysiological pathways. In fact,
they are both characterized by an hyperactivation of the innate immune response which induces
an excessive production of cytokines such as IL-17/TNFalfa. While non-surgical periodontal
therapy consists in the mechanical removal of supra and subgingival calculus, psoriasis
treatment involves the administration of either systemic or biologic drugs. Evidence is
scarce regarding the effectiveness of non-surgical periodontal therapy in ameliorating the
clinical outcomes of plaque psoriasis. The biological plausibility relies on the important
reduction of systemic inflammation caused by periodontal treatment, which could ameliorate
psoriasis phenotype.
</textblock>
</brief_summary>
<overall_status>Active, not recruiting</overall_status>
<start_date type="Actual">May 10, 2022</start_date>
<completion_date type="Anticipated">January 1, 2023</completion_date>
<primary_completion_date type="Anticipated">January 1, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>PASI (Psoriasis Area and Severity Index)- Baseline</measure>
<time_frame>PASI was registered at baseline.</time_frame>
<description>A representative area of psoriasis is selected for each body region (head and neck, upper and lower limbs, trunk). The intensity of redness, thickness, and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3), or very severe (4). The three intensity scores are added up for each of the four body regions to give subtotals A1, A2, A3, A4.
Each subtotal is multiplied by the body surface area represented by that region. The higher the score, the worse psoriasis severity.</description>
</primary_outcome>
<primary_outcome>
<measure>PASI (Psoriasis Area and Severity Index)- 10 weeks</measure>
<time_frame>PASI was registered 10 weeks after baseline.</time_frame>
<description>A representative area of psoriasis is selected for each body region (head and neck, upper and lower limbs, trunk). The intensity of redness, thickness, and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3), or very severe (4). The three intensity scores are added up for each of the four body regions to give subtotals A1, A2, A3, A4.
Each subtotal is multiplied by the body surface area represented by that region. The higher the score, the worse psoriasis severity.</description>
</primary_outcome>
<secondary_outcome>
<measure>Body Surface Area (BSA)- Baseline</measure>
<time_frame>BSA was registered at baseline.</time_frame>
<description>BSA is calculated as the extent to which the body is affected by psoriasis. The score ranges between 0 and 100; the higher the score, the worse psoriasis severity.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Body Surface Area (BSA)- 10 weeks</measure>
<time_frame>BSA was registered 10 weeks after baseline.</time_frame>
<description>BSA is calculated as the extent to which the body is affected by psoriasis. The score ranges between 0 and 100; the higher the score, the worse psoriasis severity.</description>
</secondary_outcome>
<other_outcome>
<measure>Salivary Concentration of miRNAs- Baseline</measure>
<time_frame>Salivary Concentration of miRNAs was registered at baseline.</time_frame>
<description>The salivary concentration of specific miRNAS involved in both psoriasis and periodontitis (miRNA146a, miRNA223, miRNA21, miRNA155) was detected. The higher the concentration, the worse the severity of both periodontitis and psoriasis.</description>
</other_outcome>
<other_outcome>
<measure>Salivary Concentration of miRNAs- 10 weeks</measure>
<time_frame>Salivary Concentration of miRNAs was registered 10 weeks after baseline.</time_frame>
<description>The salivary concentration of specific miRNAS involved in both psoriasis and periodontitis (miRNA146a, miRNA223, miRNA21, miRNA155) was detected. The higher the concentration, the worse the severity of both periodontitis and psoriasis.</description>
</other_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">74</enrollment>
<condition>Psoriasis Vulgaris</condition>
<condition>Psoriasis</condition>
<condition>Periodontitis</condition>
<arm_group>
<arm_group_label>Immediate periodontal treatment</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Right after the execution of a complete periodontal chart, non-surgical periodontal treatment (NST) was performed, according to the most recent clinical guidelines. NST was performed by removing supra and subgingival calculus and using both ultrasonic and manual instruments. Oral Hygiene Instructions (OHI) were provided throughout the experimental period.</description>
</arm_group>
<arm_group>
<arm_group_label>Delayed Periodontal treatment</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Right after the execution of a complete periodontal chart, the patient is informed regarding their group allocation, according to which they are asked to delay NST for 10 weeks. 10 weeks after baseline examination, NST was performed according to the most recent clinical guidelines. NST was performed by removing supra and subgingival calculus and using both ultrasonic and manual instruments.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Non-surgical periodontal treatment</intervention_name>
<description>Non-Surgical periodontal Treatment was performed by removing supra and subgingival calculus and using both ultrasonic and manual instruments. Oral Hygiene Instructions (OHI) were provided throughout the experimental period. Local anesthesia was performed only when needed.</description>
<arm_group_label>Immediate periodontal treatment</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- diagnosis of plaque psoriasis;

- diagnosis of untreated periodontitis;

- presence of at least 20 teeth;

- age between 18 and 70 years;

- ability and willingness to give informed consent.

Exclusion Criteria:

- inability of unwillingness to give informed consent;

- patients undergoing periodontal treatment within the last 6 months;

- patients undergoing immunosuppressive treatments for other systemic diseases;

- pregnancy or lactation;

- pts undergoing antibiotic therapy.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Azienda Ospedaliero Universitaria Senese</name>
<address>
<city>Siena</city>
<zip>53100</zip>
<country>Italy</country>
</address>
</facility>
</location>
<location_countries>
<country>Italy</country>
</location_countries>
<verification_date>June 2022</verification_date>
<study_first_submitted>March 16, 2022</study_first_submitted>
<study_first_submitted_qc>March 25, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>June 17, 2022</last_update_submitted>
<last_update_submitted_qc>June 17, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">June 21, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Siena</investigator_affiliation>
<investigator_full_name>Simone Grandini</investigator_full_name>
<investigator_title>Full Professor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Periodontitis</mesh_term>
<mesh_term>Psoriasis</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
<ipd_description>IPD will be made available upon reasonable request.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Both periodontitis and plaque psoriasis are non communicable chronic inflammatory diseases.
They share genetic polymorphysms (IL-1, IL-6 e TNFalfa) and risk factors (smoking, diabetes,
obesity), as well as a great resemblance in terms of pathophysiological pathways. In fact,
they are both characterized by an hyperactivation of the innate immune response which induces
an excessive production of cytokines such as IL-17/TNFalfa. While non-surgical periodontal
therapy consists in the mechanical removal of supra and subgingival calculus, psoriasis
treatment involves the administration of either systemic or biologic drugs. Evidence is
scarce regarding the effectiveness of non-surgical periodontal therapy in ameliorating the
clinical outcomes of plaque psoriasis. The biological plausibility relies on the important
reduction of systemic inflammation caused by periodontal treatment, which could ameliorate
psoriasis phenotype.
Inclusion Criteria:
- diagnosis of plaque psoriasis;
- diagnosis of untreated periodontitis;
- presence of at least 20 teeth;
- age between 18 and 70 years;
- ability and willingness to give informed consent.
Exclusion Criteria:
- inability of unwillingness to give informed consent;
- patients undergoing periodontal treatment within the last 6 months;
- patients undergoing immunosuppressive treatments for other systemic diseases;
- pregnancy or lactation;
- pts undergoing antibiotic therapy.
|
NCT0531xxxx/NCT05311514.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/NCT05311514</url>
</required_header>
<id_info>
<org_study_id>15/21-n</org_study_id>
<nct_id>NCT05311514</nct_id>
</id_info>
<brief_title>Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease</brief_title>
<official_title>Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Keratoconjunctivitis Sicca Resistant to Traditional Therapy in Patients With Chronic Ocular Graft-versus-host After Allogeneic Hematopoietic Stem Cell Transplantation.</official_title>
<sponsors>
<lead_sponsor>
<agency>St. Petersburg State Pavlov Medical University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>St. Petersburg State Pavlov Medical University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The study evaluates the efficacy and safety of allogeneic platelet lysate eye drops in
patients with severe ocular graft versus host disease refractory to conventional systemic and
local treatments. The corneal staining, conjunctival hyperemia, tear film break up
time,Schirmer test and ocular surface disease index will be evaluated before and after
allogeneic platelet lysate treatment. The safety of allogeneic platelet lysate treatment will
be also assessed.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The corneal staining with fluorescein will be assessed using Oxford grading scale.

Tear film break up time is the time in seconds taken to appear first dry sport after complete
blinking. Fluorescein is instilled into the patient tear film, the tear film is observed
under cobalt blue illumination.Schirmer test will be performed without anesthesia.
Conjunctival hyperemia will be graded from 0 to 2. The OSDI questinnaire will assess the
impact of treatment on the quality of life.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 1, 2021</start_date>
<completion_date type="Anticipated">April 1, 2024</completion_date>
<primary_completion_date type="Anticipated">April 1, 2023</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Non-Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Response of ocular chronic GVHD</measure>
<time_frame>2 years</time_frame>
<description>Measured by 2015 NIH response criteria</description>
</primary_outcome>
<secondary_outcome>
<measure>Ocular adverse events</measure>
<time_frame>2 years</time_frame>
<description>Local ocular adverse events measured by CTCAE v5.0.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Tear film breakup time</measure>
<time_frame>2 years</time_frame>
<description>Measured by fluorescein staining of the tear film</description>
</secondary_outcome>
<secondary_outcome>
<measure>Area of epithelial damage</measure>
<time_frame>2 years</time_frame>
<description>Measured by fluorescein staining of the ocular surface by the Oxford grading scale (grades 0-5 with increasing severity with higher grades)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Patient reported outcomes: severity of dry eye syndrome in patients with chronic ocular graft-versus-host and its impact on the quality of life based on 12 questions, score from 0 to 4.</measure>
<time_frame>2 years</time_frame>
<description>Ocular Surface Disease Index (OSDI) questionnaire.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">30</enrollment>
<condition>Ocular Graft-versus-host Disease</condition>
<arm_group>
<arm_group_label>Allogeneic Platelet Lysate eye drops 50%</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients with ocular chronic severe graft versus host disease receive 50% allogeneic Platelet Lysate in the form of eye drops 6-8 times a day</description>
</arm_group>
<arm_group>
<arm_group_label>Allogeneic Platelet Lysate eye drops 20%</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Patients with ocular chronic severe graft versus host disease receive 20% allogeneic Platelet Lysate in the form of eye drops 6-8 times a day</description>
</arm_group>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>Allogeneic platelet lysate eye drops</intervention_name>
<description>Eye drops</description>
<arm_group_label>Allogeneic Platelet Lysate eye drops 20%</arm_group_label>
<arm_group_label>Allogeneic Platelet Lysate eye drops 50%</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Severe ocular chronic graft-versus-host disease (keratoconjunctivitis sicca) after
allo-HSCT

- Schirmer test < 5mm\5min

- Tear Film Break-up Time < 5sec

- Corneal staining > II Gr (Oxford grading scale)

- Ocular Surface Disease Index (OSDI) >30

- Resistance to conventional therapy

Exclusion Criteria:

- Karnofsky <30%

- Other concomitant conditions, which does not allow to adequately assess the condition
of the eye surface;

- Acute bacterial, viral or fungal infection of the eyes at the time of screening;

- Somatic or mental pathology that does not allow you to sign an informed consent;

- Keratoconjunctivitis sicca associated with an anomaly of the eyelids.
</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>Natalya V Chistyakova, PhD</last_name>
<phone>+79217558218</phone>
<email>nchistik@mail.ru</email>
</overall_contact>
<overall_contact_backup>
<last_name>Ivan S Moiseev, MD, Prof.</last_name>
<phone>+78123386265</phone>
<email>moisiv@mail.ru</email>
</overall_contact_backup>
<location>
<facility>
<name>First Pavlov State Medical University of St. Petersburg</name>
<address>
<city>Saint-Petersburg</city>
<zip>197089</zip>
<country>Russian Federation</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Natalya V Chistyakova, PhD</last_name>
<phone>+79217558218</phone>
<email>nchistik@mail.ru</email>
</contact>
<contact_backup>
<last_name>Ivan S Moiseev, Prof</last_name>
<phone>+78122334551</phone>
<email>coordinatorbmt@gmail.com</email>
</contact_backup>
<investigator>
<last_name>Natalya V Chistyakova, PhD</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location_countries>
<country>Russian Federation</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>October 1, 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>April 4, 2022</last_update_submitted>
<last_update_submitted_qc>April 4, 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>St. Petersburg State Pavlov Medical University</investigator_affiliation>
<investigator_full_name>Ivan S Moiseev</investigator_full_name>
<investigator_title>Vice-director for science RM Gorbacheva Institute</investigator_title>
</responsible_party>
<keyword>Chronic Graft-versus-host Disease</keyword>
<keyword>Ocular</keyword>
<keyword>Dry eye</keyword>
<keyword>Allogeneic stem cell transplantation</keyword>
<keyword>Platelet lysate</keyword>
<keyword>Eye drops</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Graft vs Host Disease</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ophthalmic Solutions</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>The individual participant data will be available upon request to the Pavlov Ethical Committee with the description of purposes and study plan according to local standard operating procedures.</ipd_description>
<ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
<ipd_time_frame>15 years</ipd_time_frame>
<ipd_access_criteria>The individual participant data will be available upon request to the Pavlov Ethical Committee with the description of purposes and study plan according to local standard operating procedures.</ipd_access_criteria>
<ipd_url>https://www.1spbgmu.ru/ru/92-glavnaya/nauka/sovety-i-komissii/eticheskij-komitet</ipd_url>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The study evaluates the efficacy and safety of allogeneic platelet lysate eye drops in
patients with severe ocular graft versus host disease refractory to conventional systemic and
local treatments. The corneal staining, conjunctival hyperemia, tear film break up
time,Schirmer test and ocular surface disease index will be evaluated before and after
allogeneic platelet lysate treatment. The safety of allogeneic platelet lysate treatment will
be also assessed.
The corneal staining with fluorescein will be assessed using Oxford grading scale.
Tear film break up time is the time in seconds taken to appear first dry sport after complete
blinking. Fluorescein is instilled into the patient tear film, the tear film is observed
under cobalt blue illumination.Schirmer test will be performed without anesthesia.
Conjunctival hyperemia will be graded from 0 to 2. The OSDI questinnaire will assess the
impact of treatment on the quality of life.
Inclusion Criteria:
- Severe ocular chronic graft-versus-host disease (keratoconjunctivitis sicca) after
allo-HSCT
- Schirmer test < 5mm\5min
- Tear Film Break-up Time < 5sec
- Corneal staining > II Gr (Oxford grading scale)
- Ocular Surface Disease Index (OSDI) >30
- Resistance to conventional therapy
Exclusion Criteria:
- Karnofsky <30%
- Other concomitant conditions, which does not allow to adequately assess the condition
of the eye surface;
- Acute bacterial, viral or fungal infection of the eyes at the time of screening;
- Somatic or mental pathology that does not allow you to sign an informed consent;
- Keratoconjunctivitis sicca associated with an anomaly of the eyelids.
|
NCT0531xxxx/NCT05311527.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/NCT05311527</url>
</required_header>
<id_info>
<org_study_id>STU 2022-0261</org_study_id>
<nct_id>NCT05311527</nct_id>
</id_info>
<brief_title>UroLift System With SAbR for Prostate Cancer and BPH</brief_title>
<official_title>Using UroLift System With Stereotactic Ablative Body Radiotherapy For Men With Prostate Cancer and Benign Prostatic Hyperplasia (BPH): a Phase I Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Texas Southwestern Medical Center</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>NeoTract, Inc.</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>University of Texas Southwestern Medical Center</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>Yes</is_fda_regulated_device>
<is_us_export>Yes</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
Confirming safety of combining UroLift System prior to SAbR for patients with newly diagnosed
prostate cancer and a history of BPH, by measuring the acute complication rate of UroLift
System implant in patients with BPH undergoing SAbR (within 90 days of treatment completion)
</textblock>
</brief_summary>
<detailed_description>
<textblock>
UroLift System implant will be implanted transurethrally under cystoscopic guidance with a
UroLift System Delivery Device by a trained provider. Optimal placement of the implants will
be verified cystoscopically. On average, 4-6 UroLift System implants are typically implanted
but more or less can be placed per provided discretion, up to a maximum of 10 implants per
manufacturer specifications.

Given that patients will also undergo UroLift System placement, patients will be offered to
undergo UroLift System, fiducial marker placement and rectal gel spacer placement in one
single procedure, under general anesthesia.

SAbR will be performed following placement of UroLift System, prostate fiducials, rectal
spacer, and MR/CT simulation, using stereotactic immobilization/localization, rectal enema,
prophylactic medication support (tamsulosin, dexamethasone unless contraindicated), bladder
filling protocol, and appropriate imaging verification.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">January 11, 2023</start_date>
<completion_date type="Anticipated">March 1, 2025</completion_date>
<primary_completion_date type="Anticipated">March 1, 2025</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
<masking_description>Non-blinded</masking_description>
</study_design_info>
<primary_outcome>
<measure>Safety of UroLift implant when combined with SAbR for men with prostate cancer and benign prostatic hyperplasia</measure>
<time_frame>90 days</time_frame>
<description>Analyses will be performed for all subjects having received at least one fraction of radiation therapy. The study will use CTCAE version 5.0 for reporting of adverse events and, for reporting purposes, will also capture Clavien-Dindo grading system for the classification of surgical complications for reporting adverse events related to the UroLift System procedure.</description>
</primary_outcome>
<secondary_outcome>
<measure>Quality of Life with UroLift System</measure>
<time_frame>90 days</time_frame>
<description>AUA, EPIC-26 questionnaires and Noninvasive urodynamics will be obtained, these data will be analyzed once all patients have completed the scheduled trial visits.The aggregate score will be done for (urinary, sexual, bowel, and health-related) associated with UroLift System when administered prior to SABR.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">15</enrollment>
<condition>Prostate Cancer</condition>
<arm_group>
<arm_group_label>All Study participants</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Study participants will undergo Urolift System followed by SABR</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Urolift</intervention_name>
<description>Urolift Implant</description>
<arm_group_label>All Study participants</arm_group_label>
</intervention>
<intervention>
<intervention_type>Radiation</intervention_type>
<intervention_name>SABR</intervention_name>
<description>Stereotactic Body Radiation Therapy for prostate cancer</description>
<arm_group_label>All Study participants</arm_group_label>
<other_name>SBRT</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- AJCC 8th edition clinical stage T1 (a, b, or c) or T2 (a, b, or c) adenocarcinoma of
the prostate gland, Gleason 3+3 = 6 or 3+4 = 7, with no direct evidence of regional or
distant metastases following appropriate staging studies. See Appendix I for details
on AJCC 8th Edition staging criteria. T-staging may be assessed by multi-parametric
imaging alone if digital rectal examination was deferred

- Histologic confirmation of prostate cancer is required by biopsy performed within 18
months of registration.

- Age > 45 years.

- Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.

- American Society of Anesthesia (ASA) physical status score of 1-3

- Baseline AUA symptom score ≥ 17 regardless of medical therapy

- The serum PSA should be < 20 ng/ml within 120 days of registration

- Study entry PSA must not be obtained during the following time frames: (1) 10-day
period following prostate biopsy; (2) following initiation of ADT or anti-androgen
therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days
after discontinuation of dutasteride; (5) within 5 days of a digital rectal
examination

- Ultrasound or MRI based volume estimation of prostate gland < 100 grams, regardless of
cytoreduction with pharmacotherapy

- Ability to undergo general anesthesia for <60 minutes

- Ability to understand and the willingness to sign a written informed consent.

- All men must agree to use adequate contraception (barrier method of birth control;
abstinence) prior to study entry, for the duration of study participation, and for 90
days following completion of therapy.

Exclusion Criteria:

- Contraindications to UroLift System placement including:

- Prostate volume >100 cc based on imaging-based estimation

- Urethral conditions (e.g. urethral strictures and neoplams) that may prevent insertion
of UroLift System delivery system into the bladder

- Urinary incontinence due to incompetent sphincter

- An active urinary tract infection

- Current gross hematuria

- In addition to the contraindications if there is a known allergy to nickel, titanium,
or stainless steel these patients should be excluded

- Prior transurethral resection of the prostate (TURP), median lobe manipulation, simple
prostatectomy, or other ablative procedures for benign prostatic hyperplasia.

- Foley / self-catheterization in the last 12 months.

- Patients with all three intermediate risk factors (PSA >10 and ≤ 20, Gleason 7,
clinical stage T2b-T2c) who ALSO have ≥50% of the number of their template biopsy
cores positive for cancer are ineligible.

- Prior pelvic radiotherapy, chemotherapy, or surgery for prostate cancer.

- Current active androgen deprivation therapy
</textblock>
</criteria>
<gender>Male</gender>
<gender_based>Yes</gender_based>
<minimum_age>45 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Aurelie Garant, MD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Texas Southwestern Medical Center</affiliation>
</overall_official>
<overall_contact>
<last_name>Sonobia Garrett, MS</last_name>
<phone>12146458787</phone>
<email>sonobia.garrett@utsouthwestern.edu</email>
</overall_contact>
<overall_contact_backup>
<last_name>Jose Santoyo</last_name>
<phone>214-645-8764</phone>
<email>jose.santoyo@utsouthwestern.edu</email>
</overall_contact_backup>
<location>
<facility>
<name>University of Texas Southwestern Medical Center - Dallas</name>
<address>
<city>Dallas</city>
<state>Texas</state>
<zip>75390</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>January 2023</verification_date>
<study_first_submitted>March 15, 2022</study_first_submitted>
<study_first_submitted_qc>March 25, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>January 27, 2023</last_update_submitted>
<last_update_submitted_qc>January 27, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">January 31, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
<investigator_full_name>Aurelie Garant</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Prostatic Neoplasms</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Confirming safety of combining UroLift System prior to SAbR for patients with newly diagnosed
prostate cancer and a history of BPH, by measuring the acute complication rate of UroLift
System implant in patients with BPH undergoing SAbR (within 90 days of treatment completion)
UroLift System implant will be implanted transurethrally under cystoscopic guidance with a
UroLift System Delivery Device by a trained provider. Optimal placement of the implants will
be verified cystoscopically. On average, 4-6 UroLift System implants are typically implanted
but more or less can be placed per provided discretion, up to a maximum of 10 implants per
manufacturer specifications.
Given that patients will also undergo UroLift System placement, patients will be offered to
undergo UroLift System, fiducial marker placement and rectal gel spacer placement in one
single procedure, under general anesthesia.
SAbR will be performed following placement of UroLift System, prostate fiducials, rectal
spacer, and MR/CT simulation, using stereotactic immobilization/localization, rectal enema,
prophylactic medication support (tamsulosin, dexamethasone unless contraindicated), bladder
filling protocol, and appropriate imaging verification.
Inclusion Criteria:
- AJCC 8th edition clinical stage T1 (a, b, or c) or T2 (a, b, or c) adenocarcinoma of
the prostate gland, Gleason 3+3 = 6 or 3+4 = 7, with no direct evidence of regional or
distant metastases following appropriate staging studies. See Appendix I for details
on AJCC 8th Edition staging criteria. T-staging may be assessed by multi-parametric
imaging alone if digital rectal examination was deferred
- Histologic confirmation of prostate cancer is required by biopsy performed within 18
months of registration.
- Age > 45 years.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.
- American Society of Anesthesia (ASA) physical status score of 1-3
- Baseline AUA symptom score ≥ 17 regardless of medical therapy
- The serum PSA should be < 20 ng/ml within 120 days of registration
- Study entry PSA must not be obtained during the following time frames: (1) 10-day
period following prostate biopsy; (2) following initiation of ADT or anti-androgen
therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days
after discontinuation of dutasteride; (5) within 5 days of a digital rectal
examination
- Ultrasound or MRI based volume estimation of prostate gland < 100 grams, regardless of
cytoreduction with pharmacotherapy
- Ability to undergo general anesthesia for <60 minutes
- Ability to understand and the willingness to sign a written informed consent.
- All men must agree to use adequate contraception (barrier method of birth control;
abstinence) prior to study entry, for the duration of study participation, and for 90
days following completion of therapy.
Exclusion Criteria:
- Contraindications to UroLift System placement including:
- Prostate volume >100 cc based on imaging-based estimation
- Urethral conditions (e.g. urethral strictures and neoplams) that may prevent insertion
of UroLift System delivery system into the bladder
- Urinary incontinence due to incompetent sphincter
- An active urinary tract infection
- Current gross hematuria
- In addition to the contraindications if there is a known allergy to nickel, titanium,
or stainless steel these patients should be excluded
- Prior transurethral resection of the prostate (TURP), median lobe manipulation, simple
prostatectomy, or other ablative procedures for benign prostatic hyperplasia.
- Foley / self-catheterization in the last 12 months.
- Patients with all three intermediate risk factors (PSA >10 and ≤ 20, Gleason 7,
clinical stage T2b-T2c) who ALSO have ≥50% of the number of their template biopsy
cores positive for cancer are ineligible.
- Prior pelvic radiotherapy, chemotherapy, or surgery for prostate cancer.
- Current active androgen deprivation therapy
|
NCT0531xxxx/NCT05311540.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/NCT05311540</url>
</required_header>
<id_info>
<org_study_id>ZincVLBW</org_study_id>
<nct_id>NCT05311540</nct_id>
</id_info>
<brief_title>Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial</brief_title>
<official_title>Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Zekai Tahir Burak Women's Health Research and Education Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Ankara City Hospital Bilkent</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Zekai Tahir Burak Women's Health Research and Education 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>
- Zinc (Zn) is a structural component of human body and is a crucial element for a wide
variety of cascades that take place in almost all organ systems.

- Due to many reasons, preterm infants are generally believed to be naturally in a
negative Zn balance during the early periods of life.

- Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status.

- There still is a lack of knowledge in the possible relation of Zn deficiency and
development of NEC and/or feeding intolerance in preterm infants.

- Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis
and found to reduce treatment failure in these high risk population, data in preventing
infectious diseases in preterm infants is still lacking.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Background and Objectives: Preterm infants have high zinc (Zn) requirements and are generally
believed to be in a negative Zn balance in the early period of life. In this study, we aimed
to investigate the effect of high dose Zn supplementation in very low birth weight (VLBW)
infants on feeding intolerance and development of mortality and/or morbidities including
necrotizing enterocolitis (NEC), late-onset sepsis (LOS).

Methods: This is a prospective randomized trial. VLBW preterm infants with gestational age of
<32 weeks were randomly allocated on the seventh day of life to receive extra amount of
supplemental zinc along with the enteral feedings or not, besides regular low dose
supplementation, from enrollment until discharge. Outcome measures were feeding intolerance,
NEC (stage≥2), LOS and mortality.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">March 14, 2014</start_date>
<completion_date type="Actual">April 20, 2015</completion_date>
<primary_completion_date type="Actual">March 2, 2015</primary_completion_date>
<phase>Phase 4</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Sequential Assignment</intervention_model>
<primary_purpose>Prevention</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
<masking_description>An independent physician not involved in the study conducted the random assignment process. The investigators who were blinded to the randomisation process closely followed up the enrolled infants for any evidence of feeding intolerance and/or NEC, late-onset sepsis (LOS), bronchopulmonary dysplasia (BPD), hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP) along with other possible neonatal morbidities and signs of toxicity or side effects (adverse events)</masking_description>
</study_design_info>
<primary_outcome>
<measure>Incidence of feeding intolerance</measure>
<time_frame>through study completion, an average of 6 months</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Duration of hospitalization</measure>
<time_frame>through study completion, an average of 6 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of participants with necrotising enterocolitis (stage≥2)</measure>
<time_frame>through study completion, an average of 6 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of mortality</measure>
<time_frame>through study completion, an average of 6 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of participants with late onset sepsis</measure>
<time_frame>through study completion, an average of 6 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of participants with retinopathy of prematurity</measure>
<time_frame>through study completion, an average of 6 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of participants with bronchopulmonary dysplasia</measure>
<time_frame>through study completion, an average of 6 months</time_frame>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">195</enrollment>
<condition>Preterm Infant</condition>
<condition>Effect of Drugs</condition>
<condition>Zinc Deficiency Disease</condition>
<arm_group>
<arm_group_label>Zinc intervention</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>9 mg/day Zinc suspension via og tube along with the routinely used standard multivitamin product containing 3 mg daily dose of Zn, started on day 7 until discharge from hospital</description>
</arm_group>
<arm_group>
<arm_group_label>Control</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>These infants received only standard commercial multivitamin product containing 3 mg daily dose of Zn</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Zinc Sulfate</intervention_name>
<arm_group_label>Zinc intervention</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- < 32 weeks gestational age and/or <1500 gr birth weight

- Born in the study hospital

- Being able to be fed enterally, even in very small amounts, regardless of the volume
of the nutrient

Exclusion Criteria:

- Major congenital malformations and/or critical congenital heart defects

- Born in another hospital

- Severe birth asphyxia

- Severe sepsis

- Previous early-onset NEC history

- Infants on the intervention arm who did not continue Zinc supplementation during the
study period

- Hemodynamically unstability

- Infants nil per os

- No consent from the family

- Death before the 7th day of life
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>7 Days</minimum_age>
<maximum_age>9 Days</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Izmir Democracy University Faculty of Medicine</name>
<address>
<city>Izmir</city>
<zip>35290</zip>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>May 19, 2019</study_first_submitted>
<study_first_submitted_qc>March 25, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>February 3, 2023</last_update_submitted>
<last_update_submitted_qc>February 3, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 8, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Zekai Tahir Burak Women's Health Research and Education Hospital</investigator_affiliation>
<investigator_full_name>Suzan Sahin</investigator_full_name>
<investigator_title>Specialist</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Deficiency Diseases</mesh_term>
<mesh_term>Birth Weight</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Zinc Sulfate</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
- Zinc (Zn) is a structural component of human body and is a crucial element for a wide
variety of cascades that take place in almost all organ systems.
- Due to many reasons, preterm infants are generally believed to be naturally in a
negative Zn balance during the early periods of life.
- Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status.
- There still is a lack of knowledge in the possible relation of Zn deficiency and
development of NEC and/or feeding intolerance in preterm infants.
- Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis
and found to reduce treatment failure in these high risk population, data in preventing
infectious diseases in preterm infants is still lacking.
Background and Objectives: Preterm infants have high zinc (Zn) requirements and are generally
believed to be in a negative Zn balance in the early period of life. In this study, we aimed
to investigate the effect of high dose Zn supplementation in very low birth weight (VLBW)
infants on feeding intolerance and development of mortality and/or morbidities including
necrotizing enterocolitis (NEC), late-onset sepsis (LOS).
Methods: This is a prospective randomized trial. VLBW preterm infants with gestational age of
<32 weeks were randomly allocated on the seventh day of life to receive extra amount of
supplemental zinc along with the enteral feedings or not, besides regular low dose
supplementation, from enrollment until discharge. Outcome measures were feeding intolerance,
NEC (stage≥2), LOS and mortality.
Inclusion Criteria:
- < 32 weeks gestational age and/or <1500 gr birth weight
- Born in the study hospital
- Being able to be fed enterally, even in very small amounts, regardless of the volume
of the nutrient
Exclusion Criteria:
- Major congenital malformations and/or critical congenital heart defects
- Born in another hospital
- Severe birth asphyxia
- Severe sepsis
- Previous early-onset NEC history
- Infants on the intervention arm who did not continue Zinc supplementation during the
study period
- Hemodynamically unstability
- Infants nil per os
- No consent from the family
- Death before the 7th day of life
|
NCT0531xxxx/NCT05311553.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/NCT05311553</url>
</required_header>
<id_info>
<org_study_id>19-121 thinning vs drilling</org_study_id>
<nct_id>NCT05311553</nct_id>
</id_info>
<brief_title>Zona Pellucida Thinning Versus Drilling During Laser-assisted Hatching</brief_title>
<official_title>Zona Pellucida Thinning Versus Drilling During Laser-assisted Hatching of Human Embryos in Intracytoplasmic Sperm Injection</official_title>
<sponsors>
<lead_sponsor>
<agency>National Research Centre, Egypt</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>National Research Centre, 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>
Two hundred cycles will be enrolled (100 laser-assisted thinning and 100 laser-assisted
drillings).

They will be compared regarding the implantation and clinical pregnancy rates
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Two hundred cycles will be enrolled (100 laser-assisted thinning and 100 laser-assisted
drillings).

All study participants will undergo controlled ovarian stimulation by GnRH agonist long
protocol starting from mid-luteal phase. The complete pituitary suppression will be confirmed
by serumE2 level less than 30 pg/ml and serum LH level less than 2 mIU/ml, then gonadotropin
therapy will be started from day 2 to the day of maturation confirmed by the presence of 3
mature follicles or more, one of them 18 mm; at this time 10000 IU of hCG will be
administered then ovum pick up done 36 hours after hCG administration under transvaginal
ultrasound guidance Cumulus cell masses around the oocytes will be removed using pull-and-cut
denudation pipettes in a 5-well culture dish (MTG, Bruckberg, Germany) containing 27 IU/mL of
hyaluronidase.

All oocytes that will be mature at 4-6 h after oocyte collection will be inseminated
according to the quality of the spermatozoa and oocytes and the patient's previous IVF
history. Fertilization will be confirmed 17-18 h after insemination by the presence of two
distinct pronuclei. Zygotes will be cultured in 30-μL micro-drops with a 1-step medium and
overlaid with paraffin oil in an atmosphere of 6% CO2, 5%O2, and 95% humidity at 37 °C. The
available embryos will be assessed in all patients according to the criteria of equal and
regular blastomeres, a viable blastomere number, and fragmentation ratio.

LAH will be conducted using a Laser System with a 1.48-μm diode-laser at 300 m W through
thinning or drilling. The embryos will undergo either LAT or LAD in 10- to 20-μL micro-drops
consisting of G-MOPS plus medium. The embryos will be fixed in the micro-drops on the
inverted microscope. The size of one laser shot will be 5μm in the ZP using the same total
number of 3000-μs pulses. In LAT, the goal of the thinning method is to make the outer
portion of the outer protective glycoprotein layer thinner. The laser thinning will be
performed by making 2-3 holes without reaching the inner membrane at a depth of60-80% of the
ZP thickness. In LAD, the laser opening will be made from the outside to the inside of the
ZP.

The laser beam shot towards the ZP above the perivitelline space between two blastomeres to
minimize the risk of harming the embryo, under careful control. The embryos in the micro-drop
will be washed several times after LAH and then transferred to a 1-well dish (Falcon 353,653,
USA) containing G-2 culture medium. LAH was performed 2 to 3 h before embryo transfer. The
embryos will be cultured in an atmosphere of 6% CO2, 5% O2, and 95% humidity at 37 °C.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">October 1, 2020</start_date>
<completion_date type="Anticipated">December 30, 2022</completion_date>
<primary_completion_date type="Anticipated">December 30, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Other</primary_purpose>
<masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Implantation rate</measure>
<time_frame>at 6 weeks of pregnancy</time_frame>
<description>Implantation rate = the total number of early gestational sacs/the total number of transferred embryos × 100%.</description>
</primary_outcome>
<secondary_outcome>
<measure>Clinical pregnancy rate</measure>
<time_frame>at 6 weeks of pregnancy</time_frame>
<description>Clinical pregnancy rate = the number of pregnancy cycles/the total number of transfer cycles × 100%.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">200</enrollment>
<condition>Infertility</condition>
<arm_group>
<arm_group_label>Zona pellucida thinning</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>thinning will be performed without reaching the inner membrane of the Zona pellucida thickness.</description>
</arm_group>
<arm_group>
<arm_group_label>Zona pellucida drilling</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>an opening will be made from the outside to the inside of the Zona pellucida.</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Zona pellucida thinning</intervention_name>
<description>Laser-assisted hatching will be conducted using a Laser System with a 1.48-μm diode laser at 300 m W through thinning. The laser thinning will be performed by making 2-3 holes without reaching the inner membrane at a depth of60-80% of the Zona pellucida thickness.</description>
<arm_group_label>Zona pellucida thinning</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Zona pellucida drilling</intervention_name>
<description>Laser-assisted hatching will be conducted using a Laser System with a 1.48-μm diode laser at 300 m W through drilling. The laser opening will be made from the outside to the inside of the Zona pellucida.</description>
<arm_group_label>Zona pellucida drilling</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Patients who have a previous ICSI failure, unexplained infertility or male infertility

Exclusion Criteria:

- Patients with hydrosalpinx, pyosalpinx, endometriosis, or uterine fibroids
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>25 Years</minimum_age>
<maximum_age>40 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Ahmed Ayoub</last_name>
<role>Principal Investigator</role>
<affiliation>National Research Centre, Egypt</affiliation>
</overall_official>
<overall_contact>
<last_name>Mazen Abdel-Rasheed</last_name>
<phone>+201111242366</phone>
<email>doctor_mazen@hotmail.com</email>
</overall_contact>
<location>
<facility>
<name>Private IVF Center</name>
<address>
<city>Cairo</city>
<country>Egypt</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Ahmed Ayoub</last_name>
</contact>
</location>
<location_countries>
<country>Egypt</country>
</location_countries>
<verification_date>October 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>October 19, 2022</last_update_submitted>
<last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">October 21, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Infertility</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Two hundred cycles will be enrolled (100 laser-assisted thinning and 100 laser-assisted
drillings).
They will be compared regarding the implantation and clinical pregnancy rates
Two hundred cycles will be enrolled (100 laser-assisted thinning and 100 laser-assisted
drillings).
All study participants will undergo controlled ovarian stimulation by GnRH agonist long
protocol starting from mid-luteal phase. The complete pituitary suppression will be confirmed
by serumE2 level less than 30 pg/ml and serum LH level less than 2 mIU/ml, then gonadotropin
therapy will be started from day 2 to the day of maturation confirmed by the presence of 3
mature follicles or more, one of them 18 mm; at this time 10000 IU of hCG will be
administered then ovum pick up done 36 hours after hCG administration under transvaginal
ultrasound guidance Cumulus cell masses around the oocytes will be removed using pull-and-cut
denudation pipettes in a 5-well culture dish (MTG, Bruckberg, Germany) containing 27 IU/mL of
hyaluronidase.
All oocytes that will be mature at 4-6 h after oocyte collection will be inseminated
according to the quality of the spermatozoa and oocytes and the patient's previous IVF
history. Fertilization will be confirmed 17-18 h after insemination by the presence of two
distinct pronuclei. Zygotes will be cultured in 30-μL micro-drops with a 1-step medium and
overlaid with paraffin oil in an atmosphere of 6% CO2, 5%O2, and 95% humidity at 37 °C. The
available embryos will be assessed in all patients according to the criteria of equal and
regular blastomeres, a viable blastomere number, and fragmentation ratio.
LAH will be conducted using a Laser System with a 1.48-μm diode-laser at 300 m W through
thinning or drilling. The embryos will undergo either LAT or LAD in 10- to 20-μL micro-drops
consisting of G-MOPS plus medium. The embryos will be fixed in the micro-drops on the
inverted microscope. The size of one laser shot will be 5μm in the ZP using the same total
number of 3000-μs pulses. In LAT, the goal of the thinning method is to make the outer
portion of the outer protective glycoprotein layer thinner. The laser thinning will be
performed by making 2-3 holes without reaching the inner membrane at a depth of60-80% of the
ZP thickness. In LAD, the laser opening will be made from the outside to the inside of the
ZP.
The laser beam shot towards the ZP above the perivitelline space between two blastomeres to
minimize the risk of harming the embryo, under careful control. The embryos in the micro-drop
will be washed several times after LAH and then transferred to a 1-well dish (Falcon 353,653,
USA) containing G-2 culture medium. LAH was performed 2 to 3 h before embryo transfer. The
embryos will be cultured in an atmosphere of 6% CO2, 5% O2, and 95% humidity at 37 °C.
Inclusion Criteria:
- Patients who have a previous ICSI failure, unexplained infertility or male infertility
Exclusion Criteria:
- Patients with hydrosalpinx, pyosalpinx, endometriosis, or uterine fibroids
|
NCT0531xxxx/NCT05311566.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/NCT05311566</url>
</required_header>
<id_info>
<org_study_id>IMURADIO3</org_study_id>
<nct_id>NCT05311566</nct_id>
</id_info>
<brief_title>PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer</brief_title>
<official_title>Effectiveness and Safety of Camrelizumab Combined With Concurrent Chemoradiotherapy for FIGO IB2-IIIB Cervical Cancer: A Single-center, Single-arm, Open-phase II Clinical Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Lei Li</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Peking Union Medical College Hospital</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This study is a single-center, single-arm, open-phase II clinical study, the main purpose of
which is to evaluate the effectiveness and safety of camrelizumab combined with concurrent
chemoradiotherapy for early and locally advanced cervical cancer, i.e., FIGO 2018 IB2-IIIB
cervical cancer. Eligible subjects will be given cisplatin and radiotherapy, for 6-8 weeks,
camrelizumab repeated every 14 days until disease progression, toxicity intolerance, or other
reasons specified in the protocol. Subjects who finished treatment entered the safety
follow-up or survival follow-up.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 27, 2022</start_date>
<completion_date type="Anticipated">March 27, 2026</completion_date>
<primary_completion_date type="Anticipated">March 27, 2023</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>3-year OS rate</measure>
<time_frame>36 months</time_frame>
<description>Patient proportion to survival in the third year</description>
</primary_outcome>
<secondary_outcome>
<measure>Progression-free survival（PFS）</measure>
<time_frame>24 months</time_frame>
<description>The period of time between when a patient with neoplastic disease receives treatment and when the disease progresses or death from any cause occurs.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Objective response rate (ORR)</measure>
<time_frame>12 months</time_frame>
<description>Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission（CR） and partial remission（PR）.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acute Adverse Events (AEs)</measure>
<time_frame>36 months</time_frame>
<description>The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 5.0</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">92</enrollment>
<condition>Cervical Carcinoma</condition>
<condition>Chemoradiotherapy</condition>
<condition>Anti-programmed Cell Death Receptor 1</condition>
<condition>Immunotherapy</condition>
<condition>Immune Checkpoint Inhibitor</condition>
<condition>Survival Outcomes</condition>
<condition>Adverse Events</condition>
<condition>Early Stage Cervical Cancer</condition>
<condition>Locally Advanced Cervical Cancer</condition>
<arm_group>
<arm_group_label>Patients with primary IB2-IIIB cervical cancer</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients with primary IB2-IIIB cervical cancer, including squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma.</description>
</arm_group>
<intervention>
<intervention_type>Combination Product</intervention_type>
<intervention_name>Camrelizumab plus Concurrent chemoradiotherapy</intervention_name>
<description>Participants will be given intravenous administration of Camrelizumab (200mg，every 2 weeks),Cisplatin(40mg/m²，everyweek) and Radiotherapy. After completing 6~8weeks of concurrent chemoradiation, the Participants will continue to use camrelizumab as maintenance therapy until disease progression or unacceptable toxicity.</description>
<arm_group_label>Patients with primary IB2-IIIB cervical cancer</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Histologically confirmed cervical adenocarcinoma, cervical squamous cell carcinoma, or
cervical adenosquamous carcinoma and FIGO2018 IB2 to IIIB；

2. Have not received radiotherapy, chemoradiotherapy or other'system therapy
for,cervical,cancer in the past.

3. With measurable tumor lesions (meet RECIST 1.1 standard).

4. Age≥18 years old when signing the informed consent, female.

5. ECOG PS: 0-2 points.

6. Expected survival time > 6 months.

7. According with lab testing criteria in the protocol.

8. Ability and willingness to comply with research and follow-up procedures.

9. Females of childbearing potential must agree to use adequate contraception throughout
the study period and for 6 months after the end of treatment.

10. The patients voluntarily joined the clinical study and signed the informed consent,
with good compliance and follow-up.

Exclusion Criteria:

1. Have previously received an anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2
antibody, or anti-CTLA-4 antibody (or any other antibody that acts on T cell
costimulation or checkpoint pathways);

2. Have a clear history of allergies, and may have potential allergies or intolerances to
the study drug and its similar biological agents.

3. Participated in clinical trials of other antitumor drugs within 4 weeks before the
first dose, or planned to receive live attenuated vaccines within 4 weeks before the
first dose or during the study.

4. Other malignant tumors have occurred within 5 years (except for adequately treated
cutaneous squamous cell carcinoma or controlled cutaneous basal cell carcinoma).

5. Use immunosuppressive medications, excluding nasal and inhaled corticosteroids or
physiologic doses of systemic steroids (no more than 10 mg/day prednisolone or other
corticosteroids at equivalent doses),within 14 days of first use of camrelizumab.

6. Symptomatic advanced patients with visceral dissemination who are at short-term risk
of life-threatening complications (including uncontrolled massive exudates [thoracic,
pericardium, abdominal], pulmonary lymphangitis and more than 30% patients with liver
involvement).

7. Presence or history of any active autoimmune disease (including but not limited to:
autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis,
hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with
vitiligo or asthma in childhood have been completely relieved, no need for any after
adulthood Asthma patients who need bronchodilator for medical intervention can not be
included).

8. Subjects with grade II or higher myocardial ischemia or myocardial infarction, and
poorly controlled arrhythmias (including QTc interval ≥450ms in men and ≥470ms in
women). According to the New York Heart Association standard, Subjects with grade
III-IV cardiac insufficiency, or echocardiography showed left ventricular ejection
fraction (LVEF) <50%; myocardial infarction occurred within 6 months before
enrollment, and New York Heart Association grade II or above cardiac function Failure,
uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically
significant pericardial disease, or electrocardiogram suggesting acute ischemia or
active conduction system abnormalities.

9. Concurrent severe infection (eg, requiring intravenous antibiotics, antifungals, or
antivirals) within 4 weeks prior to first dose, or unexplained fever >38.5°C during
screening or before first dose.

10. Subjects with a history of psychotropic substance abuse and unable to quit or with
mental disorders.

11. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency
syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C
antibody positive, and HCV-RNA is higher than the detection limit of the analytical
method) or co-infection with hepatitis B and C.

12. Subjects with untreated central nervous system metastases, Subjects who have received
systemic, radical brain or meningeal metastases in the past (radiotherapy or surgery),
have been stable for at least 1 month if confirmed by imaging, and have stopped
systemic hormone therapy (Dose > 10mg/day prednisone or other equivalent therapeutic
hormones) for more than 2 weeks and without clinical symptoms can be included.

13. Subjects with a history of hereditary or acquired bleeding or coagulation dysfunction
(the investigator will determine whether they can be included).

14. Other conditions not considered suitable for inclusion by the researcher.
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Lei Li, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Peking Union Medical College Hospital</affiliation>
</overall_official>
<overall_contact>
<last_name>Lei Li, M.D.</last_name>
<phone>86-139-1198-8831</phone>
<email>lileigh@163.com</email>
</overall_contact>
<location>
<facility>
<name>Lei Li</name>
<address>
<city>Beijing</city>
<state>Beijing</state>
<zip>100730</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Lei Li, M.D.</last_name>
<phone>8613911988831</phone>
<email>lileigh@163.com</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>April 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>April 5, 2022</last_update_submitted>
<last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 13, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
<investigator_full_name>Lei Li</investigator_full_name>
<investigator_title>Professor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Uterine Cervical Neoplasms</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study is a single-center, single-arm, open-phase II clinical study, the main purpose of
which is to evaluate the effectiveness and safety of camrelizumab combined with concurrent
chemoradiotherapy for early and locally advanced cervical cancer, i.e., FIGO 2018 IB2-IIIB
cervical cancer. Eligible subjects will be given cisplatin and radiotherapy, for 6-8 weeks,
camrelizumab repeated every 14 days until disease progression, toxicity intolerance, or other
reasons specified in the protocol. Subjects who finished treatment entered the safety
follow-up or survival follow-up.
Inclusion Criteria:
1. Histologically confirmed cervical adenocarcinoma, cervical squamous cell carcinoma, or
cervical adenosquamous carcinoma and FIGO2018 IB2 to IIIB；
2. Have not received radiotherapy, chemoradiotherapy or other'system therapy
for,cervical,cancer in the past.
3. With measurable tumor lesions (meet RECIST 1.1 standard).
4. Age≥18 years old when signing the informed consent, female.
5. ECOG PS: 0-2 points.
6. Expected survival time > 6 months.
7. According with lab testing criteria in the protocol.
8. Ability and willingness to comply with research and follow-up procedures.
9. Females of childbearing potential must agree to use adequate contraception throughout
the study period and for 6 months after the end of treatment.
10. The patients voluntarily joined the clinical study and signed the informed consent,
with good compliance and follow-up.
Exclusion Criteria:
1. Have previously received an anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2
antibody, or anti-CTLA-4 antibody (or any other antibody that acts on T cell
costimulation or checkpoint pathways);
2. Have a clear history of allergies, and may have potential allergies or intolerances to
the study drug and its similar biological agents.
3. Participated in clinical trials of other antitumor drugs within 4 weeks before the
first dose, or planned to receive live attenuated vaccines within 4 weeks before the
first dose or during the study.
4. Other malignant tumors have occurred within 5 years (except for adequately treated
cutaneous squamous cell carcinoma or controlled cutaneous basal cell carcinoma).
5. Use immunosuppressive medications, excluding nasal and inhaled corticosteroids or
physiologic doses of systemic steroids (no more than 10 mg/day prednisolone or other
corticosteroids at equivalent doses),within 14 days of first use of camrelizumab.
6. Symptomatic advanced patients with visceral dissemination who are at short-term risk
of life-threatening complications (including uncontrolled massive exudates [thoracic,
pericardium, abdominal], pulmonary lymphangitis and more than 30% patients with liver
involvement).
7. Presence or history of any active autoimmune disease (including but not limited to:
autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis,
hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with
vitiligo or asthma in childhood have been completely relieved, no need for any after
adulthood Asthma patients who need bronchodilator for medical intervention can not be
included).
8. Subjects with grade II or higher myocardial ischemia or myocardial infarction, and
poorly controlled arrhythmias (including QTc interval ≥450ms in men and ≥470ms in
women). According to the New York Heart Association standard, Subjects with grade
III-IV cardiac insufficiency, or echocardiography showed left ventricular ejection
fraction (LVEF) <50%; myocardial infarction occurred within 6 months before
enrollment, and New York Heart Association grade II or above cardiac function Failure,
uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically
significant pericardial disease, or electrocardiogram suggesting acute ischemia or
active conduction system abnormalities.
9. Concurrent severe infection (eg, requiring intravenous antibiotics, antifungals, or
antivirals) within 4 weeks prior to first dose, or unexplained fever >38.5°C during
screening or before first dose.
10. Subjects with a history of psychotropic substance abuse and unable to quit or with
mental disorders.
11. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency
syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C
antibody positive, and HCV-RNA is higher than the detection limit of the analytical
method) or co-infection with hepatitis B and C.
12. Subjects with untreated central nervous system metastases, Subjects who have received
systemic, radical brain or meningeal metastases in the past (radiotherapy or surgery),
have been stable for at least 1 month if confirmed by imaging, and have stopped
systemic hormone therapy (Dose > 10mg/day prednisone or other equivalent therapeutic
hormones) for more than 2 weeks and without clinical symptoms can be included.
13. Subjects with a history of hereditary or acquired bleeding or coagulation dysfunction
(the investigator will determine whether they can be included).
14. Other conditions not considered suitable for inclusion by the researcher.
|
NCT0531xxxx/NCT05311579.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/NCT05311579</url>
</required_header>
<id_info>
<org_study_id>NIRAN1</org_study_id>
<nct_id>NCT05311579</nct_id>
</id_info>
<brief_title>Niraparib Plus Anlotinib for Recurrent Ovarian Cancer</brief_title>
<official_title>Efficacy and Safety of Niraparib in Combination With Anlotinib Based on CA 125 Level in Newly Diagnosed Ovarian Cancer: A Open-label, Single Arm, Prospective Phase II Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Lei Li</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Peking Union Medical College Hospital</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This is a phase II trial to explore efficacy and safety of niraparib in combination with
anlotinib based on CA 125 level in newly diagnosed ovarian cancer. After completion of
1st-line platinum-based chemotherapy with a normal CA-125 concentration, in patients with
CA-125 increased > 35U/ml, and with no evidence of imaging recurrence, niraparib and
anlotinib are used as 1st maintenance therapy for newly diagnosed advanced ovarian cancer
after achieving complete or partial remission to platinum-containing chemotherapy. The
primary objective of this study is to explore the efficacy of niraparib combined with
anlotinib based on CA 125 level in newly diagnosed ovarian cancer with no evidence of imaging
recurrence. A total o f36 patients will be enrolled in this study.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 27, 2022</start_date>
<completion_date type="Anticipated">March 27, 2024</completion_date>
<primary_completion_date type="Anticipated">March 27, 2023</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Progression free survival (PFS)</measure>
<time_frame>24 months</time_frame>
<description>Progression free survival (PFS) by RECIST v 1.1</description>
</primary_outcome>
<secondary_outcome>
<measure>Time to first subsequent therapy (TFST)</measure>
<time_frame>24 months</time_frame>
<description>Time to first subsequent therapy (TFST)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Overall survival (OS)</measure>
<time_frame>48 months</time_frame>
<description>Overall survival (OS)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Adverse events</measure>
<time_frame>24 months</time_frame>
<description>Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">36</enrollment>
<condition>Ovarian Carcinoma</condition>
<condition>Survival Outcomes</condition>
<condition>Adverse Events</condition>
<condition>Niraparib</condition>
<condition>Anlotinib</condition>
<condition>CA125</condition>
<condition>Chemotherapy</condition>
<condition>Targeted Therapy</condition>
<condition>Recurrent Ovarian Cancer</condition>
<arm_group>
<arm_group_label>Ovarian cancer patients with increased CA125</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients with CA125 >35 U/ml or increased to 2 x nadir, and with no evidence of imaging recurrence after completion of 1st-line platinum-based chemotherapy</description>
</arm_group>
<intervention>
<intervention_type>Combination Product</intervention_type>
<intervention_name>Niraparib plus anlotinib</intervention_name>
<description>Niraparib QD D1-21 plus Anlotinib 10mg QD D1-14 until disease progression or intolerable toxicity
21days/cycle</description>
<arm_group_label>Ovarian cancer patients with increased CA125</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion criteria

1. Patients must be able to understand the study procedures and agree to participate in
the study by providing written informed consent

2. Patients must be female ≥18 years of age

3. Patients must have histologically diagnosed non-mucinous ovarian cancer that is Stage
III or IV according to FIGO criteria, and niraparib is used as 1st maintenance therapy
after achieving CR/PR to front-line platinum-containing chemotherapy

4. After completion of front-line platinum-based chemotherapy with a normal CA-125
concentration: CA-125 increased > 35U/ml on 2 occasions (Repeat CA 125 any time but
normally not less than 1 week after the first elevated CA 125 level), and with no
evidence of imaging recurrence

5. After completion of front-line platinum-based chemotherapy, CA125 decreased by 90% and
was not in the normal range: the level of CA125 at the end of chemotherapy as the
nadir, CA-125 increased to 2 x nadir on 2 occasions (Repeat CA 125 any time but
normally not less than 1 week after the first elevated CA 125 level), and with no
evidence of imaging recurrence

6. Allow to combinate bevacizumab during front-line chemotherapy

7. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0 or 1

8. Patients must have adequate organ function, defined as follows:

- Absolute neutrophil count ≥ 1,500/μL

- Platelets ≥ 100,000/μL

- Hemoglobin ≥ 10 g/dL

- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine
clearance ≥ 60 mL/min using the Cockcroft-Gault equation

- Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN

- Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver
metastases are present, in which case they must be ≤ 5 x ULN

9. Pregnancy test results were negative and patients willing to use appropriate
contraceptive methods while in the trial and within 3 months after the last dose of
this study treatment; or keep abstinence during the trial; or women with no potential
fertility.

10. Ability to comply with protocol.

11. All of the adverse events caused by chemotherapy recovered to Common Terminology
Criteria Adverse Events (CTCAE) grade 1 or baseline, except for stable sensory
neuropathy or hair loss ≤ CTCAE grade 2.

Exclusion criteria

1. Allergy to active or inactive ingredients of niraparib or drugs with similar chemical
structures.

2. Allergy to active or inactive ingredients of anlotinib or drugs with similar chemical
structures.

3. Active and uncontrollable brain metastasis or leptomeningeal metastasis. Patients with
spinal cord compression can still be considered if they have received targeted
treatment and have evidence of clinical stability of the disease for at least > 28
days (controlled brain metastasis must have received radiotherapy or chemotherapy at
least 1 month prior to study entry; patients may not have new symptoms related to
brain lesions or symptoms indicating disease progression and either take stable dose
of hormone or do not need to take hormone).

4. Major surgery performed within 3 weeks before enrollment, or any surgical effects that
have not recovered from the surgery, or chemotherapy.

5. Palliative radiotherapy encompassing >20% of the bone marrow within 1 week of the
first dose of study treatment

6. Any other malignant tumor exclude ovarian cancer has been diagnosed within 2 years
before enrollment (except for completely treated basal or squamous cell skin cancer).

7. Current or previous myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)

8. Other severe or uncontrolled diseases, including but not limited to:

- Uncontrollable nausea and vomiting, inability to swallow study drug, and any
gastrointestinal disease that may interfere with the absorption and metabolism of
the drug

- Active viral infections, such as human immunodeficiency virus, hepatitis B virus,
hepatitis C virus and so on

- Uncontrolled epileptic seizures, unstable spinal cord compression, superior vena
cava syndrome or other psychiatric disorders that may affect patients' informed
consent

- Immunodeficiency (except for splenectomy), or other diseases that investigators
believe may expose patients to high-risk toxicity.

9. Have the risk or tendency of bleeding and history of thrombosis

- CTCAE grade 2 bleeding event occurred within 3 months prior to screening or CTCAE
≥ grade 3 bleeding event occurred within 3 months prior to screening

- Have history of gastrointestinal bleeding or confirmed bleeding tendency within 6
months prior to screening. e.g. esophageal varices with bleeding risk, local
active ulcer focus or fecal occult blood above ++

- Have active bleeding or coagulation dysfunction, have bleeding risk or undergoing
thrombolytic or anticoagulant therapy

- Need anticoagulant therapy with warfarin or heparin

- Need long-term anti-platelet therapy (e.g. aspirin, clopidogrel)

- Have occurred thrombus or embolism event in past 6 months, e.g. cerebral vascular
accident（including transient cerebral ischemic attack), pulmonary embolism

10. A history of severe cardiovascular disease:

- New York Heart Association (NYHA) grade 3/4 congestive heart failure (CHF)

- Unstable angina or newly diagnosed angina/myocardial infarction within 12 months
prior to screening

- Cardiac arrhythmia despite need medication (patients taking β-receptor blockers
or digoxin can be enrolled)

- CTCAE ≥ grade 2 valvular heart disease

- Poorly controlled hypertension (systolic pressure>150 mmHg or diastolic
pressure>100 mmHg)

11. The following laboratory indexed are abnormal:

- Hyponatremia (serum sodium < 130 mmol/L); baseline serum potassium < 3.5 mmol/L
(potassium supplements can be used to restore serum potassium above this before
enrollment)

- Thyroid dysfunction and cannot maintain normal despite medical treatment

12. Previous/current diseases and treatment or abnormal laboratory indexed those interfere
with study result or participation of the whole study; or the investigator confirmed
not suitable for this trial; have platelet or red blood cell transfusion within 4
weeks prior to the first dose of study treatment

13. Patients must not be pregnant, breastfeeding, or expecting to conceive children, while
receiving study treatment

14. Corrected QT interval（QTc>450 milliseconds); if patients have QTc prolongation because
of cardiac pacemaker confirmed by investigator and no other cardiac disorder, whether
enrollment need further discussion with investigator
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Lei Li, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Peking Union Medical College Hospital</affiliation>
</overall_official>
<overall_contact>
<last_name>Lei Li, M.D.</last_name>
<phone>86-139-1198-8831</phone>
<email>lileigh@163.com</email>
</overall_contact>
<location>
<facility>
<name>Lei Li</name>
<address>
<city>Beijing</city>
<state>Beijing</state>
<zip>100730</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Lei Li, M.D.</last_name>
<phone>8613911988831</phone>
<email>lileigh@163.com</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>April 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>April 5, 2022</last_update_submitted>
<last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 13, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
<investigator_full_name>Lei Li</investigator_full_name>
<investigator_title>Professor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ovarian Neoplasms</mesh_term>
<mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Niraparib</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This is a phase II trial to explore efficacy and safety of niraparib in combination with
anlotinib based on CA 125 level in newly diagnosed ovarian cancer. After completion of
1st-line platinum-based chemotherapy with a normal CA-125 concentration, in patients with
CA-125 increased > 35U/ml, and with no evidence of imaging recurrence, niraparib and
anlotinib are used as 1st maintenance therapy for newly diagnosed advanced ovarian cancer
after achieving complete or partial remission to platinum-containing chemotherapy. The
primary objective of this study is to explore the efficacy of niraparib combined with
anlotinib based on CA 125 level in newly diagnosed ovarian cancer with no evidence of imaging
recurrence. A total o f36 patients will be enrolled in this study.
Inclusion criteria
1. Patients must be able to understand the study procedures and agree to participate in
the study by providing written informed consent
2. Patients must be female ≥18 years of age
3. Patients must have histologically diagnosed non-mucinous ovarian cancer that is Stage
III or IV according to FIGO criteria, and niraparib is used as 1st maintenance therapy
after achieving CR/PR to front-line platinum-containing chemotherapy
4. After completion of front-line platinum-based chemotherapy with a normal CA-125
concentration: CA-125 increased > 35U/ml on 2 occasions (Repeat CA 125 any time but
normally not less than 1 week after the first elevated CA 125 level), and with no
evidence of imaging recurrence
5. After completion of front-line platinum-based chemotherapy, CA125 decreased by 90% and
was not in the normal range: the level of CA125 at the end of chemotherapy as the
nadir, CA-125 increased to 2 x nadir on 2 occasions (Repeat CA 125 any time but
normally not less than 1 week after the first elevated CA 125 level), and with no
evidence of imaging recurrence
6. Allow to combinate bevacizumab during front-line chemotherapy
7. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0 or 1
8. Patients must have adequate organ function, defined as follows:
- Absolute neutrophil count ≥ 1,500/μL
- Platelets ≥ 100,000/μL
- Hemoglobin ≥ 10 g/dL
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine
clearance ≥ 60 mL/min using the Cockcroft-Gault equation
- Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN
- Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver
metastases are present, in which case they must be ≤ 5 x ULN
9. Pregnancy test results were negative and patients willing to use appropriate
contraceptive methods while in the trial and within 3 months after the last dose of
this study treatment; or keep abstinence during the trial; or women with no potential
fertility.
10. Ability to comply with protocol.
11. All of the adverse events caused by chemotherapy recovered to Common Terminology
Criteria Adverse Events (CTCAE) grade 1 or baseline, except for stable sensory
neuropathy or hair loss ≤ CTCAE grade 2.
Exclusion criteria
1. Allergy to active or inactive ingredients of niraparib or drugs with similar chemical
structures.
2. Allergy to active or inactive ingredients of anlotinib or drugs with similar chemical
structures.
3. Active and uncontrollable brain metastasis or leptomeningeal metastasis. Patients with
spinal cord compression can still be considered if they have received targeted
treatment and have evidence of clinical stability of the disease for at least > 28
days (controlled brain metastasis must have received radiotherapy or chemotherapy at
least 1 month prior to study entry; patients may not have new symptoms related to
brain lesions or symptoms indicating disease progression and either take stable dose
of hormone or do not need to take hormone).
4. Major surgery performed within 3 weeks before enrollment, or any surgical effects that
have not recovered from the surgery, or chemotherapy.
5. Palliative radiotherapy encompassing >20% of the bone marrow within 1 week of the
first dose of study treatment
6. Any other malignant tumor exclude ovarian cancer has been diagnosed within 2 years
before enrollment (except for completely treated basal or squamous cell skin cancer).
7. Current or previous myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
8. Other severe or uncontrolled diseases, including but not limited to:
- Uncontrollable nausea and vomiting, inability to swallow study drug, and any
gastrointestinal disease that may interfere with the absorption and metabolism of
the drug
- Active viral infections, such as human immunodeficiency virus, hepatitis B virus,
hepatitis C virus and so on
- Uncontrolled epileptic seizures, unstable spinal cord compression, superior vena
cava syndrome or other psychiatric disorders that may affect patients' informed
consent
- Immunodeficiency (except for splenectomy), or other diseases that investigators
believe may expose patients to high-risk toxicity.
9. Have the risk or tendency of bleeding and history of thrombosis
- CTCAE grade 2 bleeding event occurred within 3 months prior to screening or CTCAE
≥ grade 3 bleeding event occurred within 3 months prior to screening
- Have history of gastrointestinal bleeding or confirmed bleeding tendency within 6
months prior to screening. e.g. esophageal varices with bleeding risk, local
active ulcer focus or fecal occult blood above ++
- Have active bleeding or coagulation dysfunction, have bleeding risk or undergoing
thrombolytic or anticoagulant therapy
- Need anticoagulant therapy with warfarin or heparin
- Need long-term anti-platelet therapy (e.g. aspirin, clopidogrel)
- Have occurred thrombus or embolism event in past 6 months, e.g. cerebral vascular
accident（including transient cerebral ischemic attack), pulmonary embolism
10. A history of severe cardiovascular disease:
- New York Heart Association (NYHA) grade 3/4 congestive heart failure (CHF)
- Unstable angina or newly diagnosed angina/myocardial infarction within 12 months
prior to screening
- Cardiac arrhythmia despite need medication (patients taking β-receptor blockers
or digoxin can be enrolled)
- CTCAE ≥ grade 2 valvular heart disease
- Poorly controlled hypertension (systolic pressure>150 mmHg or diastolic
pressure>100 mmHg)
11. The following laboratory indexed are abnormal:
- Hyponatremia (serum sodium < 130 mmol/L); baseline serum potassium < 3.5 mmol/L
(potassium supplements can be used to restore serum potassium above this before
enrollment)
- Thyroid dysfunction and cannot maintain normal despite medical treatment
12. Previous/current diseases and treatment or abnormal laboratory indexed those interfere
with study result or participation of the whole study; or the investigator confirmed
not suitable for this trial; have platelet or red blood cell transfusion within 4
weeks prior to the first dose of study treatment
13. Patients must not be pregnant, breastfeeding, or expecting to conceive children, while
receiving study treatment
14. Corrected QT interval（QTc>450 milliseconds); if patients have QTc prolongation because
of cardiac pacemaker confirmed by investigator and no other cardiac disorder, whether
enrollment need further discussion with investigator
|
NCT0531xxxx/NCT05311592.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/NCT05311592</url>
</required_header>
<id_info>
<org_study_id>2021-12757</org_study_id>
<nct_id>NCT05311592</nct_id>
</id_info>
<brief_title>Supporting Responsible Fatherhood Program (Fatherhood FIRE)</brief_title>
<acronym>FIRE</acronym>
<official_title>Montefiore Medical Center Supporting Responsible Fatherhood Program</official_title>
<sponsors>
<lead_sponsor>
<agency>Montefiore Medical Center</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Children's Bureau - Administration for Children and Families</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Montefiore Medical Center</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Montefiore Medical Center (in partnership with BronxWorks) is implementing a large-scope
program to promote responsible fatherhood in the Bronx among low-income adult (18 years or
older) fathers with non-custodial children (under the age of 24). The program, called HERO
Dads (Healthy, Empowered, Resilient, Open Dads), will promote responsible fatherhood by
enhancing relationship and anger-management skills and providing marriage education;
providing skills-based parenting education, disseminating information about good parenting
practices, and encouraging child support payments (in partnership with our local OCSE); and
fostering economic stability by providing employment-related supports inclusive of job
search, vocational skills training, job referrals, and job retention.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The program model is based on the premise that relationship and parenting skills can be
taught, and will lead to improvements in relationships (knowledge about relationships,
communication skills, stress management, reduction in destructive conflict), parenting
(knowledge about child development, engagement with non-custodial children, effective
parenting, co-parent communication, child well-being), and economic status (vocational
skills, new employment or career advancement, financial literacy, child support). The
investigator will provide core relationship and relationship education workshops using an
empirically supported curriculum (24/7 Dad) plus employment workshops, numerous supplemental
activities to promote responsible fatherhood, individualized vocational case management, and
job-driven employment services. In total, the investigator expects to enroll 1,475
non-custodial fathers in the program and provide an average of 34 hours of total programming
per participant (including 24 hours of core workshops), which the investigator believes is a
sufficient dosage to detect impacts.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 1, 2021</start_date>
<completion_date type="Anticipated">September 30, 2025</completion_date>
<primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>The investigator will run workshops virtually, through Zoom, and in person. Participants will be randomized either to the virtual condition, or to the in person condition.</intervention_model_description>
<primary_purpose>Health Services Research</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Inventory of Father Involvement (IFI) (Father Involvement)</measure>
<time_frame>Baseline</time_frame>
<description>The IFI49, is a 26-item self-report instrument that assesses indirect and direct involvement using a 7- point Likert scale ranging from 0 (very poor) to 6 (excellent). This measure addresses the 3 main domains of father involvement: engagement, accessibility, and responsibility. Overall scores can therefore range from 0 to 156. Higher scores represent increased levels of engagement. Reliability of subscales in the initial study ranged from α = .69 to α = .90.</description>
</primary_outcome>
<secondary_outcome>
<measure>Information, Family Outcomes, Reporting, and Management (nFORM) Applicant Characteristics</measure>
<time_frame>Baseline</time_frame>
<description>This is a survey developed by the Office of Family Assistance utilized by all grantees participating in the national study, that gathers demographic information regarding participants.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Information, Family Outcomes, Reporting, and Management (nFORM) Pre-Program Survey</measure>
<time_frame>At start of intervention (Week 1 of 4)</time_frame>
<description>This is a survey developed by the Office of Family Assistance utilized by all grantees participating in the national study that includes questions regarding relationship satisfaction, financial stability, and parenting.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Information, Family Outcomes, Reporting, and Management (nFORM) Post-Program Survey</measure>
<time_frame>Immediately post intervention (Week 4 of 4 weeks)</time_frame>
<description>This is a survey developed by the Office of Family Assistance utilized by all grantees participating in the national study that includes questions regarding relationship satisfaction, financial stability, and parenting.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Child-Parent Relationship Scale Short Form (CPRS-SF) (Parent-Child Relationship Quality)</measure>
<time_frame>Baseline</time_frame>
<description>CPRS-SF48 is a self-report measure about the child and parent's interactions with child related to closeness and conflict. 15-items are rated on 5-point Likert scales. The ratings can be summed into groups of items corresponding to conflict and closeness subscales. The 8-item conflict subscale measures the degree to which a parent feels that his or her relationship with a child is characterized by negativity. Scores for conflict scale range from 8-40. Higher score on the conflict questions suggest parents feel their relationship with their child is characterized by negativity and a lower score is desirable. The 7-item closeness scale assesses the extent to which a parent feels that the relationship is characterized by warmth, affection, and open communication. Scores for closeness subscale range between 7-35. A higher score on the closeness questions suggest the parent/child relationship is characterized by warmth, affection and open communication and a higher score is desirable</description>
</secondary_outcome>
<secondary_outcome>
<measure>Skills/Knowledge Assessment (Skills/Knowledge Acquisition)</measure>
<time_frame>Change from Baseline Skills at immediately post intervention and at 6 months</time_frame>
<description>The Skills/Knowledge Assessment is an outcome measure that will be developed by program staff together with the local evaluator. The measure will be a multiple-choice assessment using scenarios describing parent-child and co-parenting interactions to determine whether fathers have learned skills and techniques taught at workshops. This measure will be calculated by obtaining the percentage of correctly-scored items. Higher scores indicate great skill acquisition. Two versions of this assessment will be created to prevent practice effects. Given that this is a homegrown measure, to validate this measure, the investigators will correlate the skill assessment scores with the well validated Assessing Emotions Scale and assess whether relationship skill scores differ by key demographic and social economic factors.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Assessing Emotions Scale (Emotional Intelligence)</measure>
<time_frame>Baseline</time_frame>
<description>The Assessing Emotions Scale47 is a 33-item measure of emotional intelligence that uses a Likert scale of measurement (value 1 - 5, ranging from strongly disagree to strongly agree), calculated by summing the responses across all items. Higher scores indicate higher levels of emotional intelligence. This measure has demonstrated good internal consistency, test-retest reliability, and convergent validity.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Childhood Trauma Questionnaire Short Form (CTQ-SF) (Childhood Trauma)</measure>
<time_frame>Baseline</time_frame>
<description>The CTQ-SF45 is a 28-item measure of childhood trauma that uses a Likert scale of measurement ranging from 1 (never true) to 5 (very often true). Items are divided into 5 sub-categories: emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect. This measure is calculated by summing most responses and reverse scoring select items and has demonstrated good test-retest reliability, criterion-related validity, and internal consistency.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Parenting Alliance Inventory (PAI) (Quality of Co-Parenting Relationship)</measure>
<time_frame>Baseline</time_frame>
<description>The PAI46 is a self-report instrument that assesses the degree to which parents believe that they have a sound working relationship with their child's other parent using a 5- point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). All items are averaged to create a global parenting alliance score (α = .97). Higher scores indicate a stronger parenting alliance. This measure demonstrated excellent internal consistency and good construct and concurrent validity.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">1475</enrollment>
<condition>Parenting</condition>
<condition>Family Relations</condition>
<condition>Father-Child Relations</condition>
<arm_group>
<arm_group_label>In Person</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive all services in person, including participating in the initial intake process, and attending all workshops.</description>
</arm_group>
<arm_group>
<arm_group_label>Virtual (Zoom)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will complete their intake process in person, but will complete all workshops virtually through Zoom.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>HERO Dads Program</intervention_name>
<description>The HERO Dads Program is a 4-week series of workshops for non-custodial fathers that focuses on improving parenting, offering job support, and financial counseling.</description>
<arm_group_label>In Person</arm_group_label>
<arm_group_label>Virtual (Zoom)</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Must be over 18 years of age

- Must have a child under the age of 24

- Must be a non-custodial parent or have shared custody

- Income below 200% poverty line

Exclusion Criteria:

- Active intimate partner violence and increased risk of intimate partner violence.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Scott Weltzer, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Montefiore Medical Center</affiliation>
</overall_official>
<overall_contact>
<last_name>Traci Maynigo, PsyD</last_name>
<phone>718-401-5044</phone>
<phone_ext>224</phone_ext>
<email>tmaynigo@montefiore.org</email>
</overall_contact>
<location>
<facility>
<name>Montefiore Medical Center</name>
<address>
<city>Bronx</city>
<state>New York</state>
<zip>10451</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Traci Maynigo, PsyD</last_name>
<phone>718-401-5044</phone>
<phone_ext>224</phone_ext>
<email>tmaynigo@montefiore.org</email>
</contact>
<investigator>
<last_name>Scott Weltzer, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 28, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>February 6, 2023</last_update_submitted>
<last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 8, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Montefiore Medical Center (in partnership with BronxWorks) is implementing a large-scope
program to promote responsible fatherhood in the Bronx among low-income adult (18 years or
older) fathers with non-custodial children (under the age of 24). The program, called HERO
Dads (Healthy, Empowered, Resilient, Open Dads), will promote responsible fatherhood by
enhancing relationship and anger-management skills and providing marriage education;
providing skills-based parenting education, disseminating information about good parenting
practices, and encouraging child support payments (in partnership with our local OCSE); and
fostering economic stability by providing employment-related supports inclusive of job
search, vocational skills training, job referrals, and job retention.
The program model is based on the premise that relationship and parenting skills can be
taught, and will lead to improvements in relationships (knowledge about relationships,
communication skills, stress management, reduction in destructive conflict), parenting
(knowledge about child development, engagement with non-custodial children, effective
parenting, co-parent communication, child well-being), and economic status (vocational
skills, new employment or career advancement, financial literacy, child support). The
investigator will provide core relationship and relationship education workshops using an
empirically supported curriculum (24/7 Dad) plus employment workshops, numerous supplemental
activities to promote responsible fatherhood, individualized vocational case management, and
job-driven employment services. In total, the investigator expects to enroll 1,475
non-custodial fathers in the program and provide an average of 34 hours of total programming
per participant (including 24 hours of core workshops), which the investigator believes is a
sufficient dosage to detect impacts.
Inclusion Criteria:
- Must be over 18 years of age
- Must have a child under the age of 24
- Must be a non-custodial parent or have shared custody
- Income below 200% poverty line
Exclusion Criteria:
- Active intimate partner violence and increased risk of intimate partner violence.
|
NCT0531xxxx/NCT05311605.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/NCT05311605</url>
</required_header>
<id_info>
<org_study_id>KY-2022-029-01</org_study_id>
<nct_id>NCT05311605</nct_id>
</id_info>
<brief_title>REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion</brief_title>
<acronym>RESTORE</acronym>
<official_title>REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion</official_title>
<sponsors>
<lead_sponsor>
<agency>Beijing Tiantan Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Natural Science Foundation of China</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Beijing Municipal Science & Technology Commission</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Beijing Municipal Administration of Hospitals</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Beijing Tiantan 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 aim of the study was to establish a clinical and advanced imaging database of acute
ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion
of anterior circulation within 24 hours from stroke onset in China, and to investigate the
predictors and potential mechanisms of futile recanalization after mechanical thrombectomy.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The time-window of mechanical thrombectomy for ischemic stroke has extended from 4.5 hours to
24 hours based on the results of the DAWN and DEFUSE 3 trials. However, evidence on the
effectiveness and safety of mechanical thrombectomy within 24 hours in the real-world is
insufficient.

This is a multi-center, prospective, registry cohort study that acute ischemic stroke
patients treated with mechanical thrombectomy due to large vessel occlusion of anterior
circulation within 24 hours from stroke onset in China. A total of 1600 patients with
advanced imaging data were anticipated to be enrolled.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Anticipated">February 7, 2023</start_date>
<completion_date type="Anticipated">December 31, 2024</completion_date>
<primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
<study_type>Observational [Patient Registry]</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<target_duration>3 Months</target_duration>
<primary_outcome>
<measure>Favorable functional outcome</measure>
<time_frame>3 months from stroke onset</time_frame>
<description>proportion of mRS score 0-2 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome</description>
</primary_outcome>
<secondary_outcome>
<measure>Excellent functional outcome at 90 days</measure>
<time_frame>3 months from stroke onset</time_frame>
<description>proportion of mRS score 0-1 at 3 months</description>
</secondary_outcome>
<secondary_outcome>
<measure>Ordinal distribution of mRS at 90 days</measure>
<time_frame>3 months from stroke onset</time_frame>
<description>Number of participants with the ordinal distribution of mRS at 90 days</description>
</secondary_outcome>
<secondary_outcome>
<measure>EQ-5D score at at 90 days</measure>
<time_frame>3 months from stroke onset</time_frame>
<description>EQ-5D score at 3 months. EuroQol Five Dimensions Questionnaire scale (EQ-5D score) has a minimum value of 0 and maximum value of 100. Lower value indicated worse functional outcome</description>
</secondary_outcome>
<secondary_outcome>
<measure>Neurological improvement at 24 hours</measure>
<time_frame>24 hours from stroke onset</time_frame>
<description>NIHSS score <=1 or improvement of NIHSS score>=4 compared with baseline NIHSS. National Institution Health Stroke Scale (NIHSS) has a minimum value of 0 and maximum value of 45. Higher value indicated worse severity of neurological impairment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>recanalization post-operation</measure>
<time_frame>(Day 0) immediately the surgeon thought the thrombectomy completed and performed a second cerebral angiography .</time_frame>
<description>proportion of eTICI 2b50/2c/3. Thrombectomy is a surgical operation using a retrieve stent or aspiration catheter to remove the thrombus inside an occluded vessel and achieve recanalization.The eTICI is a scale to assess the degree of recanalization. So, once the surgeon thought he completed the thrombectomy, he needed to perform a cerebral angiography to assess the degree of recanalization using eTICI.</description>
</secondary_outcome>
<secondary_outcome>
<measure>recanalization at 24 hours</measure>
<time_frame>24 hours after thrombectomy completed</time_frame>
<description>proportion of eTICI 2b50/2c/3</description>
</secondary_outcome>
<other_outcome>
<measure>Infarction volume at 24 hours</measure>
<time_frame>24 hours after thrombectomy completed</time_frame>
<description>infarction volume: volume of the tissue with CBF <30% or ADC<600×10-6mm2/s</description>
</other_outcome>
<other_outcome>
<measure>symptomatic intracerebral hemorrhage at 36 hours</measure>
<time_frame>36 hours after thrombectomy completed</time_frame>
<description>symptomatic intracerebral hemorrhage based on Heidelberg criterion</description>
</other_outcome>
<other_outcome>
<measure>Mortality at 90 days</measure>
<time_frame>90 days after thrombectomy completed</time_frame>
<description>Mortality of all-cause</description>
</other_outcome>
<enrollment type="Anticipated">1600</enrollment>
<condition>Stroke</condition>
<condition>Vascular Occlusion</condition>
<condition>Endovascular Treatment</condition>
<condition>Mechanical Thrombectomy</condition>
<condition>Perfusion Imaging</condition>
<biospec_retention>Samples Without DNA</biospec_retention>
<biospec_descr>
<textblock>
serum sample
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
ischemic stroke patients that received mechanical thrombectomy due to large vessel
occlusion of anterior circulation within 24 hours from stroke onset and had perfusion
imaging both before and after thrombectomy.
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Older than 18 years;

- Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombectomy

- Large vessel occlusion of cerebral anterior circulation (ICA, MCA-M1 or MCA-M2)
confirmed by CTA or MRA, planned to receive or received stenting or aspiration
thrombectomy

- Time intervals ≤ 24 hours from stroke onset to groin puncture.(fulfilled the inclusion
of DAWN or DEFUSE 3 trial if the time intervals from stroke onset to groin puncture
was ≥6 hours)

- mRS score ≤2 before admission

- Informed consent obtained for longitudinal enrolled patients, waived of consent for
retrospectively included cases

Exclusion Criteria:

- Had a history of infective disease, immunity disease, radiotherapy at head or neck,
carotid dissection or other carotid disease.

- Unable to receive CT or MR scan due to heart failure, cardiac pacemaker, metal
implants or claustrophobia, etc.

- Unable to be injected with contrast agent due to allergy, renal dysfunction, etc.

- Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)

- Already participated in other drug trials
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<overall_official>
<last_name>Yunyun Xiong, MD, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Beijing Tiantan Hospital</affiliation>
</overall_official>
<overall_contact>
<last_name>Yunyun Xiong, MD, PhD</last_name>
<phone>00861059975213</phone>
<email>xiongyunyun@bjtth.org</email>
</overall_contact>
<location>
<facility>
<name>Yunyun Xiong</name>
<address>
<city>Beijing</city>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Yunyun Xiong</last_name>
<email>xiongyunyun@bjtth.org</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>February 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>February 6, 2023</last_update_submitted>
<last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 8, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
<investigator_full_name>Yunyun Xiong</investigator_full_name>
<investigator_title>Professor of Neurology and Stroke Center</investigator_title>
</responsible_party>
<keyword>ischemic stroke</keyword>
<keyword>vascular occlusion</keyword>
<keyword>endovascular treatment</keyword>
<keyword>mechanical thrombectomy</keyword>
<keyword>perfusion imaging</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Stroke</mesh_term>
<mesh_term>Ischemic Stroke</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The aim of the study was to establish a clinical and advanced imaging database of acute
ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion
of anterior circulation within 24 hours from stroke onset in China, and to investigate the
predictors and potential mechanisms of futile recanalization after mechanical thrombectomy.
The time-window of mechanical thrombectomy for ischemic stroke has extended from 4.5 hours to
24 hours based on the results of the DAWN and DEFUSE 3 trials. However, evidence on the
effectiveness and safety of mechanical thrombectomy within 24 hours in the real-world is
insufficient.
This is a multi-center, prospective, registry cohort study that acute ischemic stroke
patients treated with mechanical thrombectomy due to large vessel occlusion of anterior
circulation within 24 hours from stroke onset in China. A total of 1600 patients with
advanced imaging data were anticipated to be enrolled.
serum sample
ischemic stroke patients that received mechanical thrombectomy due to large vessel
occlusion of anterior circulation within 24 hours from stroke onset and had perfusion
imaging both before and after thrombectomy.
Inclusion Criteria:
- Older than 18 years;
- Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombectomy
- Large vessel occlusion of cerebral anterior circulation (ICA, MCA-M1 or MCA-M2)
confirmed by CTA or MRA, planned to receive or received stenting or aspiration
thrombectomy
- Time intervals ≤ 24 hours from stroke onset to groin puncture.(fulfilled the inclusion
of DAWN or DEFUSE 3 trial if the time intervals from stroke onset to groin puncture
was ≥6 hours)
- mRS score ≤2 before admission
- Informed consent obtained for longitudinal enrolled patients, waived of consent for
retrospectively included cases
Exclusion Criteria:
- Had a history of infective disease, immunity disease, radiotherapy at head or neck,
carotid dissection or other carotid disease.
- Unable to receive CT or MR scan due to heart failure, cardiac pacemaker, metal
implants or claustrophobia, etc.
- Unable to be injected with contrast agent due to allergy, renal dysfunction, etc.
- Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)
- Already participated in other drug trials
|
NCT0531xxxx/NCT05311618.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/NCT05311618</url>
</required_header>
<id_info>
<org_study_id>438-IO-101</org_study_id>
<secondary_id>KEYNOTE-E20</secondary_id>
<nct_id>NCT05311618</nct_id>
</id_info>
<brief_title>Study of NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors</brief_title>
<official_title>A Phase 1/1b Dose Escalation/Expansion Study of NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors</official_title>
<sponsors>
<lead_sponsor>
<agency>NGM Biopharmaceuticals, Inc</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
<collaborator>
<agency>Merck Sharp & Dohme LLC</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>NGM Biopharmaceuticals, Inc</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Study of NGM438 as Monotherapy and in Combination with Pembrolizumab in Advanced or
Metastatic Solid Tumors
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 11, 2022</start_date>
<completion_date type="Anticipated">June 2024</completion_date>
<primary_completion_date type="Anticipated">March 2024</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Non-Randomized</allocation>
<intervention_model>Sequential Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Number of Patients with Dose-limiting Toxicities</measure>
<time_frame>Baseline up to 21 Days</time_frame>
<description>A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0, and is considered by the Investigator to be clinically relevant and attributed to the study treatment during the first 21 days after the first dose of study treatment.</description>
</primary_outcome>
<primary_outcome>
<measure>Number of Patients with Adverse Events</measure>
<time_frame>Approximately 24 months</time_frame>
<description>Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug.
An AE is defined as any untoward medical occurrence in a patient, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of patients who experience at least one AE will be presented.</description>
</primary_outcome>
<primary_outcome>
<measure>Number of Patients with Clinically Significant Laboratory Abnormalities</measure>
<time_frame>Approximately 24 months</time_frame>
<description>Number of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0) and timing.</description>
</primary_outcome>
<primary_outcome>
<measure>Changes in potential pharmacodynamic biomarker CD163 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in CD163</measure>
<time_frame>Baseline up to 15 days</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Changes in potential pharmacodynamic biomarker MMP9 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in MMP9</measure>
<time_frame>Baseline up to 15 days</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Changes in potential pharmacodynamic biomarker CD8 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in CD8</measure>
<time_frame>Baseline up to 15 days</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Maximum Observed Serum Concentration (Cmax) of NGM438</measure>
<time_frame>Approximately 24 months. Each Cycle is 21 days.</time_frame>
<description>Cmax is defined as the observed maximum serum concentration post drug administration.
Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycles 4-6 and every third cycle thereafter</description>
</secondary_outcome>
<secondary_outcome>
<measure>Area Under the Curve (AUC) of Serum NGM438</measure>
<time_frame>Approximately 24 months. Each Cycle is 21 days.</time_frame>
<description>Area under the curve from time zero extrapolated to the last time point prior to the next dose.
Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycles 4-6 and every third cycle thereafter</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time to Maximum (Tmax) Observed Serum Concentration of NGM438</measure>
<time_frame>Approximately 24 months. Each Cycle is 21 days.</time_frame>
<description>Tmax is defined as the time to reach the observed maximum serum concentration (Cmax).
Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycles 4-6 and every third cycle thereafter</description>
</secondary_outcome>
<secondary_outcome>
<measure>Half-life (t1/2) of NGM438 in Serum</measure>
<time_frame>Approximately 24 months. Each Cycle is 21 days.</time_frame>
<description>Time measured for the serum concentration to decrease by one half during the terminal phase.
Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycles 4-6 and every third cycle thereafter</description>
</secondary_outcome>
<secondary_outcome>
<measure>Systemic Clearance (CL) of NGM438</measure>
<time_frame>Approximately 24 months. Each Cycle is 21 days.</time_frame>
<description>CL is defined as systemic clearance. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycles 4-6 and every third cycle thereafter</description>
</secondary_outcome>
<secondary_outcome>
<measure>Volume of Distribution (Vss) of NGM438 at Steady State</measure>
<time_frame>Approximately 24 months. Each Cycle is 21 days.</time_frame>
<description>Vss is defined as the volume of distribution at steady state. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycles 4-6 and every third cycle thereafter</description>
</secondary_outcome>
<secondary_outcome>
<measure>Anti-drug Antibodies (ADA) Against NGM438</measure>
<time_frame>Approximately 24 months. Each Cycle is 21 days.</time_frame>
<description>Incidence and titers of anti-drug antibodies (ADA) against NGM438. Will be measured on Day 1 of each cycle through Cycle 6 and every third cycle thereafter.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of Patients in Dose Escalation and Dose Finding Cohorts with Objective Responses</measure>
<time_frame>Approximately 24 months</time_frame>
<description>Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) divided by the total number of evaluable patients per RECIST v1.1</description>
</secondary_outcome>
<secondary_outcome>
<measure>Trough Concentrations of NGM438 in Patients in the Biopsy Cohort</measure>
<time_frame>Approximately 24 months. Each Cycle is 21 days.</time_frame>
<description>Trough Concentration refers to the serum concentration of NGM438 observed just before treatment administration.
Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">71</enrollment>
<condition>Pancreatic Cancer</condition>
<condition>Breast Cancer</condition>
<condition>Gastric Cancer</condition>
<condition>Non Small Cell Lung Cancer</condition>
<condition>Cervical Cancer</condition>
<condition>Endocervical Cancer</condition>
<condition>Squamous Cell Carcinoma of Head and Neck</condition>
<condition>Bladder Urothelial Cancer</condition>
<condition>Colorectal Cancer</condition>
<condition>Esophageal Cancer</condition>
<condition>Ovarian Cancer</condition>
<condition>Renal Cell Carcinoma</condition>
<condition>Prostate Cancer</condition>
<condition>Melanoma</condition>
<condition>Mesothelioma</condition>
<condition>Cholangiocarcinoma</condition>
<arm_group>
<arm_group_label>NGM438 Monotherapy Dose Escalation</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Part 1a Single Agent Dose Escalation</description>
</arm_group>
<arm_group>
<arm_group_label>NGM438 Combination Dose Finding with Pembrolizumab</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Part 1b NGM438 plus pembrolizumab</description>
</arm_group>
<arm_group>
<arm_group_label>Biopsy Cohort with NGM438 Monotherapy Lead-in Followed by Combination Therapy with Pembrolizumab</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Part 1C NGM438 followed by NGM438 plus pembrolizumab</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>NGM438</intervention_name>
<description>NGM438 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.</description>
<arm_group_label>Biopsy Cohort with NGM438 Monotherapy Lead-in Followed by Combination Therapy with Pembrolizumab</arm_group_label>
<arm_group_label>NGM438 Combination Dose Finding with Pembrolizumab</arm_group_label>
<arm_group_label>NGM438 Monotherapy Dose Escalation</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Pembrolizumab</intervention_name>
<description>Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle.</description>
<arm_group_label>Biopsy Cohort with NGM438 Monotherapy Lead-in Followed by Combination Therapy with Pembrolizumab</arm_group_label>
<arm_group_label>NGM438 Combination Dose Finding with Pembrolizumab</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Histologically or cytologically documented locally advanced or metastatic solid tumor
malignancy.

- Progressed or was intolerant to all available therapies known to confer clinical
benefit appropriate for their tumor type for which the patient was eligible and
willing to receive.

- Adequate bone marrow, kidney and liver function

- Performance status of 0 or 1.

- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1
except for AEs not constituting a safety risk by Investigator judgement.

Exclusion Criteria:

• Prior treatment targeting LAIR1
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>NGM Medical Director</last_name>
<phone>(650) 243-5555</phone>
<email>NGM438@ngmbio.com</email>
</overall_contact>
<location>
<facility>
<name>Yale Cancer Center</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06520</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Henry Ford Health System</name>
<address>
<city>Detroit</city>
<state>Michigan</state>
<zip>48202</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>START Midwest</name>
<address>
<city>Grand Rapids</city>
<state>Michigan</state>
<zip>49546</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Mount Sinai Hospital</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10029</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>MD Anderson</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77030</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>October 2022</verification_date>
<study_first_submitted>March 18, 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>October 6, 2022</last_update_submitted>
<last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">October 10, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Carcinoma</mesh_term>
<mesh_term>Carcinoma, Renal Cell</mesh_term>
<mesh_term>Mesothelioma</mesh_term>
<mesh_term>Cholangiocarcinoma</mesh_term>
<mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Pembrolizumab</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Study of NGM438 as Monotherapy and in Combination with Pembrolizumab in Advanced or
Metastatic Solid Tumors
Inclusion Criteria:
- Histologically or cytologically documented locally advanced or metastatic solid tumor
malignancy.
- Progressed or was intolerant to all available therapies known to confer clinical
benefit appropriate for their tumor type for which the patient was eligible and
willing to receive.
- Adequate bone marrow, kidney and liver function
- Performance status of 0 or 1.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1
except for AEs not constituting a safety risk by Investigator judgement.
Exclusion Criteria:
• Prior treatment targeting LAIR1
|
NCT0531xxxx/NCT05311631.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/NCT05311631</url>
</required_header>
<id_info>
<org_study_id>Breastfeeding</org_study_id>
<nct_id>NCT05311631</nct_id>
</id_info>
<brief_title>Breastfeeding - a Good Start Together</brief_title>
<official_title>Breastfeeding - a Good Start Together</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Copenhagen</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Danish Committee for Health Education</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>21 municipalities in Denmark</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Nordea-fonden</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Det Obelske Familiefond</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>University of Copenhagen</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The Breastfeeding - a Good Start Together intervention study aims to increase the proportion
of women who breastfeed for four and six months, and proportionately more in a group of women
who are in risk of early breastfeeding cessation; and thus reduce social inequality of mother
and infant health.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Breastfeeding has numerous health benefits for both mothers and children, and the World
Health Organization recommends exclusive breastfeeding for six months. Still, only 12 % of
mothers in Denmark breastfeed exclusively at six months postpartum and breastfeeding is
subject to significant social inequality. Mothers of young age (below 25 years) and with low
educational attainment (not exceeding primary school or vocational) breastfeed for a shorter
duration of time than their counterparts. Thus, this group is in high risk of early
breastfeeding cessation and is hereafter termed 'the high-risk group'.

The Breastfeeding - a Good Start Together intervention consists of theory based breastfeeding
support, supported by printed materials and a web-page providing support and knowledge for
families when health visitors are off work, and an intensified intervention aimed at the
high-risk group, comprising close follow-up by telephone and an extra home visit. In total,
the high-risk group will receive seven telephone calls during week two post partum and 15
weeks post partum, with the highest intensity in the first month (contact once a week),
gradually decreasing as the child grows older (contact every second week during the second
month, and every third week during the third and fourth month).

Hypothesis: Improving the relationship between health visitors and new families, drawing on
tailoring of the communication, which ensures that breastfeeding support matches the needs of
the family, will enhance trust and therefore the likelihood of families reaching out to the
health nurse when breastfeeding problems occur and thus improving chances of successful
breastfeeding in a longer duration of time. Moreover, the theory based breastfeeding support
will make the support more easily attainable for families, independent of their
sociodemographic background. Improving chances of a successful breastfeeding will improve
mother and infant health, the latter especially with regards to lower infant morbidity
related to nutrition.

The intervention is a complex intervention, designed as a cluster-randomized trial.
Twenty-one municipalities situated in the North Denmark Region and Region of Southern Denmark
participate in the study, and according to the number of births among inhabitants these have
been randomized to either intervention or control group; 11 intervention municipalities and
10 control municipalities. Basing the randomization on number of births proved to
successfully account for other factors, such as rural or urban areas and proportion of
high-risk individuals.

The intervention will be implemented from March 2022-December 2023, with data collection
commencing April 2022. Health visitors in the intervention municipalities will receive
training before delivering the new breastfeeding counselling to the families. The training is
expected to reach 225 health visitors in the intervention municipalities and 6000 families of
whom 30-40% are in the high-risk group. After the trial period, health visitors in the
control municipalities will receive the same training.

The primary outcome measures of the intervention is breastfeeding duration and proxies for
infant morbidity related to nutrition. Secondary outcomes are the families' perception of
their relationship with the health visitor and parents' action competence and self-efficacy
related to breastfeeding.

The primary and secondary outcome measures, are studied in a survey study using electronic
questionnaires distributed to mothers recruited through the health-visiting programme at
three time-points, and to fathers/partners at one time-point. Further, the effectiveness of
the intervention will be analysed using register-data. A difference-in-difference design is
applied to measure changes in primary outcomes from before to after the intervention period
in both intervention sites and control sites.

The overall target group of the intervention study is all new families accepting the health
visiting program with a specific high-risk group of families with mothers of young age or who
have low educational attainment. Outcomes of the trial will be analysed for the total
population and for the sub-group.

For sample size calculation an estimation of 8 clusters in the intervention arm and 8
clusters in the control arm were used, as this calculation was made prior to successfully
recruiting a total of 21 clusters to the trial. The investigators expect a participation of
80% with an attrition of 30%. The ambition is to improve the breastfeeding duration in the
intervention clusters to the national level, corresponding to an OR 1.32. With an interclass
correlation coefficient of 0.001, a strength of 80% and a 5% significance level can be
reached if data are collected from 111 mothers in each cluster, including 52 mothers from the
high-risk group in each cluster.

All effectiveness analyses will be using an intention-to-treat approach and will account for
the clustering of individuals and potential confounding in a controlled mixed effect
regression.

The implementation of the intervention will be analysed in a process evaluation using
qualitative and quantitative data. A realist evaluation using qualitative data will explore
the mechanisms of change in the intervention, and will highlight what works for whom, under
what circumstances.

Further, a health economic evaluation will be performed as a cost-effectiveness analysis
where health benefits are measured as changes in the proportion of women breastfeeding at
four months post partum, and as a cost-utility analysis where health benefits are measured as
gained Quality Adjusted Life-Years (QALYs). Moreover, an analysis of the costs of the
intervention related to the costs (and possible savings) in the health system surrounding the
intervention sites.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 26, 2022</start_date>
<completion_date type="Anticipated">May 1, 2024</completion_date>
<primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Clusters (municipalities) are randomized to either intervention or control (standard care). Intervention coverage 6000 infants and their families in intervention municipalities. Primary trial outcome is assessed using survey data where 3339 families from the intervention and control arm will be enrolled according to the power calculation.</intervention_model_description>
<primary_purpose>Prevention</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Maternal self-report of breastfeeding status (full vs not full)</measure>
<time_frame>Four months post partum</time_frame>
<description>Self-reported breastfeeding measured in questionnaires by the mothers and health visitors' record of breastfeeding status. Full breastfeeding is conceptualized as exclusive breastmilk-feeding after discharge from the hospital. In Denmark, the concept allows for a supplement to mother's milk of water and the like and / or a maximum of one meal with infant formula per week.</description>
</primary_outcome>
<secondary_outcome>
<measure>Infant thriving - jaundice</measure>
<time_frame>From birth to one months post partum</time_frame>
<description>Change in readmissions of children dur to jaundice is used as an indicator of infant morbidity related to nutritional problems. Measured by self-report in questionnaires and obtained from Danish registers of hospital admissions.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Infant thriving - weight loss</measure>
<time_frame>From birth to one months post partum</time_frame>
<description>Change in readmissions of children due to weight loss is used as an indicator of infant morbidity related to nutritional problems. Measured by self-report in questionnaires and obtained from Danish registers of hospital admissions.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Infant thriving - dehydration</measure>
<time_frame>From birth to one months post partum</time_frame>
<description>Change in readmissions of children due dehydration is used as an indicator of infant morbidity related to nutritional problems. Measured by self-report in questionnaires and obtained from Danish registers of hospital admissions.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Breastfeeding problems</measure>
<time_frame>One week and one month post partum</time_frame>
<description>Change in frequency of pain during breastfeeding, sores or cracks on nipples, problems with latching on, the experience of having too little milk, the experience of having too much milk, the experience that the infant wants to feed very frequently, the experience of long duration of each breastfeeding, problems with low infant weight gain, breast tension, mastitis. This will be assessed through maternal self report in questionnaires.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Trust in visiting nurse</measure>
<time_frame>One month and four months</time_frame>
<description>Maternal self reported feeling of being seen, respected and heard</description>
</secondary_outcome>
<secondary_outcome>
<measure>Breastfeeding self-efficacy</measure>
<time_frame>One month</time_frame>
<description>Maternal and paternal self report in survey</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">3339</enrollment>
<condition>Breastfeeding</condition>
<condition>Breastfeeding, Exclusive</condition>
<arm_group>
<arm_group_label>Intervention</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Improved breastfeeding support provided by health visitors supporting families after discharge from maternity ward at hospital. The intervention is implemented into the existing national health visitor program that is offered free of charge to all. The program is accepted by more than 95% of families.</description>
</arm_group>
<arm_group>
<arm_group_label>Control</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Health visitors in the control municipalities will give breastfeeding support according to standard care.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Breastfeeding support</intervention_name>
<description>The core of the intervention is a trustful relation between the health visitor and the families based on principles of needs based communication. Health visitors will enhance parents' action competence based on breastfeeding self-efficacy, focusing on parents' wishes and needs.
The breastfeeding support includes four main messages: joint parenting task, skin-to-skin contact, frequent breastfeeding, and good positioning.
Training of health visitors includes e-learning and a two-day course with physical attendance. Supportive materials are developed including communicative support tools and a web-page providing support and knowledge when the health visitor is off hours.
All families in intervention sites accepting the health visitor program will receive the improved breastfeeding support. Families in the high-risk group are offered an intensified intervention with close follow-up by telephone in planned time-intervals, thus a higher dose of the intervention.</description>
<arm_group_label>Intervention</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1a. Families discharged <72 hours post partum (from 26 April 2022 - 17 January 2023)

1b. Families discharged < 7 days post partum (from 18 January 2023 onwards due to lower
than expected recruitment rate)

2. Families with intention of breastfeeding

Exclusion Criteria:

- Insufficient skills in Danish or English language to be able to answer questionnaires
and understand interventions conveyed in Danish or English

- Families with mothers with known substance abuse or addiction

- Families expecting more than one child

- Families having delivered preterm, prior to 37 weeks of gestation

- Families with mothers or child having difficulty breastfeeding due to a known
morbidity or disablement
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>15 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Ingrid SM Nilsson, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>The Danish Committee of Health Education</affiliation>
</overall_official>
<overall_contact>
<last_name>Sarah F Villadsen, PhD</last_name>
<phone>+4535327997</phone>
<email>sfv@sund.ku.dk</email>
</overall_contact>
<overall_contact_backup>
<last_name>Ingrid SM Nilsson, PhD</last_name>
<phone>+4522672006</phone>
<email>in@sundkom.dk</email>
</overall_contact_backup>
<location>
<facility>
<name>Aabenraa Kommune</name>
<address>
<city>Aabenraa</city>
<zip>6200</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Anne Sophie Brodersen</last_name>
<email>asbr@aabenraa.dk</email>
</contact>
</location>
<location>
<facility>
<name>Jammerbugt Kommune</name>
<address>
<city>Aabybro</city>
<zip>9440</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Diane Aarestrup</last_name>
<email>dia@jammerbugt.dk</email>
</contact>
</location>
<location>
<facility>
<name>Vesthimmerland Kommune</name>
<address>
<city>Aars</city>
<zip>9600</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Ditte Vestergaard Olesen</last_name>
<email>dvol@vesthimmerland.dk</email>
</contact>
</location>
<location>
<facility>
<name>Assens Kommune</name>
<address>
<city>Assens</city>
<zip>5610</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Hanne Kondrup</last_name>
<email>hakon@assens.dk</email>
</contact>
</location>
<location>
<facility>
<name>Billund Kommune</name>
<address>
<city>Billund</city>
<zip>7190</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Maria S Christensen</last_name>
<email>mslc@billund.dk</email>
</contact>
</location>
<location>
<facility>
<name>Esbjerg Kommune</name>
<address>
<city>Esbjerg</city>
<zip>6700</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Susanne H Feddersen, 6700</last_name>
<email>shf@esbjerg.dk</email>
</contact>
</location>
<location>
<facility>
<name>Fredericia Kommune</name>
<address>
<city>Fredericia</city>
<zip>7000</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Else MR Larsen</last_name>
<email>else.larsen@fredericia.dk</email>
</contact>
</location>
<location>
<facility>
<name>Frederikshavn Kommune</name>
<address>
<city>Frederikshavn</city>
<zip>9900</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Inger Marie Staun</last_name>
<email>imst@frederikshavn.dk</email>
</contact>
</location>
<location>
<facility>
<name>Haderslev Kommune</name>
<address>
<city>Haderslev</city>
<zip>6100</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Ulla Bjørn</last_name>
<email>ulbj@haderslev.dk</email>
</contact>
</location>
<location>
<facility>
<name>Mariagerfjord Kommune</name>
<address>
<city>Hobro</city>
<zip>9500</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Kit Borup</last_name>
<email>kibor@mariagerfjord.dk</email>
</contact>
</location>
<location>
<facility>
<name>Kolding Kommune</name>
<address>
<city>Kolding</city>
<zip>6000</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Louise Mønsted</last_name>
<email>loumn@kolding.dk</email>
</contact>
</location>
<location>
<facility>
<name>Middelfart Kommune</name>
<address>
<city>Middelfart</city>
<zip>5500</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Tina Norup</last_name>
<email>tina.norup@middelfart.dk</email>
</contact>
</location>
<location>
<facility>
<name>Morsø Kommune</name>
<address>
<city>Nykøbing Mors</city>
<zip>7900</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Lone Vestergaard Eriksen</last_name>
<email>lne@morsoe.dk</email>
</contact>
</location>
<location>
<facility>
<name>Odense Kommune</name>
<address>
<city>Odense</city>
<zip>5000</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Lissi Karin S Jørgensen</last_name>
<email>likj@odense.dk</email>
</contact>
</location>
<location>
<facility>
<name>Faaborg-Midtfyn Kommune</name>
<address>
<city>Ringe</city>
<zip>5750</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jette Lauvring</last_name>
<email>jelau@fmk.dk</email>
</contact>
</location>
<location>
<facility>
<name>Svendborg Kommune</name>
<address>
<city>Svendborg</city>
<zip>5700</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jane Z Bergenhagen</last_name>
<email>jane.zenker.bergenhagen@svendborg.dk</email>
</contact>
</location>
<location>
<facility>
<name>Sønderborg Kommune</name>
<address>
<city>Sønderborg</city>
<zip>6400</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Rikke Fribo</last_name>
<email>rfth@sonderborg.dk</email>
</contact>
</location>
<location>
<facility>
<name>Thisted Kommune</name>
<address>
<city>Thisted</city>
<zip>7700</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Charlotte K Brogaard</last_name>
<email>ckb@thisted.dk</email>
</contact>
</location>
<location>
<facility>
<name>Tønder Kommune</name>
<address>
<city>Tønder</city>
<zip>6270</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Maria-Louise Bergmann</last_name>
<email>marber@toender.dk</email>
</contact>
</location>
<location>
<facility>
<name>Varde Kommune</name>
<address>
<city>Varde</city>
<zip>6800</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Annette Pedersen</last_name>
<email>aped@varde.dk</email>
</contact>
</location>
<location>
<facility>
<name>Vejen Kommune</name>
<address>
<city>Vejen</city>
<zip>6600</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Ditte Melsen</last_name>
<email>dime@vejen.dk</email>
</contact>
</location>
<location_countries>
<country>Denmark</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 11, 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>February 16, 2023</last_update_submitted>
<last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 17, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Copenhagen</investigator_affiliation>
<investigator_full_name>Sarah Fredsted Villadsen</investigator_full_name>
<investigator_title>Associate Professor</investigator_title>
</responsible_party>
<keyword>Social inequality</keyword>
<keyword>Breastfeeding self-efficacy</keyword>
<keyword>Breastfeeding support</keyword>
<keyword>Complex interventions</keyword>
<keyword>Public health</keyword>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The Breastfeeding - a Good Start Together intervention study aims to increase the proportion
of women who breastfeed for four and six months, and proportionately more in a group of women
who are in risk of early breastfeeding cessation; and thus reduce social inequality of mother
and infant health.
Breastfeeding has numerous health benefits for both mothers and children, and the World
Health Organization recommends exclusive breastfeeding for six months. Still, only 12 % of
mothers in Denmark breastfeed exclusively at six months postpartum and breastfeeding is
subject to significant social inequality. Mothers of young age (below 25 years) and with low
educational attainment (not exceeding primary school or vocational) breastfeed for a shorter
duration of time than their counterparts. Thus, this group is in high risk of early
breastfeeding cessation and is hereafter termed 'the high-risk group'.
The Breastfeeding - a Good Start Together intervention consists of theory based breastfeeding
support, supported by printed materials and a web-page providing support and knowledge for
families when health visitors are off work, and an intensified intervention aimed at the
high-risk group, comprising close follow-up by telephone and an extra home visit. In total,
the high-risk group will receive seven telephone calls during week two post partum and 15
weeks post partum, with the highest intensity in the first month (contact once a week),
gradually decreasing as the child grows older (contact every second week during the second
month, and every third week during the third and fourth month).
Hypothesis: Improving the relationship between health visitors and new families, drawing on
tailoring of the communication, which ensures that breastfeeding support matches the needs of
the family, will enhance trust and therefore the likelihood of families reaching out to the
health nurse when breastfeeding problems occur and thus improving chances of successful
breastfeeding in a longer duration of time. Moreover, the theory based breastfeeding support
will make the support more easily attainable for families, independent of their
sociodemographic background. Improving chances of a successful breastfeeding will improve
mother and infant health, the latter especially with regards to lower infant morbidity
related to nutrition.
The intervention is a complex intervention, designed as a cluster-randomized trial.
Twenty-one municipalities situated in the North Denmark Region and Region of Southern Denmark
participate in the study, and according to the number of births among inhabitants these have
been randomized to either intervention or control group; 11 intervention municipalities and
10 control municipalities. Basing the randomization on number of births proved to
successfully account for other factors, such as rural or urban areas and proportion of
high-risk individuals.
The intervention will be implemented from March 2022-December 2023, with data collection
commencing April 2022. Health visitors in the intervention municipalities will receive
training before delivering the new breastfeeding counselling to the families. The training is
expected to reach 225 health visitors in the intervention municipalities and 6000 families of
whom 30-40% are in the high-risk group. After the trial period, health visitors in the
control municipalities will receive the same training.
The primary outcome measures of the intervention is breastfeeding duration and proxies for
infant morbidity related to nutrition. Secondary outcomes are the families' perception of
their relationship with the health visitor and parents' action competence and self-efficacy
related to breastfeeding.
The primary and secondary outcome measures, are studied in a survey study using electronic
questionnaires distributed to mothers recruited through the health-visiting programme at
three time-points, and to fathers/partners at one time-point. Further, the effectiveness of
the intervention will be analysed using register-data. A difference-in-difference design is
applied to measure changes in primary outcomes from before to after the intervention period
in both intervention sites and control sites.
The overall target group of the intervention study is all new families accepting the health
visiting program with a specific high-risk group of families with mothers of young age or who
have low educational attainment. Outcomes of the trial will be analysed for the total
population and for the sub-group.
For sample size calculation an estimation of 8 clusters in the intervention arm and 8
clusters in the control arm were used, as this calculation was made prior to successfully
recruiting a total of 21 clusters to the trial. The investigators expect a participation of
80% with an attrition of 30%. The ambition is to improve the breastfeeding duration in the
intervention clusters to the national level, corresponding to an OR 1.32. With an interclass
correlation coefficient of 0.001, a strength of 80% and a 5% significance level can be
reached if data are collected from 111 mothers in each cluster, including 52 mothers from the
high-risk group in each cluster.
All effectiveness analyses will be using an intention-to-treat approach and will account for
the clustering of individuals and potential confounding in a controlled mixed effect
regression.
The implementation of the intervention will be analysed in a process evaluation using
qualitative and quantitative data. A realist evaluation using qualitative data will explore
the mechanisms of change in the intervention, and will highlight what works for whom, under
what circumstances.
Further, a health economic evaluation will be performed as a cost-effectiveness analysis
where health benefits are measured as changes in the proportion of women breastfeeding at
four months post partum, and as a cost-utility analysis where health benefits are measured as
gained Quality Adjusted Life-Years (QALYs). Moreover, an analysis of the costs of the
intervention related to the costs (and possible savings) in the health system surrounding the
intervention sites.
Inclusion Criteria:
1a. Families discharged <72 hours post partum (from 26 April 2022 - 17 January 2023)
1b. Families discharged < 7 days post partum (from 18 January 2023 onwards due to lower
than expected recruitment rate)
2. Families with intention of breastfeeding
Exclusion Criteria:
- Insufficient skills in Danish or English language to be able to answer questionnaires
and understand interventions conveyed in Danish or English
- Families with mothers with known substance abuse or addiction
- Families expecting more than one child
- Families having delivered preterm, prior to 37 weeks of gestation
- Families with mothers or child having difficulty breastfeeding due to a known
morbidity or disablement
|
NCT0531xxxx/NCT05311644.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/NCT05311644</url>
</required_header>
<id_info>
<org_study_id>49RC20_0158</org_study_id>
<nct_id>NCT05311644</nct_id>
</id_info>
<brief_title>Hymenoptera Venom Immunotherapy: Evaluation of Its Long-term Efficacy at the University Hospital of Angers (EFLOTITA2)</brief_title>
<acronym>EFLOTITA2</acronym>
<official_title>La désensibilisation Aux Venins d'hyménoptères : Quelle Est Son efficacité à Long Terme ? (EFLOTITA2)</official_title>
<sponsors>
<lead_sponsor>
<agency>University Hospital, Angers</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University Hospital, Angers</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>
Allergy to Hymenoptera venom is one of the main causes of anaphylaxis in adults, and is less
common in the paediatric population. It can be severe or even fatal.

Despite the use of an emergency kit, including an adrenaline auto-injector (AAI), at present
only hymenoptera venom immunotherapy (VIT) is effective in preventing subsequent severe
systemic reactions.

Recurrence during the 5 years following cessation of VIT is about 10-15 percent. Studies
evaluating longer-term efficacy are scarce.

At the University Hospital of Angers, hundreds of patients are treated each year, and its
allergology unit has been providing VIT for over 15 years.

The purpose of this stufy is to evaluate VIT efficacy among patients who were treated with
VIT and ceased VIT from 2005 to 2019, at the university hospital of Angers.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Allergy to Hymenoptera venom is one of the main causes of anaphylaxis in adults, and is less
common in the paediatric population. It can be severe or even fatal.

Despite the use of an emergency kit, including an adrenaline auto-injector (AAI), at present
only hymenoptera venom immunotherapy (VIT) is effective in preventing subsequent severe
systemic reactions.

Recurrence during the 5 years following cessation of VIT is about 10-15 percent. Studies
evaluating longer-term efficacy are scarce.

At the University Hospital of Angers, hundreds of patients are treated each year, and its
allergology unit has been providing VIT for over 15 years.

The purpose of this stufy is to evaluate VIT efficacy among patients who were treated with
VIT and ceased VIT from 2005 to 2019, at the university hospital of Angers.

This is a monocentric and ambispective study. In the absence of opposition from the patient
(within one month after the information letter was sent), the search for data of interest is
carried out by consulting the participant's medical record. An investigator (doctor or
intern) interviews the participant, or the legal guardian for minors, and performs a
telephone survey.

Data are collected from the participants medical records. Information gathered are as follows
: age, sexe, the date and symptoms following hyménoptera stings, the evolution of allergy
skin testing, total and venom specific immunoglobuin E (IgE), venom specifc immunoglobulin G4
(IgG4), basophil activation tests (BAT) to hymenoptera venom, exposure to hymenoptera stings.

The telephone survey assesses potential new comorbidities and new treatments, exposure to
hymeoptera stings, hymenoptera stings after VIT cessation, if known : the hymenoptera specy,
the participants reaction to the sting, and the drug that has been used to treat the
symptoms.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">February 1, 2022</start_date>
<completion_date type="Anticipated">August 2022</completion_date>
<primary_completion_date type="Anticipated">July 2022</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Cross-Sectional</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Reccurence of a systemic reaction</measure>
<time_frame>up to 17 years since the patient ceased hymenoptera venom immunotherapy.</time_frame>
<description>The recurrence of a systemic reaction after a hymenoptera sting reported by the patient during the telephone survey.</description>
</primary_outcome>
<secondary_outcome>
<measure>To describe the evolution of the results of the allergy work-up during hymenoptera venom immunotherapy</measure>
<time_frame>up to 17 years since the patient ceased hymenoptera venom immunotherapy to the last appointement in the allergy unit.</time_frame>
<description>Results of skin-testing and blood work</description>
</secondary_outcome>
<secondary_outcome>
<measure>Predicting the recurrence of systemic symptoms</measure>
<time_frame>up to 17 years since the patient ceased hymenoptera venom immunotherapy until the phone survey</time_frame>
<description>To identify any predictor of the recurrence of systemic symptoms after discontinuation of hymenoptera venom immunotherapy, among the above listed parameters.</description>
</secondary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Anticipated">450</enrollment>
<condition>Anaphylaxis Caused by Hymenoptera Venom (Disorder)</condition>
<arm_group>
<arm_group_label>Included</arm_group_label>
<description>All participants that cesed VIT between 2005 and 2019, and did not withdraw his consent to participate to the study.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Telephone survey</intervention_name>
<description>All participants are interviewed by telephone, and are asked to answer a survey.</description>
<arm_group_label>Included</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Allergy to hymenoptera venom, Treated with VIT at the university hospital of Angers, Ceased
VIT between 2005 and 2019
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Allergy to hymenoptera venom.

- Treated with VIT at the university hospital of Angers.

- Ceased VIT between 2005 and 2019.

Exclusion Criteria:

- Patient's opposition, or the Participant's legal guardian's, if minor, to participate
to the study, and/or for his data to be used.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>University hospital of Angers</name>
<address>
<city>Angers</city>
<state>Maine Et Loire</state>
<zip>49100</zip>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>MARTINE MORISSET, MD, PhD</last_name>
<phone>+33241353551</phone>
<email>martine.morisset@chu-angers.fr</email>
</contact>
<contact_backup>
<last_name>PRINCY BERIZIKY, MD</last_name>
<phone>+33241353551</phone>
<email>princy.beriziky@chu-angers.fr</email>
</contact_backup>
<investigator>
<last_name>MARTINE MORISSET, MD, PHD</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>PRINCY BERIZIKY, MD</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location_countries>
<country>France</country>
</location_countries>
<verification_date>January 2022</verification_date>
<study_first_submitted>January 31, 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 4, 2022</last_update_submitted>
<last_update_submitted_qc>April 4, 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>
<keyword>hymenoptera venom immunotherapy; anaphylaxis; venom allergy</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Anaphylaxis</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Allergy to Hymenoptera venom is one of the main causes of anaphylaxis in adults, and is less
common in the paediatric population. It can be severe or even fatal.
Despite the use of an emergency kit, including an adrenaline auto-injector (AAI), at present
only hymenoptera venom immunotherapy (VIT) is effective in preventing subsequent severe
systemic reactions.
Recurrence during the 5 years following cessation of VIT is about 10-15 percent. Studies
evaluating longer-term efficacy are scarce.
At the University Hospital of Angers, hundreds of patients are treated each year, and its
allergology unit has been providing VIT for over 15 years.
The purpose of this stufy is to evaluate VIT efficacy among patients who were treated with
VIT and ceased VIT from 2005 to 2019, at the university hospital of Angers.
Allergy to Hymenoptera venom is one of the main causes of anaphylaxis in adults, and is less
common in the paediatric population. It can be severe or even fatal.
Despite the use of an emergency kit, including an adrenaline auto-injector (AAI), at present
only hymenoptera venom immunotherapy (VIT) is effective in preventing subsequent severe
systemic reactions.
Recurrence during the 5 years following cessation of VIT is about 10-15 percent. Studies
evaluating longer-term efficacy are scarce.
At the University Hospital of Angers, hundreds of patients are treated each year, and its
allergology unit has been providing VIT for over 15 years.
The purpose of this stufy is to evaluate VIT efficacy among patients who were treated with
VIT and ceased VIT from 2005 to 2019, at the university hospital of Angers.
This is a monocentric and ambispective study. In the absence of opposition from the patient
(within one month after the information letter was sent), the search for data of interest is
carried out by consulting the participant's medical record. An investigator (doctor or
intern) interviews the participant, or the legal guardian for minors, and performs a
telephone survey.
Data are collected from the participants medical records. Information gathered are as follows
: age, sexe, the date and symptoms following hyménoptera stings, the evolution of allergy
skin testing, total and venom specific immunoglobuin E (IgE), venom specifc immunoglobulin G4
(IgG4), basophil activation tests (BAT) to hymenoptera venom, exposure to hymenoptera stings.
The telephone survey assesses potential new comorbidities and new treatments, exposure to
hymeoptera stings, hymenoptera stings after VIT cessation, if known : the hymenoptera specy,
the participants reaction to the sting, and the drug that has been used to treat the
symptoms.
Allergy to hymenoptera venom, Treated with VIT at the university hospital of Angers, Ceased
VIT between 2005 and 2019
Inclusion Criteria:
- Allergy to hymenoptera venom.
- Treated with VIT at the university hospital of Angers.
- Ceased VIT between 2005 and 2019.
Exclusion Criteria:
- Patient's opposition, or the Participant's legal guardian's, if minor, to participate
to the study, and/or for his data to be used.
|
NCT0531xxxx/NCT05311657.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/NCT05311657</url>
</required_header>
<id_info>
<org_study_id>S-615/2020</org_study_id>
<nct_id>NCT05311657</nct_id>
</id_info>
<brief_title>Oral Health and Severe COPD</brief_title>
<official_title>Oral Health in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)</official_title>
<sponsors>
<lead_sponsor>
<agency>Heidelberg University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Heidelberg University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This case-control study aims to investigate the association of severe COPD with oral health.
</textblock>
</brief_summary>
<overall_status>Active, not recruiting</overall_status>
<start_date type="Actual">September 21, 2020</start_date>
<completion_date type="Anticipated">May 31, 2022</completion_date>
<primary_completion_date type="Actual">October 4, 2021</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Cross-Sectional</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Tooth loss</measure>
<time_frame>one year</time_frame>
<description>Is the number of teeth different in patients with severe COPD compared to patients without COPD?</description>
</primary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Actual">104</enrollment>
<condition>COPD</condition>
<condition>Periodontitis</condition>
<condition>Caries</condition>
<condition>Quality of Life</condition>
<condition>Tooth Loss</condition>
<arm_group>
<arm_group_label>Test Group</arm_group_label>
<description>Severe COPD (GOLD 3 and 4).</description>
</arm_group>
<arm_group>
<arm_group_label>Control Group</arm_group_label>
<description>Matched to Test Group regarding age, sex, smoking history and number of systemic diseases.</description>
</arm_group>
<eligibility>
<study_pop>
<textblock>
Patients undergoing routine pulmonary or dental care.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Patients aged ≥ 40 years and ≤ 85 years;

- Test group: patients with COPD GOLD 3 and 4 with available pulmonary function test
values (FEV1, FVC) within the last two weeks;

- Control group: patients without diagnosed or self-suspected pulmonary disease matched
for age, sex, smoking and number of systemic diseases to the test group;

- Understanding of measures performed in the study;

- Written informed consent.

Exclusion Criteria:

- Pregnancy.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>40 Years</minimum_age>
<maximum_age>85 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>University Hospital Heidelberg</name>
<address>
<city>Heidelberg</city>
<state>Baden-Württemberg</state>
<zip>69120</zip>
<country>Germany</country>
</address>
</facility>
</location>
<location_countries>
<country>Germany</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 23, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>April 4, 2022</last_update_submitted>
<last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 5, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Heidelberg University</investigator_affiliation>
<investigator_full_name>Dr. Antonio Ciardo</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Periodontitis</mesh_term>
<mesh_term>Tooth Loss</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This case-control study aims to investigate the association of severe COPD with oral health.
Patients undergoing routine pulmonary or dental care.
Inclusion Criteria:
- Patients aged ≥ 40 years and ≤ 85 years;
- Test group: patients with COPD GOLD 3 and 4 with available pulmonary function test
values (FEV1, FVC) within the last two weeks;
- Control group: patients without diagnosed or self-suspected pulmonary disease matched
for age, sex, smoking and number of systemic diseases to the test group;
- Understanding of measures performed in the study;
- Written informed consent.
Exclusion Criteria:
- Pregnancy.
|
NCT0531xxxx/NCT05311670.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/NCT05311670</url>
</required_header>
<id_info>
<org_study_id>LCCC 2202</org_study_id>
<secondary_id>1K23HL157765-01A1</secondary_id>
<nct_id>NCT05311670</nct_id>
</id_info>
<brief_title>Pre-Implementation Study of Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)</brief_title>
<acronym>TSPRO2</acronym>
<official_title>Pre-Implementation Study of Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)</official_title>
<sponsors>
<lead_sponsor>
<agency>UNC Lineberger Comprehensive Cancer Center</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>UNC Lineberger Comprehensive Cancer Center</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 purpose of the LCCC 2202 is to evaluate the barriers and facilitators to implementing
perioperative "ePRO monitoring". This study will inform a future hybrid effectiveness study
(LCCC 2141:Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes
(ePROS). Eligible thoracic surgery patients will be enrolled to ePRO monitoring using
web-based or telephone surveys. Patients will be asked to self-report symptoms for remote
monitoring by their care team. Patients and Providers will be approached for a
semi-structured interview to understand the barriers and facilitators to ePRO use.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This is a single-site, non-randomized, interventional study in patients receiving major
thoracic surgery, which commonly involves chest wall incisions and overnight admission.
Eligible patients will be approached at any time point between their preoperative clinic
visit and up to 30 days after discharge from the hospital. Approximately 60 patients will be
enrolled in the study. Patients will complete symptom surveys via email or telephone.
Concerning symptoms will generate alerts for the clinical care team who will follow their
usual protocols for management of symptoms. Patients will be purposively selected and invited
to participate in a semi-structured interview to understand their experience using ePRO.
Interviews will continue until 30 complete interviews are obtained and/or thematic saturation
is reached. Semi-structured interviews will also be conducted with providers (n =20) with
experience using ePROs.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 7, 2022</start_date>
<completion_date type="Actual">October 10, 2022</completion_date>
<primary_completion_date type="Actual">October 10, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>The participants will have their alerts sent to the clinicians when concerning symptoms are reported.</intervention_model_description>
<primary_purpose>Health Services Research</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Barriers to use of ePROs among patients</measure>
<time_frame>One year (From one month after the study start until the thematic saturation is reached)</time_frame>
<description>Semi-structured interview with patients to evaluate ePRO use.</description>
</primary_outcome>
<primary_outcome>
<measure>Facilitators to use of ePROs among patients</measure>
<time_frame>One year (From one month after the study start until the thematic saturation is reached)</time_frame>
<description>Semi-structured interview with patients to evaluate ePRO use.</description>
</primary_outcome>
<primary_outcome>
<measure>Barriers to use of ePROs among providers</measure>
<time_frame>17 months (From one month after the study start until the end of the study)</time_frame>
<description>Semi-structured interview with providers to evaluate ePRO use.</description>
</primary_outcome>
<primary_outcome>
<measure>Facilitators to use of ePROs among providers</measure>
<time_frame>17 months (From one month after the study start until the end of the study)</time_frame>
<description>Semi-structured interview with providers to evaluate ePRO use.</description>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">40</enrollment>
<condition>Thoracic Surgery</condition>
<arm_group>
<arm_group_label>Single-arm</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>Participants will be assigned to the single-arm involving monitoring of their symptoms.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Symptom monitoring</intervention_name>
<description>Alerts will be sent to providers via email and/or the electronic medical record at pre-specified response thresholds. Providers will be instructed to respond to and document the management of alerts per their clinical routine.</description>
<arm_group_label>Single-arm</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- 18 years or older

- English speaking

- Able and willing to complete a web-based or telephonic symptom survey

- Planned to undergo surgery within 90 days or have undergone and been discharged from
major thoracic surgery within the last 30 days.

Exclusion Criteria:

- Not completing planned surgery within 3 months of obtaining informed consent (for
subjects recruited preoperatively)

- Inability to read and speak English

- Planned for foregut surgery (e.g. paraesophageal hernia repair, esophageal resection
or repair)

- Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical
mediastinoscopy)

- Dementia, altered mental status, or any psychiatric condition as determined by
thoracic surgery provider team that would prohibit the understanding or rendering of
informed consent.

- Current incarceration

- Pregnancy
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>99 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Gita Mody</last_name>
<role>Principal Investigator</role>
<affiliation>University of North Carolina, Chapel Hill</affiliation>
</overall_official>
<location>
<facility>
<name>University of North Carolina at Chapel Hill</name>
<address>
<city>Chapel Hill</city>
<state>North Carolina</state>
<zip>27599</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 10, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>May 9, 2023</last_update_submitted>
<last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 11, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Electronic Patient-Reported Outcome</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Aortic Dissection</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>No plan as of now to make IPD available to other researchers.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of the LCCC 2202 is to evaluate the barriers and facilitators to implementing
perioperative "ePRO monitoring". This study will inform a future hybrid effectiveness study
(LCCC 2141:Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes
(ePROS). Eligible thoracic surgery patients will be enrolled to ePRO monitoring using
web-based or telephone surveys. Patients will be asked to self-report symptoms for remote
monitoring by their care team. Patients and Providers will be approached for a
semi-structured interview to understand the barriers and facilitators to ePRO use.
This is a single-site, non-randomized, interventional study in patients receiving major
thoracic surgery, which commonly involves chest wall incisions and overnight admission.
Eligible patients will be approached at any time point between their preoperative clinic
visit and up to 30 days after discharge from the hospital. Approximately 60 patients will be
enrolled in the study. Patients will complete symptom surveys via email or telephone.
Concerning symptoms will generate alerts for the clinical care team who will follow their
usual protocols for management of symptoms. Patients will be purposively selected and invited
to participate in a semi-structured interview to understand their experience using ePRO.
Interviews will continue until 30 complete interviews are obtained and/or thematic saturation
is reached. Semi-structured interviews will also be conducted with providers (n =20) with
experience using ePROs.
Inclusion Criteria:
- 18 years or older
- English speaking
- Able and willing to complete a web-based or telephonic symptom survey
- Planned to undergo surgery within 90 days or have undergone and been discharged from
major thoracic surgery within the last 30 days.
Exclusion Criteria:
- Not completing planned surgery within 3 months of obtaining informed consent (for
subjects recruited preoperatively)
- Inability to read and speak English
- Planned for foregut surgery (e.g. paraesophageal hernia repair, esophageal resection
or repair)
- Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical
mediastinoscopy)
- Dementia, altered mental status, or any psychiatric condition as determined by
thoracic surgery provider team that would prohibit the understanding or rendering of
informed consent.
- Current incarceration
- Pregnancy
|
NCT0531xxxx/NCT05311683.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/NCT05311683</url>
</required_header>
<id_info>
<org_study_id>work related MSDs</org_study_id>
<nct_id>NCT05311683</nct_id>
</id_info>
<brief_title>Work Related MSDs Between Egyptian Dentists</brief_title>
<acronym>MSDs</acronym>
<official_title>Work-related Musculoskeletal Disorder Between Egyptian Pediatric Dentists and General Dentists: A Cross Sectional Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Cairo University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Cairo University</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The aim of this study is to assess the musculoskeletal pain and discomfort among specialized
pediatric dentists and general dentists.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Musculoskeletal disorders are caused by the accumulation of mechanical and various stresses
on the body, such as repetitive work of specific body parts, uncomfortable and unnatural work
postures, high work intensity, excessive force, insufficient rest, cold working environment,
and frequency. It is defined as musculoskeletal complaints, musculoskeletal pain that reflect
a number of conditions, such as neck pain, back pain, shoulder pain, pain of limbs, carpal
tunnel syndrome, myofacial dysfunction syndrome, atypical facial pain Although these
musculoskeletal disorders can appear in all occupational groups, it is known that the
incidence of musculoskeletal pain symptoms is higher in the dentist occupational group than
in other occupational groups This is because dentists have to sit or stand for a long time
and keep their head, neck, and shoulders in a fixed position for a long time.Bending motions,
twisting motions, forward bent sitting postures, and relatively static working postures,
which dentists mainly take during their treatment, are considered risk factors. According to
a study on musculoskeletal disorders in Sharkia - low-back pain was the most prevalent
musculoskeletal complaint that reported by (56.9%) of the subjects, followed by 50.4%, 47.2%
and 42.3% complained of pain in the order of wrist, neck and shoulders Valachi and Valachi
(2003) reported that approximately 81% of US dentists suffered from neck, shoulder and back
pain Moreover, with the onset of the Covid-19 pandemic, the use of additional protective
devices increases the mental stress, the risks of imbalanced postures and further reduces the
freedom of movement.

Although there are many studies on musculoskeletal disorders in the dental profession,
studies on pediatric dentistry are rare. In the case of pediatric dentists, the cooperation
of young patients is insufficient, the treatment time is short, and they are exposed to
various environments such as general anaesthesia . In addition, pediatric dental chairs do
not fit children of all ages, which affects the attitude of dentists
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">December 1, 2022</start_date>
<completion_date type="Anticipated">January 30, 2023</completion_date>
<primary_completion_date type="Anticipated">December 30, 2022</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Ecologic or Community</observational_model>
<time_perspective>Cross-Sectional</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Prevalence of (WMSDs) among Pediatric and General dentists</measure>
<time_frame>1 year</time_frame>
<description>Numerical value</description>
</primary_outcome>
<secondary_outcome>
<measure>Association between WMSDs and ergonomic assessment of their exposure to risk factor</measure>
<time_frame>1 years</time_frame>
<description>Numerical value</description>
</secondary_outcome>
<enrollment type="Anticipated">134</enrollment>
<condition>Musculoskeletal Disorder</condition>
<eligibility>
<study_pop>
<textblock>
The study will be conducted in Department of Pediatric Dentistry and Dental Public Health,
Faculty of Dentistry, Cairo University, Egypt. The questionnaire will be provided to
participants

1. Through e-mail and an internet form to complete

2. Handled personally to complete
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Graduated Egyptian dentists since 2015 , practicing in egypt since 2016

- Dentists Working hours more than 4 hours and at least 4 days per week

- Pediatric dentists treating one child at least per working day

Exclusion Criteria:

- Participants with history of serious trauma or fracture

- The presence of serious medical conditions or a transmissible disease such as
malignant disease, hepatitis, AIDS etc.

- Participants will not sign the consent or complete the questionnaire.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>29 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
</eligibility>
<overall_official>
<last_name>Hala m Abbas, Professor</last_name>
<role>Study Director</role>
<affiliation>Cairo U</affiliation>
</overall_official>
<overall_contact>
<last_name>Mohammed M Madboly, BSC</last_name>
<phone>01050150130</phone>
<email>mohammed.madboly@dentistry.cu.edu.eg</email>
</overall_contact>
<location>
<facility>
<name>Cairo university</name>
<address>
<city>Cairo</city>
<state>Giza</state>
<zip>11562</zip>
<country>Egypt</country>
</address>
</facility>
<contact>
<last_name>Hala M Abbas, Professor</last_name>
<phone>01001459467</phone>
<email>hala.mohyeldin@dentisrty.cu.edu.eg</email>
</contact>
</location>
<location_countries>
<country>Egypt</country>
</location_countries>
<reference>
<citation>Karahan A, Kav S, Abbasoglu A, Dogan N. Low back pain: prevalence and associated risk factors among hospital staff. J Adv Nurs. 2009 Mar;65(3):516-24. doi: 10.1111/j.1365-2648.2008.04905.x.</citation>
<PMID>19222649</PMID>
</reference>
<reference>
<citation>Hales TR, Bernard BP. Epidemiology of work-related musculoskeletal disorders. Orthop Clin North Am. 1996 Oct;27(4):679-709.</citation>
<PMID>8823390</PMID>
</reference>
<reference>
<citation>Marshall ED, Duncombe LM, Robinson RQ, Kilbreath SL. Musculoskeletal symptoms in New South Wales dentists. Aust Dent J. 1997 Aug;42(4):240-6. doi: 10.1111/j.1834-7819.1997.tb00128.x.</citation>
<PMID>9316311</PMID>
</reference>
<reference>
<citation>Valachi B, Valachi K. Mechanisms leading to musculoskeletal disorders in dentistry. J Am Dent Assoc. 2003 Oct;134(10):1344-50. doi: 10.14219/jada.archive.2003.0048.</citation>
<PMID>14620013</PMID>
</reference>
<reference>
<citation>Barjatya K, Vatsal A, Kambalimath HV, Kulkarni VK, Reddy NB. Pediatric dental chair vs. traditional dental chair: a pediatric dentist's poll. J Indian Soc Pedod Prev Dent. 2015 Jan-Mar;33(1):35-9. doi: 10.4103/0970-4388.148973.</citation>
<PMID>25572371</PMID>
</reference>
<verification_date>November 2022</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>November 6, 2022</last_update_submitted>
<last_update_submitted_qc>November 6, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">November 10, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Cairo University</investigator_affiliation>
<investigator_full_name>Mohammed Mahmoud Madboly</investigator_full_name>
<investigator_title>Principle investigator</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Musculoskeletal Diseases</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The aim of this study is to assess the musculoskeletal pain and discomfort among specialized
pediatric dentists and general dentists.
Musculoskeletal disorders are caused by the accumulation of mechanical and various stresses
on the body, such as repetitive work of specific body parts, uncomfortable and unnatural work
postures, high work intensity, excessive force, insufficient rest, cold working environment,
and frequency. It is defined as musculoskeletal complaints, musculoskeletal pain that reflect
a number of conditions, such as neck pain, back pain, shoulder pain, pain of limbs, carpal
tunnel syndrome, myofacial dysfunction syndrome, atypical facial pain Although these
musculoskeletal disorders can appear in all occupational groups, it is known that the
incidence of musculoskeletal pain symptoms is higher in the dentist occupational group than
in other occupational groups This is because dentists have to sit or stand for a long time
and keep their head, neck, and shoulders in a fixed position for a long time.Bending motions,
twisting motions, forward bent sitting postures, and relatively static working postures,
which dentists mainly take during their treatment, are considered risk factors. According to
a study on musculoskeletal disorders in Sharkia - low-back pain was the most prevalent
musculoskeletal complaint that reported by (56.9%) of the subjects, followed by 50.4%, 47.2%
and 42.3% complained of pain in the order of wrist, neck and shoulders Valachi and Valachi
(2003) reported that approximately 81% of US dentists suffered from neck, shoulder and back
pain Moreover, with the onset of the Covid-19 pandemic, the use of additional protective
devices increases the mental stress, the risks of imbalanced postures and further reduces the
freedom of movement.
Although there are many studies on musculoskeletal disorders in the dental profession,
studies on pediatric dentistry are rare. In the case of pediatric dentists, the cooperation
of young patients is insufficient, the treatment time is short, and they are exposed to
various environments such as general anaesthesia . In addition, pediatric dental chairs do
not fit children of all ages, which affects the attitude of dentists
The study will be conducted in Department of Pediatric Dentistry and Dental Public Health,
Faculty of Dentistry, Cairo University, Egypt. The questionnaire will be provided to
participants
1. Through e-mail and an internet form to complete
2. Handled personally to complete
Inclusion Criteria:
- Graduated Egyptian dentists since 2015 , practicing in egypt since 2016
- Dentists Working hours more than 4 hours and at least 4 days per week
- Pediatric dentists treating one child at least per working day
Exclusion Criteria:
- Participants with history of serious trauma or fracture
- The presence of serious medical conditions or a transmissible disease such as
malignant disease, hepatitis, AIDS etc.
- Participants will not sign the consent or complete the questionnaire.
|
NCT0531xxxx/NCT05311696.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/NCT05311696</url>
</required_header>
<id_info>
<org_study_id>2650</org_study_id>
<nct_id>NCT05311696</nct_id>
</id_info>
<brief_title>Residential Retreat for Veterans and First-responders</brief_title>
<official_title>Examining the Efficacy and Feasibility of a Residential Retreat Program for PTSD in First-responders and Veterans: A Non-randomized Controlled Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Valhalla Project Niagara</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Valhalla Project Niagara</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to determine the potential efficacy and feasibility of a
residential retreat program to address PTSD symptoms in Veterans and First-responders
</textblock>
</brief_summary>
<detailed_description>
<textblock>
After obtaining written consent, participants will complete their program as they had
previously intended. Each wave of the residential retreat program will last 5 days. During
the program, participants will complete the study questionnaires. They will complete these
questionnaires again 1 month after the completion of the program. As a control, individuals
completing the program in the online format will also be asked to provide written consent and
will complete the questionnaires during the program and 1-month after its completion.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Anticipated">March 27, 2022</start_date>
<completion_date type="Anticipated">November 21, 2023</completion_date>
<primary_completion_date type="Anticipated">November 21, 2022</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Symptom Management of PTSD Using the Perceived Medical Condition Self-Management Scale</measure>
<time_frame>1-month after completion of the program</time_frame>
<description>determining the potential efficacy of the residential program for improving symptom management. The scale is adapted to reflect participants management of their PTSD symptoms. Score ranges from 8 to 40. Higher scores indicate better management.</description>
</primary_outcome>
<primary_outcome>
<measure>Drop-out rate in the Residential Program</measure>
<time_frame>at the end of the 5-day residential program for the residential cohort</time_frame>
<description>Determining the extent of treatment drop-out in the Residential Program</description>
</primary_outcome>
<primary_outcome>
<measure>Symptoms of PTSD Indicated by the PTSD Checklist for DSM-5 scale.</measure>
<time_frame>1-month after completion of the program</time_frame>
<description>determining the potential efficacy of the residential program for improving PTSD symptoms. Scores range from 0 to 80. Higher scores indicate more symptoms of PTSD.</description>
</primary_outcome>
<primary_outcome>
<measure>Interpersonal and Intrapersonal Functioning Using the Brief Inventory of Psychosocial Functioning (B-IPF)</measure>
<time_frame>1-month after the completion of the program</time_frame>
<description>determining the potential efficacy of the residential program for improving interpersonal and intrapersonal functioning (e.g., relationship with family, ability to manage daily tasks, etc.). Scores range from 0 to 42. Higher scores indicate more problems and lower functioning.</description>
</primary_outcome>
<primary_outcome>
<measure>Drop-out rate in the Online Program</measure>
<time_frame>at the end of the 2 month online program for the online cohort.</time_frame>
<description>Determining the extent of treatment drop-out in the Online Program</description>
</primary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">70</enrollment>
<condition>PTSD</condition>
<arm_group>
<arm_group_label>Residential Cohort</arm_group_label>
<description>Those completing the program in a residential context</description>
</arm_group>
<arm_group>
<arm_group_label>Online Cohort</arm_group_label>
<description>Those completing the program online</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>psychoeducation</intervention_name>
<description>The program consists of psychoeducational material regarding PTSD, demonstration of various stress management techniques, and social cohesion activities</description>
<arm_group_label>Online Cohort</arm_group_label>
<arm_group_label>Residential Cohort</arm_group_label>
<other_name>demonstration of stress management techniques</other_name>
<other_name>social cohesion activities</other_name>
</intervention>
<eligibility>
<study_pop>
<textblock>
These are individuals who are veterans of the military of first-responders, who have also
been diagnosed with PTSD.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Diagnosis of PTSD, being a military veteran or first-responder, awareness of treating
physician about program attendance

Exclusion Criteria:

- None
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Jaan Reitav, PhD, C.Psych</last_name>
<role>Principal Investigator</role>
<affiliation>Canadian Memorial Chiropractic College</affiliation>
</overall_official>
<overall_contact>
<last_name>Pouria Saffaran, Bsc</last_name>
<phone>647-895-7474</phone>
<email>pouria.saffaran@alum.utoronto.ca</email>
</overall_contact>
<location>
<facility>
<name>Valhalla Project Niagara</name>
<address>
<city>Niagara-on-the-lake</city>
<state>Ontario</state>
<zip>L0S 1J0</zip>
<country>Canada</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Graham Bettes</last_name>
<phone>289-2597758</phone>
<email>grahambettes@hotmail.com</email>
</contact>
<contact_backup>
<last_name>Pouria Saffaran, Bsc</last_name>
<phone>647-895-7474</phone>
<email>pouria.saffaran@alum.utoronto.ca</email>
</contact_backup>
</location>
<location_countries>
<country>Canada</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 3, 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 4, 2022</last_update_submitted>
<last_update_submitted_qc>April 4, 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>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
<ipd_description>De-identified data may be available upon request by other researchers.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to determine the potential efficacy and feasibility of a
residential retreat program to address PTSD symptoms in Veterans and First-responders
After obtaining written consent, participants will complete their program as they had
previously intended. Each wave of the residential retreat program will last 5 days. During
the program, participants will complete the study questionnaires. They will complete these
questionnaires again 1 month after the completion of the program. As a control, individuals
completing the program in the online format will also be asked to provide written consent and
will complete the questionnaires during the program and 1-month after its completion.
These are individuals who are veterans of the military of first-responders, who have also
been diagnosed with PTSD.
Inclusion Criteria:
- Diagnosis of PTSD, being a military veteran or first-responder, awareness of treating
physician about program attendance
Exclusion Criteria:
- None
|
NCT0531xxxx/NCT05311709.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/NCT05311709</url>
</required_header>
<id_info>
<org_study_id>SOLUCOM</org_study_id>
<nct_id>NCT05311709</nct_id>
</id_info>
<brief_title>Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities</brief_title>
<acronym>SOLUCOM</acronym>
<official_title>Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities</official_title>
<sponsors>
<lead_sponsor>
<agency>Vestre Viken Hospital Trust</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Aarhus University Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Oslo University Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Rigshospitalet, Denmark</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Odense University Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Karolinska University Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University Hospital of North Norway</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Haukeland University Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>St. Olavs Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Vestre Viken Hospital Trust</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
A single-arm, multicentre trial to investigate sotorasib in KRASG12C-mutated non-small cell
lung cancer stage III/IV not amenable for curative treatment including patients with
comorbidities, and to provide translational knowledge regarding mechanism of relapse and
differences in responses, including differences among patients with different co-occurring
mutations.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
A single-arm multi-institutional phase II study to investigate sotorasib in KRASG12C-mutated
non-small cell lung cancer stage III/IV not amenable for curative treatment including
patients with comorbidities, and to provide translational knowledge regarding mechanism of
relapse and differences in responses, including differences among patients with different
co-occurring mutations.

The aim is to investigate whether treatment with sotorasib will provide significant objective
response rates in predefined KRASG12C-mutated non-small cell lung cancer patients that are
not typically included in phase III-studies. Furthermore, the trial will explore whether
patients in performance status ECOG 2 may benefit from sotorasib. In this study, a relevant
number of sotorasib-naïve patients (n=100) will be treated with sotorasib and followed for
efficacy and side effects. MRI-scans both at base-line and regularly during therapy will give
data on intracranial efficacy. Eligible patients will be previously treated with at least 1
line standard (chemo)immunotherapy, or deemed in-eligible for standard (chemo)immunotherapy.

In part II of the study, comprehensive analyses of biological samples taken pretreatment, and
post-progression will provide novel information about resistance mechanisms on sotorasib.
Furthermore, analyses of biopsies taken at partial response (estimated to be performed in
25-30% of cases) may potentially also characterize non-eradicated residual cells after
achieved response. The post-progression biopsies may indicate the optimal next-line therapy.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 30, 2022</start_date>
<completion_date type="Anticipated">March 1, 2025</completion_date>
<primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>Single arm, multinational phase II trial</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Objective Response Rate (ORR) of sotorasib reducing tumour size in the all subjects treated</measure>
<time_frame>every eigth week until progression, or up to 2 years</time_frame>
<description>Evalution of tumour size by RECIST v1.1 criteriae</description>
</primary_outcome>
<secondary_outcome>
<measure>Objective Response Rate (ORR) of sotorasib reducing tumour size in the predefined patient groups (including ECOG PS2, specific comorbidities, including immune-related adverse events after (chemo-)immunotherapy)</measure>
<time_frame>from study baseline and every eigth week until progression, or or up to 2 years</time_frame>
<description>Tumour evaluation by RECIST v1.1 criteriae</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluation of efficacy of sotorasib in pre-defined patient groups</measure>
<time_frame>From study baseline, through study completion, and average of 8 months</time_frame>
<description>Progression Free Survival (PFS)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluation of efficacy of sotorasib (response) in pre-defined patient groups</measure>
<time_frame>from baseline, through study completion, and average of 8 months</time_frame>
<description>Duration of Response (DoR)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluation of efficacy and disease control of investigational medicinal product sotorasib in pre-defined patient groups</measure>
<time_frame>from baseline, through study completion, and average of 8 months</time_frame>
<description>Disease Control Rate (DCR)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluation of efficacy of sotorasib in pre-defined patient groups</measure>
<time_frame>from baseline, through study completion, and average of 8 months</time_frame>
<description>Intracranial Disease Free Survival (iDFS)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluation of efficacy of sotorasib in pre-defined patient groups</measure>
<time_frame>through study completion, and average of 8 months</time_frame>
<description>Intracranial Time To Recurrence (iTTR)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluation of efficacy of sotorasib measured by tumour shrinkage in pre-defined patient groups</measure>
<time_frame>through study completion, and average of 8 months</time_frame>
<description>Tumour shrinkage measured by RECIST v1.1 criteriae</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluation of efficacy of sotorasib measured in overall survival, in pre-defined patient groups</measure>
<time_frame>through study completion, and average of 8 months</time_frame>
<description>Overall Survival (OS)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluation of efficacy, measured in time to progression, of sotorasib in pre-defined patient groups</measure>
<time_frame>through study completion, and average of 8 months</time_frame>
<description>Time on treatment post progression</description>
</secondary_outcome>
<secondary_outcome>
<measure>To evaluate patient-reported outcome during treatment assessed by QoL: EQ-5D-5L</measure>
<time_frame>Change from baseline over time to week 12</time_frame>
<description>EQ-5D-5L scores at each assessment and changes from baseline</description>
</secondary_outcome>
<secondary_outcome>
<measure>To evaluate patient-reported outcome during treatment assessed by QoL: QLQ-LC13</measure>
<time_frame>Change from baseline over time to week 12</time_frame>
<description>QLQ-LC13 scores at each assessment and changes from baseline</description>
</secondary_outcome>
<secondary_outcome>
<measure>To evaluate patient-reported outcome during treatment assessed by QoL: QLQ-C30</measure>
<time_frame>Change from baseline over time to week 12</time_frame>
<description>QLQ-C30 scores at each assessment</description>
</secondary_outcome>
<secondary_outcome>
<measure>to estimate the subject incidence of treatment-emergent adverse events, treatment-related adverse events, changes in vital signs, and clinical laboratory tests</measure>
<time_frame>until 28 days after last treatment dose</time_frame>
<description>NCT CTCAE</description>
</secondary_outcome>
<other_outcome>
<measure>To investigate molecular factors involved in response, resistance and toxicity</measure>
<time_frame>through study completion, and average of 8 months</time_frame>
<description>Molecular characterization of blood and tissue before commencement on sotorasib, at response and at progression on sotorasib</description>
</other_outcome>
<other_outcome>
<measure>To investigate factors involved in response, resistance and toxicity by deep sequencing of tumor tissue</measure>
<time_frame>through study completion, and average of 8 months</time_frame>
<description>NGS (deep targeted sequencing of tumour tissue)</description>
</other_outcome>
<other_outcome>
<measure>To investigate factors involved in response, resistance and toxicity by molecular analyses of blood</measure>
<time_frame>through study completion, and average of 8 months</time_frame>
<description>Molecular analyses (incl NGS, e.g. Avenio) of blood samples (ctDNA)</description>
</other_outcome>
<other_outcome>
<measure>Investigation of factors involved in response, resistance and toxicity</measure>
<time_frame>through study completion, and average of 8 months</time_frame>
<description>Array-based microRNA</description>
</other_outcome>
<other_outcome>
<measure>To investigate factors involved in response, resistance and toxicity by looking at epigenetics</measure>
<time_frame>through study completion, and average of 8 months</time_frame>
<description>Array-based methylation</description>
</other_outcome>
<other_outcome>
<measure>To investigate factors related to response, resistance and toxicity of study drug</measure>
<time_frame>through study completion, and average of 8 months</time_frame>
<description>Array-based mRNA expression</description>
</other_outcome>
<other_outcome>
<measure>To investigate factors involved in response, resistance and toxicity</measure>
<time_frame>through study completion, and average of 8 months</time_frame>
<description>Protein analyses based on IHC</description>
</other_outcome>
<other_outcome>
<measure>To investigate other factors involved in response, resistance and toxicity</measure>
<time_frame>through study completion, and average of 8 months</time_frame>
<description>Exploratory analyses to be determined</description>
</other_outcome>
<other_outcome>
<measure>Toxicity and concomitant medication</measure>
<time_frame>through study completion, and average of 8 months</time_frame>
<description>Details on concomitant medication, specifically proton pump inhibitors, correlated to response rates and toxicity to be reported in the eCRF</description>
</other_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">100</enrollment>
<condition>Lung Cancer</condition>
<condition>NSCLC, Stage III</condition>
<condition>NSCLC Stage IV</condition>
<condition>Lung Cancer Stage IV</condition>
<condition>Mutation</condition>
<condition>Cancer</condition>
<condition>Cancer, Lung</condition>
<arm_group>
<arm_group_label>Sotorasib</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Single arm trial. All patients will be included in this interventional arm.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>sotorasib</intervention_name>
<description>single group, all patients receive sotorasib</description>
<arm_group_label>Sotorasib</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Provision of signed and dated, written informed consent.

- Age > 18 years.

- Histologically or cytologically documented NSCLC stage III/IV not amenable for
curative treatment. Patients that have received systemic adjuvant therapy for
non-metastatic disease in the past will need a new biopsy before inclusion if no
biopsy acquired after adjuvant therapy is available.

- Documented KRASG12C mutation, based on tissue analysis on either archived tissue or
new biopsy before inclusion, and verified locally by a validated method.

- Subjects will have received and progressed or experienced disease recurrence on or
after receiving at least 1 prior systemic therapy for NSCLC stage III/IV not amenable
for curative treatment. Prior treatment must include checkpoint inhibitor for advanced
or metastatic disease, either given alone or in combination with chemotherapy unless
the subject has a medical contraindication to one of the required therapies.

1. Adjuvant therapy will count as a line of therapy if the subject progressed on or
within 6 months of adjuvant therapy administration.

2. Disease progression on or within 6 months of end of prior curatively intended
multimodal therapy will count as a line of therapy.

- ECOG status 0-2 and a minimum life expectancy of 12 weeks. At least 60 patients should
be in ECOG 2. When 40 patients in ECOG 0-1 are included, the inclusion criteria will
change to only ECOG 2.

- At least one lesion, not previously irradiated and not chosen for biopsy during the
study screening period, that can be accurately measured at baseline according to
RECIST 1.1. Brain metastases are not regarded measurable.

- Females should be using adequate contraceptive measures, should not be breast feeding
and must have a negative pregnancy test prior to start of dosing if of child-bearing
potential or must have evidence of non-child-bearing potential by fulfilling one of
the following criteria at screening:

- Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least
12 months following cessation of all exogenous hormonal treatments

- Women under 50 years old would be considered postmenopausal if they have been
amenorrhoeic for 12 months or more following cessation of exogenous hormonal
treatments and with Luteinizing Hormone (LH) and Follicle-Stimulating Hormone
(FSH) levels in the post-menopausal range for the institution

- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral
oophorectomy or bilateral salpingectomy but not tubal ligation.

- Male subjects must be willing to use barrier contraception.

- Mean resting corrected QT interval (QTc) < 470 msec (females) or < 450 msec (males)
using the screening clinic ECG machine derived QTc value.

- Adequate bone marrow reserve or organ function (as demonstrated by any of the
following laboratory values:

- Absolute neutrophil count > 1.5 x 109/L

- Platelet count > 100 x 109/L

- Haemoglobin > 9.0 g/dL

- Alanine aminotransferase (ALT) < 2.5 times the upper limit of normal (ULN) if no
demonstrable liver metastases or < 5 times ULN in the presence of liver
metastases

- Aspartate aminotransferase (AST) < 2.5 times ULN if no demonstrable liver
metastases or > 5 times ULN in the presence of liver metastases

- Total bilirubin < 1.5 times ULN if no liver metastases or > 3 times ULN in the
presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or
liver metastases

- Serum creatinine < 1.5 times ULN concurrent with creatinine clearance < 45 mL
/min [measured or calculated by Cockcroft and Gault equation]-confirmation of
creatinine clearance is only required when creatinine is >1.5 times ULN

Exclusion Criteria:

- Previously identified driver mutation (according to local standard of care or
guidelines) other than KRASG12C for which an approved therapy is available (including
EGFR, ALK, etc).

- Symptomatic brain metastases or leptomeningeal disease. Subjects that have received
whole brain radiation therapy ending at least 4 weeks (or stereotactic radiosurgery
ending at least 2 weeks) prior to study day 1 are eligible if they meet all the
following criteria: a) residual neurological symptoms grade ≤ 2; b) on stable doses of
dexamethasone or equivalent for at least 2 weeks, if applicable; and c) follow-up MRI
performed within 30 days prior to enrolment shows no progression or new lesions
appearing.

- Major surgery within 4 weeks of inclusion

- Radiotherapy treatment within 2 weeks of inclusion. Subjects must have recovered from
all radiotherapy related toxicity to CTCAE version 5.0 grade 1 or less with the
exception of alopecia (any grade of alopecia allowed).

- Anti-tumour therapy (chemotherapy, antibody therapy, molecular targeted therapy,
retinoid therapy, hormonal therapy [except for subjects with history of completely
resected breast cancer with no active disease on long term adjuvant endocrine
therapy], or investigational agent) within 4 weeks (chemotherapy within 2 weeks) of
study day 1. Targeted small molecule inhibitors, within 14 days of study day 1, or
within 5 half-lives, whichever is longer. Please note that bisphosphonates or anti
RANKL antibody therapy is allowed if needed for management of hypercalcemia or for
prevention of skeletal events.

- Previous treatment with sotorasib or other KRASG12C inhibitor

- Use of warfarin. Other anticoagulation is allowed.

- Patients with significant comorbidities other than those mentioned below:

- Comorbidities of special interest (up to grade 2 according to ACE-27 scoring
system (see appendix A and (20)), or toxicity CTCAE 2) are eligible (ACE-27 grade
3 or CTCAE grade 3 may be eligible after discussion with Sponsor). Patients may
have more than one comorbidity as long as all are within the severity grades as
mentioned. Comorbidities of special interest are the following:

i. Autoimmune diseases (rheumatoid, colitis, diabetes, skin, multiple sclerosis
etc), including immunotherapy-induced morbidity (colitis, pneumonitis,
endocrinopathies, non-viral hepatitis, nephritis etc). Immunotherapy-induced
colitis or pneumonitis must be resolved to maximum CTCAE 2, and a maximum use of
prednisolone 10 mg or equivalent is allowed.

ii. Smoking-induced diseases (cardiovascular (coronary artery disease, apoplexia,
thromboembolic events), COPD/emphysema etc). Note: Myocardial infarction within 6 months
prior to enrolment, unstable arrhythmias or unstable angina are not eligible.

▪ The following comorbidities are ineligibility criteria: i. Any evidence of severe or
uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding
diatheses, which in the investigator's opinion makes it undesirable for the patient to
participate in the trial or which would jeopardise compliance with the protocol, or active
infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
Screening for chronic conditions is not required.

ii. Previous malignancy (except non-melanoma skin cancers, and the following in situ
cancers: bladder, gastric, oesophageal, colon, endometrial, cervical, melanoma or breast)
unless a complete remission was achieved at least 2 years prior to study entry.

iii. Significant gastrointestinal disorder that results in requirement for intravenous
alimentation, or inability to take oral medication.

- Use of known cytochrome P450 (CYP) 3A4 sensitive substrates (with a narrow therapeutic
window), within 14 days or 5 half-lives of the drug or its major active metabolite,
whichever is longer, prior to study day 1 that was not reviewed and approved by the
principal investigator. Use of strong inducers of CYP3A4 (including herbal supplements
such as St. John's wort) within 14 days or 5 half-lives (whichever is longer) prior to
study day 1 that was not reviewed and approved by the principal investigator.

- History of hypersensitivity of active or inactive excipients of sotorasib or drugs
with a similar chemical structure or class to sotorasib.

- Treatment with an investigational drug within five half-lives of the compound or 3
months, whichever is greater.

- Previous enrolment in the present study or previous treatment with sotorasib.

- Any unresolved toxicities from prior therapy greater than CTCAE grade 2, unless
discussed with Sponsor.

- Women who are pregnant or breast-feeding, or have a positive (urine or serum)
pregnancy test prior to study entry

- Involvement in the planning and/or conduct of the study (investigator staff and/or
staff at the study site).

- Judgment by the investigator that the subject should not participate in the study if
the subject is unlikely to comply with study procedures, restrictions and
requirements.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Odd Terje Brustugun, MD, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Vestre Viken Health trust</affiliation>
</overall_official>
<overall_contact>
<last_name>Odd Terje Brustugun, MD, PhD</last_name>
<phone>+4732862464</phone>
<email>otr@vestreviken.no</email>
</overall_contact>
<overall_contact_backup>
<last_name>Inger-Johanne Eide, MD, PhD</last_name>
<phone>+4799713251</phone>
<email>ingei@vestreviken.no</email>
</overall_contact_backup>
<location>
<facility>
<name>Vestre Viken Health Trust</name>
<address>
<city>Drammen</city>
<state>Viken</state>
<zip>3004</zip>
<country>Norway</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Siri Bråthen, MSc</last_name>
<phone>+4745226100</phone>
<email>sibraa@vestreviken.no</email>
</contact>
</location>
<location_countries>
<country>Norway</country>
</location_countries>
<verification_date>May 2022</verification_date>
<study_first_submitted>September 20, 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>May 30, 2022</last_update_submitted>
<last_update_submitted_qc>May 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">June 2, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>KRAS G12C</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Lung Neoplasms</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Sotorasib</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
A single-arm, multicentre trial to investigate sotorasib in KRASG12C-mutated non-small cell
lung cancer stage III/IV not amenable for curative treatment including patients with
comorbidities, and to provide translational knowledge regarding mechanism of relapse and
differences in responses, including differences among patients with different co-occurring
mutations.
A single-arm multi-institutional phase II study to investigate sotorasib in KRASG12C-mutated
non-small cell lung cancer stage III/IV not amenable for curative treatment including
patients with comorbidities, and to provide translational knowledge regarding mechanism of
relapse and differences in responses, including differences among patients with different
co-occurring mutations.
The aim is to investigate whether treatment with sotorasib will provide significant objective
response rates in predefined KRASG12C-mutated non-small cell lung cancer patients that are
not typically included in phase III-studies. Furthermore, the trial will explore whether
patients in performance status ECOG 2 may benefit from sotorasib. In this study, a relevant
number of sotorasib-naïve patients (n=100) will be treated with sotorasib and followed for
efficacy and side effects. MRI-scans both at base-line and regularly during therapy will give
data on intracranial efficacy. Eligible patients will be previously treated with at least 1
line standard (chemo)immunotherapy, or deemed in-eligible for standard (chemo)immunotherapy.
In part II of the study, comprehensive analyses of biological samples taken pretreatment, and
post-progression will provide novel information about resistance mechanisms on sotorasib.
Furthermore, analyses of biopsies taken at partial response (estimated to be performed in
25-30% of cases) may potentially also characterize non-eradicated residual cells after
achieved response. The post-progression biopsies may indicate the optimal next-line therapy.
Inclusion Criteria:
- Provision of signed and dated, written informed consent.
- Age > 18 years.
- Histologically or cytologically documented NSCLC stage III/IV not amenable for
curative treatment. Patients that have received systemic adjuvant therapy for
non-metastatic disease in the past will need a new biopsy before inclusion if no
biopsy acquired after adjuvant therapy is available.
- Documented KRASG12C mutation, based on tissue analysis on either archived tissue or
new biopsy before inclusion, and verified locally by a validated method.
- Subjects will have received and progressed or experienced disease recurrence on or
after receiving at least 1 prior systemic therapy for NSCLC stage III/IV not amenable
for curative treatment. Prior treatment must include checkpoint inhibitor for advanced
or metastatic disease, either given alone or in combination with chemotherapy unless
the subject has a medical contraindication to one of the required therapies.
1. Adjuvant therapy will count as a line of therapy if the subject progressed on or
within 6 months of adjuvant therapy administration.
2. Disease progression on or within 6 months of end of prior curatively intended
multimodal therapy will count as a line of therapy.
- ECOG status 0-2 and a minimum life expectancy of 12 weeks. At least 60 patients should
be in ECOG 2. When 40 patients in ECOG 0-1 are included, the inclusion criteria will
change to only ECOG 2.
- At least one lesion, not previously irradiated and not chosen for biopsy during the
study screening period, that can be accurately measured at baseline according to
RECIST 1.1. Brain metastases are not regarded measurable.
- Females should be using adequate contraceptive measures, should not be breast feeding
and must have a negative pregnancy test prior to start of dosing if of child-bearing
potential or must have evidence of non-child-bearing potential by fulfilling one of
the following criteria at screening:
- Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least
12 months following cessation of all exogenous hormonal treatments
- Women under 50 years old would be considered postmenopausal if they have been
amenorrhoeic for 12 months or more following cessation of exogenous hormonal
treatments and with Luteinizing Hormone (LH) and Follicle-Stimulating Hormone
(FSH) levels in the post-menopausal range for the institution
- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral
oophorectomy or bilateral salpingectomy but not tubal ligation.
- Male subjects must be willing to use barrier contraception.
- Mean resting corrected QT interval (QTc) < 470 msec (females) or < 450 msec (males)
using the screening clinic ECG machine derived QTc value.
- Adequate bone marrow reserve or organ function (as demonstrated by any of the
following laboratory values:
- Absolute neutrophil count > 1.5 x 109/L
- Platelet count > 100 x 109/L
- Haemoglobin > 9.0 g/dL
- Alanine aminotransferase (ALT) < 2.5 times the upper limit of normal (ULN) if no
demonstrable liver metastases or < 5 times ULN in the presence of liver
metastases
- Aspartate aminotransferase (AST) < 2.5 times ULN if no demonstrable liver
metastases or > 5 times ULN in the presence of liver metastases
- Total bilirubin < 1.5 times ULN if no liver metastases or > 3 times ULN in the
presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or
liver metastases
- Serum creatinine < 1.5 times ULN concurrent with creatinine clearance < 45 mL
/min [measured or calculated by Cockcroft and Gault equation]-confirmation of
creatinine clearance is only required when creatinine is >1.5 times ULN
Exclusion Criteria:
- Previously identified driver mutation (according to local standard of care or
guidelines) other than KRASG12C for which an approved therapy is available (including
EGFR, ALK, etc).
- Symptomatic brain metastases or leptomeningeal disease. Subjects that have received
whole brain radiation therapy ending at least 4 weeks (or stereotactic radiosurgery
ending at least 2 weeks) prior to study day 1 are eligible if they meet all the
following criteria: a) residual neurological symptoms grade ≤ 2; b) on stable doses of
dexamethasone or equivalent for at least 2 weeks, if applicable; and c) follow-up MRI
performed within 30 days prior to enrolment shows no progression or new lesions
appearing.
- Major surgery within 4 weeks of inclusion
- Radiotherapy treatment within 2 weeks of inclusion. Subjects must have recovered from
all radiotherapy related toxicity to CTCAE version 5.0 grade 1 or less with the
exception of alopecia (any grade of alopecia allowed).
- Anti-tumour therapy (chemotherapy, antibody therapy, molecular targeted therapy,
retinoid therapy, hormonal therapy [except for subjects with history of completely
resected breast cancer with no active disease on long term adjuvant endocrine
therapy], or investigational agent) within 4 weeks (chemotherapy within 2 weeks) of
study day 1. Targeted small molecule inhibitors, within 14 days of study day 1, or
within 5 half-lives, whichever is longer. Please note that bisphosphonates or anti
RANKL antibody therapy is allowed if needed for management of hypercalcemia or for
prevention of skeletal events.
- Previous treatment with sotorasib or other KRASG12C inhibitor
- Use of warfarin. Other anticoagulation is allowed.
- Patients with significant comorbidities other than those mentioned below:
- Comorbidities of special interest (up to grade 2 according to ACE-27 scoring
system (see appendix A and (20)), or toxicity CTCAE 2) are eligible (ACE-27 grade
3 or CTCAE grade 3 may be eligible after discussion with Sponsor). Patients may
have more than one comorbidity as long as all are within the severity grades as
mentioned. Comorbidities of special interest are the following:
i. Autoimmune diseases (rheumatoid, colitis, diabetes, skin, multiple sclerosis
etc), including immunotherapy-induced morbidity (colitis, pneumonitis,
endocrinopathies, non-viral hepatitis, nephritis etc). Immunotherapy-induced
colitis or pneumonitis must be resolved to maximum CTCAE 2, and a maximum use of
prednisolone 10 mg or equivalent is allowed.
ii. Smoking-induced diseases (cardiovascular (coronary artery disease, apoplexia,
thromboembolic events), COPD/emphysema etc). Note: Myocardial infarction within 6 months
prior to enrolment, unstable arrhythmias or unstable angina are not eligible.
▪ The following comorbidities are ineligibility criteria: i. Any evidence of severe or
uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding
diatheses, which in the investigator's opinion makes it undesirable for the patient to
participate in the trial or which would jeopardise compliance with the protocol, or active
infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
Screening for chronic conditions is not required.
ii. Previous malignancy (except non-melanoma skin cancers, and the following in situ
cancers: bladder, gastric, oesophageal, colon, endometrial, cervical, melanoma or breast)
unless a complete remission was achieved at least 2 years prior to study entry.
iii. Significant gastrointestinal disorder that results in requirement for intravenous
alimentation, or inability to take oral medication.
- Use of known cytochrome P450 (CYP) 3A4 sensitive substrates (with a narrow therapeutic
window), within 14 days or 5 half-lives of the drug or its major active metabolite,
whichever is longer, prior to study day 1 that was not reviewed and approved by the
principal investigator. Use of strong inducers of CYP3A4 (including herbal supplements
such as St. John's wort) within 14 days or 5 half-lives (whichever is longer) prior to
study day 1 that was not reviewed and approved by the principal investigator.
- History of hypersensitivity of active or inactive excipients of sotorasib or drugs
with a similar chemical structure or class to sotorasib.
- Treatment with an investigational drug within five half-lives of the compound or 3
months, whichever is greater.
- Previous enrolment in the present study or previous treatment with sotorasib.
- Any unresolved toxicities from prior therapy greater than CTCAE grade 2, unless
discussed with Sponsor.
- Women who are pregnant or breast-feeding, or have a positive (urine or serum)
pregnancy test prior to study entry
- Involvement in the planning and/or conduct of the study (investigator staff and/or
staff at the study site).
- Judgment by the investigator that the subject should not participate in the study if
the subject is unlikely to comply with study procedures, restrictions and
requirements.
|
NCT0531xxxx/NCT05311722.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/NCT05311722</url>
</required_header>
<id_info>
<org_study_id>ORehman</org_study_id>
<nct_id>NCT05311722</nct_id>
</id_info>
<brief_title>Comparsion of IV Dexmedetomidine, Tramdol and Ketamine for Post Spinal Anesthesia Shivering.</brief_title>
<official_title>Comparing the Efficacy of Intravenous Dexmedetomidine, Tramadol and Ketamine for Control of Post Spinal Shivering in Obstetric Patients Undergoing Lower Segment C-section</official_title>
<sponsors>
<lead_sponsor>
<agency>Sheikh Zayed Medical College</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Sheikh Zayed Medical College</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
To study control of post spinal shivering in patients undergoing lower segment cesarean
section using dexmedetomidine, tramadol and ketamine
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Its a Comparison of drugs for a better control of post spinal shivering in patietns underwent
cesarean section.using grades of shivering (0-4)patients will be assessed
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 30, 2022</start_date>
<completion_date type="Anticipated">February 20, 2023</completion_date>
<primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>3 drugs were given to patients</intervention_model_description>
<primary_purpose>Health Services Research</primary_purpose>
<masking>Single (Participant)</masking>
</study_design_info>
<primary_outcome>
<measure>Assessment of post spinal shivering by observing grades of shivering</measure>
<time_frame>10 minutes</time_frame>
<description>Control of post spinal shivering dexmedetomidine, tramadol and ketamine for control of post spinal shivering.</description>
</primary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">71</enrollment>
<condition>Post-Surgical Complication</condition>
<arm_group>
<arm_group_label>Dexmedetomidine</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Inj.dexmedetomidine 0.5mcg/kg diluted in 10ml N/s given as iv infusion over 10 minutes</description>
</arm_group>
<arm_group>
<arm_group_label>Ketamine</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Inj.ketamine 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes</description>
</arm_group>
<arm_group>
<arm_group_label>Tramadol</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Inj.tramadol 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Dexmedetomidine</intervention_name>
<description>Inj dexmedetomidine, will be given in infusion over 10 mins and their effect on post spinal shivering will be assessed.</description>
<arm_group_label>Dexmedetomidine</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Ketamine</intervention_name>
<description>Ketamine</description>
<arm_group_label>Ketamine</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Tramadol</intervention_name>
<description>Tramadol</description>
<arm_group_label>Tramadol</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Woman of age 18-60

- Pregnant woman in outdoor patient department and emergency

Exclusion Criteria:

- patient. with history of hypersensitivity to opioids,

- ketamine or bupivacaine

- History of cardiovascular disease,

- Hypertension,

- psychosis,

- antepartum hemorrhage,

- cord prolapse,

- fetal distress
</textblock>
</criteria>
<gender>Female</gender>
<gender_based>Yes</gender_based>
<gender_description>All females with age between 18 -60</gender_description>
<minimum_age>18 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Obaid ur rehman Reman, Mbbs</last_name>
<phone>03335817980</phone>
<email>drobaid_55@yahoo.com</email>
</overall_contact>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 9, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>April 4, 2022</last_update_submitted>
<last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 5, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Sheikh Zayed Medical College</investigator_affiliation>
<investigator_full_name>Obaid ur Rehman</investigator_full_name>
<investigator_title>Principal investigator</investigator_title>
</responsible_party>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Dexmedetomidine</mesh_term>
<mesh_term>Ketamine</mesh_term>
<mesh_term>Tramadol</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
To study control of post spinal shivering in patients undergoing lower segment cesarean
section using dexmedetomidine, tramadol and ketamine
Its a Comparison of drugs for a better control of post spinal shivering in patietns underwent
cesarean section.using grades of shivering (0-4)patients will be assessed
Inclusion Criteria:
- Woman of age 18-60
- Pregnant woman in outdoor patient department and emergency
Exclusion Criteria:
- patient. with history of hypersensitivity to opioids,
- ketamine or bupivacaine
- History of cardiovascular disease,
- Hypertension,
- psychosis,
- antepartum hemorrhage,
- cord prolapse,
- fetal distress
|
NCT0531xxxx/NCT05311735.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/NCT05311735</url>
</required_header>
<id_info>
<org_study_id>13712</org_study_id>
<nct_id>NCT05311735</nct_id>
</id_info>
<brief_title>Mineralized and Partial Demineralized Dentin Graft Compared to FDBA</brief_title>
<official_title>Autogenous Mineralized and Partial Demineralized Dentin Graft Compared to Freeze Dried Bone Allograft: A Randomized Control Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Oklahoma</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Delta Dental Foundation</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>University of Oklahoma</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>Yes</is_fda_regulated_device>
<is_us_export>Yes</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
The bone grafting materials currently used in dentistry are autografts, allografts,
xenografts, and alloplastic grafts. Among these different types of bone graft materials,
autografts are considered to have the most predictable results due to its properties of
osteogenesis, osteoinduction and osteoconduction. However, bone autografts are rarely used
due to the high morbidity associated with harvesting the bone graft from the patient with a
second surgical site. Because of the increased risk to the patient with autogenous bone
grafts, the current standard of care is an allograft, which is a bone graft harvested from
cadaver sources such as Freeze-Dried Bone Allograft (FDBA). While allografts can only possess
the qualities of osteoinduction and osteoconduction, they also have dramatically less
morbidity due to the lack of a second surgical site.

Studies have shown that autogenous dentin grafts promote all three ideal mechanisms for bone
regeneration. There are two methods to generate autogenous dentin grafts. One is to collect
the extracted tooth and to send it to a tooth bank for the preparation process. The second is
to process the extracted tooth in a clinical setting chairside, for a graft. A dentin graft
can undergo different treatments such as demineralization, mineralization, and
partial-demineralization. Although the autogenous dentin graft has shown positive results for
bone regeneration, the comparison between partial-demineralized, mineralized autogenous
dentin grafts, and freeze-dried bone grafts in the clinical setting for immediate grafting
has not been studied in humans. Thus, there is a need to study the benefits of autogenous
dentin partial-demineralized and mineralized grafts versus freeze-dried bone allografts
regarding clinical, radiographically (bone volume and density), and efficacy results. This
research addresses these areas of need.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The bone grafting materials currently used in dentistry are autografts, allografts,
xenografts, and alloplastic grafts. Among these different types of bone graft materials,
autografts are considered to have the most predictable results due to its properties of
osteogenesis, osteoinduction and osteoconduction. However, bone autografts are rarely used
due to the high morbidity associated with harvesting the bone graft from the patient with a
second surgical site. Because of the increased risk to the patient with autogenous bone
grafts, the current standard of care is an allograft, which is a bone graft harvested from
cadaver sources such as Freeze-Dried Bone Allograft (FDBA). While allografts can only possess
the qualities of osteoinduction and osteoconduction, they also have dramatically less
morbidity due to the lack of a second surgical site.

Studies have shown that autogenous dentin grafts promote all three ideal mechanisms for bone
regeneration. There are two methods to generate autogenous dentin grafts. One is to collect
the extracted tooth and to send it to a tooth bank for the preparation process. The second is
to process the extracted tooth in a clinical setting chairside, for a graft. A dentin graft
can undergo different treatments such as demineralization, mineralization, and
partial-demineralization. Although the autogenous dentin graft has shown positive results for
bone regeneration, the comparison between partial-demineralized, mineralized autogenous
dentin grafts, and freeze-dried bone grafts in the clinical setting for immediate grafting
has not been studied in humans. Thus, there is a need to study the benefits of autogenous
dentin partial-demineralized and mineralized grafts versus freeze-dried bone allografts
regarding clinical, radiographically (bone volume and density), and efficacy results. This
research addresses these areas of need.

A. Specific Aims

Specific Aim 1:

Is there a clinical-radiographical difference in terms of bone volume and density between
mineralized dentin grafts, partial demineralized tooth grafts, and FDBA?

Null Hypothesis (Ho): Experimental groups (Mineralized, and partial demineralized dentin
grafts) do not have positive changes in terms of bone volume and density when compared to
FDBA

Alternative Hypothesis (H1): Experimental groups (Mineralized, and partial demineralized
dentin grafts) show better results in terms of bone volume and density when compared to FDBA.

Secondary Aim:

Evaluate if there is any difference in terms of efficacy among partial-demineralized dentin
graft, mineralized dentin graft and FDBA.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">October 29, 2021</start_date>
<completion_date type="Anticipated">June 2024</completion_date>
<primary_completion_date type="Anticipated">June 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Test group I (mineralized tooth graft): extracted teeth will undergo the mineralization process according to the manufacture's guidelines. Procedure will be done in a specialized equipment for tooth graft preparation (Smart Dentin Grinder® (SDG) (KometaBio), and then sites will be grafted. Remaining graft will be stored appropriately for future grafting in the same patient (according to the guidelines)
Test group II (partial-demineralized tooth graft): extracted teeth will be undergone to partial-demineralized process, according to the manufacture's guidelines. Procedures will be done in a specialized equipment for tooth graft preparation (Smart Dentin Grinder® (SDG) (KometaBio), and then sites will be grafted. Remaining graft will be stored appropriately for future grafting in the same patient (according to the guidelines).
Control group (FDBA): extracted teeth will be discarded and sites will be grafted with FDBA.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Clinical-radiographical differences in terms of bone volume between dentin tooth grafts and FDBA.</measure>
<time_frame>6 months post guided bone regeneration procedure</time_frame>
<description>Is there a clinical-radiographical difference in terms of bone volume between mineralized dentin grafts, partial demineralized tooth grafts and FDBA, as measured in millimeters, with calibrated devices?</description>
</primary_outcome>
<primary_outcome>
<measure>Clinical-radiographical differences in terms of bone density between dentin tooth grafts and FDBA.</measure>
<time_frame>6 months post guided bone regeneration procedure</time_frame>
<description>Is there a clinical-radiographical difference in terms of bone density between mineralized dentin grafts, partial demineralized tooth grafts and FDBA, as measured with Hounsfield Units?</description>
</primary_outcome>
<secondary_outcome>
<measure>Surgical efficiency utilizing dentin tooth graft and FDBA.</measure>
<time_frame>6 months post guided bone regeneration procedure</time_frame>
<description>Is there any difference in terms of surgical efficiency among partial-demineralized tooth graft, mineralized tooth graft and FDBA, as determined by length of time of surgical procedure?</description>
</secondary_outcome>
<secondary_outcome>
<measure>Surgical cost saving measurement utilizing dentin tooth graft and FDBA.</measure>
<time_frame>6 months post guided bone regeneration procedure</time_frame>
<description>Is there any difference in terms of surgical cost savings among partial-demineralized tooth graft, mineralized tooth graft and FDBA, as determined by length of time of surgical procedure, as measured by the total overhead expended per procedure type?</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">45</enrollment>
<condition>Alveolar Bone Loss</condition>
<arm_group>
<arm_group_label>Freeze-Dried Bone Allograft Control</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>-Control group (FDBA): extracted teeth will be discarded and sites will be grafted with FDBA.</description>
</arm_group>
<arm_group>
<arm_group_label>Mineralized Dentin Graft</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>-Test group I (mineralized tooth graft): extracted teeth will undergo the mineralization process according to the manufacture's guidelines. Procedure will be done in a specialized equipment for tooth graft preparation (Smart Dentin Grinder® (SDG) (KometaBio), and then sites will be grafted. Remaining graft will be stored appropriately for future grafting in the same patient (according to the guidelines)</description>
</arm_group>
<arm_group>
<arm_group_label>Partial-Demineralized Dentin Graft</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>-Test group II (partial-demineralized tooth graft): extracted teeth will be undergone to partial-demineralized process, according to the manufacture's guidelines. Procedures will be done in a specialized equipment for tooth graft preparation (Smart Dentin Grinder® (SDG) (KometaBio), and then sites will be grafted. Remaining graft will be stored appropriately for future grafting in the same patient (according to the guidelines).</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Freeze-Dried Bone Allograft control</intervention_name>
<description>Bone grafting to prevent alveolar ridge collapse after tooth removal</description>
<arm_group_label>Freeze-Dried Bone Allograft Control</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Mineralized Dentin Graft</intervention_name>
<description>Mineralized tooth graft used as a bone graft substitute to prevent alveolar ridge collapse after tooth removal</description>
<arm_group_label>Mineralized Dentin Graft</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Partial-Demineralized Dentin Graft</intervention_name>
<description>Partially mineralized tooth graft used as a bone graft substitute to prevent alveolar ridge collapse after tooth removal</description>
<arm_group_label>Partial-Demineralized Dentin Graft</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Adult patients ≥18 years old

- Able to understand and sign a written informed consent form and willing to fulfil all
study requirements.

- Alveolar sockets with intact four-wall architecture.

- Patients with at least a tooth that need to be extracted.

Exclusion Criteria:

- Uncontrolled systemic disease

- Currently smoking >10 cigarettes per day

- History of head and/or neck radiotherapy in the past five years

- Bisphosphonates current use or history of IV bisphosphonate

- Pregnant, expecting to become pregnant, or lactating women.

- Presence of active periodontal disease.

- Teeth that underwent root canal fillings

- Teeth with acute infection at the site of extraction.

- Teeth with periapical infection
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Robin Henderson, DMD MS</last_name>
<role>Principal Investigator</role>
<affiliation>University of Oklahoma College of Dentistry</affiliation>
</overall_official>
<overall_contact>
<last_name>Robin D Henderson, DMD MS</last_name>
<phone>405-271-8001</phone>
<phone_ext>34173</phone_ext>
<email>robin-henderson@ouhsc.edu</email>
</overall_contact>
<overall_contact_backup>
<last_name>Sandra Perozo, BDS</last_name>
<phone>832-991-2555</phone>
<email>sandra-perozovasquez@ouhsc.edu</email>
</overall_contact_backup>
<location>
<facility>
<name>University of Oklahoma College of Dentistry Graduate Periodontics</name>
<address>
<city>Oklahoma City</city>
<state>Oklahoma</state>
<zip>73117</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Sandra Perozo, BDS</last_name>
<phone>405-271-8001</phone>
<email>sandra-perozovazquez@ouhsc.edu</email>
</contact>
<contact_backup>
<last_name>Robin Henderson, DMD MS</last_name>
<phone>405-271-8001</phone>
<phone_ext>34173</phone_ext>
<email>robin-henderson@ouhsc.edu</email>
</contact_backup>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Jung RE, Fenner N, Hammerle CH, Zitzmann NU. Long-term outcome of implants placed with guided bone regeneration (GBR) using resorbable and non-resorbable membranes after 12-14 years. Clin Oral Implants Res. 2013 Oct;24(10):1065-73. doi: 10.1111/j.1600-0501.2012.02522.x. Epub 2012 Jun 15.</citation>
<PMID>22697628</PMID>
</reference>
<reference>
<citation>Ike M, Urist MR. Recycled dentin root matrix for a carrier of recombinant human bone morphogenetic protein. J Oral Implantol. 1998;24(3):124-32. doi: 10.1563/1548-1336(1998)0242.3.CO;2.</citation>
<PMID>9893518</PMID>
</reference>
<reference>
<citation>Saygin NE, Tokiyasu Y, Giannobile WV, Somerman MJ. Growth factors regulate expression of mineral associated genes in cementoblasts. J Periodontol. 2000 Oct;71(10):1591-600. doi: 10.1902/jop.2000.71.10.1591.</citation>
<PMID>11063392</PMID>
</reference>
<reference>
<citation>Emecen P, Akman AC, Hakki SS, Hakki EE, Demiralp B, Tozum TF, Nohutcu RM. ABM/P-15 modulates proliferation and mRNA synthesis of growth factors of periodontal ligament cells. Acta Odontol Scand. 2009;67(2):65-73. doi: 10.1080/00016350802555525.</citation>
<PMID>19031159</PMID>
</reference>
<reference>
<citation>Kim YK, Kim SG, Byeon JH, Lee HJ, Um IU, Lim SC, Kim SY. Development of a novel bone grafting material using autogenous teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Apr;109(4):496-503. doi: 10.1016/j.tripleo.2009.10.017. Epub 2010 Jan 8.</citation>
<PMID>20060336</PMID>
</reference>
<reference>
<citation>Kim YK, Kim SG, Yun PY, Yeo IS, Jin SC, Oh JS, Kim HJ, Yu SK, Lee SY, Kim JS, Um IW, Jeong MA, Kim GW. Autogenous teeth used for bone grafting: a comparison with traditional grafting materials. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Jan;117(1):e39-45. doi: 10.1016/j.oooo.2012.04.018. Epub 2012 Aug 30.</citation>
<PMID>22939321</PMID>
</reference>
<reference>
<citation>Koga T, Minamizato T, Kawai Y, Miura K, I T, Nakatani Y, Sumita Y, Asahina I. Bone Regeneration Using Dentin Matrix Depends on the Degree of Demineralization and Particle Size. PLoS One. 2016 Jan 21;11(1):e0147235. doi: 10.1371/journal.pone.0147235. eCollection 2016.</citation>
<PMID>26795024</PMID>
</reference>
<reference>
<citation>Binderman, Itzhak, Gideon Hallel, Casap Nardy, Avinoam Yaffe, and Lari Sapoznikov.</citation>
</reference>
<reference>
<citation>Phillips DJ, Swenson DT, Johnson TM. Buccal bone thickness adjacent to virtual dental implants following guided bone regeneration. J Periodontol. 2019 Jun;90(6):595-607. doi: 10.1002/JPER.18-0304. Epub 2019 Jan 10.</citation>
<PMID>30578550</PMID>
</reference>
<verification_date>May 2023</verification_date>
<study_first_submitted>February 21, 2022</study_first_submitted>
<study_first_submitted_qc>March 25, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>May 8, 2023</last_update_submitted>
<last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 9, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Alveolar Bone Loss</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>It is estimated that individual patient date will be shared to a very limited number of individuals to help with facilitating the statistical analysis of the study, as well as writing up the Master Thesis and future publications. Also, upon request, it is required to share study related information to our internal Institutional Review Board.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
<ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
<ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
<ipd_info_type>Analytic Code</ipd_info_type>
<ipd_time_frame>The estimated time frame for sharing data would be approximately until May 2025</ipd_time_frame>
<ipd_access_criteria>Institutional Review Board officials, Master Thesis Chair and Committee members, and statisticians, will be able to review data. Also, Dr. John Corbett, will be performing a followup study and possibly extending the time frame for Dr. Perozo's study measurement. It is also anticipated, but not actual, that future studies be performed for longitudinal analysis.</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The bone grafting materials currently used in dentistry are autografts, allografts,
xenografts, and alloplastic grafts. Among these different types of bone graft materials,
autografts are considered to have the most predictable results due to its properties of
osteogenesis, osteoinduction and osteoconduction. However, bone autografts are rarely used
due to the high morbidity associated with harvesting the bone graft from the patient with a
second surgical site. Because of the increased risk to the patient with autogenous bone
grafts, the current standard of care is an allograft, which is a bone graft harvested from
cadaver sources such as Freeze-Dried Bone Allograft (FDBA). While allografts can only possess
the qualities of osteoinduction and osteoconduction, they also have dramatically less
morbidity due to the lack of a second surgical site.
Studies have shown that autogenous dentin grafts promote all three ideal mechanisms for bone
regeneration. There are two methods to generate autogenous dentin grafts. One is to collect
the extracted tooth and to send it to a tooth bank for the preparation process. The second is
to process the extracted tooth in a clinical setting chairside, for a graft. A dentin graft
can undergo different treatments such as demineralization, mineralization, and
partial-demineralization. Although the autogenous dentin graft has shown positive results for
bone regeneration, the comparison between partial-demineralized, mineralized autogenous
dentin grafts, and freeze-dried bone grafts in the clinical setting for immediate grafting
has not been studied in humans. Thus, there is a need to study the benefits of autogenous
dentin partial-demineralized and mineralized grafts versus freeze-dried bone allografts
regarding clinical, radiographically (bone volume and density), and efficacy results. This
research addresses these areas of need.
The bone grafting materials currently used in dentistry are autografts, allografts,
xenografts, and alloplastic grafts. Among these different types of bone graft materials,
autografts are considered to have the most predictable results due to its properties of
osteogenesis, osteoinduction and osteoconduction. However, bone autografts are rarely used
due to the high morbidity associated with harvesting the bone graft from the patient with a
second surgical site. Because of the increased risk to the patient with autogenous bone
grafts, the current standard of care is an allograft, which is a bone graft harvested from
cadaver sources such as Freeze-Dried Bone Allograft (FDBA). While allografts can only possess
the qualities of osteoinduction and osteoconduction, they also have dramatically less
morbidity due to the lack of a second surgical site.
Studies have shown that autogenous dentin grafts promote all three ideal mechanisms for bone
regeneration. There are two methods to generate autogenous dentin grafts. One is to collect
the extracted tooth and to send it to a tooth bank for the preparation process. The second is
to process the extracted tooth in a clinical setting chairside, for a graft. A dentin graft
can undergo different treatments such as demineralization, mineralization, and
partial-demineralization. Although the autogenous dentin graft has shown positive results for
bone regeneration, the comparison between partial-demineralized, mineralized autogenous
dentin grafts, and freeze-dried bone grafts in the clinical setting for immediate grafting
has not been studied in humans. Thus, there is a need to study the benefits of autogenous
dentin partial-demineralized and mineralized grafts versus freeze-dried bone allografts
regarding clinical, radiographically (bone volume and density), and efficacy results. This
research addresses these areas of need.
A. Specific Aims
Specific Aim 1:
Is there a clinical-radiographical difference in terms of bone volume and density between
mineralized dentin grafts, partial demineralized tooth grafts, and FDBA?
Null Hypothesis (Ho): Experimental groups (Mineralized, and partial demineralized dentin
grafts) do not have positive changes in terms of bone volume and density when compared to
FDBA
Alternative Hypothesis (H1): Experimental groups (Mineralized, and partial demineralized
dentin grafts) show better results in terms of bone volume and density when compared to FDBA.
Secondary Aim:
Evaluate if there is any difference in terms of efficacy among partial-demineralized dentin
graft, mineralized dentin graft and FDBA.
Inclusion Criteria:
- Adult patients ≥18 years old
- Able to understand and sign a written informed consent form and willing to fulfil all
study requirements.
- Alveolar sockets with intact four-wall architecture.
- Patients with at least a tooth that need to be extracted.
Exclusion Criteria:
- Uncontrolled systemic disease
- Currently smoking >10 cigarettes per day
- History of head and/or neck radiotherapy in the past five years
- Bisphosphonates current use or history of IV bisphosphonate
- Pregnant, expecting to become pregnant, or lactating women.
- Presence of active periodontal disease.
- Teeth that underwent root canal fillings
- Teeth with acute infection at the site of extraction.
- Teeth with periapical infection
|
NCT0531xxxx/NCT05311748.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/NCT05311748</url>
</required_header>
<id_info>
<org_study_id>UrolUNIVPISA</org_study_id>
<nct_id>NCT05311748</nct_id>
</id_info>
<brief_title>Prospective Cross-sectional Evaluation of Penile Helicine Circulation in Veno-occlusive Erectile Dysfunction</brief_title>
<acronym>PD and VOD</acronym>
<official_title>Prospective Cross-sectional Evaluation of Penile Helicine Circulation by Power Doppler During Dynamic Ultrasound in Veno-occlusive Erectile Dysfunction</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Roma La Sapienza</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>University of Pisa</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>University of Roma La Sapienza</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>
Background: The aim of this study is to evaluate the usefulness of Power Doppler in order to
improve the diagnostic work up of veno-occlusive erectile dysfunction patients.

Materials and Methods: Two hundred and two patients affected by erectile dysfunction, mean
IIEF 5 = 13.5 (12-17) for at least 6 months, were enrolled in a prospective cross-sectional
study. All patients underwent Dynamic Power Doppler after intracevernous injection of
vasoactive drugs. Poor responders patients subsequently underwent to cavernosometry to get a
full assessment of the vascular framework.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Veno-occlusive continence is linked both to the integrity of neurological, vascular, and
endocrine structures and to the fibro-elastic characteristics of the cavernous tissue. In
most subjects with Erectile Dysfunction (ED), the erectile tissue presents histological
alterations such as the reduction of smooth muscle cells and the increased deposition of
connective tissue. A hypothesis describes these changes as promotors for the onset of
veno-occlusive dysfunction (VOD).

Dynamic cavernosometry, supplemented by contrast cavernosography, still represents the gold
standard for the diagnosis of VOD allowing the visualization of the competent venous
districts. These investigations, which had moderate popularity in the 1980s and underwent
several variations in the methodology of execution, are rarely used today due to their
invasiveness, the need for dedicated instruments and the scarce success of commonly adopted
surgical treatments (vein ligation surgery).

The recent introduction of endovascular techniques sheds new light on the correct
classification of vascular ED, especially in those patients with a sub-optimal response to
the use of drug therapy as an alternative to prosthetic surgery.

Advances in imaging techniques, including Power Doppler (PD) ultrasonography, allow an
accurate and complete study of penile circulation including the study of low-flow vessels.

The introduction of PD, during the penile duplex ultrasound routinely performed, had
additionally permitted the extension of the field of the study into the arteriolar
circulation of the corpora cavernosa, making possible the assessment of the vessels with a
"low speed flow", like the helicine arteries, which escape the standard Doppler Pulsated
evaluation; especially during the phases of the penile tumescence and partial rigidity,
phases 1-2, according to Erection Hardness Score .

From an anatomical and vascular point of view, the helicine arteries usually describe an
acute angle with the cavernous artery, delineating a Cavernous Terminal Unit (CTU).

The dynamic penile echo-color-doppler ultrasound can evaluate the correct assessment of the
CTU, by applying the PD function. In fact, the PD module, with calibration of the pulse
repetition frequency (PRF) of the transducer at 700 HZ applied to the cavernous arteries in
the dynamic phase, allows the study of the ramifications of the arteries up to the 3rd order
and their inclination in relation to the main trunk, expression or not of the integrity of
the CTU. In this contest, PD applied to dynamic penile duplex ultrasound, has established
itself as a method potentially suitable in the assessment of patients with VOD.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">January 15, 2014</start_date>
<completion_date type="Actual">July 15, 2019</completion_date>
<primary_completion_date type="Actual">March 13, 2017</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Crossover</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Echocolour doppler Evaluation of the Index of Maintenance of Erection (n.v. <0.25).</measure>
<time_frame>90 days</time_frame>
<description>Every subject will be studied by penile ultrasound with color doppler</description>
</primary_outcome>
<enrollment type="Actual">202</enrollment>
<condition>Erectile Dysfunction Due to Arterial Disease</condition>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Ultrasound and doppler</intervention_name>
<description>Penile echocolour doppler ultrasound</description>
</intervention>
<eligibility>
<study_pop>
<textblock>
Male patients affected by erectile dysfunction for at least 6 months
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Erectile dysfunction

Exclusion Criteria:

- None
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Urology Unit, Sapienza University of Rome</name>
<address>
<city>Latina</city>
<zip>04100</zip>
<country>Italy</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Alessandro Zucchi</name>
<address>
<city>Pisa</city>
<country>Italy</country>
</address>
</facility>
</location>
<location_countries>
<country>Italy</country>
</location_countries>
<results_reference>
<citation>Kim N, Azadzoi KM, Goldstein I, Saenz de Tejada I. A nitric oxide-like factor mediates nonadrenergic-noncholinergic neurogenic relaxation of penile corpus cavernosum smooth muscle. J Clin Invest. 1991 Jul;88(1):112-8. doi: 10.1172/JCI115266.</citation>
<PMID>1647413</PMID>
</results_reference>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 15, 2022</study_first_submitted>
<study_first_submitted_qc>March 25, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>March 25, 2022</last_update_submitted>
<last_update_submitted_qc>March 25, 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>University of Roma La Sapienza</investigator_affiliation>
<investigator_full_name>Antonio Luigi Pastore</investigator_full_name>
<investigator_title>PROF, MD, PhD</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Erectile Dysfunction</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Background: The aim of this study is to evaluate the usefulness of Power Doppler in order to
improve the diagnostic work up of veno-occlusive erectile dysfunction patients.
Materials and Methods: Two hundred and two patients affected by erectile dysfunction, mean
IIEF 5 = 13.5 (12-17) for at least 6 months, were enrolled in a prospective cross-sectional
study. All patients underwent Dynamic Power Doppler after intracevernous injection of
vasoactive drugs. Poor responders patients subsequently underwent to cavernosometry to get a
full assessment of the vascular framework.
Veno-occlusive continence is linked both to the integrity of neurological, vascular, and
endocrine structures and to the fibro-elastic characteristics of the cavernous tissue. In
most subjects with Erectile Dysfunction (ED), the erectile tissue presents histological
alterations such as the reduction of smooth muscle cells and the increased deposition of
connective tissue. A hypothesis describes these changes as promotors for the onset of
veno-occlusive dysfunction (VOD).
Dynamic cavernosometry, supplemented by contrast cavernosography, still represents the gold
standard for the diagnosis of VOD allowing the visualization of the competent venous
districts. These investigations, which had moderate popularity in the 1980s and underwent
several variations in the methodology of execution, are rarely used today due to their
invasiveness, the need for dedicated instruments and the scarce success of commonly adopted
surgical treatments (vein ligation surgery).
The recent introduction of endovascular techniques sheds new light on the correct
classification of vascular ED, especially in those patients with a sub-optimal response to
the use of drug therapy as an alternative to prosthetic surgery.
Advances in imaging techniques, including Power Doppler (PD) ultrasonography, allow an
accurate and complete study of penile circulation including the study of low-flow vessels.
The introduction of PD, during the penile duplex ultrasound routinely performed, had
additionally permitted the extension of the field of the study into the arteriolar
circulation of the corpora cavernosa, making possible the assessment of the vessels with a
"low speed flow", like the helicine arteries, which escape the standard Doppler Pulsated
evaluation; especially during the phases of the penile tumescence and partial rigidity,
phases 1-2, according to Erection Hardness Score .
From an anatomical and vascular point of view, the helicine arteries usually describe an
acute angle with the cavernous artery, delineating a Cavernous Terminal Unit (CTU).
The dynamic penile echo-color-doppler ultrasound can evaluate the correct assessment of the
CTU, by applying the PD function. In fact, the PD module, with calibration of the pulse
repetition frequency (PRF) of the transducer at 700 HZ applied to the cavernous arteries in
the dynamic phase, allows the study of the ramifications of the arteries up to the 3rd order
and their inclination in relation to the main trunk, expression or not of the integrity of
the CTU. In this contest, PD applied to dynamic penile duplex ultrasound, has established
itself as a method potentially suitable in the assessment of patients with VOD.
Male patients affected by erectile dysfunction for at least 6 months
Inclusion Criteria:
- Erectile dysfunction
Exclusion Criteria:
- None
|
NCT0531xxxx/NCT05311761.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/NCT05311761</url>
</required_header>
<id_info>
<org_study_id>0589-21-RMB</org_study_id>
<nct_id>NCT05311761</nct_id>
</id_info>
<brief_title>CogMe for the Prevention and Early Detection of Delirium</brief_title>
<acronym>CogMe</acronym>
<official_title>Evaluation of the CogMe Technology Platform for the Prevention and Early Detection of Delirium Among Older Patients in an Acute Hospital Setting: A Proof of Concept Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Rambam Health Care Campus</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>CogMe Ltd</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>Rambam Health Care Campus</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This study is designed as a prospective interventional study to evaluate the CogMe system for
early detection and prevention of delirium. The study will collect physiological and
cognitive measurements to evaluate the ability of the CogMe system to predict and detect
delirium and to aid the development of future delirium prevention methods.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Delirium is a syndrome defined as an acute disturbance of both consciousness and cognition
that tends to fluctuate over time and is caused by the physiological consequences of a
medical condition. It is a common disorder in acute care settings, in internal medicine
units, in post-operative patients and the intensive care unit. Delirium is associated with
increased mortality, longer hospital stays, long-term cognitive impairment and increased
healthcare costs. The pathophysiology of delirium is multifactorial and is not completely
understood.

The prevalence of delirium increases with age and is very common in elderly hospitalized
patients. In certain departments delirium rates can reach over 40%. However, delirium is
underdiagnosed in almost two thirds of cases or misdiagnosed as depression or dementia.
Furthermore, it has been previously shown that the diagnosis of delirium is often delayed,
and that the recognition and documentation of delirium by physicians and nurses is far from
optimal. Early diagnosis of delirium may improve clinical outcome, with shortened duration of
symptoms, decreased length of admission and reduced long-term complications.

Clinical studies have demonstrated that delirium may be prevented in up to one-third of cases
by multifactored non-pharmacological interventions, yet they can be costly to implement and
require specially trained staff members. In addition, they do not usually consider
physiological parameters.

Three recent technological advances now provide opportunities for a new delirium prevention
approach. First, over the recent years vital signs monitoring with wearable sensors powered
by advanced processing algorithms has become technically feasible. This development may
provide opportunities for early detection of delirium and for detection of physiological
triggers of delirium such as dehydration, infections, and lack of sleep. Second, recent
advances in virtual dialogue systems (e.g. Amazon's Alexa or Apple's Siri) provide new and
exciting opportunities for automatic patient interaction. Devices with voice or multimodal
communication can be used by older patients with little or no experience in modern mobile
technology. Lastly, recent progress in digitized data acquisition, computing infrastructure
and algorithm development, now allow artificial intelligence and machine learning
applications to expand into areas in medicine that were previously thought to be only the
province of human experts. The combination of these three data sources can greatly improve
current prediction models and allow for earlier and more accurate delirium prediction.

An automated system which could aid with delirium detection and alert clinicians to a
possible onset of the syndrome can greatly improve treatment and outcomes for patients. The
CogMe system utilizes current technology to provide a holistic and scalable approach for
delirium prediction, detection and prevention covering both physiological and cognitive
aspects. The system uses wearables for physiological vitals monitoring and communicates with
patients by a dedicated tablet app - the CogMe Personal Assistant (PA). In this study, the
data collected by the wearables and the CogMe PA, in combination with patient data from the
EMR, will be analyzed retrospectively using machine learning techniques (CogMe Data
Analytics) to evaluate the ability of the CogMe system to predict and detect delirium.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 1, 2022</start_date>
<completion_date type="Anticipated">December 31, 2024</completion_date>
<primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>Single arm single center prospective interventional study.</intervention_model_description>
<primary_purpose>Diagnostic</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>The detection of delirium by the CogMe system</measure>
<time_frame>24 hours</time_frame>
<description>Time between the detection of delirium by the CogMe Data Analytics model and the first diagnosis of delirium based on the Confusion Assessment Method (CAM) instrument.</description>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">100</enrollment>
<condition>Delirium</condition>
<arm_group>
<arm_group_label>CogMe Personal Assistant (PA)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The CogMe PA is a dedicated application built by CogMe with the purpose of assessing the cognitive functions of patients and providing them with a short and stimulating interaction. The application runs on a standard tablet. The CogMe PA is designed to be easily understandable and usable also for older adults with little or no experience in mobile applications. The questions in the Q&A session are based on validated cognitive tests shown to be associated with delirium and are built to assess the subjective wellbeing and cognitive function of the patients. The repeated use of the application will allow to detect any changes or anomalies during the hospitalization period.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>CogMe Personal Assistant (PA)</intervention_name>
<description>Twice a day, in the morning and evening, the electronic tablet with the CogMe PA will be given to the patient by the research assistant. Patients will be asked to respond to a short question and answer (Q&A) session of approximately 5-10 minutes duration. This intervention will continue throughout the hospitalization period, estimated at approximately 5 days.</description>
<arm_group_label>CogMe Personal Assistant (PA)</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Male and female patients aged 65 years of age and older.

- Patients with an expected length of hospitalization of 4 days or longer.

- Patients who are conscious and cognitively able to provide written informed consent as
suggested by a score of 0 on 4AT screening.

- Patients who have no diagnosis of delirium prior to enrollment.

Exclusion Criteria:

- Male and female patients younger than 65 years of age.

- Patients with an expected length of hospitalization of less than 4 days.

- Patients with uncorrected visual or hearing impairment.

- Patients with impaired consciousness or cognitive impairment as determined by a score
of 1 or more on 4AT screening.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>65 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Tzvi Dwolatzky, MD MBBCh</last_name>
<role>Principal Investigator</role>
<affiliation>Rambam Health Care Campus</affiliation>
</overall_official>
<overall_contact>
<last_name>Tzvi Dwolatzky, MD MBBCh</last_name>
<phone>+972502061183</phone>
<email>t_dwolatzky@rambam.health.gov.il</email>
</overall_contact>
<overall_contact_backup>
<last_name>Orit Meshulam</last_name>
<phone>+972-47772952</phone>
<email>o_meshulam@rambam.health.gov.il</email>
</overall_contact_backup>
<location>
<facility>
<name>Rambam Health Care Campus</name>
<address>
<city>Haifa</city>
<state>North</state>
<zip>3109601</zip>
<country>Israel</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Tzvi Dwolatzky</last_name>
<phone>502061183</phone>
<email>t_dwolatzky@rambam.health.gov.il</email>
</contact>
<contact_backup>
<last_name>Orit Meshulam</last_name>
<phone>972-47772952</phone>
<email>o_meshulam@rambam.health.gov.il</email>
</contact_backup>
</location>
<location_countries>
<country>Israel</country>
</location_countries>
<results_reference>
<citation>Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available. Erratum In: N Engl J Med. 2006 Apr 13;354(15):1655.</citation>
<PMID>16540616</PMID>
</results_reference>
<results_reference>
<citation>Hshieh TT, Yang T, Gartaganis SL, Yue J, Inouye SK. Hospital Elder Life Program: Systematic Review and Meta-analysis of Effectiveness. Am J Geriatr Psychiatry. 2018 Oct;26(10):1015-1033. doi: 10.1016/j.jagp.2018.06.007. Epub 2018 Jun 26.</citation>
<PMID>30076080</PMID>
</results_reference>
<results_reference>
<citation>Yu KH, Beam AL, Kohane IS. Artificial intelligence in healthcare. Nat Biomed Eng. 2018 Oct;2(10):719-731. doi: 10.1038/s41551-018-0305-z. Epub 2018 Oct 10.</citation>
<PMID>31015651</PMID>
</results_reference>
<results_reference>
<citation>O'Keeffe ST, Lavan JN. Predicting delirium in elderly patients: development and validation of a risk-stratification model. Age Ageing. 1996 Jul;25(4):317-21. doi: 10.1093/ageing/25.4.317.</citation>
<PMID>8831879</PMID>
</results_reference>
<results_reference>
<citation>Inouye SK, Bogardus ST Jr, Baker DI, Leo-Summers L, Cooney LM Jr. The Hospital Elder Life Program: a model of care to prevent cognitive and functional decline in older hospitalized patients. Hospital Elder Life Program. J Am Geriatr Soc. 2000 Dec;48(12):1697-706. doi: 10.1111/j.1532-5415.2000.tb03885.x.</citation>
<PMID>11129764</PMID>
</results_reference>
<results_reference>
<citation>Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.</citation>
<PMID>2240918</PMID>
</results_reference>
<verification_date>September 2023</verification_date>
<study_first_submitted>March 7, 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>September 1, 2023</last_update_submitted>
<last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">September 5, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
<investigator_full_name>Tzvi Dwolatzky</investigator_full_name>
<investigator_title>Director Geriatrics</investigator_title>
</responsible_party>
<keyword>Elderly</keyword>
<keyword>Acute hospitalization</keyword>
<keyword>Technology</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Delirium</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>Data will be available to other researchers on request .</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study is designed as a prospective interventional study to evaluate the CogMe system for
early detection and prevention of delirium. The study will collect physiological and
cognitive measurements to evaluate the ability of the CogMe system to predict and detect
delirium and to aid the development of future delirium prevention methods.
Delirium is a syndrome defined as an acute disturbance of both consciousness and cognition
that tends to fluctuate over time and is caused by the physiological consequences of a
medical condition. It is a common disorder in acute care settings, in internal medicine
units, in post-operative patients and the intensive care unit. Delirium is associated with
increased mortality, longer hospital stays, long-term cognitive impairment and increased
healthcare costs. The pathophysiology of delirium is multifactorial and is not completely
understood.
The prevalence of delirium increases with age and is very common in elderly hospitalized
patients. In certain departments delirium rates can reach over 40%. However, delirium is
underdiagnosed in almost two thirds of cases or misdiagnosed as depression or dementia.
Furthermore, it has been previously shown that the diagnosis of delirium is often delayed,
and that the recognition and documentation of delirium by physicians and nurses is far from
optimal. Early diagnosis of delirium may improve clinical outcome, with shortened duration of
symptoms, decreased length of admission and reduced long-term complications.
Clinical studies have demonstrated that delirium may be prevented in up to one-third of cases
by multifactored non-pharmacological interventions, yet they can be costly to implement and
require specially trained staff members. In addition, they do not usually consider
physiological parameters.
Three recent technological advances now provide opportunities for a new delirium prevention
approach. First, over the recent years vital signs monitoring with wearable sensors powered
by advanced processing algorithms has become technically feasible. This development may
provide opportunities for early detection of delirium and for detection of physiological
triggers of delirium such as dehydration, infections, and lack of sleep. Second, recent
advances in virtual dialogue systems (e.g. Amazon's Alexa or Apple's Siri) provide new and
exciting opportunities for automatic patient interaction. Devices with voice or multimodal
communication can be used by older patients with little or no experience in modern mobile
technology. Lastly, recent progress in digitized data acquisition, computing infrastructure
and algorithm development, now allow artificial intelligence and machine learning
applications to expand into areas in medicine that were previously thought to be only the
province of human experts. The combination of these three data sources can greatly improve
current prediction models and allow for earlier and more accurate delirium prediction.
An automated system which could aid with delirium detection and alert clinicians to a
possible onset of the syndrome can greatly improve treatment and outcomes for patients. The
CogMe system utilizes current technology to provide a holistic and scalable approach for
delirium prediction, detection and prevention covering both physiological and cognitive
aspects. The system uses wearables for physiological vitals monitoring and communicates with
patients by a dedicated tablet app - the CogMe Personal Assistant (PA). In this study, the
data collected by the wearables and the CogMe PA, in combination with patient data from the
EMR, will be analyzed retrospectively using machine learning techniques (CogMe Data
Analytics) to evaluate the ability of the CogMe system to predict and detect delirium.
Inclusion Criteria:
- Male and female patients aged 65 years of age and older.
- Patients with an expected length of hospitalization of 4 days or longer.
- Patients who are conscious and cognitively able to provide written informed consent as
suggested by a score of 0 on 4AT screening.
- Patients who have no diagnosis of delirium prior to enrollment.
Exclusion Criteria:
- Male and female patients younger than 65 years of age.
- Patients with an expected length of hospitalization of less than 4 days.
- Patients with uncorrected visual or hearing impairment.
- Patients with impaired consciousness or cognitive impairment as determined by a score
of 1 or more on 4AT screening.
|
NCT0531xxxx/NCT05311774.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/NCT05311774</url>
</required_header>
<id_info>
<org_study_id>Duloxetine in cancer pain</org_study_id>
<nct_id>NCT05311774</nct_id>
</id_info>
<brief_title>Efficacy of Duloxetine in Conjunction With Tramadol for Chronic Cancer Pain</brief_title>
<official_title>Efficacy of Duloxetine in Conjunction With Tramadol for Chronic Cancer Pain</official_title>
<sponsors>
<lead_sponsor>
<agency>Assiut University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Assiut University</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Cancer pain is one of the most common and problematic symptoms. Opioids are typically the
most common drugs used in the treatment of cancer pain,they are limited due to their side
effects.

Tramadol is a centrally acting non-opiate analgesic with low affinity for μ-opioid receptors,
and is effective in the treatment of moderate to severe pain.

Neuropathic pain is typically not amenable to standard opiate therapy, and the addition of
tricyclic antidepressants or/and antiepileptic drugs can offer a very effective treatment
strategy in such patients.

Duloxetine is a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) that has been used
traditionally for its antidepressant qualities and has also analgesic benefit in the
treatment of neuropathic pain. Duloxetine exerts its analgesic action through central and
peripheral pain modulation .
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Cancer pain is one of the most common and problematic symptoms.uncontrolled pain affect
quality of life and daily activities .Cancer pain has two main categories nociceptive and
neuropathic pain,Cancer pain is often a combination of nociceptive and neuropathic pain.

A framework for managing pain often starts with the World Health Organization (WHO) Analgesic
Ladder, step 1 use non opioid analgesics, step 2 weak opioids, step 3 strong opioids, step 4
interventions non pharmacological, adjuvants can be added to any step .

Opioids are typically the most common drugs used in the treatment of cancer pain. They work
by binding to μ-opioid receptors within the central nervous system, which are responsible for
opioid mediated analgesia, respiratory depression, sedation, physiological dependence, and
tolerance, they are limited due to their side effects as nausea, constipation, sedation, and
confusion, prolonged use of opioids may lead to development of tolerance, abnormal
hypersensitivity to pain.

Tramadol is a centrally acting non-opiate analgesic with low affinity for μ-opioid receptors,
and is effective in the treatment of moderate to severe pain. It has been also shown to
inhibit reuptake of serotonin and norepinephrine, which synergistically enhances its weak
opioid mechanism of action.

This may explain the reduced incidences of abuse, respiratory depression and other adverse
effects of traditional opioids in patients on long-term tramadol therapy.it is a useful drug
in patients with cancer pain both with nociceptive and neuropathic pain .Neuropathic pain is
typically not amenable to standard opiate therapy, and the addition of tricyclic
antidepressants or/and antiepileptic drugs can offer a very effective treatment strategy in
such patients.

Adjuvant analgesics are drugs primarily marketed for other indications, such as depression,
but also have an important role in cancer pain management. Antidepressants, such as
serotonin- norepinephrine reuptake inhibitors (duloxetine, venlafaxine) or tricyclics (
nortriptyline, amitriptyline) and anticonvulsants (pregabalin, gabapentin, carbamazepine)
have efficacy in the treatment of pain, particularly neuropathic pain .Duloxetine is a
Serotonin Norepinephrine Reuptake Inhibitor (SNRI) that has been used traditionally for its
antidepressant qualities and has also analgesic benefit in the treatment of neuropathic pain
. Duloxetine exerts its analgesic action through central and peripheral pain modulation , it
enhances the effect of serotonin and norepinephrine on descending inhibitory pain pathways in
the brain and spinal cord and activation of some cerebral prefrontal areas . Besides, it has
been claimed that Duloxetine has an anti-nociceptive effect through Na + channel block ,
therefore it suppresses the neuronal cell firing resulting from peripheral injury . The most
common adverse effects of duloxetine, which may lead to discontinuation of the drug, are
nausea, dizziness, and somnolence .There is a possibility that duloxetine was effective in
both activation of the descending pain modulatory system and the improvement of depressive
mood, the effect may have partly taken place due to elevation of the pain threshold through
the antidepressant effect of duloxetine . Recently, the efficacy of duloxetine has been
reported in patients with chemotherapy-induced peripheral neuropathy (CIPN) and in non-cancer
neuropathic pain. .
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 2022</start_date>
<completion_date type="Anticipated">December 2023</completion_date>
<primary_completion_date type="Anticipated">October 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>concentration of tramadol consumption</measure>
<time_frame>at one month</time_frame>
<description>all participants(400 patients) will receive tramadol 50 mg twice daily, titration will be done every 3days until 2 weeks,according to changes in visual analogue scale for pain maximum dose will be 400mg daily, one group of participants(200 patients) will receive duloxetine 30mg daily fixed dose in combination with tramadol,decrease in concentration of tramadol consumption means better results,the other group(200 patients) will receive placebo drug once daily in combination with tramadol.</description>
</primary_outcome>
<secondary_outcome>
<measure>concentration of tramadol consumption</measure>
<time_frame>at 2 month and 3 month</time_frame>
<description>all participants(400 patients) will receive tramadol 50 mg twice daily, titration will be done according to changes in visual analogue scale for pain, maximum dose will be 400mg daily, one group of participants(200 patients) will receive duloxetine 30mg daily fixed dose in combination with tramadol,decrease in concentration of tramadol consumption means better results,the other group(200 patients) will receive placebo drug once daily in combination with tramadol.</description>
</secondary_outcome>
<secondary_outcome>
<measure>- change in pain with visual analogue scale</measure>
<time_frame>at 3,6,9 and 12 days , 2 weeks,1 month,2 month,3 month</time_frame>
<description>subjective scale by the participants for pain intensity from 0 to 10, minimum value is zero that means no pain, maximum value is 10 that means unbearable pain, higher scores mean worse outcome</description>
</secondary_outcome>
<secondary_outcome>
<measure>type of pain that relieved better</measure>
<time_frame>at 1 month,2 month and 3 month</time_frame>
<description>type of pain that responds better to duloxetine and tramadol (neuropathic or nociceptive), using visual analogue scale for pain intensity (subjective scale by the participants for pain intensity from 0 to 10, minimum value is zero that means no pain, maximum value is 10 that means unbearable pain, higher scores mean worse outcome)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Leeds Assessment of Neuropathic Symptoms and Signs Scale if neuropathic pain</measure>
<time_frame>at 1 month,2 month and 3 month</time_frame>
<description>used for neuropathic pain consists of seven questions minimum value 0 ,maximum value 24,scoring a score of 12 or more suggests pain of predominantly neuropathic origin</description>
</secondary_outcome>
<secondary_outcome>
<measure>Scale Assessing Pain Intensity and Interference (Pain, Enjoyment, General Activity)</measure>
<time_frame>at 1 month,2 month and 3 month</time_frame>
<description>consisting of three questions for the participant,responses from 0 to 10 ,responses to three questions added then divided by three to get a mean score out of ten</description>
</secondary_outcome>
<secondary_outcome>
<measure>Depression scores by the Patient Health Questionnaire</measure>
<time_frame>at 1 month,2 month and 3 month</time_frame>
<description>consists of 9 questions for the participant ,This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, total score for the nine items ranges from 0 to 27,higher scores means worse outcome</description>
</secondary_outcome>
<secondary_outcome>
<measure>Anxiety scores by the Patient Health Questionnaire</measure>
<time_frame>at 1 month,2 month and 3 month</time_frame>
<description>consists of 7 questions for the participant ,This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, total score for the seven items ranges from 0 to 21,higher scores means worse outcome</description>
</secondary_outcome>
<secondary_outcome>
<measure>Flanagan Quality of Life Scale</measure>
<time_frame>at 1 month,2 month and 3 month</time_frame>
<description>consists of 16 items ,seven responses are delighted(7),pleased(6),mostly satisfied(5),mixed(4),mostly dissatisfied (3),unhappy(2),terrible(1),ranging from 16 to 112,average for healthy 90</description>
</secondary_outcome>
<secondary_outcome>
<measure>Side effects as nausea, vomiting, constipation, sedation, arrhythmia and hypertension</measure>
<time_frame>up to 3 month</time_frame>
<description>participants will be asked about side effects from duloxetine as nausea,vomiting, constipation, sedation, (onset,duration,offset, bearable or not ,affecting quality of life), arrhythmia (type of arrhythmia from electrocardiogram ,onset,duration,offset),hypertension (by measuring blood pressure ,onset ,duration ,offset)</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">400</enrollment>
<condition>Cancer Pain</condition>
<arm_group>
<arm_group_label>•tramadol and duloxetine</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>patients will receive tramadol 50 mg twice daily, titration will be done every 3days until 2 weeks, maximum dose will be 400mg daily and will receive duloxetine 30mg daily fixed dose in combination with tramadol. Investigators will follow up the patients for 3 months</description>
</arm_group>
<arm_group>
<arm_group_label>tramadol and placebo</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>patients will receive tramadol 50 mg twice daily, titration will be done every 3days until 2 weeks, maximum dose will be 400mg daily and will receive placebo drug once daily in combination with tramadol. Investigators will follow up the patients for 3 months</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Duloxetine 30 mg</intervention_name>
<description>tablet</description>
<arm_group_label>•tramadol and duloxetine</arm_group_label>
<other_name>cymbatex 30 mg</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Tramadol</intervention_name>
<description>tablet</description>
<arm_group_label>tramadol and placebo</arm_group_label>
<arm_group_label>•tramadol and duloxetine</arm_group_label>
<other_name>amadol</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>tablet</description>
<arm_group_label>tramadol and placebo</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Patients with cancer pain

1. age from 20-70 years old.

2. not receiving any type of analgesia before (opioid naïve, no adjuvants).

Exclusion Criteria:

1. Difficult to be assessed for pain.

2. Any contraindication for duloxetine or tramadol.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>20 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>khaled M Fares, MD</last_name>
<role>Study Director</role>
<affiliation>Assiut University</affiliation>
</overall_official>
<overall_official>
<last_name>Ahmad M Abd EL Rahman, MD</last_name>
<role>Study Director</role>
<affiliation>Assiut University</affiliation>
</overall_official>
<overall_official>
<last_name>Diab F Hetta, MD</last_name>
<role>Study Director</role>
<affiliation>Assiut University</affiliation>
</overall_official>
<overall_contact>
<last_name>Madona M Noman, master</last_name>
<phone>201006265867</phone>
<email>madonamisheal90@yahoo.com</email>
</overall_contact>
<reference>
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<PMID>27112310</PMID>
</reference>
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<verification_date>April 2022</verification_date>
<study_first_submitted>March 15, 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 3, 2022</last_update_submitted>
<last_update_submitted_qc>April 3, 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>Assiut University</investigator_affiliation>
<investigator_full_name>Madona M.NOMAN</investigator_full_name>
<investigator_title>Doctor</investigator_title>
</responsible_party>
<keyword>duloxetine</keyword>
<keyword>tramadol</keyword>
<keyword>cancer pain</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cancer Pain</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Tramadol</mesh_term>
<mesh_term>Duloxetine Hydrochloride</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Cancer pain is one of the most common and problematic symptoms. Opioids are typically the
most common drugs used in the treatment of cancer pain,they are limited due to their side
effects.
Tramadol is a centrally acting non-opiate analgesic with low affinity for μ-opioid receptors,
and is effective in the treatment of moderate to severe pain.
Neuropathic pain is typically not amenable to standard opiate therapy, and the addition of
tricyclic antidepressants or/and antiepileptic drugs can offer a very effective treatment
strategy in such patients.
Duloxetine is a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) that has been used
traditionally for its antidepressant qualities and has also analgesic benefit in the
treatment of neuropathic pain. Duloxetine exerts its analgesic action through central and
peripheral pain modulation .
Cancer pain is one of the most common and problematic symptoms.uncontrolled pain affect
quality of life and daily activities .Cancer pain has two main categories nociceptive and
neuropathic pain,Cancer pain is often a combination of nociceptive and neuropathic pain.
A framework for managing pain often starts with the World Health Organization (WHO) Analgesic
Ladder, step 1 use non opioid analgesics, step 2 weak opioids, step 3 strong opioids, step 4
interventions non pharmacological, adjuvants can be added to any step .
Opioids are typically the most common drugs used in the treatment of cancer pain. They work
by binding to μ-opioid receptors within the central nervous system, which are responsible for
opioid mediated analgesia, respiratory depression, sedation, physiological dependence, and
tolerance, they are limited due to their side effects as nausea, constipation, sedation, and
confusion, prolonged use of opioids may lead to development of tolerance, abnormal
hypersensitivity to pain.
Tramadol is a centrally acting non-opiate analgesic with low affinity for μ-opioid receptors,
and is effective in the treatment of moderate to severe pain. It has been also shown to
inhibit reuptake of serotonin and norepinephrine, which synergistically enhances its weak
opioid mechanism of action.
This may explain the reduced incidences of abuse, respiratory depression and other adverse
effects of traditional opioids in patients on long-term tramadol therapy.it is a useful drug
in patients with cancer pain both with nociceptive and neuropathic pain .Neuropathic pain is
typically not amenable to standard opiate therapy, and the addition of tricyclic
antidepressants or/and antiepileptic drugs can offer a very effective treatment strategy in
such patients.
Adjuvant analgesics are drugs primarily marketed for other indications, such as depression,
but also have an important role in cancer pain management. Antidepressants, such as
serotonin- norepinephrine reuptake inhibitors (duloxetine, venlafaxine) or tricyclics (
nortriptyline, amitriptyline) and anticonvulsants (pregabalin, gabapentin, carbamazepine)
have efficacy in the treatment of pain, particularly neuropathic pain .Duloxetine is a
Serotonin Norepinephrine Reuptake Inhibitor (SNRI) that has been used traditionally for its
antidepressant qualities and has also analgesic benefit in the treatment of neuropathic pain
. Duloxetine exerts its analgesic action through central and peripheral pain modulation , it
enhances the effect of serotonin and norepinephrine on descending inhibitory pain pathways in
the brain and spinal cord and activation of some cerebral prefrontal areas . Besides, it has
been claimed that Duloxetine has an anti-nociceptive effect through Na + channel block ,
therefore it suppresses the neuronal cell firing resulting from peripheral injury . The most
common adverse effects of duloxetine, which may lead to discontinuation of the drug, are
nausea, dizziness, and somnolence .There is a possibility that duloxetine was effective in
both activation of the descending pain modulatory system and the improvement of depressive
mood, the effect may have partly taken place due to elevation of the pain threshold through
the antidepressant effect of duloxetine . Recently, the efficacy of duloxetine has been
reported in patients with chemotherapy-induced peripheral neuropathy (CIPN) and in non-cancer
neuropathic pain. .
Inclusion Criteria:
- Patients with cancer pain
1. age from 20-70 years old.
2. not receiving any type of analgesia before (opioid naïve, no adjuvants).
Exclusion Criteria:
1. Difficult to be assessed for pain.
2. Any contraindication for duloxetine or tramadol.
|
NCT0531xxxx/NCT05311787.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/NCT05311787</url>
</required_header>
<id_info>
<org_study_id>315030310071</org_study_id>
<nct_id>NCT05311787</nct_id>
</id_info>
<brief_title>The Strategy of Implementation of the ERAS Protocol After Esophageal Surgery</brief_title>
<official_title>The Strategy of Implementation of the ERAS Protocol After Esophageal Surgery Based on Innovative Technologies</official_title>
<sponsors>
<lead_sponsor>
<agency>Vishnevsky Center of Surgery</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Vishnevsky Center of Surgery</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>
Application of the perioperative enhanced recovery protocol has allowed to carry out
esophagectomy to the patients with severe comorbidities and has led reducing the risks of
severe postoperative complications.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The clinical trial included the parients who participated in the protocol ERAS since 2011,
who uderwent esophagectomy with simultaneous reconstruction. The parients had benign or
malignant esophageal diseases. The ERAS protocol consisted of components of perioperative
recovery. The number of patients until now has reached 400 patients. During trial there was
modifications of aspects of ERAS protocol such as a rejection of nasogastric tube or cervical
drenage. The role of multidisplinary team is the main success of the result of the
implemented ERAS protocol.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">January 2011</start_date>
<completion_date type="Anticipated">March 2026</completion_date>
<primary_completion_date type="Actual">March 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>All the patients over 18 years old with esophageal diseases who are required surgical treatment include in trial.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>mortality</measure>
<time_frame>30 days</time_frame>
<description>the rate of mortality after surgery</description>
</primary_outcome>
<primary_outcome>
<measure>morbidity</measure>
<time_frame>30 days</time_frame>
<description>the rate of morbidity after surgery</description>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">500</enrollment>
<condition>ERAS</condition>
<condition>Esophageal Diseases</condition>
<arm_group>
<arm_group_label>Early oral feeding</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>The part of our investigation was prostective randomised trial which compared the result of patients with early oral feeding (since first day) and traditional group (oral feeding since 5th day)</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>esophagectomy with simultaneous reconstruction</intervention_name>
<description>Subtotal resection of esophagus and simultaneous reconstruction by gastric pull-up or colon conduit</description>
<arm_group_label>Early oral feeding</arm_group_label>
<other_name>esophagectomy with gastric pull-up</other_name>
<other_name>esophagectomy with colon conduit</other_name>
<other_name>McKeown</other_name>
<other_name>transhiatal esophagectomy</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- all patients with esophageal diseases

Exclusion Criteria:

- before 18 years old

- who do not need surgery as a treatment

- who not underwent simultaneous recontruction
</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>Mary Yan</name>
<address>
<city>Moscow</city>
<zip>117639</zip>
<country>Russian Federation</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Mary Yan, junior reseacher, MD</last_name>
<phone>89299521460</phone>
<email>yanmaria88@mail.ru</email>
</contact>
<investigator>
<last_name>Dmitry Ruchkin, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Kovalerova Natalia, PhD</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Omelchenko George, MD</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Raevskaya Mariana, PhD</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Sizov Vadim, PhD</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Yan Mary, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Mary Yan</name>
<address>
<city>Moscow</city>
<zip>117639</zip>
<country>Russian Federation</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Mary Yan, MD</last_name>
<phone>89299521460</phone>
<email>yanmaria88@mail.ru</email>
</contact>
<investigator>
<last_name>Dmitry Ruchkin, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Mary Yan, MD</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Kovalerova Natalia, PhD</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Omelchenko George, MD</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Raevskaya Marianna, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Sizov Vadim, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>Russian Federation</country>
</location_countries>
<link>
<url>https://intensive-care.ru/rannee-peroralnoe-pitanie-kak-komponent-programmy-uskorennogo-vosstanovleniya-posle-subtotalnoj-ezofagektomii-s-odnomomentnoj-plastikoj-pishhevoda-prospektivnoe-randomizirovannoe-issledovanie/</url>
<description>Related Info</description>
</link>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 22, 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>Principal Investigator</responsible_party_type>
<investigator_affiliation>Vishnevsky Center of Surgery</investigator_affiliation>
<investigator_full_name>Maria Yan</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Esophageal Diseases</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>all IPD</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
<ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
<ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
<ipd_time_frame>By the 2026, open access</ipd_time_frame>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Application of the perioperative enhanced recovery protocol has allowed to carry out
esophagectomy to the patients with severe comorbidities and has led reducing the risks of
severe postoperative complications.
The clinical trial included the parients who participated in the protocol ERAS since 2011,
who uderwent esophagectomy with simultaneous reconstruction. The parients had benign or
malignant esophageal diseases. The ERAS protocol consisted of components of perioperative
recovery. The number of patients until now has reached 400 patients. During trial there was
modifications of aspects of ERAS protocol such as a rejection of nasogastric tube or cervical
drenage. The role of multidisplinary team is the main success of the result of the
implemented ERAS protocol.
Inclusion Criteria:
- all patients with esophageal diseases
Exclusion Criteria:
- before 18 years old
- who do not need surgery as a treatment
- who not underwent simultaneous recontruction
|
NCT0531xxxx/NCT05311800.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/NCT05311800</url>
</required_header>
<id_info>
<org_study_id>ID-RCB 2019-A02999-48</org_study_id>
<nct_id>NCT05311800</nct_id>
</id_info>
<brief_title>High-Intensity Interval Training and Fat Mass Losses</brief_title>
<acronym>RIESLING</acronym>
<official_title>Effect of Two Isoenergetic Modes of High-Intensity Interval Training on Total and Abdominal Fat Mass Loss in Men With Overweight or Obesity.</official_title>
<sponsors>
<lead_sponsor>
<agency>Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The aims of this study was to compare two isoenergetic HIIT (High-intensity Interval
training) programs (cycling vs. running) on body composition, substrate oxidation at rest and
during a moderate exercise, muscle functionality, glycaemic control, lipid profile,
inflammation, maximal aerobic capacity (VO2max) and gut microbiota composition in men with
overweight or obesity.

The investigators hypothesized that both programs could decrease total, abdominal and
visceral fat mass but due to differences in muscle solicitation, metabolism adaptation and
blood flow, and that running could favors greater fat mass losses.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The first aim of this study was to compare two isoenergetic HIIT programs (cycling vs.
running) on body composition in men with overweight or obesity.

20 men with overweight or obesity should completed HIIT program three times a week during
twelve weeks.

i) High intensity interval training - BIKE (HIIE BIKE) 10 cycles of speeding up for 45 s at
80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (37min30s) ii) High intensity
interval training - RUN (HIIE RUN) 9 cycles of speeding up for 45 s at 80-thPHR followed by
pedaling slowly (40% thPHR) for 1m30s (35min15s)

Body composition will be measured before and after HIIT program by Dual-energy X-ray
absorptiometry (DXA).
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">September 1, 2021</start_date>
<completion_date type="Actual">July 1, 2022</completion_date>
<primary_completion_date type="Actual">July 1, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>2 groups : running vs cycling</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Participant)</masking>
<masking_description>Data collected on the volunteers will be made anonymous.</masking_description>
</study_design_info>
<primary_outcome>
<measure>HIIT mode and fat mass change (g)</measure>
<time_frame>At the first and the last training - week 1 and 12</time_frame>
<description>change of total fat mass (in grams from DXA analysis) after 3 months of training- HIIT mode comparison</description>
</primary_outcome>
<primary_outcome>
<measure>HIIT mode and abdominal fat mass change (g)</measure>
<time_frame>At the first and the last training - week 1 and 12</time_frame>
<description>change of abdominal fat mass (in grams from DXA analysis) after 3 months of training- HIIT mode comparison</description>
</primary_outcome>
<secondary_outcome>
<measure>Rate of carbohydrate and lipid oxidation (g.min-1) during a sub-maximal exercise by measuring gaz exchange.</measure>
<time_frame>At the first and the last training - week 1 and 12</time_frame>
<description>Carbohydrate and lipid oxidation rate (g.min-1) during a submaximal exercise before and after the HIIT protocol. HIIT mode comparison.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">9</enrollment>
<condition>Overweight and Obesity</condition>
<condition>Men</condition>
<arm_group>
<arm_group_label>High intensity interval training - BIKE (HIIE BIKE)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>10 cycles of speeding up for 45 s at 80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (37min30s)</description>
</arm_group>
<arm_group>
<arm_group_label>High intensity interval training - RUN (HIIE RUN)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>9 cycles of speeding up for 45 s at 80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (35min15s)</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Physical activity</intervention_name>
<description>Comparison of HIIT mode (running vs cycling)</description>
<arm_group_label>High intensity interval training - BIKE (HIIE BIKE)</arm_group_label>
<arm_group_label>High intensity interval training - RUN (HIIE RUN)</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- men (18 to 65 years old)

- with overweight or obesity (BMI > 25 kg/m2 and ≤ 40 kg/m2)

Exclusion Criteria:

- medical contraindications to intense physical activity,

- painful joints,

- taking ß-blocker
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>CREPS Auvergne Rhône-Alpes / Vichy</name>
<address>
<city>Bellerive-sur-Allier</city>
<state>Allier</state>
<zip>03321</zip>
<country>France</country>
</address>
</facility>
</location>
<location_countries>
<country>France</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 16, 2022</study_first_submitted>
<study_first_submitted_qc>March 25, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>February 22, 2023</last_update_submitted>
<last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 24, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>cycling</keyword>
<keyword>running</keyword>
<keyword>high-intensity interval training</keyword>
<keyword>fat mass</keyword>
<keyword>visceral tissue</keyword>
<keyword>health</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Obesity</mesh_term>
<mesh_term>Overweight</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The aims of this study was to compare two isoenergetic HIIT (High-intensity Interval
training) programs (cycling vs. running) on body composition, substrate oxidation at rest and
during a moderate exercise, muscle functionality, glycaemic control, lipid profile,
inflammation, maximal aerobic capacity (VO2max) and gut microbiota composition in men with
overweight or obesity.
The investigators hypothesized that both programs could decrease total, abdominal and
visceral fat mass but due to differences in muscle solicitation, metabolism adaptation and
blood flow, and that running could favors greater fat mass losses.
The first aim of this study was to compare two isoenergetic HIIT programs (cycling vs.
running) on body composition in men with overweight or obesity.
20 men with overweight or obesity should completed HIIT program three times a week during
twelve weeks.
i) High intensity interval training - BIKE (HIIE BIKE) 10 cycles of speeding up for 45 s at
80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (37min30s) ii) High intensity
interval training - RUN (HIIE RUN) 9 cycles of speeding up for 45 s at 80-thPHR followed by
pedaling slowly (40% thPHR) for 1m30s (35min15s)
Body composition will be measured before and after HIIT program by Dual-energy X-ray
absorptiometry (DXA).
Inclusion Criteria:
- men (18 to 65 years old)
- with overweight or obesity (BMI > 25 kg/m2 and ≤ 40 kg/m2)
Exclusion Criteria:
- medical contraindications to intense physical activity,
- painful joints,
- taking ß-blocker
|
NCT0531xxxx/NCT05311813.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/NCT05311813</url>
</required_header>
<id_info>
<org_study_id>REC-H-PhBSU-21013</org_study_id>
<nct_id>NCT05311813</nct_id>
</id_info>
<brief_title>Safety and Efficacy of Enoxaparin and Hydroxychloroquine in COVID-19</brief_title>
<official_title>Evaluation of Safety and Efficacy of Monotherapy Versus Polytherapy of Enoxaparin and Hydroxychloroquine for the Treatment of Covid-19</official_title>
<sponsors>
<lead_sponsor>
<agency>Beni-Suef University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Beni-Suef University</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
In this randomized controlled study, two hundred patients with positive PCR and laboratory
confirmed COVID-19 will be classified randomly into four groups. The first group is the
control group and will be given the conventional treatment of covid-19 only. The second group
will be given enoxaparin plus the conventional treatment of Covid-19. The third group will be
given hydroxychloroquine (HCQ 400 mg/day) for five days plus the conventional treatment of
covid-19. The last group will be given combined therapy of HCQ 400 mg/day and enoxaparin plus
the conventional therapy of covid-19

The efficacy will be assessed by the time of undetectable viral RNA, duration of treatment
and length of hospital stay. The safety will be assessed by measuring the severity of side
effects by following up the patients after treatment.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Although numerous therapeutic agents for COVID-19 are under investigation, an effective
therapy remains a challenge among researchers. To date, hydroxychloroquine has been widely
used for covid-19 treatment, despite that its efficacy and safety need further
investigations. Coagulopathies are major complications of covid-19 infection, hence
prophylactic anticoagulation has been recommended in all hospitalized patients. This study
aims to assess the efficacy and safety of Enoxaparin and hydroxychloroquine used separately
or combined and added to standard care versus standard care alone in Covid-19 infected
patients. An observational study including two hundred patients (98 males, 102 females) with
laboratory confirmed covid-19 infection was conducted. Patients admitted to hospital were
randomly allocated into four equal treatment groups. The first group received standard
Covid-19 therapy, second group received enoxaparin 40mg/day SC for 14 days plus standard
Covid-19 therapy, third group received 400 mg/day HCQ for five days plus standard Covid-19
therapy. The fourth group received a combination of 400 mg/day HCQ and enoxaparin plus
standard Covid-19 therapy. The clinical disease course progression was evaluated by duration
to a negative PCR, length of hospital or ICU stay, and mortality rate. The safety of
treatments was evaluated by measuring liver biochemistries (ALT, AST), random blood glucose
levels and adverse effects during the 28 days of treatment. Patients on Enoxaparin plus
standard Covid-19 therapy significantly showed a decrease in length of hospital stay, ICU
admission and mortality compared to all other treatments. However, the duration to both
negative PCR and clinical improvement did not find any significance. These findings suggest
that enoxaparin treatment was safe, effective, and well tolerated and has a role in
decreasing the progression of the disease and its complications while HCQ did not discover
any evidence of extra therapeutic benefits over other treatments.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">June 1, 2021</start_date>
<completion_date type="Actual">December 30, 2021</completion_date>
<primary_completion_date type="Actual">December 1, 2021</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Study Patients were randomized into four parallel equal groups using a computerized random number generator using simple randomization with an equal allocation ratio. Two hundred and twenty patients were eligible. Twenty patients were excluded due to not meeting the inclusion criteria (n=14) or the decline to be enrolled in the study (n=4). The sample size was calculated by G.power version 3.1 for windows (Faul et al., 2009). With a priori calculating the sample size based on the length of stay among the studied groups using one way ANOVA test (F-test group), at an effect size (0.306), alpha probability (0.05) and power (95%), the calculated sample size was 184 in the 4 groups that increased to 200 (with 6% increase) to overcome the missing of data and dropout or loss of follow up.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Assessment of efficacy</measure>
<time_frame>6 monthes</time_frame>
<description>The hospital stay of COVID-19 patients</description>
</primary_outcome>
<secondary_outcome>
<measure>Assessment of Safety</measure>
<time_frame>6 monthes</time_frame>
<description>Mortality of COVID-19 patients</description>
</secondary_outcome>
<number_of_arms>4</number_of_arms>
<enrollment type="Actual">200</enrollment>
<condition>COVID-19 Pandemic</condition>
<arm_group>
<arm_group_label>Control group</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>The control group including 50 patients (n=50) receiving the conventional therapy of Covid-19 adopted by the Egyptian ministry of health for 15 days.</description>
</arm_group>
<arm_group>
<arm_group_label>Enaxoprin group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>The enoxaparin group (n=50) which received 40mg/day SC for 14 days (for patients with normal renal function and body weight between 50 and 100kg) plus the conventional therapy of Covid-19 adopted by the Egyptian ministry of health for 15 days.</description>
</arm_group>
<arm_group>
<arm_group_label>Hydroxychloroquine group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>The HCQ group which received 400 mg/day HCQ for five days plus the conventional therapy of Covid-19 adopted by the Egyptian ministry of health for 15 days(n=50).</description>
</arm_group>
<arm_group>
<arm_group_label>Enoxaparin plus Hydroxychloroquine group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>The HCQ plus Enoxaparin combination group including 50 patients receiving combined therapy of 400 mg/day HCQ for five days and 40mg/day enoxaparin for 14 days plus the conventional therapy of COVID-19 adopted by the Egyptian ministry of health for 15 days</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Enoxaparin, Hydroxychloroquine</intervention_name>
<description>To compare efficiency and safety of Enoxaparin and Hydroxychloroquine as monotherapy versus Polytherapy</description>
<arm_group_label>Control group</arm_group_label>
<arm_group_label>Enaxoprin group</arm_group_label>
<arm_group_label>Enoxaparin plus Hydroxychloroquine group</arm_group_label>
<arm_group_label>Hydroxychloroquine group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Laboratory confirmed COVID-19 infection by PCR test within 7 days prior to admission
or during admission to hospital, CT or radiographic findings of pneumonia. Clinically
suspected infection by symptoms like loss of smell and taste. No medical history that
may interfere with treatment or with this clinical trial.

Exclusion Criteria:

- Patient who had allergy or contraindication to HCQ, pregnant and lactating females,
and patients with immune diseases, cardiac problem, had history of acute kidney injury
or who received multiple cycles of anticoagulants were excluded from the study.
Written informed consent was obtained from each participant. All study risks and
benefits were thoroughly explained to patients' prior participation
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Beni-Suef University teaching Hospital</name>
<address>
<city>Banī Suwayf</city>
<state>Cairo</state>
<zip>62511</zip>
<country>Egypt</country>
</address>
</facility>
</location>
<location_countries>
<country>Egypt</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>April 4, 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 4, 2022</last_update_submitted>
<last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 11, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Beni-Suef University</investigator_affiliation>
<investigator_full_name>Raghda R.S. Hussein</investigator_full_name>
<investigator_title>Assistant Professor of Clinical Pharmacy</investigator_title>
</responsible_party>
<keyword>COVID-19 infection</keyword>
<keyword>Enoxaparin</keyword>
<keyword>Hydroxychloroquine</keyword>
<keyword>ICU stay</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>COVID-19</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Hydroxychloroquine</mesh_term>
<mesh_term>Enoxaparin</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
In this randomized controlled study, two hundred patients with positive PCR and laboratory
confirmed COVID-19 will be classified randomly into four groups. The first group is the
control group and will be given the conventional treatment of covid-19 only. The second group
will be given enoxaparin plus the conventional treatment of Covid-19. The third group will be
given hydroxychloroquine (HCQ 400 mg/day) for five days plus the conventional treatment of
covid-19. The last group will be given combined therapy of HCQ 400 mg/day and enoxaparin plus
the conventional therapy of covid-19
The efficacy will be assessed by the time of undetectable viral RNA, duration of treatment
and length of hospital stay. The safety will be assessed by measuring the severity of side
effects by following up the patients after treatment.
Although numerous therapeutic agents for COVID-19 are under investigation, an effective
therapy remains a challenge among researchers. To date, hydroxychloroquine has been widely
used for covid-19 treatment, despite that its efficacy and safety need further
investigations. Coagulopathies are major complications of covid-19 infection, hence
prophylactic anticoagulation has been recommended in all hospitalized patients. This study
aims to assess the efficacy and safety of Enoxaparin and hydroxychloroquine used separately
or combined and added to standard care versus standard care alone in Covid-19 infected
patients. An observational study including two hundred patients (98 males, 102 females) with
laboratory confirmed covid-19 infection was conducted. Patients admitted to hospital were
randomly allocated into four equal treatment groups. The first group received standard
Covid-19 therapy, second group received enoxaparin 40mg/day SC for 14 days plus standard
Covid-19 therapy, third group received 400 mg/day HCQ for five days plus standard Covid-19
therapy. The fourth group received a combination of 400 mg/day HCQ and enoxaparin plus
standard Covid-19 therapy. The clinical disease course progression was evaluated by duration
to a negative PCR, length of hospital or ICU stay, and mortality rate. The safety of
treatments was evaluated by measuring liver biochemistries (ALT, AST), random blood glucose
levels and adverse effects during the 28 days of treatment. Patients on Enoxaparin plus
standard Covid-19 therapy significantly showed a decrease in length of hospital stay, ICU
admission and mortality compared to all other treatments. However, the duration to both
negative PCR and clinical improvement did not find any significance. These findings suggest
that enoxaparin treatment was safe, effective, and well tolerated and has a role in
decreasing the progression of the disease and its complications while HCQ did not discover
any evidence of extra therapeutic benefits over other treatments.
Inclusion Criteria:
- Laboratory confirmed COVID-19 infection by PCR test within 7 days prior to admission
or during admission to hospital, CT or radiographic findings of pneumonia. Clinically
suspected infection by symptoms like loss of smell and taste. No medical history that
may interfere with treatment or with this clinical trial.
Exclusion Criteria:
- Patient who had allergy or contraindication to HCQ, pregnant and lactating females,
and patients with immune diseases, cardiac problem, had history of acute kidney injury
or who received multiple cycles of anticoagulants were excluded from the study.
Written informed consent was obtained from each participant. All study risks and
benefits were thoroughly explained to patients' prior participation
|
NCT0531xxxx/NCT05311826.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/NCT05311826</url>
</required_header>
<id_info>
<org_study_id>RachideResp</org_study_id>
<nct_id>NCT05311826</nct_id>
</id_info>
<brief_title>Diaphragmatic Breathing Exercise for Patients Undergoing Arthrodesis Surgery for Adolescent Idiopathic Scoliosis.</brief_title>
<official_title>Effectiveness of Postoperative Respiratory Physiotherapy for Pain Management in Patients Undergoing Spinal Fusion for Adolescent Idiopathic Scoliosis: a Randomized Controlled Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Antonio Culcasi</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Istituto Ortopedico Rizzoli</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe
intervention that can be introduced for pain management.

The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise
in the management of pain in the postoperative care in patients undergoing spinal fusion for
adolescent idiopathic scoliosis.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Adolescent idiopathic scoliosis (AIS) is a common orthopedic condition with a prevalence of
2-3% in children aged from 10 to 16 years. It is a developmental deformity that affects both
physical and psychological domains, interfering with self-esteem and mental well-being.
Diagnosis is made within the first 18 years of life; in some cases, instrumented arthrodesis
surgery is required, performed within the age of 25. Corrective surgery for scoliosis can be
a stressful intervention for patients and their caregivers.

Postoperative pain is the major concern for patients undergoing orthopedic surgery.
Significant postoperative pain also adversely affects other outcomes by hindering the healing
process and delaying rehabilitation with loss of movement and walking. After arthrodesis the
pain reported by the patients is significant.

Various strategies have been explored for acute pain management in patients undergoing
surgery for scoliosis, with a focus on the first days post surgery. The link between
breathing, lumbar spine function and pain perception is an aspect that has always been
studied. The diaphragm plays an important role in spinal control and in the management of
pain perception. Dysfunction of the diaphragm can lead to alterations in the biomechanics of
the lumbar spine, with less proprioceptive abilities, less spinal mobility and reduced the
spinal column's functionality of the tissues. Diaphragmatic rehabilitation techniques produce
significant and clinically relevant improvements in the treatment of pathologies of the spine
and especially in the management of painful symptoms.

A systematic review highlights how pain is able to influence the flow, frequency and volume
of the respiratory act. At the same time, a regulation of breathing can be an useful tool in
the control of painful symptoms.

After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe
tool that can be introduced for the control of painful symptoms.

The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise
in the management of pain in the postoperative phase in patients undergoing arthrodesis
surgery for adolescent idiopathic scoliosis.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 29, 2022</start_date>
<completion_date type="Anticipated">May 2024</completion_date>
<primary_completion_date type="Anticipated">May 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Outcomes Assessor)</masking>
<masking_description>it will be masking also data analyzer</masking_description>
</study_design_info>
<primary_outcome>
<measure>intensity of pain</measure>
<time_frame>The pain will be detected 3 times a day (8am/2 pm/8 pm) starting from the day of the first rehabilitation treatment until the fifth postoperative day.</time_frame>
<description>numeric rating scale (NRS) (from 0 to 10); The 11-point numerical scale ranges from "0" representing one pain extreme (eg "No pain") to "10" representing the other pain extreme (eg "More severe pain than you can imagine" or "worst pain imaginable").</description>
</primary_outcome>
<secondary_outcome>
<measure>intensity of pain (short term)</measure>
<time_frame>the values of the NRS scale will be detected before and after the rehabilitation treatment up to fifth day</time_frame>
<description>numeric rating scale (NRS) (from 0 to 10); The 11-point numerical scale ranges from "0" representing one pain extreme (eg "No pain") to "10" representing the other pain extreme (eg "More severe pain than you can imagine" or "worst pain imaginable").</description>
</secondary_outcome>
<secondary_outcome>
<measure>TUG - Time Up and Go</measure>
<time_frame>the TUG test will be administered during the 5th postoperative day</time_frame>
<description>Timed up and go is a simple test to measure a person's mobility level and requires static and dynamic balancing skills. It consists of measuring how many seconds it takes the patient to get up from the chair, walk a distance of 3 meters, turn around, return to the chair and sit down again.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">100</enrollment>
<condition>Adolescent Idiopathic Scoliosis</condition>
<condition>Spinal Fusion</condition>
<condition>Pain Management</condition>
<condition>Exercise</condition>
<arm_group>
<arm_group_label>STANDARD PHYSIOTHERAPY TREATMENT - CTL GROUP</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Patients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis.</description>
</arm_group>
<arm_group>
<arm_group_label>EXPERIMENTAL diaphragmatic breathing exercise - EXP GROUP</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis.</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>STANDARD PHYSIOTHERAPY TREATMENT</intervention_name>
<description>The standard postoperative rehabilitation process starts from the first postoperative day. Two sessions are provided daily, with the exception of Sunday and Saturday afternoon. A single physiotherapy session, lasting 30 minutes, can include bed exercises for upper and lower limbs and recovery of autonomy (sitting position, standing and ambulation). In this phase, the sessions are characterized by educational and counseling activities.
The patient will be encouraged to carry out the activities independently.</description>
<arm_group_label>STANDARD PHYSIOTHERAPY TREATMENT - CTL GROUP</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>EXPERIMENTAL diaphragmatic breathing exercise</intervention_name>
<description>The subjects in the intervention group (EXP) will receive, in addition to standard physiotherapy treatment, diaphragmatic breathing exercise. Four exercises in different position (supine and side lying) will be provided for each physiotherapy session by a senior physiotherapist. Patients will be instructed to perform the same exercises independently to achieve relaxation and relief of pain symptoms.</description>
<arm_group_label>EXPERIMENTAL diaphragmatic breathing exercise - EXP GROUP</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- All subjects hospitalized for corrective arthrodesis surgery with Adolescent
Idiopathic Scoliosis (AIS) diagnosis, aged from 12 and 24 years will be consecutively
enrolled.

Exclusion Criteria:

- Subjects who cannot understand the Italian language and who do not provide consent to
study will be excluded.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>12 Years</minimum_age>
<maximum_age>24 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>antonio culcasi, PT</last_name>
<role>Principal Investigator</role>
<affiliation>Istituto Ortopedico Rizzoli</affiliation>
</overall_official>
<overall_contact>
<last_name>antonio culcasi, PT</last_name>
<phone>00390516366354</phone>
<email>antonio.culcasi@ior.it</email>
</overall_contact>
<overall_contact_backup>
<last_name>mattia morri, PT</last_name>
<phone>00390516366354</phone>
<email>mattia.morri@ior.it</email>
</overall_contact_backup>
<location>
<facility>
<name>Istituto Ortopedico Rizzoli</name>
<address>
<city>Bologna</city>
<state>Emilia Romagna</state>
<zip>40136</zip>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>antonio culcasi, PT</last_name>
<phone>00390516366354</phone>
<email>antonio.culcasi@ior.it</email>
</contact>
<contact_backup>
<last_name>mattia morri, PT</last_name>
<phone>00390516366354</phone>
<email>mattia.morri@ior.it</email>
</contact_backup>
</location>
<location_countries>
<country>Italy</country>
</location_countries>
<reference>
<citation>Lotan S, Kalichman L. Manual therapy treatment for adolescent idiopathic scoliosis. J Bodyw Mov Ther. 2019 Jan;23(1):189-193. doi: 10.1016/j.jbmt.2018.01.005. Epub 2018 Feb 3.</citation>
<PMID>30691751</PMID>
</reference>
<reference>
<citation>Agabegi SS, Kazemi N, Sturm PF, Mehlman CT. Natural History of Adolescent Idiopathic Scoliosis in Skeletally Mature Patients: A Critical Review. J Am Acad Orthop Surg. 2015 Dec;23(12):714-23. doi: 10.5435/JAAOS-D-14-00037. Epub 2015 Oct 28.</citation>
<PMID>26510624</PMID>
</reference>
<reference>
<citation>Lamontagne LL, Hepworth JT, Salisbury MH. Anxiety and postoperative pain in children who undergo major orthopedic surgery. Appl Nurs Res. 2001 Aug;14(3):119-24. doi: 10.1053/apnr.2001.24410.</citation>
<PMID>11481590</PMID>
</reference>
<reference>
<citation>Sjoling M, Nordahl G, Olofsson N, Asplund K. The impact of preoperative information on state anxiety, postoperative pain and satisfaction with pain management. Patient Educ Couns. 2003 Oct;51(2):169-76. doi: 10.1016/s0738-3991(02)00191-x.</citation>
<PMID>14572947</PMID>
</reference>
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<citation>Ballantyne JC, Carr DB, deFerranti S, Suarez T, Lau J, Chalmers TC, Angelillo IF, Mosteller F. The comparative effects of postoperative analgesic therapies on pulmonary outcome: cumulative meta-analyses of randomized, controlled trials. Anesth Analg. 1998 Mar;86(3):598-612. doi: 10.1097/00000539-199803000-00032.</citation>
<PMID>9495424</PMID>
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<citation>Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.</citation>
<PMID>15763409</PMID>
</reference>
<reference>
<citation>Beaulieu P, Cyrenne L, Mathews S, Villeneuve E, Vischoff D. Patient-controlled analgesia after spinal fusion for idiopathic scoliosis. Int Orthop. 1996;20(5):295-9. doi: 10.1007/s002640050081.</citation>
<PMID>8930721</PMID>
</reference>
<reference>
<citation>Vitale MG, Choe JC, Hwang MW, Bauer RM, Hyman JE, Lee FY, Roye DP Jr. Use of ketorolac tromethamine in children undergoing scoliosis surgery. an analysis of complications. Spine J. 2003 Jan-Feb;3(1):55-62. doi: 10.1016/s1529-9430(02)00446-1.</citation>
<PMID>14589246</PMID>
</reference>
<reference>
<citation>Wong GT, Yuen VM, Chow BF, Irwin MG. Persistent pain in patients following scoliosis surgery. Eur Spine J. 2007 Oct;16(10):1551-6. doi: 10.1007/s00586-007-0361-7. Epub 2007 Apr 5.</citation>
<PMID>17410382</PMID>
</reference>
<reference>
<citation>Kotzer AM. Factors predicting postoperative pain in children and adolescents following spine fusion. Issues Compr Pediatr Nurs. 2000 Apr-Jun;23(2):83-102. doi: 10.1080/01460860050121411.</citation>
<PMID>11111499</PMID>
</reference>
<reference>
<citation>Busch V, Magerl W, Kern U, Haas J, Hajak G, Eichhammer P. The effect of deep and slow breathing on pain perception, autonomic activity, and mood processing--an experimental study. Pain Med. 2012 Feb;13(2):215-28. doi: 10.1111/j.1526-4637.2011.01243.x. Epub 2011 Sep 21.</citation>
<PMID>21939499</PMID>
</reference>
<reference>
<citation>Janssens L, Brumagne S, McConnell AK, Hermans G, Troosters T, Gayan-Ramirez G. Greater diaphragm fatigability in individuals with recurrent low back pain. Respir Physiol Neurobiol. 2013 Aug 15;188(2):119-23. doi: 10.1016/j.resp.2013.05.028. Epub 2013 May 31.</citation>
<PMID>23727158</PMID>
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<citation>Bordoni B, Marelli F. Failed back surgery syndrome: review and new hypotheses. J Pain Res. 2016 Jan 12;9:17-22. doi: 10.2147/JPR.S96754. eCollection 2016.</citation>
<PMID>26834497</PMID>
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<citation>Kolar P, Sulc J, Kyncl M, Sanda J, Cakrt O, Andel R, Kumagai K, Kobesova A. Postural function of the diaphragm in persons with and without chronic low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):352-62. doi: 10.2519/jospt.2012.3830. Epub 2011 Dec 21.</citation>
<PMID>22236541</PMID>
</reference>
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<citation>Marti-Salvador M, Hidalgo-Moreno L, Domenech-Fernandez J, Lison JF, Arguisuelas MD. Osteopathic Manipulative Treatment Including Specific Diaphragm Techniques Improves Pain and Disability in Chronic Nonspecific Low Back Pain: A Randomized Trial. Arch Phys Med Rehabil. 2018 Sep;99(9):1720-1729. doi: 10.1016/j.apmr.2018.04.022. Epub 2018 May 19.</citation>
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<citation>Grams ST, Ono LM, Noronha MA, Schivinski CI, Paulin E. Breathing exercises in upper abdominal surgery: a systematic review and meta-analysis. Rev Bras Fisioter. 2012 Sep-Oct;16(5):345-53. doi: 10.1590/s1413-35552012005000052. Epub 2012 Oct 9.</citation>
<PMID>23060237</PMID>
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<citation>Cloyd C, Moffett BS, Bernhardt MB, Monico EM, Patel N, Hanson D. Efficacy of liposomal bupivacaine in pediatric patients undergoing spine surgery. Paediatr Anaesth. 2018 Nov;28(11):982-986. doi: 10.1111/pan.13482. Epub 2018 Sep 11.</citation>
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<citation>Sloman R, Wruble AW, Rosen G, Rom M. Determination of clinically meaningful levels of pain reduction in patients experiencing acute postoperative pain. Pain Manag Nurs. 2006 Dec;7(4):153-8. doi: 10.1016/j.pmn.2006.09.001.</citation>
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</reference>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 26, 2022</study_first_submitted>
<study_first_submitted_qc>March 26, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>February 28, 2023</last_update_submitted>
<last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 2, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>Istituto Ortopedico Rizzoli</investigator_affiliation>
<investigator_full_name>Antonio Culcasi</investigator_full_name>
<investigator_title>Pt - physical therapist</investigator_title>
</responsible_party>
<keyword>spinal fusion</keyword>
<keyword>early rehabilitation</keyword>
<keyword>diaphragmatic breathing exercise</keyword>
<keyword>Adolescent Idiopathic Scoliosis</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Scoliosis</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe
intervention that can be introduced for pain management.
The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise
in the management of pain in the postoperative care in patients undergoing spinal fusion for
adolescent idiopathic scoliosis.
Adolescent idiopathic scoliosis (AIS) is a common orthopedic condition with a prevalence of
2-3% in children aged from 10 to 16 years. It is a developmental deformity that affects both
physical and psychological domains, interfering with self-esteem and mental well-being.
Diagnosis is made within the first 18 years of life; in some cases, instrumented arthrodesis
surgery is required, performed within the age of 25. Corrective surgery for scoliosis can be
a stressful intervention for patients and their caregivers.
Postoperative pain is the major concern for patients undergoing orthopedic surgery.
Significant postoperative pain also adversely affects other outcomes by hindering the healing
process and delaying rehabilitation with loss of movement and walking. After arthrodesis the
pain reported by the patients is significant.
Various strategies have been explored for acute pain management in patients undergoing
surgery for scoliosis, with a focus on the first days post surgery. The link between
breathing, lumbar spine function and pain perception is an aspect that has always been
studied. The diaphragm plays an important role in spinal control and in the management of
pain perception. Dysfunction of the diaphragm can lead to alterations in the biomechanics of
the lumbar spine, with less proprioceptive abilities, less spinal mobility and reduced the
spinal column's functionality of the tissues. Diaphragmatic rehabilitation techniques produce
significant and clinically relevant improvements in the treatment of pathologies of the spine
and especially in the management of painful symptoms.
A systematic review highlights how pain is able to influence the flow, frequency and volume
of the respiratory act. At the same time, a regulation of breathing can be an useful tool in
the control of painful symptoms.
After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe
tool that can be introduced for the control of painful symptoms.
The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise
in the management of pain in the postoperative phase in patients undergoing arthrodesis
surgery for adolescent idiopathic scoliosis.
Inclusion Criteria:
- All subjects hospitalized for corrective arthrodesis surgery with Adolescent
Idiopathic Scoliosis (AIS) diagnosis, aged from 12 and 24 years will be consecutively
enrolled.
Exclusion Criteria:
- Subjects who cannot understand the Italian language and who do not provide consent to
study will be excluded.
|
NCT0531xxxx/NCT05311839.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/NCT05311839</url>
</required_header>
<id_info>
<org_study_id>PT3465</org_study_id>
<nct_id>NCT05311839</nct_id>
</id_info>
<brief_title>Effect of Thera Band Exercises on Adhesive Capsulitis Post Mastectomy</brief_title>
<acronym>Mastectomy</acronym>
<official_title>Combined Effect of Graded Thera Band and Scapular Stabilization Exercises on Shoulder Adhesive Capsulitis Post Mastectomy</official_title>
<sponsors>
<lead_sponsor>
<agency>Maged Basha</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Cairo University</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Qassim 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>
Breast cancer surgeries particularly mastectomy results in limited shoulder movement which
can lead to arm, shoulder pain and stiffness. Females who underwent mastectomy have reported
a significantly higher incidence of shoulder morbidity
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Exercise therapy might help in reduction of pain and restoration of the range, coordination
and control of movement in patients with adhesive capsulitis. Graded resistance exercises are
effective in decreasing fatigue levels, enhancing functional capacity and muscle strength.
Rehabilitation exercises which strengthen the scapular stability can be extremely beneficial
in rehabilitation treatment of patients with shoulder pain and problems
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">January 10, 2021</start_date>
<completion_date type="Actual">January 5, 2022</completion_date>
<primary_completion_date type="Actual">December 25, 2021</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Shoulder range of motion</measure>
<time_frame>at baseline</time_frame>
<description>A digital goniometer flexion and abduction, internal and external rotation range of motion</description>
</primary_outcome>
<primary_outcome>
<measure>Shoulder range of motion</measure>
<time_frame>after 8 weeks</time_frame>
<description>A digital goniometer flexion and abduction, internal and external rotation range of motion</description>
</primary_outcome>
<primary_outcome>
<measure>physical function</measure>
<time_frame>at baseline</time_frame>
<description>the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function</description>
</primary_outcome>
<primary_outcome>
<measure>physical function</measure>
<time_frame>after 8weeks</time_frame>
<description>the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function</description>
</primary_outcome>
<primary_outcome>
<measure>Health-related quality of life</measure>
<time_frame>at baseline</time_frame>
<description>assessed using the Medical Outcomes Study short-form (SF-36).</description>
</primary_outcome>
<primary_outcome>
<measure>Health-related quality of life</measure>
<time_frame>after 8 weeks</time_frame>
<description>assessed using the Medical Outcomes Study short-form (SF-36).</description>
</primary_outcome>
<secondary_outcome>
<measure>Muscle strength</measure>
<time_frame>at baseline</time_frame>
<description>A handheld dynamometer (J Tech Commender Muscle Tester, Salt Lake City, Utah, USA)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Muscle strength</measure>
<time_frame>after 8 weeks</time_frame>
<description>A handheld dynamometer (J Tech Commender Muscle Tester, Salt Lake City, Utah, USA)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Visual analogue scale</measure>
<time_frame>at baseline</time_frame>
<description>used to assess the intensity of shoulder pain. consists of 10-cm line, and was utilized to quantify the pain severity within shoulder, where the score of zero means no pain, while a score of ten means significant pain</description>
</secondary_outcome>
<secondary_outcome>
<measure>Visual analogue scale</measure>
<time_frame>after 8 weeks</time_frame>
<description>used to assess the intensity of shoulder pain.consists of 10-cm line, and was utilized to quantify the pain severity within shoulder, where the score of zero means no pain, while a score of ten means significant pain</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">70</enrollment>
<condition>Adhesive Capsulitis of Shoulder</condition>
<arm_group>
<arm_group_label>Thera band exercises group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>received graded Thera band exercises for 5 days per week for eight weeks in addition to the conventional physical therapy program.</description>
</arm_group>
<arm_group>
<arm_group_label>conventional physiotherapy program group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>received a conventional physical therapy program.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Exercise</intervention_name>
<description>Hot packs, active range of motion exercises, pendular exercises, wall climb exercises, mobilization exercises, and shoulder capsular stretching</description>
<arm_group_label>Thera band exercises group</arm_group_label>
<arm_group_label>conventional physiotherapy program group</arm_group_label>
<other_name>conventional physical therapy program</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Thera band</intervention_name>
<description>graded Thera band exercises for shoulder flexion, abduction, internal, and external rotation</description>
<arm_group_label>Thera band exercises group</arm_group_label>
<other_name>graded Thera band exercises and scapular stabilization exercises</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Age ranged from 40-60 years.

- 2nd stage of adhesive capsulitis,

- Shoulder pain and stiffness for at least 3 months.

- Restriction in shoulder flexion, abduction, internal and external rotation ROM less
than 50% when compared to the other shoulder.

Exclusion Criteria:

- Shoulder or acromioclavicular joint osteoarthritis.

- Bone diseases.

- Infection.

- Severe osteoporosis.

- Tumors or metastasis.

- History of previous shoulder trauma or accidental injuries.

- Previous history of dislocation.

- Previous history of surgery on the specific shoulder.

- Any other shoulder problems.
</textblock>
</criteria>
<gender>Female</gender>
<gender_based>Yes</gender_based>
<gender_description>Breast Cancer, post-mastectomy</gender_description>
<minimum_age>40 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Noha Kamel, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Cairo University</affiliation>
</overall_official>
<overall_official>
<last_name>Nancy Aboelnour, PhD</last_name>
<role>Study Chair</role>
<affiliation>Cairo University</affiliation>
</overall_official>
<location>
<facility>
<name>Faculty of Physical Therapy, Cairo University</name>
<address>
<city>Giza</city>
<state>Dokki</state>
<zip>11432</zip>
<country>Egypt</country>
</address>
</facility>
</location>
<location_countries>
<country>Egypt</country>
</location_countries>
<reference>
<citation>Cheing GL, So EM, Chao CY. Effectiveness of electroacupuncture and interferential eloctrotherapy in the management of frozen shoulder. J Rehabil Med. 2008 Mar;40(3):166-70. doi: 10.2340/16501977-0142.</citation>
<PMID>18292916</PMID>
</reference>
<results_reference>
<citation>Dilaveri CA, Sandhu NP, Neal L, Neben-Wittich MA, Hieken TJ, Mac Bride MB, Wahner-Roedler DL, Ghosh K. Medical factors influencing decision making regarding radiation therapy for breast cancer. Int J Womens Health. 2014 Nov 19;6:945-54. doi: 10.2147/IJWH.S71591. eCollection 2014.</citation>
<PMID>25429241</PMID>
</results_reference>
<results_reference>
<citation>Sabari JS, Maltzev I, Lubarsky D, Liszkay E, Homel P. Goniometric assessment of shoulder range of motion: comparison of testing in supine and sitting positions. Arch Phys Med Rehabil. 1998 Jun;79(6):647-51. doi: 10.1016/s0003-9993(98)90038-7.</citation>
<PMID>9630143</PMID>
</results_reference>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 26, 2022</study_first_submitted>
<study_first_submitted_qc>March 26, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>April 19, 2022</last_update_submitted>
<last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 26, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>Qassim University</investigator_affiliation>
<investigator_full_name>Maged Basha</investigator_full_name>
<investigator_title>Assistant Professor, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt.</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Bursitis</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_time_frame>6 months after publication</ipd_time_frame>
<ipd_access_criteria>relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Breast cancer surgeries particularly mastectomy results in limited shoulder movement which
can lead to arm, shoulder pain and stiffness. Females who underwent mastectomy have reported
a significantly higher incidence of shoulder morbidity
Exercise therapy might help in reduction of pain and restoration of the range, coordination
and control of movement in patients with adhesive capsulitis. Graded resistance exercises are
effective in decreasing fatigue levels, enhancing functional capacity and muscle strength.
Rehabilitation exercises which strengthen the scapular stability can be extremely beneficial
in rehabilitation treatment of patients with shoulder pain and problems
Inclusion Criteria:
- Age ranged from 40-60 years.
- 2nd stage of adhesive capsulitis,
- Shoulder pain and stiffness for at least 3 months.
- Restriction in shoulder flexion, abduction, internal and external rotation ROM less
than 50% when compared to the other shoulder.
Exclusion Criteria:
- Shoulder or acromioclavicular joint osteoarthritis.
- Bone diseases.
- Infection.
- Severe osteoporosis.
- Tumors or metastasis.
- History of previous shoulder trauma or accidental injuries.
- Previous history of dislocation.
- Previous history of surgery on the specific shoulder.
- Any other shoulder problems.
|
NCT0531xxxx/NCT05311852.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/NCT05311852</url>
</required_header>
<id_info>
<org_study_id>PEA-LUT-in-Post-Covid-19</org_study_id>
<nct_id>NCT05311852</nct_id>
</id_info>
<brief_title>Effects of PEA-LUT on Frontal Lobe Functions and GABAergic Transmission in Long-Covid Patients</brief_title>
<acronym>PL-PC19</acronym>
<official_title>Effects of Palmitoylethanolamide Co-ultramicronized With Luteoline (Pea-lut) on Frontal Lobe Functions and GABAergic Transmission in Long Covid Patients. An 8-week Randomized Controlled Trial.</official_title>
<sponsors>
<lead_sponsor>
<agency>Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>I.R.C.C.S. Fondazione Santa Lucia</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The study explore the efficacy of PEA-LUT in patients suffering from neurological symptoms of
Long-Covid
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Aim of this study was testing the possible therapeutic effects of an 8-week therapy with
PEA-LUT on GABAB-ergic neurotransmission, LTP-like synaptic plasticity, indexed with
transient potentiation of motor evoked potentials (MEP) amplitude after repetitive TMS given
as intermittent theta burst stimulation (iTBS) in long COVID patients with cognitive
complaints and fatigue.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">August 16, 2021</start_date>
<completion_date type="Actual">March 15, 2022</completion_date>
<primary_completion_date type="Actual">February 15, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Participants are randomized and assigned to one of two or more groups in parallel for the duration of the study</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
<masking_description>This is a double-blind randomized placebo-controlled study</masking_description>
</study_design_info>
<primary_outcome>
<measure>changes in % of test amplitude in LICI 100</measure>
<time_frame>LICI 100 was assessed two times, at enrollment and after 8 weeks of treatment duration</time_frame>
<description>changes % of test amplitude in long-interval intracortical inhibition, indexing intracortical GABAB-ergic, transmission, are expected</description>
</primary_outcome>
<secondary_outcome>
<measure>changes in % of test amplitude in SAI 20</measure>
<time_frame>SAI 20 was assessed two times, at enrollment and after 8 weeks of treatment duration</time_frame>
<description>changes % of test amplitude in short-latency afferent inhibition, to evaluate M1 inhibition induced by sensory afferents, are expected</description>
</secondary_outcome>
<secondary_outcome>
<measure>change in LTP-like cortical plasticity</measure>
<time_frame>LTP-like cortical plasticity was assessed at two times, at enrollment and after 8 weeks of treatment duration</time_frame>
<description>change of MEP modulation after intermittent theta burst stimulation (iTBS)</description>
</secondary_outcome>
<other_outcome>
<measure>changes in Montreal Cognitive Assessment score</measure>
<time_frame>Montreal Cognitive Assessment was assessed at enrollment and after 8 weeks of treatment duration</time_frame>
<description>changes in Montreal Cognitive Assessment score, for evaluating the global cognition, are expected</description>
</other_outcome>
<other_outcome>
<measure>changes in Frontal Assessment Battery score</measure>
<time_frame>Frontal Assessment Battery was assessed at enrollment and after 8 weeks of treatment duration</time_frame>
<description>changes in Frontal Assessment Battery score, for evaluating the executive functions, are expected</description>
</other_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">34</enrollment>
<condition>Fatigue</condition>
<condition>Cognitive Deficit</condition>
<condition>COVID-19</condition>
<condition>Neurophysiologic Abnormality</condition>
<arm_group>
<arm_group_label>PEA-LUT</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>patients were required to assume granulated PEA-LUT 700/70 mg, 2 time/day for 8 weeks</description>
</arm_group>
<arm_group>
<arm_group_label>Placebo</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>patients were required to assume granulated placebo, 2 time/day for 8 weeks</description>
</arm_group>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)</intervention_name>
<description>assumption of the product at dosage of 700/70 mg 2 time/day for 8 weeks</description>
<arm_group_label>PEA-LUT</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>assumption of a placebo product 2 time/day for 8 weeks</description>
<arm_group_label>Placebo</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- previous diagnosis of SARS-CoV-2 infection confirmed through detection of virus RNA by
polymerase chain reaction (PCR) testing of a nasopharyngeal swab;

- subsequent recovery from infection as defined by two consecutive negative PCR tests
separated by at least a day;

- mild form of COVID-19 (symptoms may include fever, cough, sore throat, malaise,
myalgia, anorexia, nausea, diarrhoea, anosmia and ageusia) without necessitating
hospital admission;

- complaints of cognitive difficulties and/or sense of fatigue, persisting after
SARS-CoV-2 infection.

Exclusion Criteria:

- prior or concurrent diagnosis of neurological, psychiatric, endocrine, metabolic or
cardiopulmonary conditions;

- clinical and/or radiological evidence of COVID-19 related pneumonia during the active
phase of the disease;

- anaemia;

- current pharmacological treatment with corticosteroids, antihistamines,
antihypertensives, diuretics, antidepressants, anxiolytic or hypnotic drugs at the
time of study
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Leopold Saltuari, Md</last_name>
<role>Study Director</role>
<affiliation>Department of Neurorehabiliation - Hospital of Vipiteno-Sterzing</affiliation>
</overall_official>
<location>
<facility>
<name>Hospital of Vipiteno-Sterzing</name>
<address>
<city>Vipiteno</city>
<state>BZ</state>
<zip>39049</zip>
<country>Italy</country>
</address>
</facility>
</location>
<location_countries>
<country>Italy</country>
</location_countries>
<verification_date>September 2022</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>September 22, 2022</last_update_submitted>
<last_update_submitted_qc>September 22, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">September 26, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy</investigator_affiliation>
<investigator_full_name>Paola Ortelli</investigator_full_name>
<investigator_title>PsyD, Principal Investigator</investigator_title>
</responsible_party>
<keyword>fatigue</keyword>
<keyword>cognitive deficits</keyword>
<keyword>post-covid19 syndrome</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>COVID-19</mesh_term>
<mesh_term>Post-Acute COVID-19 Syndrome</mesh_term>
<mesh_term>Fatigue</mesh_term>
<mesh_term>Cognition Disorders</mesh_term>
<mesh_term>Cognitive Dysfunction</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Palmidrol</mesh_term>
<mesh_term>Antioxidants</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The study explore the efficacy of PEA-LUT in patients suffering from neurological symptoms of
Long-Covid
Aim of this study was testing the possible therapeutic effects of an 8-week therapy with
PEA-LUT on GABAB-ergic neurotransmission, LTP-like synaptic plasticity, indexed with
transient potentiation of motor evoked potentials (MEP) amplitude after repetitive TMS given
as intermittent theta burst stimulation (iTBS) in long COVID patients with cognitive
complaints and fatigue.
Inclusion Criteria:
- previous diagnosis of SARS-CoV-2 infection confirmed through detection of virus RNA by
polymerase chain reaction (PCR) testing of a nasopharyngeal swab;
- subsequent recovery from infection as defined by two consecutive negative PCR tests
separated by at least a day;
- mild form of COVID-19 (symptoms may include fever, cough, sore throat, malaise,
myalgia, anorexia, nausea, diarrhoea, anosmia and ageusia) without necessitating
hospital admission;
- complaints of cognitive difficulties and/or sense of fatigue, persisting after
SARS-CoV-2 infection.
Exclusion Criteria:
- prior or concurrent diagnosis of neurological, psychiatric, endocrine, metabolic or
cardiopulmonary conditions;
- clinical and/or radiological evidence of COVID-19 related pneumonia during the active
phase of the disease;
- anaemia;
- current pharmacological treatment with corticosteroids, antihistamines,
antihypertensives, diuretics, antidepressants, anxiolytic or hypnotic drugs at the
time of study
|
NCT0531xxxx/NCT05311865.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/NCT05311865</url>
</required_header>
<id_info>
<org_study_id>ANRS0066s</org_study_id>
<nct_id>NCT05311865</nct_id>
</id_info>
<brief_title>Transmission of Covid-19 During Clubbing Events in Closed Places</brief_title>
<acronym>ITOC</acronym>
<official_title>Transmission of Covid-19 During Clubbing Events in Closed Places</official_title>
<sponsors>
<lead_sponsor>
<agency>ANRS, Emerging Infectious Diseases</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Cerballiance</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Kappa Santé</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>ANRS, Emerging Infectious Diseases</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The ITOC study is a cluster randomised, controlled, multicentre trial in Paris region,
France. The intervention is an 8-hour indoor clubbing event with no mask wearing, no social
distancing, at maximum room capacity. 1,200 healthy volunteers aged 18-49 years and fully
vaccinated will be included. Participants are recruited by group of up to 10, to be
randomized 2:1 to experimental group (800 volunteers in a venue ) or control group (400
volunteers asked to stay at home). All participants will provide a salivary sample the day of
experiment and seven days later. Participants will also answer surveys on the social and
psychological impact of lockdown and indoor club closing, attitude towards vaccination,
behaviour at risk of COVID-19 transmission during the day of the event (for both groups) as
well as follow-up surveys on symptoms that participant may experience. Virological analyses
include polymerase chain reaction (PCR) of salivary samples and air of the venue,
investigating SARS-CoV-2 PCR.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">September 4, 2021</start_date>
<completion_date type="Actual">February 26, 2022</completion_date>
<primary_completion_date type="Actual">October 17, 2021</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Open-label, multicenter, randomized controlled intervention study with 1200 participants distributed 2: 1 in two groups of volunteers.</intervention_model_description>
<primary_purpose>Health Services Research</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Number of positive RT-PCR at day 7</measure>
<time_frame>Day 7</time_frame>
<description>Number of participants in each groups with a positive salivary RT-PCR</description>
</primary_outcome>
<secondary_outcome>
<measure>Number of SARS-CoV-2 infection cases</measure>
<time_frame>Day 5 up to day 10</time_frame>
<description>Numbers of asymptomatic, symptomatic, and severe SARS-CoV-2 infection according to a self-assessment by a questionnaire sent online in each group</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of participants with seasonal respiratory viruses</measure>
<time_frame>Day 0 and day 7</time_frame>
<description>Number of participants in each group with a positive seasonal respiratory viruses PCR</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of symptomatic and asymptomatic respiratory infection</measure>
<time_frame>Day 5 to day 10</time_frame>
<description>Numbers of asymptomatic, symptomatic, and severe seasonal respiratory viruses infection according to a self-assessment by a questionnaire sent online</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of detected virus in the air</measure>
<time_frame>Day 0</time_frame>
<description>Number of detected virus in the air, by the AerosolSense</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of mutations, deletions and insertions on the viral genome in participants samples</measure>
<time_frame>Day 0 and day 7</time_frame>
<description>Whole genome sequencing of virus detected in participants samples : number of mutations, deletions or insertions on all the viral genes of consensus sequences</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of mutations, deletions and insertions on the viral genome in Aerosol samples</measure>
<time_frame>Day 0 and day 7</time_frame>
<description>Whole genome sequencing of virus detected in Aerosol samples : number of mutations, deletions or insertions on all the viral genes of consensus sequences</description>
</secondary_outcome>
<secondary_outcome>
<measure>Percentage of divergence between phylogenetic analysis of participants and aerosol samples</measure>
<time_frame>Day 0 and day 7</time_frame>
<description>Establishing the distance matrix between the viruses in participants samples and viruses detected by aerosol sense</description>
</secondary_outcome>
<secondary_outcome>
<measure>Percentage of Health protocol adherence</measure>
<time_frame>Day 1</time_frame>
<description>Percentage of positive responses to a questionnaire assessing degree of adherence to the health protocol by questionnaire sent online to participants and organizers after the evenings.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Percentage of Interactions between the participants during the event</measure>
<time_frame>Day 1</time_frame>
<description>Percentage of responses to a questionnaire assessing number of individual interactions during the event</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">1216</enrollment>
<condition>Healthy Participant</condition>
<arm_group>
<arm_group_label>participating to the event</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Non partipating to the event</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Club event</intervention_name>
<description>Participate in a club event without a mask, indoors, with vaccinated people.</description>
<arm_group_label>participating to the event</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Aged between 18 and 49 years old

- Vaccination completed

- People who declared to have no risk factor to severe form for Covid-19 disease

- People who declared not to live in the same place as someone with these risk factors

- People residing in Ile-de-France area

- People affiliated with the the French social security citizen scheme

Exclusion criteria:

- Presence of symptoms of COVID in the 2 weeks before the event

- Pregnant woman or woman who declares not having an effective contraception method

- Self identification of medical conditions or comorbidities identified as a proven risk
of severe COVID infection

- People living with a person with these risk factors

- Confirmed diagnosis of SARS-CoV-2 within two weeks before the event

- Participants under tutorship or curatorship;

- Underage participants;

- Participants unable to give free and informed consent;

- Participants not affiliated to the French social security citizen scheme: obligation
to join a social security scheme or be a beneficiary thereof.

- Participants under legal protection
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>49 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Yazdan Yazdanpanah, Pr</last_name>
<role>Study Director</role>
<affiliation>ANRS, Emerging Infectious Diseases</affiliation>
</overall_official>
<location>
<facility>
<name>ANRS</name>
<address>
<city>Paris</city>
<zip>75013</zip>
<country>France</country>
</address>
</facility>
</location>
<location_countries>
<country>France</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 8, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>April 1, 2022</last_update_submitted>
<last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 5, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>SARS CoV-2</keyword>
<keyword>Transmission</keyword>
<keyword>vaccinated</keyword>
<keyword>Night-club</keyword>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The ITOC study is a cluster randomised, controlled, multicentre trial in Paris region,
France. The intervention is an 8-hour indoor clubbing event with no mask wearing, no social
distancing, at maximum room capacity. 1,200 healthy volunteers aged 18-49 years and fully
vaccinated will be included. Participants are recruited by group of up to 10, to be
randomized 2:1 to experimental group (800 volunteers in a venue ) or control group (400
volunteers asked to stay at home). All participants will provide a salivary sample the day of
experiment and seven days later. Participants will also answer surveys on the social and
psychological impact of lockdown and indoor club closing, attitude towards vaccination,
behaviour at risk of COVID-19 transmission during the day of the event (for both groups) as
well as follow-up surveys on symptoms that participant may experience. Virological analyses
include polymerase chain reaction (PCR) of salivary samples and air of the venue,
investigating SARS-CoV-2 PCR.
Inclusion Criteria:
- Aged between 18 and 49 years old
- Vaccination completed
- People who declared to have no risk factor to severe form for Covid-19 disease
- People who declared not to live in the same place as someone with these risk factors
- People residing in Ile-de-France area
- People affiliated with the the French social security citizen scheme
Exclusion criteria:
- Presence of symptoms of COVID in the 2 weeks before the event
- Pregnant woman or woman who declares not having an effective contraception method
- Self identification of medical conditions or comorbidities identified as a proven risk
of severe COVID infection
- People living with a person with these risk factors
- Confirmed diagnosis of SARS-CoV-2 within two weeks before the event
- Participants under tutorship or curatorship;
- Underage participants;
- Participants unable to give free and informed consent;
- Participants not affiliated to the French social security citizen scheme: obligation
to join a social security scheme or be a beneficiary thereof.
- Participants under legal protection
|
NCT0531xxxx/NCT05311878.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/NCT05311878</url>
</required_header>
<id_info>
<org_study_id>2020030073_p2</org_study_id>
<nct_id>NCT05311878</nct_id>
</id_info>
<brief_title>Non-invasive BCI for Cognitive Enhancement</brief_title>
<official_title>Non-invasive Brain Computer Interface for Cognitive Enhancement</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Texas at Austin</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Texas at Austin</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>Yes</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
People's perceptual skills can significantly affect their abilities to make optimal
decisions, judgments, and actions in real-world dynamic environments. Perceptual learning
refers to training and experiences to induce improvements in the ability to make sense of
what people see, hear, feel, taste or smell based on ambiguous sensory information. In this
study, investigators hypothesise that there exist neural signatures that robustly encode the
conscious visual perception of rotations of a cursor and the magnitudes of these rotations in
a novel, rotation-based perceptual learning task. Investigators also hypothesise that online,
instantaneous EEG-based feedback on subjects' visual perceptions of rotations with an
EEG-based Brain Computer Interface (BCI) can foster perceptual learning much more effectively
than behaviour perceptual training, especially in very small rotation magnitudes that
represent extremely difficult perceptual tasks.
</textblock>
</brief_summary>
<overall_status>Suspended</overall_status>
<why_stopped>
Recruitment of new participants currently on hold until further notice
</why_stopped>
<start_date type="Actual">January 1, 2021</start_date>
<completion_date type="Anticipated">May 30, 2022</completion_date>
<primary_completion_date type="Anticipated">May 30, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Change in correct answer rate of different rotation magnitudes across 5 intervention sessions</measure>
<time_frame>Difference is measured every 24 hours, before versus after each intervention session</time_frame>
<description>The correct answer rate per rotation magnitude reflects the improvements in perceptual skills across the two conditions. It measures the percentage of each rotation magnitude spotted correctly. The score is 0-100, and the higher the value, the better the outcome.</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in neural correlates of conscious perception across 5 intervention sessions</measure>
<time_frame>Difference is measured every 24 hours, before versus after each intervention session</time_frame>
<description>This outcome measures whether neural correlates of conscious perception (e.g. amplitude, peak-to-peak, band power and connectivity measures of neural correlates) change across sessions as a result of intervention.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">32</enrollment>
<condition>Healthy Subjects</condition>
<condition>Neuropsychiatric Disorders</condition>
<arm_group>
<arm_group_label>EEG based perceptual training</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Subjects complete a perceptual learning task in which EEG-based visual feedback is provided</description>
</arm_group>
<arm_group>
<arm_group_label>Behavior based perceptual training</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Subjects complete a perceptual learning task in which ground truth visual feedback is provided</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>EEG-based perceptual training</intervention_name>
<description>Electroencephalography (EEG) signals will be recorded from subjects as they perform rotation-based perceptual tasks. The neural correlates of conscious perception of rotations will be processed and decoded in real-time using machine learning algorithms to provide feedback. Subjects are instructed to assume a mental state/find a strategy to maximise the accuracy of feedback. In total, each subject will complete 5 sessions of perceptual training with this intervention.</description>
<arm_group_label>EEG based perceptual training</arm_group_label>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Behavior based perceptual training</intervention_name>
<description>Subjects complete the rotation-based perceptual tasks, and ground truth visual feedback is provided indicating whether subjects have spotted the rotations correctly. Subjects are instructed to spot as many rotation as possible to maximise the accuracy of feedback. In total, each subject will complete 5 sessions of perceptual training with this intervention.</description>
<arm_group_label>Behavior based perceptual training</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

Able-bodied volunteers:

- good general health

- normal or corrected vision

- no history of neurological/psychiatric disease

- ability to read and understand English

- ability to understand information and ability to give a free and informed consent

Subjects with neuropsychiatric diseases

- Subjects with neuropsychiatric diseases such as bipolar disorder and schizophrenia.

- normal or corrected vision

- ability to read and understand English

- ability to understand information and ability to give a free and informed consent

Exclusion Criteria:

- short attentional spans or cognitive deficits that prevent to remain concentrated
during the experimental sessions

- concomitant serious illnesses (e.g., metabolic disorders, cardiac arrest)

- factors hindering proper EEG acquisition (e.g., scalp wound, uncontrolled muscle
activity)
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Jose del R. Millan, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>The University of Texas at Austin</affiliation>
</overall_official>
<location>
<facility>
<name>Engineering Education and Research Center</name>
<address>
<city>Austin</city>
<state>Texas</state>
<zip>78712</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>May 2022</verification_date>
<study_first_submitted>February 22, 2022</study_first_submitted>
<study_first_submitted_qc>March 25, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>May 19, 2022</last_update_submitted>
<last_update_submitted_qc>May 19, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">May 26, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>All data will be made available by the online publication date. These data will be placed in public servers for any interested researcher to access it</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
People's perceptual skills can significantly affect their abilities to make optimal
decisions, judgments, and actions in real-world dynamic environments. Perceptual learning
refers to training and experiences to induce improvements in the ability to make sense of
what people see, hear, feel, taste or smell based on ambiguous sensory information. In this
study, investigators hypothesise that there exist neural signatures that robustly encode the
conscious visual perception of rotations of a cursor and the magnitudes of these rotations in
a novel, rotation-based perceptual learning task. Investigators also hypothesise that online,
instantaneous EEG-based feedback on subjects' visual perceptions of rotations with an
EEG-based Brain Computer Interface (BCI) can foster perceptual learning much more effectively
than behaviour perceptual training, especially in very small rotation magnitudes that
represent extremely difficult perceptual tasks.
Inclusion Criteria:
Able-bodied volunteers:
- good general health
- normal or corrected vision
- no history of neurological/psychiatric disease
- ability to read and understand English
- ability to understand information and ability to give a free and informed consent
Subjects with neuropsychiatric diseases
- Subjects with neuropsychiatric diseases such as bipolar disorder and schizophrenia.
- normal or corrected vision
- ability to read and understand English
- ability to understand information and ability to give a free and informed consent
Exclusion Criteria:
- short attentional spans or cognitive deficits that prevent to remain concentrated
during the experimental sessions
- concomitant serious illnesses (e.g., metabolic disorders, cardiac arrest)
- factors hindering proper EEG acquisition (e.g., scalp wound, uncontrolled muscle
activity)
|
NCT0531xxxx/NCT05311891.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/NCT05311891</url>
</required_header>
<id_info>
<org_study_id>ANRS 0136s</org_study_id>
<nct_id>NCT05311891</nct_id>
</id_info>
<brief_title>Variants of SARS-CoV-2 Causing COVID-19 in Africa</brief_title>
<acronym>South-Spike</acronym>
<official_title>Variants of SARS-CoV-2 in Central and West Africa: Frequency of Circulating Viruses and Implications for the Management and Control of the Pandemic</official_title>
<sponsors>
<lead_sponsor>
<agency>ANRS, Emerging Infectious Diseases</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Institut de Recherche pour le Developpement</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>ANRS, Emerging Infectious Diseases</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The main objective of this research is to identify and characterize the different molecular
variants of SARS-CoV-2, emerging and / or circulating in several countries of Sub-Saharan
Africa (Burkina Faso, Côte d'Ivoire, Gabon, Mali, Chad and Republic of Congo) and determine
their role in the evolution of the pandemic.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The main objective of this research is to identify and characterize the different molecular
variants of SARS-CoV-2, emerging and / or circulating in several countries of Sub-Saharan
Africa (Burkina Faso, Côte d'Ivoire, Gabon, Mali, Chad and Republic of Congo) and determine
their role in the evolution of the pandemic.

The research will combine retrospective and prospective approaches to determine the
evolutionary dynamics of the virus since the start of the pandemic. It is planned to sequence
the entire Spike protein gene for 1550 viruses and make 300 entire genomes. This work will be
supplemented by antibody seroneutralization and respiratory transcriptomics tests, in order
to estimate the immuno-virological response of the COVID-19 disease associated with the
identified SARS-CoV-2 variants.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">September 2022</start_date>
<completion_date type="Anticipated">October 2022</completion_date>
<primary_completion_date type="Anticipated">October 2022</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>Other</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Number of SARS-CoV-2 sequences generated partially and in whole genome</measure>
<time_frame>Through study completion, an average of 1 year.</time_frame>
<description>This outcome represent our main gaol and will include sequences that were partially generated in the Spike proteine and full genomes as well. Our current target is 1550 sequences.</description>
</primary_outcome>
<secondary_outcome>
<measure>Number of individuals tested positive for COVID-19</measure>
<time_frame>Up to six months</time_frame>
<description>This outcome will be focused on the number of persons that will be tested positive for COVID-19 throughout the study, using SARS-CoV-2 rapid antigen tests. We planned to screen 12000 individuals overall in the six participating countries.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of new SARS-CoV-2 variants identify</measure>
<time_frame>Through study completion, an average of 1 year.</time_frame>
<description>This outcome represents the number of new viruses that are identified at the end of the study and have not been reported previously.</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">12600</enrollment>
<condition>COVID-19</condition>
<arm_group>
<arm_group_label>Retrospective</arm_group_label>
<description>12000 participants positive for SARS-COV-2</description>
</arm_group>
<arm_group>
<arm_group_label>Prospective</arm_group_label>
<description>600 participants positive for SARS-COV-2</description>
</arm_group>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>RT PCR</intervention_name>
<description>Characterize the different molecular variants of SARS-CoV-2, determine the escape potential of the new variants from neutralization by monoclonal antibodies and currently available vaccines and characterization of the mRNAs expressed in infected persons</description>
<arm_group_label>Prospective</arm_group_label>
<arm_group_label>Retrospective</arm_group_label>
<other_name>Sequencing of the S gene</other_name>
<other_name>Sequencing of the entire SARS-COV-2 genome</other_name>
<other_name>Seroneutralization of antibodies</other_name>
<other_name>Respiratory transcriptomics</other_name>
</intervention>
<biospec_retention>Samples Without DNA</biospec_retention>
<biospec_descr>
<textblock>
Nasopharyngeal sample (virus)
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
Participant presenting for a SARS COV2 diagnosis, with or without symptoms
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Major subject (cf. country)

- Presenting for a SARS-COV-2 diagnosis, whether symptomatic or not

- Not objecting to participating in the research

Exclusion Criteria:

- NA
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Centre de Référence pour les pathogènes émergents et réémergent</name>
<address>
<city>Bobo-Dioulasso</city>
<zip>BP 2161</zip>
<country>Burkina Faso</country>
</address>
</facility>
<contact>
<last_name>Abdoul Salam OUEDRAOGO, Pr</last_name>
<phone>0022670017046</phone>
<email>abdousal2000@yahoo.fr</email>
</contact>
</location>
<location>
<facility>
<name>Centre Hospitalier Universitaire la Référence Nationale (CHU-RN)</name>
<address>
<city>N'Djamena</city>
<zip>BP : 130</zip>
<country>Chad</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Laboratoire National de Santé Publique Brazzaville</name>
<address>
<city>Brazzaville</city>
<country>Congo</country>
</address>
</facility>
</location>
<location>
<facility>
<name>CIRBA</name>
<address>
<city>Abidjan</city>
<country>Côte D'Ivoire</country>
</address>
</facility>
<contact>
<last_name>Thomas d'Aquin TONI, Dr</last_name>
<phone>+ 225 05 89 81 49</phone>
<email>tonithomasd@gmail.com</email>
</contact>
</location>
<location>
<facility>
<name>Unité Mixte de Recherche CIRMF-SSM</name>
<address>
<city>Libreville</city>
<zip>20404</zip>
<country>Gabon</country>
</address>
</facility>
<contact>
<last_name>Berthe Amelie IROUNGOU, Dr</last_name>
<phone>077 44-85-85</phone>
<email>abertheamelie@gmail.com</email>
</contact>
</location>
<location>
<facility>
<name>SEREFO</name>
<address>
<city>Bamako</city>
<zip>BP: 1805</zip>
<country>Mali</country>
</address>
</facility>
<contact>
<last_name>Almoustapha MIAGA</last_name>
<phone>+ 223 20 22 67 86</phone>
<email>almoustapha@gmail.com</email>
</contact>
</location>
<location_countries>
<country>Burkina Faso</country>
<country>Chad</country>
<country>Congo</country>
<country>Côte D'Ivoire</country>
<country>Gabon</country>
<country>Mali</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 23, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>May 26, 2022</last_update_submitted>
<last_update_submitted_qc>May 26, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">May 27, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>COVID-19</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The main objective of this research is to identify and characterize the different molecular
variants of SARS-CoV-2, emerging and / or circulating in several countries of Sub-Saharan
Africa (Burkina Faso, Côte d'Ivoire, Gabon, Mali, Chad and Republic of Congo) and determine
their role in the evolution of the pandemic.
The main objective of this research is to identify and characterize the different molecular
variants of SARS-CoV-2, emerging and / or circulating in several countries of Sub-Saharan
Africa (Burkina Faso, Côte d'Ivoire, Gabon, Mali, Chad and Republic of Congo) and determine
their role in the evolution of the pandemic.
The research will combine retrospective and prospective approaches to determine the
evolutionary dynamics of the virus since the start of the pandemic. It is planned to sequence
the entire Spike protein gene for 1550 viruses and make 300 entire genomes. This work will be
supplemented by antibody seroneutralization and respiratory transcriptomics tests, in order
to estimate the immuno-virological response of the COVID-19 disease associated with the
identified SARS-CoV-2 variants.
Nasopharyngeal sample (virus)
Participant presenting for a SARS COV2 diagnosis, with or without symptoms
Inclusion Criteria:
- Major subject (cf. country)
- Presenting for a SARS-COV-2 diagnosis, whether symptomatic or not
- Not objecting to participating in the research
Exclusion Criteria:
- NA
|
NCT0531xxxx/NCT05311904.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/NCT05311904</url>
</required_header>
<id_info>
<org_study_id>CHUBX 2020/68</org_study_id>
<nct_id>NCT05311904</nct_id>
</id_info>
<brief_title>Efficacy and Safety of Vaccination Against COVID-19 in Neuromuscular Patients</brief_title>
<acronym>VA-C-NEMUS</acronym>
<official_title>Observatory of the Efficacy and Safety of Vaccination Against SARS-CoV-2 in Neuromuscular Patients</official_title>
<sponsors>
<lead_sponsor>
<agency>University Hospital, Bordeaux</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University Hospital, Bordeaux</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The frequency of severe forms of COVID-19 is higher in people with neuromuscular disease and
in severe cases and long hospital stays, the disability of some neuromuscular patients may
worsen due to prolonged bed rest . Finally, the symptoms of certain diseases such as
myasthenia gravis can worsen after an infection such as COVID-19.

Thanks to an unprecedented research effort, vaccines are now available and others still in
development. The first studies published in medical journals are reassuring about the
efficacy and safety of these vaccines. However, they have been studied in the general
population and we do not yet have specific information in neuromuscular patients.

This is the reason why the Va-C-NEMUS observatory was launched.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Prevention of COVID-19 in neuromuscular patients is therefore fundamental and vaccination is
eagerly awaited by patients and their healthcare teams. An unprecedented research effort has
made it possible to create vaccines in a very short time when no vaccine directed against a
coronavirus has existed until now. Some of these vaccines are based on proven technologies
while others such as RNA vaccines are very innovative. The results of the phase III studies
of 3 of them have just been published (Pfizer/BioNTech, Moderna and Astra-Zeneca). Among
them, the Pfizer-BioNTech and Moderna vaccines have received authorization for use from the
European Medicines Agency. The data on the individuals enrolled in these trials are still not
very detailed. However, we already know that in the Pfizer/BioNTech trial, patients on
immunosuppressants were excluded. For the Astra-Zeneca vaccine, the publication combines data
from 4 different trials. In two of them the patients had to be in "good health". In any case,
we do not know the pathologies presented by patients outside the usual risk factors for the
severe form of COVID-19 (age, obesity, cardiovascular diseases, respiratory diseases). No
data on neuromuscular patients are currently known. The vaccination campaign began in France
in January 2021. The first neuromuscular patients should be vaccinated soon depending on
their comorbidities, but many questions arise in these patients both in terms of safety and
efficacy.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 11, 2021</start_date>
<completion_date type="Anticipated">March 15, 2023</completion_date>
<primary_completion_date type="Anticipated">March 15, 2023</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>the frequency of serious adverse reactions (SAEs)</measure>
<time_frame>at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>the frequency of serious adverse reactions (SAEs) in the population of neuromuscular patients vaccinated against COVID19 Serious adverse reaction or event (Article R1123-46 of the Public Health Code and ICH-E2B guideline)
Any adverse reaction or event that:
results in death,
endangers the life of the participant,
requires hospitalisation or prolongation of hospitalisation,
causes an inability or significant or long-term disability,
results in an abnormality or congenital malformation,
or any event considered to be medically serious, and with respect to the drug, regardless of the dose administered. The expression "life-threatening" is reserved for an immediate life threat at the time of the adverse event.</description>
</primary_outcome>
<primary_outcome>
<measure>the frequency of unexpected adverse reactions (SUSARs)</measure>
<time_frame>at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Unexpected adverse event or suspected adverse reaction refers to an event or reaction that is not listed in the investigator's brochure or is not listed at the specificity or severity that has been observed; or, if an investigator's brochure is not required or available, is not consistent with the risk information</description>
</primary_outcome>
<secondary_outcome>
<measure>vaccination's global safety : Frequency of Adverse Effects (AEs)</measure>
<time_frame>at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Frequency of Adverse Effects (AEs) in the population of neuromuscular patients vaccinated against COVID19</description>
</secondary_outcome>
<secondary_outcome>
<measure>Risk of worsening autoimmune myasthenia gravis after vaccination</measure>
<time_frame>at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Myasthenia Gravis Foundation of America classification</description>
</secondary_outcome>
<secondary_outcome>
<measure>Frequency of worsening of the autonomy of the patients evaluated with the MG-ADL</measure>
<time_frame>at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Frequency of worsening of the MG-ADL activity score by more than 2 points between the week before vaccination and the week following vaccination will be evaluated The Myasthenia Gravis-specific Activities of Daily Living scale consists of the assessment of 8 parameters: speaking, chewing, swallowing, breathing, self-care activities (brushing the teeth or combing the hair), simple physical activities (getting up from a chair), double vision and eye lid dropping. Each parameter is subjected to assessment depending on the degree of symptoms intensification, awarding points from 0 to 3 points. The maximum number a patient may receive is 24 points. The higher the score of points, the bigger limitations of the patient in everyday life activities caused by intensification of myasthenia gravis (Wolfe GI, Herbelin L, Nations SP, Foster B, Bryan WW, Barohn RJ. Myasthenia gravis activities of daily living profile. Neurology 1999;52:1487-1489.)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Frequency of hospitalizations for myasthenic crisis</measure>
<time_frame>at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Frequency of hospitalizations for myasthenic crisis in the month following vaccination</description>
</secondary_outcome>
<secondary_outcome>
<measure>effectiveness of the vaccination</measure>
<time_frame>at least 7 days after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Frequency of COVID-19 cases confirmed by a PCR test or an antigen test</description>
</secondary_outcome>
<secondary_outcome>
<measure>effectiveness of the vaccination</measure>
<time_frame>at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Frequency of COVID-19 cases confirmed by a PCR test or an antigen test occurring</description>
</secondary_outcome>
<secondary_outcome>
<measure>effectiveness of the vaccination</measure>
<time_frame>at 2 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Frequency of COVID-19 cases confirmed by a PCR test or an antigen test occurring</description>
</secondary_outcome>
<secondary_outcome>
<measure>effectiveness of the vaccination</measure>
<time_frame>at 3 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Frequency of COVID-19 cases confirmed by a PCR test or an antigen test occurring</description>
</secondary_outcome>
<secondary_outcome>
<measure>effectiveness of the vaccination</measure>
<time_frame>at 4 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Frequency of COVID-19 cases confirmed by a PCR test or an antigen test occurring</description>
</secondary_outcome>
<secondary_outcome>
<measure>effectiveness of the vaccination</measure>
<time_frame>at 5 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Frequency of COVID-19 cases confirmed by a PCR test or an antigen test occurring</description>
</secondary_outcome>
<secondary_outcome>
<measure>effectiveness of the vaccination</measure>
<time_frame>at 6 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Frequency of COVID-19 cases confirmed by a PCR test or an antigen test occurring</description>
</secondary_outcome>
<secondary_outcome>
<measure>the frequency of serious adverse reactions (SAEs) at 2 months</measure>
<time_frame>at 2 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>the frequency of serious adverse reactions (SAEs) in the population of neuromuscular patients vaccinated against COVID19 Serious adverse reaction or event (Article R1123-46 of the Public Health Code and ICH-E2B guideline)
Any adverse reaction or event that:
results in death,
endangers the life of the participant,
requires hospitalisation or prolongation of hospitalisation,
causes an inability or significant or long-term disability,
results in an abnormality or congenital malformation,
or any event considered to be medically serious, and with respect to the drug, regardless of the dose administered. The expression "life-threatening" is reserved for an immediate life threat at the time of the adverse event.</description>
</secondary_outcome>
<secondary_outcome>
<measure>the frequency of serious adverse reactions (SAEs) at 3 months</measure>
<time_frame>at 3 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>the frequency of serious adverse reactions (SAEs) in the population of neuromuscular patients vaccinated against COVID19 Serious adverse reaction or event (Article R1123-46 of the Public Health Code and ICH-E2B guideline)
Any adverse reaction or event that:
results in death,
endangers the life of the participant,
requires hospitalisation or prolongation of hospitalisation,
causes an inability or significant or long-term disability,
results in an abnormality or congenital malformation,
or any event considered to be medically serious, and with respect to the drug, regardless of the dose administered. The expression "life-threatening" is reserved for an immediate life threat at the time of the adverse event.</description>
</secondary_outcome>
<secondary_outcome>
<measure>the frequency of serious adverse reactions (SAEs) at 4 months</measure>
<time_frame>at 4 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>the frequency of serious adverse reactions (SAEs) in the population of neuromuscular patients vaccinated against COVID19 Serious adverse reaction or event (Article R1123-46 of the Public Health Code and ICH-E2B guideline)
Any adverse reaction or event that:
results in death,
endangers the life of the participant,
requires hospitalisation or prolongation of hospitalisation,
causes an inability or significant or long-term disability,
results in an abnormality or congenital malformation,
or any event considered to be medically serious, and with respect to the drug, regardless of the dose administered. The expression "life-threatening" is reserved for an immediate life threat at the time of the adverse event.</description>
</secondary_outcome>
<secondary_outcome>
<measure>the frequency of serious adverse reactions (SAEs) at 5 months</measure>
<time_frame>at 5 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>the frequency of serious adverse reactions (SAEs) in the population of neuromuscular patients vaccinated against COVID19 Serious adverse reaction or event (Article R1123-46 of the Public Health Code and ICH-E2B guideline)
Any adverse reaction or event that:
results in death,
endangers the life of the participant,
requires hospitalisation or prolongation of hospitalisation,
causes an inability or significant or long-term disability,
results in an abnormality or congenital malformation,
or any event considered to be medically serious, and with respect to the drug, regardless of the dose administered. The expression "life-threatening" is reserved for an immediate life threat at the time of the adverse event.</description>
</secondary_outcome>
<secondary_outcome>
<measure>the frequency of serious adverse reactions (SAEs) at 6 months</measure>
<time_frame>at 6 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>the frequency of serious adverse reactions (SAEs) in the population of neuromuscular patients vaccinated against COVID19 Serious adverse reaction or event (Article R1123-46 of the Public Health Code and ICH-E2B guideline)
Any adverse reaction or event that:
results in death,
endangers the life of the participant,
requires hospitalisation or prolongation of hospitalisation,
causes an inability or significant or long-term disability,
results in an abnormality or congenital malformation,
or any event considered to be medically serious, and with respect to the drug, regardless of the dose administered. The expression "life-threatening" is reserved for an immediate life threat at the time of the adverse event.</description>
</secondary_outcome>
<secondary_outcome>
<measure>the frequency of unexpected adverse reactions (SUSARs) at 2 months</measure>
<time_frame>at 2 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Unexpected adverse event or suspected adverse reaction refers to an event or reaction that is not listed in the investigator's brochure or is not listed at the specificity or severity that has been observed; or, if an investigator's brochure is not required or available, is not consistent with the risk information</description>
</secondary_outcome>
<secondary_outcome>
<measure>the frequency of unexpected adverse reactions (SUSARs) at 3 months</measure>
<time_frame>at 3 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Unexpected adverse event or suspected adverse reaction refers to an event or reaction that is not listed in the investigator's brochure or is not listed at the specificity or severity that has been observed; or, if an investigator's brochure is not required or available, is not consistent with the risk information</description>
</secondary_outcome>
<secondary_outcome>
<measure>the frequency of unexpected adverse reactions (SUSARs) at 4 months</measure>
<time_frame>at 4 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Unexpected adverse event or suspected adverse reaction refers to an event or reaction that is not listed in the investigator's brochure or is not listed at the specificity or severity that has been observed; or, if an investigator's brochure is not required or available, is not consistent with the risk information</description>
</secondary_outcome>
<secondary_outcome>
<measure>the frequency of unexepected adverse reactions (SUSARs) at 5 months</measure>
<time_frame>at 5 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Unexpected adverse event or suspected adverse reaction refers to an event or reaction that is not listed in the investigator's brochure or is not listed at the specificity or severity that has been observed; or, if an investigator's brochure is not required or available, is not consistent with the risk information</description>
</secondary_outcome>
<secondary_outcome>
<measure>the frequency of unexpected adverse reactions (SUSARs) at 6 months</measure>
<time_frame>at 6 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).</time_frame>
<description>Unexpected adverse event or suspected adverse reaction refers to an event or reaction that is not listed in the investigator's brochure or is not listed at the specificity or severity that has been observed; or, if an investigator's brochure is not required or available, is not consistent with the risk information</description>
</secondary_outcome>
<enrollment type="Anticipated">5000</enrollment>
<condition>Neuromuscular Diseases</condition>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Survey</intervention_name>
<description>1 initial questionnaire and 1 monthly follow-up questionnaire for 11 months</description>
</intervention>
<eligibility>
<study_pop>
<textblock>
Patient with a neuromuscular disease
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. Patient with one of the following neuromuscular diseases:

- Autoimmune myasthenia gravis, Lambert-Eaton syndrome

- Congenital myasthenic syndromes

- Myositis

- Inflammatory neuropathies

- Hereditary neuropathies (Charcot-Marie-Tooth disease, etc.)

- Amyloid neuropathies

- Spinal atrophies

- Myotonic dystrophies type 1 (Steinert disease) and 2 (PROMM)

- Duchenne and Becker muscular dystrophies

- Muscular dystrophies of the girdles

- Pump disease

- Congenital myopathies

- Congenital muscular dystrophies

- Metabolic myopathies

- Other myopathies with confirmed genetic diagnosis

2. Patient over 18 years old

3. Patient having understood that the follow-up of a possible side effect of the
vaccination or of a COVID-19 must be carried out by his usual doctor (s) and not by
the observatory team Va-C-NEMUS

4. Patients having been informed of the study and having expressed their agreement

Exclusion Criteria:

1. Patient under legal protection, curatorship or tutorship
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>100 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Guilhem SOLE, MD</last_name>
<phone>0557821380</phone>
<email>guilhem.sole@chu-bordeaux.fr</email>
</overall_contact>
<overall_contact_backup>
<last_name>Aurore CAPELLI, PhD</last_name>
<phone>0557820877</phone>
<email>aurore.capelli@chu-bordeaux.fr</email>
</overall_contact_backup>
<location>
<facility>
<name>CHU de Bordeaux</name>
<address>
<city>Bordeaux</city>
<zip>33076</zip>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Guilhem SOLE, MD</last_name>
<phone>0557821380</phone>
<email>guilhem.sole@chu-bordeaux.fr</email>
</contact>
</location>
<location_countries>
<country>France</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 31, 2021</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>April 1, 2022</last_update_submitted>
<last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 5, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>COVID-19</keyword>
<keyword>vaccination</keyword>
<keyword>safety</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Neuromuscular Diseases</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The frequency of severe forms of COVID-19 is higher in people with neuromuscular disease and
in severe cases and long hospital stays, the disability of some neuromuscular patients may
worsen due to prolonged bed rest . Finally, the symptoms of certain diseases such as
myasthenia gravis can worsen after an infection such as COVID-19.
Thanks to an unprecedented research effort, vaccines are now available and others still in
development. The first studies published in medical journals are reassuring about the
efficacy and safety of these vaccines. However, they have been studied in the general
population and we do not yet have specific information in neuromuscular patients.
This is the reason why the Va-C-NEMUS observatory was launched.
Prevention of COVID-19 in neuromuscular patients is therefore fundamental and vaccination is
eagerly awaited by patients and their healthcare teams. An unprecedented research effort has
made it possible to create vaccines in a very short time when no vaccine directed against a
coronavirus has existed until now. Some of these vaccines are based on proven technologies
while others such as RNA vaccines are very innovative. The results of the phase III studies
of 3 of them have just been published (Pfizer/BioNTech, Moderna and Astra-Zeneca). Among
them, the Pfizer-BioNTech and Moderna vaccines have received authorization for use from the
European Medicines Agency. The data on the individuals enrolled in these trials are still not
very detailed. However, we already know that in the Pfizer/BioNTech trial, patients on
immunosuppressants were excluded. For the Astra-Zeneca vaccine, the publication combines data
from 4 different trials. In two of them the patients had to be in "good health". In any case,
we do not know the pathologies presented by patients outside the usual risk factors for the
severe form of COVID-19 (age, obesity, cardiovascular diseases, respiratory diseases). No
data on neuromuscular patients are currently known. The vaccination campaign began in France
in January 2021. The first neuromuscular patients should be vaccinated soon depending on
their comorbidities, but many questions arise in these patients both in terms of safety and
efficacy.
Patient with a neuromuscular disease
Inclusion Criteria:
1. Patient with one of the following neuromuscular diseases:
- Autoimmune myasthenia gravis, Lambert-Eaton syndrome
- Congenital myasthenic syndromes
- Myositis
- Inflammatory neuropathies
- Hereditary neuropathies (Charcot-Marie-Tooth disease, etc.)
- Amyloid neuropathies
- Spinal atrophies
- Myotonic dystrophies type 1 (Steinert disease) and 2 (PROMM)
- Duchenne and Becker muscular dystrophies
- Muscular dystrophies of the girdles
- Pump disease
- Congenital myopathies
- Congenital muscular dystrophies
- Metabolic myopathies
- Other myopathies with confirmed genetic diagnosis
2. Patient over 18 years old
3. Patient having understood that the follow-up of a possible side effect of the
vaccination or of a COVID-19 must be carried out by his usual doctor (s) and not by
the observatory team Va-C-NEMUS
4. Patients having been informed of the study and having expressed their agreement
Exclusion Criteria:
1. Patient under legal protection, curatorship or tutorship
|
NCT0531xxxx/NCT05311917.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/NCT05311917</url>
</required_header>
<id_info>
<org_study_id>1400.610</org_study_id>
<nct_id>NCT05311917</nct_id>
</id_info>
<brief_title>Home Vision Therapy and Prism Prescription in Presbyopic Persons With Convergence Insufficiency</brief_title>
<official_title>To Compare Home Vision Therapy and Prism Prescription in Presbyopic Persons With Convergence Insufficiency</official_title>
<sponsors>
<lead_sponsor>
<agency>Shahid Beheshti University of Medical Sciences</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Shahid Beheshti University of Medical Sciences</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>
convergence insufficiency is one of the most common binocular vision problems in which the
eyes tend to have more exophoria in near than distance activities. Its prevalence is
typically reported from 2.25% to 29.6% depending on the study population and its definition.
Most of its symptoms include difficulty seeing at close works, headache, eye pain during
study, blurred vision, diplopia, movement of words in reading, a feeling of pressure in the
eye, and lack of concentration. Its signs include increasing near point of convergence, more
exophoria at near than distance, decreased AC / A ratio, decreased positive fusional
vergence.

In patients with convergent insufficiency, the first valid and standard questionnaire to
assess the frequency and type of symptoms used before and after convergence insufficiency
treatment is the convergence insufficiency symptom survey (CISS) questionnaire.

Generally, vision therapy is the first choice for convergence insufficiency management and
the other choice is base in prism prescription. On the other hand, due to the changes in the
interaction of the accommodation and convergence systems with increasing age, It is necessary
to study how these systems interact and compare their responses to the active treatment of
vision therapy and inactive prescription of base in prism.

In this controlled study, investigators will evaluate and compare the effect of vision
therapy and base in prism prescription in patients over 40 years of age. this investigation
will help to clarify which treatment is more effective.

This study will have two phases. In the first phase, investigators will seek to check the
reliability and validity of the Persian version of CISS questionnaire for the elderly
patients. For this purpose, investigators will use the Persian version questionnaire in
previous study that assessed for young adults, and the investigators will modify it and check
the reliability and validity of the final Persian version for subjects with presbyopia. This
modified CISS questionnaire will be investigated in the elderly participants and the
appropriate cut off point to differentiate between the normal group and the group with
convergence insufficiency will be determined.

in the second phase one optometrist (Z.K.R) will do the preliminary examination and another
optometrist (S.A) will do the interventions. After the initial examination and having the
inclusion criteria, patients will be invited to participate in the study, the nature of the
research will be explained to subjects and informed consent will be obtained from them.
Before randomization, patients are asked to complete the CISS questionnaire and submit this
questionnaire to Optometrist No. 1 (Z.K.R).According to the randomization all patients will
be assigned to one of the treatment or control groups by optometrist No. 1. Vision therapy
exercises, necessary trainings and prescriptions are given to all patients by Optometrist No.
2 (S.A).For the participants in the control group only near glasses will be prescribed as a
conventional treatment, for the second group near glasses with base in prism according to
sheard's criterion will be prescribed and in the third group, the prescription of near
glasses will be given along with the complete training of the home exercises.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Between non-strabismic binocular vision problems, convergence insufficiency is the most
common problem (6) even in people with presbyopia this problem has high prevalence. (11) The
most common ocular finding in these patients is an increase in near exophoria and thus
reduces person's performance in activities such as reading, computer working and near
activities. (12) Despite the effectiveness of vision therapy in reducing patients' symptoms
and improving visual function, the different accommodation and vergence systems in the
elderly may cause different results (1) so a comprehensive study of adult patients over the
age of 40 with convergence insufficiency is needed. According to our knowledge the only study
in these patients was done by MH Birnbaum (13) in 1999 which had several limitations. For
example, in their study, the results were classified and recorded as success and failure in
functional therapy and improvement or non-improvement of asthenopia; Success in treatment was
achieved when two criteria were met: 1. The criterion of asthenopia includes achieving the
ability to study for at least one hour without diplopia; And the ability to study without
headache, eye pain and loss of concentration at least 75% of the time 2- Achieving 3 options
of functional criteria including having an appropriate near point of convergence, having
appropriate near point of convergence with red lens, having low near phoria and positive
fusional vergence.

Another problem of this study was: not using the CISS questionnaire, which is a valid
questionnaire of convergence insufficiency, and only considered success in treatment based on
the two criteria, it should be mentioned that in their study the method for patients'
selection did not report; On the other hand, the study was not blind, the importance of
designing blind studies has been proven. Only one study by B Teitelbaum assessed prism
prescription in patients over 40 years with convergence insufficiency (14) their study had
two main problems, first: selected patients did not necessarily have convergence
insufficiency, because the two basic criteria for convergence insufficiency (near point of
convergence and positive fusion vergence) did not include in their study. Second: not using
commercial progressive add lenses in patients glasses and it was unique lens with special
design with limitation in base in prism prescription.

Because of the effects of various factors on vision therapy including patients' motivation,
lack of cooperation in eye exercise, inappropriate age and unfavorable economic conditions,
(especially in developing countries like Iran) or pandemic condition like COVID19 pandemy,
vision therapy may not always be possible (1-3) and clinicians may have to prescribe base in
prism for these patients. On the other hand, due to the changes in accommodation and
convergence system and their interaction with aging (1, 3-4) study of their responses to the
two types of treatments including active vision therapy and passive base in prism therapy and
comparing them are noticeable matter and solving this challenge is absolutely necessary.

This study includes two phases. In the first phase, investigators will evaluate the
reliability and validity of the Persian version of questionnaire for the elderly patients,
this version was validated for young patients (38). Investigators will modify this questioner
for presbyopic patients. For this purpose, six optometrists experienced in binocular vision
will assess the questioner in two aspects: validity and reliability.

The validity of the modified Persian CISS include face validity (use of meaningful words),
content validity (relevancy, clarity, comprehensiveness), discriminant validity Using a
6-point Likert scale (very weak, weak, moderate, good, very good, best), face validity will
be assessed according to the aspects of fluency in elderly patients' cultural acceptance in
iran and a score of ≥4 for each question will be passable. Content validity will be
determined based on 1-relevancy (the extent to which the question of interest can being
closely connected or appropriate for characteristics of the content under study), 2-clarity
(appropriateness of the selected items in terms of being coherent and intelligible in concept
and writing style), and 3-comprehensiveness (the ability of the questioner to cover all
domains related to the topic under study). Relevancy and clarity will be assessed item by
item and for the whole items in the questioners using a 4-point Likert scale (1-undesirable,
2-relatively desirable, 3-desirable, 4-completely desirable), and the Item Content Validity
Index (I-CVI) and Scale Content Validity Index (S-CVI) will be calculated for the indices.
Universal agreement approach will be used to check, the I-CVI value and it will be between
0-100%, and I-CVI≥ 0.8 will be considered passable. 20 The S-CVI for relevancy and clarity
will be determined by averaging all I-CVI values. Comprehensiveness will be only measured at
the scale level using a 4-point Likert scale (1- incomprehensive, 2- relatively
comprehensive, 3- comprehensive, and 4- totally comprehensive). Then, the reliability of the
questionnaire will be assessed using test-retest reliability analysis between first and
second questioner administration in a group of 50 presbyopic patients aged 40-60 with
convergence insufficiency. The elderly participants will be asked to participate in a second
administration of the questionnaire 7-14 days later. To assess discriminant validity,
convergence insufficiency will be categorized to 3 groups of mild (PFV ≥1.50 × near
exophoria), severe (PFV < near exophoria), and moderate (values in between these groups)
based on the severity of clinical manifestations according to the Convergence Insufficiency
Treatment Trial guideline, and the mean overall CISS score Will be compared between these
three groups.

Also, to evaluate the validity and reliability of the CISS questionnaire in the elderly
patients and to determine the appropriate cut off point to differentiate between the normal
group and the group with the problem of convergence insufficiency, a group of 50 people aged
40-60 with normal binocular vision to compare the scores will be considered to fill out the
questionnaire and participants will complete the questionnaire again within 7 to 14 days.

T-test will be used to compare the scores of the convergence insufficiency group and the
group with normal binocular vision; The area under the ROC curve will also be used to assess
the ability of CISS scores to differentiate between individuals with convergence
insufficiency and individuals with normal binocular vision. Intraclass Correlation
Coefficient (ICC) will be used to assess the reliability of the CISS questionnaire.

In the second phase, After the initial examination and having the inclusion criteria,
patients will be invited to participate in the study, all the steps and nature of the
research will be explained to them and informed consent will be obtained from them. We will
have two optometrists, all patients will be assigned to one of the treatment or control
groups by optometrist number (1) (Zahra Kamary Rad). Before randomization, patients will be
asked to complete the CISS questionnaire and submit this questionnaire to Optometrist No.1.
Optometric examinations will be done by optometrist No1 (Zahra Kamary Rad) . First distance
and near uncorrected visual acuity will be measured, then patients refraction will be
measured by autokeratorefractometer (TOPCON, KR8800, Japan) and refraction will be repeated
by retinoscope(beta 200 Heine Germany ). Subjective refraction with positive maximal lens
method with maximum visual acuity will be obtained, distance heterophoria will be measured at
six meters with covzer and prism bar and target two lines above the best visual acuity. The
best visual acuity will be measured with near glasses at a distance of 40 cm and the cover
test results are repeated three times and bracketing method will be used to determine the
final result of the heterophoria measurements. The near point of convergence will be
evaluated by red-green filters method. In this method the near point of convergence will be
measured three times and the results will be averaged. The near point of convergence is
recorded based on break and recovery point with near glasses. The amplitude of monocular
accommodation will be calculated by push-up method, first in the right eye and then in the
left eye.

Near step PFV will be measured by base out prism bar using 20/30 column at 40 cm with
patients near glasses. Near vergence facility will be evaluated by flipper prism (3 base in
and 12 base out) with target two lines above the best near-corrected visual acuity. This test
will be also recorded by the patient's near glasses.

Stereopsis will be evaluated by the patients near glasses and red-green filters using TNO
test. To check the prism adaptation, one hour after wearing the glasses, the amount of
heterophoria will be measured again and the amount of change in the heterophoria is recorded
as prism adaptation in percentag. Tropicamide 1% will be then dropped twice 5 minutes apart,
in both eyes, and twenty minutes after the second drop refraction will be repeated; An
ophthalmologist will check and confirm the health status of the eyes with a slit lamp and a
+90 lens. After examining the patients by optometrist No. 1 vision therapy exercises and
necessary trainings will be given to all patients by optometrist No. 2 (Saeid Abdi) In order
to assign patients to each of the randomized treatment groups based on blocks classified
according to age, gender and severity of convergence insufficiency.

For patients in control group new near glasses as a conventional treatment with the practice
of random and aimless eye movements, without convergence and accommodation effects will be
prescribed by optometrist No. 2 (Saeid Abdi) in Patients with base in prism prescription
using sheards criterion near prismatic glasses will be prescribed and the amount of prism
will be divided between two eyes; and random and aimless eye movements, without convergence
and accommodation effects will be prescribed by optometrist No. 2 (Saeid Abdi).

In patients in the home exercise group , near glasses will be prescribed along with a
complete training of the exercises and with a form of information about how and how long to
do the exercise, along with random and aimless eye movements, by optometrist No 2 (Saeid
Abdi).

These accommodation/ convergence training includes:

Voluntary convergence, Bug on string, Eccentric Circles, Jumping vergence , Barrel card,
chiastopic fusion, Brock string, push-up These exercises will be performed by the patient in
a variety of ways in each session. Which will be 3 days a week for 20 minutes ( 10 minutes at
noon and 10 minutes at night ) and must record these exercises for 2 month. Home exercises
include eight vision therapy exercises and patients willdo two exercises each day at noon and
two exercises at night. Also, each exercise will be done five minutes , so subjects have to
do four different exercises every day, and in the next session participants have to do the
next four exercises.

Participants should register these trainings in a special form for 2 months. The total number
of training sessions will be two months( 24 sessions) All prescribed glasses will be checked
and used after confirmation, and patients do not know in which group categorized.

Practice and use of glasses will continue for 2 months and the participants will refer for
the final examination and all optometric examinations will be repeated by optometrist No. 1
It should also be noted that base in prism will be prescribed according to the sheards
criterion and will be rounded upwards and this amount of prism is evenly divided between the
two eye.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 3, 2022</start_date>
<completion_date type="Anticipated">August 2023</completion_date>
<primary_completion_date type="Anticipated">July 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>treatment success criteria</measure>
<time_frame>2 month after intervention</time_frame>
<description>achieving near point of convergence below 6 cm or 4 cm reduction in its distance, positive fusional vergence according to sheard criterion or grater than 15 prism or 10 prism improvement.
achieving normal limit in CISS or 10 score improvement in total score.</description>
</primary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">250</enrollment>
<condition>Convergence Insufficiency</condition>
<arm_group>
<arm_group_label>home vision therapy</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>near glasses will be prescribed along with a complete training of the exercises and with a eye exercise form of information about how and how long to do the exercise, by optometrist No 2 (Saeid Abdi).training includes: Voluntary convergence, Bug on string, Eccentric Circles, Jumping vergence , Barrel card, chiastopic fusion, Brock string, push-up These exercises will be done 3 days a week for 20 minutes ( 10 minutes at noon and 10 minutes at night ) for 2 month. Home exercises include eight vision therapy exercises and patients will do two exercises each day at noon and two exercises at night.</description>
</arm_group>
<arm_group>
<arm_group_label>base in prism prescription</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>base in prism prescription using sheards criterion near prismatic glasses will be prescribed and the amount of prism will be divided between two eyes; and random and aimless eye movements, without convergence and accommodation effects will be prescribed by optometrist No. 2 (Saeid Abdi). patients should complete their checking form for eye exercises.</description>
</arm_group>
<arm_group>
<arm_group_label>conventional</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>new near glasses as a conventional treatment with the practice of random and aimless eye movements, without convergence and accommodation effects will be prescribed by optometrist No. 2 (Saeid Abdi). patients should complete the form of their eye training.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>home vision therapy</intervention_name>
<description>a group of vision therapy procedures in home to improve convergence insufficiency</description>
<arm_group_label>home vision therapy</arm_group_label>
<other_name>home eye training</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>base in prism prescription</intervention_name>
<description>base in prism prescription according to sheards criterion</description>
<arm_group_label>base in prism prescription</arm_group_label>
<other_name>prism prescription</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>conventional placebo</intervention_name>
<description>using near glasses with aimless eye training</description>
<arm_group_label>conventional</arm_group_label>
<other_name>placebo</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

CISS score more than the estimated cut off point

Best corrected visual acuity=20/20 for near and far

Having Convergence Insufficiency

Near exophoria should be at least 4 prisms more than distant exophoria

NPC more than 6 cm

Inadequate near-positive positive fusion according to the Convergence Insufficiency
Treatment Trial (CITT) study (8)

Normal monocular accomodation amplitude according to Hofster formula

Exclusion Criteria:

Any type of strabismus

Amblyopia

Refractive error more than 6 diopters

Patients with history of prism prescription

History of vision therapy from 5 years ago

History of strabismus surgery or refractive error surgery

History of eye trauma

Use of any ophthalmic or general ophthalmic drugs affect ocular accommodation such as
phenylephrine, anticholinergic drugs (mydriatics), carbonic anhydrase inhibitors,
antihistamines, morphine and its derivatives, antidepressants amphetamine and imipramine

More than one prism of vertical phoria

Any mechanical limitations in the eye muscles

Ocular muscle paralysis

Nystagmus

Any systemic and neurological diseases affecting binocular vision such as diabetes,
myasthenia gravis, Graves', multiple sclerosis
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>40 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Saeid Abdi, PhD student</last_name>
<phone>0989181071851</phone>
<email>opto.abdi@gmail.com</email>
</overall_contact>
<location>
<facility>
<name>Shahid Beheshti University of Medical Sciences</name>
<address>
<city>Tehran</city>
<country>Iran, Islamic Republic of</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Saeid Abdi, PhD student</last_name>
<phone>0989181071851</phone>
<email>opto.abdi@gmail.com</email>
</contact>
</location>
<location_countries>
<country>Iran, Islamic Republic of</country>
</location_countries>
<verification_date>April 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>April 22, 2023</last_update_submitted>
<last_update_submitted_qc>April 22, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">April 25, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
<investigator_full_name>Saeid Abdi</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>vision therapy</keyword>
<keyword>prism prescription</keyword>
<keyword>convergence insufficiency</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ocular Motility Disorders</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
convergence insufficiency is one of the most common binocular vision problems in which the
eyes tend to have more exophoria in near than distance activities. Its prevalence is
typically reported from 2.25% to 29.6% depending on the study population and its definition.
Most of its symptoms include difficulty seeing at close works, headache, eye pain during
study, blurred vision, diplopia, movement of words in reading, a feeling of pressure in the
eye, and lack of concentration. Its signs include increasing near point of convergence, more
exophoria at near than distance, decreased AC / A ratio, decreased positive fusional
vergence.
In patients with convergent insufficiency, the first valid and standard questionnaire to
assess the frequency and type of symptoms used before and after convergence insufficiency
treatment is the convergence insufficiency symptom survey (CISS) questionnaire.
Generally, vision therapy is the first choice for convergence insufficiency management and
the other choice is base in prism prescription. On the other hand, due to the changes in the
interaction of the accommodation and convergence systems with increasing age, It is necessary
to study how these systems interact and compare their responses to the active treatment of
vision therapy and inactive prescription of base in prism.
In this controlled study, investigators will evaluate and compare the effect of vision
therapy and base in prism prescription in patients over 40 years of age. this investigation
will help to clarify which treatment is more effective.
This study will have two phases. In the first phase, investigators will seek to check the
reliability and validity of the Persian version of CISS questionnaire for the elderly
patients. For this purpose, investigators will use the Persian version questionnaire in
previous study that assessed for young adults, and the investigators will modify it and check
the reliability and validity of the final Persian version for subjects with presbyopia. This
modified CISS questionnaire will be investigated in the elderly participants and the
appropriate cut off point to differentiate between the normal group and the group with
convergence insufficiency will be determined.
in the second phase one optometrist (Z.K.R) will do the preliminary examination and another
optometrist (S.A) will do the interventions. After the initial examination and having the
inclusion criteria, patients will be invited to participate in the study, the nature of the
research will be explained to subjects and informed consent will be obtained from them.
Before randomization, patients are asked to complete the CISS questionnaire and submit this
questionnaire to Optometrist No. 1 (Z.K.R).According to the randomization all patients will
be assigned to one of the treatment or control groups by optometrist No. 1. Vision therapy
exercises, necessary trainings and prescriptions are given to all patients by Optometrist No.
2 (S.A).For the participants in the control group only near glasses will be prescribed as a
conventional treatment, for the second group near glasses with base in prism according to
sheard's criterion will be prescribed and in the third group, the prescription of near
glasses will be given along with the complete training of the home exercises.
Between non-strabismic binocular vision problems, convergence insufficiency is the most
common problem (6) even in people with presbyopia this problem has high prevalence. (11) The
most common ocular finding in these patients is an increase in near exophoria and thus
reduces person's performance in activities such as reading, computer working and near
activities. (12) Despite the effectiveness of vision therapy in reducing patients' symptoms
and improving visual function, the different accommodation and vergence systems in the
elderly may cause different results (1) so a comprehensive study of adult patients over the
age of 40 with convergence insufficiency is needed. According to our knowledge the only study
in these patients was done by MH Birnbaum (13) in 1999 which had several limitations. For
example, in their study, the results were classified and recorded as success and failure in
functional therapy and improvement or non-improvement of asthenopia; Success in treatment was
achieved when two criteria were met: 1. The criterion of asthenopia includes achieving the
ability to study for at least one hour without diplopia; And the ability to study without
headache, eye pain and loss of concentration at least 75% of the time 2- Achieving 3 options
of functional criteria including having an appropriate near point of convergence, having
appropriate near point of convergence with red lens, having low near phoria and positive
fusional vergence.
Another problem of this study was: not using the CISS questionnaire, which is a valid
questionnaire of convergence insufficiency, and only considered success in treatment based on
the two criteria, it should be mentioned that in their study the method for patients'
selection did not report; On the other hand, the study was not blind, the importance of
designing blind studies has been proven. Only one study by B Teitelbaum assessed prism
prescription in patients over 40 years with convergence insufficiency (14) their study had
two main problems, first: selected patients did not necessarily have convergence
insufficiency, because the two basic criteria for convergence insufficiency (near point of
convergence and positive fusion vergence) did not include in their study. Second: not using
commercial progressive add lenses in patients glasses and it was unique lens with special
design with limitation in base in prism prescription.
Because of the effects of various factors on vision therapy including patients' motivation,
lack of cooperation in eye exercise, inappropriate age and unfavorable economic conditions,
(especially in developing countries like Iran) or pandemic condition like COVID19 pandemy,
vision therapy may not always be possible (1-3) and clinicians may have to prescribe base in
prism for these patients. On the other hand, due to the changes in accommodation and
convergence system and their interaction with aging (1, 3-4) study of their responses to the
two types of treatments including active vision therapy and passive base in prism therapy and
comparing them are noticeable matter and solving this challenge is absolutely necessary.
This study includes two phases. In the first phase, investigators will evaluate the
reliability and validity of the Persian version of questionnaire for the elderly patients,
this version was validated for young patients (38). Investigators will modify this questioner
for presbyopic patients. For this purpose, six optometrists experienced in binocular vision
will assess the questioner in two aspects: validity and reliability.
The validity of the modified Persian CISS include face validity (use of meaningful words),
content validity (relevancy, clarity, comprehensiveness), discriminant validity Using a
6-point Likert scale (very weak, weak, moderate, good, very good, best), face validity will
be assessed according to the aspects of fluency in elderly patients' cultural acceptance in
iran and a score of ≥4 for each question will be passable. Content validity will be
determined based on 1-relevancy (the extent to which the question of interest can being
closely connected or appropriate for characteristics of the content under study), 2-clarity
(appropriateness of the selected items in terms of being coherent and intelligible in concept
and writing style), and 3-comprehensiveness (the ability of the questioner to cover all
domains related to the topic under study). Relevancy and clarity will be assessed item by
item and for the whole items in the questioners using a 4-point Likert scale (1-undesirable,
2-relatively desirable, 3-desirable, 4-completely desirable), and the Item Content Validity
Index (I-CVI) and Scale Content Validity Index (S-CVI) will be calculated for the indices.
Universal agreement approach will be used to check, the I-CVI value and it will be between
0-100%, and I-CVI≥ 0.8 will be considered passable. 20 The S-CVI for relevancy and clarity
will be determined by averaging all I-CVI values. Comprehensiveness will be only measured at
the scale level using a 4-point Likert scale (1- incomprehensive, 2- relatively
comprehensive, 3- comprehensive, and 4- totally comprehensive). Then, the reliability of the
questionnaire will be assessed using test-retest reliability analysis between first and
second questioner administration in a group of 50 presbyopic patients aged 40-60 with
convergence insufficiency. The elderly participants will be asked to participate in a second
administration of the questionnaire 7-14 days later. To assess discriminant validity,
convergence insufficiency will be categorized to 3 groups of mild (PFV ≥1.50 × near
exophoria), severe (PFV < near exophoria), and moderate (values in between these groups)
based on the severity of clinical manifestations according to the Convergence Insufficiency
Treatment Trial guideline, and the mean overall CISS score Will be compared between these
three groups.
Also, to evaluate the validity and reliability of the CISS questionnaire in the elderly
patients and to determine the appropriate cut off point to differentiate between the normal
group and the group with the problem of convergence insufficiency, a group of 50 people aged
40-60 with normal binocular vision to compare the scores will be considered to fill out the
questionnaire and participants will complete the questionnaire again within 7 to 14 days.
T-test will be used to compare the scores of the convergence insufficiency group and the
group with normal binocular vision; The area under the ROC curve will also be used to assess
the ability of CISS scores to differentiate between individuals with convergence
insufficiency and individuals with normal binocular vision. Intraclass Correlation
Coefficient (ICC) will be used to assess the reliability of the CISS questionnaire.
In the second phase, After the initial examination and having the inclusion criteria,
patients will be invited to participate in the study, all the steps and nature of the
research will be explained to them and informed consent will be obtained from them. We will
have two optometrists, all patients will be assigned to one of the treatment or control
groups by optometrist number (1) (Zahra Kamary Rad). Before randomization, patients will be
asked to complete the CISS questionnaire and submit this questionnaire to Optometrist No.1.
Optometric examinations will be done by optometrist No1 (Zahra Kamary Rad) . First distance
and near uncorrected visual acuity will be measured, then patients refraction will be
measured by autokeratorefractometer (TOPCON, KR8800, Japan) and refraction will be repeated
by retinoscope(beta 200 Heine Germany ). Subjective refraction with positive maximal lens
method with maximum visual acuity will be obtained, distance heterophoria will be measured at
six meters with covzer and prism bar and target two lines above the best visual acuity. The
best visual acuity will be measured with near glasses at a distance of 40 cm and the cover
test results are repeated three times and bracketing method will be used to determine the
final result of the heterophoria measurements. The near point of convergence will be
evaluated by red-green filters method. In this method the near point of convergence will be
measured three times and the results will be averaged. The near point of convergence is
recorded based on break and recovery point with near glasses. The amplitude of monocular
accommodation will be calculated by push-up method, first in the right eye and then in the
left eye.
Near step PFV will be measured by base out prism bar using 20/30 column at 40 cm with
patients near glasses. Near vergence facility will be evaluated by flipper prism (3 base in
and 12 base out) with target two lines above the best near-corrected visual acuity. This test
will be also recorded by the patient's near glasses.
Stereopsis will be evaluated by the patients near glasses and red-green filters using TNO
test. To check the prism adaptation, one hour after wearing the glasses, the amount of
heterophoria will be measured again and the amount of change in the heterophoria is recorded
as prism adaptation in percentag. Tropicamide 1% will be then dropped twice 5 minutes apart,
in both eyes, and twenty minutes after the second drop refraction will be repeated; An
ophthalmologist will check and confirm the health status of the eyes with a slit lamp and a
+90 lens. After examining the patients by optometrist No. 1 vision therapy exercises and
necessary trainings will be given to all patients by optometrist No. 2 (Saeid Abdi) In order
to assign patients to each of the randomized treatment groups based on blocks classified
according to age, gender and severity of convergence insufficiency.
For patients in control group new near glasses as a conventional treatment with the practice
of random and aimless eye movements, without convergence and accommodation effects will be
prescribed by optometrist No. 2 (Saeid Abdi) in Patients with base in prism prescription
using sheards criterion near prismatic glasses will be prescribed and the amount of prism
will be divided between two eyes; and random and aimless eye movements, without convergence
and accommodation effects will be prescribed by optometrist No. 2 (Saeid Abdi).
In patients in the home exercise group , near glasses will be prescribed along with a
complete training of the exercises and with a form of information about how and how long to
do the exercise, along with random and aimless eye movements, by optometrist No 2 (Saeid
Abdi).
These accommodation/ convergence training includes:
Voluntary convergence, Bug on string, Eccentric Circles, Jumping vergence , Barrel card,
chiastopic fusion, Brock string, push-up These exercises will be performed by the patient in
a variety of ways in each session. Which will be 3 days a week for 20 minutes ( 10 minutes at
noon and 10 minutes at night ) and must record these exercises for 2 month. Home exercises
include eight vision therapy exercises and patients willdo two exercises each day at noon and
two exercises at night. Also, each exercise will be done five minutes , so subjects have to
do four different exercises every day, and in the next session participants have to do the
next four exercises.
Participants should register these trainings in a special form for 2 months. The total number
of training sessions will be two months( 24 sessions) All prescribed glasses will be checked
and used after confirmation, and patients do not know in which group categorized.
Practice and use of glasses will continue for 2 months and the participants will refer for
the final examination and all optometric examinations will be repeated by optometrist No. 1
It should also be noted that base in prism will be prescribed according to the sheards
criterion and will be rounded upwards and this amount of prism is evenly divided between the
two eye.
Inclusion Criteria:
CISS score more than the estimated cut off point
Best corrected visual acuity=20/20 for near and far
Having Convergence Insufficiency
Near exophoria should be at least 4 prisms more than distant exophoria
NPC more than 6 cm
Inadequate near-positive positive fusion according to the Convergence Insufficiency
Treatment Trial (CITT) study (8)
Normal monocular accomodation amplitude according to Hofster formula
Exclusion Criteria:
Any type of strabismus
Amblyopia
Refractive error more than 6 diopters
Patients with history of prism prescription
History of vision therapy from 5 years ago
History of strabismus surgery or refractive error surgery
History of eye trauma
Use of any ophthalmic or general ophthalmic drugs affect ocular accommodation such as
phenylephrine, anticholinergic drugs (mydriatics), carbonic anhydrase inhibitors,
antihistamines, morphine and its derivatives, antidepressants amphetamine and imipramine
More than one prism of vertical phoria
Any mechanical limitations in the eye muscles
Ocular muscle paralysis
Nystagmus
Any systemic and neurological diseases affecting binocular vision such as diabetes,
myasthenia gravis, Graves', multiple sclerosis
|
NCT0531xxxx/NCT05311930.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/NCT05311930</url>
</required_header>
<id_info>
<org_study_id>TPO-RAs-old patients</org_study_id>
<nct_id>NCT05311930</nct_id>
</id_info>
<brief_title>Efficacy and Safety of TPO Receptor Agonists in the Treatment of Elderly ITP Patients</brief_title>
<official_title>Efficacy and Safety of TPO Receptor Agonists as First-line Drugs in the Treatment of Newly Diagnosed Elderly ITP Patients in China-an Open Label Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Wuhan Union Hospital, China</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Jiangsu Hengrui Pharmaceutical Co., Ltd.</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>Wuhan Union Hospital, China</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>
Elderly ITP patients have many underlying diseases, hormone contraindications and many
adverse reactions during the use of hormones. TPO-RAs are oral small-molecule non-peptide
drugs. Retrospective studies have shown that they have good efficacy and high safety in
elderly patients. Therefore, this study is a prospective trial to evaluate TPO-RAs as the
first-choice drug for the treatment of elderly ITP patients with contraindications to
hormones, aiming to improve the efficacy-risk ratio of elderly patients
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Primary immune thrombocytopenia (ITP) is an immune disorder characterized by decreased
production and increased destruction of platelets. In recent years, with the in-depth
exploration of its pathogenesis and the continuous influx of new drugs, the status of
second-line treatment drugs, mainly TPO receptor agonists (TPO-RAs), has been continuously
improved, which has brought great importance to the treatment and management of ITP patients.
However, for elderly ITP patients with severe underlying diseases, poor hormone tolerance,
severe adverse reactions or hormone contraindications, whether TPO receptor agonists can be
used as the first-choice drug and its efficacy and safety are still lacking relevant
research, and for elderly ITP patients There is a lack of uniform guidelines for the
treatment and management of patients. Limited retrospective studies have shown that TPO
receptor agonists have good safety and efficacy, and are expected to become the recommended
drugs for the treatment of elderly patients with ITP. However, whether TPO receptor agonists
can be directly used as the first-choice drug for newly diagnosed elderly ITP patients who
are not suitable for first-line treatment and its efficacy are uncertain.

This study will include newly diagnosed elderly ITP patients with hormonal contraindications
or potential serious side effects of hormonal therapy, take the TPO-RA drug hetropoda as the
first-choice treatment drug, and explore the effectiveness of hetrompopag in such patients
and safety analysis. This study will provide new ideas and clinical basis for standardized
and individualized treatment of elderly ITP patients, and provide practical experience for
promoting the establishment of elderly ITP treatment guidelines.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">May 1, 2022</start_date>
<completion_date type="Anticipated">December 30, 2024</completion_date>
<primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date>
<phase>Phase 4</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>This is a single-arm open-label trial. After enrollment, patients received an initial dose of 2.5 mg of hetropoda for 4 weeks, and blood routine monitoring was performed regularly during treatment.</intervention_model_description>
<primary_purpose>Other</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Treatment response</measure>
<time_frame>28 days</time_frame>
<description>Proportion of subjects with platelet counts ≥50×10^9/L after 28 days of treatment</description>
</primary_outcome>
<secondary_outcome>
<measure>Remission rate</measure>
<time_frame>28 days</time_frame>
<description>Complete response, effective, ineffective proportion of testers after 28 days of treatment</description>
</secondary_outcome>
<secondary_outcome>
<measure>Drug efficacy</measure>
<time_frame>28 days</time_frame>
<description>During treatment, the proportion of subjects, which the platelet count at least once reached ≥50×109/L.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluation of effectiveness</measure>
<time_frame>28 days</time_frame>
<description>During treatment, the proportion of subjects, which the platelet count increased at least 2 times compared with baseline.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Adverse events</measure>
<time_frame>6 months from treatment</time_frame>
<description>Evaluate the incidence and severity of bleeding based on the ITP-BAT bleeding score</description>
</secondary_outcome>
<secondary_outcome>
<measure>Adverse events</measure>
<time_frame>6 months from treatment</time_frame>
<description>During treatment, the proportion of subjects, which received at least once rescue</description>
</secondary_outcome>
<secondary_outcome>
<measure>Side effects of drugs</measure>
<time_frame>1 month from treatment</time_frame>
<description>Assessing safety through the adverse events,such as liver damage, etc.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">69</enrollment>
<condition>Primary Immune Thrombocytopenia</condition>
<arm_group>
<arm_group_label>2.5mg/d</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>After the subjects signed the informed consent and passed the screening, they entered the treatment period and received a starting dose of 2.5 mg/d of Hetrabopag. During the treatment process, the clinician adjusted the drug dose according to the patient's own conditions. The maximum drug dose was 7.5 mg qd, 28 d Evaluate efficacy and safety after completion;</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>2.5mg/d Hetrombopag</intervention_name>
<description>After the subjects signed the informed consent and passed the screening, they entered the treatment period and received a starting dose of 2.5 mg/d of Hytrombopag. During the treatment process, the clinician adjusted the drug dose according to the patient's own conditions. The maximum drug dose was 7.5 mg qd, 28 d Evaluate efficacy and safety after completion;</description>
<arm_group_label>2.5mg/d</arm_group_label>
<other_name>no use</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- 1. The patient voluntarily signed the informed consent; 2. The patient is a newly
diagnosed ITP patient, aged ≥60 years old; 3. Two consecutive PLTs < 30×109/L, or two
consecutive PLTs < 30×109/L≤PLT<50×109/L but with risk factors such as bleeding (such
as previous bleeding history and/or anticoagulation/antiplatelet) Concomitant
medication) or age > 75 years; 4. Have not received first-line treatment such as
hormones, IVIG, etc.; 5. There is any hormonal contraindication (with active peptic
ulcer, recent gastrointestinal anastomosis, corneal ulcer, severe hypertension (high
blood pressure ≥ grade 2), diabetes with poor blood sugar control, infection that
cannot be controlled by antibiotics ( Bacterial and viral infections), heart failure
and adrenal hyperfunction, severe mental illnesses such as epilepsy, severe
osteoporosis, rheumatoid arthritis, tuberculosis, fractures, patients with combined
antithrombotic and antiplatelet drugs, etc.); 6. The following clinical biochemical
indicators must be within ±20% of the upper and lower limits of normal values:
creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin and
alkaline phosphatase.

Exclusion Criteria:

- 1. Exclude immune diseases such as systemic lupus erythematosus, antiphospholipid
syndrome, etc.; 2. Exclude drug-related thrombocytopenia; 3. Bone marrow-related
examinations suggest the presence of other primary diseases of the blood system (such
as MDS, AA, thrombotic thrombocytopenic purpura, etc.) or the presence of
myelofibrosis MF≥2; 4. Participated in other clinical trials affecting platelet count
and function 3 months before the trial; 5. Previously received first-line therapy such
as hormones, IVIG; 6. Previous use of TPO-RAs or poor efficacy against known TPO
drugs; 7. The patient has experienced severe arterial or venous thrombosis (stroke,
transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary
embolism), or clinical symptoms suggest thrombophilia; 8. HIV, hepatitis B or C
seropositive or a history of liver cirrhosis or portal hypertension; 9.
Life-threatening bleeding (WHO bleeding score 4) or the patient is expected to require
salvage treatment before the first dose; 10. Has a history of malignant tumor or is
accompanied by malignant tumor; 11. The investigator believes that there are any other
circumstances that may cause the subjects to fail to complete the study or bring
obvious risks to the subjects.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>60 Years</minimum_age>
<maximum_age>100 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Heng Mei, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Wuhan Union Hospital, China</affiliation>
</overall_official>
<overall_contact>
<last_name>Heng Mei, PhD</last_name>
<phone>86-13886160811</phone>
<phone_ext>8613986183871</phone_ext>
<email>hmei@hust.edu.cn</email>
</overall_contact>
<overall_contact_backup>
<last_name>Min Xu, MD</last_name>
<phone>86-13212794115</phone>
<phone_ext>8613986183871</phone_ext>
<email>xu_min1015@163.com</email>
</overall_contact_backup>
<reference>
<citation>Frederiksen H, Schmidt K. The incidence of idiopathic thrombocytopenic purpura in adults increases with age. Blood. 1999 Aug 1;94(3):909-13.</citation>
<PMID>10419881</PMID>
</reference>
<reference>
<citation>Moulis G, Palmaro A, Montastruc JL, Godeau B, Lapeyre-Mestre M, Sailler L. Epidemiology of incident immune thrombocytopenia: a nationwide population-based study in France. Blood. 2014 Nov 20;124(22):3308-15. doi: 10.1182/blood-2014-05-578336. Epub 2014 Oct 10.</citation>
<PMID>25305203</PMID>
</reference>
<reference>
<citation>Glynn RJ, Field TS, Rosner B, Hebert PR, Taylor JO, Hennekens CH. Evidence for a positive linear relation between blood pressure and mortality in elderly people. Lancet. 1995 Apr 1;345(8953):825-9. doi: 10.1016/s0140-6736(95)92964-9.</citation>
<PMID>7898229</PMID>
</reference>
<reference>
<citation>Neunert C, Terrell DR, Arnold DM, Buchanan G, Cines DB, Cooper N, Cuker A, Despotovic JM, George JN, Grace RF, Kuhne T, Kuter DJ, Lim W, McCrae KR, Pruitt B, Shimanek H, Vesely SK. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019 Dec 10;3(23):3829-3866. doi: 10.1182/bloodadvances.2019000966. Erratum In: Blood Adv. 2020 Jan 28;4(2):252.</citation>
<PMID>31794604</PMID>
</reference>
<reference>
<citation>Cortelazzo S, Finazzi G, Buelli M, Molteni A, Viero P, Barbui T. High risk of severe bleeding in aged patients with chronic idiopathic thrombocytopenic purpura. Blood. 1991 Jan 1;77(1):31-3.</citation>
<PMID>1984800</PMID>
</reference>
<reference>
<citation>Ruggeri M, Tosetto A, Palandri F, Polverelli N, Mazzucconi MG, Santoro C, Gaidano G, Lunghi M, Zaja F, De Stefano V, Sartori R, Fazi P, Rodeghiero F; Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Anemia and Thrombocytopenias Working Party. GIMEMA Study ITP0311. Thrombotic risk in patients with primary immune thrombocytopenia is only mildly increased and explained by personal and treatment-related risk factors. J Thromb Haemost. 2014 Aug;12(8):1266-73. doi: 10.1111/jth.12636. Epub 2014 Jul 16.</citation>
<PMID>24942752</PMID>
</reference>
<reference>
<citation>Michel M, Rauzy OB, Thoraval FR, Languille L, Khellaf M, Bierling P, Godeau B. Characteristics and outcome of immune thrombocytopenia in elderly: results from a single center case-controlled study. Am J Hematol. 2011 Dec;86(12):980-4. doi: 10.1002/ajh.22170. Epub 2011 Sep 28.</citation>
<PMID>21956157</PMID>
</reference>
<reference>
<citation>Daou S, Federici L, Zimmer J, Maloisel F, Serraj K, Andres E. Idiopathic thrombocytopenic purpura in elderly patients: a study of 47 cases from a single reference center. Eur J Intern Med. 2008 Oct;19(6):447-51. doi: 10.1016/j.ejim.2007.07.006. Epub 2008 Feb 20.</citation>
<PMID>18848179</PMID>
</reference>
<reference>
<citation>Zhou H, Fu R, Wang H, Zhou F, Li H, Zhou Z, Zhang L, Yang R. Immune thrombocytopenia in the elderly: clinical course in 525 patients from a single center in China. Ann Hematol. 2013 Jan;92(1):79-87. doi: 10.1007/s00277-012-1567-2. Epub 2012 Sep 6.</citation>
<PMID>22956151</PMID>
</reference>
<verification_date>March 2022</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>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>
<keyword>hetrombopag</keyword>
<keyword>Primary Immune Thrombocytopenia</keyword>
<keyword>platelets</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Thrombocytopenia</mesh_term>
<mesh_term>Purpura, Thrombocytopenic, Idiopathic</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>the data will share to others if they not involve patient privacy</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_time_frame>the data will be shared after the study is completed, it will take 2 years.</ipd_time_frame>
<ipd_access_criteria>Not sure yet</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Elderly ITP patients have many underlying diseases, hormone contraindications and many
adverse reactions during the use of hormones. TPO-RAs are oral small-molecule non-peptide
drugs. Retrospective studies have shown that they have good efficacy and high safety in
elderly patients. Therefore, this study is a prospective trial to evaluate TPO-RAs as the
first-choice drug for the treatment of elderly ITP patients with contraindications to
hormones, aiming to improve the efficacy-risk ratio of elderly patients
Primary immune thrombocytopenia (ITP) is an immune disorder characterized by decreased
production and increased destruction of platelets. In recent years, with the in-depth
exploration of its pathogenesis and the continuous influx of new drugs, the status of
second-line treatment drugs, mainly TPO receptor agonists (TPO-RAs), has been continuously
improved, which has brought great importance to the treatment and management of ITP patients.
However, for elderly ITP patients with severe underlying diseases, poor hormone tolerance,
severe adverse reactions or hormone contraindications, whether TPO receptor agonists can be
used as the first-choice drug and its efficacy and safety are still lacking relevant
research, and for elderly ITP patients There is a lack of uniform guidelines for the
treatment and management of patients. Limited retrospective studies have shown that TPO
receptor agonists have good safety and efficacy, and are expected to become the recommended
drugs for the treatment of elderly patients with ITP. However, whether TPO receptor agonists
can be directly used as the first-choice drug for newly diagnosed elderly ITP patients who
are not suitable for first-line treatment and its efficacy are uncertain.
This study will include newly diagnosed elderly ITP patients with hormonal contraindications
or potential serious side effects of hormonal therapy, take the TPO-RA drug hetropoda as the
first-choice treatment drug, and explore the effectiveness of hetrompopag in such patients
and safety analysis. This study will provide new ideas and clinical basis for standardized
and individualized treatment of elderly ITP patients, and provide practical experience for
promoting the establishment of elderly ITP treatment guidelines.
Inclusion Criteria:
- 1. The patient voluntarily signed the informed consent; 2. The patient is a newly
diagnosed ITP patient, aged ≥60 years old; 3. Two consecutive PLTs < 30×109/L, or two
consecutive PLTs < 30×109/L≤PLT<50×109/L but with risk factors such as bleeding (such
as previous bleeding history and/or anticoagulation/antiplatelet) Concomitant
medication) or age > 75 years; 4. Have not received first-line treatment such as
hormones, IVIG, etc.; 5. There is any hormonal contraindication (with active peptic
ulcer, recent gastrointestinal anastomosis, corneal ulcer, severe hypertension (high
blood pressure ≥ grade 2), diabetes with poor blood sugar control, infection that
cannot be controlled by antibiotics ( Bacterial and viral infections), heart failure
and adrenal hyperfunction, severe mental illnesses such as epilepsy, severe
osteoporosis, rheumatoid arthritis, tuberculosis, fractures, patients with combined
antithrombotic and antiplatelet drugs, etc.); 6. The following clinical biochemical
indicators must be within ±20% of the upper and lower limits of normal values:
creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin and
alkaline phosphatase.
Exclusion Criteria:
- 1. Exclude immune diseases such as systemic lupus erythematosus, antiphospholipid
syndrome, etc.; 2. Exclude drug-related thrombocytopenia; 3. Bone marrow-related
examinations suggest the presence of other primary diseases of the blood system (such
as MDS, AA, thrombotic thrombocytopenic purpura, etc.) or the presence of
myelofibrosis MF≥2; 4. Participated in other clinical trials affecting platelet count
and function 3 months before the trial; 5. Previously received first-line therapy such
as hormones, IVIG; 6. Previous use of TPO-RAs or poor efficacy against known TPO
drugs; 7. The patient has experienced severe arterial or venous thrombosis (stroke,
transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary
embolism), or clinical symptoms suggest thrombophilia; 8. HIV, hepatitis B or C
seropositive or a history of liver cirrhosis or portal hypertension; 9.
Life-threatening bleeding (WHO bleeding score 4) or the patient is expected to require
salvage treatment before the first dose; 10. Has a history of malignant tumor or is
accompanied by malignant tumor; 11. The investigator believes that there are any other
circumstances that may cause the subjects to fail to complete the study or bring
obvious risks to the subjects.
|
NCT0531xxxx/NCT05311943.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/NCT05311943</url>
</required_header>
<id_info>
<org_study_id>OLV20220331</org_study_id>
<nct_id>NCT05311943</nct_id>
</id_info>
<brief_title>Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.</brief_title>
<official_title>Treatment With Olverembatinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Failed to at Least Two Previously Administered Second-generation Tyrosine Kinase Inhibitors: a Prospective, Single-arm Clinical Trial.</official_title>
<sponsors>
<lead_sponsor>
<agency>Shenzhen Second People's Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Shenzhen Second People's 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 purpose of this trial is to evaluate the efficacy and safety of olverembatinib(HQP1351)
in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or
intolerant to at least two second-generation tyrosine kinase inhibitors. The efficacy of
olverembatinib is determined by evaluating the major molecular responses(MMR) at the and of
12 months.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">July 1, 2022</start_date>
<completion_date type="Anticipated">June 30, 2025</completion_date>
<primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>olverembatinib, 40mg, taken orally once every other day of a 28-day cycle</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>The proportion of patients who achieve and maintain major molecular response(MMR) at 12 months using RQ-PCR test.</measure>
<time_frame>12 months</time_frame>
<description>Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.</description>
</primary_outcome>
<secondary_outcome>
<measure>The proportion of patients with MMR at 3, 6, 9 months.</measure>
<time_frame>3, 6, 9 months.</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>The proportion of patients with MR 4.0 at 3, 6, 9, 12 months.</measure>
<time_frame>3, 6, 9, 12 months.</time_frame>
<description>Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.</measure>
<time_frame>3, 6, 9, 12 months.</time_frame>
<description>Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Progression free survival (PFS)</measure>
<time_frame>12 months</time_frame>
<description>PFS is defined as the interval between the first dose date and the first date at which the criteria for progression are met, or death.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Overall survive (OS)</measure>
<time_frame>12 months</time_frame>
<description>OS is defined as the interval between the first dose date and date of death, censored at the last contact date to be alive.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib.</measure>
<time_frame>12 months.</time_frame>
<description>Evaluation of adverse events (AEs), serious AEs (SAEs)</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">40</enrollment>
<condition>Olverembatinib</condition>
<condition>Chronic Myeloid Leukemia, Chronic Phase</condition>
<condition>Tyrosine Kinase Inhibitors</condition>
<arm_group>
<arm_group_label>olverembatinib</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>40mg, taken orally once every other day of a 28-day cycle</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>olverembatinib</intervention_name>
<description>olverembatinib, 40mg, taken orally once every other day of a 28-day cycle</description>
<arm_group_label>olverembatinib</arm_group_label>
<other_name>HQP1351</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Age ≥ 18 years and ≤75 years.

- Diagnosis of CML-CP.

- ECOG performance of 0-2.

- Adequate end organ function defined as the following: total bilirubin <1.5xULN, SGPT
<2.5x ULN, creatinine <1.5x ULN.

- Resistance and/or intolerance of at least two second-generation TKIs.

- Patients must sign an informed consent form (ICF) indicating they are aware of the
investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria:

- Known to be allergic to study drug ingredients or their analogues.

- History of undergone major surgery within 4 weeks.

- Patients unwilling or unable to comply with the protocol.

- Pregnant or breast-feeding patients.

- patients with other malignant tumor.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Xin Du, Phd</last_name>
<role>Study Chair</role>
<affiliation>Shenzhen Second People's Hospital</affiliation>
</overall_official>
<overall_contact>
<last_name>Xin Du, Phd</last_name>
<phone>075583366388</phone>
<email>duxingz@medmail.com.cn</email>
</overall_contact>
<overall_contact_backup>
<last_name>Xin Du, Phd</last_name>
</overall_contact_backup>
<location>
<facility>
<name>Shenzhen Second People's Hospital</name>
<address>
<city>Shenzhen</city>
<state>Guangdong</state>
<zip>518035</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Xin Du, Phd</last_name>
<phone>075583366388</phone>
<phone_ext>8196</phone_ext>
<email>duxingz@medmail.com.cn</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 28, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>July 26, 2022</last_update_submitted>
<last_update_submitted_qc>July 26, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">July 29, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>olverembatinib, CML-CP</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Leukemia</mesh_term>
<mesh_term>Leukemia, Myeloid</mesh_term>
<mesh_term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this trial is to evaluate the efficacy and safety of olverembatinib(HQP1351)
in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or
intolerant to at least two second-generation tyrosine kinase inhibitors. The efficacy of
olverembatinib is determined by evaluating the major molecular responses(MMR) at the and of
12 months.
Inclusion Criteria:
- Age ≥ 18 years and ≤75 years.
- Diagnosis of CML-CP.
- ECOG performance of 0-2.
- Adequate end organ function defined as the following: total bilirubin <1.5xULN, SGPT
<2.5x ULN, creatinine <1.5x ULN.
- Resistance and/or intolerance of at least two second-generation TKIs.
- Patients must sign an informed consent form (ICF) indicating they are aware of the
investigational nature of this study, in keeping with the policies of the hospital.
Exclusion Criteria:
- Known to be allergic to study drug ingredients or their analogues.
- History of undergone major surgery within 4 weeks.
- Patients unwilling or unable to comply with the protocol.
- Pregnant or breast-feeding patients.
- patients with other malignant tumor.
|
NCT0531xxxx/NCT05311956.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/NCT05311956</url>
</required_header>
<id_info>
<org_study_id>21-07023793</org_study_id>
<secondary_id>R01DK131050</secondary_id>
<secondary_id>22048</secondary_id>
<nct_id>NCT05311956</nct_id>
</id_info>
<brief_title>Pain Reduction Using NEurostimulation Study</brief_title>
<acronym>PRUNE</acronym>
<official_title>Delivery of an At-Home Nonpharmacologic Intervention (Transcranial Neurostimulation) to Mitigate Pain in Patients With End Stage Kidney Disease Receiving Hemodialysis</official_title>
<sponsors>
<lead_sponsor>
<agency>Weill Medical College of Cornell University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Metropolitan Jewish Health System</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Rogosin Institute</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Cornell University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Weill Medical College of Cornell University</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>Yes</is_fda_regulated_device>
<is_unapproved_device>Yes</is_unapproved_device>
<is_us_export>Yes</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
This is a 4-year project to see if a small battery-powered, device attached to a headband,
that sits on the skin surface and delivers what is a hardly noticeable level of electrical
stimulation can reduce pain in patients who receive hemodialysis on an ongoing basis.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This is a 4-year R01 project to conduct a randomized controlled trial to evaluate the
efficacy of an at-home transcranial direct current stimulation (tDCS) device to mitigate pain
in persons receiving hemodialysis (HD) on account of end-stage kidney disease (ESKD). Pain is
a highly common and morbid condition among persons with ESKD requiring HD. Because the
current method of managing pain in this population typically involves the use of analgesic
medications that confer substantial health risks, novel non-drug therapies are needed to
reduce pain and lessen reliance on opioid and other drug therapies. The investigators will
undertake a randomized controlled trial to determine the efficacy of an at-home
neuromodulatory device to mitigate pain and improve other salient outcomes (e.g., mood,
quality of life) in a stratified sample of Hispanic or Latino(a), Black or African American,
and non-Hispanic White ESKD patients requiring HD. However, no individuals will be excluded
based on race/ethnicity
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">October 24, 2022</start_date>
<completion_date type="Anticipated">December 31, 2025</completion_date>
<primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Change in worst pain intensity over past 7 days</measure>
<time_frame>Baseline, 8 weeks (at the end of intervention)</time_frame>
<description>Pain intensity will be measured by one question from the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity - Short Form 3a. This 3-item instrument assesses how much a person hurts. This question asks in the past 7 days, "How intense was your pain at its worst?" Respondents report their pain on a 5-point scale: 1=Had no pain, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe.</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in worst pain intensity over past 7 days</measure>
<time_frame>Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.</time_frame>
<description>Pain intensity will be measured by one question from the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity - Short Form 3a. This 3-item instrument assesses how much a person hurts. This question asks in the past 7 days, "How intense was your pain at its worst?" Respondents report their pain on a 5-point scale: 1=Had no pain, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in average pain intensity over past 7 days (PROMIS pain intensity short form)</measure>
<time_frame>Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.</time_frame>
<description>Pain intensity will be measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity - Short Form 3a. This 3-item instrument assesses how much a person hurts. The first two items assess pain intensity utilizing a 7-day recall period (items include the phrase "the past 7 days") while the last item asks patients to rate their pain intensity "right now." Respondents report their pain on a 5-point scale: 1=Had no pain, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in self-report pain and pain-related medication use</measure>
<time_frame>Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.</time_frame>
<description>Participants will be asked what pain and pain related medications they are taking including the dose of each medication and how often they take them. A worksheet will be personalized to each participant to minimize the amount of recording that participants have to do in this phase of the study. The Y axis will list the medication (if taken more than once a day, each time point will have its own line) while the X axis will have the dates these data need to be collected. The participant will indicate how many pills they took in the table itself. The total dose of each pain and pain-related medication taken over the 5-day recording periods will be compared.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Pain interference (PROMIS pain interference short form)</measure>
<time_frame>Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.</time_frame>
<description>Pain interference will be measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference - Short Form 6b. This 6-item instrument measures the self-reported impact of pain on a person's life and assesses the extent to which pain may interfere with engagement with social, cognitive, emotional, physical, and recreational activities over a 7-day recall period. Pain Interference also incorporates items problem sleep and enjoyment in life, though the item bank only contains one sleep item. Respondents report levels of pain interference on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, and 5=Very much.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Depressive Symptoms (Patient Health Questionnaire; PHQ-8)</measure>
<time_frame>Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.</time_frame>
<description>Depressive Symptoms will be measured by PHQ-8 (Patient Health Questionnaire). This 8-item instruments measures symptoms of depression over the past 2 weeks such as, 'feeling down, depressed, or hopeless' or 'poor appetite or overeating'. Respondents report level of depression symptoms on a 4-point scale: 0=not at all, 1=Several days, 2=More than half the days, and 3=Nearly every day. The overall score range is 0 to 24 with a higher score indicating higher depressive symptoms.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Quality of Life Questionnaire Score (WHOQOL-BREF)</measure>
<time_frame>Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.</time_frame>
<description>Quality of Life will be measured by the Quality of Life Questionnaire (WHOQOL-BREF), a 26-item widely used and validated measure developed by the World Health Organization. Specific domains asked looking back over the last 2 weeks include physical health (e.g., enough energy for everyday life), psychological health (e.g., frequency of negative feelings), social relationships (e.g., satisfaction of support from friends), and environment (e.g., access to health services). Respondents answer each question on a 5-point scale and are transformed linearly to an overall adjusted score ranging from 0 to 100; with a higher score indicating higher quality of life.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Satisfaction with the tDCS-TH device and procedure</measure>
<time_frame>8 weeks (at the end of intervention)</time_frame>
<description>Satisfaction with the tDCS-TH device and procedure is assessed using the tDCS User Survey that includes 8 statements describing various aspects of user's experience, such as education and training on tDCS use, ease of the procedure, or user's interest in future use of the device. on the first 7 statements are rated on a 5-point scale with anchor points Strongly Agree- Strongly Disagree. The last question is an open ended question asking about challenges and ways to improve</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of related adverse events</measure>
<time_frame>Up to 26-weeks post-baseline</time_frame>
<description>Occurrence of the number of related side effects and adverse events will be compared between groups.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of probably related adverse events</measure>
<time_frame>Up to 26-weeks post-baseline</time_frame>
<description>Occurrence of the number of probably related side effects and adverse events will be compared between groups.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of possibly related adverse events</measure>
<time_frame>Up to 26-weeks post-baseline</time_frame>
<description>Occurrence of the number of possibly related side effects and adverse events will be compared between groups.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">125</enrollment>
<condition>End Stage Kidney Disease</condition>
<condition>Chronic Pain</condition>
<arm_group>
<arm_group_label>Experimental</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients will receive tDCS delivered over the motor cortex, at an intensity of 2mA, delivered for 20 minutes 5 times each week over eight consecutive weeks (40 applications in total).</description>
</arm_group>
<arm_group>
<arm_group_label>Sham Comparator</arm_group_label>
<arm_group_type>Sham Comparator</arm_group_type>
<description>Sham treatment will consist of 30 seconds of the direct current at 2mA and 0 current for the remaining time of the 20-minute application 5 times per week over eight consecutive weeks (40 applications in total).</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Active tDCS</intervention_name>
<description>The study intervention will be participants self-applying 40 tDCS active stimulations with in-person supervision provided by trained study personnel. The self-applied intervention will continue 5 times per week over eight consecutive weeks. Treatment will occur in the home.</description>
<arm_group_label>Experimental</arm_group_label>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Sham tDCS</intervention_name>
<description>In this arm of the study participants will self-apply 40 sham tDCS stimulations with in-person supervision provided by trained study personnel. The self-applied intervention will continue 5 times per week over eight consecutive weeks. Treatment will occur in the home.</description>
<arm_group_label>Sham Comparator</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

Patients:

- Age ≥ 21 years

- Diagnosis of end stage kidney disease (OCD 18.6) and receiving hemodialysis at a
Rogosin site

- Montreal Cognitive Assessment (MoCA-Blind) adjusted score of >21;

- Pain for ≥3 months, with a self-reported pain intensity of ≥4 (on a 0-10 scale) during
the week preceding the screening;

- Speaks English

- Medically stable, as determined by clinician and defined as unlikely to undergo a
substantial change in illness or treatment during the next 3 months

- Able to provide written informed consent.

Caregivers:

- Age ≥21 years

- Serves as primary caregiver for ESKD patient (e.g., partner, adult child, friend)

- Speaks English

Exclusion Criteria:

- Active medical or major psychiatric illnesses that will impact pain or interfere with
study procedures

- History of head trauma, seizures, brain surgery, stroke, or cancer affecting head,
metal implants in the head, or compromised skin integrity on the head in the area
where electrodes will be placed

- Use of another neurostimulation device (such as spinal cord stimulator,
cardio-stimulator implanted cardioverter-defibrillator)

- Not able to respond to brief questionnaires and rating scales that will interfere with
study procedures

- Does not tolerate tDCS at a skin test (performed at training Visit 2)

- Does not provide informed consent

Exclusion criteria for all above groups:

- Does not speak English
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Cary Reid, MD, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Weill Medical College of Cornell University</affiliation>
</overall_official>
<overall_contact>
<last_name>Cary Reid, MD, PhD</last_name>
<phone>212-746-1378</phone>
<email>mcr2004@med.cornell.edu</email>
</overall_contact>
<overall_contact_backup>
<last_name>Patricia Kim, MSW</last_name>
<phone>212-746-1758</phone>
<email>pak2020@med.cornell.edu</email>
</overall_contact_backup>
<location>
<facility>
<name>The Rogosin Institute</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10021</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Nathaniel Berman, MD</last_name>
<phone>212-746-9766</phone>
<email>nab2009@nyp.org</email>
</contact>
</location>
<location>
<facility>
<name>NewYork-Presbyterian - Weill Cornell Medicine</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10065</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Cary Reid, MD, PhD</last_name>
<phone>212-746-1378</phone>
<email>mcr2004@med.cornell.edu</email>
</contact>
<contact_backup>
<last_name>Patricia Kim, MSW</last_name>
<phone>212-746-1758</phone>
<email>pak2020@med.cornell.edu</email>
</contact_backup>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>November 2022</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>November 1, 2022</last_update_submitted>
<last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">November 2, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Dialysis</keyword>
<keyword>transcranial direct current stimulation (tDCS)</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Kidney Diseases</mesh_term>
<mesh_term>Kidney Failure, Chronic</mesh_term>
<mesh_term>Chronic Pain</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This is a 4-year project to see if a small battery-powered, device attached to a headband,
that sits on the skin surface and delivers what is a hardly noticeable level of electrical
stimulation can reduce pain in patients who receive hemodialysis on an ongoing basis.
This is a 4-year R01 project to conduct a randomized controlled trial to evaluate the
efficacy of an at-home transcranial direct current stimulation (tDCS) device to mitigate pain
in persons receiving hemodialysis (HD) on account of end-stage kidney disease (ESKD). Pain is
a highly common and morbid condition among persons with ESKD requiring HD. Because the
current method of managing pain in this population typically involves the use of analgesic
medications that confer substantial health risks, novel non-drug therapies are needed to
reduce pain and lessen reliance on opioid and other drug therapies. The investigators will
undertake a randomized controlled trial to determine the efficacy of an at-home
neuromodulatory device to mitigate pain and improve other salient outcomes (e.g., mood,
quality of life) in a stratified sample of Hispanic or Latino(a), Black or African American,
and non-Hispanic White ESKD patients requiring HD. However, no individuals will be excluded
based on race/ethnicity
Inclusion Criteria:
Patients:
- Age ≥ 21 years
- Diagnosis of end stage kidney disease (OCD 18.6) and receiving hemodialysis at a
Rogosin site
- Montreal Cognitive Assessment (MoCA-Blind) adjusted score of >21;
- Pain for ≥3 months, with a self-reported pain intensity of ≥4 (on a 0-10 scale) during
the week preceding the screening;
- Speaks English
- Medically stable, as determined by clinician and defined as unlikely to undergo a
substantial change in illness or treatment during the next 3 months
- Able to provide written informed consent.
Caregivers:
- Age ≥21 years
- Serves as primary caregiver for ESKD patient (e.g., partner, adult child, friend)
- Speaks English
Exclusion Criteria:
- Active medical or major psychiatric illnesses that will impact pain or interfere with
study procedures
- History of head trauma, seizures, brain surgery, stroke, or cancer affecting head,
metal implants in the head, or compromised skin integrity on the head in the area
where electrodes will be placed
- Use of another neurostimulation device (such as spinal cord stimulator,
cardio-stimulator implanted cardioverter-defibrillator)
- Not able to respond to brief questionnaires and rating scales that will interfere with
study procedures
- Does not tolerate tDCS at a skin test (performed at training Visit 2)
- Does not provide informed consent
Exclusion criteria for all above groups:
- Does not speak English
|
NCT0531xxxx/NCT05311969.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/NCT05311969</url>
</required_header>
<id_info>
<org_study_id>EXEPA</org_study_id>
<nct_id>NCT05311969</nct_id>
</id_info>
<brief_title>Prevalence of Impaired Executive Functions</brief_title>
<acronym>EXEPA</acronym>
<official_title>Prevalence of Impaired Executive Functions in Institutionalized Elderly</official_title>
<sponsors>
<lead_sponsor>
<agency>Fondation Korian pour le Bien Vieillir</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Gerontopôle des Pays de la Loire</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Fondation Korian pour le Bien Vieillir</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 evaluation of executive functions, as well as the means of stimulating and preserving
them, are at the heart of the challenges for maintaining a level of functional autonomy in
the elderly, but also during the loss of this functional autonomy and when entering a
situation of dependence and/or dementia. Research that has demonstrated the preponderant role
of executive functions on functional abilities are examples of this. Components such as
planning, organization, initiation, mental flexibility appear to be strongly correlated with
the effective performance of complex activities of daily living. In addition, the capacities
for autonomy were found to be significantly reduced, and significantly with the severity of
the executive deficits. In addition, if these data have since contributed to determining a
level of impairment of the executive processes specific to an early loss of autonomy, they
are so in the context of early diagnosis of dementia and validation of a detection tool,
early loss of autonomy. The scientific advances of the last five years contribute to a better
understanding of the impact of executive disorders, but on the other hand, the diversity of
the explanatory phenomena of these disorders considerably complicates their nosology within
neuro-evolutionary pathologies. Ultimately, an analysis of executive function disorders must
take into account cognitive and behavioral aspects, that is to say, beyond performance on
tests identified as involving executive functions, behavioral disorders, emotional status and
level of autonomy in activities of daily living. In the state of our knowledge, the
consideration of executive functions represents a strategic point at the crossroads of the
evaluation of the act of care and treatment. Establishing data on the prevalence of
alterations in the executive functions of residents, exploring the possibilities of
evaluation with a battery of tests little used in this context and linking "executive"
profiles and clinical situations seems to us a relevant and interesting first step. However
essential to provide a beginning of answer to these questions. This study being an
exploratory study. The results of this study will constitute new prevalence data in the
population of residents of nursing homes. The aim here is to establish data on the prevalence
of alterations in the executive functions of residents, to explore the possibilities of
evaluation with a battery of tests little used in this context and to relate the profiles
"executives" and clinical situations. This in order to develop a methodology to draw up a
general assessment, and to make comparisons of the different profiles, inter/intra
pathologies and stages of evolution. Thus, a more in-depth knowledge of the specific profiles
of Nursing Home residents will also lead to the reflection of pharmacological and
non-pharmacological therapeutic strategies. Finally, it will ultimately be a question of
presenting an inventory of the situation of Nursing Home to alert public policies. The main
objective is to study the prevalence of impaired executive functions in nursing home
residents. The secondary objectives are to explore the feasibility of carrying out executive
function tests and to examine the coorelationbetween the levels of impairment of executive
functions and the clinical and functional characteristics of residents.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Participants will be recruited by the investigating doctor and the healthcare team.
Participants must meet the defined inclusion criteria The steps:

1. Screening Pre-selection of participants potentially eligible for the study
(inclusion/non-inclusion criteria) and collection of data from medical records and the
healthcare database.

The information can be collected by the nursing coordinator of the Nursing home. The
diagnosis will be determined by the investigating physician of each center and the
inclusion criteria checked.

2. Pre-inclusion-inclusion visit

- Confirmation of eligibility criteria for participants selected for the screening
phase

- Delivery of Consent forms for reading, for explanation of the study methods
(procedure, context, objective, constraints), and to answer any questions. If the
participant agrees to participate in the study. The consent forms must be signed
and dated before any act carried out within the framework of the research. A time
of reflection can be granted before the signature. The evaluation of global
cognitive functioning with the Mini Mental State Examination will be carried out.
Each potentially eligible participant will be given an information note on the
conduct of the study followed by an informed consent form that he and the
investigator will need to sign before the start of the study.

The course of the study for the participant will consist of 4 visits with the
psychologist and/or the doctor:

Pre-inclusion consultation, Visit 0: during which the participant will take a
questionnaire carried out by the psychologist to assess overall cognitive functioning,
and the inclusion consultation by the on-site investigator doctor to check whether the
participant corresponds to all study criteria. Following this visit, the participant may
choose to participate in the research by signing the consent form.

The visits will take place as follows, spread over 14 to a maximum of 65 days from
Pré-inclusion

3. Visits

Visit 1. (20 to 45 minutes, up to 15 days after Visit 0). This visit will allow to do:

- a clinical assessment with the investigating doctor,

- a behavioral assessment by the nursing staff or the psychologist.

- four cognitive tests for a total duration of approximately 15 minutes carried out by the
psychologist.

- Additional visit (10 days later maximum): only if one or more tests have not been
carried out or completed during visit 1.

Visit 2. (About 25 minutes, 7 to 10 days after visit Visit 1). This visit will allow you to:

- an evaluation of executive functions by the neuropsychologist with four new cognitive
tests:

- Additional visit (10 days later maximum): only if one or more tests have not been
carried out or completed during visit 2.

Visit 3. (About 30 minutes, 7 to 10 days after visit Visit 2). This visit will allow you to:

- a final evaluation of executive functions by the neuropsychologist with four new
cognitive tests:

- Additional visit (10 days later maximum): only if one or more tests have not been
carried out or completed during visit 3.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 18, 2022</start_date>
<completion_date type="Anticipated">March 30, 2024</completion_date>
<primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Diagnostic</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Prevalence of executive functions impairment</measure>
<time_frame>12 months</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Rate of passed tests</measure>
<time_frame>12 months</time_frame>
<description>ability of nursing home residents to pass tests provided for in the protocol to evaluate executive functions</description>
</secondary_outcome>
<secondary_outcome>
<measure>Correlation between executive functions impairment and percentage of dependence residents Correlation between executive functions impairment and percentage of residents with</measure>
<time_frame>12 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Correlation between executive functions impairment and behavioral disorders</measure>
<time_frame>12 months</time_frame>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">200</enrollment>
<condition>Executive Dysfunctions</condition>
<arm_group>
<arm_group_label>groups/cohort</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>participants will perform the various neuropsychological tests provided for in the protocol</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>cognitive evaluations and non cognitive evaluations</intervention_name>
<description>Cognitive evaluations with executive functions evaluations :
Mini Mental State Examination
Stroop Victoria Test
Hayling test
Frontal Assessment Battery test mental flexibility:
Trial Making Test (TMT) A and B
Connection test
Alphaflex test
Verbal and visuospatial working memory
Wechsler Adult Intelligence Scale (WAIS) span
Visuo-spatial span
Visuo-spatial span simplified version
Month Of the Year Backwards (MOTYB) Planning
Tinker Toy test
Clock Test
Non-cognitive evaluations:
The Katz Autonomy Scale Neuropsychiatric Inventory version Care team Geriatric Depression Scale 15-item version Apathy inventory</description>
<arm_group_label>groups/cohort</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Permanent resident in Nursing Home or in temporary accommodation for more than 3
months

- speak and understand the French language

- Mini Mental State Examination (MMSE) between 7 and 24 dating from 8 maximum days

- Compulsorily affiliated with a social security scheme

- Agree to participate in the study in agreement with the trusted person (if applicable)

- co-signatures of the Consent Form between the investigator and the participant or the
person of trust (if applicable)

Exclusion Criteria:

- Refusal to sign the consent form

- Resident in a specialized unit for behavioral disorders (Cognitive Behavioral Unit
(CBU), Reinforced Accommodation Unit (RAU), Disoriented Elderly Unit (DEU), Centers of
Natural Activities Drawn from Useful Occupations (NADUO) et cetera)

- Communication difficulties, sensory and/or motor deficits

- Medical contraindication in relation to a psychological state that could be altered
due to participation in the study

- Resident at end of life (life expectancy < 3 months)

- Resident under legal protection

- Participation within 48 hours prior to inclusion in another research
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>75 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Gilles BERRUT</last_name>
<role>Study Director</role>
<affiliation>Gerontopôle des Pays de la Loire</affiliation>
</overall_official>
<overall_official>
<last_name>Leila LAIFA-MARY</last_name>
<role>Principal Investigator</role>
<affiliation>Korian</affiliation>
</overall_official>
<overall_contact>
<last_name>Bine Mariam NDIONGUE</last_name>
<phone>+33699035042</phone>
<email>bine-mariam.ndiongue@korian.fr</email>
</overall_contact>
<overall_contact_backup>
<last_name>Marie-Anne FOURRIER</last_name>
<phone>+33669458844</phone>
<email>marie-anne.fourrier@korian.fr</email>
</overall_contact_backup>
<reference>
<citation>Miyake A, Friedman NP, Emerson MJ, Witzki AH, Howerter A, Wager TD. The unity and diversity of executive functions and their contributions to complex "Frontal Lobe" tasks: a latent variable analysis. Cogn Psychol. 2000 Aug;41(1):49-100. doi: 10.1006/cogp.1999.0734.</citation>
<PMID>10945922</PMID>
</reference>
<reference>
<citation>Belleville S, Rouleau N, Van der Linden M. Use of the Hayling task to measure inhibition of prepotent responses in normal aging and Alzheimer's disease. Brain Cogn. 2006 Nov;62(2):113-9. doi: 10.1016/j.bandc.2006.04.006. Epub 2006 Jun 6.</citation>
<PMID>16757076</PMID>
</reference>
<reference>
<citation>Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.</citation>
<PMID>7991117</PMID>
</reference>
<reference>
<citation>Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621.</citation>
<PMID>11113214</PMID>
</reference>
<reference>
<citation>Fisk JE, Sharp CA. Age-related impairment in executive functioning: updating, inhibition, shifting, and access. J Clin Exp Neuropsychol. 2004 Oct;26(7):874-90. doi: 10.1080/13803390490510680.</citation>
<PMID>15742539</PMID>
</reference>
<reference>
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<citation>Makino T, Umegaki H, Suzuki Y, Yanagawa M, Nonogaki Z, Nakashima H, Kuzuya M. Relationship between small cerebral white matter lesions and cognitive function in patients with Alzheimer's disease and amnestic mild cognitive impairment. Geriatr Gerontol Int. 2014 Oct;14(4):819-26. doi: 10.1111/ggi.12176. Epub 2013 Nov 12.</citation>
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<citation>Blanco Martin E, Ugarriza Serrano I, Elcoroaristizabal Martin X, Galdos Alcelay L, Molano Salazar A, Bereincua Gandarias R, Ingles Borda S, Uterga Valiente JM, Indakoetxea Juanbeltz MB, Moraza Lopez J, Barandiaran Amillano M, Fernandez-Martinez M. Dysexecutive syndrome in amnesic mild cognitive impairment: a multicenter study. BMC Neurol. 2016 Jun 4;16:88. doi: 10.1186/s12883-016-0607-2.</citation>
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<citation>Perry RJ, Hodges JR. Differentiating frontal and temporal variant frontotemporal dementia from Alzheimer's disease. Neurology. 2000 Jun 27;54(12):2277-84. doi: 10.1212/wnl.54.12.2277.</citation>
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<citation>Robert PH, Clairet S, Benoit M, Koutaich J, Bertogliati C, Tible O, Caci H, Borg M, Brocker P, Bedoucha P. The apathy inventory: assessment of apathy and awareness in Alzheimer's disease, Parkinson's disease and mild cognitive impairment. Int J Geriatr Psychiatry. 2002 Dec;17(12):1099-105. doi: 10.1002/gps.755.</citation>
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<citation>Roussel M, Lhommee E, Narme P, Czernecki V, Gall DL, Krystkowiak P, Diouf M, Godefroy O; GREFEX study group. Dysexecutive syndrome in Parkinson's disease: the GREFEX study. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2017 Sep;24(5):496-507. doi: 10.1080/13825585.2016.1226248. Epub 2016 Sep 1.</citation>
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<citation>Stuss DT. Functions of the frontal lobes: relation to executive functions. J Int Neuropsychol Soc. 2011 Sep;17(5):759-65. doi: 10.1017/S1355617711000695. Epub 2011 May 24.</citation>
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<PMID>26079417</PMID>
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<verification_date>March 2022</verification_date>
<study_first_submitted>March 11, 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>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>
<keyword>executive functions</keyword>
<keyword>nursing home</keyword>
<keyword>resident</keyword>
<keyword>dependence</keyword>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The evaluation of executive functions, as well as the means of stimulating and preserving
them, are at the heart of the challenges for maintaining a level of functional autonomy in
the elderly, but also during the loss of this functional autonomy and when entering a
situation of dependence and/or dementia. Research that has demonstrated the preponderant role
of executive functions on functional abilities are examples of this. Components such as
planning, organization, initiation, mental flexibility appear to be strongly correlated with
the effective performance of complex activities of daily living. In addition, the capacities
for autonomy were found to be significantly reduced, and significantly with the severity of
the executive deficits. In addition, if these data have since contributed to determining a
level of impairment of the executive processes specific to an early loss of autonomy, they
are so in the context of early diagnosis of dementia and validation of a detection tool,
early loss of autonomy. The scientific advances of the last five years contribute to a better
understanding of the impact of executive disorders, but on the other hand, the diversity of
the explanatory phenomena of these disorders considerably complicates their nosology within
neuro-evolutionary pathologies. Ultimately, an analysis of executive function disorders must
take into account cognitive and behavioral aspects, that is to say, beyond performance on
tests identified as involving executive functions, behavioral disorders, emotional status and
level of autonomy in activities of daily living. In the state of our knowledge, the
consideration of executive functions represents a strategic point at the crossroads of the
evaluation of the act of care and treatment. Establishing data on the prevalence of
alterations in the executive functions of residents, exploring the possibilities of
evaluation with a battery of tests little used in this context and linking "executive"
profiles and clinical situations seems to us a relevant and interesting first step. However
essential to provide a beginning of answer to these questions. This study being an
exploratory study. The results of this study will constitute new prevalence data in the
population of residents of nursing homes. The aim here is to establish data on the prevalence
of alterations in the executive functions of residents, to explore the possibilities of
evaluation with a battery of tests little used in this context and to relate the profiles
"executives" and clinical situations. This in order to develop a methodology to draw up a
general assessment, and to make comparisons of the different profiles, inter/intra
pathologies and stages of evolution. Thus, a more in-depth knowledge of the specific profiles
of Nursing Home residents will also lead to the reflection of pharmacological and
non-pharmacological therapeutic strategies. Finally, it will ultimately be a question of
presenting an inventory of the situation of Nursing Home to alert public policies. The main
objective is to study the prevalence of impaired executive functions in nursing home
residents. The secondary objectives are to explore the feasibility of carrying out executive
function tests and to examine the coorelationbetween the levels of impairment of executive
functions and the clinical and functional characteristics of residents.
Participants will be recruited by the investigating doctor and the healthcare team.
Participants must meet the defined inclusion criteria The steps:
1. Screening Pre-selection of participants potentially eligible for the study
(inclusion/non-inclusion criteria) and collection of data from medical records and the
healthcare database.
The information can be collected by the nursing coordinator of the Nursing home. The
diagnosis will be determined by the investigating physician of each center and the
inclusion criteria checked.
2. Pre-inclusion-inclusion visit
- Confirmation of eligibility criteria for participants selected for the screening
phase
- Delivery of Consent forms for reading, for explanation of the study methods
(procedure, context, objective, constraints), and to answer any questions. If the
participant agrees to participate in the study. The consent forms must be signed
and dated before any act carried out within the framework of the research. A time
of reflection can be granted before the signature. The evaluation of global
cognitive functioning with the Mini Mental State Examination will be carried out.
Each potentially eligible participant will be given an information note on the
conduct of the study followed by an informed consent form that he and the
investigator will need to sign before the start of the study.
The course of the study for the participant will consist of 4 visits with the
psychologist and/or the doctor:
Pre-inclusion consultation, Visit 0: during which the participant will take a
questionnaire carried out by the psychologist to assess overall cognitive functioning,
and the inclusion consultation by the on-site investigator doctor to check whether the
participant corresponds to all study criteria. Following this visit, the participant may
choose to participate in the research by signing the consent form.
The visits will take place as follows, spread over 14 to a maximum of 65 days from
Pré-inclusion
3. Visits
Visit 1. (20 to 45 minutes, up to 15 days after Visit 0). This visit will allow to do:
- a clinical assessment with the investigating doctor,
- a behavioral assessment by the nursing staff or the psychologist.
- four cognitive tests for a total duration of approximately 15 minutes carried out by the
psychologist.
- Additional visit (10 days later maximum): only if one or more tests have not been
carried out or completed during visit 1.
Visit 2. (About 25 minutes, 7 to 10 days after visit Visit 1). This visit will allow you to:
- an evaluation of executive functions by the neuropsychologist with four new cognitive
tests:
- Additional visit (10 days later maximum): only if one or more tests have not been
carried out or completed during visit 2.
Visit 3. (About 30 minutes, 7 to 10 days after visit Visit 2). This visit will allow you to:
- a final evaluation of executive functions by the neuropsychologist with four new
cognitive tests:
- Additional visit (10 days later maximum): only if one or more tests have not been
carried out or completed during visit 3.
Inclusion Criteria:
- Permanent resident in Nursing Home or in temporary accommodation for more than 3
months
- speak and understand the French language
- Mini Mental State Examination (MMSE) between 7 and 24 dating from 8 maximum days
- Compulsorily affiliated with a social security scheme
- Agree to participate in the study in agreement with the trusted person (if applicable)
- co-signatures of the Consent Form between the investigator and the participant or the
person of trust (if applicable)
Exclusion Criteria:
- Refusal to sign the consent form
- Resident in a specialized unit for behavioral disorders (Cognitive Behavioral Unit
(CBU), Reinforced Accommodation Unit (RAU), Disoriented Elderly Unit (DEU), Centers of
Natural Activities Drawn from Useful Occupations (NADUO) et cetera)
- Communication difficulties, sensory and/or motor deficits
- Medical contraindication in relation to a psychological state that could be altered
due to participation in the study
- Resident at end of life (life expectancy < 3 months)
- Resident under legal protection
- Participation within 48 hours prior to inclusion in another research
|
NCT0531xxxx/NCT05311982.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/NCT05311982</url>
</required_header>
<id_info>
<org_study_id>Tdcs Autism ufpb</org_study_id>
<nct_id>NCT05311982</nct_id>
</id_info>
<brief_title>Transcranial Direct Current Stimulation in Autistic Spectrum Disorder</brief_title>
<acronym>TDCSinASD</acronym>
<official_title>Transcranial Direct Current Stimulation Modulates Spectral Power and Coherence in Autism Spectrum Disorder: a Triple-blind, Placebo-controlled Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Federal University of Paraíba</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Federal University of Paraíba</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
To understand the changes in the resting electroencephalogram (EEG) brain networks of
children and adolescents with autistic spectrum disorder (ASD) induced by transcranial direct
current stimulation (tDCS), we asked two questions. First: how can tDCS modulate the
expression of neural network dynamics? Second: how can tDCS modulate functional connections
at specific frequencies? We hypothesized that the tDCS mechanism results in increased
cortical frequencies in the areas under the anode, which may reflect an increase in synaptic
connectivity, and that this tDCS-related increase changes connection profiles at specific
frequencies important for ASD, indicating improvement in symptoms. To verify this
improvement, the researchers used the Autism Treatment Evaluation Checklist (ATEC) after an
intervention, comparing baseline scores with post-treatment scores.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">March 1, 2021</start_date>
<completion_date type="Actual">September 30, 2021</completion_date>
<primary_completion_date type="Actual">July 30, 2021</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>to compare the effectiveness of Neuromodulation techniques - transcranial direct current stimulation (tDCS) - in the treatment of people with Autism Spectrum Disorder</measure>
<time_frame>7 weeks</time_frame>
<description>EEG and TDCS</description>
</primary_outcome>
<secondary_outcome>
<measure>Check the effects of tDCS modulations on cognitive responses through Autism Treatment Evaluation Checklist</measure>
<time_frame>7 weeks</time_frame>
<description>ATEC and EEG</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Actual">12</enrollment>
<condition>Autistic Disorders Spectrum</condition>
<arm_group>
<arm_group_label>DLPFC-L F3 (Block A)</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>The study was developed through a triple-blind, crossover, randomized, placebo-controlled clinical trial (dummy tDCS). Participants were randomized into three groups receiving unilateral tDCS in DLPFC-L F3 (Block A)</description>
</arm_group>
<arm_group>
<arm_group_label>tDCS combined in DLPFC-L (F3) and DLPFC-R (F4)</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>The study was developed through a triple-blind, crossover, randomized, placebo-controlled clinical trial (dummy tDCS). Participants were randomized into three groups receiving unilateral tDCS in tDCS combined in DLPFC-L (F3) and DLPFC-R (F4)</description>
</arm_group>
<arm_group>
<arm_group_label>Sham (Block C)</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>The study was developed through a triple-blind, crossover, randomized, placebo-controlled clinical trial (dummy tDCS). Participants were randomized into three groups receiving unilateral tDCS in tDCS Sham</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>DLPFC-R (F4) TDCS</intervention_name>
<description>direct current brain stimulation- The study was developed through a triple-blind, crossover, randomized, placebo-controlled clinical trial (dummy tDCS). Participants were randomized into three groups receiving unilateral tDCS in DLPFC-L F3 (Block A), combined tDCS in DLPFC-L (F3) and DLPFC-R (F4) simultaneously (Block B) or sham-tDCS (Block C) with equal electrode configuration guaranteed blindness. After the procedures, each participant received the following intervention in the order ABC, BCA or CAB with a period of 1 week between each one. Each block took 3 weeks, organized into: 1) Assessment; 2) Application of stimulation; 3) Reassessment and washout week. Adding 1 more week of final evaluation, the study totaled the period of 10 weeks. During this period, patients were instructed to continue their behavioral/educational treatment and medication routines.</description>
<arm_group_label>DLPFC-L F3 (Block A)</arm_group_label>
<arm_group_label>tDCS combined in DLPFC-L (F3) and DLPFC-R (F4)</arm_group_label>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>DLPFC-L (F3) and DLPFC-R (F4) TDCS</intervention_name>
<description>DLPFC-L (F3) and DLPFC-R (F4) (Bock B)</description>
<arm_group_label>DLPFC-L F3 (Block A)</arm_group_label>
<arm_group_label>tDCS combined in DLPFC-L (F3) and DLPFC-R (F4)</arm_group_label>
<other_name>nibs</other_name>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>sham-tDCS</intervention_name>
<description>sham-tDCS (Block C) with equal electrode configuration guaranteed blindness</description>
<arm_group_label>DLPFC-L F3 (Block A)</arm_group_label>
<arm_group_label>tDCS combined in DLPFC-L (F3) and DLPFC-R (F4)</arm_group_label>
<other_name>NIBS</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

Patients with ASD reported by a Neuropediatrician; Age group between 5 and 18 years; Mild
and moderate clinical symptoms

Exclusion Criteria:

Patients with severe mental illness; Use of a pacemaker or other metal device on the body;
Brain tumor or intracranial infection; Uncooperative parents or caregivers; Epilepsy;
structural change in the skull
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>5 Years</minimum_age>
<maximum_age>18 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Federal University of Paraíba,Department of Psychology</name>
<address>
<city>João Pessoa,</city>
<state>Paraiba</state>
<zip>58051-900</zip>
<country>Brazil</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Suellen Marinho Andrade</name>
<address>
<city>João Pessoa</city>
<state>Paraíba</state>
<zip>58.051-900</zip>
<country>Brazil</country>
</address>
</facility>
</location>
<location_countries>
<country>Brazil</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 16, 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>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>Federal University of Paraíba</investigator_affiliation>
<investigator_full_name>Suellen Marinho Andrade</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>Autism</keyword>
<keyword>Tdcs</keyword>
<keyword>EEG</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Autistic Disorder</mesh_term>
<mesh_term>Autism Spectrum Disorder</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
To understand the changes in the resting electroencephalogram (EEG) brain networks of
children and adolescents with autistic spectrum disorder (ASD) induced by transcranial direct
current stimulation (tDCS), we asked two questions. First: how can tDCS modulate the
expression of neural network dynamics? Second: how can tDCS modulate functional connections
at specific frequencies? We hypothesized that the tDCS mechanism results in increased
cortical frequencies in the areas under the anode, which may reflect an increase in synaptic
connectivity, and that this tDCS-related increase changes connection profiles at specific
frequencies important for ASD, indicating improvement in symptoms. To verify this
improvement, the researchers used the Autism Treatment Evaluation Checklist (ATEC) after an
intervention, comparing baseline scores with post-treatment scores.
Inclusion Criteria:
Patients with ASD reported by a Neuropediatrician; Age group between 5 and 18 years; Mild
and moderate clinical symptoms
Exclusion Criteria:
Patients with severe mental illness; Use of a pacemaker or other metal device on the body;
Brain tumor or intracranial infection; Uncooperative parents or caregivers; Epilepsy;
structural change in the skull
|
NCT0531xxxx/NCT05311995.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/NCT05311995</url>
</required_header>
<id_info>
<org_study_id>2021/267</org_study_id>
<nct_id>NCT05311995</nct_id>
</id_info>
<brief_title>Which Trocar Access Site Should We Use in Laparoscopic Appendectomy?</brief_title>
<official_title>Which Trocar Access Site Should We Use in Laparoscopic Appendectomy?</official_title>
<sponsors>
<lead_sponsor>
<agency>Inonu University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Inonu 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>
Open appendectomy has been used in the treatment of appendicitis, which is among the most
common emergency pathologies worldwide, since the end of the 19th century. In the 20th
century, laparoscopic appendectomy came to the fore and the frequency of use increased
gradually. Despite the frequency of laparoscopic appendectomy, there is no consensus on the
best way to perform each procedural step. One of these steps is the trocar entry areas. In
this study, investigator's aim is to compare the trocar entry areas, which are various
reports in the literature, and to find the localization with the optimal usage area. 140
patients who underwent laparoscopic appendectomy between 2021-2022 were randomized into four
groups and included in the study. Demographic data, peroperative findings, complications,
length of stay and post-operative VAS values of the patients were evaluated.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 1, 2021</start_date>
<completion_date type="Actual">February 20, 2022</completion_date>
<primary_completion_date type="Actual">December 30, 2021</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Four trocar tecnıques groups in literature</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Pain Intensity measure</measure>
<time_frame>1 year</time_frame>
<description>self reported pain intensity morning. item is scored 0-10 ( 0: no pain- 10: pain as bad as</description>
</primary_outcome>
<number_of_arms>4</number_of_arms>
<enrollment type="Actual">140</enrollment>
<condition>Pain</condition>
<arm_group>
<arm_group_label>Group 1</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>trocar entry areas:Periumblical, left lower quadrant, suprapubic</description>
</arm_group>
<arm_group>
<arm_group_label>Group 2</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>trocar entry areas: Periumblical, left lower quadrant, right lower quadrant</description>
</arm_group>
<arm_group>
<arm_group_label>group 3</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>trocar entry areas: Periumblical, right lower quadrant, suprapubic</description>
</arm_group>
<arm_group>
<arm_group_label>Group 4</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>trocar entry areas: Periumblical, left lower quadrant, left upper quadrant</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Only different trocar sites</intervention_name>
<description>Only different trocar sites in literature</description>
<arm_group_label>Group 1</arm_group_label>
<arm_group_label>Group 2</arm_group_label>
<arm_group_label>Group 4</arm_group_label>
<arm_group_label>group 3</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- patients who underwent laparoscopic appendectomy

Exclusion Criteria:

patients who underwent open surgery and did not want to be involved in the study process
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>90 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Ersin Gundogan</name>
<address>
<city>Kayseri</city>
<state>Kocasinan</state>
<zip>38090</zip>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 14, 2022</study_first_submitted>
<study_first_submitted_qc>March 28, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>Inonu University</investigator_affiliation>
<investigator_full_name>Ersin Gündoğan</investigator_full_name>
<investigator_title>Assoc Prof</investigator_title>
</responsible_party>
<keyword>Laparoscopy</keyword>
<keyword>Minimally invasive surgery</keyword>
<keyword>appendicitis</keyword>
<keyword>colorectal</keyword>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Open appendectomy has been used in the treatment of appendicitis, which is among the most
common emergency pathologies worldwide, since the end of the 19th century. In the 20th
century, laparoscopic appendectomy came to the fore and the frequency of use increased
gradually. Despite the frequency of laparoscopic appendectomy, there is no consensus on the
best way to perform each procedural step. One of these steps is the trocar entry areas. In
this study, investigator's aim is to compare the trocar entry areas, which are various
reports in the literature, and to find the localization with the optimal usage area. 140
patients who underwent laparoscopic appendectomy between 2021-2022 were randomized into four
groups and included in the study. Demographic data, peroperative findings, complications,
length of stay and post-operative VAS values of the patients were evaluated.
Inclusion Criteria:
- patients who underwent laparoscopic appendectomy
Exclusion Criteria:
patients who underwent open surgery and did not want to be involved in the study process
|
NCT0531xxxx/NCT05312008.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/NCT05312008</url>
</required_header>
<id_info>
<org_study_id>10002</org_study_id>
<nct_id>NCT05312008</nct_id>
</id_info>
<brief_title>Does Oxytocin Alter Tolerance to or Motivation for Alcohol</brief_title>
<official_title>Does Oxytocin Alter Tolerance to Alcohol or Motivation for Alcohol in Heavy Drinking Human Subjects: Testing a Novel Anti-Addiction Mechanism</official_title>
<sponsors>
<lead_sponsor>
<agency>Indiana University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Indiana University</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This pilot study will seek evidence that oxytocin, compared to placebo, reverses tolerance
and alcohol seeking in humans.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This pilot study will seek evidence that intranasal oxytocin reverses tolerance and alcohol
seeking in humans by employing state-of-the-art computer-assisted intravenous alcohol
administration. Two separate experiments will be run. In the first, tolerance will be
assessed using sensitive tests of subjective response and cognitive function during an
intravenous infusion that maintains a steady breath and therefore brain exposure to alcohol.
In the second, an intravenous alcohol self-administration paradigm that requires increasing
effort for each additional infusion will be used to assess change in motivation for alcohol.
Demonstrating that oxytocin (compared to placebo) worsens test performances in
alcohol-dependent individuals and/or reduces the compulsive drive to self-administer alcohol
would be strong evidence for its potential to treat alcohol use disorders.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">January 16, 2022</start_date>
<completion_date type="Anticipated">December 2023</completion_date>
<primary_completion_date type="Anticipated">December 2023</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>2 Arms; both 2 session parallel design</intervention_model_description>
<primary_purpose>Basic Science</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
<masking_description>The pharmacy will prepare the intranasal spray (both oxytocin and placebo) and deliver it in coded syringes to the lab. Investigators, laboratory staff and subjects will be unaware of the identity of the spray on session days. The pharmacy will provide the unmasking information after all sessions are completed..</masking_description>
</study_design_info>
<primary_outcome>
<measure>Subjective effects of alcohol</measure>
<time_frame>2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo</time_frame>
<description>Difference between oxytocin compared to placebo sessions in tolerance to the subjective effects of alcohol as measured using a self-report questionnaire</description>
</primary_outcome>
<primary_outcome>
<measure>Stop Signal Response task</measure>
<time_frame>2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo</time_frame>
<description>Difference between oxytocin compared to placebo sessions in tolerance to the effects of alcohol on stop signal response times and performance</description>
</primary_outcome>
<primary_outcome>
<measure>Stroop test</measure>
<time_frame>2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo</time_frame>
<description>Difference between oxytocin compared to placebo sessions in tolerance to the effects of alcohol on stroop test response times and performance</description>
</primary_outcome>
<primary_outcome>
<measure>Alcohol self-administration</measure>
<time_frame>2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo</time_frame>
<description>Difference between oxytocin versus placebo sessions in motivation for alcohol as indicated by number of alcohol infusions earned, progressive ratio breakpoint, and/or breath alcohol concentration achieved.</description>
</primary_outcome>
<primary_outcome>
<measure>Alcohol purchase task</measure>
<time_frame>2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo</time_frame>
<description>Difference between oxytocin versus placebo sessions in motivation for alcohol as indicated by the maximum price subjects endorse.</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">12</enrollment>
<condition>Alcohol Use Disorder</condition>
<arm_group>
<arm_group_label>Clamp</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Clamped alcohol exposure, repeated tests of subjective and cognitive effects of alcohol, 2 sessions (intranasal oxytocin or placebo), double blind</description>
</arm_group>
<arm_group>
<arm_group_label>Progressive work for alcohol</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Progressive work alcohol exposure, 2 sessions (intranasal oxytocin or placebo), double blind</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Intranasal oxytocin</intervention_name>
<description>Initial dose 40 IU in 1 ml; 2 booster doses of 24 IU in 0.6 mls each, spaced about 1 hour apart</description>
<arm_group_label>Clamp</arm_group_label>
<arm_group_label>Progressive work for alcohol</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Intranasal placebo</intervention_name>
<description>Initial volume 1 ml; 2 booster volumes of 0.6 mls each, spaced about 1 hour apart</description>
<arm_group_label>Clamp</arm_group_label>
<arm_group_label>Progressive work for alcohol</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Heavy alcohol drinkers.

- Able to understand/complete questionnaires and procedures in English.

- Have venous access sufficient to allow blood sampling.

Exclusion Criteria:

- Latex allergy.

- Nasal condition that compromises delivery and/or absorption of intra-nasal oxytocin

- Pregnant or breast-feeding women.

- Desire to be treated for any substance use disorder or court ordered to not drink
alcohol

- Medical disorders or other conditions such as alcohol withdrawal seizures or delirium
tremens that may influence study outcome or participant safety.

- Positive urine drug screen for amphetamines/ methamphetamines, barbiturates,
benzodiazepines, cocaine, opiates, or phencyclidine if determined by the PI to
adversely affect participant safety or data integrity.

- Medications (past 30 days) that could influence participant safety or data integrity
(e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by the PI.

- DSM 5 Disorders (other than alcohol) or current/history of neurological disease of
cerebral origin, or head injury with > 20 min loss of consciousness, if determined by
the PI to affect participant safety or data integrity.

- Positive breath alcohol reading at beginning of the experimental session.

- Actively suicidal (for example, any current suicidal intent, including a plan) or are
at serious suicidal risk, by clinical judgment of the PI.

- Any condition for which the PI and investigative team determine it is unsafe or not
prudent to enroll a participant.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Martin H Plawecki, MD, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Psychiatry, Indiana University School of Medicine</affiliation>
</overall_official>
<overall_contact>
<last_name>Ann E Kosobud, PhD</last_name>
<phone>(317) 274-0087</phone>
<email>akosobud@iupui.edu</email>
</overall_contact>
<location>
<facility>
<name>University Hospital</name>
<address>
<city>Indianapolis</city>
<state>Indiana</state>
<zip>46202</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Recruiter</last_name>
<phone>317-948-6551</phone>
<email>erptest@iupui.edu</email>
</contact>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>February 26, 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>May 18, 2023</last_update_submitted>
<last_update_submitted_qc>May 18, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 19, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Indiana University</investigator_affiliation>
<investigator_full_name>Martin Plawecki</investigator_full_name>
<investigator_title>Associate Professor of Psychiatry</investigator_title>
</responsible_party>
<keyword>Alcohol use disorder</keyword>
<keyword>Oxytocin, intranasal</keyword>
<keyword>Alcohol tolerance</keyword>
<keyword>Alcohol intake</keyword>
<keyword>Alcohol treatment</keyword>
<keyword>Alcohol, intravenous</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Alcoholism</mesh_term>
<mesh_term>Alcohol Drinking</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Oxytocin</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>The final raw dataset will be available to other researchers when we have collected all subjects, completed our own planned analyses, and, if warranted, sought and obtained funding based on the outcome of this pilot study.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
<ipd_time_frame>The dataset will be available indefinitely</ipd_time_frame>
<ipd_access_criteria>On request to the PI</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This pilot study will seek evidence that oxytocin, compared to placebo, reverses tolerance
and alcohol seeking in humans.
This pilot study will seek evidence that intranasal oxytocin reverses tolerance and alcohol
seeking in humans by employing state-of-the-art computer-assisted intravenous alcohol
administration. Two separate experiments will be run. In the first, tolerance will be
assessed using sensitive tests of subjective response and cognitive function during an
intravenous infusion that maintains a steady breath and therefore brain exposure to alcohol.
In the second, an intravenous alcohol self-administration paradigm that requires increasing
effort for each additional infusion will be used to assess change in motivation for alcohol.
Demonstrating that oxytocin (compared to placebo) worsens test performances in
alcohol-dependent individuals and/or reduces the compulsive drive to self-administer alcohol
would be strong evidence for its potential to treat alcohol use disorders.
Inclusion Criteria:
- Heavy alcohol drinkers.
- Able to understand/complete questionnaires and procedures in English.
- Have venous access sufficient to allow blood sampling.
Exclusion Criteria:
- Latex allergy.
- Nasal condition that compromises delivery and/or absorption of intra-nasal oxytocin
- Pregnant or breast-feeding women.
- Desire to be treated for any substance use disorder or court ordered to not drink
alcohol
- Medical disorders or other conditions such as alcohol withdrawal seizures or delirium
tremens that may influence study outcome or participant safety.
- Positive urine drug screen for amphetamines/ methamphetamines, barbiturates,
benzodiazepines, cocaine, opiates, or phencyclidine if determined by the PI to
adversely affect participant safety or data integrity.
- Medications (past 30 days) that could influence participant safety or data integrity
(e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by the PI.
- DSM 5 Disorders (other than alcohol) or current/history of neurological disease of
cerebral origin, or head injury with > 20 min loss of consciousness, if determined by
the PI to affect participant safety or data integrity.
- Positive breath alcohol reading at beginning of the experimental session.
- Actively suicidal (for example, any current suicidal intent, including a plan) or are
at serious suicidal risk, by clinical judgment of the PI.
- Any condition for which the PI and investigative team determine it is unsafe or not
prudent to enroll a participant.
|
NCT0531xxxx/NCT05312021.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/NCT05312021</url>
</required_header>
<id_info>
<org_study_id>IMR687-HFP-201</org_study_id>
<secondary_id>2021-006535-25</secondary_id>
<nct_id>NCT05312021</nct_id>
</id_info>
<brief_title>Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction</brief_title>
<acronym>SP9In-HFpEF</acronym>
<official_title>Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction: a Safety and Efficacy Phase 2 Randomized Clinical Study (SP9In-HFpEF)</official_title>
<sponsors>
<lead_sponsor>
<agency>Imara, Inc.</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Imara, Inc.</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This study is to evaluate whether 16 weeks of treatment with IMR-687 is a safe and effective
treatment for patients with Heart Failure with Preserved Ejection Fraction (HFpEF). The
primary objective is to evaluate whether IMR-687 reduces NT-proBNP compared to placebo in
these patients.
</textblock>
</brief_summary>
<overall_status>Withdrawn</overall_status>
<why_stopped>
Study Termination
</why_stopped>
<start_date type="Anticipated">April 2022</start_date>
<completion_date type="Anticipated">November 2023</completion_date>
<primary_completion_date type="Anticipated">September 2023</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Change in NT-proBNP</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>Calculated as the percent change from Baseline to Week 16 in NT-proBNP</description>
</primary_outcome>
<secondary_outcome>
<measure>To evaluate the safety and tolerability in IMR-687 versus placebo (TEAEs: Treatment-emergent adverse events</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>An adverse event (AE) is an untoward medical occurrence in a subject who received study drug without regard to the possibility of a causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; and any other medically important serious event as judged by the investigator. AEs are considered treatment-emergent if they have started or worsened after the first application of study drug up to 30 days after end of treatment with study drug.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Baseline to Week 16 in the Kansas City Cardiomyopathy Questionnaire overall summary score</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment, and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>NYHA Classification</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>Change from Baseline to Week 16 in NYHA classification</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Baseline to Week 16 in Clinical Composite Score</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>The clinical composite score is defined as follows: Improved = participant improved in KCCQ score questionnaire with no major adverse cardiovascular event. Worsened = participant worsened (markedly or moderately) in KCCQ score or experienced a major adverse cardiovascular event. Unchanged = participant had no worsening in KCCQ score with no major adverse cardiovascular event.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change From Baseline in Echocardiography (ECHO) Parameters: Left Ventricular End (LVE) Diastolic Diameter, LVE Systolic Diameter, Septal End Diastolic Thickness, Posterior LV Wall End Diastolic Thickness, Relative Wall Thickness, Left Atrial Dimension</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>A limited two-dimensional and Doppler ECHO examination will be done to assess ECHO parameters. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change From Baseline in Echocardiography Parameters: LVE Diastolic Volume, LVE Systolic Volume, Left Ventricular Stroke Volume, Left Atrial Volume</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>A limited two-dimensional and Doppler ECHO examination will be done to assess ECHO parameters. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>A limited two-dimensional and Doppler ECHO examination will be done to assess ECHO parameters. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change From Baseline in Echocardiography Parameters: Left Ventricular Mass</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>A limited two-dimensional and Doppler ECHO examination will be done to assess ECHO parameters. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change From Baseline in Echocardiography Parameters: Left Ventricular Mass Index</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>A limited two-dimensional and Doppler ECHO examination will be done to assess ECHO parameters. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change From Baseline in Echocardiography Parameters: Left Atrial Volume Index</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>A limited two-dimensional and Doppler ECHO examination will be done to assess ECHO parameters. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change From Baseline in Echocardiography Parameters: Ewave Velocity, A Wave Velocity, e' at Septal Mitral Annulus, e' at Lateral Mitral Annulus</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>A limited two-dimensional and Doppler ECHO examination will be done to assess ECHO parameters. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change From Baseline in Echocardiography Parameters: Ratio of E to A Velocity, E/e' Ratio</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>A limited two-dimensional and Doppler ECHO examination will be done to assess ECHO parameters. A ratio < 1 indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Echocardiography Parameters: Isovolumic Relaxation Time</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>A limited two-dimensional and Doppler ECHO examination will be done to assess ECHO parameters. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change From Baseline in Echocardiography Parameters: Tricuspid Regurgitation Velocity</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>A limited two-dimensional and Doppler ECHO examination will be done to assess ECHO parameters. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Exercise Capacity</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>Change from Baseline to Week 16 in 6MWT</description>
</secondary_outcome>
<secondary_outcome>
<measure>Body Composition and Biomarker Measures</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>Change from Baseline to Week 16 for body composition by waist-to-hip ratio, BMI, and Tissue Inhibitor of Metalloproteinases (TIMP)
Evaluation of TIMP will be performed by central laboratory assessment. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Body Composition and Biomarker Measures</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>Change from Baseline to Week 16 for Procollagen III N-terminal Peptide (PIIINP)
Evaluation of PIIINP will be performed by central laboratory assessment. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Body Composition and Biomarker Measures</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>Change from Baseline to Week 16 for Matrix Metalloproteinase-2 (MMP-2)
Evaluation of serum MMP-2 will be performed by central laboratory assessment. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Body Composition and Biomarker Measures</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>Change from Baseline to Week 16 for C-peptide
Evaluation of serum C-peptide will be performed by central laboratory assessment. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Body Composition and Biomarker Measures</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>Change from Baseline to Week 16 for Interleukin-6 (IL-6)
Evaluation of serum IL-6 will be performed by central laboratory assessment. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline to Week 16 for Estimated Glomerular Filtration Rate (eGFR)</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>eGFR will be calculated from the serum creatinine concentration determined by central laboratory assessment. A positive change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline to Week 16 for Interferon-gamma (Ifn-gamma)</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>Evaluation of serum Ifn-gamma will be performed by central laboratory. A negative change from baseline indicates improvement.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline to Week 16 in body composition quantification by dual-energy X-ray absorptiometry scan (at selected sites)</measure>
<time_frame>Baseline to Week 16</time_frame>
<description>A dual-energy X-ray absorptiometry scan will be done to assess body composition parameters. A negative change indicates improvement</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">0</enrollment>
<condition>Heart Failure With Preserved Ejection Fraction</condition>
<arm_group>
<arm_group_label>IMR-687</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants randomly assigned to this arm will take IMR-687 orally with food BID for 16 weeks. IMR-687 dosing will be 300 mg BID for participants weighing less than 100 kg and 400 mg BID for participants weighing 100 kg or more.</description>
</arm_group>
<arm_group>
<arm_group_label>Placebo</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Participants randomly assigned to this arm will take placebo orally with food BID for 16 weeks.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>IMR-687</intervention_name>
<description>150 mg and 200 mg tablets</description>
<arm_group_label>IMR-687</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>IMR-687 Placebo</intervention_name>
<description>Matching placebo to IMR-687</description>
<arm_group_label>Placebo</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Males or females ≥45 years

- Weight 60 to 160 kg, inclusive

- LVEF ≥45% by echo within 6 months prior to Screening Visit

- Symptoms of HFpEF requiring treatment with a diuretic(s) for at least 30 days prior to
Screening

- NYHA class II to IV at the time of Screening

- LV hypertrophy, by echo within 6 months of screening, defined by either LV mass/BSA
>95 g/m² for females and 115 g/m² for males or LV mass/m² for males >44 g/m2.7 for
females and 48 g/m2.7 for males

- NT-proBNP criteria either ≥300 pg/mL if in sinus rhythm or ≥700 pg/mL if in atrial
fibrillation at screening

- Elevated LV filling pressure criteria are defined as ONE OR MORE of the following:

1. HF hospitalization within 12 months prior to screening

2. LA enlargement (LA width (diameter) ≥3.8 cm, LA length ≥5.0 cm, LA area ≥20 cm² ,
LA volume ≥55 mL, or LA volume index >29 mL/m²) within 6 months of screening for
a participant in sinus rhythm

3. Cardiac catheterization with at least one of the following in the 12 months prior
to screening: rest LVEDP or PCWP ≥15 mm Hg, exercise PCWP ≥25 mm Hg, or fluid
challenge PCWP ≥18 mm Hg

4. Echocardiogram criteria of one or more within 6 months of screening for a
participant in sinus rhythm: E/e' (mean of lateral and septal) >13, E/e' lateral
>12, or E/e' septal >14; or for a participant in atrial fibrillation: E/e' septal
>11

- For WOCBP: Two negative pregnancy tests and the use of highly effective contraception
up to 3 months following end of study

Exclusion Criteria:

- Any prior echocardiographic imaging measurement of LVEF <40%

- Six-minute walk test (6MWT) distance <100 m or >450 m at Screening Visit

- Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of >80

- Major cardiovascular surgery, or urgent percutaneous coronary intervention (PCI)
within the 3 months prior to Screening Visit, or an elective PCI within 30 days prior
to Screening Visit

- Any clinical event within 6 months prior to Screening Visit that could have reduced
the LVEF (eg, myocardial infarction, coronary artery bypass graft) unless an
echocardiographic measurement was performed at least 1 month after the event
confirming the LVEF to be ≥45%
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>45 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Steve Luperchio</last_name>
<role>Study Director</role>
<affiliation>Cardurion Pharmaceuticals</affiliation>
</overall_official>
<verification_date>March 2023</verification_date>
<study_first_submitted>March 8, 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>March 6, 2023</last_update_submitted>
<last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 8, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>heart failure</keyword>
<keyword>HFpEF</keyword>
<keyword>preserved ejection fraction</keyword>
<keyword>IMR-687</keyword>
<keyword>PDE9</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Heart Failure</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study is to evaluate whether 16 weeks of treatment with IMR-687 is a safe and effective
treatment for patients with Heart Failure with Preserved Ejection Fraction (HFpEF). The
primary objective is to evaluate whether IMR-687 reduces NT-proBNP compared to placebo in
these patients.
Inclusion Criteria:
- Males or females ≥45 years
- Weight 60 to 160 kg, inclusive
- LVEF ≥45% by echo within 6 months prior to Screening Visit
- Symptoms of HFpEF requiring treatment with a diuretic(s) for at least 30 days prior to
Screening
- NYHA class II to IV at the time of Screening
- LV hypertrophy, by echo within 6 months of screening, defined by either LV mass/BSA
>95 g/m² for females and 115 g/m² for males or LV mass/m² for males >44 g/m2.7 for
females and 48 g/m2.7 for males
- NT-proBNP criteria either ≥300 pg/mL if in sinus rhythm or ≥700 pg/mL if in atrial
fibrillation at screening
- Elevated LV filling pressure criteria are defined as ONE OR MORE of the following:
1. HF hospitalization within 12 months prior to screening
2. LA enlargement (LA width (diameter) ≥3.8 cm, LA length ≥5.0 cm, LA area ≥20 cm² ,
LA volume ≥55 mL, or LA volume index >29 mL/m²) within 6 months of screening for
a participant in sinus rhythm
3. Cardiac catheterization with at least one of the following in the 12 months prior
to screening: rest LVEDP or PCWP ≥15 mm Hg, exercise PCWP ≥25 mm Hg, or fluid
challenge PCWP ≥18 mm Hg
4. Echocardiogram criteria of one or more within 6 months of screening for a
participant in sinus rhythm: E/e' (mean of lateral and septal) >13, E/e' lateral
>12, or E/e' septal >14; or for a participant in atrial fibrillation: E/e' septal
>11
- For WOCBP: Two negative pregnancy tests and the use of highly effective contraception
up to 3 months following end of study
Exclusion Criteria:
- Any prior echocardiographic imaging measurement of LVEF <40%
- Six-minute walk test (6MWT) distance <100 m or >450 m at Screening Visit
- Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of >80
- Major cardiovascular surgery, or urgent percutaneous coronary intervention (PCI)
within the 3 months prior to Screening Visit, or an elective PCI within 30 days prior
to Screening Visit
- Any clinical event within 6 months prior to Screening Visit that could have reduced
the LVEF (eg, myocardial infarction, coronary artery bypass graft) unless an
echocardiographic measurement was performed at least 1 month after the event
confirming the LVEF to be ≥45%
|
NCT0531xxxx/NCT05312034.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/NCT05312034</url>
</required_header>
<id_info>
<org_study_id>15054519.3.0000.5249C</org_study_id>
<nct_id>NCT05312034</nct_id>
</id_info>
<brief_title>Application of an Antimicrobial Stewardship Program in Brazilian ICUs Using Machine Learning Techniques and an Educational Model</brief_title>
<official_title>Application of an Antimicrobial Stewardship Program in Brazilian ICUs Using Machine Learning Techniques and an Educational Model</official_title>
<sponsors>
<lead_sponsor>
<agency>D'Or Institute for Research and Education</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>D'Or Institute for Research and Education</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>
Antimicrobial agents are frequently used empirically and include therapy for both
Gram-positive and Gram-negative bacteria. In Brazil, multidrug-resistant Gram-negative
pathogens are the cause of most nosocomial infections in ICUs. Therefore, the excessive use
of antimicrobials to treat Gram-positive bacteria represents an opportunity to reduce
unnecessary antibiotic use in critically ill patients. Besides, the success of a program
aimed at reducing the use of antibiotics to treat gram-positive bacteria could also evolve to
include other microorganisms, such as gram-negative bacteria and fungi. Analyzing data from
the ICUs of the associated hospital network, high use of broad-spectrum antibiotics and
vancomycin were observed, although MRSA infections rarely occur.

Thus, if physicians could identify patients at high risk of infection by gram-positive
bacteriaa reduction in antibiotic consumption could occur.. The more accurate treatments
could result in better patient outcomes, reduce the antibiotics' adverse effects, and
decrease the prevalence of multidrug-resistant bacteria. Therefore, our main goal is to
reduce antibiotic use by applying an intervention with three main objectives: (i) to educate
the medical team, (ii) to provide a tool that can help physicians prescribing antibiotics,
and (iii) to find and reduce differences in antibiotic prescription between hospitals with
low- and high-resources.

To achieve these objectives, he same intervention will be applied in ICUs of two hospitals
with different access to resources. Both are part of a network of hospitals associated with
our group.

First, baseline data corresponding to patient characteristics, antibiotic use,
microbiological outcomes and current administration programs in practice at selected
hospitals will be analyzed. TThen, a predictive model to detect patients at high risk of
Gram-positive infection will be developed. After that, t will be applied for three months as
an educational tool to improve medical decisions regarding antibiotic prescription. After
obtaining feedback and suggestions from physicians and other hospital and infection control
members, the model will be adjusted and applied in the two selected hospitals for use in real
time. For one year, we will monitor the intervention and analyze the data monthly.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This proposal is a five-step quality improvement project.

1. Analysis of baseline data [3 months]: Retrospective data will be collected from ten
hospitals of Rede D'Or São Luiz. Patient characteristics, microbiological results and
the use of antimicrobial agents will be analyzed. Stewardship programs currently in
place will also be recorded.

2. Development of the predictive model [3 months]: Collected data and machine learning
techniques will be used to develop a predictive model to identify patients at risk of
Gram-positive infection. This model will be evaluated using standard methods (e.g.,
accuracy and confusion matrix) and through clinical decision curves. This model will be
embedded in an app and a web page to provide real-time guidance on the predicted
probability of infection due to Gram-positive agents.

3. Educational and calibration phase [3 months]: Firstly it will be used use the predictive
model as a simulation tool to educate physicians. For three months, physicians will use
the model to understand the main factors associated with Gram-positive infection. They
will test the model using real-case data previously collected at the hospitals. The
model will provide them information such as the probability of that patient having a
Gram-positive infection and the proportion of infected patients in that ICU and
hospital.

After that, a meeting with all ICU and infection control members from participating hospitals
will be held. A specific probability cutoff will be defined for starting gram-positive
coverage. For example, the members can define that they feel comfortable not treating
empirically gram-positive bacteria if the predicted probability is below a given threshold
(say 5%). Quality improvement protocol will also involve other traditional methods to
decrease antibiotic use, including audit feedback and daily remembrances to withdraw
gram-positive antibiotic coverage. Educational material will be developed and provided for
all sites, as well as in-site training.

This phase will motivate the involvement of the hospital members, especially physicians,
which can improve engagement to the intervention to be implemented afterward. Hopefully, it
will also generate insights and feedback from the medical team to improve the tool to be
implemented.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 1, 2022</start_date>
<completion_date type="Anticipated">December 29, 2023</completion_date>
<primary_completion_date type="Anticipated">December 29, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>A predictive model to identify patients at risk of Gram-positive infection. This model will be embedded in an app and a web page to provide real-time guidance on the predicted probability of infection due to Gram-positive agents.
The intervention will be implemented in two selected hospitals, aiming at monthly decreasing the use of broad-spectrum antibiotics while maintaining or reducing the ICU standardized mortality ratio and the standardized resource use.</intervention_model_description>
<primary_purpose>Prevention</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Antimicrobial consumption</measure>
<time_frame>Baseline</time_frame>
<description>It was evaluated through the Defined Daily Dose (DDD): The assumed average maintenance dose per day for a drug used for its main indication in adults; and Duration of Treatment (DOT):Duration of Treatment with antibiotics.</description>
</primary_outcome>
<primary_outcome>
<measure>Antimicrobial consumption</measure>
<time_frame>During the intervention</time_frame>
<description>It was evaluated through the Defined Daily Dose (DDD): The assumed average maintenance dose per day for a drug used for its main indication in adults; and Duration of Treatment (DOT): Duration of Treatment with antibiotics</description>
</primary_outcome>
<secondary_outcome>
<measure>Mortality</measure>
<time_frame>number of deaths in 60 days</time_frame>
<description>ICU Mortality</description>
</secondary_outcome>
<secondary_outcome>
<measure>Gram-positive infection</measure>
<time_frame>immediately after the microbiologics analysis</time_frame>
<description>Number of patients with missed Gram-positive infection</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">100</enrollment>
<condition>Nosocomial Infection</condition>
<condition>Sepsis</condition>
<arm_group>
<arm_group_label>Application of an antimicrobial stewardship program in ICUs</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Application of an antimicrobial stewardship program in Brazilian ICUs using machine learning techniques and an educational model</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Implementation of the predictive model for an antimicrobial management program</intervention_name>
<description>Firstly it will be used the predictive model as a simulation tool to educate physicians. For three months, physicians will use the model to understand the main factors associated with Gram-positive infection. They will test the model using real-case data previously collected at the hospitals. The model will provide them information such as the probability of that patient having a Gram-positive infection and the proportion of infected patients in that ICU and hospital.
This model will be embedded in an app and a web page to provide real-time guidance on the predicted probability of infection due to Gram-positive agents.
The intervention will be implemented in two selected hospitals, aiming at monthly decreasing the use of broad-spectrum antibiotics while maintaining or reducing the ICU standardized mortality ratio and the standardized resource use.</description>
<arm_group_label>Application of an antimicrobial stewardship program in ICUs</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- prescribers from the hospital units participating in the study.

Exclusion Criteria:

- prescribers who do not work in intensive care units.

- refusal to participate
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Fernando Bozza, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>D'Or Institute for Research and Education (IDOR)</affiliation>
</overall_official>
<overall_contact>
<last_name>Fernando Bozza, PhD</last_name>
<phone>55 21 993031551</phone>
<email>bozza.fernando@gmail.com</email>
</overall_contact>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 16, 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>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>
<keyword>antimicrobial</keyword>
<keyword>antibiotics</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cross Infection</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Anti-Infective Agents</mesh_term>
<mesh_term>Anti-Bacterial Agents</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Antimicrobial agents are frequently used empirically and include therapy for both
Gram-positive and Gram-negative bacteria. In Brazil, multidrug-resistant Gram-negative
pathogens are the cause of most nosocomial infections in ICUs. Therefore, the excessive use
of antimicrobials to treat Gram-positive bacteria represents an opportunity to reduce
unnecessary antibiotic use in critically ill patients. Besides, the success of a program
aimed at reducing the use of antibiotics to treat gram-positive bacteria could also evolve to
include other microorganisms, such as gram-negative bacteria and fungi. Analyzing data from
the ICUs of the associated hospital network, high use of broad-spectrum antibiotics and
vancomycin were observed, although MRSA infections rarely occur.
Thus, if physicians could identify patients at high risk of infection by gram-positive
bacteriaa reduction in antibiotic consumption could occur.. The more accurate treatments
could result in better patient outcomes, reduce the antibiotics' adverse effects, and
decrease the prevalence of multidrug-resistant bacteria. Therefore, our main goal is to
reduce antibiotic use by applying an intervention with three main objectives: (i) to educate
the medical team, (ii) to provide a tool that can help physicians prescribing antibiotics,
and (iii) to find and reduce differences in antibiotic prescription between hospitals with
low- and high-resources.
To achieve these objectives, he same intervention will be applied in ICUs of two hospitals
with different access to resources. Both are part of a network of hospitals associated with
our group.
First, baseline data corresponding to patient characteristics, antibiotic use,
microbiological outcomes and current administration programs in practice at selected
hospitals will be analyzed. TThen, a predictive model to detect patients at high risk of
Gram-positive infection will be developed. After that, t will be applied for three months as
an educational tool to improve medical decisions regarding antibiotic prescription. After
obtaining feedback and suggestions from physicians and other hospital and infection control
members, the model will be adjusted and applied in the two selected hospitals for use in real
time. For one year, we will monitor the intervention and analyze the data monthly.
This proposal is a five-step quality improvement project.
1. Analysis of baseline data [3 months]: Retrospective data will be collected from ten
hospitals of Rede D'Or São Luiz. Patient characteristics, microbiological results and
the use of antimicrobial agents will be analyzed. Stewardship programs currently in
place will also be recorded.
2. Development of the predictive model [3 months]: Collected data and machine learning
techniques will be used to develop a predictive model to identify patients at risk of
Gram-positive infection. This model will be evaluated using standard methods (e.g.,
accuracy and confusion matrix) and through clinical decision curves. This model will be
embedded in an app and a web page to provide real-time guidance on the predicted
probability of infection due to Gram-positive agents.
3. Educational and calibration phase [3 months]: Firstly it will be used use the predictive
model as a simulation tool to educate physicians. For three months, physicians will use
the model to understand the main factors associated with Gram-positive infection. They
will test the model using real-case data previously collected at the hospitals. The
model will provide them information such as the probability of that patient having a
Gram-positive infection and the proportion of infected patients in that ICU and
hospital.
After that, a meeting with all ICU and infection control members from participating hospitals
will be held. A specific probability cutoff will be defined for starting gram-positive
coverage. For example, the members can define that they feel comfortable not treating
empirically gram-positive bacteria if the predicted probability is below a given threshold
(say 5%). Quality improvement protocol will also involve other traditional methods to
decrease antibiotic use, including audit feedback and daily remembrances to withdraw
gram-positive antibiotic coverage. Educational material will be developed and provided for
all sites, as well as in-site training.
This phase will motivate the involvement of the hospital members, especially physicians,
which can improve engagement to the intervention to be implemented afterward. Hopefully, it
will also generate insights and feedback from the medical team to improve the tool to be
implemented.
Inclusion Criteria:
- prescribers from the hospital units participating in the study.
Exclusion Criteria:
- prescribers who do not work in intensive care units.
- refusal to participate
|
NCT0531xxxx/NCT05312047.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/NCT05312047</url>
</required_header>
<id_info>
<org_study_id>PR(AMI)631-2021</org_study_id>
<nct_id>NCT05312047</nct_id>
</id_info>
<brief_title>Continence After Vaginal Prolapse Surgery</brief_title>
<official_title>Urinary Continence Status After Vaginal Surgery for Prolapse Correction.</official_title>
<sponsors>
<lead_sponsor>
<agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Consorci Sanitari de Terrassa</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital Parc Taulí, Sabadell</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital de Viladecans</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital Universitari de Bellvitge</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital d'Igualada</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital de Mataró</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Fundació Hospital de l'Esperit Sant</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Germans Trias i Pujol Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital Santa Caterina</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital de Granollers</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital del Mar</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital Universitari Joan XXIII de Tarragona.</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Hospital Universitari Vall d'Hebron Research Institute</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Urinary incontinence after surgical correction of pelvic organ prolapse (POP) could occur.
This is a condition that decreases both patients' satisfaction and quality of life. Reports
on the prevalence of urinary incontinence after POP surgery are controversial. Concomitant
surgery for incontinence could reduce this prevalence, whereas it increases treatment costs
and the likelihood of surgical complications. Therefore, it is of paramount importance to
know the exact prevalence of urinary incontinence after POP surgery in our population and the
potential risk factors associated with this condition.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 4, 2022</start_date>
<completion_date type="Anticipated">May 2024</completion_date>
<primary_completion_date type="Anticipated">May 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>Stress urinary incontinence (SUI).</measure>
<time_frame>1 year after surgery.</time_frame>
<description>A "Yes" response to any of three questions on the spanish version of the Pelvic Floor Distress Inventory (PFDI) stress incontinence subscale regarding leakage with coughing, sneezing, or laughing; physical exercise; and lifting or bending over (PFDI questions 20, 21 and 22) .</description>
</primary_outcome>
<primary_outcome>
<measure>Urgency urinary incontinence (UUI).</measure>
<time_frame>1 year after surgery.</time_frame>
<description>A "Yes" response to PFDI question 19, "usually experiences urine leakage associated with a feeling of urgency, that is, a strong sensation of needing to go to the bathroom".</description>
</primary_outcome>
<secondary_outcome>
<measure>Incontinence severity</measure>
<time_frame>1 year after surgery.</time_frame>
<description>Both SUI and UII severity will be assessed using the spanish versions of the Sandvik's severity index and the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Patients' satisfaction with the procedure.</measure>
<time_frame>1 year after surgery.</time_frame>
<description>Assessed with the Patient Impression of Improvement (PGI-I) form.</description>
</secondary_outcome>
<enrollment type="Anticipated">600</enrollment>
<condition>Pelvic Organ Prolapse</condition>
<condition>Urinary Incontinence</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Pelvic organ prolapse surgery</intervention_name>
<description>Vaginal surgery of any compartment for pelvic organ prolapse</description>
</intervention>
<eligibility>
<study_pop>
<textblock>
Patients referred to different Spanish-Catalan hospitals with symptomatic pelvic organ
prolapse who are candidates for surgical correction of their POP.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Women who will undergo vaginal surgery for pelvic organ prolapse.

Exclusion Criteria:

- Inability to give consent to the study.
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>99 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Marina Catalan, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Vall d'Hebron Barcelona Hospital Campus</affiliation>
</overall_official>
<overall_official>
<last_name>Jordi Sabadell, MD</last_name>
<role>Study Director</role>
<affiliation>Vall d'Hebron Barcelona Hospital Campus</affiliation>
</overall_official>
<overall_contact>
<last_name>Jordi Sabadell, MD</last_name>
<phone>+34934894010</phone>
<email>jordi.sabadell@vallhebron.cat</email>
</overall_contact>
<overall_contact_backup>
<last_name>Marina Catalan, MD</last_name>
<email>marina.catalan@vallhebron.cat</email>
</overall_contact_backup>
<location>
<facility>
<name>Hospital Germans Trias i Pujol</name>
<address>
<city>Badalona</city>
<state>Barcelona</state>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Rosana Díaz-Souto</last_name>
</contact>
<investigator>
<last_name>Rosana Díaz-Souto</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Hospital General de Granollers</name>
<address>
<city>Granollers</city>
<state>Barcelona</state>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Ana Pereda</last_name>
</contact>
<investigator>
<last_name>Ana Pereda</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Hospital General de l'Hospitalet</name>
<address>
<city>Hospitalet de Llobregat</city>
<state>Barcelona</state>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jordi Genovés</last_name>
</contact>
<investigator>
<last_name>Jordi Genovés</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Cristina Berdié</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Hospital d'Igualada</name>
<address>
<city>Igualada</city>
<state>Barcelona</state>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Alda Amela</last_name>
</contact>
<investigator>
<last_name>Alda Amela</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Alba Lopez</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Hospital Universitari de Bellvitge</name>
<address>
<city>L'Hospitalet De Llobregat</city>
<state>Barcelona</state>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Miriam Campos</last_name>
</contact>
<investigator>
<last_name>Miriam Campos</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Parc Taulí Hospital Universitari</name>
<address>
<city>Sabadell</city>
<state>Barcelona</state>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Montserrat Mestre</last_name>
</contact>
<investigator>
<last_name>Montserrat Mestre</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Hospital de l'Esperit Sant</name>
<address>
<city>Santa Coloma De Gramenet</city>
<state>Barcelona</state>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Sira Capote</last_name>
</contact>
<investigator>
<last_name>Judit Lleberia</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Sira Capote</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Consorci Sanitari de Terrassa</name>
<address>
<city>Terrassa</city>
<state>Barcelona</state>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Albert Font</last_name>
</contact>
<investigator>
<last_name>Albert Font</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Marino Romero</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Hospital de Viladecans</name>
<address>
<city>Viladecans</city>
<state>Barcelona</state>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Cristina Molinet</last_name>
</contact>
<investigator>
<last_name>Cristina Molinet</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Carmen Gonzalez</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Vall d'Hebron Barcelona Hospital Campus</name>
<address>
<city>Barcelona</city>
<zip>08035</zip>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jordi Sabadell</last_name>
</contact>
<investigator>
<last_name>Marina Catalan</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Hospital de Sant Pau</name>
<address>
<city>Barcelona</city>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Irene Mora</last_name>
</contact>
<investigator>
<last_name>Irene Mora</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Hospital del Mar</name>
<address>
<city>Barcelona</city>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Iris Aran</last_name>
</contact>
<investigator>
<last_name>Iris Aran</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Elisabet del Amo</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Hospital Santa Caterina</name>
<address>
<city>Girona</city>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Mª del Àngel Ribary</last_name>
</contact>
<investigator>
<last_name>Mª del Àngel Ribary</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Alicia Carrera</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Hospital Joan XXIII</name>
<address>
<city>Tarragona</city>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Mª Jose Miranda</last_name>
</contact>
<investigator>
<last_name>Mª Jose Miranda</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Miriam de la Flor</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location_countries>
<country>Spain</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>March 17, 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>June 8, 2023</last_update_submitted>
<last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 9, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Pelvic organ prolapse</keyword>
<keyword>Surgery</keyword>
<keyword>Urinary incontinence</keyword>
<keyword>Stress urinary incontinence</keyword>
<keyword>Urge-urinary incontinence</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Urinary Incontinence</mesh_term>
<mesh_term>Enuresis</mesh_term>
<mesh_term>Prolapse</mesh_term>
<mesh_term>Pelvic Organ Prolapse</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Urinary incontinence after surgical correction of pelvic organ prolapse (POP) could occur.
This is a condition that decreases both patients' satisfaction and quality of life. Reports
on the prevalence of urinary incontinence after POP surgery are controversial. Concomitant
surgery for incontinence could reduce this prevalence, whereas it increases treatment costs
and the likelihood of surgical complications. Therefore, it is of paramount importance to
know the exact prevalence of urinary incontinence after POP surgery in our population and the
potential risk factors associated with this condition.
Patients referred to different Spanish-Catalan hospitals with symptomatic pelvic organ
prolapse who are candidates for surgical correction of their POP.
Inclusion Criteria:
- Women who will undergo vaginal surgery for pelvic organ prolapse.
Exclusion Criteria:
- Inability to give consent to the study.
|
NCT0531xxxx/NCT05312060.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/NCT05312060</url>
</required_header>
<id_info>
<org_study_id>0014626/22</org_study_id>
<nct_id>NCT05312060</nct_id>
</id_info>
<brief_title>Pneumatic Compression Versus Anti-thromboembolic Exercises for Patients Undergoing Total Hip Arthroplasty</brief_title>
<official_title>Pneumatic Compression Versus Anti-thromboembolic Exercises: Effects on Edema of the Lower Limbs and the Outcomes of Patients Undergoing Total Hip Arthroplasty: Randomized Controlled Clinical Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Luca Marin</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Pavia</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This study is a randomized controlled trial, with two parallel arms. The open-label study
will be conducted in accordance with the helsinky statement and good clinical practice
standards.

The main objective is to compare the reduction of postoperative edema following Total Hip
Arthroplasty (THA) between patients undergoing postoperative treatment with pneumatic
compression (PC, experimental group) and patients undergoing postoperative treatment with
antithromboembolic exercises. (AE, control group). We also aim to compare the pre-post
treatment variations of joint function measurements (joint excursion), referred pain and
functional capabilities.

48 patients will meet the criteria listed below will be recruited.

Inclusion criteria:

- total hip arthroplasty under election regime

- aged between 50 and 80 at the time of recruitment, both sexes.

Exclusion criteria:

- obesity (BMI> 30);

- other orthopedic or neurological pathologies that modify walking ability;

- pathologies that modify balance (neurological and / or vestibular);

- contraindications to the use of the medical equipment used in the study;

- inability to understand and sign informed consent. Participants will be assigned,
through a block randomization, to one of the two study groups: experimental group will
undergo pneumatic compression treatment (PC), control group will perform
antithromboembolic exercises (AE).

For both, the treatment will last 10 working days, starting from the first post surgery day
(T0). The PC will undergo two daily 30-minute sessions of sequential pneumatic compression
(I-Press®, I-Tech Medical Division, Martellago, Italy) while AE will perform two supervised
antithromboembolic exercises sessions daily lasting 30 minutes. All participants will carry
out the antithrombotic prophylaxis in use at the department of orthopedics: drug therapy,
graduated compression stocking and indirect electrostimulation (T-One Rehab®, I-Tech Medical
Division, Martellago, Italy).

Assessments of edema, joint range of motion, pain and functional capabilities will be made at
T0 and at the end of the treatment (T1).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This study is a randomized controlled trial, with two parallel arms. The open-label study
will be conducted in accordance with the helsinky statement and good clinical practice
standards.

To compare the reduction of postoperative edema following Total Hip Arthroplasty (THA)
between patients undergoing postoperative treatment with pneumatic compression (PC,
experimental group) and patients undergoing postoperative treatment with antithromboembolic
exercises. (AE, control group). We also aim to compare the pre-post treatment variations of
joint function measurements (joint excursion), referred pain and functional capabilities.

48 patients will be recruited at the Department of Orthopedic Surgery of the City of Pavia,
University Hospital.

Participants will be assigned, through a block randomization, to one of the two study groups:
experimental group will undergo pneumatic compression treatment (PC), control group will
perform antithromboembolic exercises (AE). For both, the treatment will last 10 working days,
starting from the first post surgery day (T0). The PC will undergo two daily 30-minute
sessions of sequential pneumatic compression (I-Press®, I-Tech Medical Division, Martellago,
Italy) while AE will perform two supervised antithromboembolic exercises sessions daily
lasting 30 minutes. All participants will carry out the antithrombotic prophylaxis in use at
the department of orthopedics: drug therapy, graduated compression stocking and indirect
electrostimulation (T-One Rehab®, I-Tech Medical Division, Martellago, Italy).

At T0 and at the end of the treatment (T1) the following assessments of the operated limb
will be carried out:

- circumference of the distal third of the thigh

- circumference of the proximal third of the leg

- range of motion of the knee flexion

- range of motion of the ankle dorsiflexion

The following assessments will also be carried out:

- perceived pain, with the Numeric Rating Scale of Pain (NRS)

- functional capability, with 20 m walk test (20 m). Walking autonomy will be carried out
at T1 with the 6 minutes walking test (6MWT).

STATISTICAL ANALYSIS Quantitative variables will be described with mean and standard
deviation if normally distributed, with median and interquartile range if not normally
distributed.

Categorical variables will be expressed with counts and percentages. Continuous variables
will be compared between the two groups with Student's t test or with the analogous
non-parametric Mann-Whitney test, considering the normality of the distribution (evaluated
with graphical methods or with the Shapiro-Wilk test).

Possible associations between categorical variables will be evaluated with Pearson's
chi-square test or with Fisher's exact test.

All tests will be two-tailed; the level of significance is set at alpha 0.05 (statistical
significance if p value <0.05).
</textblock>
</detailed_description>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Actual">April 11, 2022</start_date>
<completion_date type="Anticipated">September 30, 2022</completion_date>
<primary_completion_date type="Anticipated">September 30, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Operated limb edema</measure>
<time_frame>Ten days</time_frame>
<description>circumference of the distal third of the thigh
circumference of the proximal third of the leg circumference of the distal third of the thigh
circumference of the proximal third of the leg thigh and leg circumference</description>
</primary_outcome>
<secondary_outcome>
<measure>Perceived Pain</measure>
<time_frame>Ten days</time_frame>
<description>Perceived pain, assessed with Numeric Rating Scale. Where 0 is no pain and 10 is the maximum pain felt</description>
</secondary_outcome>
<secondary_outcome>
<measure>Functional capability</measure>
<time_frame>Ten Days</time_frame>
<description>Walking capability, assessed with 20 meters walking test</description>
</secondary_outcome>
<secondary_outcome>
<measure>Operated lower limb range of motion</measure>
<time_frame>Ten Days</time_frame>
<description>Knee and ankle range of motion</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">48</enrollment>
<condition>Edema Leg</condition>
<arm_group>
<arm_group_label>Pneumatic Compression (PC)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The PC will undergo two daily 30-minute sessions of sequential pneumatic compression.</description>
</arm_group>
<arm_group>
<arm_group_label>Antithromboembolic exercises (AE)</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>AE will perform two supervised antithromboembolic exercises sessions daily lasting 30 minutes.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>PC Pneumatic compression</intervention_name>
<description>Pneumatic compression of the operated limb</description>
<arm_group_label>Pneumatic Compression (PC)</arm_group_label>
<other_name>I-Press®, I-Tech Medical Division, Martellago, Italy</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>AE Antithromboembolic exercises</intervention_name>
<description>Exercises for the edema</description>
<arm_group_label>Antithromboembolic exercises (AE)</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- total hip arthroplasty, scheduled surgery

- aged between 50 and 80 at the time of recruitment

Exclusion Criteria:

- obesity (BMI> 30);

- other orthopedic or neurological pathologies that modify walking ability;

- pathologies that modify balance (neurological and / or vestibular);

- contraindications to the use of the medical equipment used in the study;

- inability to understand and sign informed consent.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>50 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Luca Marin, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>University fo Pavia</affiliation>
</overall_official>
<location>
<facility>
<name>Istituto di Cura Città di Pavia</name>
<address>
<city>Pavia</city>
<zip>27100</zip>
<country>Italy</country>
</address>
</facility>
</location>
<location_countries>
<country>Italy</country>
</location_countries>
<link>
<url>http://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects</url>
<description>Declaration of Helsinki</description>
</link>
<reference>
<citation>Santana DC, Emara AK, Orr MN, Klika AK, Higuera CA, Krebs VE, Molloy RM, Piuzzi NS. An Update on Venous Thromboembolism Rates and Prophylaxis in Hip and Knee Arthroplasty in 2020. Medicina (Kaunas). 2020 Aug 19;56(9):416. doi: 10.3390/medicina56090416.</citation>
<PMID>32824931</PMID>
</reference>
<reference>
<citation>O'Reilly RF, Burgess IA, Zicat B. The prevalence of venous thromboembolism after hip and knee replacement surgery. Med J Aust. 2005 Feb 21;182(4):154-9. doi: 10.5694/j.1326-5377.2005.tb06643.x.</citation>
<PMID>15720169</PMID>
</reference>
<reference>
<citation>Williams KJ, Ravikumar R, Gaweesh AS, Moore HM, Lifsitz AD, Lane TR, Shalhoub J, Babber A, Davies AH. A Review of the Evidence to Support Neuromuscular Electrical Stimulation in the Prevention and Management of Venous Disease. Adv Exp Med Biol. 2017;906:377-386. doi: 10.1007/5584_2016_128.</citation>
<PMID>27620314</PMID>
</reference>
<reference>
<citation>Westrich GH, Specht LM, Sharrock NE, Sculco TP, Salvati EA, Pellicci PM, Trombley JF, Peterson M. Pneumatic compression hemodynamics in total hip arthroplasty. Clin Orthop Relat Res. 2000 Mar;(372):180-91. doi: 10.1097/00003086-200003000-00020.</citation>
<PMID>10738427</PMID>
</reference>
<reference>
<citation>Berliner JL, Ortiz PA, Lee YY, Miller TT, Westrich GH. Venous Hemodynamics After Total Hip Arthroplasty: A Comparison Between Portable vs Stationary Pneumatic Compression Devices and the Effect of Body Position. J Arthroplasty. 2018 Jan;33(1):162-166. doi: 10.1016/j.arth.2017.08.005. Epub 2017 Aug 24.</citation>
<PMID>28927565</PMID>
</reference>
<reference>
<citation>Pitto RP, Hamer H, Kuhle JW, Radespiel-Troger M, Pietsch M. [Hemodynamics of the lower extremity with pneumatic foot compression. Effect on leg position]. Biomed Tech (Berl). 2001 May;46(5):124-8. doi: 10.1515/bmte.2001.46.5.124. German.</citation>
<PMID>11413908</PMID>
</reference>
<reference>
<citation>Pitto RP, Young S. Foot pumps without graduated compression stockings for prevention of deep-vein thrombosis in total joint replacement: efficacy, safety and patient compliance. A comparative, prospective clinical trial. Int Orthop. 2008 Jun;32(3):331-6. doi: 10.1007/s00264-007-0326-9. Epub 2007 Feb 15. Erratum In: Int Orthop. 2008 Jun;32(3):337. Int Orthop. 2008 Jun;32(3):337.</citation>
<PMID>17653546</PMID>
</reference>
<reference>
<citation>Fujisawa M, Naito M, Asayama I, Kambe T, Koga K. Effect of calf-thigh intermittent pneumatic compression device after total hip arthroplasty: comparative analysis with plantar compression on the effectiveness of reducing thrombogenesis and leg swelling. J Orthop Sci. 2003;8(6):807-11. doi: 10.1007/s00776-003-0706-y.</citation>
<PMID>14648269</PMID>
</reference>
<reference>
<citation>Zhao JM, He ML, Xiao ZM, Li TS, Wu H, Jiang H. Different types of intermittent pneumatic compression devices for preventing venous thromboembolism in patients after total hip replacement. Cochrane Database Syst Rev. 2014 Dec 22;2014(12):CD009543. doi: 10.1002/14651858.CD009543.pub3.</citation>
<PMID>25528992</PMID>
</reference>
<reference>
<citation>Kakkos SK, Caprini JA, Geroulakos G, Nicolaides AN, Stansby G, Reddy DJ, Ntouvas I. Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism. Cochrane Database Syst Rev. 2016 Sep 7;9(9):CD005258. doi: 10.1002/14651858.CD005258.pub3.</citation>
<PMID>27600864</PMID>
</reference>
<verification_date>May 2022</verification_date>
<study_first_submitted>March 27, 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>May 16, 2022</last_update_submitted>
<last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">May 23, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>University of Pavia</investigator_affiliation>
<investigator_full_name>Luca Marin</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>Total hip arthroplasty</keyword>
<keyword>functional capabilities</keyword>
<keyword>Pneumatic compression</keyword>
<keyword>antithromboembolic exercises</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Edema</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study is a randomized controlled trial, with two parallel arms. The open-label study
will be conducted in accordance with the helsinky statement and good clinical practice
standards.
The main objective is to compare the reduction of postoperative edema following Total Hip
Arthroplasty (THA) between patients undergoing postoperative treatment with pneumatic
compression (PC, experimental group) and patients undergoing postoperative treatment with
antithromboembolic exercises. (AE, control group). We also aim to compare the pre-post
treatment variations of joint function measurements (joint excursion), referred pain and
functional capabilities.
48 patients will meet the criteria listed below will be recruited.
Inclusion criteria:
- total hip arthroplasty under election regime
- aged between 50 and 80 at the time of recruitment, both sexes.
Exclusion criteria:
- obesity (BMI> 30);
- other orthopedic or neurological pathologies that modify walking ability;
- pathologies that modify balance (neurological and / or vestibular);
- contraindications to the use of the medical equipment used in the study;
- inability to understand and sign informed consent. Participants will be assigned,
through a block randomization, to one of the two study groups: experimental group will
undergo pneumatic compression treatment (PC), control group will perform
antithromboembolic exercises (AE).
For both, the treatment will last 10 working days, starting from the first post surgery day
(T0). The PC will undergo two daily 30-minute sessions of sequential pneumatic compression
(I-Press®, I-Tech Medical Division, Martellago, Italy) while AE will perform two supervised
antithromboembolic exercises sessions daily lasting 30 minutes. All participants will carry
out the antithrombotic prophylaxis in use at the department of orthopedics: drug therapy,
graduated compression stocking and indirect electrostimulation (T-One Rehab®, I-Tech Medical
Division, Martellago, Italy).
Assessments of edema, joint range of motion, pain and functional capabilities will be made at
T0 and at the end of the treatment (T1).
This study is a randomized controlled trial, with two parallel arms. The open-label study
will be conducted in accordance with the helsinky statement and good clinical practice
standards.
To compare the reduction of postoperative edema following Total Hip Arthroplasty (THA)
between patients undergoing postoperative treatment with pneumatic compression (PC,
experimental group) and patients undergoing postoperative treatment with antithromboembolic
exercises. (AE, control group). We also aim to compare the pre-post treatment variations of
joint function measurements (joint excursion), referred pain and functional capabilities.
48 patients will be recruited at the Department of Orthopedic Surgery of the City of Pavia,
University Hospital.
Participants will be assigned, through a block randomization, to one of the two study groups:
experimental group will undergo pneumatic compression treatment (PC), control group will
perform antithromboembolic exercises (AE). For both, the treatment will last 10 working days,
starting from the first post surgery day (T0). The PC will undergo two daily 30-minute
sessions of sequential pneumatic compression (I-Press®, I-Tech Medical Division, Martellago,
Italy) while AE will perform two supervised antithromboembolic exercises sessions daily
lasting 30 minutes. All participants will carry out the antithrombotic prophylaxis in use at
the department of orthopedics: drug therapy, graduated compression stocking and indirect
electrostimulation (T-One Rehab®, I-Tech Medical Division, Martellago, Italy).
At T0 and at the end of the treatment (T1) the following assessments of the operated limb
will be carried out:
- circumference of the distal third of the thigh
- circumference of the proximal third of the leg
- range of motion of the knee flexion
- range of motion of the ankle dorsiflexion
The following assessments will also be carried out:
- perceived pain, with the Numeric Rating Scale of Pain (NRS)
- functional capability, with 20 m walk test (20 m). Walking autonomy will be carried out
at T1 with the 6 minutes walking test (6MWT).
STATISTICAL ANALYSIS Quantitative variables will be described with mean and standard
deviation if normally distributed, with median and interquartile range if not normally
distributed.
Categorical variables will be expressed with counts and percentages. Continuous variables
will be compared between the two groups with Student's t test or with the analogous
non-parametric Mann-Whitney test, considering the normality of the distribution (evaluated
with graphical methods or with the Shapiro-Wilk test).
Possible associations between categorical variables will be evaluated with Pearson's
chi-square test or with Fisher's exact test.
All tests will be two-tailed; the level of significance is set at alpha 0.05 (statistical
significance if p value <0.05).
Inclusion Criteria:
- total hip arthroplasty, scheduled surgery
- aged between 50 and 80 at the time of recruitment
Exclusion Criteria:
- obesity (BMI> 30);
- other orthopedic or neurological pathologies that modify walking ability;
- pathologies that modify balance (neurological and / or vestibular);
- contraindications to the use of the medical equipment used in the study;
- inability to understand and sign informed consent.
|
NCT0531xxxx/NCT05312073.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/NCT05312073</url>
</required_header>
<id_info>
<org_study_id>APHP210692</org_study_id>
<nct_id>NCT05312073</nct_id>
</id_info>
<brief_title>Study of in Vivo and in Vitro Transcriptomic and Proteomic Signatures in Unhereditary Ichtyosis</brief_title>
<acronym>OMICHTYOSE</acronym>
<official_title>Study of In Vivo and in Vitro Transcriptomic and Proteomic Signatures in Unhereditary Ichtyosis</official_title>
<sponsors>
<lead_sponsor>
<agency>Assistance Publique - Hôpitaux de Paris</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Assistance Publique - Hôpitaux de Paris</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The goal of this study is to identify important biological pathways involved in a variety of
ichtyosis, using transcriptomic and proteomic techniques, with the aim of guiding the
development of new therapeutis.
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 2022</start_date>
<completion_date type="Anticipated">February 2023</completion_date>
<primary_completion_date type="Anticipated">February 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>Single Group Assignment</intervention_model>
<primary_purpose>Other</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Transcript and protein levels of all genes measured by NGS mRNA sequencing and by mass spectrometry in lesioned skin biopsies</measure>
<time_frame>Up to 6 months post inclusion</time_frame>
<description>A two-fold increase or decrease in the transcript or protein levels between patients with different ARCI, EI, and between ARCI and EI patients and healthy controls (patients without ichtyosis) will allow to identify "upregulated" and "downregulated" genes.</description>
</primary_outcome>
<secondary_outcome>
<measure>Transcript and protein levels of all genes assessed by NGS mRNA sequencing and by mass spectrometry (keratinocytes)</measure>
<time_frame>Up to 6 months post inclusion</time_frame>
<description>To determine, in vitro, the contribution from ARCI and EI keratinocytes in the overall transcriptomic and proteomic signature observed in vivo. A two-fold increase or decrease in the transcript or protein levels between patients and controls (th different ARCI, EI, and between ARCI and EI patients and healthy controls (patients without ichtyosis) will allow to identify "upregulated" and "downregulated" genes.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Phenotype of circulating PBMCS assessed by flow cytometry analysis using monoclonal Antibodies (mAbs)</measure>
<time_frame>Up to 6 months post inclusion</time_frame>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">20</enrollment>
<condition>Autosomal Recessive Congenital Ichthyosis</condition>
<condition>Epidermolytic Ichthyosis</condition>
<arm_group>
<arm_group_label>Patients with ichtyosis</arm_group_label>
<arm_group_type>Other</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Patients without ichtyosis</arm_group_label>
<arm_group_type>Other</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Biological samples</intervention_name>
<description>Blood samples Superficial skin Biopsy Collection of fallen squames Tapes - stripping</description>
<arm_group_label>Patients with ichtyosis</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Skin biopsy</intervention_name>
<description>healthy skin from surgery interventions</description>
<arm_group_label>Patients without ichtyosis</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Aged 15-80 years old

- Having an ARCI or EI, confirmed by a molecular diagnosis of a mutation in at least one
of the following genes: TGM1, ALOX12B, NIPAL4, ABCA12, keratin 1 and keratin 10)

- Having stopped all topical treatments in at least 1% of the total body surface
(equivalent to one palm of the hand of the patient), at least 8 days before the skin
biopsy (which will be performed on this untreated area).

- No contraindication to skin biopsy

- Health insurance coverage

- Signature of written consent

Exclusion Criteria:

- Aged less than 15 of over 80 years old

- Ichtyosis without a molecular confirmed diagnosis or with a different diagnosis

- History, in the 8 previous days, of any topical treatment on the area intended for the
skin biopsy.

- No health insurance coverage

- Pregnant or breastfeeding woman

- Patient under guardianship or curatorship

- Patient under State Medical Assistance (AME)
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>15 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Emmanuelle BOURRAT, Dr</last_name>
<phone>+331 42 49 90 90</phone>
<email>emmanuelle.bourrat@aphp.fr</email>
</overall_contact>
<overall_contact_backup>
<last_name>Matthieu RESCHE-RIGON, Pr</last_name>
<phone>+33142499742</phone>
<email>matthieu.resche-rigon@u-paris.fr</email>
</overall_contact_backup>
<location>
<facility>
<name>Saint Louis Hospital</name>
<address>
<city>Paris</city>
<zip>75010</zip>
<country>France</country>
</address>
</facility>
<contact>
<last_name>Emmanuelle Bourrat</last_name>
</contact>
</location>
<location_countries>
<country>France</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>December 10, 2021</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>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>Ichthyosis</mesh_term>
<mesh_term>Ichthyosis, Lamellar</mesh_term>
<mesh_term>Ichthyosiform Erythroderma, Congenital</mesh_term>
<mesh_term>Hyperkeratosis, Epidermolytic</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 goal of this study is to identify important biological pathways involved in a variety of
ichtyosis, using transcriptomic and proteomic techniques, with the aim of guiding the
development of new therapeutis.
Inclusion Criteria:
- Aged 15-80 years old
- Having an ARCI or EI, confirmed by a molecular diagnosis of a mutation in at least one
of the following genes: TGM1, ALOX12B, NIPAL4, ABCA12, keratin 1 and keratin 10)
- Having stopped all topical treatments in at least 1% of the total body surface
(equivalent to one palm of the hand of the patient), at least 8 days before the skin
biopsy (which will be performed on this untreated area).
- No contraindication to skin biopsy
- Health insurance coverage
- Signature of written consent
Exclusion Criteria:
- Aged less than 15 of over 80 years old
- Ichtyosis without a molecular confirmed diagnosis or with a different diagnosis
- History, in the 8 previous days, of any topical treatment on the area intended for the
skin biopsy.
- No health insurance coverage
- Pregnant or breastfeeding woman
- Patient under guardianship or curatorship
- Patient under State Medical Assistance (AME)
|
NCT0531xxxx/NCT05312086.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/NCT05312086</url>
</required_header>
<id_info>
<org_study_id>2020-A01386-33</org_study_id>
<nct_id>NCT05312086</nct_id>
</id_info>
<brief_title>Muscle Abnormalities in Children With XLH</brief_title>
<acronym>MDmuscleXLH</acronym>
<official_title>Prospective Analysis of Quantitative and Qualitative Muscle Abnormalities in Children With X-linked Hypophosphatemia (XLH)</official_title>
<sponsors>
<lead_sponsor>
<agency>Assistance Publique - Hôpitaux de Paris</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Assistance Publique - Hôpitaux de Paris</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>
XLH rickets is a rare disease with muscle weakness. Fat parameters such as IMAT and intraMAT
could be increased in this disease. IMAT and intraMAT will be calculated on MRI for 11 XLH
children versus 20 typically developing children. The investigator will compare the
percentage of IMAT in the XLH group versus control group and the difference concerning the
intraMAT between the two groups.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Single-center, prospective, non-randomized, controlled study with XLH and healthy volunteer
children.

This study involves performing muscle MRI in healthy child volunteers to assess and compare
the structure and composition of muscles to those of muscles in children with XLH pathology
(muscle MRI of XLH patients is performed as part of standard medical care).

During this study we will have two groups: XLH group and a control group with typically
developing children. In the XLH group, composed of 10 patients aged between 5 ans 17 years,
female or male and ongoing growth (lesser bone age than 15 years old), have XLH and the most
severe radiological deformities,clinical complications (pain and muscular weakness), have
already done a muscle MRI of the lower limb during their follow-up.

The control group composed of 20 healthy volunteers aged between 5 ans 17 years old, female
or male and without any endocrine pathology. A muscle MRI is necessary for healthy
volunteers.

Every child will be alone After signing the informed consent by the 2 parents, the patient or
the healthy volunteer and his parents, the MRI assessment will be performed on the same day.

Performing the muscle MRI requires the cooperation of the child in order to remain lying down
and motionless throughout the duration of the MRI, i.e. approximately 45 minutes.

Performing MRI does not require the injection of contrast products or radiopharmaceuticals.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 15, 2022</start_date>
<completion_date type="Anticipated">June 15, 2023</completion_date>
<primary_completion_date type="Anticipated">June 15, 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>Other</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Quantify and compare muscle composition in XLH children versus healthy control children to demonstrate a link between muscle function and muscle quality.</measure>
<time_frame>1 day</time_frame>
<description>calculation of inter-muscular adipose tissue will be done in cm2</description>
</primary_outcome>
<secondary_outcome>
<measure>Measurement of muscle strength on force platforms, during gait analysis. Power test by mechanography of the jump (bipod and monopodal). Grasping test and correlation of fatty infiltration and functional data.</measure>
<time_frame>1 day</time_frame>
<description>The Outcome Measure is BMI (Kg/m²)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Quantitative analysis of the muscles of the lower limbs (volume and length)</measure>
<time_frame>1 day</time_frame>
<description>The Outcome Measure is BMI (Kg/m²)</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">30</enrollment>
<condition>Muscle Weakness</condition>
<condition>XLH</condition>
<arm_group>
<arm_group_label>patients with X-linked hypophosphatemic</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>Patient group composed of 10 patients aged between 5 to 17 years old, female or male, with X-linked hypophosphatemic (XLH) rickets, severity of clinical and radiological damage (pain, muscle weakness and severe bone deformities) and ongoing growth (lesser bone age than 15 years old), child under conventional treatment</description>
</arm_group>
<arm_group>
<arm_group_label>healthy volunteers</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>control group composed of 20 helthy volunteers aged between 5 to 17 years old, female or male, without any endocrine pathology, not suffering from XLH, matching by age (+/- 6 months) and sex</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>MRI</intervention_name>
<description>Performing the muscle MRI requires the cooperation of the child in order to remain lying down and motionless throughout the duration of the MRI, about 45 minutes.
Performing MRI does not require the injection of contrast products or radiopharmaceuticals.</description>
<arm_group_label>healthy volunteers</arm_group_label>
<arm_group_label>patients with X-linked hypophosphatemic</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria common criteria to the 2 groups:

- Age: between 5 and 17 years.

- Sex: male or female.

- Informed consent, signed by both parents or holder of parental autority after being
informated of the study.

- Affiliation to a social security schema or having the right to.

Inclusion criteria for XLH Patients :

- Patient suffer of X-linked hypophosphatemia rickets.

- Severity of clinical and radiological damage (pain, muscle weakness and severe bone
deformities).

- Growth in progress (bone age less than 15 years).

- Child under conventional treatment: patient responding to conventional treatment or

- under treatment with Burosumab (patient in treatment failure under treatment
conventional).

incluion criteria for helthy volunteers :

- Healthy voluntary subjects, not suffering from XLH.

- Matching by age (+/- 6 months) and sex.

Exclusion Criteria common to the 2 groups :

- Not being able to stay still during the MRI examination (approximately 45 min).

- Growth completed.

- History of lower limb surgery.

- Contraindications to MRI

- Holders of parental authority under AME.

- Holders of parental authority under tutorship / curatorship.

Exclusion criteria for Healthy volunteers :

- Patients with endocrine, contracted or muscular pathology.

- Patient receives a long-term treatment.

- Patients with a high athletic level.

- BMI-IOTF <20 or> 27.8
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>5 Years</minimum_age>
<maximum_age>17 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Agnés LINGLART, Pr</last_name>
<phone>0145217116</phone>
<email>agnes.linglart@aphp.fr</email>
</overall_contact>
<overall_contact_backup>
<last_name>Philippe WICART, Pr</last_name>
<phone>0144494310</phone>
<email>p.wicart@aphp.fr</email>
</overall_contact_backup>
<verification_date>January 2022</verification_date>
<study_first_submitted>January 24, 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>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>
<keyword>XLH rickets</keyword>
<keyword>IMAT</keyword>
<keyword>intraMAT</keyword>
<keyword>muscle weakness</keyword>
<keyword>MRI</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Muscle Weakness</mesh_term>
<mesh_term>Paresis</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
XLH rickets is a rare disease with muscle weakness. Fat parameters such as IMAT and intraMAT
could be increased in this disease. IMAT and intraMAT will be calculated on MRI for 11 XLH
children versus 20 typically developing children. The investigator will compare the
percentage of IMAT in the XLH group versus control group and the difference concerning the
intraMAT between the two groups.
Single-center, prospective, non-randomized, controlled study with XLH and healthy volunteer
children.
This study involves performing muscle MRI in healthy child volunteers to assess and compare
the structure and composition of muscles to those of muscles in children with XLH pathology
(muscle MRI of XLH patients is performed as part of standard medical care).
During this study we will have two groups: XLH group and a control group with typically
developing children. In the XLH group, composed of 10 patients aged between 5 ans 17 years,
female or male and ongoing growth (lesser bone age than 15 years old), have XLH and the most
severe radiological deformities,clinical complications (pain and muscular weakness), have
already done a muscle MRI of the lower limb during their follow-up.
The control group composed of 20 healthy volunteers aged between 5 ans 17 years old, female
or male and without any endocrine pathology. A muscle MRI is necessary for healthy
volunteers.
Every child will be alone After signing the informed consent by the 2 parents, the patient or
the healthy volunteer and his parents, the MRI assessment will be performed on the same day.
Performing the muscle MRI requires the cooperation of the child in order to remain lying down
and motionless throughout the duration of the MRI, i.e. approximately 45 minutes.
Performing MRI does not require the injection of contrast products or radiopharmaceuticals.
Inclusion Criteria common criteria to the 2 groups:
- Age: between 5 and 17 years.
- Sex: male or female.
- Informed consent, signed by both parents or holder of parental autority after being
informated of the study.
- Affiliation to a social security schema or having the right to.
Inclusion criteria for XLH Patients :
- Patient suffer of X-linked hypophosphatemia rickets.
- Severity of clinical and radiological damage (pain, muscle weakness and severe bone
deformities).
- Growth in progress (bone age less than 15 years).
- Child under conventional treatment: patient responding to conventional treatment or
- under treatment with Burosumab (patient in treatment failure under treatment
conventional).
incluion criteria for helthy volunteers :
- Healthy voluntary subjects, not suffering from XLH.
- Matching by age (+/- 6 months) and sex.
Exclusion Criteria common to the 2 groups :
- Not being able to stay still during the MRI examination (approximately 45 min).
- Growth completed.
- History of lower limb surgery.
- Contraindications to MRI
- Holders of parental authority under AME.
- Holders of parental authority under tutorship / curatorship.
Exclusion criteria for Healthy volunteers :
- Patients with endocrine, contracted or muscular pathology.
- Patient receives a long-term treatment.
- Patients with a high athletic level.
- BMI-IOTF <20 or> 27.8
|
NCT0531xxxx/NCT05312099.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/NCT05312099</url>
</required_header>
<id_info>
<org_study_id>2018-20</org_study_id>
<nct_id>NCT05312099</nct_id>
</id_info>
<brief_title>The Effect of Menopause on Sexual Life and Depression: a Case-control Study.</brief_title>
<acronym>menopause</acronym>
<official_title>The Effect of Menopause on Sexual Life and Depression: a Case-control Study.</official_title>
<sponsors>
<lead_sponsor>
<agency>Hitit University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Hitit 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>
work completed but not yet published
</textblock>
</brief_summary>
<detailed_description>
<textblock>
work completed but not yet published
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">January 14, 2019</start_date>
<completion_date type="Actual">February 16, 2021</completion_date>
<primary_completion_date type="Actual">April 17, 2019</primary_completion_date>
<study_type>Observational [Patient Registry]</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Cross-Sectional</time_perspective>
</study_design_info>
<target_duration>3 Months</target_duration>
<primary_outcome>
<measure>The effect of menopause on sexual life and depression: a case-control study.</measure>
<time_frame>14.01.2019-16.02.2021</time_frame>
<description>Data completed in April 2019</description>
</primary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Actual">3</enrollment>
<condition>Menopause</condition>
<condition>Depression</condition>
<condition>Sexual Dysfunction</condition>
<arm_group>
<arm_group_label>Case group</arm_group_label>
<description>Women who have entered early menopause (before the age of 40), have chronic systemic diseases (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history), and use psychiatric drugs were not included in the study.</description>
</arm_group>
<arm_group>
<arm_group_label>Control group</arm_group_label>
<description>Women under the age of 45, over the age of 55 with chronic systemic diseases (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history) and using psychiatric drugs were not included in the study.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Case control</intervention_name>
<description>Case control study</description>
<arm_group_label>Case group</arm_group_label>
<arm_group_label>Control group</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Çorum Hitit University Erol Olçok Training and Research Hospital Obstetrics and Gynecology
Policlinic was composed of 200 married women between the ages of 45-65, 113 of them in the
postmenopausal period and 87 of them did not go through menopause.
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Case group: Women between the ages of 45-65, who are in the postmenopausal period, who
are literate, who do not have communication difficulties / mental disabilities, and
who volunteer to participate in the study were included.

Control Group: Women between the ages of 45-55, who were not menopausal, who were literate,
who had no communication difficulties / mental disabilities and who volunteered to
participate in the study were included.

Exclusion Criteria:

- For case group: Women with premature menopause (before the age of 40), chronic
systemic disease (diabetes, heart disease, hypertension, thyroid, rheumatic disease,
psychiatric disease history) and using psychiatric drugs were not included in the
study.

For control group: Women under the age of 45, over the age of 55 with chronic systemic
diseases (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric
disease history) and using psychiatric drugs were not included in the study.
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>45 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
</eligibility>
<overall_official>
<last_name>Fatma Yıldırım</last_name>
<role>Principal Investigator</role>
<affiliation>Fatma</affiliation>
</overall_official>
<location>
<facility>
<name>Hitit university</name>
<address>
<city>Corum</city>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>December 3, 2021</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>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>Hitit University</investigator_affiliation>
<investigator_full_name>Fatma Yildirim</investigator_full_name>
<investigator_title>Research assistant</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Depression</mesh_term>
<mesh_term>Depressive Disorder</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
work completed but not yet published
work completed but not yet published
Çorum Hitit University Erol Olçok Training and Research Hospital Obstetrics and Gynecology
Policlinic was composed of 200 married women between the ages of 45-65, 113 of them in the
postmenopausal period and 87 of them did not go through menopause.
Inclusion Criteria:
- Case group: Women between the ages of 45-65, who are in the postmenopausal period, who
are literate, who do not have communication difficulties / mental disabilities, and
who volunteer to participate in the study were included.
Control Group: Women between the ages of 45-55, who were not menopausal, who were literate,
who had no communication difficulties / mental disabilities and who volunteered to
participate in the study were included.
Exclusion Criteria:
- For case group: Women with premature menopause (before the age of 40), chronic
systemic disease (diabetes, heart disease, hypertension, thyroid, rheumatic disease,
psychiatric disease history) and using psychiatric drugs were not included in the
study.
For control group: Women under the age of 45, over the age of 55 with chronic systemic
diseases (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric
disease history) and using psychiatric drugs were not included in the study.
|
NCT0531xxxx/NCT05312112.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/NCT05312112</url>
</required_header>
<id_info>
<org_study_id>305432</org_study_id>
<secondary_id>305432</secondary_id>
<nct_id>NCT05312112</nct_id>
</id_info>
<brief_title>Real World Outcomes Using Novel Agents for AML in the UK</brief_title>
<official_title>Real World Outcomes Using Novel Agents for Acute Myeloid Leukaemia in the United Kingdom</official_title>
<sponsors>
<lead_sponsor>
<agency>Guy's and St Thomas' NHS Foundation Trust</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>King's College London</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Guy's and St Thomas' NHS Foundation Trust</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This project will collect data on patients with acute myeloid leukemia in the United Kingdom
who were treated with two new targeted therapies during the coronavirus pandemic
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Acute myeloid leukaemia (AML) is a blood cancer which in fit young adults is typically
treated with intensive chemotherapy. While this is potentially curative, it is associated
with significant side effects and the requirement for long hospital admissions. Infection is
a major issue during AML treatment, as both the disease and the chemotherapy impair the
immune system.

Early data suggested that COVID-19 is associated with a very high rate of death in AML
patients undergoing intensive chemotherapy. Because of this, and the need for significant
hospital resources to deliver intensive chemotherapy, the NHS made available two new, less
intensive, targeted therapies for the treatment of AML during the COVID-19 pandemic -
venetoclax and gilteritinib. The aim was to reduce mortality and healthcare resource use.

Many hundreds of patients across the UK have been treated with these two medications on the
temporary access scheme. The research aims to collect de-identified data from treating
patients to describe the outcomes of patients treated with these approaches, both in terms of
the safety and effectiveness.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 1, 2022</start_date>
<completion_date type="Anticipated">October 1, 2023</completion_date>
<primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Retrospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Overall survival</measure>
<time_frame>1 year</time_frame>
<description>Overall survival measured from time of treatment initiation</description>
</primary_outcome>
<primary_outcome>
<measure>Early death rate</measure>
<time_frame>Day 60 after starting treatment</time_frame>
<description>Early death rate measured at day 60 after treatment initiation</description>
</primary_outcome>
<secondary_outcome>
<measure>Response rate</measure>
<time_frame>After 2 cycles of therapy (each cycle is 28 days although may be extended if recovery is delayed)</time_frame>
<description>Response rate as defined by ELN 2017</description>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of relapse in patients achieving remission</measure>
<time_frame>1 year</time_frame>
<description>Relapse incidence measured from the time of achieving remission</description>
</secondary_outcome>
<secondary_outcome>
<measure>Relapse-free survival</measure>
<time_frame>1 year</time_frame>
<description>RFS as defined by ELN</description>
</secondary_outcome>
<secondary_outcome>
<measure>Treatment toxicity 1</measure>
<time_frame>During the first cycle of therapy (each cycle is 28 days although may be extended if recovery is delayed)</time_frame>
<description>Number of days in hospital and number of days of intensive care</description>
</secondary_outcome>
<secondary_outcome>
<measure>Treatment toxicity 2</measure>
<time_frame>During the first cycle of therapy (each cycle is 28 days although may be extended if recovery is delayed)</time_frame>
<description>Duration of neutropenia and thrombocytopenia</description>
</secondary_outcome>
<secondary_outcome>
<measure>Treatment toxicity 3</measure>
<time_frame>During the first cycle of therapy (each cycle is 28 days although may be extended if recovery is delayed)</time_frame>
<description>Number of blood and platelet transfusions</description>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison of survival between patient sub-groups</measure>
<time_frame>1 year</time_frame>
<description>Overall survival compared between disease groups</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">1000</enrollment>
<condition>Acute Myeloid Leukemia</condition>
<arm_group>
<arm_group_label>Venetoclax</arm_group_label>
<description>Venetoclax in newly diagnosed AML</description>
</arm_group>
<arm_group>
<arm_group_label>FLT3 inhibitors</arm_group_label>
<description>FLT3 inhibitors including gilteritinib in relapsed AML</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Venetoclax</intervention_name>
<description>Observational study of venetoclax in AML</description>
<arm_group_label>Venetoclax</arm_group_label>
<other_name>Venclyxto</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Gilteritinib</intervention_name>
<description>Observational study of gilteritinib in AML</description>
<arm_group_label>FLT3 inhibitors</arm_group_label>
<other_name>Xospata</other_name>
</intervention>
<eligibility>
<study_pop>
<textblock>
The NHS criteria for access to venetoclax was that a patient was fit for IC and was:

- Aged >16y with NPM1 mutation without FLT3 internal tandem duplication (ITD)

- Aged >50y with NPM1, IDH1 or IDH2 mutations (regardless of FLT3 status)

- Patients aged >60y without favourable-risk cytogenetics

Gilteritinib was made available to all patients aged >16y with relapse or refractory FLT3
mutated AML. Other FLT3 inhibitors are available to patients through various access schemes
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Venetoclax cohort Inclusion criteria

1. Newly diagnosed acute myeloid leukaemia

2. No prior therapies for AML, apart from hydroxyurea (or similar) for cytoreduction.
Previous treatments for MDS or other conditions are allowed

3. Treated with venetoclax in combination with either azacitidine or LDAC No exclusion
criteria

Gilteritinib/FLT3 cohort Inclusion criteria

1. Relapsed acute myeloid leukaemia, including molecular relapse

2. Treated with FLT3 inhibitor No exclusion criteria
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>16 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<overall_official>
<last_name>Richard Dillon</last_name>
<role>Principal Investigator</role>
<affiliation>King's College London</affiliation>
</overall_official>
<overall_contact>
<last_name>Richard Dillon</last_name>
<phone>020 7188 257</phone>
<email>richard.dillon@kcl.ac.uk</email>
</overall_contact>
<location>
<facility>
<name>Guy's and St Thomas' NHS Foundation Trust</name>
<address>
<city>London</city>
<zip>SE1 9RT</zip>
<country>United Kingdom</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Richard Dillon</last_name>
</contact>
</location>
<location_countries>
<country>United Kingdom</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 9, 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>February 28, 2023</last_update_submitted>
<last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 2, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Leukemia</mesh_term>
<mesh_term>Leukemia, Myeloid</mesh_term>
<mesh_term>Leukemia, Myeloid, Acute</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Venetoclax</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This project will collect data on patients with acute myeloid leukemia in the United Kingdom
who were treated with two new targeted therapies during the coronavirus pandemic
Acute myeloid leukaemia (AML) is a blood cancer which in fit young adults is typically
treated with intensive chemotherapy. While this is potentially curative, it is associated
with significant side effects and the requirement for long hospital admissions. Infection is
a major issue during AML treatment, as both the disease and the chemotherapy impair the
immune system.
Early data suggested that COVID-19 is associated with a very high rate of death in AML
patients undergoing intensive chemotherapy. Because of this, and the need for significant
hospital resources to deliver intensive chemotherapy, the NHS made available two new, less
intensive, targeted therapies for the treatment of AML during the COVID-19 pandemic -
venetoclax and gilteritinib. The aim was to reduce mortality and healthcare resource use.
Many hundreds of patients across the UK have been treated with these two medications on the
temporary access scheme. The research aims to collect de-identified data from treating
patients to describe the outcomes of patients treated with these approaches, both in terms of
the safety and effectiveness.
The NHS criteria for access to venetoclax was that a patient was fit for IC and was:
- Aged >16y with NPM1 mutation without FLT3 internal tandem duplication (ITD)
- Aged >50y with NPM1, IDH1 or IDH2 mutations (regardless of FLT3 status)
- Patients aged >60y without favourable-risk cytogenetics
Gilteritinib was made available to all patients aged >16y with relapse or refractory FLT3
mutated AML. Other FLT3 inhibitors are available to patients through various access schemes
Venetoclax cohort Inclusion criteria
1. Newly diagnosed acute myeloid leukaemia
2. No prior therapies for AML, apart from hydroxyurea (or similar) for cytoreduction.
Previous treatments for MDS or other conditions are allowed
3. Treated with venetoclax in combination with either azacitidine or LDAC No exclusion
criteria
Gilteritinib/FLT3 cohort Inclusion criteria
1. Relapsed acute myeloid leukaemia, including molecular relapse
2. Treated with FLT3 inhibitor No exclusion criteria
|
NCT0531xxxx/NCT05312125.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/NCT05312125</url>
</required_header>
<id_info>
<org_study_id>GaziUniPA</org_study_id>
<nct_id>NCT05312125</nct_id>
</id_info>
<brief_title>Physiotherapy After Botulinum Toxin Injection and Serial Casting</brief_title>
<official_title>Comparison of the Effectiveness of Different Physiotherapy and Rehabilitation Programs After Onabotulinum Toxin-A Injection and Serial Casting in Children With Cerebral Palsy</official_title>
<sponsors>
<lead_sponsor>
<agency>Gazi University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Gulhane Training and Research Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Ankara Eğitim ve Araştırma Hastanesi</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Gazi University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The effects of different physiotherapy programs on children with cerebral palsy who have been
received botulinum toxin injection and serial casting application will be determined.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
CP children who underwent botulinum toxin injection to medial gastrocnemius muscle and serial
casting application in last two months will be included in the study. The effects of
traditional physiotherapy and downhill backward treadmill training plus to traditional
physiotherapy on muscle morphology, activity, walking, quality of life and selectivity will
be determined.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 6, 2022</start_date>
<completion_date type="Actual">April 20, 2023</completion_date>
<primary_completion_date type="Actual">December 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>
<intervention_model_description>2 groups of children with Cerebral palsy are going to be involved at the same time. One of the groups will be enrolled in the routine physiotherapy intervention. The other group will be enrolled to the routine physiotherapy intervention + backward downhill walking.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Muscle morphology</measure>
<time_frame>Before the intervention</time_frame>
<description>Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements</description>
</primary_outcome>
<primary_outcome>
<measure>Muscle morphology</measure>
<time_frame>After six weeks intervention</time_frame>
<description>Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements</description>
</primary_outcome>
<primary_outcome>
<measure>Vascularization</measure>
<time_frame>Before the the intervention</time_frame>
<description>Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements</description>
</primary_outcome>
<primary_outcome>
<measure>Vascularization</measure>
<time_frame>After six weeks intervention</time_frame>
<description>Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements</description>
</primary_outcome>
<primary_outcome>
<measure>Muscle strenght</measure>
<time_frame>Before the intervention</time_frame>
<description>Will be measured by manual muscle tester</description>
</primary_outcome>
<primary_outcome>
<measure>Muscle strenght</measure>
<time_frame>After six weeks intervention</time_frame>
<description>Will be measured by manual muscle tester</description>
</primary_outcome>
<primary_outcome>
<measure>Range of motion</measure>
<time_frame>Before the intervention.</time_frame>
<description>Will be measured with goniometer</description>
</primary_outcome>
<primary_outcome>
<measure>Range of motion</measure>
<time_frame>After six weeks intervention</time_frame>
<description>Will be measured with goniometer</description>
</primary_outcome>
<primary_outcome>
<measure>Edinburgh visual gait analysis</measure>
<time_frame>Before the intervention</time_frame>
<description>Gait will be recorded as video and this video will be scored</description>
</primary_outcome>
<primary_outcome>
<measure>Edinburgh visual gait analysis</measure>
<time_frame>After six weeks intervention</time_frame>
<description>Gait will be recorded as video and this video will be scored</description>
</primary_outcome>
<primary_outcome>
<measure>Modified Tardieu Scale</measure>
<time_frame>Before the intervention</time_frame>
<description>Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity</description>
</primary_outcome>
<primary_outcome>
<measure>Modified Tardieu Scale</measure>
<time_frame>After six weeks intervention</time_frame>
<description>Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity</description>
</primary_outcome>
<secondary_outcome>
<measure>Demographic data</measure>
<time_frame>Before the intervention</time_frame>
<description>Face-to-face interview with family. Will be recorded in data registration form</description>
</secondary_outcome>
<secondary_outcome>
<measure>Demographic data</measure>
<time_frame>After six weeks intervention</time_frame>
<description>Face-to-face interview with family. Will be recorded in data registration form</description>
</secondary_outcome>
<secondary_outcome>
<measure>Child Health Questionnare (Parent form)</measure>
<time_frame>Before the intervention</time_frame>
<description>Quality of life will be measured by this questionnare</description>
</secondary_outcome>
<secondary_outcome>
<measure>Child Health Questionnare (Parent form)</measure>
<time_frame>After six weeks intervention</time_frame>
<description>Quality of life will be measured by this questionnare</description>
</secondary_outcome>
<secondary_outcome>
<measure>Children Functional Independence Measurement Scale</measure>
<time_frame>Before the intervention</time_frame>
<description>Functional Independency will be measured by this scale. Higher scores mean better independence.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Children Functional Independence Measurement Scale</measure>
<time_frame>After six weeks intervention</time_frame>
<description>Functional Independency will be measured by this scale. Higher scores mean better independence.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Lower extremity selective control measurement</measure>
<time_frame>Before the intervention</time_frame>
<description>Selective movement will be measured with this scale. Higher scores mean better selective control.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Lower extremity selective control measurement</measure>
<time_frame>After six weeks intervention</time_frame>
<description>Selective movement will be measured with this scale. Higher scores mean better selective control.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">19</enrollment>
<condition>Cerebral Palsy</condition>
<condition>Cerebral Palsy, Spastic</condition>
<arm_group>
<arm_group_label>control group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Children in this group will take routine physiotherapy (stretching, strengthening) program during 6 weeks. 3 days/week.</description>
</arm_group>
<arm_group>
<arm_group_label>intervention group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Children in this group will take routine physiotherapy (stretching, strengthening) program + backward downhill walking (10 minutes in a day) during 6 weeks. 3 days/week.</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>backward downhill walking</intervention_name>
<description>Children in the intervention group will take backward downhill walking program plus to routine physiotherapy.</description>
<arm_group_label>intervention group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>routine physiotherapy</intervention_name>
<description>Children in one of the groups will take routine physiotherapy programme</description>
<arm_group_label>control group</arm_group_label>
<arm_group_label>intervention group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Being diagnosed with cerebral palsy (CP) (hemiplegic-diplegic)

2. To have undergone botulinum toxin and serial casting interventions in the last 2
months

3. to be between 5-10 years old

4. Being at the level of I-II-III (ambulatory or assisted ambulatory) according to Gross
Motor Function Classification System

5. To have the mental competence to understand and apply assessments and exercises

Exclusion Criteria:

1. Having undergone surgery involving the lower extremity in the last 6 months

2. Refusing to participate in the study

3. Having other accompanying neurometabolic or orthopedic disorders
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>5 Years</minimum_age>
<maximum_age>10 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Pelin Atalan</name>
<address>
<city>İ̇zmi̇r</city>
<state>Bornova</state>
<zip>35050</zip>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>March 8, 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>June 14, 2023</last_update_submitted>
<last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 15, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Gazi University</investigator_affiliation>
<investigator_full_name>pelin atalan</investigator_full_name>
<investigator_title>Physiotherapist, MSc</investigator_title>
</responsible_party>
<keyword>cerebral palsy</keyword>
<keyword>botulinum toxin</keyword>
<keyword>serial casting</keyword>
<keyword>physiotherapy</keyword>
<keyword>muscle morphology</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Paralysis</mesh_term>
<mesh_term>Cerebral Palsy</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The effects of different physiotherapy programs on children with cerebral palsy who have been
received botulinum toxin injection and serial casting application will be determined.
CP children who underwent botulinum toxin injection to medial gastrocnemius muscle and serial
casting application in last two months will be included in the study. The effects of
traditional physiotherapy and downhill backward treadmill training plus to traditional
physiotherapy on muscle morphology, activity, walking, quality of life and selectivity will
be determined.
Inclusion Criteria:
1. Being diagnosed with cerebral palsy (CP) (hemiplegic-diplegic)
2. To have undergone botulinum toxin and serial casting interventions in the last 2
months
3. to be between 5-10 years old
4. Being at the level of I-II-III (ambulatory or assisted ambulatory) according to Gross
Motor Function Classification System
5. To have the mental competence to understand and apply assessments and exercises
Exclusion Criteria:
1. Having undergone surgery involving the lower extremity in the last 6 months
2. Refusing to participate in the study
3. Having other accompanying neurometabolic or orthopedic disorders
|
NCT0531xxxx/NCT05312138.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/NCT05312138</url>
</required_header>
<id_info>
<org_study_id>patak</org_study_id>
<nct_id>NCT05312138</nct_id>
</id_info>
<brief_title>Multiple Sclerosis and Overactive Bladder Treatment</brief_title>
<official_title>The Effect of Different Neuromodulation Techniques in the Treatment of Multiple Sclerosis Patients With Neurogenic Bladder Dysfunction</official_title>
<sponsors>
<lead_sponsor>
<agency>Istanbul Medipol University Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Istanbul Medipol University Hospital</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Urinary symptoms are frequently seen in patients with Multiple Sclerosis (MS). Early
evaluation of the patients in terms of the urinary system, planning the appropriate treatment
and following up at regular intervals are extremely important in terms of preventing urinary
system complications. Neuromodulation applications are used reliably in the urological
treatment of MS patients. The aim of this study was to compare the efficacy of different
neuromodulation techniques, transcutaneous posterior tibial nerve stimulation and repetitive
transcranial magnetic stimulation, in patients with MS reporting lower urinary tract
symptoms.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Bladder dysfunction is one of the most disturbing symptoms of MS. The frequency of bladder
dysfunction in patients with MS is reported to be %52-97. Urinary symptoms are among the
initial symptoms in %10-15 of patients, while it is the only initial symptom in up to %2 of
patients. Patients is seen with irritative symptoms (such as frequent urination, urgency,
urinary incontinence, nocturia), obstructive symptoms (such as difficulty in initiating
urination, inability to urinate, feeling of incomplete emptying, weak urine flow) or mixed
type symptoms.In line with these symptoms, early evaluation of MS patients in terms of
urinary system, planning of appropriate treatment and regular follow-up are extremely
important in terms of preventing urinary system complications. Pharmacotherapy and clean
intermittent catheterization are the first step treatments for lower urinary tract symptoms
in multiple sclerosis. It has been reported in the literature that electrical nerve
stimulation therapy (neuromodulation methods) and behavior change methods (pelvic floor
muscle exercise, bladder training, urinary diary keeping) are also used as a second step
treatment option due to the side effects of anticholinergic use and lack of motivation and
skill in catheterization. It is reported that neuromodulation applications are performed in
MS patients and it is a reliable method. Deep brain stimulation, transcranial magnetic
stimulation, posterior tibial nerve stimulation, sacral neuromodulation and spinal cord
stimulation are generally recommended in the treatment of bladder dysfunction, which is one
of the neuromodulation methods. The superiority of these methods to each other is debatable.
In line with this information, the aim of the study is to compare the effectiveness of
different neuromodulation techniques, transcutaneous posterior tibial nerve stimulation and
repetitive transcranial magnetic stimulation, in MS patients reporting lower urinary tract
symptoms.

According to the treatment protocols of the patients to be included in the study; will be
divided into 2 groups as transcutaneous posterior tibial nerve stimulation group (8 patients)
and repetitive transcranial magnetic stimulation group (8 patients). Which method will be
applied to which individual will be determined randomly. Treatment sessions will be carried
out for 5 consecutive days in 2 consecutive weeks, 1 time per day for a total of 10 sessions.
The urological parameters of the patients in all groups will be evaluated before and after
the treatment.

Statistical method(s); Statistical analysis of the data obtained from the study will be done
in the Statistical Package for the Social Sciences (SPSS) 22.0 package program. The mean
standard deviation, median, minimum and maximum values will be used to define the data.
Comparison of continuous variables between groups will be done with Mann Whitney U test,
comparison of discrete variables will be done with chi-square test. Spearman or Pearson
correlation test will be used to evaluate the correlation between variables. In the data
analysis, p < 0.05 level will be considered statistically significant.
</textblock>
</detailed_description>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Actual">June 8, 2021</start_date>
<completion_date type="Anticipated">December 2022</completion_date>
<primary_completion_date type="Anticipated">October 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Urodynamics Test</measure>
<time_frame>"10 days" the amount of change after 10 days from the baseline</time_frame>
<description>While the bladder is being filled, it will be carried out to measure the pressures in the bladder and in the abdomen, to examine the nerves that provide bladder contractions, and to explain the cases of urinary incontinence or inability by examining the bladder contraction pressures and electrical activity during urination.</description>
</primary_outcome>
<primary_outcome>
<measure>Extended Disability Status Scale (EDSS)</measure>
<time_frame>"10 days" the amount of change after 10 days from the baseline</time_frame>
<description>It is the most commonly used scale to assess disability in MS. EDSS scoring is based on the neurological examination results of eight functional systems and the patient's ambulation status. Functional systems are listed as pyramidal, cerebellar, brainstem, sensory, bladder and intestinal, visual, cerebral, and others. A score of 0-10 is given.0 denotes normal neurological examination, 10 denotes death due to MS. 1.0-4.5 refers to fully ambulatory, 5.0-9.5 refers to impaired ambulation. From 7.0 onwards there is wheelchair use and increasingly bed dependency.</description>
</primary_outcome>
<primary_outcome>
<measure>Overactive Bladder Questionnaire-V8 (OAB-V8)</measure>
<time_frame>"10 days" the amount of change after 10 days from the baseline</time_frame>
<description>The severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and too many (5) it consists of 8 questions that can be graded. The total score can vary between 0 and 40.</description>
</primary_outcome>
<primary_outcome>
<measure>Incontinence Quality of Life -I-QOL</measure>
<time_frame>"10 days" the amount of change after 10 days from the baseline</time_frame>
<description>It consists of a total of 22 questions with three sub-dimensions. Sub-dimensions; limitation of behaviors (1,2,3,4,10,11,13,20 items), psychosocial influence (5,6,7,9,15,16,17,21,22 items) and social isolation (8,12 ,14,18,19 items). All items are evaluated with a five-point Likert type (1= too much, 2= a quite, 3= moderately, 4= a little, 5= not at all) and the Likert types are recalculated to take a value between 0-100 points in order to better understand the total score calculated. Higher scores indicate better quality of life.</description>
</primary_outcome>
<primary_outcome>
<measure>Voiding Diary</measure>
<time_frame>"10 days" the amount of change after 10 days from the baseline</time_frame>
<description>It is recommended to present the information given by the patients in an objective way. Although not entirely diagnostic, diary data can reveal normal and abnormal conditions. The 3-day voiding diary is a viable, reliable and valid tool in the evaluation of patients with lower urinary tract symptoms.</description>
</primary_outcome>
<primary_outcome>
<measure>Incontinence Severity Index (ISI)</measure>
<time_frame>"10 days" the amount of change after 10 days from the baseline</time_frame>
<description>It consists of 2 questions, and the total score is obtained by multiplying the frequency of urinary incontinence and the amount of urine leaked, and the score range varies between 1-12. According to their score, 1-2 points are light; 3-6 points average; 8-9 points indicate severe and 12 points very severe urinary incontinence.</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">16</enrollment>
<condition>Neurogenic Bladder Dysfunction</condition>
<arm_group>
<arm_group_label>Transcutaneous Posterior Tibial Nerve Stimulation Group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The treatment will be carried out by the physiotherapist using the TenStem Eco Basic device.</description>
</arm_group>
<arm_group>
<arm_group_label>Repetitive Transcranial Magnetic Stimulation Group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>The treatment will be applied with a Power Mag device.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Repetitive Transcranial Magnetic Stimulation</intervention_name>
<description>The treatment will be internally cooled 70 mm double coil and 110 mm round coil, accompanied by a physiotherapist and neurologist. The coil will be placed on the precentral gyrus. Practices will be held, with each session lasting 20 minutes. Cortical excitability will be provided by high frequency (HF) stimulation (5-Hz).</description>
<arm_group_label>Repetitive Transcranial Magnetic Stimulation Group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Transcutaneous Posterior Tibial Nerve Stimulation</intervention_name>
<description>The treatment parameters will be applied with a pulse current time of 200 μsec, a fixed frequency of 10 Hz, a treatment time of 20 minutes, and a current intensity that the patient can tolerate, which will not cause flexion in the big toe or fan movement in the other fingers. Self-adhesive surface electrodes will be used for stimulation. During the treatment, the patient will lie on his back. The negative electrode will be placed 2 cm posterior to the medial malleolus and the positive electrode will be placed 10 cm proximal.</description>
<arm_group_label>Transcutaneous Posterior Tibial Nerve Stimulation Group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- 18-65 years old

- Woman

- Volunteer to participate in the study

- Neurogenic overactive bladder due to MS

- EDSS <7.0

- Not benefiting from pharmacological treatment

Exclusion Criteria:

- With urinary tract infection

- Diagnosed with diabetes mellitus

- Using diuretic medication

- Using clean intermittent catheterization

- Having a history of different urological diseases

- Those who have conditions that would be contraindicated for electrical stimulation
(pacemaker, brain pacemaker, prosthesis)
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Pınar Atak Çakır</last_name>
<role>Principal Investigator</role>
</overall_official>
<location>
<facility>
<name>Istanbul Medipol Mega University Hospital</name>
<address>
<city>Istanbul</city>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<reference>
<citation>Nardone R, Versace V, Sebastianelli L, Brigo F, Golaszewski S, Christova M, Saltuari L, Trinka E. Transcranial magnetic stimulation and bladder function: A systematic review. Clin Neurophysiol. 2019 Nov;130(11):2032-2037. doi: 10.1016/j.clinph.2019.08.020. Epub 2019 Sep 3.</citation>
<PMID>31541980</PMID>
</reference>
<reference>
<citation>de Seze M, Raibaut P, Gallien P, Even-Schneider A, Denys P, Bonniaud V, Game X, Amarenco G. Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: results of a multicenter prospective study. Neurourol Urodyn. 2011 Mar;30(3):306-11. doi: 10.1002/nau.20958. Epub 2011 Feb 8.</citation>
<PMID>21305588</PMID>
</reference>
<reference>
<citation>Abboud H, Hill E, Siddiqui J, Serra A, Walter B. Neuromodulation in multiple sclerosis. Mult Scler. 2017 Nov;23(13):1663-1676. doi: 10.1177/1352458517736150.</citation>
<PMID>29115915</PMID>
</reference>
<reference>
<citation>Fingerman JS, Finkelstein LH. The overactive bladder in multiple sclerosis. J Am Osteopath Assoc. 2000 Mar;100(3 Suppl):S9-12.</citation>
<PMID>10763312</PMID>
</reference>
<verification_date>March 2022</verification_date>
<study_first_submitted>December 26, 2021</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>August 15, 2022</last_update_submitted>
<last_update_submitted_qc>August 15, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">August 16, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Multiple Sclerosis</keyword>
<keyword>Overactive Bladder</keyword>
<keyword>Neurogenic Bladder</keyword>
<keyword>Electrical stimulation</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Multiple Sclerosis</mesh_term>
<mesh_term>Urinary Bladder, Neurogenic</mesh_term>
<mesh_term>Sclerosis</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>No Plan Description</ipd_description>
</patient_data>
<provided_document_section>
<provided_document>
<document_type>Study Protocol</document_type>
<document_has_protocol>Yes</document_has_protocol>
<document_has_icf>No</document_has_icf>
<document_has_sap>No</document_has_sap>
<document_date>January 25, 2022</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT05312138/Prot_000.pdf</document_url>
</provided_document>
<provided_document>
<document_type>Statistical Analysis Plan</document_type>
<document_has_protocol>No</document_has_protocol>
<document_has_icf>No</document_has_icf>
<document_has_sap>Yes</document_has_sap>
<document_date>January 25, 2022</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT05312138/SAP_001.pdf</document_url>
</provided_document>
<provided_document>
<document_type>Informed Consent Form</document_type>
<document_has_protocol>No</document_has_protocol>
<document_has_icf>Yes</document_has_icf>
<document_has_sap>No</document_has_sap>
<document_date>January 25, 2022</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT05312138/ICF_002.pdf</document_url>
</provided_document>
</provided_document_section>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Urinary symptoms are frequently seen in patients with Multiple Sclerosis (MS). Early
evaluation of the patients in terms of the urinary system, planning the appropriate treatment
and following up at regular intervals are extremely important in terms of preventing urinary
system complications. Neuromodulation applications are used reliably in the urological
treatment of MS patients. The aim of this study was to compare the efficacy of different
neuromodulation techniques, transcutaneous posterior tibial nerve stimulation and repetitive
transcranial magnetic stimulation, in patients with MS reporting lower urinary tract
symptoms.
Bladder dysfunction is one of the most disturbing symptoms of MS. The frequency of bladder
dysfunction in patients with MS is reported to be %52-97. Urinary symptoms are among the
initial symptoms in %10-15 of patients, while it is the only initial symptom in up to %2 of
patients. Patients is seen with irritative symptoms (such as frequent urination, urgency,
urinary incontinence, nocturia), obstructive symptoms (such as difficulty in initiating
urination, inability to urinate, feeling of incomplete emptying, weak urine flow) or mixed
type symptoms.In line with these symptoms, early evaluation of MS patients in terms of
urinary system, planning of appropriate treatment and regular follow-up are extremely
important in terms of preventing urinary system complications. Pharmacotherapy and clean
intermittent catheterization are the first step treatments for lower urinary tract symptoms
in multiple sclerosis. It has been reported in the literature that electrical nerve
stimulation therapy (neuromodulation methods) and behavior change methods (pelvic floor
muscle exercise, bladder training, urinary diary keeping) are also used as a second step
treatment option due to the side effects of anticholinergic use and lack of motivation and
skill in catheterization. It is reported that neuromodulation applications are performed in
MS patients and it is a reliable method. Deep brain stimulation, transcranial magnetic
stimulation, posterior tibial nerve stimulation, sacral neuromodulation and spinal cord
stimulation are generally recommended in the treatment of bladder dysfunction, which is one
of the neuromodulation methods. The superiority of these methods to each other is debatable.
In line with this information, the aim of the study is to compare the effectiveness of
different neuromodulation techniques, transcutaneous posterior tibial nerve stimulation and
repetitive transcranial magnetic stimulation, in MS patients reporting lower urinary tract
symptoms.
According to the treatment protocols of the patients to be included in the study; will be
divided into 2 groups as transcutaneous posterior tibial nerve stimulation group (8 patients)
and repetitive transcranial magnetic stimulation group (8 patients). Which method will be
applied to which individual will be determined randomly. Treatment sessions will be carried
out for 5 consecutive days in 2 consecutive weeks, 1 time per day for a total of 10 sessions.
The urological parameters of the patients in all groups will be evaluated before and after
the treatment.
Statistical method(s); Statistical analysis of the data obtained from the study will be done
in the Statistical Package for the Social Sciences (SPSS) 22.0 package program. The mean
standard deviation, median, minimum and maximum values will be used to define the data.
Comparison of continuous variables between groups will be done with Mann Whitney U test,
comparison of discrete variables will be done with chi-square test. Spearman or Pearson
correlation test will be used to evaluate the correlation between variables. In the data
analysis, p < 0.05 level will be considered statistically significant.
Inclusion Criteria:
- 18-65 years old
- Woman
- Volunteer to participate in the study
- Neurogenic overactive bladder due to MS
- EDSS <7.0
- Not benefiting from pharmacological treatment
Exclusion Criteria:
- With urinary tract infection
- Diagnosed with diabetes mellitus
- Using diuretic medication
- Using clean intermittent catheterization
- Having a history of different urological diseases
- Those who have conditions that would be contraindicated for electrical stimulation
(pacemaker, brain pacemaker, prosthesis)
|
NCT0531xxxx/NCT05312151.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/NCT05312151</url>
</required_header>
<id_info>
<org_study_id>COMP201</org_study_id>
<nct_id>NCT05312151</nct_id>
</id_info>
<brief_title>The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder</brief_title>
<official_title>The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder</official_title>
<sponsors>
<lead_sponsor>
<agency>COMPASS Pathways</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>COMPASS Pathways</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The Safety and Tolerability of COMP360 administered under supportive conditions in
participants with Post-traumatic Stress Disorder
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 10, 2022</start_date>
<completion_date type="Anticipated">April 2024</completion_date>
<primary_completion_date type="Anticipated">December 2023</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Safety</measure>
<time_frame>Up to 12 weeks</time_frame>
<description>Proportion of patients with adverse events (AEs)</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline</measure>
<time_frame>Up to 12 weeks</time_frame>
<description>CAPS-5 is a 30 item scale, each item is scored from 0-4; Higher scores denote greater severity for each item</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in PTSD checklist for DSM-5 (PCL-5) from baseline</measure>
<time_frame>Up to 12 weeks</time_frame>
<description>PCL-5 is a 20-item self-reported scale, each item is scored from 0-4; Higher scores denote greater severity for each item</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Sheehan Disability Scale (SDS) total score from baseline</measure>
<time_frame>Up to 12 weeks</time_frame>
<description>SDS is a 5-item scale, the total score is from 0 to 30; Higher scores denote greater impairment of function</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">20</enrollment>
<condition>Post Traumatic Stress Disorder</condition>
<arm_group>
<arm_group_label>COMP360 Psilocybin</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>25 mg COMP360 Psilocybin</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Psilocybin</intervention_name>
<description>Open label</description>
<arm_group_label>COMP360 Psilocybin</arm_group_label>
<other_name>COMP360</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Key Inclusion Criteria:

- Meet DSM-5 criteria for current PTSD resulting from a trauma experienced during
adulthood measured via the PCL-5 in combination with the LEC-5 at screening

- Meet DSM-5 criteria for current PTSD resulting from a trauma experienced during
adulthood as assessed by the CAPS, with a minimum score of 25 at baseline

- Able to identify a next of kin who is willing and able to be reached by the
investigators in case of emergency

- Have successfully discontinued all prohibited medications at least two weeks prior to
baseline visit. For fluoxetine (Prozac), immediate cessation at screening period visit
1a followed by at least four weeks of run-in will be required prior to baseline

Key Exclusion Criteria:

- Current or past history of schizophrenia, schizoaffective disorder or any other form
of psychotic disorder, obsessive compulsive disorder, personality disorders, bipolar
disorder, or any other significant disorder as assessed by clinician judgement and a
structured clinical interview (MINI 7.0.2)

- Diagnosis of complex PTSD according to the International Trauma Questionnaire (ITQ)

- Borderline Personality Disorder as demonstrated by both the McLean Screening
Instrument for Borderline Personality Disorder (MSI- BPD) score ≥ 7 and clinical
confirmation of diagnosis by the study clinician and Medical Monitor

- Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or
5 on the C-SSRS within the past year, during screening or at baseline, or; (2)
suicidal behaviours within the past year, or; (3) history of serious suicide attempt
that required a rescuing medical intervention, or; (4) clinical assessment of
significant suicidal risk during participant interview

- Current (within the last year) alcohol or substance use disorder as informed by DSM-5
assessed via the MINI 7.0.2 at screening

- Other personal circumstances and behaviour judged to be incompatible with
establishment of rapport or safe exposure to psilocybin

- Exposure to 3,4-methylenedioxymethamphetamine (MDMA), psilocybin, or any other
psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide (LSD), or
peyote in the past year

- Primary diagnosis of major depressive disorder within 6 months of study entry

- Exposure to a traumatic experience in the past 3 months

- Significant childhood physical or sexual abuse based on clinician judgment with the
use of CTQ

- Enrolment in a psychological therapy programme that will not remain stable for the
duration of the study. Psychological therapies cannot have been initiated within 21
days of baseline
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Medical Director, MD</last_name>
<email>info@compasspathways.com</email>
</overall_contact>
<location>
<facility>
<name>Icahn School of Medicine at Mount Sinai</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10029</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Carolyn Macleod</last_name>
<phone>646-438-5044</phone>
<email>carolyn.macleod@va.gov</email>
</contact>
<investigator>
<last_name>Rachel Yehuda, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Kings College London, Institute of Psychiatry, Psychology and Neurology</name>
<address>
<city>London</city>
<country>United Kingdom</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>James Rucker, MD</last_name>
<email>COMP201@kcl.ac.uk</email>
</contact>
</location>
<location_countries>
<country>United Kingdom</country>
<country>United States</country>
</location_countries>
<verification_date>June 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>June 12, 2023</last_update_submitted>
<last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 13, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>psilocybin</keyword>
<keyword>COMP360</keyword>
<keyword>COMPASS</keyword>
<keyword>PTSD</keyword>
<keyword>Post Traumatic Stress Disorder</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Stress Disorders, Traumatic</mesh_term>
<mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Psilocybin</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder
The Safety and Tolerability of COMP360 administered under supportive conditions in
participants with Post-traumatic Stress Disorder
Key Inclusion Criteria:
- Meet DSM-5 criteria for current PTSD resulting from a trauma experienced during
adulthood measured via the PCL-5 in combination with the LEC-5 at screening
- Meet DSM-5 criteria for current PTSD resulting from a trauma experienced during
adulthood as assessed by the CAPS, with a minimum score of 25 at baseline
- Able to identify a next of kin who is willing and able to be reached by the
investigators in case of emergency
- Have successfully discontinued all prohibited medications at least two weeks prior to
baseline visit. For fluoxetine (Prozac), immediate cessation at screening period visit
1a followed by at least four weeks of run-in will be required prior to baseline
Key Exclusion Criteria:
- Current or past history of schizophrenia, schizoaffective disorder or any other form
of psychotic disorder, obsessive compulsive disorder, personality disorders, bipolar
disorder, or any other significant disorder as assessed by clinician judgement and a
structured clinical interview (MINI 7.0.2)
- Diagnosis of complex PTSD according to the International Trauma Questionnaire (ITQ)
- Borderline Personality Disorder as demonstrated by both the McLean Screening
Instrument for Borderline Personality Disorder (MSI- BPD) score ≥ 7 and clinical
confirmation of diagnosis by the study clinician and Medical Monitor
- Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or
5 on the C-SSRS within the past year, during screening or at baseline, or; (2)
suicidal behaviours within the past year, or; (3) history of serious suicide attempt
that required a rescuing medical intervention, or; (4) clinical assessment of
significant suicidal risk during participant interview
- Current (within the last year) alcohol or substance use disorder as informed by DSM-5
assessed via the MINI 7.0.2 at screening
- Other personal circumstances and behaviour judged to be incompatible with
establishment of rapport or safe exposure to psilocybin
- Exposure to 3,4-methylenedioxymethamphetamine (MDMA), psilocybin, or any other
psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide (LSD), or
peyote in the past year
- Primary diagnosis of major depressive disorder within 6 months of study entry
- Exposure to a traumatic experience in the past 3 months
- Significant childhood physical or sexual abuse based on clinician judgment with the
use of CTQ
- Enrolment in a psychological therapy programme that will not remain stable for the
duration of the study. Psychological therapies cannot have been initiated within 21
days of baseline
|
NCT0531xxxx/NCT05312164.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/NCT05312164</url>
</required_header>
<id_info>
<org_study_id>003785</org_study_id>
<nct_id>NCT05312164</nct_id>
</id_info>
<brief_title>Physio-Anatomy Clinical Data Collection Study</brief_title>
<official_title>Physio-Anatomy Clinical Data Collection Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Gentuity, LLC</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Gentuity, LLC</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>Yes</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
This is an on-label clinical study design intended for the collection of three different
types of interventional procedural data using FDA-cleared cardiac catheterization
technologies and drugs, each used according to its product labeling and standard practice of
medicine.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
These devices and drugs are commonly used for patient evaluation during PCI procedures
performed by Interventional Cardiologists. The three device technologies used in a single
catheterization laboratory visit for assessment of the coronary arteries include:

- A coronary angiography imaging system to X-ray the coronary arteries for the evaluation
of vessel narrowing or blocking.

- Pressure guidewire from one or more manufacturers for the measurement of coronary
physiology parameters.

- Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging catheter for imaging and
sizing of the stenosed coronary arteries.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 14, 2022</start_date>
<completion_date type="Anticipated">December 31, 2024</completion_date>
<primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Only</observational_model>
<time_perspective>Other</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Collection of angiography images, HF-OCT images, and FFR pressure wire data</measure>
<time_frame>2 years</time_frame>
<description>There are no efficacy or safety outcomes in this study. This study is a simple data collection study to help the sponsor develop next-generation HF-OCT software. Pressure wire data will be paired with HF-OCT images and angiography images for analysis to determine if the HF-OCT imaging technology can predict FFR physiology information from the OCT pullback.</description>
</primary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Anticipated">150</enrollment>
<condition>Coronary Stenosis</condition>
<arm_group>
<arm_group_label>Candidates for PCI</arm_group_label>
<description>Patients undergoing diagnostic cardiac catheterization/PCI.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>HF-OCT Imaging</intervention_name>
<description>Subjects undergo HF-OCT imaging of stenosed coronary arteries</description>
<arm_group_label>Candidates for PCI</arm_group_label>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>FFR Pressure Wire</intervention_name>
<description>Subjects undergo FFR physiology assessment of stenosed coronary arteries</description>
<arm_group_label>Candidates for PCI</arm_group_label>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Angiography</intervention_name>
<description>Subjects undergo angiography imaging of stenosed coronary arteries</description>
<arm_group_label>Candidates for PCI</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Patients who are candidates for PCI who already have a scheduled visit to the cardiac cath
lab.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Patients >18 years of age.

- Patients provide written informed consent.

- Clinical presentation consistent with suspected coronary disease.

- Patients who are candidates for PCI and scheduled for coronary diagnostics in the
cardiac catheter lab with the intent to perform a physiological assessment for de novo
lesions with stenosis, if clinically indicated.

Exclusion Criteria:

- Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath
lab procedure.

- Contraindication for FFR examination or administration of vasodilators.

- Bacteremia or sepsis.

- Major coagulation system abnormalities.

- Severe hemodynamic instability or shock.

- Heart Failure NYHA Class IV.

- Severe valvular heart disease.

- Prior heart transplant.

- Acute renal failure based on diagnostic practice of the treating physician at time of
screening.

- Patient is pregnant.

- Patient is currently enrolled in another clinical study that may impact the results of
this study.

- Patient has other co-morbid condition(s) that, in the opinion of the Investigator,
could limit their
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<overall_contact>
<last_name>Arjun Bhat, MD, MBA</last_name>
<phone>978-202-4108</phone>
<email>abhat@gentuity.com</email>
</overall_contact>
<location>
<facility>
<name>Veteran's Administration Palo Alto</name>
<address>
<city>Palo Alto</city>
<state>California</state>
<zip>94304</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>William Fearon, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Tampa General Hospital</name>
<address>
<city>Tampa</city>
<state>Florida</state>
<zip>33606</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Thanh Tran</last_name>
<phone>813-844-8544</phone>
<email>tqtran@usf.edu</email>
</contact>
<investigator>
<last_name>Hiram Bezerra, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Atlanta VA Medical Center</name>
<address>
<city>Decatur</city>
<state>Georgia</state>
<zip>30033</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Gautam Kumar, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Beth Israel Deaconess Medical Center</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02215</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Eric A Osborn, MD, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Minneapolis VA Medical Center</name>
<address>
<city>Minneapolis</city>
<state>Minnesota</state>
<zip>55417</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Alok Sharma, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>The Christ Hospital</name>
<address>
<city>Cincinnati</city>
<state>Ohio</state>
<zip>45219</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Jarrod Frizzell, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Vanderbilt University Medical Center</name>
<address>
<city>Nashville</city>
<state>Tennessee</state>
<zip>37232</zip>
<country>United States</country>
</address>
</facility>
<status>Not yet recruiting</status>
<investigator>
<last_name>Colin Barker, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>April 2023</verification_date>
<study_first_submitted>March 18, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>June 29, 2023</last_update_submitted>
<last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">July 3, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Coronary Stenosis</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This is an on-label clinical study design intended for the collection of three different
types of interventional procedural data using FDA-cleared cardiac catheterization
technologies and drugs, each used according to its product labeling and standard practice of
medicine.
These devices and drugs are commonly used for patient evaluation during PCI procedures
performed by Interventional Cardiologists. The three device technologies used in a single
catheterization laboratory visit for assessment of the coronary arteries include:
- A coronary angiography imaging system to X-ray the coronary arteries for the evaluation
of vessel narrowing or blocking.
- Pressure guidewire from one or more manufacturers for the measurement of coronary
physiology parameters.
- Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging catheter for imaging and
sizing of the stenosed coronary arteries.
Patients who are candidates for PCI who already have a scheduled visit to the cardiac cath
lab.
Inclusion Criteria:
- Patients >18 years of age.
- Patients provide written informed consent.
- Clinical presentation consistent with suspected coronary disease.
- Patients who are candidates for PCI and scheduled for coronary diagnostics in the
cardiac catheter lab with the intent to perform a physiological assessment for de novo
lesions with stenosis, if clinically indicated.
Exclusion Criteria:
- Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath
lab procedure.
- Contraindication for FFR examination or administration of vasodilators.
- Bacteremia or sepsis.
- Major coagulation system abnormalities.
- Severe hemodynamic instability or shock.
- Heart Failure NYHA Class IV.
- Severe valvular heart disease.
- Prior heart transplant.
- Acute renal failure based on diagnostic practice of the treating physician at time of
screening.
- Patient is pregnant.
- Patient is currently enrolled in another clinical study that may impact the results of
this study.
- Patient has other co-morbid condition(s) that, in the opinion of the Investigator,
could limit their
|
NCT0531xxxx/NCT05312177.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/NCT05312177</url>
</required_header>
<id_info>
<org_study_id>CHILD-DS</org_study_id>
<secondary_id>3U24HL135691-03S1</secondary_id>
<nct_id>NCT05312177</nct_id>
</id_info>
<brief_title>Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)</brief_title>
<acronym>CHILD-DS</acronym>
<official_title>Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)</official_title>
<sponsors>
<lead_sponsor>
<agency>Carelon Research</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
<collaborator>
<agency>National Institutes of Health (NIH)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Carelon Research</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The study objective is to compare neurodevelopmental (ND) and behavioral outcomes between
children with Down syndrome (DS) who had complete atrioventricular septal defect (CAVSD)
repair and children from the same clinical sites with DS without major congenital heart
disease (CHD) requiring previous or planned CHD surgery.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
We will conduct a multicenter cohort study, ancillary to the Pediatric Heart Network (PHN)
Residual Lesion Score (RLS) study, to investigate determinants of ND and behavioral outcomes
in children with DS, focusing on the role of CHD surgery. We will only include RLS Study
children with DS who had CAVSD repair, as this group comprises 91% of all children with DS in
the RLS Study, with similar underlying congenital cardiac defect and surgical repair
complexity, allowing our children with DS and CHD to be a homogeneous group. Moreover, one in
five individuals with DS is born with an AVSD, a 2000 times higher incidence than in those
with normal chromosomes. In addition to recruiting RLS Study children with DS who had CAVSD
repair, we will recruit similarly-aged children with DS who do not have documented major CHD
(i.e., CHD requiring previous or planned CHD surgery) to come into the same PHN site for a
single study visit consisting of detailed phenotyping by completion of a Health &
Developmental History Intake form, ND and behavioral assessments, and optional collection and
storage of saliva specimens in the PHN Biorepository. By building our sample from RLS Study
participants and recruiting a comparison group from the same PHN sites, we will leverage rich
prospective data in a group of DS children with CAVSD repair from a nationally representative
sample, and the expertise of the PHN and Boston Children's Hospital (BCH).
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 30, 2022</start_date>
<completion_date type="Anticipated">June 30, 2023</completion_date>
<primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Neurodevelopmental outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD.</measure>
<time_frame>1 day</time_frame>
<description>Verbal and non-verbal ratio intelligent quotients (IQs) derived from the Stanford Binet Intelligence Scales will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.</description>
</primary_outcome>
<primary_outcome>
<measure>Behavioral outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD.</measure>
<time_frame>1 day</time_frame>
<description>Adaptive composite scores from the Vineland Adaptive Behavior Scales will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.</description>
</primary_outcome>
<primary_outcome>
<measure>Language abilities compared between the children with DS and CAVSD repair and the children with DS without major CHD.</measure>
<time_frame>1 day</time_frame>
<description>Using the Peabody Picture Vocabulary Test, Expressive Vocabulary Test, and Leiter International Performance Scale total language, auditory comprehension, and expressive communication will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.</description>
</primary_outcome>
<primary_outcome>
<measure>Emotional outcomes compared between the children with DS and CAVSD repair and the children with DS without major CHD.</measure>
<time_frame>1 day</time_frame>
<description>Using the Repetitive Behavior Scale and Aberrant Behavior Checklist , behavioral and emotional problems will be compared will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.</description>
</primary_outcome>
<primary_outcome>
<measure>Social Communication compared between the children with DS and CAVSD repair and the children with DS without major CHD.</measure>
<time_frame>1 day</time_frame>
<description>Using the Social Communication Questionnaire, social communication, social interactions, play and behavior will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.</description>
</primary_outcome>
<secondary_outcome>
<measure>Comorbidities as predictors of neurodevelopment and behavior</measure>
<time_frame>1 day</time_frame>
<description>Comorbidities will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Sociodemographic factors as predictors of neurodevelopment and behavior</measure>
<time_frame>1 day</time_frame>
<description>Sociodemographic factors, such as will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">320</enrollment>
<condition>Down Syndrome</condition>
<condition>Congenital Heart Disease</condition>
<arm_group>
<arm_group_label>DS with CAVSD Repair</arm_group_label>
<description>Children between the ages of 5 and 8 years with Down syndrome who had Complete atrioventricular septal defect (CAVSD) repair in the first year of life and their parent(s) will be administered the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5), Expressive Vocabulary Test, Third Edition (EVT-3), Leiter International Performance Scale, Third Edition (Leiter-3), Vineland-3 Q-global Comprehensive Report (Vineland-3) ,Social Communication Questionnaire, Current version (SCQ), Aberrant Behavior Checklist, Second Edition, (ABC-2) and Repetitive Behavior Scale, Revised (RBS-R)</description>
</arm_group>
<arm_group>
<arm_group_label>DS without major CHD</arm_group_label>
<description>Children between the ages of 5 and 8 years with Down syndrome without major Congenital Heart Disease(CHD) and their parent(s) will be administered the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5), Expressive Vocabulary Test, Third Edition (EVT-3), Leiter International Performance Scale, Third Edition (Leiter-3), Vineland-3 Q-global Comprehensive Report (Vineland-3) ,Social Communication Questionnaire, Current version (SCQ), Aberrant Behavior Checklist, Second Edition, (ABC-2) and Repetitive Behavior Scale, Revised (RBS-R)</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Stanford Binet Intelligence Scales, Fifth Edition</intervention_name>
<description>The SB-5 is a comprehensive measure of cognitive and intellectual functioning for individuals from age two through 85 years of age. The SB-5 individually assess a child's functioning in five areas of cognitive functioning: Fluid Reasoning, Knowledge, Quantitative Reasoning, Visual Spatial, and Working Memory. The SB-5 is well established in the existing research literature as an assessment tool to evaluate developmental and intellectual abilities in children with ND disorders.</description>
<arm_group_label>DS with CAVSD Repair</arm_group_label>
<arm_group_label>DS without major CHD</arm_group_label>
<other_name>SB-5</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Vineland Adaptive Behavior Scales Third Edition</intervention_name>
<description>The VABS-3 are a parent report, interview style measure of adaptive behavior for individuals ages birth through 90 months. The VABS-3 assesses adaptive behavior in four broad domains of Communication, Daily Living Skills, Socialization, and Motor Skills, and includes a Maladaptive Behavior Domain that assesses problem behaviors.</description>
<arm_group_label>DS with CAVSD Repair</arm_group_label>
<arm_group_label>DS without major CHD</arm_group_label>
<other_name>VABS-3</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Peabody Picture Vocabulary Test, Fifth Edition</intervention_name>
<description>The PPVT-5 is a norm-referenced language measure that evaluates single-word receptive vocabulary. The PPVT-5 provides standard scores for individuals ages 2.6 through 90 years.</description>
<arm_group_label>DS with CAVSD Repair</arm_group_label>
<arm_group_label>DS without major CHD</arm_group_label>
<other_name>PPVT-5</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Expressive Vocabulary Test, Third Edition</intervention_name>
<description>The EVT-3 is a norm-referenced language measure that evaluates single-word expressive vocabulary. The EVT-3 provides standard scores for individuals ages 2.6 through 90 years.</description>
<arm_group_label>DS with CAVSD Repair</arm_group_label>
<arm_group_label>DS without major CHD</arm_group_label>
<other_name>EVT-3</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Leiter International Performance Scale, Third Edition</intervention_name>
<description>The Leiter-3 is a nonverbal measure of cognitive functioning and fluid reasoning skills in individuals ages 3 through 75 years. The Leiter-3 measures nonverbal IQ across four subscales, including Sequential Order (SO), Form Completion (FC), Classification and Analogies (CA), and Figure Ground (FG).</description>
<arm_group_label>DS with CAVSD Repair</arm_group_label>
<arm_group_label>DS without major CHD</arm_group_label>
<other_name>Leiter-3</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Social Communication Questionnaire, Current Form</intervention_name>
<description>The SCQ is a parent-report measure of social communication, social interactions, play, and behavior.</description>
<arm_group_label>DS with CAVSD Repair</arm_group_label>
<arm_group_label>DS without major CHD</arm_group_label>
<other_name>SCQ</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Aberrant Behavior Checklist</intervention_name>
<description>The ABC-2 is a parent report measure of problematic behavior at home and in the community. It measures behavior on five subscales (1) Irritability, (2) Social Withdrawal, (3) Stereotypic Behavior, (4) Hyperactivity/Noncompliance, and (5) Inappropriate Speech.</description>
<arm_group_label>DS with CAVSD Repair</arm_group_label>
<arm_group_label>DS without major CHD</arm_group_label>
<other_name>ABC-2</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Repetitive Behavior Scale, Revised</intervention_name>
<description>The RBS-R is a parent report measure that comprehensively surveys for the presence of repetitive behaviors.</description>
<arm_group_label>DS with CAVSD Repair</arm_group_label>
<arm_group_label>DS without major CHD</arm_group_label>
<other_name>RBS-R</other_name>
</intervention>
<biospec_retention>Samples With DNA</biospec_retention>
<biospec_descr>
<textblock>
We aim to collect saliva samples from study participants during the single study visit at the
PHN site, which will be preserved and processed by the PHN Biorepository for DNA storage for
future targeted research studies.
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
PHN RLS Study participants with DS and CAVSD repair from the 13 PHN sites are eligible to
participate in this study. Children with a diagnosis of mosaic DS will be excluded, as
these forms of DS show different ND trajectories and are usually excluded. While data on
mosaic DS were not collected in the RLS Study, we anticipate few if any to have this
diagnosis. The DS comparison group will be required to have no major CHD, defined as CHD
that requires CHD surgery (a) in the period between birth and recruitment into the CHILD-DS
Study or (b) planned for a future date.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

Down Syndrome CAVSD Repair Group:

- Trisomy 21

- Male or Female, age 5 years through 8 years

- Pediatric Heart Network (PHN) Residual Lesion Score (RLS) study participant having
CAVSD repair within the first year of life at a subset of recruitment sites

- Parent or guardian and patient willing to comply with protocol, complete all study
assessments, and provide written informed consent using the English language

- Child and parent able to speak and understand English

Down Syndrome Comparison Group

- Trisomy 21

- Male or Female, age 5 years through 8 years

- No major CHD, defined as CHD requiring previous or planned CHD surgery

- Parent or guardian and patient willing to comply with protocol, complete all study
assessments, and provide written informed consent using the English language

- Child and parent able to speak and understand English

Exclusion Criteria:

Both Groups

- Mosaic DS

Down Syndrome CAVSD Repair Group only - Not a participant in the PHN RLS Study

Down Syndrome Comparison Group only

- Major CHD requiring previous or planned CHD surgery - i.e., CHD surgery occurring (a) in
the period between birth and time of recruitment into the CHILD-DS Study, or (b) planned
for a future date.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>60 Months</minimum_age>
<maximum_age>108 Months</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Maria VanRompay, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Carelon Research</affiliation>
</overall_official>
<overall_contact>
<last_name>Maria VanRompay, PhD</last_name>
<phone>617-584-7142</phone>
<email>MVanRompay@HealthCore.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Melissa Lamberti, MSW</last_name>
<phone>339-222-2804</phone>
<email>mlamberti@healthcore.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Alfred I. duPont Hospital for Children</name>
<address>
<city>Wilmington</city>
<state>Delaware</state>
<zip>19899</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Carol Prospero, RN</last_name>
<email>cprosper@NEMOURS.ORG</email>
</contact>
<contact_backup>
<last_name>Varsha Zadokar</last_name>
<email>Varsha.Zadokar@nemours.org</email>
</contact_backup>
<investigator>
<last_name>Christian Pizarro, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Children's Healthcare of Atlanta at Egleston</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<zip>30033</zip>
<country>United States</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Jean McColl</last_name>
<email>jean.luan@emory.edu</email>
</contact>
<investigator>
<last_name>Amy Talboy, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Riley Children's Hospital</name>
<address>
<city>Indianapolis</city>
<state>Indiana</state>
<zip>46202</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Leanne Dunn</last_name>
<email>lkhernan@iu.edu</email>
</contact>
<contact_backup>
<last_name>Mary Stumpf</last_name>
<email>mestumpf@iu.edu</email>
</contact_backup>
<investigator>
<last_name>Marcus Schamberger, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Boston Children's Hospital</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02111</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Thomas Giorgio</last_name>
<email>Thomas.Giorgio@cardio.chboston.org</email>
</contact>
<contact_backup>
<last_name>Lisa Jean Buckley</last_name>
<email>LisaJeanBuckley@cardio.chboston.org</email>
</contact_backup>
<investigator>
<last_name>Meena Nathan, MD</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Nicole Baumer, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>University of Michigan Health System/Mott Hospital</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<zip>48109</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Tammy Doman</last_name>
<email>tpaterso@med.umich.edu</email>
</contact>
<investigator>
<last_name>Caren Goldberg</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Children's Mercy Hospital</name>
<address>
<city>Kansas City</city>
<state>Missouri</state>
<zip>64108</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jennifer Nelson</last_name>
<email>jnelson@cmh.edu</email>
</contact>
<investigator>
<last_name>Geetha Raghuveer, MD</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Nasreen Talib, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Columbia College of Physicians and Surgeons</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10032</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Chantal Sanchez</last_name>
<email>Cms2330@cumc.columbia.edu</email>
</contact>
<contact_backup>
<last_name>Chanel Rojas</last_name>
<email>Cr2651@cumc.columbia.edu</email>
</contact_backup>
<investigator>
<last_name>Brett Anderson, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Cincinnati Children's Hospital Medical Center</name>
<address>
<city>Cincinnati</city>
<state>Ohio</state>
<zip>45229</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Lauryn Dugan</last_name>
<email>lauryn.dugan@cchmc.org</email>
</contact>
<investigator>
<last_name>Nadine Kasparian, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Children's Hospital of Philadelphia</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104</zip>
<country>United States</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Aayush Raman</last_name>
<email>ramana@chop.edu</email>
</contact>
<contact_backup>
<last_name>Donna Sylvester</last_name>
<email>sylvesterd@email.chop.edu</email>
</contact_backup>
<investigator>
<last_name>Mary Pipan, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Medical University of South Carolina</name>
<address>
<city>Charleston</city>
<state>South Carolina</state>
<zip>29425</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Layla Al Sarraf</last_name>
<email>alsarral@musc.edu</email>
</contact>
<investigator>
<last_name>Angela LaRosa, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Baylor College of Medicine - Texas Children's Hospital</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77030</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Sandra Pena</last_name>
<email>sypena@texaschildrens.org</email>
</contact>
<investigator>
<last_name>Lisa Noll, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Primary Children's Hospital</name>
<address>
<city>Salt Lake City</city>
<state>Utah</state>
<zip>84132</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Andrea Cureless</last_name>
<email>andrea.curless@hsc.utah.edu</email>
</contact>
<investigator>
<last_name>Whitnee Hogan, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Hospital for Sick Children</name>
<address>
<city>Toronto</city>
<state>Ontario</state>
<zip>M5G 1X8</zip>
<country>Canada</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jessica Bainton</last_name>
<email>jessica.bainton@sickkids.ca</email>
</contact>
<investigator>
<last_name>Steven Schwartz, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>Canada</country>
<country>United States</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>February 24, 2020</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>August 3, 2022</last_update_submitted>
<last_update_submitted_qc>August 3, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">August 5, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Down Syndrome</keyword>
<keyword>CHD</keyword>
<keyword>Congenital Heart Disease</keyword>
<keyword>Pediatric Heart Network</keyword>
<keyword>INCLUDE</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Down Syndrome</mesh_term>
<mesh_term>Heart Diseases</mesh_term>
<mesh_term>Heart Defects, Congenital</mesh_term>
<mesh_term>Syndrome</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>Public Use Datasets are created after study closeout and are made available on the PHN public website. Annotated study data collection forms, Statistical Analysis Program (SAS) datasets, and excel datasets are made available, as well as de-identified study cohort characteristics.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
<ipd_time_frame>Data is available one year after study closeout and is available indefinitely.</ipd_time_frame>
<ipd_access_criteria>log-in and password</ipd_access_criteria>
<ipd_url>https://www.pediatricheartnetwork.org/login/</ipd_url>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The study objective is to compare neurodevelopmental (ND) and behavioral outcomes between
children with Down syndrome (DS) who had complete atrioventricular septal defect (CAVSD)
repair and children from the same clinical sites with DS without major congenital heart
disease (CHD) requiring previous or planned CHD surgery.
We will conduct a multicenter cohort study, ancillary to the Pediatric Heart Network (PHN)
Residual Lesion Score (RLS) study, to investigate determinants of ND and behavioral outcomes
in children with DS, focusing on the role of CHD surgery. We will only include RLS Study
children with DS who had CAVSD repair, as this group comprises 91% of all children with DS in
the RLS Study, with similar underlying congenital cardiac defect and surgical repair
complexity, allowing our children with DS and CHD to be a homogeneous group. Moreover, one in
five individuals with DS is born with an AVSD, a 2000 times higher incidence than in those
with normal chromosomes. In addition to recruiting RLS Study children with DS who had CAVSD
repair, we will recruit similarly-aged children with DS who do not have documented major CHD
(i.e., CHD requiring previous or planned CHD surgery) to come into the same PHN site for a
single study visit consisting of detailed phenotyping by completion of a Health &
Developmental History Intake form, ND and behavioral assessments, and optional collection and
storage of saliva specimens in the PHN Biorepository. By building our sample from RLS Study
participants and recruiting a comparison group from the same PHN sites, we will leverage rich
prospective data in a group of DS children with CAVSD repair from a nationally representative
sample, and the expertise of the PHN and Boston Children's Hospital (BCH).
We aim to collect saliva samples from study participants during the single study visit at the
PHN site, which will be preserved and processed by the PHN Biorepository for DNA storage for
future targeted research studies.
PHN RLS Study participants with DS and CAVSD repair from the 13 PHN sites are eligible to
participate in this study. Children with a diagnosis of mosaic DS will be excluded, as
these forms of DS show different ND trajectories and are usually excluded. While data on
mosaic DS were not collected in the RLS Study, we anticipate few if any to have this
diagnosis. The DS comparison group will be required to have no major CHD, defined as CHD
that requires CHD surgery (a) in the period between birth and recruitment into the CHILD-DS
Study or (b) planned for a future date.
Inclusion Criteria:
Down Syndrome CAVSD Repair Group:
- Trisomy 21
- Male or Female, age 5 years through 8 years
- Pediatric Heart Network (PHN) Residual Lesion Score (RLS) study participant having
CAVSD repair within the first year of life at a subset of recruitment sites
- Parent or guardian and patient willing to comply with protocol, complete all study
assessments, and provide written informed consent using the English language
- Child and parent able to speak and understand English
Down Syndrome Comparison Group
- Trisomy 21
- Male or Female, age 5 years through 8 years
- No major CHD, defined as CHD requiring previous or planned CHD surgery
- Parent or guardian and patient willing to comply with protocol, complete all study
assessments, and provide written informed consent using the English language
- Child and parent able to speak and understand English
Exclusion Criteria:
Both Groups
- Mosaic DS
Down Syndrome CAVSD Repair Group only - Not a participant in the PHN RLS Study
Down Syndrome Comparison Group only
- Major CHD requiring previous or planned CHD surgery - i.e., CHD surgery occurring (a) in
the period between birth and time of recruitment into the CHILD-DS Study, or (b) planned
for a future date.
|
NCT0531xxxx/NCT05312190.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/NCT05312190</url>
</required_header>
<id_info>
<org_study_id>ZhenQi202201</org_study_id>
<nct_id>NCT05312190</nct_id>
</id_info>
<brief_title>Clinical and Basic Researches Related to ZhenQi Buxue Oral Liquid in Treating Menstrual Disorders</brief_title>
<official_title>Clinical and Basic Researches Related to ZhenQi Buxue Oral Liquid in Treating Menstrual Disorders</official_title>
<sponsors>
<lead_sponsor>
<agency>Peking Union Medical College Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>West China Second University Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Chongqing Medical University No.1 Affiliated Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>The Second Hospital of Hebei Medical University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Second Affiliated Hospital of Nanchang University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Zhongda Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hubei Maternal and Child Health Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Liuzhou Maternity and Child Healthcare Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Zhejiang University Medical College Affiliated Hangzhou First People's Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Guangzhou Women and Children's Medical Center</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Peking Union Medical College Hospital</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This study is a national multicenter prospective, randomized, controlled trial, which
evaluates Zhenqi Buxue Oral Liquid，Progesterone Capsules and the addition of Zhenqi Buxue
Oral Liquid to Progesterone Capsules in the treatment of menstrual disorders in adults women.
One third of participanta will receive Zhenqi Buxue Oral Liquid, one third of participanta
will receive Progesterone Capsules, and the another third will receive Zhenqi Buxue Oral
Liquid and Progesterone Capsules in combination.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Menstrual disorders are one of the most common clinical symptoms in women. Since puberty,
about 70% of women have experienced menstrual disorders, including early, delayed, shortened,
prolonged, and more importantly oligomenorrhea, amenorrhea, and decreased menstrual flow.At
present, the main method of western medicine for the treatment of menstrual disorders is
hormone replacement therapy, but the incidence of adverse reactions is high, and the clinical
effect is mediocre. Traditional Chinese medicine in my country mostly adopts holistic
conditioning therapy for the treatment of irregular menstruation.

Zhenqi Buxue Oral Liquid consists of sheep placenta, pearl, red ginseng, wolfberry,
astragalus, angelica, coix seed, ginger and jujube. The excipients are protein sugar and
sodium benzoate. Nourishes qi and blood. It is suitable for dizziness, pale complexion,
fatigue, lack of energy and lazy words caused by insufficient qi and blood.

This study will conduct a comprehensive and in-depth study on its treatment of mental and
psychological stress and menstrual disorders with "oligomenorrhea, amenorrhea, amenorrhea and
decreased menstrual flow" as the main manifestations. The molecular mechanism and clinical
improvement, and the safety and adverse reactions of its use paln to be clarified.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 15, 2022</start_date>
<completion_date type="Anticipated">June 30, 2023</completion_date>
<primary_completion_date type="Anticipated">December 30, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>This study is a national multicenter prospective, randomized, controlled trial. One third of participanta will receive Zhenqi Buxue Oral Liquid, one third of participanta will receive Progesterone Capsules, and the another third will receive Zhenqi Buxue Oral Liquid and Progesterone Capsules in combination.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Menstrual improvement</measure>
<time_frame>Within 3 months after the trial complete</time_frame>
<description>Menstrual improvement in cycle period</description>
</primary_outcome>
<primary_outcome>
<measure>Menstrual improvement</measure>
<time_frame>Within 3 months after the trial complete</time_frame>
<description>Menstrual improvement in menstrual volume</description>
</primary_outcome>
<primary_outcome>
<measure>Menstrual improvement</measure>
<time_frame>Within 3 months after the trial complete</time_frame>
<description>Menstrual improvement in number of days with bleeding or spotting</description>
</primary_outcome>
<primary_outcome>
<measure>Menstrual improvement</measure>
<time_frame>Within 3 months after the trial complete</time_frame>
<description>Menstrual improvement in monthly rates of amenorrhea</description>
</primary_outcome>
<secondary_outcome>
<measure>Sex hormone levels</measure>
<time_frame>Within 3 months after the trial complete</time_frame>
<description>mainly FSH, LH，E2 and AMH</description>
</secondary_outcome>
<secondary_outcome>
<measure>AFC</measure>
<time_frame>Within 3 months after the trial complete</time_frame>
<description>Changes in AFC in pelvic ultrasonography</description>
</secondary_outcome>
<secondary_outcome>
<measure>SF-36</measure>
<time_frame>Within 3 months after the trial complete</time_frame>
<description>The change of the MOS item short from health survey</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">330</enrollment>
<condition>Menstrual Disorders</condition>
<arm_group>
<arm_group_label>Zhenqi Buxue Oral Liquid</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Zhenqi Buxue Oral Liquid, 10 ml each time, 2 times a day for 3 menstrual cycles, orally</description>
</arm_group>
<arm_group>
<arm_group_label>Zhenqi Buxue Oral Liquid and Progesterone Capsules</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Zhenqi Buxue Oral Liquid was taken orally, 10 ml at a time, twice a day for 3 menstrual cycles + orally from the second half of menstrual cycle, Progesterone Capsules 200mg, once a day for 10 days for 3 menstrual cycles</description>
</arm_group>
<arm_group>
<arm_group_label>Progesterone Capsules</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Progesterone Capsules 200mg, qd*10 days*3 menstrual cycles, orally</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>ZhenQi BuXue KouFuYe</intervention_name>
<description>Zhenqi Buxue Oral Liquid consists of sheep placenta, pearl, red ginseng, wolfberry, astragalus, angelica, coix seed, ginger and jujube. The excipients are protein sugar and sodium benzoate. Nourishes qi and blood. It is suitable for dizziness, pale complexion, fatigue, lack of energy and lazy words caused by insufficient qi and blood.</description>
<arm_group_label>Zhenqi Buxue Oral Liquid</arm_group_label>
<arm_group_label>Zhenqi Buxue Oral Liquid and Progesterone Capsules</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Progesterone Capsules</intervention_name>
<description>The main ingredient of Progesterone Capsules is abbsolutely progesterone,a kind of hormone,which is the main method of western medicine for the treatment of menstrual disorders</description>
<arm_group_label>Progesterone Capsules</arm_group_label>
<arm_group_label>Zhenqi Buxue Oral Liquid and Progesterone Capsules</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Aged between 25 and 40 years old;

2. Patients with oligomenorrhea or oligomenorrhea or menopause within three months (see
Appendix 1: Diagnostic Criteria of Traditional Chinese and Western Medicine)

3. Meet the clinical medication conditions for progesterone to regulate menstruation

4. The research subjects were informed and voluntarily participated in this study, and
signed the informed consent at the same time.

Exclusion Criteria:

1. Age <25 years or >40 years old, pregnant or breastfeeding women

2. Ovarian dysfunction caused by local ovarian surgery, radiotherapy and chemotherapy for
previous malignant tumors, taking hormones or immunosuppressive drugs;

3. Combined with serious or unstable physical diseases that may affect the efficacy of
drugs and the conduct of trials, including liver, kidney, gastrointestinal,
cardiovascular, respiratory, endocrine, neurological, immune or blood system diseases,
etc., mental patients .

4. Those who were allergic to the drugs used in the trial or had serious adverse
reactions in the past;

5. Breast cancer or family history of breast cancer in first-degree relatives, irregular
vaginal bleeding, uterine fibroids (≥3cm), endometriosis, atypical endometrial
hyperplasia, endometrial cancer and other hormone-dependent reproduction Systemic
diseases and other malignant tumors;

6. Those with a history of thromboembolic disease or thrombosis;

7. Participated in a clinical trial of another research drug within 3 months prior to
inclusion in this study (the first interview);

8. Those who have used related drugs in the past 3 months or have abused or depended on
substances (alcohol or drugs) in the past 3 months; heavy smokers (smokers who smoke
20 or more cigarettes per day);

9. Those who met the inclusion criteria, did not follow the doctor's advice, were unable
to judge the curative effect or were unable to evaluate the curative effect due to
incomplete data.
</textblock>
</criteria>
<gender>Female</gender>
<gender_based>Yes</gender_based>
<gender_description>Female</gender_description>
<minimum_age>25 Years</minimum_age>
<maximum_age>40 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Lei Li</name>
<address>
<city>Beijing</city>
<state>Beijing</state>
<zip>10000</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Lei L Li, MD</last_name>
<phone>13911988831</phone>
<phone_ext>＋86</phone_ext>
<email>lileigh@163.com</email>
</contact>
</location>
<location>
<facility>
<name>Peking Union Medical College Hospital</name>
<address>
<city>Beijing</city>
<state>Beijing</state>
<zip>1000730</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Aijun Sun</last_name>
<phone>01018600045466</phone>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 8, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>March 31, 2022</last_update_submitted>
<last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 5, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Menstrual disorders</keyword>
<keyword>Traditional Chinese medicine</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Menstruation Disturbances</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Progesterone</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<provided_document_section>
<provided_document>
<document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
<document_has_protocol>Yes</document_has_protocol>
<document_has_icf>Yes</document_has_icf>
<document_has_sap>Yes</document_has_sap>
<document_date>March 20, 2022</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT05312190/Prot_SAP_ICF_000.pdf</document_url>
</provided_document>
</provided_document_section>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study is a national multicenter prospective, randomized, controlled trial, which
evaluates Zhenqi Buxue Oral Liquid，Progesterone Capsules and the addition of Zhenqi Buxue
Oral Liquid to Progesterone Capsules in the treatment of menstrual disorders in adults women.
One third of participanta will receive Zhenqi Buxue Oral Liquid, one third of participanta
will receive Progesterone Capsules, and the another third will receive Zhenqi Buxue Oral
Liquid and Progesterone Capsules in combination.
Menstrual disorders are one of the most common clinical symptoms in women. Since puberty,
about 70% of women have experienced menstrual disorders, including early, delayed, shortened,
prolonged, and more importantly oligomenorrhea, amenorrhea, and decreased menstrual flow.At
present, the main method of western medicine for the treatment of menstrual disorders is
hormone replacement therapy, but the incidence of adverse reactions is high, and the clinical
effect is mediocre. Traditional Chinese medicine in my country mostly adopts holistic
conditioning therapy for the treatment of irregular menstruation.
Zhenqi Buxue Oral Liquid consists of sheep placenta, pearl, red ginseng, wolfberry,
astragalus, angelica, coix seed, ginger and jujube. The excipients are protein sugar and
sodium benzoate. Nourishes qi and blood. It is suitable for dizziness, pale complexion,
fatigue, lack of energy and lazy words caused by insufficient qi and blood.
This study will conduct a comprehensive and in-depth study on its treatment of mental and
psychological stress and menstrual disorders with "oligomenorrhea, amenorrhea, amenorrhea and
decreased menstrual flow" as the main manifestations. The molecular mechanism and clinical
improvement, and the safety and adverse reactions of its use paln to be clarified.
Inclusion Criteria:
1. Aged between 25 and 40 years old;
2. Patients with oligomenorrhea or oligomenorrhea or menopause within three months (see
Appendix 1: Diagnostic Criteria of Traditional Chinese and Western Medicine)
3. Meet the clinical medication conditions for progesterone to regulate menstruation
4. The research subjects were informed and voluntarily participated in this study, and
signed the informed consent at the same time.
Exclusion Criteria:
1. Age <25 years or >40 years old, pregnant or breastfeeding women
2. Ovarian dysfunction caused by local ovarian surgery, radiotherapy and chemotherapy for
previous malignant tumors, taking hormones or immunosuppressive drugs;
3. Combined with serious or unstable physical diseases that may affect the efficacy of
drugs and the conduct of trials, including liver, kidney, gastrointestinal,
cardiovascular, respiratory, endocrine, neurological, immune or blood system diseases,
etc., mental patients .
4. Those who were allergic to the drugs used in the trial or had serious adverse
reactions in the past;
5. Breast cancer or family history of breast cancer in first-degree relatives, irregular
vaginal bleeding, uterine fibroids (≥3cm), endometriosis, atypical endometrial
hyperplasia, endometrial cancer and other hormone-dependent reproduction Systemic
diseases and other malignant tumors;
6. Those with a history of thromboembolic disease or thrombosis;
7. Participated in a clinical trial of another research drug within 3 months prior to
inclusion in this study (the first interview);
8. Those who have used related drugs in the past 3 months or have abused or depended on
substances (alcohol or drugs) in the past 3 months; heavy smokers (smokers who smoke
20 or more cigarettes per day);
9. Those who met the inclusion criteria, did not follow the doctor's advice, were unable
to judge the curative effect or were unable to evaluate the curative effect due to
incomplete data.
|
NCT0531xxxx/NCT05312203.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/NCT05312203</url>
</required_header>
<id_info>
<org_study_id>2021GR0585</org_study_id>
<nct_id>NCT05312203</nct_id>
</id_info>
<brief_title>Alleviating Stress by Mobile Application' for Depression</brief_title>
<acronym>ASMA-D</acronym>
<official_title>A Randomized Control Trial to Investigate the Effectiveness of Smart Mental Health Interventions for Stress Reduction(inMind) During the Pharmacological Treatment in Mild to Moderate Major Depressive Disorder.</official_title>
<sponsors>
<lead_sponsor>
<agency>Korea University Guro Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Ministry of Trade, Industry & Energy, Republic of Korea</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Korea University Guro Hospital</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This study is a single-blind, multicenter, randomized, controlled crossover trial. The App,
developed in South Korea, is an application that provides integrated interventions for stress
reduction for the general population. The App provides three contents based on MBSR, CBT, and
relaxation sounds that are known to be effective in stress reduction ("Meditation category",
"Cognitive approach", and "Relaxation Sound", respectively). Participants (n = 215) recruited
via medical practitioner referral will be randomized to App first group (fAPP) or a waitlist
crossover group (dAPP). Inclusion criteria are age 19-65; diagnosed with mild to moderate
major depressive disorders (Score of 7-24 on the Hamilton Rating Scale for Depression);
Stable medication for 28 days prior to study participation. The study was conducted over
eight weeks, the fAPP group used The App for the first four weeks and the dAPP group for the
next four weeks, and during all study periods, the participants received usual
pharmacological treatment. Primary outcome measures are the Depression Anxiety Stress
Scale-21. The analysis will use mixed-model repeated measures.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This study is a single-blind, multicenter, randomized, controlled crossover trial. All
subjects who met the inclusion and exclusion criteria will be randomly assigned to the App
first group (fAPP) and or a waitlist crossover group (dAPP). Due to the intervention's
nature, this will be a single-blind study in which the results will be assessed blindly but
participants will be aware of their group assignment. Participants assigned to fAPP group
will use the App initially for 28 consecutive days (T1). During T1, participants assigned to
the dAPP arm will maintain the usual treatment. After T1, during the next 28 consecutive days
(T2) without washout period, dAPP will use the APP, and fAPP will only maintain the usual
treatment. We assumed that there would be no carry-over effect as the App utilized in this
study is not a curative treatment but rather a tool for relieving stress in patients with
depression. Therefore, we decided to use a cross-over design without a wash-out period.

The three University Hospitals in the Republic of Korea participating in the study will
recruit depressive patients for applying the App. The Korea University Guro Hospital and
Korea University Anam Hospital are in the inner center of the Capital, and Korea University
Ansan Hospital is in Ansan city, outskirts of the capital area. Each hospital is a general
hospital, and the Korea University Guro Hospital will lead the ASMA-D study as. For patient
recruitment, 96 patients (48 interventions and 48 controls) in the Korea University Guro
Hospital and 60 patients (30 interventions and 30 controls) in each from Korea University
Anam Hospital and Korea University Ansan Hospital will be expected.

Screening will begin for those who are interested in advertisements posted in the
participating hospital among the depressive patients who visit the hospital. After interested
patients will contact the research team. the patients will be screened for eligibility
according to the above-described criteria by the psychiatrist. After eligibility is
confirmed, details of study will be explained to potential participant. Once participant
agrees to participate, Informed consent is obtained, patient is enrolled, and randomization
only occurs after enrollment.

Successful volunteers will be randomly assigned to the fAPP of dAPP. Randomization is
conducted using block randomization by each clinical center. To prevent bias towards one
treatment group, eight patients will be configured in blocks and will be randomly assigned to
groups fAPP and dAPP within each block. For consistent allocation, randomization will be done
using a pre-built program. This program is created by Korea University Guro Hospital to blind
the researcher from the information of assignment in advance.

Assessments are obtained clinician rating scale and self-rating scales during hospital
visits. Assessments conducted at the hospital visit were acquired at the baseline (V0) and
every two weeks (V1, V2, V3, and V4) during T1 and T2. The baseline assessments will be
collected when participants are enrolled and include sociodemographic and clinical
characteristics. All instruments have been translated to Korean with reliable psychometric
properties. The data collection process implanted in the evaluation module of the mobile App
will be activated through an ID issued after enrollment and randomization.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 15, 2022</start_date>
<completion_date type="Anticipated">December 31, 2023</completion_date>
<primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<intervention_model_description>This study is a single-blind, multicenter, randomized, controlled crossover trial.</intervention_model_description>
<primary_purpose>Supportive Care</primary_purpose>
<masking>Single (Outcomes Assessor)</masking>
<masking_description>Due to the intervention's nature, this will be a single-blind study in which the results will be assessed blindly, but participants will be aware of their group assignment. Most of the assessments are self-rated, and the clinician rating, HAM-D, will be assessed by an independent blinded evaluator not participating in the assignment and care providing.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Change in Depression, Anxiety and Stress Scale (DASS-21)</measure>
<time_frame>Baseline / 2 week / 4 week / 6 week / 8 week</time_frame>
<description>DASS-21 is s a self-report measure of anxiety, depression and stress levels used in diverse settings developed by Lovibond [47]. The Korean version of DASS-21 was developed by Eun-Hyun Lee in 2018 [48]. This version was tested in Korean speaking samples and indicated that the items had been adequately and appropriately translated and adapted. Korean version of DASS-21 was tested in 481 Korean adults, the result showed that the Cronbach's α was 0.93.</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in Perceived stress scale (PSS)</measure>
<time_frame>Baseline / 4 week / 8 week</time_frame>
<description>The perceived stress scale (PSS) is used to measure the extent to which respondents feel that their stress is unpredictable, uncontrollable and overwhelming (e.g. In the last month, how often have you felt you were unable to control the important things in your life?) [49]. The validated Korean short version of the perceived stress scale (K-PSS) was used in the present study [50]. The K-PSS is a 10-item self-report questionnaire using a five-point Likert scale ranging from 0 (never) to 4 (very often). Total scores range from 0 to 40, with higher scores indicative of greater perceived stress (Cronbach's α = 0.819).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Posttraumatic embitterment disorders scale (PTED)</measure>
<time_frame>Baseline / 4 week / 8 week</time_frame>
<description>Post Traumatic Embitterment Disorder Self-Rating Scale (PTED Scale) is designed to assess the features of embitterment reactions to negative life events [51]. Consisting of 19 items, the PTED Scale asked participants to rate their reactions to each negative life event during recent years using a 5-point scale ranging from 0 (not true at all) to 4 (extremely true). A mean total score of 2.5 was used as a cut-off score to detect the clinically significant reactive embitterment [51]. The Korean version of the PTED Scale was translated and validated with good internal consistency (Cronbach's α = 0.962) [52].</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in 9-item Patient Health Questionnaire (PHQ-9)</measure>
<time_frame>Baseline / 2 week / 4 week / 6 week / 8 week</time_frame>
<description>The 9-item version of the Patient Health Questionnaire (PHQ-9) was developed from the historical Primary Care Evaluation of Mental Disorders (PRIME-MD), which was shortened to maximize clinical usefulness [53]. This measure has been widely used in primary care settings for psychiatric purposes, with major depression diagnosed if 5 or more of the 9 symptoms have been present more than half the days of the past 2 weeks, one of these symptoms being either depressed mood or anhedonia. Each item is rated on a scale from 0 to 3, and the total score can range from 0 to 27. The total scores of ≥5, ≥10 and ≥15 represent mild, moderate and severe levels of depression severity [54]. The Korean version of the PHQ-9 was translated and validated with good internal consistency (Cronbach's α = 0.86) [55].</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Hamilton depression rating scale (HAM-D)</measure>
<time_frame>Baseline / 2 week / 4 week / 6 week / 8 week</time_frame>
<description>he Hamilton Depression Rating Scale (HAM-D) is an inventory of questions that is employed to detect and identify the intensity or severity of the signs and symptoms of depression in patients who have been diagnosed with clinical depression [56]. The 17-item version of the HAM-D is more commonly used than the 21-item version, which contains four additional items that measure symptoms related to depression, such as paranoia and obsession, rather than the severity of the depressive symptoms themselves. The Korean version of the HAM-D was translated and validated with good internal consistency (Cronbach's α = 0.76) [57].</description>
</secondary_outcome>
<secondary_outcome>
<measure>Intervention engagement</measure>
<time_frame>4 week for fAPP 8 week for dAPP</time_frame>
<description>Activities on the application such as number of visits, time in-between logins and number of usages of each category, will be assessed through track and change functionalities (log files). Data on how patients use online modules (frequency, duration, order, completion), how they rate them and to what extent they adhere, will also be obtained through usage statistics on the App online server. All patient information from the server will be encrypted via Hypertext Transfer Protocol Secure which ensures no external parties are able to view it during transfer. Data access from server is also authenticated by a passphrase which is supplied from the Study coordinator, ensuring only the research assistants will be able to request and review patient data.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">215</enrollment>
<condition>Major Depressive Disorder</condition>
<arm_group>
<arm_group_label>the App first group (fAPP)</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>Participants assigned to fAPP group will use the App initially for 28 consecutive days (T1). After T1, during the next 28 consecutive days (T2) without washout period, fAPP will only maintain the usual treatment.</description>
</arm_group>
<arm_group>
<arm_group_label>wait list crossover group (dAPP)</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>During T1, participants assigned to the dAPP arm will maintain the usual treatment. After T1, during the next 28 consecutive days (T2) without washout period, dAPP will use the APP.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>the App</intervention_name>
<description>The App provides content for mobile-based stress relief that can be used on most Android and iOS-based mobile devices. Content for stress relief consists of three modules; meditation, cognitive approach, and relaxation sounds. Additionally, the App includes the module for objective stress monitoring. The APP was originally designed and developed in Korean, but English, Chinese, and Japanese versions are also available. For use in the treatment environment, the manufacturer also provides a service that allows therapists to check their patients' application usage and their stress level measured by the stress monitoring module.</description>
<arm_group_label>the App first group (fAPP)</arm_group_label>
<arm_group_label>wait list crossover group (dAPP)</arm_group_label>
<other_name>Integrated mobile application for stress reduction</other_name>
<other_name>"inMind" (Demand, Republic of Korea, http://www.demand.co.kr)</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Adults between the ages of 19 and 65;

2. Diagnosed with mild to moderate major depressive disorders in an expert interview
evaluation according to the DSM-IV diagnostic criteria (Score of 7-24 on the Hamilton
Rating Scale for Depression [HAM-D]);

3. Stable medication for 28 days prior to study participation;

4. Informed consent and voluntary participation.

Exclusion Criteria:

1. Hard to use smart phone or unable to independently use Application;

2. Diagnosed with severe major depressive disorder in an expert interview evaluation
according to the DSM-5 diagnostic criteria (score of 25 or more on HAM-D);

3. Severe mental disorders (current or in the past), including Major depressive disorder
with psychotic features, bipolar affective disorder, personality disorder, obsessive
compulsive disorder, autism spectrum disorder, substance use disorder;

4. History of brain injury, epileptic seizures, intellectual disability, or cognitive
disorders;

5. History of severe physical disorders, including cancer, tuberculosis, severe
cardiovascular disease, etc.

6. Individuals participating in other cognitive behavioral therapy or activities related
to stress relief
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>19 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Changsu Han, MD, PhD</last_name>
<role>Study Chair</role>
<affiliation>Department of Psychiatry, Korea University Guro Hospital, Korea University College of Medicine</affiliation>
</overall_official>
<overall_official>
<last_name>Junhyung Kim, MD, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Department of Psychiatry, Korea University Guro Hospital, Korea University College of Medicine</affiliation>
</overall_official>
<overall_official>
<last_name>Cheolmin Shin, MD, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Department of Psychiatry, Korea University Ansan Hospital, Korea University College of Medicine</affiliation>
</overall_official>
<overall_official>
<last_name>Kyu-Man Han, MD, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Department of Psychiatry, Korea University Anam Hospital, Korea University College of Medicine</affiliation>
</overall_official>
<overall_contact>
<last_name>Junhyung Kim, MD, PhD</last_name>
<phone>10-9317-1776</phone>
<phone_ext>82</phone_ext>
<email>jhcabilover@gmail.com</email>
</overall_contact>
<location>
<facility>
<name>Department of Psychiatry, Korea University Guro Hospital</name>
<address>
<city>Seoul</city>
<state>Guro Gu</state>
<zip>08308</zip>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Junhyung Kim, MD, PhD</last_name>
<phone>010-9317-1776</phone>
<email>jhcabilover@gmail.com</email>
</contact>
</location>
<location_countries>
<country>Korea, Republic of</country>
</location_countries>
<verification_date>November 2022</verification_date>
<study_first_submitted>March 23, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>November 9, 2022</last_update_submitted>
<last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">November 14, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Korea University Guro Hospital</investigator_affiliation>
<investigator_full_name>Han, Chang Su</investigator_full_name>
<investigator_title>Professor</investigator_title>
</responsible_party>
<keyword>Stress</keyword>
<keyword>Major depressive disorders</keyword>
<keyword>Mobile health</keyword>
<keyword>Mindfulness-based intervention</keyword>
<keyword>Cognitive-behavior therapy</keyword>
<keyword>Relaxation Therapy</keyword>
<keyword>Cost-effectiveness</keyword>
<keyword>Randomised controlled trial</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Depressive Disorder</mesh_term>
<mesh_term>Depression</mesh_term>
<mesh_term>Depressive Disorder, Major</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>The datasets used and analyzed during the current study will be available from the corresponding author on reasonable request.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
<ipd_time_frame>The time when all research processes have been completed and the relevant results are published.</ipd_time_frame>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study is a single-blind, multicenter, randomized, controlled crossover trial. The App,
developed in South Korea, is an application that provides integrated interventions for stress
reduction for the general population. The App provides three contents based on MBSR, CBT, and
relaxation sounds that are known to be effective in stress reduction ("Meditation category",
"Cognitive approach", and "Relaxation Sound", respectively). Participants (n = 215) recruited
via medical practitioner referral will be randomized to App first group (fAPP) or a waitlist
crossover group (dAPP). Inclusion criteria are age 19-65; diagnosed with mild to moderate
major depressive disorders (Score of 7-24 on the Hamilton Rating Scale for Depression);
Stable medication for 28 days prior to study participation. The study was conducted over
eight weeks, the fAPP group used The App for the first four weeks and the dAPP group for the
next four weeks, and during all study periods, the participants received usual
pharmacological treatment. Primary outcome measures are the Depression Anxiety Stress
Scale-21. The analysis will use mixed-model repeated measures.
This study is a single-blind, multicenter, randomized, controlled crossover trial. All
subjects who met the inclusion and exclusion criteria will be randomly assigned to the App
first group (fAPP) and or a waitlist crossover group (dAPP). Due to the intervention's
nature, this will be a single-blind study in which the results will be assessed blindly but
participants will be aware of their group assignment. Participants assigned to fAPP group
will use the App initially for 28 consecutive days (T1). During T1, participants assigned to
the dAPP arm will maintain the usual treatment. After T1, during the next 28 consecutive days
(T2) without washout period, dAPP will use the APP, and fAPP will only maintain the usual
treatment. We assumed that there would be no carry-over effect as the App utilized in this
study is not a curative treatment but rather a tool for relieving stress in patients with
depression. Therefore, we decided to use a cross-over design without a wash-out period.
The three University Hospitals in the Republic of Korea participating in the study will
recruit depressive patients for applying the App. The Korea University Guro Hospital and
Korea University Anam Hospital are in the inner center of the Capital, and Korea University
Ansan Hospital is in Ansan city, outskirts of the capital area. Each hospital is a general
hospital, and the Korea University Guro Hospital will lead the ASMA-D study as. For patient
recruitment, 96 patients (48 interventions and 48 controls) in the Korea University Guro
Hospital and 60 patients (30 interventions and 30 controls) in each from Korea University
Anam Hospital and Korea University Ansan Hospital will be expected.
Screening will begin for those who are interested in advertisements posted in the
participating hospital among the depressive patients who visit the hospital. After interested
patients will contact the research team. the patients will be screened for eligibility
according to the above-described criteria by the psychiatrist. After eligibility is
confirmed, details of study will be explained to potential participant. Once participant
agrees to participate, Informed consent is obtained, patient is enrolled, and randomization
only occurs after enrollment.
Successful volunteers will be randomly assigned to the fAPP of dAPP. Randomization is
conducted using block randomization by each clinical center. To prevent bias towards one
treatment group, eight patients will be configured in blocks and will be randomly assigned to
groups fAPP and dAPP within each block. For consistent allocation, randomization will be done
using a pre-built program. This program is created by Korea University Guro Hospital to blind
the researcher from the information of assignment in advance.
Assessments are obtained clinician rating scale and self-rating scales during hospital
visits. Assessments conducted at the hospital visit were acquired at the baseline (V0) and
every two weeks (V1, V2, V3, and V4) during T1 and T2. The baseline assessments will be
collected when participants are enrolled and include sociodemographic and clinical
characteristics. All instruments have been translated to Korean with reliable psychometric
properties. The data collection process implanted in the evaluation module of the mobile App
will be activated through an ID issued after enrollment and randomization.
Inclusion Criteria:
1. Adults between the ages of 19 and 65;
2. Diagnosed with mild to moderate major depressive disorders in an expert interview
evaluation according to the DSM-IV diagnostic criteria (Score of 7-24 on the Hamilton
Rating Scale for Depression [HAM-D]);
3. Stable medication for 28 days prior to study participation;
4. Informed consent and voluntary participation.
Exclusion Criteria:
1. Hard to use smart phone or unable to independently use Application;
2. Diagnosed with severe major depressive disorder in an expert interview evaluation
according to the DSM-5 diagnostic criteria (score of 25 or more on HAM-D);
3. Severe mental disorders (current or in the past), including Major depressive disorder
with psychotic features, bipolar affective disorder, personality disorder, obsessive
compulsive disorder, autism spectrum disorder, substance use disorder;
4. History of brain injury, epileptic seizures, intellectual disability, or cognitive
disorders;
5. History of severe physical disorders, including cancer, tuberculosis, severe
cardiovascular disease, etc.
6. Individuals participating in other cognitive behavioral therapy or activities related
to stress relief
|
NCT0531xxxx/NCT05312216.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/NCT05312216</url>
</required_header>
<id_info>
<org_study_id>HCCLEPL1</org_study_id>
<nct_id>NCT05312216</nct_id>
</id_info>
<brief_title>Durvalumab Plus Lenvatinib as First-line Treatment for Unresectable Hepatocellular Carcinoma</brief_title>
<official_title>A Study on the Efficiency and Safety of Durvalumab Plus Lenvatinib as First-line Treatment for Unresectable Hepatocellular Carcinoma: an Open, Single Arm, Phase II Clinical Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Zhejiang University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Zhejiang University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This is a phase II, open-label study to evaluate the efficacy and safety of Durvalumab plus
Lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the
efficacy and safety of Durvalumab plus Lenvatinib as first-line treatment in patients with
unresectable hepatocellular carcinoma. The primary endpoint is the objective response rate
(ORR) according to RECIST v1.1. Safety evaluation will be taken according to CTCAE v5.0.
Disease control rate (DCR), duration of response (DOR), progression-free survival (PFS) and
overall survival (OS) are secondary endpoints. Multi-omics analysis will be performed to
identify potential biomarkers for treatment response.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 2023</start_date>
<completion_date type="Anticipated">June 2024</completion_date>
<primary_completion_date type="Anticipated">March 2024</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Objective response rate (ORR)</measure>
<time_frame>up o one year</time_frame>
<description>The proportion of patients who had tumor response evaluated as CR or PR according to RECIST v1.1 during study.</description>
</primary_outcome>
<secondary_outcome>
<measure>Disease control rate (DCR)</measure>
<time_frame>up to one year</time_frame>
<description>The proportion of patients who had tumor response evaluated as CR or PR or SD according to RECIST v1.1 during study.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of response (DOR)</measure>
<time_frame>up to one year</time_frame>
<description>The duration from the first assessment of CR or PR to the first assessment of PD or death of any cause.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Progression-free survival (PFS)</measure>
<time_frame>up to one year</time_frame>
<description>The duration from the date of initial treatment to the date of disease progression (defined by RECIST v1.1) or death due to any cause.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Overall survival (OS)</measure>
<time_frame>up to two years</time_frame>
<description>The duration from the date of initial treatment to the date of death due to any cause.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Adverse events (AEs)</measure>
<time_frame>up to two years</time_frame>
<description>Any adverse events (including type, frequency and severity ) related with treatment drugs according to CTCAE v5.0.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">25</enrollment>
<condition>Hepatocellular Carcinoma</condition>
<arm_group>
<arm_group_label>Durvalumab plus Lenvatinib</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Durvalumab is a human IgG1 κ monoclonal antibody that inhibits binding of PD-L1 to its receptors PD-1 and CD80.
Lenvatinib is a multi- kinase inhibitor of VEGF receptors 1 to 3, FGF receptors 1 to 4, PDGFRa, RET, and KIT.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Durvalumab plus Lenvatinib</intervention_name>
<description>Durvalumab: 1500mg, iv.drip, Q4w Lenvatinib: 8mg, QD (body weight < 60kg) or 12mg, QD (body weight ≥ 60kg)
Number of cycle: until subjects withdrawing the informed consent OR progressive disease OR developing unacceptable toxicity events</description>
<arm_group_label>Durvalumab plus Lenvatinib</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Subjects volunteer to participate in the study and sign the informed consent before
enrollment.

- 18-80 years of age.

- ECOG score of 0-1.

- Primary liver cancer with a pathological diagnosis of hepatocellular carcinoma.

- Child-Pugh grade A (5-6 points).

- BCLC C stage or BCLC B stage not suitable/refused for locoreginal treatments.

- Tumor volume ≤ 50% of the total liver volume.

- Without prior systemic therapy and unwilling to receive standard systemic therapy or
unsuitable for standard systemic therapy.

- At least one measurable lesion as defined by RECIST v1.1 criteria.

- Patients infected with hepatitis virus should receive antiviral therapy regularly.

- No history of drug allergy.

- Function of vital organs in accordance with the following requirements (no blood
components, cell growth factors and other corrective therapeutic agents are allowed
within 14 days prior to enrolment): Absolute neutrophil count ≥ 1.5 x 10^9/L;
Platelets ≥ 80 x 10^9/L; Haemoglobin ≥ 90 g/L; Serum albumin ≥ 35 g/L; Thyrotropin
(TSH) ≤ 1×ULN (if abnormal, FT3 and FT4 levels should be examined at the same time, if
FT3 and FT4 levels are normal, enrollment is allowed); Serum bilirubin ≤ 1.5 x ULN
(within 7 days prior to first dose); ALT and AST ≤ 5 x ULN (within 7 days prior to
first dose); International normalised ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5
x ULN; Serum creatinine ≤ 1.5 x ULN.

- Female patients who are non-surgically sterilised or of childbearing age are required
to use contraception (e.g. IUD, pill or condom) during and for 3 months after the end
of the treatment; female patients of childbearing age who are non-surgically
sterilised must have a negative serum or urine HCG test within 72h prior to study
entry; and must be non-lactating; male patients whose partners are women of
childbearing age should be tested during the trial and for 3 months after the last
dose. Male patients whose partners are women of childbearing age should use an
effective method of contraception during the trial and for 3 months after the last
dose.

Exclusion Criteria:

- Patients with any active autoimmune disease or history of autoimmune disease (e.g. the
following but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis,
enterocolitis, autoimmune hepatitis, pituitary inflammation, vasculitis, nephritis,
hyperthyroidism, vitiligo. Patients with complete remission of asthma in childhood who
do not require any intervention in adulthood may be included, but those require
bronchodilators cannot be included.

- Patients who are on immunosuppressive drugs, or require systemic hormone therapy for
immunosuppression purposes (doses >10 mg/day of prednisone or other isotonic hormones)
and who continue to use them within 2 weeks prior to enrollment.

- Receiving systemic therapy previously or other anti-cancer treatments (e.g.
radiofrequency ablation, interventional therapy, radiotherapy, etc.)

- Patients with a known history of central neural system metastases or hepatic
encephalopathy.

- Patients with clinically symptomatic ascites requiring puncture or drainage or those
who have received ascites drainage within the previous 3 months.

- Patients with hypertension that is not well controlled by antihypertensive medication
(systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).

- Having clinical cardiac symptoms or disease not well controlled, such as (1) NYHA
class 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction
within 1 year (4) clinically significant supraventricular or ventricular arrhythmias
requiring treatment or intervention (5) QTc > 450 ms (men); QTc > 470 ms (women).

- With abnormal coagulation (INR > 2.0, PT > 16s), bleeding tendency or on thrombolytic
or anticoagulant therapy. Prophylactic use of low-dose aspirin or low molecular
heparin is allowed.

- Patients had clinically significant bleeding symptoms or a clear bleeding tendency
within the 3 months prior to enrollment.

- Having arterial/venous thrombotic events within the 6 months prior to enrollment.

- With hereditary or acquired bleeding and thrombotic tendencies.

- With urine protein ≥ ++ and confirmed by 24-hour urine protein amount > 1.0 g.

- Patients with active infection, unexplained fever ≥ 38.5°C within 7 days prior to the
first dose, or baseline white blood cell count > 15 x 10^9/L.

- Patient with a congenital or acquired immune deficiency (e.g. HIV infection).

- Patient with other malignancies (except cured basal cell carcinoma of the skin and
carcinoma in situ of the cervix) within the previous 3 years or concurrently.

- Patients who have other factors that could affect the outcome of the study or force
the termination of the study, such as alcoholism, substance abuse, other serious
illnesses (including psychiatric illness) requiring comorbid treatment.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Tingbo Liang, PhD</last_name>
<role>Study Chair</role>
<affiliation>Zhejiang University</affiliation>
</overall_official>
<overall_contact>
<last_name>Tingbo Liang, PhD</last_name>
<phone>+86 19941463683</phone>
<email>liangtingbo@zju.edu.cn</email>
</overall_contact>
<location>
<facility>
<name>the First Affiliated Hospital, School of Medicine, Zhejiang University</name>
<address>
<city>Hangzhou</city>
<state>Zhejiang</state>
<zip>310003</zip>
<country>China</country>
</address>
</facility>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>January 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>January 25, 2023</last_update_submitted>
<last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">January 26, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Zhejiang University</investigator_affiliation>
<investigator_full_name>TingBo Liang</investigator_full_name>
<investigator_title>The chairman of the First Affiliated Hospital of Zhejiang</investigator_title>
</responsible_party>
<keyword>hepatocellular carcinoma</keyword>
<keyword>Durvalumab</keyword>
<keyword>Lenvatinib</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Carcinoma</mesh_term>
<mesh_term>Carcinoma, Hepatocellular</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Durvalumab</mesh_term>
<mesh_term>Lenvatinib</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This is a phase II, open-label study to evaluate the efficacy and safety of Durvalumab plus
Lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma.
This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the
efficacy and safety of Durvalumab plus Lenvatinib as first-line treatment in patients with
unresectable hepatocellular carcinoma. The primary endpoint is the objective response rate
(ORR) according to RECIST v1.1. Safety evaluation will be taken according to CTCAE v5.0.
Disease control rate (DCR), duration of response (DOR), progression-free survival (PFS) and
overall survival (OS) are secondary endpoints. Multi-omics analysis will be performed to
identify potential biomarkers for treatment response.
Inclusion Criteria:
- Subjects volunteer to participate in the study and sign the informed consent before
enrollment.
- 18-80 years of age.
- ECOG score of 0-1.
- Primary liver cancer with a pathological diagnosis of hepatocellular carcinoma.
- Child-Pugh grade A (5-6 points).
- BCLC C stage or BCLC B stage not suitable/refused for locoreginal treatments.
- Tumor volume ≤ 50% of the total liver volume.
- Without prior systemic therapy and unwilling to receive standard systemic therapy or
unsuitable for standard systemic therapy.
- At least one measurable lesion as defined by RECIST v1.1 criteria.
- Patients infected with hepatitis virus should receive antiviral therapy regularly.
- No history of drug allergy.
- Function of vital organs in accordance with the following requirements (no blood
components, cell growth factors and other corrective therapeutic agents are allowed
within 14 days prior to enrolment): Absolute neutrophil count ≥ 1.5 x 10^9/L;
Platelets ≥ 80 x 10^9/L; Haemoglobin ≥ 90 g/L; Serum albumin ≥ 35 g/L; Thyrotropin
(TSH) ≤ 1×ULN (if abnormal, FT3 and FT4 levels should be examined at the same time, if
FT3 and FT4 levels are normal, enrollment is allowed); Serum bilirubin ≤ 1.5 x ULN
(within 7 days prior to first dose); ALT and AST ≤ 5 x ULN (within 7 days prior to
first dose); International normalised ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5
x ULN; Serum creatinine ≤ 1.5 x ULN.
- Female patients who are non-surgically sterilised or of childbearing age are required
to use contraception (e.g. IUD, pill or condom) during and for 3 months after the end
of the treatment; female patients of childbearing age who are non-surgically
sterilised must have a negative serum or urine HCG test within 72h prior to study
entry; and must be non-lactating; male patients whose partners are women of
childbearing age should be tested during the trial and for 3 months after the last
dose. Male patients whose partners are women of childbearing age should use an
effective method of contraception during the trial and for 3 months after the last
dose.
Exclusion Criteria:
- Patients with any active autoimmune disease or history of autoimmune disease (e.g. the
following but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis,
enterocolitis, autoimmune hepatitis, pituitary inflammation, vasculitis, nephritis,
hyperthyroidism, vitiligo. Patients with complete remission of asthma in childhood who
do not require any intervention in adulthood may be included, but those require
bronchodilators cannot be included.
- Patients who are on immunosuppressive drugs, or require systemic hormone therapy for
immunosuppression purposes (doses >10 mg/day of prednisone or other isotonic hormones)
and who continue to use them within 2 weeks prior to enrollment.
- Receiving systemic therapy previously or other anti-cancer treatments (e.g.
radiofrequency ablation, interventional therapy, radiotherapy, etc.)
- Patients with a known history of central neural system metastases or hepatic
encephalopathy.
- Patients with clinically symptomatic ascites requiring puncture or drainage or those
who have received ascites drainage within the previous 3 months.
- Patients with hypertension that is not well controlled by antihypertensive medication
(systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
- Having clinical cardiac symptoms or disease not well controlled, such as (1) NYHA
class 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction
within 1 year (4) clinically significant supraventricular or ventricular arrhythmias
requiring treatment or intervention (5) QTc > 450 ms (men); QTc > 470 ms (women).
- With abnormal coagulation (INR > 2.0, PT > 16s), bleeding tendency or on thrombolytic
or anticoagulant therapy. Prophylactic use of low-dose aspirin or low molecular
heparin is allowed.
- Patients had clinically significant bleeding symptoms or a clear bleeding tendency
within the 3 months prior to enrollment.
- Having arterial/venous thrombotic events within the 6 months prior to enrollment.
- With hereditary or acquired bleeding and thrombotic tendencies.
- With urine protein ≥ ++ and confirmed by 24-hour urine protein amount > 1.0 g.
- Patients with active infection, unexplained fever ≥ 38.5°C within 7 days prior to the
first dose, or baseline white blood cell count > 15 x 10^9/L.
- Patient with a congenital or acquired immune deficiency (e.g. HIV infection).
- Patient with other malignancies (except cured basal cell carcinoma of the skin and
carcinoma in situ of the cervix) within the previous 3 years or concurrently.
- Patients who have other factors that could affect the outcome of the study or force
the termination of the study, such as alcoholism, substance abuse, other serious
illnesses (including psychiatric illness) requiring comorbid treatment.
|
NCT0531xxxx/NCT05312229.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/NCT05312229</url>
</required_header>
<id_info>
<org_study_id>PIX 22-001</org_study_id>
<secondary_id>PII 21-285</secondary_id>
<nct_id>NCT05312229</nct_id>
</id_info>
<brief_title>Housing Transitions QUERI</brief_title>
<official_title>Implementing and Sustaining Critical Time Intervention (CTI) in Case Management Programs for Homeless-experienced Veterans (PII 21-285)</official_title>
<sponsors>
<lead_sponsor>
<agency>VA Office of Research and Development</agency>
<agency_class>U.S. Fed</agency_class>
</lead_sponsor>
<collaborator>
<agency>University of California, Los Angeles</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Center for the Advancement of Critical Time Intervention</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of Southern California</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>VA Office of Research and Development</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
The VA Grant and Per Diem (GPD) case management aftercare program provides six months of case
management for homeless-experienced Veterans undergoing housing transitions. This Partnered
Implementation Initiative (PII) proposes to implement and evaluate Critical Time Intervention
(CTI)-an evidence-based, structured, and time-limited case management practice-in 32 GPD case
management aftercare sites across the nation.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The VA Grant and Per Diem case management (GPD-CM) program provides six months of case
management for homeless-experienced Veterans (HEVs) undergoing housing transitions. At
present, no specific case management paradigm is required in the GPD-CM program, resulting in
practice variation across sites. This Partnered Implementation Initiative (PII) implements
Critical Time Intervention (CTI)-an evidence-based, structured, and time-limited case
management practice-at 32 VA GPD-CM sites. The investigators will use the Replicating
Effective Programs (REP) implementation bundle to support CTI implementation at all 32 sites.
Half of these sites will also receive 9 months of external facilitation (enhanced REP) as
additional support for CTI implementation. In a type 3 hybrid trial, the investigators will
use mixed methods to examine the impacts of REP versus enhanced REP. Using trial data, the
investigators will develop a business case analysis and implementation playbook for the
investigators' program partners to support continued CTI spread and sustainment in the GPD-CM
program.
</textblock>
</detailed_description>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Actual">October 1, 2021</start_date>
<completion_date type="Anticipated">September 30, 2025</completion_date>
<primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>The investigators are implementing Critical Time Intervention (CTI), an evidence-based, time limited case management practice for individuals experiencing homelessness. The investigators will be randomizing sites receiving CTI into one of two levels of implementation support (low vs. high intensity support).</intervention_model_description>
<primary_purpose>Other</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Fidelity to CTI</measure>
<time_frame>12 months after implementation start</time_frame>
<description>% of Sites with adequate fidelity to CTI at 12 months, as measured by the CTI fidelity scale</description>
</primary_outcome>
<primary_outcome>
<measure>Sustainment of CTI</measure>
<time_frame>18 months after implementation start</time_frame>
<description>% of Sites with adequate fidelity to CTI at 18 months, as measured by the CTI fidelity scale</description>
</primary_outcome>
<primary_outcome>
<measure>Dollars spent delivering CTI at each site</measure>
<time_frame>Between 6 and 18 months after implementation start</time_frame>
<description>Case manager salary and benefits</description>
</primary_outcome>
<secondary_outcome>
<measure>Housing stability</measure>
<time_frame>Between 6 and 18 months after implementation start</time_frame>
<description>Days between entry into the GPD case management program and indicator of housing instability</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cost of CTI as Implemented</measure>
<time_frame>Between 6 and 18 months after implementation start</time_frame>
<description>Mean monthly cost of CTI case management per GPD case management Veteran served, compared to the mean monthly cost in the non-CTI GPD case management programs.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Hospitalization rates</measure>
<time_frame>Between 6 and 18 months after implementation start</time_frame>
<description>Number of days between entry into the GPD case management program and hospitalization, number of hospitalizations, number of bed days</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cost of Implementation Strategies</measure>
<time_frame>Through study completion, 4 years</time_frame>
<description>Dollars spent on REP versus enhanced REP</description>
</secondary_outcome>
<secondary_outcome>
<measure>Return on Investment (ROI) of CTI</measure>
<time_frame>6-, 12-, and 18-months after GPD case management program enrollment</time_frame>
<description>Dollars saved via improved housing stability and decreased hospitalizations among patients engaged in CTI versus control participants</description>
</secondary_outcome>
<secondary_outcome>
<measure>Outpatient service use</measure>
<time_frame>Between 6 and 18 months after implementation start</time_frame>
<description>Number of outpatient appointments</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">64</enrollment>
<condition>Homelessness</condition>
<arm_group>
<arm_group_label>Replicating Effective Programs (REP)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>A stakeholder-informed training and technical assistance implementation strategy</description>
</arm_group>
<arm_group>
<arm_group_label>REP + External Facilitation (Enhanced REP)</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>REP plus site specific weekly facilitation to support CTI implementation.</description>
</arm_group>
<arm_group>
<arm_group_label>Control Group</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>No CTI implementation</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Critical Time Intervention</intervention_name>
<description>An evidence-based, structured, and time-limited case management practice</description>
<arm_group_label>REP + External Facilitation (Enhanced REP)</arm_group_label>
<arm_group_label>Replicating Effective Programs (REP)</arm_group_label>
<other_name>CTI</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>External Facilitation</intervention_name>
<description>Site-specific support to help sites develop tailored plans to implement CTI.</description>
<arm_group_label>REP + External Facilitation (Enhanced REP)</arm_group_label>
<other_name>Coaching</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Replicating Effective Programs</intervention_name>
<description>A stakeholder-informed training and technical assistance implementation strategy</description>
<arm_group_label>REP + External Facilitation (Enhanced REP)</arm_group_label>
<arm_group_label>Replicating Effective Programs (REP)</arm_group_label>
<other_name>REP</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Grant and Per Diem (GPD) case management aftercare grantees in 7 Veterans Integrated
Service Networks (VISN), all of whom provide 6-months of case management to Veterans
who have experienced homelessness.

Exclusion Criteria:

- None
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Sonya Emi Gabrielian, MD MPH</last_name>
<role>Principal Investigator</role>
<affiliation>VA Greater Los Angeles Healthcare System, West Los Angeles, CA</affiliation>
</overall_official>
<location>
<facility>
<name>VA Greater Los Angeles Healthcare System, West Los Angeles, CA</name>
<address>
<city>West Los Angeles</city>
<state>California</state>
<zip>90073-1003</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>https://www.VACTItoolkit.com</url>
<description>Resources for VA Grant and Per Diem (GPD) case management aftercare grantee sites to implement and sustain Critical Time Intervention (CTI) at their sites.</description>
</link>
<verification_date>March 2023</verification_date>
<study_first_submitted>March 10, 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>March 7, 2023</last_update_submitted>
<last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 8, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Care Management</keyword>
<keyword>Homeless</keyword>
<keyword>Implementation</keyword>
<keyword>Mental Health Care</keyword>
<keyword>Quality Assurance, Improvement</keyword>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_info_type>Study Protocol</ipd_info_type>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The VA Grant and Per Diem (GPD) case management aftercare program provides six months of case
management for homeless-experienced Veterans undergoing housing transitions. This Partnered
Implementation Initiative (PII) proposes to implement and evaluate Critical Time Intervention
(CTI)-an evidence-based, structured, and time-limited case management practice-in 32 GPD case
management aftercare sites across the nation.
The VA Grant and Per Diem case management (GPD-CM) program provides six months of case
management for homeless-experienced Veterans (HEVs) undergoing housing transitions. At
present, no specific case management paradigm is required in the GPD-CM program, resulting in
practice variation across sites. This Partnered Implementation Initiative (PII) implements
Critical Time Intervention (CTI)-an evidence-based, structured, and time-limited case
management practice-at 32 VA GPD-CM sites. The investigators will use the Replicating
Effective Programs (REP) implementation bundle to support CTI implementation at all 32 sites.
Half of these sites will also receive 9 months of external facilitation (enhanced REP) as
additional support for CTI implementation. In a type 3 hybrid trial, the investigators will
use mixed methods to examine the impacts of REP versus enhanced REP. Using trial data, the
investigators will develop a business case analysis and implementation playbook for the
investigators' program partners to support continued CTI spread and sustainment in the GPD-CM
program.
Inclusion Criteria:
- Grant and Per Diem (GPD) case management aftercare grantees in 7 Veterans Integrated
Service Networks (VISN), all of whom provide 6-months of case management to Veterans
who have experienced homelessness.
Exclusion Criteria:
- None
|
NCT0531xxxx/NCT05312242.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/NCT05312242</url>
</required_header>
<id_info>
<org_study_id>IRB00017475</org_study_id>
<nct_id>NCT05312242</nct_id>
</id_info>
<brief_title>Introduction of MMS to Antenatal Care in Bamako, Mali</brief_title>
<acronym>MAMAN</acronym>
<official_title>Introduction of Multiple Micronutrient Supplementation to Antenatal Care in Bamako, Mali</official_title>
<sponsors>
<lead_sponsor>
<agency>Johns Hopkins Bloomberg School of Public Health</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Jhpiego</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Bill and Melinda Gates Foundation</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Center for Vaccine Development - Mali</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Johns Hopkins Bloomberg School of Public Health</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The aim of this implementation research is to compare how different implementation strategies
influence the acceptability and adherence to antenatal supplement use in pregnancy.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
In the past several decades, the République du Mali (Mali) has achieved reductions in both
maternal mortality ratio and neonatal mortality rate. However, with an estimated 562 maternal
deaths per 100,000 live births and 65.8 infant deaths per 1,000 births, substantial changes
to maternal child health services will likely need to be implemented to realize the benefits
of universal healthcare for mothers and children and recover from the damaging impacts of
colonialism and conflict. The prevalence of low birth weight (<2.5 kg) among children whose
birth weights are known is estimated to be approximately 16%, but is likely underestimated.
The Malian decentralized health system places antenatal care (ANC) at Centre de Santé
Communautaire (CSCOM), a type of community-based health center. Approximately 36% of women in
Mali access ANC in the first trimester. Within the context of ANC, the current national
policy in Mali recommends that pregnant women take daily IFA supplements that contain 60 mg
of iron and 400 μg of folic acid starting at the first ANC contact and ending three months
after delivery. However, recent DHS data indicates that coverage of iron for pregnant women
for at least 90 days has remained sub-optimal, and may be decreasing, with only 28% of women
taking iron tablets for at least 90 days during their last pregnancy.

While IFA supplements have been a component of the "gold standard" of antenatal nutritional
care for decades, there is clear and consistent evidence from clinical trials that MMS
provide additional benefits over IFA in reducing adverse pregnancy outcomes. As compared to
IFA, MMS performs better in reducing the occurrence of small for gestational age (SGA), low
birth weight (LBW), preterm birth, and stillbirth. MMS performs even better than IFA with
respect to pregnancy outcomes and infant survival when used by pregnant women who are anemic
or underweight. Further, MMS has been demonstrated to be safe, cost-effective, and possible
to produce at price parity with IFA. In 2020, the WHO released updated ANC guidelines
recommending the use of MMS containing iron and folic acid in the context of rigorous
research, including implementation research (IR) to establish the impact of switching from
IFA supplements to MMS, including evaluation of uptake, acceptability, adherence, and
cost-effectiveness.

This implementation research study design will facilitate answering the following questions,
all of which were deemed to be of importance when considering the potential switch from
supplementation with iron and folic acid (IFA) to multiple micronutrient supplementation
(MMS) in the Malian context:

1. How does adherence to antenatal supplement use compare across study arms?

2. How does acceptability of antenatal supplements compare across study arms for both ANC
clients and midwives?

3. What level of acceptability is associated with a novel counseling package for MMS?

4. What is the cost-effectiveness of switching from IFA to MMS in the Malian context?
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 10, 2022</start_date>
<completion_date type="Actual">April 15, 2023</completion_date>
<primary_completion_date type="Actual">April 15, 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>To examine differences in acceptability and adherence across three different approaches to antenatal micronutrient supplementation within the context of ANC</intervention_model_description>
<primary_purpose>Health Services Research</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Adherence to the Antenatal Supplement Intervention (pill count)</measure>
<time_frame>4 weeks post-enrollment (ANC-2)</time_frame>
<description>Adherence assessment (pill count report)</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to the Antenatal Supplement Intervention (pill count)</measure>
<time_frame>ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2</time_frame>
<description>Adherence assessment (pill count report)</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to the Antenatal Supplement Intervention (pill count)</measure>
<time_frame>ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3</time_frame>
<description>Adherence assessment (pill count report)</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to the Antenatal Supplement Intervention (pill count)</measure>
<time_frame>ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4</time_frame>
<description>Adherence assessment (pill count report)</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to the Antenatal Supplement Intervention (pill count)</measure>
<time_frame>ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5</time_frame>
<description>Adherence assessment (pill count report)</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to the Antenatal Supplement Intervention (pill count)</measure>
<time_frame>ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6</time_frame>
<description>Adherence assessment (pill count report)</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to the Antenatal Supplement Intervention (pill count)</measure>
<time_frame>ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7</time_frame>
<description>Adherence assessment (pill count report)</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to the Antenatal Supplement Intervention (pill count)</measure>
<time_frame>Postnatal visit (6 weeks after delivery of infant)</time_frame>
<description>Adherence assessment (pill count report)</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to Antenatal Supplement Intervention (self report)</measure>
<time_frame>4 weeks post-enrollment (ANC-2)</time_frame>
<description>Interviewer administered retrospective self report</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to Antenatal Supplement Intervention (self report)</measure>
<time_frame>ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2</time_frame>
<description>Interviewer administered retrospective self report</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to Antenatal Supplement Intervention (self report)</measure>
<time_frame>ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3</time_frame>
<description>Interviewer administered retrospective self report</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to Antenatal Supplement Intervention (self report)</measure>
<time_frame>ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4</time_frame>
<description>Interviewer administered retrospective self report</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to Antenatal Supplement Intervention (self report)</measure>
<time_frame>ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5</time_frame>
<description>Interviewer administered retrospective self report</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to Antenatal Supplement Intervention (self report)</measure>
<time_frame>ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6</time_frame>
<description>Interviewer administered retrospective self report</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to Antenatal Supplement Intervention (self report)</measure>
<time_frame>ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7</time_frame>
<description>Interviewer administered retrospective self report</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to Antenatal Supplement Intervention (self report)</measure>
<time_frame>Postnatal visit (6 weeks after delivery of infant)</time_frame>
<description>Interviewer administered retrospective self report</description>
</primary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Supplement (i.e., pregnant women)</measure>
<time_frame>At 4 weeks post-enrollment (ANC-2)</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Supplement (i.e., pregnant women)</measure>
<time_frame>ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Supplement (i.e., pregnant women)</measure>
<time_frame>ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Supplement (i.e., pregnant women)</measure>
<time_frame>ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Supplement (i.e., pregnant women)</measure>
<time_frame>ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Supplement (i.e., pregnant women)</measure>
<time_frame>ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Supplement (i.e., pregnant women)</measure>
<time_frame>ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Supplement (i.e., pregnant women)</measure>
<time_frame>Postnatal visit (6 weeks after delivery of infant)</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Counseling (i.e., pregnant women)</measure>
<time_frame>At 4 weeks post-enrollment (ANC-2)</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Counseling (i.e., pregnant women)</measure>
<time_frame>ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable. Perceptions of midwives, pharmacists, and family members on counseling acceptability.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Counseling (i.e., pregnant women)</measure>
<time_frame>ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable. Perceptions of midwives, pharmacists, and family members on counseling acceptability.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Counseling (i.e., pregnant women)</measure>
<time_frame>ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable. Perceptions of midwives, pharmacists, and family members on counseling acceptability.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Counseling (i.e., pregnant women)</measure>
<time_frame>ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable. Perceptions of midwives, pharmacists, and family members on counseling acceptability.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Counseling (i.e., pregnant women)</measure>
<time_frame>ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable. Perceptions of midwives, pharmacists, and family members on counseling acceptability.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Counseling (i.e., pregnant women)</measure>
<time_frame>ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable. Perceptions of midwives, pharmacists, and family members on counseling acceptability.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Counseling (i.e., pregnant women)</measure>
<time_frame>Postnatal visit (6 weeks after delivery of infant)</time_frame>
<description>Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Supplement (i.e., midwives) - Global Acceptability Assessment Form (supplement) and Focus Group Discussion Guide</measure>
<time_frame>Within 2 months of study completion</time_frame>
<description>Proportion of midwives who find the antenatal supplement to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Supplement (i.e., pharmacists) - Global Acceptability Assessment Form (supplement) and Focus Group Discussion Guide</measure>
<time_frame>Within 2 months of study completion</time_frame>
<description>Proportion of pharmacists who find the antenatal supplement to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Supplement (i.e., family members) - Global Acceptability Assessment Form (supplement) and Focus Group Discussion Guide</measure>
<time_frame>Within 2 months of study completion</time_frame>
<description>Proportion of family members of ANC clients who find the antenatal supplement to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Counseling (i.e., midwives) - Global Acceptability Assessment Form (counseling) and Focus Group Discussion Guide</measure>
<time_frame>Within 2 months of study completion</time_frame>
<description>Proportion of midwives who find the antenatal counseling to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Counseling (i.e., pharmacists) - Global Acceptability Assessment Form (counseling) and Focus Group Discussion Guide</measure>
<time_frame>Within 2 months of study completion</time_frame>
<description>Proportion of pharmacists who find the antenatal counseling to be acceptable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Antenatal Counseling (i.e., family members) - Global Acceptability Assessment Form (counseling) and Focus Group Discussion Guide</measure>
<time_frame>Within 2 months of study completion</time_frame>
<description>Proportion of family members of ANC clients who find the antenatal counseling to be acceptable.</description>
</secondary_outcome>
<other_outcome>
<measure>Pregnancy Outcome - Maternal Hemoglobin (Exploratory outcomes)</measure>
<time_frame>Collected at delivery via health record review</time_frame>
<description>Maternal hemoglobin collected at delivery admission as reported on health record.</description>
</other_outcome>
<other_outcome>
<measure>Pregnancy Outcome - Gestational Age (Exploratory outcomes)</measure>
<time_frame>Collected at delivery via health record review</time_frame>
<description>Gestational age collected at delivery as reported on health record (best obstetric estimate)</description>
</other_outcome>
<other_outcome>
<measure>Birth outcome (Exploratory outcomes)</measure>
<time_frame>Collected at delivery via health record review</time_frame>
<description>Birthweight as reported on health record.</description>
</other_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Actual">486</enrollment>
<condition>Adherence, Medication</condition>
<arm_group>
<arm_group_label>IFA + Standard of Care</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Iron and Folic Acid (IFA) tablets dispensed 30 tablets at a time + standard of care [Represents standard of care comparison]</description>
</arm_group>
<arm_group>
<arm_group_label>MMS 30 + novel counseling</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>MMS dispensed 30 tablets at a time (MMS 30) with novel counseling</description>
</arm_group>
<arm_group>
<arm_group_label>MMS 180 + novel counseling</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>MMS dispensed 180 tablets at a time (MMS 30) with novel counseling</description>
</arm_group>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMS</intervention_name>
<description>Introduction of UNIMMAP MMS along with novel counseling strategies to increase acceptability and adherence to prenatal supplementation</description>
<arm_group_label>MMS 180 + novel counseling</arm_group_label>
<arm_group_label>MMS 30 + novel counseling</arm_group_label>
<other_name>novel counseling strategies</other_name>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Iron Folic Acid Supplement</intervention_name>
<description>Standard of Care Intervention</description>
<arm_group_label>IFA + Standard of Care</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
INCLUSION CRITERIA:

Sample Group 1: Pregnant Women

Potential supplementation trial participants must meet all the following criteria to be
eligible for inclusion in the study:

1. Age 18 years or older at screening.

2. At time of enrollment, able and willing to comply with all study requirements and
complete all study procedures.

3. Able and willing to provide verbal informed consent to be screened for and to take
part in the study.

4. Intention to stay within study catchment area for study duration and willingness to
give adequate locator information, as defined in site standard operating procedures
(SOPs).

5. Presenting for first ANC visit.

6. Pregnant, as confirmed by at least one of the following:

1. Uterine examination

2. Urine human chorionic gonadotropin (HCG)

3. Ultrasound

Sample Group 2: Midwives

Midwives who participated in delivery of the intervention will be recruited from the six
health center study sites. Inclusion criteria includes the provision of verbal informed
consent.

Sample Group 3: Pharmacists

Pharmacists who participated in delivery of the intervention will be recruited from the six
health center study sites. Inclusion criteria includes the provision of verbal informed
consent.

Sample Group 4: Family Members

Family members (e.g., male partners and mothers/mothers-in-law) will be recruited based on
participation of their female family member in the study protocol. Inclusion criteria
includes the provision of verbal informed consent.

EXCLUSION CRITERIA:

Sample Group 1: Pregnant Women

Potential supplementation trial participants who meet any of the following criteria will be
excluded from the study:

1. At time of enrollment, evidence of gestational age greater than 26 0/7 weeks, using
one or more of the following methods: a) Uterine examination, b) First day of last
normal menstrual period, and c) Ultrasound

2. As determined by the site investigator, any significant uncontrolled active or chronic
cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric,
endocrine, respiratory, immunologic disorder, or infectious disease. Note: examples of
uncontrolled conditions include but are not limited to the following: HIV not virally
suppressed, COVID-19 infection, symptomatic malaria infection.

3. Has any other condition that, in the opinion of the site investigator, would preclude
verbal informed consent, make study participation unsafe, complicate interpretation of
study outcome data, or otherwise interfere with achieving the study objectives.

4. At time of enrollment, any known condition requiring routine antenatal care to take
place at a location other than the study site CSCOM, e.g., Rh- negative status.

5. At enrollment, reports either of the following: a) Participation in any research study
involving drugs, vaccines, or medical devices during the current pregnancy, b)
Expected to participate in other research studies involving drugs, vaccines, or
medical devices for the duration of study participation

Sample Group 2: Midwives

Potential participants who do not provide verbal informed consent will not be included.

Sample Group 3: Pharmacists

Potential participants who do not provide verbal informed consent will not be included.

Sample Group 4: Family Members

Potential participants who do not provide verbal informed consent will not be included.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Kristen M Hurley, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
</overall_official>
<overall_official>
<last_name>Lisa Noguchi, PhD</last_name>
<role>Study Director</role>
<affiliation>Jhpiego</affiliation>
</overall_official>
<overall_official>
<last_name>Samba Sow, MD</last_name>
<role>Study Director</role>
<affiliation>Center for Vaccine Development - Mali</affiliation>
</overall_official>
<location>
<facility>
<name>JPIEGO Mali</name>
<address>
<city>Bamako</city>
<country>Mali</country>
</address>
</facility>
</location>
<location_countries>
<country>Mali</country>
</location_countries>
<reference>
<citation>Bourassa MW, Osendarp SJM, Adu-Afarwuah S, Ahmed S, Ajello C, Bergeron G, Black R, Christian P, Cousens S, de Pee S, Dewey KG, Arifeen SE, Engle-Stone R, Fleet A, Gernand AD, Hoddinott J, Klemm R, Kraemer K, Kupka R, McLean E, Moore SE, Neufeld LM, Persson LA, Rasmussen KM, Shankar AH, Smith E, Sudfeld CR, Udomkesmalee E, Vosti SA. Review of the evidence regarding the use of antenatal multiple micronutrient supplementation in low- and middle-income countries. Ann N Y Acad Sci. 2019 May;1444(1):6-21. doi: 10.1111/nyas.14121. Epub 2019 May 27.</citation>
<PMID>31134643</PMID>
</reference>
<reference>
<citation>Engle-Stone R, Kumordzie SM, Meinzen-Dick L, Vosti SA. Replacing iron-folic acid with multiple micronutrient supplements among pregnant women in Bangladesh and Burkina Faso: costs, impacts, and cost-effectiveness. Ann N Y Acad Sci. 2019 May;1444(1):35-51. doi: 10.1111/nyas.14132. Epub 2019 May 27.</citation>
<PMID>31134641</PMID>
</reference>
<reference>
<citation>Demographic Health Survey Mali 2018. https://link.edgepilot.com/s/58ae5387/4L1KP3pdmU6VyyFqGxSdsQ?u=https://dhsprogram.com/methodology/survey/survey-display-517.cfm</citation>
</reference>
<reference>
<citation>Institut National de la Statistique - INSTAT, Cellule de Planification et de Statistique Secteur Santé-Développement Social et Promotion de la Famille CPS/SS-DS-PF et ICF. 2019. Enquête Démographique et de Santé au Mali 2018.Bamako, Mali et Rockville, Maryland, USA : INSTAT, CPS/SS-DS-PF et ICF.</citation>
</reference>
<reference>
<citation>Keats EC, Haider BA, Tam E, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2019 Mar 14;3(3):CD004905. doi: 10.1002/14651858.CD004905.pub6.</citation>
<PMID>30873598</PMID>
</reference>
<reference>
<citation>Smith ER, Shankar AH, Wu LS, Aboud S, Adu-Afarwuah S, Ali H, Agustina R, Arifeen S, Ashorn P, Bhutta ZA, Christian P, Devakumar D, Dewey KG, Friis H, Gomo E, Gupta P, Kaestel P, Kolsteren P, Lanou H, Maleta K, Mamadoultaibou A, Msamanga G, Osrin D, Persson LA, Ramakrishnan U, Rivera JA, Rizvi A, Sachdev HPS, Urassa W, West KP Jr, Zagre N, Zeng L, Zhu Z, Fawzi WW, Sudfeld CR. Modifiers of the effect of maternal multiple micronutrient supplementation on stillbirth, birth outcomes, and infant mortality: a meta-analysis of individual patient data from 17 randomised trials in low-income and middle-income countries. Lancet Glob Health. 2017 Nov;5(11):e1090-e1100. doi: 10.1016/S2214-109X(17)30371-6.</citation>
<PMID>29025632</PMID>
</reference>
<reference>
<citation>WHO antenatal care recommendations for a positive pregnancy experience: Nutritional interventions update: Multiple micronutrient supplements during pregnancy [Internet]. Geneva: World Health Organization; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK560384/</citation>
<PMID>32783435</PMID>
</reference>
<reference>
<citation>United Nations Interagency Group for Child Mortality Estimation. Level and trend in child mortality report. 2017</citation>
</reference>
<reference>
<citation>Alkema L, Chou D, Hogan D, Zhang S, Moller AB, Gemmill A, Fat DM, Boerma T, Temmerman M, Mathers C, Say L; United Nations Maternal Mortality Estimation Inter-Agency Group collaborators and technical advisory group. Global, regional, and national levels and trends in maternal mortality between 1990 and 2015, with scenario-based projections to 2030: a systematic analysis by the UN Maternal Mortality Estimation Inter-Agency Group. Lancet. 2016 Jan 30;387(10017):462-74. doi: 10.1016/S0140-6736(15)00838-7. Epub 2015 Nov 13.</citation>
<PMID>26584737</PMID>
</reference>
<verification_date>February 2023</verification_date>
<study_first_submitted>January 27, 2022</study_first_submitted>
<study_first_submitted_qc>March 25, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>April 28, 2023</last_update_submitted>
<last_update_submitted_qc>April 28, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 1, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Multiple Micronutrient Supplements (MMS)</keyword>
<keyword>Adherence</keyword>
<keyword>Acceptability</keyword>
<keyword>Implementation Research</keyword>
<keyword>Antenatal Care</keyword>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Folic Acid</mesh_term>
<mesh_term>Micronutrients</mesh_term>
<mesh_term>Trace Elements</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>After data collection and analysis, Johns Hopkins Biostatistics Center (JHBC) and Johns Hopkins University (JHU) investigators will de-identify the data. The de-identified data will be shared with Research Triangle Institute (RTI) who is responsible for managing access to the shared data from all partners across the Gates ANC-PNC research collaborative, of which Jhpiego is a partner. This data will be collected and stored through the Synapse platform. The data will not be individually identifiable. The investigators will also adhere to JHBC's data sharing policies.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
<ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
<ipd_info_type>Analytic Code</ipd_info_type>
<ipd_time_frame>After data collection and analysis. The individual personal data (IPD) will be share after the data analysis for the described research questions (see above) is complete</ipd_time_frame>
<ipd_access_criteria>The data will be collected and stored through the Synapse platform. The data will not be individually identifiable. Investigators will also adhere to JHBC's data sharing policies.</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The aim of this implementation research is to compare how different implementation strategies
influence the acceptability and adherence to antenatal supplement use in pregnancy.
In the past several decades, the République du Mali (Mali) has achieved reductions in both
maternal mortality ratio and neonatal mortality rate. However, with an estimated 562 maternal
deaths per 100,000 live births and 65.8 infant deaths per 1,000 births, substantial changes
to maternal child health services will likely need to be implemented to realize the benefits
of universal healthcare for mothers and children and recover from the damaging impacts of
colonialism and conflict. The prevalence of low birth weight (<2.5 kg) among children whose
birth weights are known is estimated to be approximately 16%, but is likely underestimated.
The Malian decentralized health system places antenatal care (ANC) at Centre de Santé
Communautaire (CSCOM), a type of community-based health center. Approximately 36% of women in
Mali access ANC in the first trimester. Within the context of ANC, the current national
policy in Mali recommends that pregnant women take daily IFA supplements that contain 60 mg
of iron and 400 μg of folic acid starting at the first ANC contact and ending three months
after delivery. However, recent DHS data indicates that coverage of iron for pregnant women
for at least 90 days has remained sub-optimal, and may be decreasing, with only 28% of women
taking iron tablets for at least 90 days during their last pregnancy.
While IFA supplements have been a component of the "gold standard" of antenatal nutritional
care for decades, there is clear and consistent evidence from clinical trials that MMS
provide additional benefits over IFA in reducing adverse pregnancy outcomes. As compared to
IFA, MMS performs better in reducing the occurrence of small for gestational age (SGA), low
birth weight (LBW), preterm birth, and stillbirth. MMS performs even better than IFA with
respect to pregnancy outcomes and infant survival when used by pregnant women who are anemic
or underweight. Further, MMS has been demonstrated to be safe, cost-effective, and possible
to produce at price parity with IFA. In 2020, the WHO released updated ANC guidelines
recommending the use of MMS containing iron and folic acid in the context of rigorous
research, including implementation research (IR) to establish the impact of switching from
IFA supplements to MMS, including evaluation of uptake, acceptability, adherence, and
cost-effectiveness.
This implementation research study design will facilitate answering the following questions,
all of which were deemed to be of importance when considering the potential switch from
supplementation with iron and folic acid (IFA) to multiple micronutrient supplementation
(MMS) in the Malian context:
1. How does adherence to antenatal supplement use compare across study arms?
2. How does acceptability of antenatal supplements compare across study arms for both ANC
clients and midwives?
3. What level of acceptability is associated with a novel counseling package for MMS?
4. What is the cost-effectiveness of switching from IFA to MMS in the Malian context?
INCLUSION CRITERIA:
Sample Group 1: Pregnant Women
Potential supplementation trial participants must meet all the following criteria to be
eligible for inclusion in the study:
1. Age 18 years or older at screening.
2. At time of enrollment, able and willing to comply with all study requirements and
complete all study procedures.
3. Able and willing to provide verbal informed consent to be screened for and to take
part in the study.
4. Intention to stay within study catchment area for study duration and willingness to
give adequate locator information, as defined in site standard operating procedures
(SOPs).
5. Presenting for first ANC visit.
6. Pregnant, as confirmed by at least one of the following:
1. Uterine examination
2. Urine human chorionic gonadotropin (HCG)
3. Ultrasound
Sample Group 2: Midwives
Midwives who participated in delivery of the intervention will be recruited from the six
health center study sites. Inclusion criteria includes the provision of verbal informed
consent.
Sample Group 3: Pharmacists
Pharmacists who participated in delivery of the intervention will be recruited from the six
health center study sites. Inclusion criteria includes the provision of verbal informed
consent.
Sample Group 4: Family Members
Family members (e.g., male partners and mothers/mothers-in-law) will be recruited based on
participation of their female family member in the study protocol. Inclusion criteria
includes the provision of verbal informed consent.
EXCLUSION CRITERIA:
Sample Group 1: Pregnant Women
Potential supplementation trial participants who meet any of the following criteria will be
excluded from the study:
1. At time of enrollment, evidence of gestational age greater than 26 0/7 weeks, using
one or more of the following methods: a) Uterine examination, b) First day of last
normal menstrual period, and c) Ultrasound
2. As determined by the site investigator, any significant uncontrolled active or chronic
cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric,
endocrine, respiratory, immunologic disorder, or infectious disease. Note: examples of
uncontrolled conditions include but are not limited to the following: HIV not virally
suppressed, COVID-19 infection, symptomatic malaria infection.
3. Has any other condition that, in the opinion of the site investigator, would preclude
verbal informed consent, make study participation unsafe, complicate interpretation of
study outcome data, or otherwise interfere with achieving the study objectives.
4. At time of enrollment, any known condition requiring routine antenatal care to take
place at a location other than the study site CSCOM, e.g., Rh- negative status.
5. At enrollment, reports either of the following: a) Participation in any research study
involving drugs, vaccines, or medical devices during the current pregnancy, b)
Expected to participate in other research studies involving drugs, vaccines, or
medical devices for the duration of study participation
Sample Group 2: Midwives
Potential participants who do not provide verbal informed consent will not be included.
Sample Group 3: Pharmacists
Potential participants who do not provide verbal informed consent will not be included.
Sample Group 4: Family Members
Potential participants who do not provide verbal informed consent will not be included.
|
NCT0531xxxx/NCT05312255.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/NCT05312255</url>
</required_header>
<id_info>
<org_study_id>I 1680221</org_study_id>
<secondary_id>NCI-2022-01918</secondary_id>
<secondary_id>I 1680221</secondary_id>
<nct_id>NCT05312255</nct_id>
</id_info>
<brief_title>Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma</brief_title>
<official_title>Improving Host Factors in Patients With Monoclonal Gammopathies</official_title>
<sponsors>
<lead_sponsor>
<agency>Roswell Park Cancer Institute</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Roswell Park Cancer Institute</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
This clinical trial investigates the effect of non-chemotherapeutic interventions in patients
with multiple myeloma. Non-chemotherapeutic interventions such as physical activity and
nutritional interventions (e.g., modifications in diet) have been shown to positively affect
the immune system and improve overall quality of life. Another purpose of this study is for
researchers to learn how the addition of a beta-blocker (propranolol) to the standard
treatment regimen in patients with newly diagnosed multiple myeloma affects immune response
and quality of life. A study from the Mayo Clinic looked at multiple myeloma patients who
were on a beta-blocker while undergoing chemotherapy and found that the use of a beta-blocker
resulted in improved patient survival outcomes. Non-chemotherapeutic treatment options may
help decrease symptoms and improve quality of life for patients with multiple myeloma.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
PRIMARY OBJECTIVES:

I. To assess the impact of different lifestyle and low side effect interventions (exercise,
nutrition, stress effects reduction) on immune markers in patients with monoclonal plasma
cell disorders.

SECONDARY OBJECTIVES:

I. To assess the impact of different lifestyle and low side effect interventions (exercise,
nutrition) on bone turnover parameters, body composition, the microbiome and physical fitness
in patients with monoclonal plasma cell disorders.

II. To assess the impact of different lifestyle and low side effect interventions (exercise,
nutrition, stress effect reduction) on parameters of stress, mental health and quality of
life in patients with monoclonal plasma cell disorders.

OUTLINE: Patients are assigned to Module A, B or C.

MODULE A: Patients undergo strength training sessions twice weekly supervised by a licensed
and specialized personal trainer via the internet (e.g., remote access) for 6 months.
Patients also wear a FitBit device and receive prompts via email or text on a cell phone or
other electronic device to incrementally increase physical activity over 6 months.

MODULE B: Patients undergo intermittent fasting for 1 month. This consists of restricting all
eating to a consecutive 8-hour time period each day followed by 16 consecutive hours of not
eating.

MODULE C: Patients are assigned to group 1 (are not currently taking beta-blockers) or group
2 (current taking beta-blockers).

GROUP I: Patients receive propranolol orally (PO) twice daily (BID) for 3 months.

GROUP II: Patients continue receiving beta-blocker regimen as per standard of care (SOC) for
3 months.

After completion of the study interventions, patients in module A are followed every 3 months
for 1 year. Patients in module B are followed at 3 and 5 months. Patients in module C are
followed for 3 months.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 28, 2022</start_date>
<completion_date type="Anticipated">June 28, 2026</completion_date>
<primary_completion_date type="Anticipated">June 28, 2025</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>Changes in immune cell subsets</measure>
<time_frame>At baseline and at 1 year</time_frame>
<description>Will be assessed by flow cytometry, comparing levels before and after one of three lifestyle interventions (physical exercise, intermittent fasting, beta blocker therapy). Will use a linear mixed model. Since the form of the model is unknown a priori, the power calculations are based on comparing any two timepoints using a two-sided paired t-test. With n=100, we have 80% power (at alpha = 0.05/3) to detect a difference of at least 0.33 standard deviations (SD).</description>
</primary_outcome>
<secondary_outcome>
<measure>Changes in the gut microbiome</measure>
<time_frame>At 1 and 3 months</time_frame>
<description>Fecal samples will be collected and compared from group with physical exercise,compared to group doing intermittent fasting).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Comparison in bone markers</measure>
<time_frame>At 1 and 3 months</time_frame>
<description>Will be assessed from intermittent fasting serum samples compared to serum samples of those doing physical exercise.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in body composition</measure>
<time_frame>3 months</time_frame>
<description>Dexa (bone density scan) will be performed at 1 and 3 months</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in stress</measure>
<time_frame>At 1 and 3 months</time_frame>
<description>Significant differences among groups in the mean Perceived Stress Scale (PSS) score, which measures the stress severity perceived by the subjects in the last month. The scale is constituted by 10 items that are self-rated by the subject on a 0-4 Likert scale. The scale minimum total score is 0, the maximum is 40. Higher total scores indicate a worse outcome</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in anxiety</measure>
<time_frame>At 1 and 3 months</time_frame>
<description>As assessed by the Generalized Anxiety Disorder 7-item Scale</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in fatigue as assessed by EORTC-LQLQ-FA12</measure>
<time_frame>At 1 and 3 months</time_frame>
<description>12-item multidimensional fatigue questionnaire.The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). The range is 3. For the raw score, less points are considered to have a better outcome.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in functional status</measure>
<time_frame>At 1 and 3 months</time_frame>
<description>basic assessment of physical activity before diagnosis will be compared to one administered at follow up</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in nutritional behavior before and after intermittent fasting</measure>
<time_frame>Up to 5 months</time_frame>
<description>Will be modeled using a GEE logistic model. Rates of positive nutritional behavior will be compared beween time points.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in stress-related biomarkers</measure>
<time_frame>Up to 6 months</time_frame>
<description>Will be evaluated using a linear mixed model and will be used to compare mean levels between timepoints.</description>
</secondary_outcome>
<number_of_arms>4</number_of_arms>
<enrollment type="Anticipated">150</enrollment>
<condition>Plasma Cell Myeloma</condition>
<condition>Recurrent Plasma Cell Myeloma</condition>
<condition>Refractory Plasma Cell Myeloma</condition>
<condition>Smoldering Plasma Cell Myeloma</condition>
<arm_group>
<arm_group_label>Module A (strength training, behavioral intervention)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients undergo strength training sessions twice weekly supervised by a licensed and specialized personal trainer via the internet (e.g., remote access) for 6 months. Patients also wear a FitBit device and receive prompts via email or text on a cell phone or other electronic device to incrementally increase physical activity over 6 months.</description>
</arm_group>
<arm_group>
<arm_group_label>Module B (intermittent fasting)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients undergo intermittent fasting for 1 month. This consists of restricting all eating to a consecutive 8-hour time period each day followed by 16 consecutive hours of not eating.</description>
</arm_group>
<arm_group>
<arm_group_label>Module C Group I (propranolol)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients receive propranolol PO BID for 3 months.</description>
</arm_group>
<arm_group>
<arm_group_label>Module C Group II (propranolol)</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Patients continue receiving beta-blocker regimen as per SOC for 3 months.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Behavioral Intervention</intervention_name>
<description>Wear a FitBit device and receive prompts for 6 months</description>
<arm_group_label>Module A (strength training, behavioral intervention)</arm_group_label>
<other_name>Behavior Conditioning Therapy</other_name>
<other_name>Behavior Modification</other_name>
<other_name>Behavior or Life Style Modifications</other_name>
<other_name>Behavior Therapy</other_name>
<other_name>Behavioral Interventions</other_name>
<other_name>Behavioral Modification</other_name>
<other_name>Behavioral Therapy</other_name>
<other_name>Behavioral Treatment</other_name>
<other_name>Behavioral Treatments</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Beta-Adrenergic Antagonist</intervention_name>
<description>Receive beta-blocker regimen as per SOC</description>
<arm_group_label>Module C Group II (propranolol)</arm_group_label>
<other_name>Beta Blocker</other_name>
<other_name>Beta-Adrenergic Blocking Agent</other_name>
<other_name>Beta-Blockers</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Propranolol</intervention_name>
<description>Given PO</description>
<arm_group_label>Module C Group I (propranolol)</arm_group_label>
<other_name>1-[(1-Methylethyl)amino]-3-(1-naphthalenyloxy)-2-propanol</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Quality-of-Life Assessment</intervention_name>
<description>Ancillary studies</description>
<arm_group_label>Module A (strength training, behavioral intervention)</arm_group_label>
<arm_group_label>Module B (intermittent fasting)</arm_group_label>
<arm_group_label>Module C Group I (propranolol)</arm_group_label>
<arm_group_label>Module C Group II (propranolol)</arm_group_label>
<other_name>Quality of Life Assessment</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Questionnaire Administration</intervention_name>
<description>Ancillary studies</description>
<arm_group_label>Module A (strength training, behavioral intervention)</arm_group_label>
<arm_group_label>Module B (intermittent fasting)</arm_group_label>
<arm_group_label>Module C Group I (propranolol)</arm_group_label>
<arm_group_label>Module C Group II (propranolol)</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Resistance Training</intervention_name>
<description>Undergo strength training for 6 months</description>
<arm_group_label>Module A (strength training, behavioral intervention)</arm_group_label>
<other_name>Strength Training</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Short-Term Fasting</intervention_name>
<description>Participate in intermittent fasting</description>
<arm_group_label>Module B (intermittent fasting)</arm_group_label>
<other_name>Intermittent Fasting</other_name>
<other_name>Short-term Intermittent Fasting</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Age >= 18 years of age

- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of:

- Module A: ECOG 0 - 1

- Module B: ECOG 0 - 2

- Module C: ECOG 0 - 2

- Have a diagnosis of smoldering multiple myeloma or multiple myeloma

- Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would
put them in danger when participating in the study according to the physician's
discretion

- Are able to understand and follow assessment and intervention procedures

- Participant must understand the investigational nature of this study and sign an
Independent Ethics Committee/Institutional Review Board approved written informed
consent form prior to receiving any study related procedure

- MODULE A (PHYSICAL ACTIVITY): Participant has access to a personal computer or tablet
with camera, microphone, speakers and internet access

- MODULE B (NUTRITION): Not applicable

- MODULE C (BETA BLOCKER): Newly diagnosed patients with multiple myeloma necessitating
treatment and before initiation of systemic therapy

- MODULE C (BETA BLOCKER): Eligibility for autologous stem cell transplantation

- MODULE C (BETA BLOCKER): Bone marrow biopsy planned as standard of care at first
diagnosis and before stem cell collection (Flow Cytometry Standard of Care [SOC] -
III)

- MODULE C (BETA BLOCKER): Female participants of child-bearing potential must have a
negative pregnancy test at study entry and then agree to use adequate contraceptive
methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study
entry. Male patients with female partners of child-bearing potential should also use
adequate contraceptive methods (see above). Should a woman become pregnant or suspect
she is pregnant while she or her partner is participating in this study, she should
inform her treating physician immediately

Exclusion Criteria:

- Major comorbidities that would cause danger to the patient when participating in the
study and that would have a risk of progression if the patient took part in the study
(including, but not limited to): cardiac or pulmonary and infectious diseases (e.g.,
ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia) or, psychiatric illness/social situations that would
limit compliance with study requirements

- Unwilling or unable to follow protocol requirements

- Any condition which in the investigator's opinion deems the participant an unsuitable
candidate to take part in study intervention (comorbidities, myeloma symptoms,
treatment side effects)

- MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or
severely advanced instability of the musculo-skeletal system that is deemed to making
the patient unsafe to participate. This will be assessed by radiologist, a
neurosurgeon and/or an orthopedic surgeon, if applicable.

- MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or
severely advanced instability of the musculo-skeletal system

- MODULE A (PHYSICAL ACTIVITY): Acute bone instability as assessed by whole body
low-dose computed tomography and evaluated by an experienced surgeon

- MODULE B (NUTRITION): Clinical signs of malnutrition (body mass index [BMI] < 18)

- MODULE B (NUTRITION): Special diets (physician prescribed)

- MODULE B (NUTRITION): Diabetic treated with glucose-lowering medications and/or
insulin

- MODULE B (NUTRITION): Other reasons not to withhold food

- MODULE B (NUTRITION): Any condition which in the investigator's opinion deems the
participant an unsuitable candidate to limit food consumption

- MODULE C (BETA BLOCKER): Current use of a beta blocker (includes all non-selective and
beta-1 selective blockers) or, use of a beta-blocker within 3 months of study
enrollment

- MODULE C (BETA BLOCKER): Contraindications to the use of beta-blockers, e.g.; severe
sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree,
uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New
York Heart Association [NYHA] Grade III or IV), hypotension ( systolic blood pressure
< 100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD),
uncontrolled type I or type II diabetes mellitus (HbA1C > 8.5 or 12h fasting plasma
glucose > 160 mg/dL at screening), symptomatic peripheral arterial disease or
Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use
(Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and
amiodarone. Patients with pacemakers will be excluded

- MODULE C (BETA BLOCKER): Pregnant or nursing female participants, where pregnancy is
defined as the state of a female after conception and until the termination of
gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Jens Hillengass</last_name>
<role>Principal Investigator</role>
<affiliation>Roswell Park Cancer Institute</affiliation>
</overall_official>
<location>
<facility>
<name>Roswell Park Cancer Institute</name>
<address>
<city>Buffalo</city>
<state>New York</state>
<zip>14263</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jens Hillengass</last_name>
<phone>716-845-3863</phone>
<email>jens.hillengass@roswellpark.org</email>
</contact>
<investigator>
<last_name>Jens Hillengass</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 18, 2022</study_first_submitted>
<study_first_submitted_qc>March 28, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>February 27, 2023</last_update_submitted>
<last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 1, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Multiple Myeloma</mesh_term>
<mesh_term>Neoplasms, Plasma Cell</mesh_term>
<mesh_term>Smoldering Multiple Myeloma</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Propranolol</mesh_term>
<mesh_term>Adrenergic beta-Antagonists</mesh_term>
<mesh_term>Adrenergic Agents</mesh_term>
<mesh_term>Adrenergic Antagonists</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This clinical trial investigates the effect of non-chemotherapeutic interventions in patients
with multiple myeloma. Non-chemotherapeutic interventions such as physical activity and
nutritional interventions (e.g., modifications in diet) have been shown to positively affect
the immune system and improve overall quality of life. Another purpose of this study is for
researchers to learn how the addition of a beta-blocker (propranolol) to the standard
treatment regimen in patients with newly diagnosed multiple myeloma affects immune response
and quality of life. A study from the Mayo Clinic looked at multiple myeloma patients who
were on a beta-blocker while undergoing chemotherapy and found that the use of a beta-blocker
resulted in improved patient survival outcomes. Non-chemotherapeutic treatment options may
help decrease symptoms and improve quality of life for patients with multiple myeloma.
PRIMARY OBJECTIVES:
I. To assess the impact of different lifestyle and low side effect interventions (exercise,
nutrition, stress effects reduction) on immune markers in patients with monoclonal plasma
cell disorders.
SECONDARY OBJECTIVES:
I. To assess the impact of different lifestyle and low side effect interventions (exercise,
nutrition) on bone turnover parameters, body composition, the microbiome and physical fitness
in patients with monoclonal plasma cell disorders.
II. To assess the impact of different lifestyle and low side effect interventions (exercise,
nutrition, stress effect reduction) on parameters of stress, mental health and quality of
life in patients with monoclonal plasma cell disorders.
OUTLINE: Patients are assigned to Module A, B or C.
MODULE A: Patients undergo strength training sessions twice weekly supervised by a licensed
and specialized personal trainer via the internet (e.g., remote access) for 6 months.
Patients also wear a FitBit device and receive prompts via email or text on a cell phone or
other electronic device to incrementally increase physical activity over 6 months.
MODULE B: Patients undergo intermittent fasting for 1 month. This consists of restricting all
eating to a consecutive 8-hour time period each day followed by 16 consecutive hours of not
eating.
MODULE C: Patients are assigned to group 1 (are not currently taking beta-blockers) or group
2 (current taking beta-blockers).
GROUP I: Patients receive propranolol orally (PO) twice daily (BID) for 3 months.
GROUP II: Patients continue receiving beta-blocker regimen as per standard of care (SOC) for
3 months.
After completion of the study interventions, patients in module A are followed every 3 months
for 1 year. Patients in module B are followed at 3 and 5 months. Patients in module C are
followed for 3 months.
Inclusion Criteria:
- Age >= 18 years of age
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of:
- Module A: ECOG 0 - 1
- Module B: ECOG 0 - 2
- Module C: ECOG 0 - 2
- Have a diagnosis of smoldering multiple myeloma or multiple myeloma
- Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would
put them in danger when participating in the study according to the physician's
discretion
- Are able to understand and follow assessment and intervention procedures
- Participant must understand the investigational nature of this study and sign an
Independent Ethics Committee/Institutional Review Board approved written informed
consent form prior to receiving any study related procedure
- MODULE A (PHYSICAL ACTIVITY): Participant has access to a personal computer or tablet
with camera, microphone, speakers and internet access
- MODULE B (NUTRITION): Not applicable
- MODULE C (BETA BLOCKER): Newly diagnosed patients with multiple myeloma necessitating
treatment and before initiation of systemic therapy
- MODULE C (BETA BLOCKER): Eligibility for autologous stem cell transplantation
- MODULE C (BETA BLOCKER): Bone marrow biopsy planned as standard of care at first
diagnosis and before stem cell collection (Flow Cytometry Standard of Care [SOC] -
III)
- MODULE C (BETA BLOCKER): Female participants of child-bearing potential must have a
negative pregnancy test at study entry and then agree to use adequate contraceptive
methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study
entry. Male patients with female partners of child-bearing potential should also use
adequate contraceptive methods (see above). Should a woman become pregnant or suspect
she is pregnant while she or her partner is participating in this study, she should
inform her treating physician immediately
Exclusion Criteria:
- Major comorbidities that would cause danger to the patient when participating in the
study and that would have a risk of progression if the patient took part in the study
(including, but not limited to): cardiac or pulmonary and infectious diseases (e.g.,
ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia) or, psychiatric illness/social situations that would
limit compliance with study requirements
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable
candidate to take part in study intervention (comorbidities, myeloma symptoms,
treatment side effects)
- MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or
severely advanced instability of the musculo-skeletal system that is deemed to making
the patient unsafe to participate. This will be assessed by radiologist, a
neurosurgeon and/or an orthopedic surgeon, if applicable.
- MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or
severely advanced instability of the musculo-skeletal system
- MODULE A (PHYSICAL ACTIVITY): Acute bone instability as assessed by whole body
low-dose computed tomography and evaluated by an experienced surgeon
- MODULE B (NUTRITION): Clinical signs of malnutrition (body mass index [BMI] < 18)
- MODULE B (NUTRITION): Special diets (physician prescribed)
- MODULE B (NUTRITION): Diabetic treated with glucose-lowering medications and/or
insulin
- MODULE B (NUTRITION): Other reasons not to withhold food
- MODULE B (NUTRITION): Any condition which in the investigator's opinion deems the
participant an unsuitable candidate to limit food consumption
- MODULE C (BETA BLOCKER): Current use of a beta blocker (includes all non-selective and
beta-1 selective blockers) or, use of a beta-blocker within 3 months of study
enrollment
- MODULE C (BETA BLOCKER): Contraindications to the use of beta-blockers, e.g.; severe
sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree,
uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New
York Heart Association [NYHA] Grade III or IV), hypotension ( systolic blood pressure
< 100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD),
uncontrolled type I or type II diabetes mellitus (HbA1C > 8.5 or 12h fasting plasma
glucose > 160 mg/dL at screening), symptomatic peripheral arterial disease or
Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use
(Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and
amiodarone. Patients with pacemakers will be excluded
- MODULE C (BETA BLOCKER): Pregnant or nursing female participants, where pregnancy is
defined as the state of a female after conception and until the termination of
gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
|
NCT0531xxxx/NCT05312268.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/NCT05312268</url>
</required_header>
<id_info>
<org_study_id>2021-KY-097-001</org_study_id>
<nct_id>NCT05312268</nct_id>
</id_info>
<brief_title>Rasburicase Treatment in Chronic Gouty Arthritis</brief_title>
<official_title>Efficacy and Safety of Rasburicase in the Treatment of Chronic Gouty Arthritis: A Multicenter Randomized Controlled Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The study will establish efficacy and safety of rasburicase in chronic gouty arthritis
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The study hypothesis is that the proportion of patients who achieved the primary endpoint
after 12 weeks of treatment with rasburicase combined with oral urate-lowering therapy is
superior to 12 weeks of treatment with oral urate-lowering therapy.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 15, 2022</start_date>
<completion_date type="Anticipated">April 15, 2025</completion_date>
<primary_completion_date type="Anticipated">October 15, 2024</primary_completion_date>
<phase>Phase 4</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Monosodium urate crystal volume change evaluated by dual energy CT</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
<description>Dual energy CT at baseline, week 12 and week 24</description>
</primary_outcome>
<secondary_outcome>
<measure>Tophus volume change evaluated by physical examination</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>The percentage of patients who have at least one tophi disappeared</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>The percentage of patients who had achieved serum urate concentrations less than 300 μmol/L (5mg/dl) after 3 months of rasburicase treatment</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of gout flare</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Change of patient global assessment</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
<description>The patient global assessment is given as a single question, scored from 0-10, with higher numbers representing worse perceived disease activity or overall health.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of physician global assessment</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
<description>The physician global assessment is given as a single question, scored from 0-10, with higher numbers representing worse perceived disease activity or overall health.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of Visual Analog Scale (VAS) for Pain in gout flare</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
<description>Visual Analog for Pain consists of a horizontal line, usually 100mm in length. The left end of the line signifies no pain while the right end signifies the worst possible pain.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of global functional status</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
<description>The criteria are as follows: class I = able to perform usual activities of daily living (self-care, vocational, and avocational); class II = able to perform usual self-care and vocational activities, but limited in avocational activities; class III = able to perform usual self-care activities but limited in vocational and avocational activities; class IV = limited in ability to perform usual self-care, vocational, and avocational activities.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of Short Form 12 health survey score</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Change of Tophus Impact Questionnaire (TIQ)-20 score</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Adverse event</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Severe adverse event</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of patients who have positive anti-rasburicase antibodies</measure>
<time_frame>Baseline to week 12 and week 12 to week 24</time_frame>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">60</enrollment>
<condition>Chronic Gout</condition>
<arm_group>
<arm_group_label>Group A</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>Rasburicase treatment at week 1, 4 and 8 with stable dose oral urate-lowering therapy for 24 weeks.</description>
</arm_group>
<arm_group>
<arm_group_label>Group B</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>Rasburicase treatment at week 12, 16 and 20 with stable dose oral urate-lowering therapy for 24 weeks.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Rasburicase</intervention_name>
<description>Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.</description>
<arm_group_label>Group A</arm_group_label>
<arm_group_label>Group B</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Written informed consent must be obtained before any assessment is performed, able to
understand and comply with the requirements of the study;

- Male and female patients 18 to 70 years of age;

- Fulfill the ACR/EULAR 2015 gout classification criteria;

- Tophi detected by physical examination;

- Serum urate>300μmol/L (5mg/dl) after one-month maximum dose of urate-lowering therapy
(allopurinol 600mg/d or febuxostat 80mg/d in combination with benzbromarone 100mg/d)
unless intolerable OR no reduction in size of tophi after serum urate<300μmol/L
(5mg/dl) for six month;

Exclusion Criteria:

- Pregnant women, lactating women, and men or women who have recently prepared for
pregnancy;

- Abnormal liver function with AST, ALT, and GGT >3 times ULN;

- Blood WBC<4.0×10^9/L, and/or hemoglobin <90g/L, and/or platelets;<100×10^9/L; or other
hematologic disorders;

- eGFR<15 ml/min;

- Receive following medications: azathioprine, mercaptopurine, cyclosporine,
pyrazinamide, ethambutol and sulfamethoxazole

- Psychiatric disorders, history of alcoholism, drug or other substance abuse

- Immunodeficiency diseases, uncontrolled infection, etc;

- Sericosis, glucose-6-phosphate dehydrogenase activity deficiency

- Allergy to biological agents and chronic active urticaria.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Qianhua Li, M.D.&Ph.D</last_name>
<role>Principal Investigator</role>
<affiliation>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</affiliation>
</overall_official>
<overall_contact>
<last_name>Qianhua Li, M.D.&Ph.D</last_name>
<phone>862081332572</phone>
<email>liqianhua@mail.sysu.edu.cn</email>
</overall_contact>
<location>
<facility>
<name>Shunde Hospital of Southern Medical University</name>
<address>
<city>Foshan</city>
<state>Guangdong</state>
<country>China</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Bin Yang, M.D.&Ph.D</last_name>
<phone>2075722318000</phone>
</contact>
<investigator>
<last_name>Bin Liu, M.D.&Ph.D</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Sun Yat-sen Memorial Hospital, Sun Yat-sen University</name>
<address>
<city>Guangzhou</city>
<state>Guangdong</state>
<zip>510120</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Li Qianhua</last_name>
<phone>862081332572</phone>
<email>sumsliqianh@163.com</email>
</contact>
</location>
<location>
<facility>
<name>Panyu Central Hospital</name>
<address>
<city>Guangzhou</city>
<state>Guangdong</state>
<country>China</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Haijun Liu, M.D.&Ph.D</last_name>
<phone>862034858888</phone>
<email>kayjun0753@126.com</email>
</contact>
<investigator>
<last_name>Haijun Liu, M.D.&Ph.D</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Shenshan Medical Center</name>
<address>
<city>Shanwei</city>
<state>Guangdong</state>
<zip>516600</zip>
<country>China</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Yingqian Mo, M.D.&Ph.D</last_name>
<phone>866603863000</phone>
<email>moyingq@mail.sysu.edu.cn</email>
</contact>
<investigator>
<last_name>Yingqian Mo, M.D.&Ph.D</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>April 2023</verification_date>
<study_first_submitted>March 16, 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>May 8, 2023</last_update_submitted>
<last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 9, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Chronic gouty arthritis</keyword>
<keyword>Rasburicase</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Arthritis</mesh_term>
<mesh_term>Arthritis, Gouty</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Rasburicase</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The study will establish efficacy and safety of rasburicase in chronic gouty arthritis
The study hypothesis is that the proportion of patients who achieved the primary endpoint
after 12 weeks of treatment with rasburicase combined with oral urate-lowering therapy is
superior to 12 weeks of treatment with oral urate-lowering therapy.
Inclusion Criteria:
- Written informed consent must be obtained before any assessment is performed, able to
understand and comply with the requirements of the study;
- Male and female patients 18 to 70 years of age;
- Fulfill the ACR/EULAR 2015 gout classification criteria;
- Tophi detected by physical examination;
- Serum urate>300μmol/L (5mg/dl) after one-month maximum dose of urate-lowering therapy
(allopurinol 600mg/d or febuxostat 80mg/d in combination with benzbromarone 100mg/d)
unless intolerable OR no reduction in size of tophi after serum urate<300μmol/L
(5mg/dl) for six month;
Exclusion Criteria:
- Pregnant women, lactating women, and men or women who have recently prepared for
pregnancy;
- Abnormal liver function with AST, ALT, and GGT >3 times ULN;
- Blood WBC<4.0×10^9/L, and/or hemoglobin <90g/L, and/or platelets;<100×10^9/L; or other
hematologic disorders;
- eGFR<15 ml/min;
- Receive following medications: azathioprine, mercaptopurine, cyclosporine,
pyrazinamide, ethambutol and sulfamethoxazole
- Psychiatric disorders, history of alcoholism, drug or other substance abuse
- Immunodeficiency diseases, uncontrolled infection, etc;
- Sericosis, glucose-6-phosphate dehydrogenase activity deficiency
- Allergy to biological agents and chronic active urticaria.
|
NCT0531xxxx/NCT05312281.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/NCT05312281</url>
</required_header>
<id_info>
<org_study_id>GBH-O1</org_study_id>
<nct_id>NCT05312281</nct_id>
</id_info>
<brief_title>Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis.</brief_title>
<acronym>SURGIMMO</acronym>
<official_title>Prospective Randomised Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis. With and Without Immobilisation in an Orthosis</official_title>
<sponsors>
<lead_sponsor>
<agency>SRH Gesundheitszentrum Bad Herrenalb</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>SRH Gesundheitszentrum Bad Herrenalb</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The aim of the study is to assess the benefit of wearing a lumbar orthosis after surgery for
spinal stenosis. It will be evaluated if a post-surgery immobilization for 6 weeks with a
lumbar orthosis reduces early recurrence, increases walking distance, decreases significantly
faster pain and pain medication after surgery
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Spinal stenosis and orthoses The study situation in this regard is very poor, high-quality
level 1 studies are not available.

A study by Prateepavanich et al. from 2001 shows advantages in the therapy with lumbar
orthoses in neurogenic spinal claudication in the context of conservative therapy (9).
Regarding postoperative prescription, expert opinions have long diverged (10). Nevertheless,
in a survey of North American spine surgeons, over 60% reported prescribing an orthosis
postoperatively (11).

2 Aim of the study

The aim of this study is to show that patients after surgical decompression for lumbar spinal
stenosis and patients after surgical sequestrectomy benefit from temporary postoperative
immobilization using a lumbar orthosis.

To show that postoperative therapy with a lumbar orthosis prolongs walking distance and
reduces early recurrence.

It will be shown that postoperative pain decreases significantly faster and thus pain
medication can be reduced faster early postoperatively.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Anticipated">June 28, 2022</start_date>
<completion_date type="Anticipated">December 1, 2025</completion_date>
<primary_completion_date type="Anticipated">December 1, 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Care Provider)</masking>
</study_design_info>
<primary_outcome>
<measure>Recurrence rate or reherniation/restenosis by means of MRI results</measure>
<time_frame>at 104 weeks</time_frame>
<description>symptomatic reduction of Walking distance</description>
</primary_outcome>
<secondary_outcome>
<measure>Pain and Disability Index</measure>
<time_frame>At 0, 2, 6, 12, 24, 52 and 104 weeks</time_frame>
<description>Visual analog scale (VAS) (visual analog scale of 0-10, 0 means no pain, 10 means extreme pain, we expect better outcome with Lombastab), Oswestry Disability Questionaire (german version scale of 0-50, 0 means no impairment at all, 50 means highest possible impairment, we expect lower impairment due to Lombastab)</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">100</enrollment>
<condition>Spinal Stenosis</condition>
<arm_group>
<arm_group_label>Control group "without lumbar belt"</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Control group "without lumbar belt"</description>
</arm_group>
<arm_group>
<arm_group_label>Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo</intervention_name>
<description>Wear for 6 weeks post-surgery</description>
<arm_group_label>Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Decompression with hemi-/ partial laminectomy, one. Laminectomy, and foraminotomy.
Flavectomy with undercutting due to uni-and multi-segmental spinal stenosis.

- Age 20-80 years

- Pre-operative walking distance at least 100m

- Consent form signed by the patient

Exclusion Criteria:

- Fusion surgery or recurrent surgery

- Tumors of the spine

- Cervical spinal stenosis or myelopathy

- Rheumatoid arthritis or similar autoimmune disease

- Infection - request for a pension

- Dyspnea due to heart failure with limited walking distance

- Peripheral Arterial Occlusive Disease (PAOD)-
</textblock>
</criteria>
<gender>All</gender>
<gender_based>Yes</gender_based>
<minimum_age>18 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Andreas Veihelmann, Prof</last_name>
<role>Study Chair</role>
<affiliation>SRH Ges.-Zentrum Bad Herrenalb</affiliation>
</overall_official>
<overall_contact>
<last_name>Uwe Spetzger, Prof</last_name>
<phone>+497219740</phone>
<email>uwe.spetzger@klinikum-karlsruhe.de</email>
</overall_contact>
<overall_contact_backup>
<last_name>Andreas Veihelmann, Prof</last_name>
<phone>+497083926</phone>
<phone_ext>4023</phone_ext>
<email>andreas.veihelmann@sportklinik-stuttgart.de</email>
</overall_contact_backup>
<location>
<facility>
<name>Klinikum Karlsruhe</name>
<address>
<city>Karlsruhe</city>
<zip>76133</zip>
<country>Germany</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Uwe Spetzger</last_name>
<phone>+497219740</phone>
<email>uwe.spetzger@klinikum-karlsruhe.de</email>
</contact>
<contact_backup>
<last_name>Andreas Veihelmann</last_name>
<phone>+497083926</phone>
<email>andreas.veihelmann@sportklinik-stuttgart.de</email>
</contact_backup>
</location>
<location_countries>
<country>Germany</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 10, 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>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>Spinal Stenosis</mesh_term>
<mesh_term>Constriction, Pathologic</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The aim of the study is to assess the benefit of wearing a lumbar orthosis after surgery for
spinal stenosis. It will be evaluated if a post-surgery immobilization for 6 weeks with a
lumbar orthosis reduces early recurrence, increases walking distance, decreases significantly
faster pain and pain medication after surgery
Spinal stenosis and orthoses The study situation in this regard is very poor, high-quality
level 1 studies are not available.
A study by Prateepavanich et al. from 2001 shows advantages in the therapy with lumbar
orthoses in neurogenic spinal claudication in the context of conservative therapy (9).
Regarding postoperative prescription, expert opinions have long diverged (10). Nevertheless,
in a survey of North American spine surgeons, over 60% reported prescribing an orthosis
postoperatively (11).
2 Aim of the study
The aim of this study is to show that patients after surgical decompression for lumbar spinal
stenosis and patients after surgical sequestrectomy benefit from temporary postoperative
immobilization using a lumbar orthosis.
To show that postoperative therapy with a lumbar orthosis prolongs walking distance and
reduces early recurrence.
It will be shown that postoperative pain decreases significantly faster and thus pain
medication can be reduced faster early postoperatively.
Inclusion Criteria:
- Decompression with hemi-/ partial laminectomy, one. Laminectomy, and foraminotomy.
Flavectomy with undercutting due to uni-and multi-segmental spinal stenosis.
- Age 20-80 years
- Pre-operative walking distance at least 100m
- Consent form signed by the patient
Exclusion Criteria:
- Fusion surgery or recurrent surgery
- Tumors of the spine
- Cervical spinal stenosis or myelopathy
- Rheumatoid arthritis or similar autoimmune disease
- Infection - request for a pension
- Dyspnea due to heart failure with limited walking distance
- Peripheral Arterial Occlusive Disease (PAOD)-
|
NCT0531xxxx/NCT05312294.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/NCT05312294</url>
</required_header>
<id_info>
<org_study_id>FLM-03-2020</org_study_id>
<nct_id>NCT05312294</nct_id>
</id_info>
<brief_title>Tolerability, Safety and Immunogenicity Trial of the Flu-M® Inactivated Vaccine in Volunteers Aged 18 to 60 Years</brief_title>
<official_title>Multicenter, Double-blind, Comparative, Randomized Tolerability, Safety and Immunogenicity Trial of the Flu-M® Inactivated Vaccine in Volunteers Aged 18 to 60 Years</official_title>
<sponsors>
<lead_sponsor>
<agency>St. Petersburg Research Institute of Vaccines and Sera</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>St. Petersburg Research Institute of Vaccines and Sera</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Comparative assessment of the tolerability, safety, and immunogenicity of the Flu-M®
Inactivated Split Influenza Vaccine (without preservative) and the Flu-M® vaccine (with
preservative) in volunteers aged between 18 and 60
</textblock>
</brief_summary>
<detailed_description>
<textblock>
1. Assessment of the tolerability and safety of the Flu-M® inactivated split influenza
vaccine (without preservative) and Flu-M® (with preservative).

2. Assessment of the immunogenicity of the Flu-M® inactivated split influenza vaccine (with
preservative) and Flu-M® (without preservative).

Single administration of the trial products. Duration of follow-up - 28+3 (outpatient visit)
and Long-term follow-up - 180±3 days.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">December 7, 2020</start_date>
<completion_date type="Actual">November 15, 2021</completion_date>
<primary_completion_date type="Actual">September 3, 2021</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Prevention</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Change from baseline geometric mean titer ratio of antibodies for each virus strain (GMT (Flu-M w/p) / GMT (Flu-M w/o/p) at 6 months</measure>
<time_frame>days 0-180</time_frame>
<description>The upper limit of bilateral 95% CI for the GMT ratio (GMT (Flu-M w/p) / GMT (Flu-M w/o/p) should not exceed 1.5</description>
</primary_outcome>
<primary_outcome>
<measure>Change from baseline the difference between seroconversion rates (seroconversion rate Flu-M w/p - seroconversion rate Flu-M w/o/p) at 6 months</measure>
<time_frame>days 0-180</time_frame>
<description>The upper limit of bilateral 95% CI for the difference between seroconversion rates (seroconversion rate Flu-M w/p - seroconversion rate Flu-M w/o/p) should not exceed 10%</description>
</primary_outcome>
<secondary_outcome>
<measure>Geometric mean titer of antibodies for each virus strain (A (H1N1), A (H3N2) and B)</measure>
<time_frame>days 0,28,180</time_frame>
<description>Specific anti-influenza antibodies were determined using haemagglutination inhibition assay (HI assay)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B)</measure>
<time_frame>days 0,28,180</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Seroconversion factor for each virus strain (A (H1N1), A (H3N2) and B)</measure>
<time_frame>days 0,28,180</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Seroprotection rate for each virus strain (A (H1N1), A (H3N2) and B)</measure>
<time_frame>days 0,28,180</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence, severity, and duration of influenza or ARVI during 6 months after vaccination</measure>
<time_frame>days 1-180</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of adverse events (AEs)</measure>
<time_frame>days 1-180</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of serious adverse events (SAEs)</measure>
<time_frame>days 1-180</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of patients with abnormal results of blood pressure (BP)</measure>
<time_frame>days 0,1,7,28,180</time_frame>
<description>BP measurements include the systolic and diastolic blood pressure.BP is measured on the brachial artery according to the Korotkoff method using a certified sphygmomanometer or tonometer. It is also allowed to use a certified electronic tonometer for measuring.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of patients with abnormal results of heart rate (HR)</measure>
<time_frame>days 0,1,7,28,180</time_frame>
<description>The HR is measured during auscultation of the heart in parallel with determining the pulse rate on the radial artery (or on the carotid artery in case of weak pulsation in the radial artery) for a minute while sitting.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of patients with abnormal results of respiratory rate (RR)</measure>
<time_frame>days 0,1,7,28,180</time_frame>
<description>The RR is measured for a minute at rest in the sitting position, by registering the breathing movements of the chest or abdominal wall.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of patients with abnormal results of body temperature (>37 °С)</measure>
<time_frame>days 0,1,7,28,180</time_frame>
<description>Body temperature (°C) is measured with a mercury or digital thermometer in the armpit for at least 5 minutes or with a non-contact infrared digital thermometer.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of patients with abnormal results of physical examination</measure>
<time_frame>days 0,1,7,28,180</time_frame>
<description>Physical examination of volunteers includes an interview, discovery of complaints and symptoms, when required, palpation, auscultation, percussion.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of patients with abnormal results of neurological status</measure>
<time_frame>days 0,7,28</time_frame>
<description>Assessment of:
Cranial nerve function
Motor sphere
Reflex sphere
Sensitive sphere
Coordination sphere
Pelvic functions
Higher mental functions</description>
</secondary_outcome>
<secondary_outcome>
<measure>Determination of total IgE</measure>
<time_frame>days 0,7,28</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of patients with abnormal results of electrocardiography (ECG)</measure>
<time_frame>days 0,7</time_frame>
<description>2-lead electrocardiography (ECG). Assessment of: PQ, QT,QTc intervals, QRS complex</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">654</enrollment>
<condition>Influenza</condition>
<condition>Flu, Human</condition>
<arm_group>
<arm_group_label>FLU-M w/o/p</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Volunteers were vaccinated with a single dose of the Flu-M vaccine (without preservative) intramuscularly in a dose of 0.5 mL.</description>
</arm_group>
<arm_group>
<arm_group_label>FLU-M w/p</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Volunteers were vaccinated with a single dose of the Flu-M vaccine (with preservative) intramuscularly in a dose of 0.5 mL.</description>
</arm_group>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>Flu-M [inactivated split influenza vaccine] without preservative</intervention_name>
<description>Solution for intramuscular injection, 0.5 ml</description>
<arm_group_label>FLU-M w/o/p</arm_group_label>
</intervention>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>Flu-M [inactivated split influenza vaccine] with preservative</intervention_name>
<description>Solution for intramuscular injection, 0.5 ml</description>
<arm_group_label>FLU-M w/p</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Healthy volunteers (men and women) aged 18-60 years;

2. Written informed consent of volunteers to participate in the clinical trial;

3. Volunteers able to fulfill requirements of the Protocol (i.e. fill out the patient's
diary, come to follow-up visits);

4. For fertile women - a negative result of the pregnancy test and consent to observe
adequate methods of contraception during the trial and at least two months after
vaccination

5. For fertile men - consent to observe adequate methods of contraception during the
trial and at least two months after vaccination, except for men after vasectomy with
documented azoospermia, and their sexual partners should use methods of contraception
that ensure more than 90% reliability or be incapable of conception after a surgical
sterilization or have a natural menopause for at least 2 years.

Exclusion Criteria:

1. History of influenza/ARVI or previous influenza vaccination during 6 months before the
trial;

2. Positive result of the SARS-CoV-2 test;

3. A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more
than 8 cm in diameter) or complications (collapse or shock-like condition that
developed within 48 hours after vaccination; convulsions accompanied or not
accompanied by a fever due to any previous vaccination);

4. Allergic reactions to vaccine components or any previous vaccination;

5. History of allergic reaction to chicken protein;

6. Guillain-Barré syndrome (acute polyneuropathy) in the medical history;

7. Previous vaccination with rabies vaccines less than 2 months before immunization or
scheduled vaccination with rabies vaccines within 1 month after immunization with the
trial vaccines;

8. Use of any vaccines within 1 month before the vaccination, excluding vaccines
according to the National Calendar of Preventive Vaccination, including for epidemic
reasons;

9. History of leukemia, cancer, autoimmune diseases;

10. (Positive blood test results for HIV, syphilis, hepatitis B/C;

11. Volunteers who received immunoglobulin or blood products or had a blood transfusion
during the last three months before the trial;

12. History of long-term use (more than 14 days) of immunosuppressants or immunomodulatory
drugs for six months before the trial;

13. History of any confirmed or suspected immunosuppressive or immunodeficiency condition;

14. History of chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine
systems, the gastrointestinal tract, liver, kidneys, hematopoietic or immune systems,
mental disease in the acute stage or in the decompensation stage (recovery less than 4
weeks before vaccination);

15. Diabetes mellitus, thyrotoxicosis or other diseases of the endocrine system;

16. History of eczema;

17. Treatment with glucocorticosteroids, including in small doses, as well as local use of
drugs containing steroids (> 10 mg of prednisolone or its equivalent for more than 14
days before the screening);

18. Tuberculosis, neurological or mental disorders, a convulsive syndrome, including in
the past medical history;

19. History of acute infectious diseases (recovery less than 4 weeks before vaccination);

20. Consumption of more than 10 units of alcohol per week or history of alcohol addiction,
drug addiction or abuse of pharmaceutical products;

21. Smoking of more than 10 cigarettes per day;

22. Participation in another clinical trial during the last 3 months;

23. Pregnancy or lactation;

24. Coagulopathy, including hemophilia;

25. Taking aspirin or other antiplatelet agents in high doses.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>State Autonomous Health Institution "Engels City Clinical Hospital No1"</name>
<address>
<city>Engels</city>
<country>Russian Federation</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Limited Liability Company "Professorskaya Clinica"</name>
<address>
<city>Perm</city>
<country>Russian Federation</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Limited Liability Company "Clinika Zvezdnaya"</name>
<address>
<city>Saint Petersburg</city>
<country>Russian Federation</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Limited Liability Company "MEDICINSKAYA CLINIKA"</name>
<address>
<city>Saint Petersburg</city>
<country>Russian Federation</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Limited Liability Company "PeterClinic"</name>
<address>
<city>Saint Petersburg</city>
<country>Russian Federation</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Limited Liability Company "Scientific Research Center Eco-Safety"</name>
<address>
<city>Saint Petersburg</city>
<country>Russian Federation</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Saint Petersburg State Budgetary Healthcare Institution "State Polyclinic No. 117"</name>
<address>
<city>Saint Petersburg</city>
<country>Russian Federation</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Limited Liability Company "Medical Center Diagnostics and Prevention Plus"</name>
<address>
<city>Yaroslavl</city>
<country>Russian Federation</country>
</address>
</facility>
</location>
<location_countries>
<country>Russian Federation</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 17, 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>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>
<keyword>Influenza</keyword>
<keyword>Flu</keyword>
<keyword>Vaccine</keyword>
<keyword>FLU-M</keyword>
<keyword>SPbSRIVS</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Influenza, Human</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Vaccines</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Comparative assessment of the tolerability, safety, and immunogenicity of the Flu-M®
Inactivated Split Influenza Vaccine (without preservative) and the Flu-M® vaccine (with
preservative) in volunteers aged between 18 and 60
1. Assessment of the tolerability and safety of the Flu-M® inactivated split influenza
vaccine (without preservative) and Flu-M® (with preservative).
2. Assessment of the immunogenicity of the Flu-M® inactivated split influenza vaccine (with
preservative) and Flu-M® (without preservative).
Single administration of the trial products. Duration of follow-up - 28+3 (outpatient visit)
and Long-term follow-up - 180±3 days.
Inclusion Criteria:
1. Healthy volunteers (men and women) aged 18-60 years;
2. Written informed consent of volunteers to participate in the clinical trial;
3. Volunteers able to fulfill requirements of the Protocol (i.e. fill out the patient's
diary, come to follow-up visits);
4. For fertile women - a negative result of the pregnancy test and consent to observe
adequate methods of contraception during the trial and at least two months after
vaccination
5. For fertile men - consent to observe adequate methods of contraception during the
trial and at least two months after vaccination, except for men after vasectomy with
documented azoospermia, and their sexual partners should use methods of contraception
that ensure more than 90% reliability or be incapable of conception after a surgical
sterilization or have a natural menopause for at least 2 years.
Exclusion Criteria:
1. History of influenza/ARVI or previous influenza vaccination during 6 months before the
trial;
2. Positive result of the SARS-CoV-2 test;
3. A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more
than 8 cm in diameter) or complications (collapse or shock-like condition that
developed within 48 hours after vaccination; convulsions accompanied or not
accompanied by a fever due to any previous vaccination);
4. Allergic reactions to vaccine components or any previous vaccination;
5. History of allergic reaction to chicken protein;
6. Guillain-Barré syndrome (acute polyneuropathy) in the medical history;
7. Previous vaccination with rabies vaccines less than 2 months before immunization or
scheduled vaccination with rabies vaccines within 1 month after immunization with the
trial vaccines;
8. Use of any vaccines within 1 month before the vaccination, excluding vaccines
according to the National Calendar of Preventive Vaccination, including for epidemic
reasons;
9. History of leukemia, cancer, autoimmune diseases;
10. (Positive blood test results for HIV, syphilis, hepatitis B/C;
11. Volunteers who received immunoglobulin or blood products or had a blood transfusion
during the last three months before the trial;
12. History of long-term use (more than 14 days) of immunosuppressants or immunomodulatory
drugs for six months before the trial;
13. History of any confirmed or suspected immunosuppressive or immunodeficiency condition;
14. History of chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine
systems, the gastrointestinal tract, liver, kidneys, hematopoietic or immune systems,
mental disease in the acute stage or in the decompensation stage (recovery less than 4
weeks before vaccination);
15. Diabetes mellitus, thyrotoxicosis or other diseases of the endocrine system;
16. History of eczema;
17. Treatment with glucocorticosteroids, including in small doses, as well as local use of
drugs containing steroids (> 10 mg of prednisolone or its equivalent for more than 14
days before the screening);
18. Tuberculosis, neurological or mental disorders, a convulsive syndrome, including in
the past medical history;
19. History of acute infectious diseases (recovery less than 4 weeks before vaccination);
20. Consumption of more than 10 units of alcohol per week or history of alcohol addiction,
drug addiction or abuse of pharmaceutical products;
21. Smoking of more than 10 cigarettes per day;
22. Participation in another clinical trial during the last 3 months;
23. Pregnancy or lactation;
24. Coagulopathy, including hemophilia;
25. Taking aspirin or other antiplatelet agents in high doses.
|
NCT0531xxxx/NCT05312307.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/NCT05312307</url>
</required_header>
<id_info>
<org_study_id>STR-006-001</org_study_id>
<nct_id>NCT05312307</nct_id>
</id_info>
<brief_title>Strata EXPress™: A Study Using StrataEXP™ to Identify RNA-Expression Biomarkers in Advanced Cancer Patients</brief_title>
<acronym>StrataEXPress</acronym>
<official_title>Strata EXPress™: A Study Using StrataEXP™ to Identify RNA-Expression Biomarkers in Advanced Cancer Patients</official_title>
<sponsors>
<lead_sponsor>
<agency>Strata Oncology</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Strata Oncology</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The primary goal of this study is to identify patients with RNA expression profiles
consistent with eligibility requirements for therapeutic clinical trials across solid tumors.
Left-over tumor tissue will be collected from eligible participants for RNA expression
analysis using next-generation sequencing.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The primary goal of this study is to identify patients with RNA expression profiles
consistent with eligibility requirements for therapeutic clinical trials across solid tumors.
Left-over tumor tissue will be collected from eligible participants for RNA expression
analysis using next-generation sequencing.

A parallel study, StrataPATH™ (STR-004-001), has been developed to support therapeutic
hypotheses. Participants may be consented and screened for enrollment separately into
StrataPATH with an eligible matching biomarker/drug treatment cohort upon positive
identification of a relevant expression signature. Treatment effectiveness of antibody drug
conjugates and other targeted therapies will be evaluated in these molecularly defined
cohorts.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">February 6, 2023</start_date>
<completion_date type="Anticipated">February 6, 2031</completion_date>
<primary_completion_date type="Anticipated">February 6, 2028</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Other</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>To identify subjects with RNA signatures who may be eligible for clinical trial enrollment</measure>
<time_frame>5 years</time_frame>
<description>The percentage of participants identified as eligible for therapeutic clinical trials.</description>
</primary_outcome>
<enrollment type="Anticipated">2000</enrollment>
<condition>Cancer</condition>
<eligibility>
<study_pop>
<textblock>
Participants are male or female ≥ 18 years of age; must have pathologically confirmed
advanced, metastatic, or recurrent solid tumor; measurable disease; have an Eastern
Cooperative Oncology Group (ECOG) performance status score of 0-2; must meet at least 1 of
the following: a. Is/has not adequately responded to standard therapy, or b. For whom no
life extending standard therapy exists, or c. Who decline standard therapy, or d. In the
opinion of the investigator, is not a candidate for or would be unlikely to tolerate or
derive significant clinical benefit from standard therapy; have adequate cardiac, bone
marrow, organ function & laboratory parameters as determined by the treating physician for
potential participation in a clinical trial; have leftover formalin-fixed,
paraffin-embedded (FFPE) tumor tissue available for StrataEXP testing.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. Must be ≥18 years of age,

2. Participant must have pathologically confirmed advanced, metastatic, or recurrent
solid tumor,

3. Measurable disease,

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

5. Participant must meet at least 1 of the following:

1. Is/has not adequately responded to standard therapy, or

2. For whom no life-extending standard therapy exists, or

3. Who decline standard therapy, or

4. In the opinion of the investigator, is not a candidate for or would be unlikely
to tolerate or derive significant clinical benefit from standard therapy

6. Adequate cardiac, bone marrow, organ function & laboratory parameters as determined by
the treating physician for potential participation in a clinical trial,

7. Leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for StrataEXP
testing

Exclusion Criteria:

1. Females who are pregnant or nursing,

2. History of stroke including transient ischemic attack (TIA) or acute myocardial
infarction within 4 months of enrollment,

3. Any other clinically significant medical condition that, in the opinion of the
treating physician, makes participation in a clinical trial undesirable, including but
not limited to ongoing or active infection, significant uncontrolled hypertension, or
severe psychiatric illness.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Kat Kwiatkowski, PhD</last_name>
<role>Study Director</role>
<affiliation>Strata Oncology</affiliation>
</overall_official>
<overall_contact>
<last_name>Stephanie Bush</last_name>
<phone>734-527-1000</phone>
<email>stephanie.bush@strataoncology.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Melissa Wolfe</last_name>
<phone>734-527-1000</phone>
<email>melissa.wolfe@strataoncology.com</email>
</overall_contact_backup>
<location>
<facility>
<name>University of Iowa Hospitals & Clinics</name>
<address>
<city>Iowa City</city>
<state>Iowa</state>
<zip>52242</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Strata Oncology</last_name>
<phone>734-527-1000</phone>
</contact>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 26, 2022</study_first_submitted>
<study_first_submitted_qc>March 26, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>February 23, 2023</last_update_submitted>
<last_update_submitted_qc>February 23, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 24, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The primary goal of this study is to identify patients with RNA expression profiles
consistent with eligibility requirements for therapeutic clinical trials across solid tumors.
Left-over tumor tissue will be collected from eligible participants for RNA expression
analysis using next-generation sequencing.
The primary goal of this study is to identify patients with RNA expression profiles
consistent with eligibility requirements for therapeutic clinical trials across solid tumors.
Left-over tumor tissue will be collected from eligible participants for RNA expression
analysis using next-generation sequencing.
A parallel study, StrataPATH™ (STR-004-001), has been developed to support therapeutic
hypotheses. Participants may be consented and screened for enrollment separately into
StrataPATH with an eligible matching biomarker/drug treatment cohort upon positive
identification of a relevant expression signature. Treatment effectiveness of antibody drug
conjugates and other targeted therapies will be evaluated in these molecularly defined
cohorts.
Participants are male or female ≥ 18 years of age; must have pathologically confirmed
advanced, metastatic, or recurrent solid tumor; measurable disease; have an Eastern
Cooperative Oncology Group (ECOG) performance status score of 0-2; must meet at least 1 of
the following: a. Is/has not adequately responded to standard therapy, or b. For whom no
life extending standard therapy exists, or c. Who decline standard therapy, or d. In the
opinion of the investigator, is not a candidate for or would be unlikely to tolerate or
derive significant clinical benefit from standard therapy; have adequate cardiac, bone
marrow, organ function & laboratory parameters as determined by the treating physician for
potential participation in a clinical trial; have leftover formalin-fixed,
paraffin-embedded (FFPE) tumor tissue available for StrataEXP testing.
Inclusion Criteria:
1. Must be ≥18 years of age,
2. Participant must have pathologically confirmed advanced, metastatic, or recurrent
solid tumor,
3. Measurable disease,
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2,
5. Participant must meet at least 1 of the following:
1. Is/has not adequately responded to standard therapy, or
2. For whom no life-extending standard therapy exists, or
3. Who decline standard therapy, or
4. In the opinion of the investigator, is not a candidate for or would be unlikely
to tolerate or derive significant clinical benefit from standard therapy
6. Adequate cardiac, bone marrow, organ function & laboratory parameters as determined by
the treating physician for potential participation in a clinical trial,
7. Leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for StrataEXP
testing
Exclusion Criteria:
1. Females who are pregnant or nursing,
2. History of stroke including transient ischemic attack (TIA) or acute myocardial
infarction within 4 months of enrollment,
3. Any other clinically significant medical condition that, in the opinion of the
treating physician, makes participation in a clinical trial undesirable, including but
not limited to ongoing or active infection, significant uncontrolled hypertension, or
severe psychiatric illness.
|
NCT0531xxxx/NCT05312320.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/NCT05312320</url>
</required_header>
<id_info>
<org_study_id>20/09003-10-521</org_study_id>
<nct_id>NCT05312320</nct_id>
</id_info>
<brief_title>Improving Sexual Function After Myocardial Infarction</brief_title>
<acronym>Sex/MI</acronym>
<official_title>Improving Sexual Function After Myocardial Infarction - a Randomized Controlled Trial.</official_title>
<sponsors>
<lead_sponsor>
<agency>Sorlandet Hospital HF</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Oslo University Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Sorlandet Hospital HF</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The study is completely digital. Men and women who recently had an MI will be invited through
a written brochure that will be present in all Norwegian departments of cardiology. Post-MI
patients can check the investigators web site (www.sefh.no) to determine whether they are
eligible for the study. After consent and answering the baseline questionnaire, each
participant will be randomized to either the intervention or control group.

Control group: Standard surveillance after MI (no specific focus on sexual activity and
functioning) Intervention group: Online sexual counselling including a short information
film.

In order to assess the generalizability of the results, we will compare the age, sex and MI
treatment of the respondents with data on Norwegian MI-patients in general.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The investigators will include 600 women and 600 men within 4 weeks after an acute MI. The
investigators will invite the same number of women and men from the general population,
invited through mass and social media.

All participants will be provided the same questionnaire at 4 weeks. Then outcome data will
be obtained by a follow-up quest after 6 and 12 months.

The intervention is a film with the following main message:

- Sexual activity after MI does not increase risk of recurrence or death

- Sexual activity is associated with improved outcome after MI

- Resuming sexual activity as normal is recommended and completely safe
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">November 7, 2022</start_date>
<completion_date type="Anticipated">November 2024</completion_date>
<primary_completion_date type="Anticipated">November 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Supportive Care</primary_purpose>
<masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Does specific sexual counselling improve sexual functioning in post-MI?</measure>
<time_frame>12 months</time_frame>
<description>The investigators will measure sexual function by Brief Sexual Function Inventory (BSFI) for male participants and Female Sexual Function Index (FSFI) for female participants at 6 and 12 months after their MI.</description>
</primary_outcome>
<primary_outcome>
<measure>Changes in sexual activity and functioning after MI</measure>
<time_frame>12 months</time_frame>
<description>The investigators will measure sexual activity and function at baseline, and 6 and 12 months after MI.
The investigators will measure sexual function by Brief Sexual Function Inventory (BSFI) for male participants and Female Sexual Function Index (FSFI) for female participants.</description>
</primary_outcome>
<primary_outcome>
<measure>Establish predictors of improved sexual functioning in post-MI patients</measure>
<time_frame>12 months</time_frame>
<description>In order to identify MI patients at risk of sexual dysfunction, the participants will answer questionnaires on quality of life (RAND-12), depression and anxiety (HADS), demographic data, comorbidity, medications and other factors that may have impact on sexual function.</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">1200</enrollment>
<condition>Sexual Function Disturbances</condition>
<condition>Myocardial Infarction</condition>
<arm_group>
<arm_group_label>Information film</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Randomized to receive a short information film online.</description>
</arm_group>
<arm_group>
<arm_group_label>Standard care</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>No film, only questionnaire.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Information film</intervention_name>
<description>Sexual activity after MI does not increase risk of recurrence or death
Sexual activity is associated with improved outcome after MI
Resuming sexual activity as normal is recommended and completely safe</description>
<arm_group_label>Information film</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Men and women ≥18 years old

- Acute MI during the last 6 weeks

- Informed consent for participation

Exclusion Criteria:

- Lack of ability to cooperate

- Known alcohol- or drug-abuse, or use of narcotics

- Pregnancy or breast-feeding

- Serious comorbidity with a life expectancy <12 months

- Unstable or refractory angina

- Uncontrolled hypertension

- Congestive heart failure (NYHA class III/IV)

- High-risk arrhythmias

- Hypertrophic obstructive and other cardiomyopathies

- Severe valvular disease
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>110 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Frode Gallefoss</last_name>
<role>Study Director</role>
<affiliation>Sorlandets hospital HF</affiliation>
</overall_official>
<overall_contact>
<last_name>Vibeke Salvesen, MD</last_name>
<phone>+47 47304802</phone>
<email>vibeke.salvesen@sshf.no</email>
</overall_contact>
<overall_contact_backup>
<last_name>Nora Johansen, Ph.D</last_name>
<phone>+47 40496612</phone>
<email>nora.johansen@sshf.no</email>
</overall_contact_backup>
<location>
<facility>
<name>Www.Sefh.No</name>
<address>
<city>Arendal</city>
<country>Norway</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Vibeke Salvesen, MD</last_name>
</contact>
</location>
<location_countries>
<country>Norway</country>
</location_countries>
<link>
<url>http://betami.org</url>
<description>control group</description>
</link>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 11, 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>November 11, 2022</last_update_submitted>
<last_update_submitted_qc>November 11, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">November 16, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Myocardial Infarction</mesh_term>
<mesh_term>Infarction</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The study is completely digital. Men and women who recently had an MI will be invited through
a written brochure that will be present in all Norwegian departments of cardiology. Post-MI
patients can check the investigators web site (www.sefh.no) to determine whether they are
eligible for the study. After consent and answering the baseline questionnaire, each
participant will be randomized to either the intervention or control group.
Control group: Standard surveillance after MI (no specific focus on sexual activity and
functioning) Intervention group: Online sexual counselling including a short information
film.
In order to assess the generalizability of the results, we will compare the age, sex and MI
treatment of the respondents with data on Norwegian MI-patients in general.
The investigators will include 600 women and 600 men within 4 weeks after an acute MI. The
investigators will invite the same number of women and men from the general population,
invited through mass and social media.
All participants will be provided the same questionnaire at 4 weeks. Then outcome data will
be obtained by a follow-up quest after 6 and 12 months.
The intervention is a film with the following main message:
- Sexual activity after MI does not increase risk of recurrence or death
- Sexual activity is associated with improved outcome after MI
- Resuming sexual activity as normal is recommended and completely safe
Inclusion Criteria:
- Men and women ≥18 years old
- Acute MI during the last 6 weeks
- Informed consent for participation
Exclusion Criteria:
- Lack of ability to cooperate
- Known alcohol- or drug-abuse, or use of narcotics
- Pregnancy or breast-feeding
- Serious comorbidity with a life expectancy <12 months
- Unstable or refractory angina
- Uncontrolled hypertension
- Congestive heart failure (NYHA class III/IV)
- High-risk arrhythmias
- Hypertrophic obstructive and other cardiomyopathies
- Severe valvular disease
|
NCT0531xxxx/NCT05312333.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/NCT05312333</url>
</required_header>
<id_info>
<org_study_id>Soh-Med-22-03-12</org_study_id>
<nct_id>NCT05312333</nct_id>
</id_info>
<brief_title>Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital</brief_title>
<official_title>Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital</official_title>
<sponsors>
<lead_sponsor>
<agency>Sohag University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Sohag University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Holter Monitoring is a way to continuously check the electrical activity of the heart .

Continuous ECG recording show to be one of the most effective noninvasive clinical tools in
the diagnosis of cardiac symptoms prognostic assessment and in the evaluation of many cardiac
therapeutic intervention.

The clinical utility of ambulatory ECG lies in its ability to examine continuously a patient
over an extended period of time, permitting patient ambulatory activity and facilitating the
diurnal electrocardiographic examination of a patient in a changing environmental conditions
(both physical and psychological) .
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 9, 2022</start_date>
<completion_date type="Anticipated">March 2023</completion_date>
<primary_completion_date type="Anticipated">March 2023</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<primary_outcome>
<measure>Abnormalities detecred in Holter monitoring of critically-ill childern</measure>
<time_frame>one year</time_frame>
<description>the relation between abnormalities detected in Holter and prognosis of critically-ill childern</description>
</primary_outcome>
<primary_outcome>
<measure>The relation between heart rate variability and outcome ,prognosis of illness</measure>
<time_frame>one year</time_frame>
<description>Increased illness severity and poor outcomes ,the most common method of objectively assesing autonomic nervous system dysregulation is through measurement of heart rate variability ,which reflect the normal ,physiologic alternation in the intervals in the time between consecutive heart beats that occur when there is balance of sympathetic and parasympathetic inputs on the electrical conduction system of the heart.</description>
</primary_outcome>
<primary_outcome>
<measure>Arrhythmia detected in critically-ill childern</measure>
<time_frame>one year</time_frame>
<description>arrhythmia detected in Holter of critically ill childern whom have any critical illness</description>
</primary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Anticipated">100</enrollment>
<condition>Critically Ill Childern in PICU</condition>
<arm_group>
<arm_group_label>critically-ill childern</arm_group_label>
</arm_group>
<eligibility>
<study_pop>
<textblock>
Critically ill children are those children whom requiring, or potentially requiring, high
reliance or serious consideration.

There are variant emergent conditions may affect the child, such as airway problems which
includes tonsillitis, airway obstruction which caused be foreign-body, pneumonia, asthma,
and bronchitis, in addition to cardiac arrest and respiratory failure. There is also
abdominal pain diarrhea, nausea, and vomiting. Child also may face seizures, poisoning
sudden infant death syndrome (SIDS).

- Having seizures; unusual movements.

- No spontaneous development, unfit to sit or stand.

- Less alert or drew in with clinician or parental figure; not resisting of the
examination.

- No interaction or eye-to-eye connection with individuals and the surrounding.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- 1- children admitted to pediatric department as in :

- Pediatric intensive care unit (PICU).

- Pediatric critical care unit (PCCU).

- Emergency room (ER). 2- Age from 1 month- 12 years. 3- Critical ill child fulfill
these criteria:

- Persistent convulsions.

- Abnormal GCS

- Haemodynamic instability

- Foreign body inhalation

- Sever cardiac problem

- Irregular breathing

- DKA

- Others

Exclusion Criteria:1-Neonates 2-End-stage or those with end-organ failure . 3-Whom GCS is
below 6. 4-Whom done cardiac catheterization for any purpose . 5-Previously done Holter.
6-Multiple traumatized patient.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>1 Month</minimum_age>
<maximum_age>12 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Sohag University Hospital</name>
<address>
<city>Sohag</city>
<country>Egypt</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Osama R ElSherif, professor</last_name>
<email>portal@med.sohag.edu.eg</email>
</contact>
</location>
<location_countries>
<country>Egypt</country>
</location_countries>
<reference>
<citation>Kennedy HL. The history, science, and innovation of Holter technology. Ann Noninvasive Electrocardiol. 2006 Jan;11(1):85-94. doi: 10.1111/j.1542-474X.2006.00067.x.</citation>
<PMID>16472287</PMID>
</reference>
<reference>
<citation>Marsillio LE, Manghi T, Carroll MS, Balmert LC, Wainwright MS. Heart rate variability as a marker of recovery from critical illness in children. PLoS One. 2019 May 17;14(5):e0215930. doi: 10.1371/journal.pone.0215930. eCollection 2019.</citation>
<PMID>31100075</PMID>
</reference>
<reference>
<citation>Leteurtre S, Duhamel A, Salleron J, Grandbastien B, Lacroix J, Leclerc F; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). PELOD-2: an update of the PEdiatric logistic organ dysfunction score. Crit Care Med. 2013 Jul;41(7):1761-73. doi: 10.1097/CCM.0b013e31828a2bbd.</citation>
<PMID>23685639</PMID>
</reference>
<reference>
<citation>Rijnbeek PR, Witsenburg M, Schrama E, Hess J, Kors JA. New normal limits for the paediatric electrocardiogram. Eur Heart J. 2001 Apr;22(8):702-11. doi: 10.1053/euhj.2000.2399.</citation>
<PMID>11286528</PMID>
</reference>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 13, 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>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>Sohag University</investigator_affiliation>
<investigator_full_name>Nourhan Ahmed Mohamed</investigator_full_name>
<investigator_title>resident doctor at pediateric department sohag university hospital</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Critical Illness</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Holter Monitoring is a way to continuously check the electrical activity of the heart .
Continuous ECG recording show to be one of the most effective noninvasive clinical tools in
the diagnosis of cardiac symptoms prognostic assessment and in the evaluation of many cardiac
therapeutic intervention.
The clinical utility of ambulatory ECG lies in its ability to examine continuously a patient
over an extended period of time, permitting patient ambulatory activity and facilitating the
diurnal electrocardiographic examination of a patient in a changing environmental conditions
(both physical and psychological) .
Critically ill children are those children whom requiring, or potentially requiring, high
reliance or serious consideration.
There are variant emergent conditions may affect the child, such as airway problems which
includes tonsillitis, airway obstruction which caused be foreign-body, pneumonia, asthma,
and bronchitis, in addition to cardiac arrest and respiratory failure. There is also
abdominal pain diarrhea, nausea, and vomiting. Child also may face seizures, poisoning
sudden infant death syndrome (SIDS).
- Having seizures; unusual movements.
- No spontaneous development, unfit to sit or stand.
- Less alert or drew in with clinician or parental figure; not resisting of the
examination.
- No interaction or eye-to-eye connection with individuals and the surrounding.
Inclusion Criteria:
- 1- children admitted to pediatric department as in :
- Pediatric intensive care unit (PICU).
- Pediatric critical care unit (PCCU).
- Emergency room (ER). 2- Age from 1 month- 12 years. 3- Critical ill child fulfill
these criteria:
- Persistent convulsions.
- Abnormal GCS
- Haemodynamic instability
- Foreign body inhalation
- Sever cardiac problem
- Irregular breathing
- DKA
- Others
Exclusion Criteria:1-Neonates 2-End-stage or those with end-organ failure . 3-Whom GCS is
below 6. 4-Whom done cardiac catheterization for any purpose . 5-Previously done Holter.
6-Multiple traumatized patient.
|
NCT0531xxxx/NCT05312346.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/NCT05312346</url>
</required_header>
<id_info>
<org_study_id>Soh-Med-22-03-04</org_study_id>
<nct_id>NCT05312346</nct_id>
</id_info>
<brief_title>Factors Predicting Erythropoietin Responsiveness in Children on Hemodialysis at Sohag University Hospital</brief_title>
<official_title>University Hospital</official_title>
<sponsors>
<lead_sponsor>
<agency>Sohag University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Sohag University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Anemia is common in patients on hemodialysis (HD) due to lack of erythropoietin (EPO)
synthesis and iron deficiency is occurring in HD patients due to chronic blood loss through
the dialysis circuit, repeated blood sampling, shortened red blood cell life span and lack of
adherence to treatment .

Anemia is one of the most important complications that affects morbidity and mortality in
chronic kidney disease (CKD) patients. It has significant impacts on those patients such as
fatigue, weakness, shortness of breath, decreased quality of life, exercise capacity and
physical activity, growth retardation and decreased cognitive functions, left ventricular
hypertrophy, and congestive heart failure So, proper management of anemia is very important .
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 1, 2022</start_date>
<completion_date type="Anticipated">April 1, 2023</completion_date>
<primary_completion_date type="Anticipated">April 1, 2023</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Hb g/dl</measure>
<time_frame>one year</time_frame>
<description>measure hemoglobin level</description>
</primary_outcome>
<primary_outcome>
<measure>Iron profile</measure>
<time_frame>one year</time_frame>
<description>measure iron profile on blood</description>
</primary_outcome>
<primary_outcome>
<measure>Serum creatinine</measure>
<time_frame>one year</time_frame>
<description>serum creatinine</description>
</primary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Anticipated">50</enrollment>
<condition>Pediatric Patients on Hemodialysis</condition>
<arm_group>
<arm_group_label>responsiveness to erythropoietin stimulating agent</arm_group_label>
<description>we evolute responsiveness of patients on hemodialysis for erythropoietin stimulating agents or not and factors effecting this response</description>
</arm_group>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>seum zinic,vit B12, parathyriod function</intervention_name>
<description>seum zinic,vit B12, parathyriod function</description>
<arm_group_label>responsiveness to erythropoietin stimulating agent</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
These children are attending in our Pediatric dialysis unit at Sohag University Hospital,
Egypt between April 2022 and April 2023.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- (1) patients started dialysis in the age range of 1-18years. (2) Patient will be on
regular hemodialysis.

Exclusion Criteria:

- Children who have no other co existent hematological disorder .
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>1 Year</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>hanan N fawzi, specialist</last_name>
<phone>01009351849</phone>
<email>hanan_nagdy_post@med.sohag.edu.eg</email>
</overall_contact>
<overall_contact_backup>
<last_name>Alzahraa A Ahmed, professor</last_name>
</overall_contact_backup>
<location>
<facility>
<name>Sohag University Hospital</name>
<address>
<city>Sohag</city>
<country>Egypt</country>
</address>
</facility>
<contact>
<last_name>Osama R ElSherif, professor</last_name>
<email>portal@med.sohag.edu.eg</email>
</contact>
</location>
<location_countries>
<country>Egypt</country>
</location_countries>
<reference>
<citation>Allali S, Brousse V, Sacri AS, Chalumeau M, de Montalembert M. Anemia in children: prevalence, causes, diagnostic work-up, and long-term consequences. Expert Rev Hematol. 2017 Nov;10(11):1023-1028. doi: 10.1080/17474086.2017.1354696. Epub 2017 Oct 12.</citation>
<PMID>29023171</PMID>
</reference>
<reference>
<citation>Mikhail A, Brown C, Williams JA, Mathrani V, Shrivastava R, Evans J, Isaac H, Bhandari S. Renal association clinical practice guideline on Anaemia of Chronic Kidney Disease. BMC Nephrol. 2017 Nov 30;18(1):345. doi: 10.1186/s12882-017-0688-1.</citation>
<PMID>29191165</PMID>
</reference>
<reference>
<citation>Bamgbola OF. Pattern of resistance to erythropoietin-stimulating agents in chronic kidney disease. Kidney Int. 2011 Sep;80(5):464-74. doi: 10.1038/ki.2011.179. Epub 2011 Jun 22.</citation>
<PMID>21697809</PMID>
</reference>
<reference>
<citation>Akbari A, Clase CM, Acott P, Battistella M, Bello A, Feltmate P, Grill A, Karsanji M, Komenda P, Madore F, Manns BJ, Mahdavi S, Mustafa RA, Smyth A, Welcher ES. Canadian Society of Nephrology commentary on the KDIGO clinical practice guideline for CKD evaluation and management. Am J Kidney Dis. 2015 Feb;65(2):177-205. doi: 10.1053/j.ajkd.2014.10.013. Epub 2014 Nov 4.</citation>
<PMID>25511161</PMID>
</reference>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 14, 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>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>Sohag University</investigator_affiliation>
<investigator_full_name>Hanan Nagdy Fawzy</investigator_full_name>
<investigator_title>pediatric specialist</investigator_title>
</responsible_party>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Hydroxocobalamin</mesh_term>
<mesh_term>Vitamin B 12</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Anemia is common in patients on hemodialysis (HD) due to lack of erythropoietin (EPO)
synthesis and iron deficiency is occurring in HD patients due to chronic blood loss through
the dialysis circuit, repeated blood sampling, shortened red blood cell life span and lack of
adherence to treatment .
Anemia is one of the most important complications that affects morbidity and mortality in
chronic kidney disease (CKD) patients. It has significant impacts on those patients such as
fatigue, weakness, shortness of breath, decreased quality of life, exercise capacity and
physical activity, growth retardation and decreased cognitive functions, left ventricular
hypertrophy, and congestive heart failure So, proper management of anemia is very important .
These children are attending in our Pediatric dialysis unit at Sohag University Hospital,
Egypt between April 2022 and April 2023.
Inclusion Criteria:
- (1) patients started dialysis in the age range of 1-18years. (2) Patient will be on
regular hemodialysis.
Exclusion Criteria:
- Children who have no other co existent hematological disorder .
|
NCT0531xxxx/NCT05312359.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/NCT05312359</url>
</required_header>
<id_info>
<org_study_id>JDu-010</org_study_id>
<nct_id>NCT05312359</nct_id>
</id_info>
<brief_title>Brain Mechanism and Intervention of Executive-control Dysfunction Among Substance Dependents</brief_title>
<official_title>Brain Mechanism and Intervention of Executive-control Dysfunction Caused by Impaired Prefrontal-ventral Striatum Synchronization Among Substance Dependents</official_title>
<sponsors>
<lead_sponsor>
<agency>Shanghai Mental Health Center</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Shanghai Mental Health Center</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The investigators assume that tACS could improve amphetamine and alcohol dependent patients'
executive-control function by adjusting the synchronization patterns and enhancing the
functional connectivity of the prefrontal-ventral striatum pathway. A random controlled trial
will be used to test the effect of θ-tACS treatment. Three months follow-up assessment will
be conducted to test the changing of executive-control function and its mechanism.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Substance abuse has become a major social and public health problem in China, especially for
amphetamine abuse and alcohol abuse. Executive-control dysfunction is the main symptom for
substance dependents. Previous studies have demonstrated the relationship between cognitive
dysfunction and prefrontal-ventral striatum pathway. Studies have shown that abnormal phase
synchronization and phase-amplitude coupling (PAC) induced the impairment of cognitive, and
tACS could improve executive-control function by adjusting the abnormal synchronization. But
it has not been verified among MA or alcohol patients. The investigators assume that tACS
could improve MA and alcohol dependent patients' executive-control function by adjusting the
synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral
striatum pathway. A random controlled trial will be used to test the effect of θ-tACS
treatment. Three months follow-up assessment will be conducted to test the changing of
executive-control function and its mechanism. This study will provide a practical and
theoretical basis for developing a novel treatment for substance dependents.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">June 1, 2022</start_date>
<completion_date type="Anticipated">December 31, 2025</completion_date>
<primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>The change of inhibitory control ability</measure>
<time_frame>baseline, immediately after the intervention, one month after the intervention, three months after the intervention</time_frame>
<description>The change of inhibitory control ability will be reflected by participants' performance in the Go/No Go task.</description>
</primary_outcome>
<primary_outcome>
<measure>The change of theta(θ) phase synchronicity</measure>
<time_frame>baseline, immediately after the intervention, one month after the intervention, three months after the intervention</time_frame>
<description>The change of θ phase synchronicity in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.</description>
</primary_outcome>
<primary_outcome>
<measure>The change of theta-gamma phase amplitude coupling(θ-γ PAC)</measure>
<time_frame>baseline, immediately after the intervention, one month after the intervention, three months after the intervention</time_frame>
<description>The change of θ-γ PAC in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.</description>
</primary_outcome>
<secondary_outcome>
<measure>The change of working memory</measure>
<time_frame>baseline, immediately after the intervention, one month after the intervention, three months after the intervention</time_frame>
<description>The change of working memory will be measured by the two-back task.</description>
</secondary_outcome>
<secondary_outcome>
<measure>DA metabolic rate</measure>
<time_frame>baseline</time_frame>
<description>DA metabolism was measured by Positron Emission Computed Tomography</description>
</secondary_outcome>
<secondary_outcome>
<measure>The change of decision-making ability</measure>
<time_frame>baseline, immediately after the intervention, one month after the intervention, three months after the intervention</time_frame>
<description>The change of decision-making ability will be measured by the Balloon Analog Risk Task.</description>
</secondary_outcome>
<other_outcome>
<measure>The The change of depression</measure>
<time_frame>baseline, immediately after the intervention, one month after the intervention, three months after the intervention</time_frame>
<description>Depression will be measured by the Patient Health Questionnaire-9(PHQ-9). The total score of PHQ-9 ranged from 0 to 27, in which higher scores mean a higher level of depression.</description>
</other_outcome>
<other_outcome>
<measure>The change of anxiety</measure>
<time_frame>baseline, immediately after the intervention, one month after the intervention, three months after the intervention</time_frame>
<description>Anxiety will be measured by the questionnaire of Generalized Anxiety Disorder(GAD-7). The total score of GAD-7 ranged from 0 to 21, in which higher scores mean a higher level of anxiety.</description>
</other_outcome>
<number_of_arms>5</number_of_arms>
<enrollment type="Anticipated">210</enrollment>
<condition>Substance Dependence</condition>
<condition>Executive Function Disorder</condition>
<condition>Transcranial Alternating Current Stimulation</condition>
<arm_group>
<arm_group_label>Healthy control group</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>No intervention is conducted in the healthy control group.</description>
</arm_group>
<arm_group>
<arm_group_label>Intervention group of amphetamine addiction</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>A 20-minute tACS intervention of real-stimulus is conducted twice a day for a total of 10 days in the intervention group of amphetamine addiction.</description>
</arm_group>
<arm_group>
<arm_group_label>Control group of amphetamine addiction</arm_group_label>
<arm_group_type>Sham Comparator</arm_group_type>
<description>A 20-minute tACS intervention of sham-stimulus is conducted twice a day for a total of 10 days in the control group of amphetamine addiction.</description>
</arm_group>
<arm_group>
<arm_group_label>Intervention group of alcohol addiction</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>A 20-minute tACS intervention of real-stimulus is conducted twice a day for a total of 10 days in the intervention group of alcohol addiction.</description>
</arm_group>
<arm_group>
<arm_group_label>Control group of alcohol addiction</arm_group_label>
<arm_group_type>Sham Comparator</arm_group_type>
<description>A 20-minute tACS intervention of sham-stimulus is conducted twice a day for a total of 10 days in the control group of alcohol addiction.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Transcranial alternating current stimulation-true stimulus</intervention_name>
<description>The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively. Before the intervention, the individual alpha frequency (IAF) of the subjects was measured according to the average peak value of α waves at dorsolateral prefrontal cortex in the closed state. Then an alternating current at θ frequency (θ = IAF - 5Hz) was applied to each subject based on its IAF value. The amplitude of stimulation was increased with a step of 20μA starting from 0. When the subjects had a slight prickling sensation or optical illusion, the stimulation current was decreased with a step of 20μA until the sensation disappeared. The current value at this time was used as the stimulation current of the subjects.</description>
<arm_group_label>Intervention group of alcohol addiction</arm_group_label>
<arm_group_label>Intervention group of amphetamine addiction</arm_group_label>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Transcranial alternating current stimulation-sham stimulus</intervention_name>
<description>The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively. The actual stimulation waveform was just implemented in the first 60 s (or more longer) and then faded out.</description>
<arm_group_label>Control group of alcohol addiction</arm_group_label>
<arm_group_label>Control group of amphetamine addiction</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Aged 18-60, male or female, with 9 or more years of education, and able to complete
questionnaire evaluation and behavioral tests

- Meet DSM-5 diagnostic criteria for amphetamine-type substance addiction or alcohol
addiction

- Have used amphetamine or alcohol for at least one year (at least once a week)

- Normal vision and hearing, or within the normal range after correction

- Agree to cooperate in the follow-up evaluation

- No metal implantation in the head, no history of nerve problems or head injury, and no
skin sensitivity

Exclusion Criteria:

- Have severe cognitive impairment, such as a history of head trauma, cerebrovascular
disease, epilepsy, etc.

- Have used drugs promoting cognitive function in the last 6 months

- Have impaired intelligence (IQ<70)

- Abuse or dependence of other psychoactive substances (except nicotine) in the last 5
years
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Jiang Du</last_name>
<phone>021-64906315</phone>
<email>dujiangdou@163.com</email>
</overall_contact>
<location>
<facility>
<name>Shanghai Mental Health Center</name>
<address>
<city>Shanghai</city>
<state>Shanghai</state>
<zip>200000</zip>
<country>China</country>
</address>
</facility>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>January 2022</verification_date>
<study_first_submitted>March 5, 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>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>
<keyword>Substance dependence</keyword>
<keyword>Execution-control dysfunction</keyword>
<keyword>Synchronization</keyword>
<keyword>Transcranial alternating current stimulation</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Substance-Related Disorders</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The investigators assume that tACS could improve amphetamine and alcohol dependent patients'
executive-control function by adjusting the synchronization patterns and enhancing the
functional connectivity of the prefrontal-ventral striatum pathway. A random controlled trial
will be used to test the effect of θ-tACS treatment. Three months follow-up assessment will
be conducted to test the changing of executive-control function and its mechanism.
Substance abuse has become a major social and public health problem in China, especially for
amphetamine abuse and alcohol abuse. Executive-control dysfunction is the main symptom for
substance dependents. Previous studies have demonstrated the relationship between cognitive
dysfunction and prefrontal-ventral striatum pathway. Studies have shown that abnormal phase
synchronization and phase-amplitude coupling (PAC) induced the impairment of cognitive, and
tACS could improve executive-control function by adjusting the abnormal synchronization. But
it has not been verified among MA or alcohol patients. The investigators assume that tACS
could improve MA and alcohol dependent patients' executive-control function by adjusting the
synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral
striatum pathway. A random controlled trial will be used to test the effect of θ-tACS
treatment. Three months follow-up assessment will be conducted to test the changing of
executive-control function and its mechanism. This study will provide a practical and
theoretical basis for developing a novel treatment for substance dependents.
Inclusion Criteria:
- Aged 18-60, male or female, with 9 or more years of education, and able to complete
questionnaire evaluation and behavioral tests
- Meet DSM-5 diagnostic criteria for amphetamine-type substance addiction or alcohol
addiction
- Have used amphetamine or alcohol for at least one year (at least once a week)
- Normal vision and hearing, or within the normal range after correction
- Agree to cooperate in the follow-up evaluation
- No metal implantation in the head, no history of nerve problems or head injury, and no
skin sensitivity
Exclusion Criteria:
- Have severe cognitive impairment, such as a history of head trauma, cerebrovascular
disease, epilepsy, etc.
- Have used drugs promoting cognitive function in the last 6 months
- Have impaired intelligence (IQ<70)
- Abuse or dependence of other psychoactive substances (except nicotine) in the last 5
years
|
NCT0531xxxx/NCT05312372.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/NCT05312372</url>
</required_header>
<id_info>
<org_study_id>CL1-95033-002</org_study_id>
<secondary_id>2022-000250-29</secondary_id>
<nct_id>NCT05312372</nct_id>
</id_info>
<brief_title>S095033 in Combination With Paclitaxel as 2nd- or 3rd-line Treatment in Participants With Advanced or Metastatic ESCC</brief_title>
<official_title>A Phase 1/2, Open -Label, Multicenter Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antineoplastic Activity of S095033 (MAT2A Inhibitor) in Combination With Paclitaxel in Participants With Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)</official_title>
<sponsors>
<lead_sponsor>
<agency>Institut de Recherches Internationales Servier</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>ADIR, a Servier Group company</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>Servier</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to determinate the safety profile, tolerability,
pharmacokinetics, and preliminary antineoplastic activity of S095033 in combination with
paclitaxel in participants with advanced or metastatic esophageal squamous cell carcinoma
(ESCC)
</textblock>
</brief_summary>
<overall_status>Withdrawn</overall_status>
<why_stopped>
Strategic development reasons
</why_stopped>
<start_date type="Anticipated">May 2025</start_date>
<completion_date type="Anticipated">June 2026</completion_date>
<primary_completion_date type="Anticipated">June 2026</primary_completion_date>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Dose-limiting toxicities (DLTs) associated with S095033 administration during the first cycle of treatment (Phase 1)</measure>
<time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
<description>DLTs observed during a 28-day period</description>
</primary_outcome>
<primary_outcome>
<measure>Adverse events (AEs) (Phase 1)</measure>
<time_frame>up to 28 days after the last IMP administration (for all AEs) or up to 4 years (for all SAE related to the research)</time_frame>
<description>Including adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAE, version 5.0</description>
</primary_outcome>
<primary_outcome>
<measure>Changes in laboratory assessments (hematology and blood biochemistry) (Phase 1)</measure>
<time_frame>Screening, Day1(D1) D8 D15 and D22 from Cycle 1 to Cycle 4 (each cycle is 28 days),D1 and D15 from Cycle 5 (each cycle is 28 days) up to 28 days after the last IMP administration</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Changes in physical examination and in performance status (ECOG) (Phase 1)</measure>
<time_frame>Screening, D1 and D15 of Cycle 1, D1 for all the remaining cycles up to 28 days after the last IMP administration</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Abnormalities in 12-lead ECG parameters (Phase 1)</measure>
<time_frame>Screening, D1 and D2 of Cycle 1, D1 for all the following cycles until withdrawal visit (within 5 days after the last IMP administration)</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Changes in vital signs: SBP, DBP, respiratory rate and temperature (Phase 1)</measure>
<time_frame>Screening, D1 D8 D15 and D22 of Cycle 1, D1 for all the following cycles up to 28 days after the last IMP administration</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Objective response per central review of antitumor activity (using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) (Phase 2)</measure>
<time_frame>Screening,and after the completion of every 2 cycles until disease progression</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>The PK (pharmacokinetic) profile of S095033 and paclitaxel plasma concentration : Area under the plasma concentration-time curve (AUC) (Phase 1 and phase 2)</measure>
<time_frame>D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>The PK profile of S095033 and paclitaxel plasma concentration : Time to maximum concentration (Tmax) (Phase 1 and phase 2)</measure>
<time_frame>D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>The PK profile of S095033 and paclitaxel plasma concentration : Maximum plasma concentration (Cmax) (Phase 1 and phase 2)</measure>
<time_frame>D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>The PK profile of S095033 and paclitaxel plasma concentration : Trough concentation (Ctrough) (Phase 1 and phase 2)</measure>
<time_frame>: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>The PK profile of S095033 and paclitaxel plasma concentration : Half time (t1/2) (Phase 1 and phase 2)</measure>
<time_frame>D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>The PK profile of S095033 and paclitaxel plasma concentration :apparent volume of distribution (Vd/F) (Phase 1 and phase 2)</measure>
<time_frame>D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>The PK profile of S095033 and paclitaxel plasma concentration :apparent clearance (CL/F) (Phase 1 and phase 2)</measure>
<time_frame>D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in plasma concentration of S-adenosylmethionine (SAM) and methionine (Phase 1 and phase 2)</measure>
<time_frame>D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until withdrawal visit (within 5 days after the last IMP administration)</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Objective response per Investigator assessment of antitumor activity (using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) (Phase 1 and phase 2)</measure>
<time_frame>Screening, and after the completion of every 2 cycles until disease progression</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Clinical Benefit (CB) (Phase 1 and phase 2)</measure>
<time_frame>Screening, and after the completion of every 2 cycles until disease progression</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of response (DOR) (Phase 1 and phase 2)</measure>
<time_frame>Screening, and after the completion of every 2 cycles until disease progression</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Progression-free survival (PFS) (Phase 1 and phase 2)</measure>
<time_frame>Screening, and after the completion of every 2 cycles until disease progression</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Overall survival (OS) (Phase 1 and phase 2)</measure>
<time_frame>Screening, and after the completion of every 2 cycles up to 6 months after the last IMP administration</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Time To Response (TTR) (Phase 1 and phase 2)</measure>
<time_frame>Screening, and after the completion of every 2 cycles until the first occurrence of a complete response (CR) or partial response (PR), whichever occurs first</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Adverse events (AEs) (Phase 2)</measure>
<time_frame>up to 28 days after the last IMP administration (for all AEs) or up to 4 years (for all SAE related to the research)</time_frame>
<description>Including adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAE, version 5.0</description>
</secondary_outcome>
<secondary_outcome>
<measure>DLT associated with S095033 administration during the first cycle of treatment (Phase 2)</measure>
<time_frame>At the end of Cycle1 (each cycle is 28 days)</time_frame>
<description>DLTs observed during a 28-day period</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in laboratory assessments (hematology and blood biochemistry ) (Phase 2)</measure>
<time_frame>Screening, D1, D8 D15 and D22 from Cycle 1 to Cycle 4 (each cycle is 28 days), D1 and D15 from Cycle 5 (each cycle is 28 days) up to 28 days after the last IMP administration</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in physical examination and in performance status (ECOG) (Phase 2)</measure>
<time_frame>Screening, D1 and D15 of Cycle 1, D1 for all the remaining cycles up to 28 days after the last IMP administration</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Abnormalities in 12-lead ECG parameters (Phase 2)</measure>
<time_frame>Screening, D1 and D2 of Cycle 1, D1 for all the following cycles until withdrawal visit (within 5 days after the last IMP administration)</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in vital signs : SBP, DBP, respiratory rate and temperature (Phase 2)</measure>
<time_frame>Screening, D1 D8 D15 and D22 of Cycle 1, D1 for all the following cycles up to 28 days after the last IMP administration</time_frame>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">0</enrollment>
<condition>Esophageal Squamous Cell Carcinoma</condition>
<arm_group>
<arm_group_label>S095033 in combination with paclitaxel</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Dose escalation - phase 1: S095033 will be administrated at dose of 100 mg,150 mg or 200 mg everyday during a 28-day cycle. The participants will also receive paclitaxel intravenously on D1, D8 and D15 last for 28 days.
Dose expansion - phase 2: Participants with MTAP-deletion and those with MTAP-wild type tumors will be evaluated in separate and independent dose expansion subpopulations.S095033 will be administrated every day during a 28-day cycle at recommended phase 2 dose (RP2D). Paclitaxel given intravenously on D1, D8, and D15 during a 28-day cycle.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Combination (S095033 + paclitaxel)</intervention_name>
<description>Phase 1- dose escalation S095033 ; paclitaxel started at 80 mg/m²,(IV)
Phase 2 - S095033 at RP2D; paclitaxel started at 80 mg/m²,(IV)</description>
<arm_group_label>S095033 in combination with paclitaxel</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Male or female participant aged ≥ 18 years of age.

2. Estimated life expectancy ≥12 weeks.

3. Eastern Cooperative Oncology Group (ECOG) performance status < 2.

4. Women of childbearing potential (WOCBP) must use a highly effective method of birth
control during study treatment until at least 6 months after the last dose of
investigational medicinal product (IMP). In case of use of oral contraception, women
should have been stable on the same contraceptive drug (i.e. same active principle)
for at least 3 months prior to the first IMP administration.

5. Male participants with WOCBP partners must use a condom during the study and until at
least 6 months after the last dose of IMP. In addition, contraception should be
considered for their female partners. Contraceptive measures do not apply if the
participant is sterile, vasectomized or sexually abstinent. Sperm donation will not be
allowed during the study and for 6 months after the last dose of IMP.

6. Obtained informed consent (ICF) prior to any study-specific procedure.

7. Participants with histologically confirmed advanced or metastatic esophageal squamous
cell carcinoma that has failed to respond to or has progressed after treatment with
standard fluorouracil and platinum-based chemotherapy, or with an anti-PD1 or PD-L1
antibody and not previously treated with a taxane.

8. Participants who have received one or two prior lines of systemic therapy.

9. Documented progression on prior line of therapy.

10. Participants must have at least one measurable lesion, as defined by Response
Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors.

11. For participants with MTAP deletion, evidence of homozygous loss of MTAP in archival
or fresh tumor tissue.

12. For participants with MTAP wild type, evidence of the presence of MTAP in archival or
fresh tumor tissue.

13. Adequate hematological function based on the last assessment performed within 7 days
prior to the first IMP administration.

14. Adequate coagulation function for all participants. For participants receiving anti-
coagulant therapy (except platelet anti-aggregants), the adequate therapeutic levels
of INR should be confirmed.

15. Adequate renal function based on the last assessment performed within 7 days prior to
the first IMP administration.

16. Adequate hepatic function based on the last assessment performed within 7 days prior
to the first IMP administration.

17. Serum albumin ≥ 3 g/dL.

Exclusion Criteria:

1. Non-ability to swallow oral medication.

2. Pregnant and lactating women.

3. WOCBP tested positive in a pregnancy test within 7 days prior to the first day of IMP
administration.

4. Participation in another interventional study at the same time or within 2 weeks prior
to the first IMP administration.

5. Participant already enrolled in the study (informed consent signed) and having
received at least 1 dose of S095033 and/or paclitaxel.

6. Known prior severe hypersensitivity to investigational products or any component in
their formulations.

7. Participants who have not recovered from toxicity of previous anticancer therapy,
including Grade ≥ 1 non-hematologic toxicity, according to the National Cancer
Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) version 5.0, prior
to the first IMP administration.

8. Major surgery within 4 weeks prior to the first IMP administration or participants who
have not recovered from side effects of the surgery.

9. Participants who do not have a biopsy (or sections of it) available or readily
obtainable for central confirmation of MTAP status.

10. Have a history of Gilbert's syndrome.

11. History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula
within 6 months prior to randomization.

12. Apparent tumor invasion into organs located adjacent to the esophageal disease site
(e.g. aorta or respiratory tract) at an increased risk of fistula in the study
treatment assessed by investigator.

13. Have a degenerative retinal disease that could increase the risk for visual loss with
S095033 or confound the interpretation of retinal changes in the course of S095033
treatment.

14. Severe or uncontrolled active acute or chronic infection.

15. Participants with a known clinically significant cardiovascular disease or condition.

16. Participants with thrombosis, or a history of deep vein thrombosis or pulmonary
embolism, within 4 weeks prior to first IMP administration.

17. Symptoms suggesting central nervous system involvement, including symptomatic
metastasis, for which treatment is required.

18. Participants who have received systemic anticancer treatment or radiotherapy less than
2 weeks before the first dose of S095033.

19. Any clinically significant medical condition (e.g. organ dysfunction) or laboratory
abnormality likely to jeopardize the participant's safety or to interfere with the
conduct of the study, in the investigator's opinion.

20. Any contraindication to the use of paclitaxel as per standard labelling and local
guidance.

21. For prior and forbidden concomitant medication.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<link>
<url>http://clinicaltrials.servier.com/</url>
<description>Find Results on Servier Clinical Trial Data website</description>
</link>
<verification_date>December 2022</verification_date>
<study_first_submitted>March 4, 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>December 5, 2022</last_update_submitted>
<last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">December 7, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Carcinoma</mesh_term>
<mesh_term>Carcinoma, Squamous Cell</mesh_term>
<mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Paclitaxel</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.
In addition, access can be requested for all interventional clinical studies in patients:
sponsored by Servier.
with a first patient enrolled as of 1 January 2004 onwards.
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
<ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
<ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
<ipd_time_frame>After Marketing Authorisation in EEA or US if the study is used for the approval.</ipd_time_frame>
<ipd_access_criteria>Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.</ipd_access_criteria>
<ipd_url>http://clinicaltrials.servier.com/</ipd_url>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to determinate the safety profile, tolerability,
pharmacokinetics, and preliminary antineoplastic activity of S095033 in combination with
paclitaxel in participants with advanced or metastatic esophageal squamous cell carcinoma
(ESCC)
Inclusion Criteria:
1. Male or female participant aged ≥ 18 years of age.
2. Estimated life expectancy ≥12 weeks.
3. Eastern Cooperative Oncology Group (ECOG) performance status < 2.
4. Women of childbearing potential (WOCBP) must use a highly effective method of birth
control during study treatment until at least 6 months after the last dose of
investigational medicinal product (IMP). In case of use of oral contraception, women
should have been stable on the same contraceptive drug (i.e. same active principle)
for at least 3 months prior to the first IMP administration.
5. Male participants with WOCBP partners must use a condom during the study and until at
least 6 months after the last dose of IMP. In addition, contraception should be
considered for their female partners. Contraceptive measures do not apply if the
participant is sterile, vasectomized or sexually abstinent. Sperm donation will not be
allowed during the study and for 6 months after the last dose of IMP.
6. Obtained informed consent (ICF) prior to any study-specific procedure.
7. Participants with histologically confirmed advanced or metastatic esophageal squamous
cell carcinoma that has failed to respond to or has progressed after treatment with
standard fluorouracil and platinum-based chemotherapy, or with an anti-PD1 or PD-L1
antibody and not previously treated with a taxane.
8. Participants who have received one or two prior lines of systemic therapy.
9. Documented progression on prior line of therapy.
10. Participants must have at least one measurable lesion, as defined by Response
Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors.
11. For participants with MTAP deletion, evidence of homozygous loss of MTAP in archival
or fresh tumor tissue.
12. For participants with MTAP wild type, evidence of the presence of MTAP in archival or
fresh tumor tissue.
13. Adequate hematological function based on the last assessment performed within 7 days
prior to the first IMP administration.
14. Adequate coagulation function for all participants. For participants receiving anti-
coagulant therapy (except platelet anti-aggregants), the adequate therapeutic levels
of INR should be confirmed.
15. Adequate renal function based on the last assessment performed within 7 days prior to
the first IMP administration.
16. Adequate hepatic function based on the last assessment performed within 7 days prior
to the first IMP administration.
17. Serum albumin ≥ 3 g/dL.
Exclusion Criteria:
1. Non-ability to swallow oral medication.
2. Pregnant and lactating women.
3. WOCBP tested positive in a pregnancy test within 7 days prior to the first day of IMP
administration.
4. Participation in another interventional study at the same time or within 2 weeks prior
to the first IMP administration.
5. Participant already enrolled in the study (informed consent signed) and having
received at least 1 dose of S095033 and/or paclitaxel.
6. Known prior severe hypersensitivity to investigational products or any component in
their formulations.
7. Participants who have not recovered from toxicity of previous anticancer therapy,
including Grade ≥ 1 non-hematologic toxicity, according to the National Cancer
Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) version 5.0, prior
to the first IMP administration.
8. Major surgery within 4 weeks prior to the first IMP administration or participants who
have not recovered from side effects of the surgery.
9. Participants who do not have a biopsy (or sections of it) available or readily
obtainable for central confirmation of MTAP status.
10. Have a history of Gilbert's syndrome.
11. History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula
within 6 months prior to randomization.
12. Apparent tumor invasion into organs located adjacent to the esophageal disease site
(e.g. aorta or respiratory tract) at an increased risk of fistula in the study
treatment assessed by investigator.
13. Have a degenerative retinal disease that could increase the risk for visual loss with
S095033 or confound the interpretation of retinal changes in the course of S095033
treatment.
14. Severe or uncontrolled active acute or chronic infection.
15. Participants with a known clinically significant cardiovascular disease or condition.
16. Participants with thrombosis, or a history of deep vein thrombosis or pulmonary
embolism, within 4 weeks prior to first IMP administration.
17. Symptoms suggesting central nervous system involvement, including symptomatic
metastasis, for which treatment is required.
18. Participants who have received systemic anticancer treatment or radiotherapy less than
2 weeks before the first dose of S095033.
19. Any clinically significant medical condition (e.g. organ dysfunction) or laboratory
abnormality likely to jeopardize the participant's safety or to interfere with the
conduct of the study, in the investigator's opinion.
20. Any contraindication to the use of paclitaxel as per standard labelling and local
guidance.
21. For prior and forbidden concomitant medication.
|
NCT0531xxxx/NCT05312385.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/NCT05312385</url>
</required_header>
<id_info>
<org_study_id>SED003</org_study_id>
<nct_id>NCT05312385</nct_id>
</id_info>
<brief_title>Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)</brief_title>
<acronym>INSPiRE-ICU1</acronym>
<official_title>A Phase 3, Multicenter, Randomized, Controlled, Open Label, Assessor-Blinded Study to Evaluate the Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)</official_title>
<sponsors>
<lead_sponsor>
<agency>Sedana Medical</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Sedana Medical</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This is a study to compare safety and efficacy of inhaled isoflurane administered via the
Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically
ventilated patients in the Intensive Care Unit (ICU) setting.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This is a phase 3, multicenter, randomized, controlled, open-label, assessor-blinded study to
evaluate the efficacy and safety of inhaled isoflurane delivered via the Sedaconda ACD-S
compared to intravenous propofol for sedation of mechanically ventilated Intensive Care Unit
(ICU) adult patients.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 28, 2022</start_date>
<completion_date type="Anticipated">April 30, 2024</completion_date>
<primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Percentage of time adequate sedation depth</measure>
<time_frame>During study treatment up to 48 (±6) hours</time_frame>
<description>To compare the percentage of time sedation depth is maintained within the target range, in absence of rescue sedation, as assessed according to the RASS scale, in isoflurane- vs propofol-treated patients</description>
</primary_outcome>
<secondary_outcome>
<measure>Key Secondary: Compare the use of opioids</measure>
<time_frame>During study treatment up to 48 (±6) hours</time_frame>
<description>To compare the effect of isoflurane vs propofol on use of opioids during the study drug treatment period measuring CPOT</description>
</secondary_outcome>
<secondary_outcome>
<measure>Key Secondary: Compare the wake up time</measure>
<time_frame>End of study treatment (EOT)</time_frame>
<description>To compare the effect of isoflurane vs propofol on the wake up time at end of study drug treatment</description>
</secondary_outcome>
<secondary_outcome>
<measure>Key Secondary: Compare the cognitive recovery after EOT</measure>
<time_frame>60 minutes after EOT</time_frame>
<description>To compare the effect of isoflurane vs propofol on cognitive recovery after EOT by measuring CAM-ICU-7</description>
</secondary_outcome>
<secondary_outcome>
<measure>Key Secondary: Compare the spontaneous breathing effort</measure>
<time_frame>During study treatment up to 48 (±6) hours</time_frame>
<description>To compare the effect of isoflurane vs propofol on spontaneous breathing effort during the study drug treatment period by measuring
• Airway occlusion pressure, pressure support or if observed respiratory rate exceeds set respiratory rate</description>
</secondary_outcome>
<secondary_outcome>
<measure>Other secondary: Compare time from sedation termination to extubation</measure>
<time_frame>During study treatment</time_frame>
<description>To compare the effect of isoflurane vs propofol on time from sedation termination to extubation in patients for whom study drug is terminated for extubation</description>
</secondary_outcome>
<secondary_outcome>
<measure>Other secondary: Compare days alive and free of mechanical ventilation through Study Day 30</measure>
<time_frame>From start of study treatment up to 30 days</time_frame>
<description>To compare the effect of isoflurane vs propofol on days alive and free of mechanical ventilation through Study Day 30</description>
</secondary_outcome>
<secondary_outcome>
<measure>Other secondary: Compare days alive and free of the ICU</measure>
<time_frame>From start of study treatment up to 30 days</time_frame>
<description>To compare the effect of isoflurane vs propofol on days alive and free of the ICU</description>
</secondary_outcome>
<secondary_outcome>
<measure>Other secondary: Compare delirium and coma free days until 7 days after EOT</measure>
<time_frame>From start of study treatment until 7 days after EOT</time_frame>
<description>To compare the effect of isoflurane vs propofol on delirium and coma free days until 7 days after EOT</description>
</secondary_outcome>
<secondary_outcome>
<measure>Other secondary: Compare mortality at 30 days after randomization</measure>
<time_frame>Until 30 days after randomization</time_frame>
<description>To compare the effect of isoflurane vs propofol on mortality at 30 days after randomization</description>
</secondary_outcome>
<secondary_outcome>
<measure>Other secondary: Compare mortality at 3 months after randomization</measure>
<time_frame>Until 3 months after randomization</time_frame>
<description>To compare the effect of isoflurane vs propofol on mortality at 3 months after randomization</description>
</secondary_outcome>
<secondary_outcome>
<measure>Other secondary: Compare mortality at 6 months after randomization</measure>
<time_frame>Until 6 months after randomization</time_frame>
<description>To compare the effect of isoflurane vs propofol on mortality at 6 months after randomization</description>
</secondary_outcome>
<secondary_outcome>
<measure>Other secondary: To compare the safety profile of isoflurane vs propofol</measure>
<time_frame>Baseline to end of study treatment, safety lab from baseline up to 48hrs post treatment, AEs from start study treatment up to day 30</time_frame>
<description>To compare the safety profile of isoflurane vs propofol in respect to reported Adverse Event</description>
</secondary_outcome>
<secondary_outcome>
<measure>Other secondary: To assess Sedaconda ACD-S device deficiencies in patients receiving isoflurane</measure>
<time_frame>During study treatment up to 48 (±6) hours</time_frame>
<description>To assess Sedaconda ACD-S device deficiencies in patients receiving isoflurane by Sedaconda ACD-S by reported Adverse Event</description>
</secondary_outcome>
<secondary_outcome>
<measure>Other secondary: To compare the use of restraints in patients receiving isoflurane vs propofol</measure>
<time_frame>During study treatment up to 48 (±6) hours</time_frame>
<description>Incidence of restraints measured twice daily</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">235</enrollment>
<condition>Sedation</condition>
<arm_group>
<arm_group_label>Isoflurane</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Inhaled isoflurane administered via Sedaconda ACD-S</description>
</arm_group>
<arm_group>
<arm_group_label>Propofol</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Propofol administered as intravenous infusion</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Isoflurane</intervention_name>
<description>Inhaled isoflurane administered by Sedaconda ACD-S</description>
<arm_group_label>Isoflurane</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Propofol</intervention_name>
<description>Intravenous infusion of propofol</description>
<arm_group_label>Propofol</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Adults ≥18 years of age;

- Patients who are anticipated to require >12 hours of invasive mechanical ventilation
and continuous sedation in the ICU; and

- Receipt of continuous sedation due to clinical need for sedation to RASS <0.

Exclusion Criteria:

- Need for RASS -5;

- Sedation for invasive mechanical ventilation immediately prior to Baseline for >72
hours;

- Severe neurological condition before ICU admission that causes the patient to lack
ability to participate in the study (ie, unable to be assessed for RASS and CPOT);

- Ventilator tidal volume <200 or >1000 mL at Baseline;

- Need for extracorporeal membrane oxygenation (ECMO), extracorporeal CO2 removal
(ECCO2R), high frequency oscillation ventilation (HFOV), or high frequency percussive
ventilation (HFPV) at Screening;

- Comfort care only (end of life care);

- Contraindication to propofol or isoflurane;

- Known or family history of MH;

- Severe hemodynamic compromise, defined as the need for norepinephrine ≥0.3 mcg/kg/min
(or equivalent vasopressor dose) to maintain blood pressure within acceptable range,
assumed to be mean arterial pressure ≥65 mmHg unless prescribed clinically;

- Allergy to isoflurane or propofol, or have propofol infusion syndrome.

- History of ventricular tachycardia/Long QT Syndrome;

- Requirement of IV benzodiazepine or barbiturate administration for seizures or
dependencies, including alcohol withdrawal

- Neuromuscular disease that impairs spontaneous ventilation (eg, C5 or higher spinal
cord injury, amyotrophic lateral sclerosis, etc);

- Concurrent enrollment in another study that, in the Investigator's opinion, would
impact the patient's safety or assessments of this study;

- Participation in other study involving investigational drug(s) or devices(s) within 30
days prior to Randomization;

- Anticipated requirement of treatment with continuous infusion of a neuromuscular
blocking agent for >4 hours;

- Female patients who are pregnant or breast-feeding;

- Imperative need for continuous active humidification through mechanical ventilation
circuit;

- Attending physician's refusal to include the patient; or

- Inability to obtain informed consent.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Kimberly Rengel, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Vanderbilt University Medical Center</affiliation>
</overall_official>
<overall_contact>
<last_name>Magnus Falkenhav, M.D.</last_name>
<phone>+46 70 856 1687</phone>
<email>magnus.falkenhav@sedanamedical.com</email>
</overall_contact>
<location>
<facility>
<name>University of Colorado Anschutz Medical Campus</name>
<address>
<city>Aurora</city>
<state>Colorado</state>
<zip>80045</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>University of Chicago</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<zip>60637</zip>
<country>United States</country>
</address>
</facility>
<status>Not yet recruiting</status>
</location>
<location>
<facility>
<name>Tufts Medical Center</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02111</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>The Brigham and Women´s Hospital</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02115</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Mayo Clinic</name>
<address>
<city>Rochester</city>
<state>Minnesota</state>
<zip>55905</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>The Cleveland Clinic Foundation</name>
<address>
<city>Cleveland</city>
<state>Ohio</state>
<zip>44195</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Vanderbilt University Medical Center</name>
<address>
<city>Nashville</city>
<state>Tennessee</state>
<zip>37232</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>University of Texas Southwestern Medical Center</name>
<address>
<city>Dallas</city>
<state>Texas</state>
<zip>75390</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Houston Methodist Hospital</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77030</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>MD Anderson Cancer Center</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77030</zip>
<country>United States</country>
</address>
</facility>
<status>Not yet recruiting</status>
</location>
<location>
<facility>
<name>Intermountain Health Care Health Services</name>
<address>
<city>Salt Lake City</city>
<state>Utah</state>
<zip>84111</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>University of Virginia</name>
<address>
<city>Charlottesville</city>
<state>Virginia</state>
<zip>22903</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>https://www.medicines.org.uk/emc/product/9800/smpc#gref</url>
<description>Isoflurane 100% inhalation vapour, liquid. Summary of product characteristics. West Drayton, United Kingdon. Piramal Critical Care Ltd. Electronic medicines compendium(emc), last updated 29 October 2019. Accessed 09 September 2020.</description>
</link>
<reference>
<citation>Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.</citation>
<PMID>30113379</PMID>
</reference>
<reference>
<citation>Shehabi Y, Howe BD, Bellomo R, Arabi YM, Bailey M, Bass FE, Bin Kadiman S, McArthur CJ, Murray L, Reade MC, Seppelt IM, Takala J, Wise MP, Webb SA; ANZICS Clinical Trials Group and the SPICE III Investigators. Early Sedation with Dexmedetomidine in Critically Ill Patients. N Engl J Med. 2019 Jun 27;380(26):2506-2517. doi: 10.1056/NEJMoa1904710. Epub 2019 May 19.</citation>
<PMID>31112380</PMID>
</reference>
<reference>
<citation>Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.</citation>
<PMID>10816184</PMID>
</reference>
<reference>
<citation>Mehta S, Burry L, Cook D, Fergusson D, Steinberg M, Granton J, Herridge M, Ferguson N, Devlin J, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Skrobik Y, Hebert P, Sabri E, Meade M; SLEAP Investigators; Canadian Critical Care Trials Group. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial. JAMA. 2012 Nov 21;308(19):1985-92. doi: 10.1001/jama.2012.13872. Erratum In: JAMA. 2013 Jan 16;309(3):237.</citation>
<PMID>23180503</PMID>
</reference>
<reference>
<citation>Sackey PV, Martling CR, Carlsward C, Sundin O, Radell PJ. Short- and long-term follow-up of intensive care unit patients after sedation with isoflurane and midazolam--a pilot study. Crit Care Med. 2008 Mar;36(3):801-6. doi: 10.1097/CCM.0B013E3181652FEE.</citation>
<PMID>18431266</PMID>
</reference>
<reference>
<citation>Mesnil M, Capdevila X, Bringuier S, Trine PO, Falquet Y, Charbit J, Roustan JP, Chanques G, Jaber S. Long-term sedation in intensive care unit: a randomized comparison between inhaled sevoflurane and intravenous propofol or midazolam. Intensive Care Med. 2011 Jun;37(6):933-41. doi: 10.1007/s00134-011-2187-3. Epub 2011 Mar 29.</citation>
<PMID>21445642</PMID>
</reference>
<reference>
<citation>Meiser A, Volk T, Wallenborn J, Guenther U, Becher T, Bracht H, Schwarzkopf K, Knafelj R, Faltlhauser A, Thal SC, Soukup J, Kellner P, Druner M, Vogelsang H, Bellgardt M, Sackey P; Sedaconda study group. Inhaled isoflurane via the anaesthetic conserving device versus propofol for sedation of invasively ventilated patients in intensive care units in Germany and Slovenia: an open-label, phase 3, randomised controlled, non-inferiority trial. Lancet Respir Med. 2021 Nov;9(11):1231-1240. doi: 10.1016/S2213-2600(21)00323-4. Epub 2021 Aug 26.</citation>
<PMID>34454654</PMID>
</reference>
<reference>
<citation>Kong KL, Willatts SM, Prys-Roberts C. Isoflurane compared with midazolam for sedation in the intensive care unit. BMJ. 1989 May 13;298(6683):1277-80. doi: 10.1136/bmj.298.6683.1277.</citation>
<PMID>2500195</PMID>
</reference>
<reference>
<citation>Chanques G, Constantin JM, Devlin JW, Ely EW, Fraser GL, Gelinas C, Girard TD, Guerin C, Jabaudon M, Jaber S, Mehta S, Langer T, Murray MJ, Pandharipande P, Patel B, Payen JF, Puntillo K, Rochwerg B, Shehabi Y, Strom T, Olsen HT, Kress JP. Analgesia and sedation in patients with ARDS. Intensive Care Med. 2020 Dec;46(12):2342-2356. doi: 10.1007/s00134-020-06307-9. Epub 2020 Nov 10.</citation>
<PMID>33170331</PMID>
</reference>
<reference>
<citation>Jerath A, Ferguson ND, Cuthbertson B. Inhalational volatile-based sedation for COVID-19 pneumonia and ARDS. Intensive Care Med. 2020 Aug;46(8):1563-1566. doi: 10.1007/s00134-020-06154-8. Epub 2020 Jun 25.</citation>
<PMID>32588067</PMID>
</reference>
<reference>
<citation>Bellgardt M, Bomberg H, Herzog-Niescery J, Dasch B, Vogelsang H, Weber TP, Steinfort C, Uhl W, Wagenpfeil S, Volk T, Meiser A. Survival after long-term isoflurane sedation as opposed to intravenous sedation in critically ill surgical patients: Retrospective analysis. Eur J Anaesthesiol. 2016 Jan;33(1):6-13. doi: 10.1097/EJA.0000000000000252.</citation>
<PMID>25793760</PMID>
</reference>
<reference>
<citation>Hughes CG, Mailloux PT, Devlin JW, Swan JT, Sanders RD, Anzueto A, Jackson JC, Hoskins AS, Pun BT, Orun OM, Raman R, Stollings JL, Kiehl AL, Duprey MS, Bui LN, O'Neal HR Jr, Snyder A, Gropper MA, Guntupalli KK, Stashenko GJ, Patel MB, Brummel NE, Girard TD, Dittus RS, Bernard GR, Ely EW, Pandharipande PP; MENDS2 Study Investigators. Dexmedetomidine or Propofol for Sedation in Mechanically Ventilated Adults with Sepsis. N Engl J Med. 2021 Apr 15;384(15):1424-1436. doi: 10.1056/NEJMoa2024922. Epub 2021 Feb 2.</citation>
<PMID>33528922</PMID>
</reference>
<reference>
<citation>Krannich A, Leithner C, Engels M, Nee J, Petzinka V, Schroder T, Jorres A, Kruse J, Storm C. Isoflurane Sedation on the ICU in Cardiac Arrest Patients Treated With Targeted Temperature Management: An Observational Propensity-Matched Study. Crit Care Med. 2017 Apr;45(4):e384-e390. doi: 10.1097/CCM.0000000000002185.</citation>
<PMID>27941501</PMID>
</reference>
<reference>
<citation>Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.</citation>
<PMID>18191684</PMID>
</reference>
<reference>
<citation>Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.</citation>
<PMID>24088092</PMID>
</reference>
<verification_date>April 2023</verification_date>
<study_first_submitted>March 11, 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>April 17, 2023</last_update_submitted>
<last_update_submitted_qc>April 17, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">April 18, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>sedation</keyword>
<keyword>mechanical ventilation</keyword>
<keyword>isoflurane</keyword>
<keyword>propofol</keyword>
<keyword>ICU</keyword>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Propofol</mesh_term>
<mesh_term>Isoflurane</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This is a study to compare safety and efficacy of inhaled isoflurane administered via the
Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically
ventilated patients in the Intensive Care Unit (ICU) setting.
This is a phase 3, multicenter, randomized, controlled, open-label, assessor-blinded study to
evaluate the efficacy and safety of inhaled isoflurane delivered via the Sedaconda ACD-S
compared to intravenous propofol for sedation of mechanically ventilated Intensive Care Unit
(ICU) adult patients.
Inclusion Criteria:
- Adults ≥18 years of age;
- Patients who are anticipated to require >12 hours of invasive mechanical ventilation
and continuous sedation in the ICU; and
- Receipt of continuous sedation due to clinical need for sedation to RASS <0.
Exclusion Criteria:
- Need for RASS -5;
- Sedation for invasive mechanical ventilation immediately prior to Baseline for >72
hours;
- Severe neurological condition before ICU admission that causes the patient to lack
ability to participate in the study (ie, unable to be assessed for RASS and CPOT);
- Ventilator tidal volume <200 or >1000 mL at Baseline;
- Need for extracorporeal membrane oxygenation (ECMO), extracorporeal CO2 removal
(ECCO2R), high frequency oscillation ventilation (HFOV), or high frequency percussive
ventilation (HFPV) at Screening;
- Comfort care only (end of life care);
- Contraindication to propofol or isoflurane;
- Known or family history of MH;
- Severe hemodynamic compromise, defined as the need for norepinephrine ≥0.3 mcg/kg/min
(or equivalent vasopressor dose) to maintain blood pressure within acceptable range,
assumed to be mean arterial pressure ≥65 mmHg unless prescribed clinically;
- Allergy to isoflurane or propofol, or have propofol infusion syndrome.
- History of ventricular tachycardia/Long QT Syndrome;
- Requirement of IV benzodiazepine or barbiturate administration for seizures or
dependencies, including alcohol withdrawal
- Neuromuscular disease that impairs spontaneous ventilation (eg, C5 or higher spinal
cord injury, amyotrophic lateral sclerosis, etc);
- Concurrent enrollment in another study that, in the Investigator's opinion, would
impact the patient's safety or assessments of this study;
- Participation in other study involving investigational drug(s) or devices(s) within 30
days prior to Randomization;
- Anticipated requirement of treatment with continuous infusion of a neuromuscular
blocking agent for >4 hours;
- Female patients who are pregnant or breast-feeding;
- Imperative need for continuous active humidification through mechanical ventilation
circuit;
- Attending physician's refusal to include the patient; or
- Inability to obtain informed consent.
|
NCT0531xxxx/NCT05312398.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/NCT05312398</url>
</required_header>
<id_info>
<org_study_id>CAPRI2-MS062202-0123</org_study_id>
<nct_id>NCT05312398</nct_id>
</id_info>
<brief_title>CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen</brief_title>
<official_title>CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio- Marker-driven Cetuximab-based Treatment Regimen Over 3 Treatment Lines in mCRC Patients With RAS/BRAF wt Tumors at Start of First Line</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Campania "Luigi Vanvitelli"</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Campania "Luigi Vanvitelli"</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 clinical program aims to evaluate the activity and efficacy of cetuximab continuation of
treatment for three lines of therapy with rotation of chemotherapy (FOLFIRI, FOLFOX,
irinotecan) in mCRC patients, whose tumors remain RAS/BRAF WT. The study will also evaluate
the activity and efficacy of cetuximab re-introduction in combination with irinotecan as
third line therapy in the concept of re-challenge for those patients that will be treated in
second line with chemotherapy plus anti-angiogenic drugs (FOLFOX plus bevacizumab), having a
RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line
treatment. A novel characteristic of this program is that the therapeutic algorithm will be
defined at each treatment decision (first line, second line and third line) in a prospective
fashion in each patient by liquid biopsy assessment of RAS/BRAF status.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Based on dynamic and longitudinal liquid biopsy assessment of RAS/BRAF status, that will be
prospectively performed before each line of treatment, mCRC patients will be treated with
cetuximab in combination with chemotherapy throughout three lines of therapy, as follows:
FOLFIRI plus cetuximab (first line); FOLFOX plus cetuximab (second line); irinotecan plus
cetuximab (third line) in case of RAS/BRAF WT at each time point of progression. If at
progression after the first line, the liquid biopsy assessment indicates RAS and or BRAF
mutant status, patients will be treated with FOLFOX plus bevacizumab as the second line of
therapy. If at progression after the second line, the liquid biopsy assessment indicates RAS
and or BRAF mutant status, patients will be treated with regorafenib or
trifluridine-tipiracil (investigator's choice), as third line of therapy. Each treatment will
be administered using standard doses and schedules until progression of disease or
unacceptable toxicity.

This study will also evaluate the activity and efficacy of cetuximab re-introduction in
combination with irinotecan as third line therapy in the concept of re-challenge for those
patients that will be treated in second line with FOLFOX plus bevacizumab, having a RAS or
BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line
treatment. A novel characteristic of this program is that the therapeutic algorithm will be
defined at each treatment decision (first line, second line and third line) in a prospective
fashion in each patient by liquid biopsy assessment of RAS/BRAF status
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">July 15, 2021</start_date>
<completion_date type="Anticipated">June 15, 2026</completion_date>
<primary_completion_date type="Anticipated">August 15, 2025</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>RR</measure>
<time_frame>up to 59 months</time_frame>
<description>Response rate (RR) for each line of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with RAS/BRAF wild type (WT) mCRCregimen over 3 treatment lines in patients with RAS/BRAF wild type (WT) mCRC at start of first line therapy</description>
</primary_outcome>
<secondary_outcome>
<measure>PFS</measure>
<time_frame>from 8 weeks to 59 months (from the start of therapy until the first observation of disease progression or death due to any cause)</time_frame>
<description>Progression free survival (PFS) for each line</description>
</secondary_outcome>
<secondary_outcome>
<measure>OS</measure>
<time_frame>up to 59 months</time_frame>
<description>Overall Survival</description>
</secondary_outcome>
<secondary_outcome>
<measure>AE</measure>
<time_frame>from screening up to 59 months</time_frame>
<description>Safety: Adverse events graded according NCI CTCAE v 5.0</description>
</secondary_outcome>
<secondary_outcome>
<measure>EORTC Core Quality of Life questionnaire EORTC QLQ C30</measure>
<time_frame>At screening, for each line of therapy at Week 4, at Week 25 of treatment start and at progression</time_frame>
<description>The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items</description>
</secondary_outcome>
<secondary_outcome>
<measure>DERMATOLOGY LIFE QUALITY INDEX (DLQI)</measure>
<time_frame>at screening, for each line of therapy at Week 4, at Week 25 of treatment start and at progression</time_frame>
<description>The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week.</description>
</secondary_outcome>
<other_outcome>
<measure>Explorative objective: RR for each line of therapy</measure>
<time_frame>from screening up to 23 months</time_frame>
<description>the response rates for each line of therapy of RAS/BRAF WT mCRC patients who will be treated in a continuum of care strategy with cetuximab across all three therapy lines</description>
</other_outcome>
<other_outcome>
<measure>Exploratory objective: cumulative PFS</measure>
<time_frame>from screening up to 23 months</time_frame>
<description>the cumulative progression free survivals of RAS/BRAF WT mCRC patients who will be treated in a continuum of care strategy with cetuximab across all three therapy lines</description>
</other_outcome>
<other_outcome>
<measure>Explorative objective: overall survival</measure>
<time_frame>from screening up to 23 months</time_frame>
<description>overall survival of RAS/BRAF WT mCRC patients who will be treated in a continuum of care strategy with cetuximab across all three therapy lines</description>
</other_outcome>
<other_outcome>
<measure>Translational analyses using next generation sequencing (NGS) technologies</measure>
<time_frame>At day 1 of each line of therapy</time_frame>
<description>Molecular profiles of tumor tissue and liquid biopsy samples (somatic mutations identified in tumor tissue by next generation sequencing) and surrogate markers of treatment activity (changes in molecular profile of liquid biopsies). Translational analyses of tumor biomarkers will be performed
These include mutation in RAS, BRAF, PI3KCA; amplification of HER2, MET and loss of PTEN expression, all of which are implicated in resistance to anti-EGFR treatment.
Moreover, 324 genes NGS panels will provide information regarding potential predictive and prognostic biomarkers of colorectal cancer disease.
Fecal samples will be used for gut microbioma analysis, to understand how the composition of gut microbiome could influence treatment outcome and tolerability.</description>
</other_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">200</enrollment>
<condition>Metastatic Colorectal Adenocarcinoma</condition>
<arm_group>
<arm_group_label>single arm</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>This is an open-label phase II study investigating the efficacy and safety of a bio-marker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line. Based on dynamic and longitudinal liquid biopsy assessment of RAS/BRAF status, that will be prospectively performed before each line of treatment, mCRC patients will be treated with cetuximab in combination with chemotherapy throughout three lines of therapy, as follows:
FOLFIRI plus cetuximab (first line);
FOLFOX plus cetuximab (second line);
irinotecan plus cetuximab (third line).
If at progression after the first line or after the second line, the liquid biopsy assessment indicates RAS and or BRAF mutant status, patients will be treated with FOLFOX plus bevacizumab as second line of therapy, or with regorafenib or with trifluridine-tipiracil (investigator's choice) as third line therapy.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Cetuximab</intervention_name>
<description>I LINE:
- FOLFIRI + cetuximab
FOLFIRI: 200 mg L-folinic acid with 180 mg/ m² irinotecan over 1.30 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.
Cetuximab: 400 mg/m2 initial dose (120-minute IV infusion on cycle 1 day 1), then 250 mg/m2 once weekly thereafter
II LINE:
- FOLFOX + cetuximab
FOLFOX: 200 mg L-folinic acid given concurrently with 85 mg/ m² oxaliplatin over 2 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.
Cetuximab: as I line
THIRD LINE:
- Irinotecan + cetuximab
Irinotecan: 180 mg/ m² irinotecan over 1.30 h, IV infusion every 2 weeks. Cetuximab: as I line</description>
<arm_group_label>single arm</arm_group_label>
<other_name>Erbitux</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>FOLFIRI</intervention_name>
<description>I LINE:
- FOLFIRI + cetuximab
FOLFIRI: 200 mg L-folinic acid given concurrently with 180 mg/ m² irinotecan over 1.30 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.
Cetuximab: 400 mg/m2 initial dose (120-minute IV infusion on cycle 1 day 1), then 250 mg/m2 once weekly thereafter</description>
<arm_group_label>single arm</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>FOLFOX regimen</intervention_name>
<description>II LINE:
- FOLFOX + cetuximab
FOLFOX: 200 mg L-folinic acid given concurrently with 85 mg/ m² oxaliplatin over 2 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.
Cetuximab: as I line</description>
<arm_group_label>single arm</arm_group_label>
<other_name>FOLFOX</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Irinotecan</intervention_name>
<description>III LINE:
- Irinotecan + cetuximab
Irinotecan: 180 mg/ m² irinotecan over 1.30 h, IV infusion every 2 weeks. Cetuximab: as I line</description>
<arm_group_label>single arm</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Histologically proven diagnosis of colorectal adenocarcinoma

2. Diagnosis of metastatic disease

3. RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or
related metastasis

4. Measurable disease according to Response Evaluation Criteria in Solid Tumors RECIST
criteria, vers.1.1)

5. Male or female patients ≥ 18 years of age

6. ECOG Performance Status 0,1

7. Adequate bone marrow, liver and renal function assessed within 14 days before starting
study treatment as defined by the following parameters:

Bone marrow:

- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L

- Hemoglobin (Hgb) ≥ 9 g/dL

- Platelets ≥ 100 x 109/L

Liver function:

• Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) Aspartate aminotransferase
(AST) (serum glutamic oxaloacetic transaminase [SGOT]) and ALT (SGPT) ≤ 2.5 x ULN,
except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x
ULN

Renal function:

• Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min

8. If female and of childbearing potential, have a negative result on a pregnancy test
performed a maximum of 7 days before initiation of study treatment

9. If female and of childbearing potential, or if male, agreement to use adequate
contraception (e.g., abstinence, intrauterine device, oral contraceptive, or
double-barrier method), during the study and until at least 3 months after last dose
of study treatment administration, based on the judgment of the Investigator or a
designated associate

10. Signed informed consent obtained before screening.

Exclusion Criteria:

1. Any contraindication to the use of cetuximab, Irinotecan, 5-FU, oxaliplatin, folinic
acid,bevacizumab, trifluridine-tipiracil, regorafenib

2. Active uncontrolled infections, active disseminated intravascular coagulation or
history of interstitial lung disease

3. Past or current history of malignancies other than colorectal carcinoma, except for
curatively treated basal and squamous cell carcinoma of the skin cancer or in situ
carcinoma of the cervix

4. Pregnancy (exclusion to be ascertained by a beta hCG test)

5. Breastfeeding

6. Fertile women (<2 years after last menstruation) and men of childbearing potential not
willing to use effective means of contraception•

7. Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or
without stenting within the past 12 months before inclusion in the study, Grade III or
IV heart failure (NYHA classification)

8. Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta
blockers or digoxin

9. Medical or psychological impairments associated with restricted ability to give
consent or not allowing conduct of the study

10. Previous chemotherapy for the colorectal cancer with the exception of adjuvant
treatment, completed at least 6 months before entering the study

11. Participation in a clinical study or experimental drug treatment within 30 days prior
to study inclusion or during participation in the study

12. Known or clinically suspected brain metastases

13. History of acute or subacute intestinal occlusion or chronic inflammatory bowel
disease or chronic diarrhoea

14. Severe, non-healing wounds, ulcers or bone fractures

15. Uncontrolled hypertension

16. Marked proteinuria (nephrotic syndrome)

17. Known DPD deficiency (specific screening not required)

18. Known history of alcohol or drug abuse

19. A significant concomitant disease which, in the investigating physician's opinion,
rules out the patient's participation in the study

20. Absent or restricted legal capacity
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Fortunato Ciardiello</last_name>
<role>Principal Investigator</role>
<affiliation>A.O.U. dell'Università degli studi della Campania "Luigi Vanvitelli"</affiliation>
</overall_official>
<overall_contact>
<last_name>Fortunato Ciardiello</last_name>
<phone>0815666760</phone>
<email>fortunato.ciardiello@unicampania.it</email>
</overall_contact>
<overall_contact_backup>
<last_name>Giulia Martini</last_name>
<phone>0815666729</phone>
<email>giulia.martini@unicampania.it</email>
</overall_contact_backup>
<location>
<facility>
<name>A.O.U. Ospedali Riuniti</name>
<address>
<city>Ancona</city>
<state>AN</state>
<country>Italy</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>Ente Ecclesiastico Ospedale Generale Regionale 'F. Miulli'</name>
<address>
<city>Acquaviva Delle Fonti</city>
<state>BA</state>
<country>Italy</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>IRCCS Istituto Tumori 'Giovanni Paolo II'</name>
<address>
<city>Bari</city>
<state>BA</state>
<country>Italy</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>Ospedale IRCCS 'Saverio de Bellis'</name>
<address>
<city>Castellana Grotte</city>
<state>BA</state>
<country>Italy</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>Ospedale Sacro Cuore di Gesù - FATEBENEFRATELLI</name>
<address>
<city>Benevento</city>
<state>BN</state>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Antonio Febbraro</last_name>
</contact>
</location>
<location>
<facility>
<name>P.O. Antonio Perrino</name>
<address>
<city>Brindisi</city>
<state>BR</state>
<country>Italy</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>A.O.U. Cagliari - Presidio Policlinico D. Casula</name>
<address>
<city>Monserrato</city>
<state>CA</state>
<country>Italy</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>A.R.N.A.S. Garibaldi - P.O. Garibaldi-Nesima</name>
<address>
<city>Catania</city>
<state>CT</state>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Roberto Bordonaro</last_name>
</contact>
</location>
<location>
<facility>
<name>A.O.U. Mater Domini</name>
<address>
<city>Catanzaro</city>
<state>CZ</state>
<country>Italy</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Pierosandro Tagliaferri</last_name>
</contact>
</location>
<location>
<facility>
<name>Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza</name>
<address>
<city>San Giovanni Rotondo</city>
<state>FG</state>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Evaristo Maiello</last_name>
</contact>
</location>
<location>
<facility>
<name>P.O. 'Vito Fazzi'</name>
<address>
<city>Lecce</city>
<state>LE</state>
<country>Italy</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>A.O. 'Pia Fondazione Cardinale G. Panico'</name>
<address>
<city>Tricase</city>
<state>LE</state>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Emiliano Tamburini</last_name>
</contact>
</location>
<location>
<facility>
<name>Istituto Europeo di Oncologia</name>
<address>
<city>Milano</city>
<state>MI</state>
<country>Italy</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Maria Giulia Zampino</last_name>
</contact>
</location>
<location>
<facility>
<name>A.O.U. Policlinico 'P. Giaccone'</name>
<address>
<city>Palermo</city>
<state>PA</state>
<country>Italy</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>Istituto Oncologico Veneto IRCCS</name>
<address>
<city>Padova</city>
<state>PD</state>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Sara Lonardi</last_name>
</contact>
</location>
<location>
<facility>
<name>A.O.U. Pisana</name>
<address>
<city>Pisa</city>
<state>PI</state>
<country>Italy</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>A.O. San Carlo</name>
<address>
<city>Potenza</city>
<state>PZ</state>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Gerardo Rosati</last_name>
</contact>
</location>
<location>
<facility>
<name>A.U.S.L. - IRCCS di Reggio Emilia - P.O. Arcispedale S.Maria Nuova</name>
<address>
<city>Reggio Emilia</city>
<state>RE</state>
<country>Italy</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>A.S.P. Ragusa - Ospedale Maria Paternò Arezzo</name>
<address>
<city>Ragusa</city>
<state>RG</state>
<country>Italy</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Stefano Cordio</last_name>
</contact>
</location>
<location>
<facility>
<name>A.O. San Camillo-Forlanini</name>
<address>
<city>Roma</city>
<state>RM</state>
<country>Italy</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS</name>
<address>
<city>Roma</city>
<state>RM</state>
<country>Italy</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>Ospedale San Giuseppe Moscati</name>
<address>
<city>Statte</city>
<state>TA</state>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Salvatore Pisconti</last_name>
</contact>
</location>
<location>
<facility>
<name>A.O. Ordine Mauriziano</name>
<address>
<city>Torino</city>
<state>TO</state>
<country>Italy</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>A.O.U. dell'Università degli studi della Campania "Luigi Vanvitelli"</name>
<address>
<city>Napoli</city>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Fortunato Ciardiello</last_name>
</contact>
</location>
<location>
<facility>
<name>Istituto Nazionale Tumori 'Fondazione G. Pascale'</name>
<address>
<city>Napoli</city>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Antonio Avallone</last_name>
</contact>
</location>
<location_countries>
<country>Italy</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 1, 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>March 28, 2022</last_update_submitted>
<last_update_submitted_qc>March 28, 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>University of Campania "Luigi Vanvitelli"</investigator_affiliation>
<investigator_full_name>Fortunato Ciardiello</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Adenocarcinoma</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Irinotecan</mesh_term>
<mesh_term>Cetuximab</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This clinical program aims to evaluate the activity and efficacy of cetuximab continuation of
treatment for three lines of therapy with rotation of chemotherapy (FOLFIRI, FOLFOX,
irinotecan) in mCRC patients, whose tumors remain RAS/BRAF WT. The study will also evaluate
the activity and efficacy of cetuximab re-introduction in combination with irinotecan as
third line therapy in the concept of re-challenge for those patients that will be treated in
second line with chemotherapy plus anti-angiogenic drugs (FOLFOX plus bevacizumab), having a
RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line
treatment. A novel characteristic of this program is that the therapeutic algorithm will be
defined at each treatment decision (first line, second line and third line) in a prospective
fashion in each patient by liquid biopsy assessment of RAS/BRAF status.
Based on dynamic and longitudinal liquid biopsy assessment of RAS/BRAF status, that will be
prospectively performed before each line of treatment, mCRC patients will be treated with
cetuximab in combination with chemotherapy throughout three lines of therapy, as follows:
FOLFIRI plus cetuximab (first line); FOLFOX plus cetuximab (second line); irinotecan plus
cetuximab (third line) in case of RAS/BRAF WT at each time point of progression. If at
progression after the first line, the liquid biopsy assessment indicates RAS and or BRAF
mutant status, patients will be treated with FOLFOX plus bevacizumab as the second line of
therapy. If at progression after the second line, the liquid biopsy assessment indicates RAS
and or BRAF mutant status, patients will be treated with regorafenib or
trifluridine-tipiracil (investigator's choice), as third line of therapy. Each treatment will
be administered using standard doses and schedules until progression of disease or
unacceptable toxicity.
This study will also evaluate the activity and efficacy of cetuximab re-introduction in
combination with irinotecan as third line therapy in the concept of re-challenge for those
patients that will be treated in second line with FOLFOX plus bevacizumab, having a RAS or
BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line
treatment. A novel characteristic of this program is that the therapeutic algorithm will be
defined at each treatment decision (first line, second line and third line) in a prospective
fashion in each patient by liquid biopsy assessment of RAS/BRAF status
Inclusion Criteria:
1. Histologically proven diagnosis of colorectal adenocarcinoma
2. Diagnosis of metastatic disease
3. RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or
related metastasis
4. Measurable disease according to Response Evaluation Criteria in Solid Tumors RECIST
criteria, vers.1.1)
5. Male or female patients ≥ 18 years of age
6. ECOG Performance Status 0,1
7. Adequate bone marrow, liver and renal function assessed within 14 days before starting
study treatment as defined by the following parameters:
Bone marrow:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- Hemoglobin (Hgb) ≥ 9 g/dL
- Platelets ≥ 100 x 109/L
Liver function:
• Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) Aspartate aminotransferase
(AST) (serum glutamic oxaloacetic transaminase [SGOT]) and ALT (SGPT) ≤ 2.5 x ULN,
except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x
ULN
Renal function:
• Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min
8. If female and of childbearing potential, have a negative result on a pregnancy test
performed a maximum of 7 days before initiation of study treatment
9. If female and of childbearing potential, or if male, agreement to use adequate
contraception (e.g., abstinence, intrauterine device, oral contraceptive, or
double-barrier method), during the study and until at least 3 months after last dose
of study treatment administration, based on the judgment of the Investigator or a
designated associate
10. Signed informed consent obtained before screening.
Exclusion Criteria:
1. Any contraindication to the use of cetuximab, Irinotecan, 5-FU, oxaliplatin, folinic
acid,bevacizumab, trifluridine-tipiracil, regorafenib
2. Active uncontrolled infections, active disseminated intravascular coagulation or
history of interstitial lung disease
3. Past or current history of malignancies other than colorectal carcinoma, except for
curatively treated basal and squamous cell carcinoma of the skin cancer or in situ
carcinoma of the cervix
4. Pregnancy (exclusion to be ascertained by a beta hCG test)
5. Breastfeeding
6. Fertile women (<2 years after last menstruation) and men of childbearing potential not
willing to use effective means of contraception•
7. Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or
without stenting within the past 12 months before inclusion in the study, Grade III or
IV heart failure (NYHA classification)
8. Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta
blockers or digoxin
9. Medical or psychological impairments associated with restricted ability to give
consent or not allowing conduct of the study
10. Previous chemotherapy for the colorectal cancer with the exception of adjuvant
treatment, completed at least 6 months before entering the study
11. Participation in a clinical study or experimental drug treatment within 30 days prior
to study inclusion or during participation in the study
12. Known or clinically suspected brain metastases
13. History of acute or subacute intestinal occlusion or chronic inflammatory bowel
disease or chronic diarrhoea
14. Severe, non-healing wounds, ulcers or bone fractures
15. Uncontrolled hypertension
16. Marked proteinuria (nephrotic syndrome)
17. Known DPD deficiency (specific screening not required)
18. Known history of alcohol or drug abuse
19. A significant concomitant disease which, in the investigating physician's opinion,
rules out the patient's participation in the study
20. Absent or restricted legal capacity
|
NCT0531xxxx/NCT05312411.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/NCT05312411</url>
</required_header>
<id_info>
<org_study_id>ENLIGHTen-01</org_study_id>
<nct_id>NCT05312411</nct_id>
</id_info>
<brief_title>A Phase I Feasibility And Safety Study of Fluorescein-Specific (FITC-E2) CAR T Cells In Combination With Parenterally Administered Folate-Fluorescein (UB-TT170) For Osteogenic Sarcoma</brief_title>
<official_title>A Phase I Feasibility And Safety Study of Fluorescein-Specific (FITC-Ew) CAR T Cells In Combination With Parenterally Administered Folate-Fluorescein (UB-TT170) For Osteogenic Sarcoma</official_title>
<sponsors>
<lead_sponsor>
<agency>Seattle Children's Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Umoja BioPharma, Inc.</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Seattle Children's Hospital</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to see if a new treatment could help patients who have
osteosarcoma that does not go away with treatment (is refractory) or comes back after
treatment (is recurrent).This study is testing a combination of study therapies, UB-TT170 and
genetically modified chimeric antigen receptor T lymphocyte (CAR T) cells, which work
together in a way that is different from chemotherapy.

In this study, researchers will take some of your blood and remove the T cells in a process
called "apheresis". Then the T cells are taken to a lab and changed to CAR T cells that
recognize the flags from UB-TT170. Once researchers think they have grown enough CAR T cells,
called antiFL(FITC-E2) CAR T cells, to fight your cancer, you may get some chemotherapy to
make room in your body for the new cells and then have those cells put back in your body.

A few days after the you get your CAR T cell infusion you will start to get infusions of
UB-TT170, with the dose slowly increasing for the first few infusions until you have reached
a maximum dose that you will get on a regular schedule. The UB-TT170 will attach to your
tumor cells and flag them so that they attract the CAR T cells. When the CAR T cells see the
labeled tumor cells they can kill the tumor cells.

The active part of the study lasts about 8 months, and if you get the CAR T cell infusion you
will be in long-term follow-up for 15 years.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 20, 2022</start_date>
<completion_date type="Anticipated">April 30, 2040</completion_date>
<primary_completion_date type="Anticipated">April 30, 2025</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Adverse events associated with ex-vivo expanded autologous T cells genetically modified to express an antiFL(FITC-E2) CAR administered with UB-TT170 will be assessed</measure>
<time_frame>30 days</time_frame>
<description>The type, frequency, severity, and duration of adverse events will be summarized</description>
</primary_outcome>
<secondary_outcome>
<measure>Ability to manufacture antiFL(FITC-E2) CAR cells</measure>
<time_frame>28 Days</time_frame>
<description>The number of successfully manufactured antiFL(FITC-E2) CAR products will be assessed</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluate the pharmacokinetics of UB-TT170 in combination with the anti-FL(FITC-E2) CAR T cells</measure>
<time_frame>25 days</time_frame>
<description>Pharmacokinetics of UB-TT170 in combination with the anti-FL(FITC-E2) CAR T cells</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">21</enrollment>
<condition>Osteosarcoma</condition>
<arm_group>
<arm_group_label>UB-TT170 following SCRI-E2CAR_EGFrtv1</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Following CAR T cell administration, subjects will receive a first Course of 3 escalating doses of UB-TT170 over 2 weeks followed by fixed weekly dosing for 2 weeks. If eligible, subjects may proceed to Courses 2 - 4 consisting of 7 weekly doses of UB-TT170.</description>
</arm_group>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>SCRI-E2CAR_EGFRtv1</intervention_name>
<description>Autologous CD4+ and CD8+ T cells that have been genetically modified to express antiFL(FITC-E2)</description>
<arm_group_label>UB-TT170 following SCRI-E2CAR_EGFrtv1</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>UB_TT170</intervention_name>
<description>Bispecific small molecule adapter formulated with phosphate buffered saline</description>
<arm_group_label>UB-TT170 following SCRI-E2CAR_EGFrtv1</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Refractory or recurrent/progressive osteosarcoma that has failed first line therapy
for Osteosarcoma per NCCN or upfront Children's Oncology Group clinical trial and is
not amenable to surgical resection (must meet one of the following):

1. New site of measurable disease by radiographic imaging or histologic confirmation

2. New site of evaluable disease by radiographic imaging (including FDG-PET) or
histologic confirmation

3. Greater than 20% increase in at least one tumor dimension documented by CT/MRI,
AND a maximum absolute increase of 5 mm in longest dimension of existing
lesion(s) (previously irradiated lesions may be included)

4. Persistent measurable disease or FDG-PET avid bone metastasis that has failed to
achieve complete remission to upfront conventional therapy (surgery, radiotherapy
and/or chemotherapy)

- Able to tolerate apheresis, including placement of temporary apheresis catheter, if
necessary, or already has an apheresis product available for use in manufacturing

- Life expectancy ≥ 8 weeks

- Lansky or Karnofsky score ≥ 50

- Anti-cancer agents, radiotherapy, cytoxic chemotherapy, biologic therapy, anti-tumor
antibody therapy, genetically modified cell therapy, and, if no apheresis product
available, corticosteroid therapy (excluding physiologic replacement), discontinued
within protocol specified wash-out period

- Adequate hematologic, renal, hepatic, cardiac, and respiratory function.

- Negative HIV, hepatitis B and C test within 3 months

- If of child-bearing or fathering potential, willing to use highly effective
contraception through 12 months following final stud drug infusion

Exclusion Criteria:

- Active malignancy other than primary malignant solid tumor diagnosis (CNS intracranial
metastases are allowed)

- Ongoing, symptomatic CNS pathology requiring medical intervention

- Receiving external beam radiotherapy

- Presence of active, severe infection

- Primary immunodeficiency syndrome

- Pregnant or breast feeding

- Unwilling to provide consent/assent for study participation, including 15 year follow
up

- Presence of any condition that, in the opinion of the investigator, would prohibit the
subject from undergoing treatment under this protocol.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>15 Years</minimum_age>
<maximum_age>30 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Catherine Albert, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Seattle Children's Hospital</affiliation>
</overall_official>
<overall_contact>
<last_name>Catherine Albert, MD</last_name>
<phone>206-987-2106</phone>
<email>immunotherapy@seattlechildrens.org</email>
</overall_contact>
<location>
<facility>
<name>Seattle Children's Hospital</name>
<address>
<city>Seattle</city>
<state>Washington</state>
<zip>98105</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Catherine Albert, MD</last_name>
<phone>206-987-2106</phone>
<email>immunotherapy@seattlechildrens.org</email>
</contact>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>March 20, 2019</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>June 27, 2023</last_update_submitted>
<last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 29, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
<investigator_full_name>Colleen Annesley</investigator_full_name>
<investigator_title>Medical Director, Seattle Children's Therapeutics</investigator_title>
</responsible_party>
<keyword>osteosarcoma</keyword>
<keyword>bone cancer</keyword>
<keyword>pediatric sarcoma</keyword>
<keyword>young adult sarcoma</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Sarcoma</mesh_term>
<mesh_term>Osteosarcoma</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to see if a new treatment could help patients who have
osteosarcoma that does not go away with treatment (is refractory) or comes back after
treatment (is recurrent).This study is testing a combination of study therapies, UB-TT170 and
genetically modified chimeric antigen receptor T lymphocyte (CAR T) cells, which work
together in a way that is different from chemotherapy.
In this study, researchers will take some of your blood and remove the T cells in a process
called "apheresis". Then the T cells are taken to a lab and changed to CAR T cells that
recognize the flags from UB-TT170. Once researchers think they have grown enough CAR T cells,
called antiFL(FITC-E2) CAR T cells, to fight your cancer, you may get some chemotherapy to
make room in your body for the new cells and then have those cells put back in your body.
A few days after the you get your CAR T cell infusion you will start to get infusions of
UB-TT170, with the dose slowly increasing for the first few infusions until you have reached
a maximum dose that you will get on a regular schedule. The UB-TT170 will attach to your
tumor cells and flag them so that they attract the CAR T cells. When the CAR T cells see the
labeled tumor cells they can kill the tumor cells.
The active part of the study lasts about 8 months, and if you get the CAR T cell infusion you
will be in long-term follow-up for 15 years.
Inclusion Criteria:
- Refractory or recurrent/progressive osteosarcoma that has failed first line therapy
for Osteosarcoma per NCCN or upfront Children's Oncology Group clinical trial and is
not amenable to surgical resection (must meet one of the following):
1. New site of measurable disease by radiographic imaging or histologic confirmation
2. New site of evaluable disease by radiographic imaging (including FDG-PET) or
histologic confirmation
3. Greater than 20% increase in at least one tumor dimension documented by CT/MRI,
AND a maximum absolute increase of 5 mm in longest dimension of existing
lesion(s) (previously irradiated lesions may be included)
4. Persistent measurable disease or FDG-PET avid bone metastasis that has failed to
achieve complete remission to upfront conventional therapy (surgery, radiotherapy
and/or chemotherapy)
- Able to tolerate apheresis, including placement of temporary apheresis catheter, if
necessary, or already has an apheresis product available for use in manufacturing
- Life expectancy ≥ 8 weeks
- Lansky or Karnofsky score ≥ 50
- Anti-cancer agents, radiotherapy, cytoxic chemotherapy, biologic therapy, anti-tumor
antibody therapy, genetically modified cell therapy, and, if no apheresis product
available, corticosteroid therapy (excluding physiologic replacement), discontinued
within protocol specified wash-out period
- Adequate hematologic, renal, hepatic, cardiac, and respiratory function.
- Negative HIV, hepatitis B and C test within 3 months
- If of child-bearing or fathering potential, willing to use highly effective
contraception through 12 months following final stud drug infusion
Exclusion Criteria:
- Active malignancy other than primary malignant solid tumor diagnosis (CNS intracranial
metastases are allowed)
- Ongoing, symptomatic CNS pathology requiring medical intervention
- Receiving external beam radiotherapy
- Presence of active, severe infection
- Primary immunodeficiency syndrome
- Pregnant or breast feeding
- Unwilling to provide consent/assent for study participation, including 15 year follow
up
- Presence of any condition that, in the opinion of the investigator, would prohibit the
subject from undergoing treatment under this protocol.
|
NCT0531xxxx/NCT05312424.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/NCT05312424</url>
</required_header>
<id_info>
<org_study_id>L22-130</org_study_id>
<nct_id>NCT05312424</nct_id>
</id_info>
<brief_title>Annatto-derived GG for Statin-associated Myopathy</brief_title>
<acronym>GG-statin</acronym>
<official_title>Effect of Annatto-derived Geranylgeraniol (GG) on Statin-associated Myopathy</official_title>
<sponsors>
<lead_sponsor>
<agency>Texas Tech University Health Sciences Center</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Texas Tech University Health Sciences Center</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on
statin-associated skeletal muscle health.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Statins are widely prescribed cholesterol-lowering oral drugs. The majority of reported
adverse effects due to statin include muscle pain, weakness, cramp, and tiredness. CoQ10
supplementation has been widely used to reduce statin-related muscle complaints. Several
human studies have been reported with inconsistent effects of CoQ10 on statin-related
symptoms. This study is to investigate the role of 3-month annatto-derived geranylgeraniol
(GG) in statin-related muscle outcomes in humans. Qualified subjects will be matched by age,
gender, and body weight, and then randomly assigned to a no GG group, a low GG dose group, or
a high GG dose group. The outcome measures will be assessed at baseline and after 3 months.
Muscle-associated measurements will be recorded using subject questionnaires (also follow-up
after 3 and 6 months), muscle performance results, and blood samples. We will monitor the
safety of subjects after 3 months. Food intake, physical activity, and medication changes
will be recorded at baseline and after 3 months. All data will be analyzed statistically.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">July 15, 2022</start_date>
<completion_date type="Anticipated">December 31, 2023</completion_date>
<primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>SAMS-CI</measure>
<time_frame>change in SAMS-CI at 3 months</time_frame>
<description>Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is to assess muscle pain, muscle weakness, tiredness, and cramps.</description>
</primary_outcome>
<primary_outcome>
<measure>BPI</measure>
<time_frame>change in BPI at 3 months</time_frame>
<description>Brief Pain Inventory (BPI) is to assess pain and interference of pain with everyday life.</description>
</primary_outcome>
<secondary_outcome>
<measure>Lower body isometric strength</measure>
<time_frame>change in lower body isometric strength at 3 months</time_frame>
<description>Lower body (i.e., predominantly of the quadriceps and hip extensors) isometric strength is measured using a dynamometer</description>
</secondary_outcome>
<secondary_outcome>
<measure>Functional lower body strength</measure>
<time_frame>change in functional lower body strength at 3 months</time_frame>
<description>Functional lower body strength is measured using a loaded 50m walk.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Wall-sit test</measure>
<time_frame>change in wall-sit test at 3 months</time_frame>
<description>Wall-sit test (wall-slide test) is to assess static leg strength and endurance, particularly of the quadriceps and hip extensors</description>
</secondary_outcome>
<secondary_outcome>
<measure>Heel raise test</measure>
<time_frame>change in heel raise test at 3 months</time_frame>
<description>Heel raise test is commonly used to test calf muscle endurance, function, and performance. Single-leg or both-leg raise will be tested while staining on a step bench</description>
</secondary_outcome>
<secondary_outcome>
<measure>blood biomarkers: serum creatinine kinase activity</measure>
<time_frame>change in serum creatinine kinase activity at 3 months</time_frame>
<description>Creatine kinase is to assess muscle damage.</description>
</secondary_outcome>
<secondary_outcome>
<measure>blood biomarkers: myostatin</measure>
<time_frame>changes in serum myostatin at 3 months</time_frame>
<description>Myostatin is to assess muscle damage</description>
</secondary_outcome>
<secondary_outcome>
<measure>blood biomarkers: atrogin 1</measure>
<time_frame>changes in serum atrogin 1 at 3 months</time_frame>
<description>atrogin 1 is to assess muscle damage</description>
</secondary_outcome>
<secondary_outcome>
<measure>blood biomarkers: hsCRP</measure>
<time_frame>changes in serum hsCRP at 3 months</time_frame>
<description>hsCRP is to assess inflammation</description>
</secondary_outcome>
<secondary_outcome>
<measure>blood biomarker: IL-6</measure>
<time_frame>changes in serum IL-6 at 3 months</time_frame>
<description>IL-6 is to assess inflammation</description>
</secondary_outcome>
<secondary_outcome>
<measure>blood lipid profiles</measure>
<time_frame>changes in blood lipid profiles at 3 months</time_frame>
<description>lipid profiles include total triglycerides, total cholesterol, HDL, and calculated LDL</description>
</secondary_outcome>
<secondary_outcome>
<measure>plasma menaquinone-4 (MK4) + menaquinone-4 (MK7)</measure>
<time_frame>changes in plasma MK4+MK7 at 3 months</time_frame>
<description>MK4 and MK4 are vitamin K2 homologues and are measured by HPLC</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">95</enrollment>
<condition>Myopathy; Primary</condition>
<arm_group>
<arm_group_label>Placebo</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Placebo group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg olive oil) after dinner</description>
</arm_group>
<arm_group>
<arm_group_label>Low GG</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>LOW GG group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg GG) after dinner</description>
</arm_group>
<arm_group>
<arm_group_label>High GG</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>HIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner</description>
</arm_group>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>300 mg olive oil</description>
<arm_group_label>Placebo</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Low GG</intervention_name>
<description>150 mg GG</description>
<arm_group_label>Low GG</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>High GG</intervention_name>
<description>300 mg GG</description>
<arm_group_label>High GG</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Age ≥40 of either sex

- Statin-treated patients with muscle pain alone or accompanied by other symptoms.

- Patients currently receiving a statin who developed new-onset myalgias in within 90
day of initiation or a dosage increase

Exclusion Criteria:

- Malignancy or significant neurological or psychiatric disturbances, including alcohol
or drug abuse.

- Woman who is pregnant, breastfeeding, or of childbearing potential and not taking
adequate contraceptive precautions.

- Had CoQ10 supplement one month before starting the study.

- Genetic musculoskeletal and neurologic disorder known to affect skeletal muscle
metabolism

- Had steroid medication one month before starting the study.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>40 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Chwan-Li (Leslie) Shen, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Texas Tech Health Science Center</affiliation>
</overall_official>
<overall_contact>
<last_name>Chwan-Li (Leslie) Shen, PhD</last_name>
<phone>8067432815</phone>
<email>leslie.shen@ttuhsc.edu</email>
</overall_contact>
<location>
<facility>
<name>Texas Tech University Health Sciences Center</name>
<address>
<city>Lubbock</city>
<state>Texas</state>
<zip>79430</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Chwan-Li (Leslie) Shen, PhD</last_name>
<phone>806-743-2815</phone>
<email>Leslie.Shen@ttuhsc.edu</email>
</contact>
<investigator>
<last_name>Chwan-Li (Leslie) Shen, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2022</verification_date>
<study_first_submitted>March 9, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>December 7, 2022</last_update_submitted>
<last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">December 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Muscular Diseases</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on
statin-associated skeletal muscle health.
Statins are widely prescribed cholesterol-lowering oral drugs. The majority of reported
adverse effects due to statin include muscle pain, weakness, cramp, and tiredness. CoQ10
supplementation has been widely used to reduce statin-related muscle complaints. Several
human studies have been reported with inconsistent effects of CoQ10 on statin-related
symptoms. This study is to investigate the role of 3-month annatto-derived geranylgeraniol
(GG) in statin-related muscle outcomes in humans. Qualified subjects will be matched by age,
gender, and body weight, and then randomly assigned to a no GG group, a low GG dose group, or
a high GG dose group. The outcome measures will be assessed at baseline and after 3 months.
Muscle-associated measurements will be recorded using subject questionnaires (also follow-up
after 3 and 6 months), muscle performance results, and blood samples. We will monitor the
safety of subjects after 3 months. Food intake, physical activity, and medication changes
will be recorded at baseline and after 3 months. All data will be analyzed statistically.
Inclusion Criteria:
- Age ≥40 of either sex
- Statin-treated patients with muscle pain alone or accompanied by other symptoms.
- Patients currently receiving a statin who developed new-onset myalgias in within 90
day of initiation or a dosage increase
Exclusion Criteria:
- Malignancy or significant neurological or psychiatric disturbances, including alcohol
or drug abuse.
- Woman who is pregnant, breastfeeding, or of childbearing potential and not taking
adequate contraceptive precautions.
- Had CoQ10 supplement one month before starting the study.
- Genetic musculoskeletal and neurologic disorder known to affect skeletal muscle
metabolism
- Had steroid medication one month before starting the study.
|
NCT0531xxxx/NCT05312437.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/NCT05312437</url>
</required_header>
<id_info>
<org_study_id>210865</org_study_id>
<nct_id>NCT05312437</nct_id>
</id_info>
<brief_title>Clinical Decision Support to Prevent Suicide</brief_title>
<acronym>CDS_PS</acronym>
<official_title>A Pragmatic Randomized Controlled Trial of Machine Learning-driven Clinical Decision Support to Improve Suicide Risk Screening in Ambulatory Care Settings</official_title>
<sponsors>
<lead_sponsor>
<agency>Vanderbilt University Medical Center</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Vanderbilt University Medical Center</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Suicide kills 132 Americans every day. The first step of suicide prevention is risk
identification and prognostication. Researchers like this study team have developed and
validated predictive models that use routinely collected Electronic Health Record (EHR) data
like past diagnoses and medications to predict future suicide attempt risk. The study team's
model based in machine learning is known as the Vanderbilt Suicide Attempt and Ideation
Likelihood (VSAIL). VSAIL has been validated prospectively and externally to predict suicide
attempt risk with a number needed to screen (NNS) of 271 for suicide attempt and 23 for
suicidal ideation. NNS is the number of people who need to receive a test result to prevent
one outcome - lower NNS is better.

This study will evaluate the effectiveness of a Clinical Decision Support System called
Vanderbilt Safecourse using VSAIL to prompt a novel Best Practice Advisory (BPA) to prompt
face-to-face screening with a validated suicide screening instrument like the Columbia
Suicide Severity Rating Scale (CSSRS).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The investigators seek to study if identifying patients at high predicted risk of suicide in
clinical settings where suicide risk screening only happens sporadically, if at all, will
improve face-to-face screening rates and documentation of suicide risk assessment in their
EHRs.

The investigators will measure the VSAIL-prompted BPA's effectiveness in real-world clinical
settings to increase rates of face-to-face suicide risk screening. VSAIL requires only data
already collected in routine clinical encounters and is calculated in real- time (seconds) at
the start of a clinical visit (inpatient or outpatient) at VUMC.

VSAIL does not replace clinical judgment in treating suicidality, but the investigators seek
to measure whether VSAIL increases the rates at which the important problem of suicide is
addressed and screened effectively.

The investigators seek to compare an active, Interruptive intervention, a VSAIL-prompted BPA
pushed to providers, to a passive, non-interruptive visual prompt to determine if 1) CDS
driven by automated risk modeling improves face-to-face screening rates and 2) whether or not
that CDS needs to be interruptive or non-interruptive to be effective. In the latter case,
effective non-interruptive CDS would improve care without worsening "alert fatigue." For
equipoise, risk scores for all patients in the study sites would be made available in Epic
flowsheets for review by providers if they choose to do so.

In the first phase, The investigators will pilot this CDS in Neurology outpatient clinics for
six months. If study goals are met, The investigators will scale the CDS intervention trial
across non-mental health specialty settings at VUMC over the following 18 months.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">August 16, 2022</start_date>
<completion_date type="Actual">February 16, 2023</completion_date>
<primary_completion_date type="Actual">February 16, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Prevention</primary_purpose>
<masking>Single (Participant)</masking>
<masking_description>Those randomized to intervention arm will have the intervention BPA prompt. Those randomized to the control arm will not have an associated BPA prompt. Risk predictions for all participants in study settings will be visible in eStar flowsheets for equipoise.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Face-to-face screening by clinician</measure>
<time_frame>Up to 24 hours</time_frame>
<description>Documentation of the validated, brief-version of the Columbia Suicide Severity Rating Scale (https://www.cms.gov/files/document/cssrs-screen-version-instrument.pdf) or recording a binary response "Will screen with alternative method" input by providers into the intervention Best Practice Advisory using a button in the Acknowledge Reason section of the BPA.</description>
</primary_outcome>
<secondary_outcome>
<measure>Subsequent encounter for suicidal ideation within sixty days</measure>
<time_frame>Sixty days after study encounter</time_frame>
<description>Documented clinical encounter anywhere in health system with documented diagnostic code (ICD10CM) for suicidal ideation
The Electronic Health Record (EHR) will be queried every month and all ICD10CM codes documented for patients seen in the study sites will be analyzed for the presence of any ICD10CM codes in a reference list for suicidal ideation. In ICD10CM, a single code, R45.81, is used to document suicidal ideation. If any ICD10CM codes that match that list are found within sixty days of the encounter date in study settings, the outcome will be marked as a case of subsequent suicidal ideation.
This outcome is measured on a binary scale, 1= presence of encounter for suicidal ideation and 0 = absence</description>
</secondary_outcome>
<secondary_outcome>
<measure>Subsequent encounter for suicide attempt within sixty days</measure>
<time_frame>Sixty days after study encounter</time_frame>
<description>Documented clinical encounter anywhere in health system with documented diagnostic code (ICD10CM) for suicide attempt
The EHR will be queried every month and all ICD10CM codes documented for patients seen in the study sites will be analyzed for the presence of any ICD10CM codes in a reference list for suicide attempt. In ICD10CM, the National Center for Health Statistics provides a full list of acceptable codes that will be used for reference (https://www.cdc.gov/nchs/data/nhsr/nhsr108.pdf). If any ICD10CM codes that match that list are found within sixty days of the encounter date in study settings, the outcome will be marked as a case of subsequent suicidal ideation.
This outcome is measured on a binary scale, 1= presence of encounter for suicide attempt and 0 = absence</description>
</secondary_outcome>
<secondary_outcome>
<measure>Emergency Department Utilization</measure>
<time_frame>Sixty days after study encounter</time_frame>
<description>Any Emergency Department Encounter within sixty days of study encounter and reason for Emergency Department Encounter
The EHR will be queried every month and all clinical encounters (aka visits) will be analyzed for location, which is recorded in both Visit Type fields (type "E") in our records and by location (e.g., "Emergency Department"). The presence of a recorded visit occurring within sixty days of a clinical encounter in the study settings will be marked as a case of Emergency Department Utilization for trial purposes. The reason for visit will be analyzed as the ICD10CM codes billed for that encounter, also stored in the EHR.
This outcome is measured on a binary scale, 1= presence of Emergency Department encounter and 0 = absence. The reason for encounter will be analyzed secondarily and descriptive statistics used to count the most common reasons related to subsequent Emergency Department encounters.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">596</enrollment>
<condition>Suicide, Attempted</condition>
<condition>Suicidal Ideation</condition>
<arm_group>
<arm_group_label>Interruptive Best Practice Advisory - CDS Intervention</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Adults at Elevated Predicted Risk (>=2% predicted risk, based on our study, DOI: 10.1001/jamanetworkopen.2021.1428) at visit registration (aka "check-in") will be randomized to either Interruptive Alert or Passive Prompt CDS interventions.
In the Interruptive Alert, the physician who next opens that patient's chart will be prompted to review a BPA describing the patient's risk and asking the physician to choose from the BPA options (see Interventions).
The BPA will need to be dismissed to the Epic Storyboard or completed as above to continue clinical workflow.</description>
</arm_group>
<arm_group>
<arm_group_label>Passive Storyboard Prompt - CDS Intervention</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Adult patients in the highest predicted risk tier (>=2% predicted risk, based on our research study, DOI: 10.1001/jamanetworkopen.2021.1428) at the time of visit registration (aka "check-in") will be randomized to either the Interruptive Alert or Passive Prompt CDS intervention arms.
In the Passive Prompt arm, the physician who next opens the patients' charts after check-in (e.g., "Chart Review") will see a Storyboard icon for Elevated Suicide Risk on the left side of the screen. Hovering over this icon will bring up a window with the BPA information in a view identical to the Interruptive Alert arm. Clicking on the window will bring up the BPA with full functionality as in the Interruptive Alert arm.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Interruptive Alert, CDS</intervention_name>
<description>Experimental: CDS Intervention Adult patients in the highest predicted risk tier (>=2% predicted risk) at the time visit registration (aka "check-in").
The Intervention would then be described as:
Physicians review a Best Practice Advisory describing the patient's risk and choose from the following options:
Document face-to-face suicide risk screening with the Columbia Suicide Severity Rating Scale (CDS complete once the CSSRS is complete)
Agree to screen using an alternative method chosen at the clinician's discretion (CDS complete)
Disagree with alert and provide a rationale for disagreement (CDS complete)
Indicate suicide risk face-to-face screening has already occurred (CDS complete)
Dismiss the alert. The alert will be available in Epic "Storyboard" persistently until acted on further. The Storyboard functionality after dismissal is identical to the Passive Prompt, CDS intervention (below)</description>
<arm_group_label>Interruptive Best Practice Advisory - CDS Intervention</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Passive Prompt, CDS</intervention_name>
<description>Adult patients in the highest predicted risk tier (>=2% predicted risk, based on our research study, DOI: 10.1001/jamanetworkopen.2021.1428) at the time of visit registration (aka "check-in") will be randomized to either the Interruptive Alert or Passive Prompt CDS intervention arms.
In the Passive Prompt arm, the physician who next opens the patients' charts after check-in (e.g., "Chart Review") will see a Storyboard icon for Elevated Suicide Risk on the left side of the screen. Hovering over this icon will bring up a window with the BPA information in a view identical to the Interruptive Alert arm. Clicking on the window will bring up the BPA with full functionality as in the Interruptive Alert arm.</description>
<arm_group_label>Passive Storyboard Prompt - CDS Intervention</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. > 18 years of age

2. A visit in Neurology (first phase) or other non-mental health specialty setting at
VUMC (second phase)

Exclusion Criteria:

1) A CSSRS conducted within one week of the visit in another care setting at VUMC (recent
screening)
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Colin G Walsh, MD, MA</last_name>
<role>Principal Investigator</role>
<affiliation>Vanderbilt University Medical Center</affiliation>
</overall_official>
<location>
<facility>
<name>Vanderbilt University Medical Center</name>
<address>
<city>Nashville</city>
<state>Tennessee</state>
<zip>37203</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Walsh CG, Johnson KB, Ripperger M, Sperry S, Harris J, Clark N, Fielstein E, Novak L, Robinson K, Stead WW. Prospective Validation of an Electronic Health Record-Based, Real-Time Suicide Risk Model. JAMA Netw Open. 2021 Mar 1;4(3):e211428. doi: 10.1001/jamanetworkopen.2021.1428.</citation>
<PMID>33710291</PMID>
</reference>
<verification_date>March 2023</verification_date>
<study_first_submitted>March 7, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>March 10, 2023</last_update_submitted>
<last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 14, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
<investigator_full_name>Colin G. Walsh</investigator_full_name>
<investigator_title>Associate Professor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Suicide</mesh_term>
<mesh_term>Suicidal Ideation</mesh_term>
<mesh_term>Suicide, Attempted</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Suicide kills 132 Americans every day. The first step of suicide prevention is risk
identification and prognostication. Researchers like this study team have developed and
validated predictive models that use routinely collected Electronic Health Record (EHR) data
like past diagnoses and medications to predict future suicide attempt risk. The study team's
model based in machine learning is known as the Vanderbilt Suicide Attempt and Ideation
Likelihood (VSAIL). VSAIL has been validated prospectively and externally to predict suicide
attempt risk with a number needed to screen (NNS) of 271 for suicide attempt and 23 for
suicidal ideation. NNS is the number of people who need to receive a test result to prevent
one outcome - lower NNS is better.
This study will evaluate the effectiveness of a Clinical Decision Support System called
Vanderbilt Safecourse using VSAIL to prompt a novel Best Practice Advisory (BPA) to prompt
face-to-face screening with a validated suicide screening instrument like the Columbia
Suicide Severity Rating Scale (CSSRS).
The investigators seek to study if identifying patients at high predicted risk of suicide in
clinical settings where suicide risk screening only happens sporadically, if at all, will
improve face-to-face screening rates and documentation of suicide risk assessment in their
EHRs.
The investigators will measure the VSAIL-prompted BPA's effectiveness in real-world clinical
settings to increase rates of face-to-face suicide risk screening. VSAIL requires only data
already collected in routine clinical encounters and is calculated in real- time (seconds) at
the start of a clinical visit (inpatient or outpatient) at VUMC.
VSAIL does not replace clinical judgment in treating suicidality, but the investigators seek
to measure whether VSAIL increases the rates at which the important problem of suicide is
addressed and screened effectively.
The investigators seek to compare an active, Interruptive intervention, a VSAIL-prompted BPA
pushed to providers, to a passive, non-interruptive visual prompt to determine if 1) CDS
driven by automated risk modeling improves face-to-face screening rates and 2) whether or not
that CDS needs to be interruptive or non-interruptive to be effective. In the latter case,
effective non-interruptive CDS would improve care without worsening "alert fatigue." For
equipoise, risk scores for all patients in the study sites would be made available in Epic
flowsheets for review by providers if they choose to do so.
In the first phase, The investigators will pilot this CDS in Neurology outpatient clinics for
six months. If study goals are met, The investigators will scale the CDS intervention trial
across non-mental health specialty settings at VUMC over the following 18 months.
Inclusion Criteria:
1. > 18 years of age
2. A visit in Neurology (first phase) or other non-mental health specialty setting at
VUMC (second phase)
Exclusion Criteria:
1) A CSSRS conducted within one week of the visit in another care setting at VUMC (recent
screening)
|
NCT0531xxxx/NCT05312450.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/NCT05312450</url>
</required_header>
<id_info>
<org_study_id>20211117ZJS001</org_study_id>
<nct_id>NCT05312450</nct_id>
</id_info>
<brief_title>Westlake Diabetes Study</brief_title>
<official_title>Diabetes Cohort From A Clinic for Patients With Integrated Traditional Chinese Medicine and Nutrition Treatments</official_title>
<sponsors>
<lead_sponsor>
<agency>Westlake University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Zhejiang Provincial Tongde Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Westlake University</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This is a prospective cohort study that takes place in a clinic of Hangzhou, China. The aim
of this study is to explore the molecular mechanism of special Chinese medicine formula
combined with personalized nutrition to assist the treatment of diabetes from the aspect of
multi-omics view. This study also aims to explore the relationship between gut microbiome and
blood glucose in the process of personalized diet intervention.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Traditional Chinese medicine has a history of more than two thousand years in China for
treating diabetes based on the theory of "medicine and food homology". Modern pharmacological
research and clinical research have shown that proprietary Chinese medicines and Chinese
herbal decoctions have the advantages of overall regulation and fewer side effects for the
treatment of type 2 diabetes and its complications. Meanwhile, dietary intervention is
essential for the treatment of diabetes. In a clinic of Hangzhou, China, Chinese medicine
doctors use a special Chinese medicine formula combined with dietary intervention to treat
diabetes, and achieve good therapeutic effects without obvious adverse effects. The diet
treatment plan is based on the results of the patient's food tolerance test, and dietary
recommendations are provided based on the food glycemic index. In the first week of the
treatment, patients are limit carbohydrate intake. Patients are evaluated every one month,
and are instructed to choose foods rich in fiber and low glycemic index to reduce blood sugar
fluctuations. Every patient is followed by one nutritionist, who provides dietary
instructions for the patient. Patients use fingertip blood glucose to detect postprandial
blood glucose. One course of treatment is three months, all patients will be treated for one
course in this study. During the treatment, the dosage of western medicine hypoglycemic drugs
was adjusted according to the Chinese Diabetes Prevention and Control Guidelines. Both
Chinese medicine prescriptions and nutrition prescriptions were followed for the treatment to
work towards the direction of drug injections-only oral drugs-drug reduction-drug
discontinuation-drug discontinuation and stability-cure. Baseline information of demography,
lifestyle, diet, physical activity, comorbidity, medication history, and so on is collected
when patients enter the clinic to receive treatments. Meanwhile, the saliva, stool, fasting
blood, fasting urine samples are collected. During the treatment, the dietary information is
collected through photos taken by patients themselves. The saliva, stool, fasting blood,
fasting urine samples are also collected when the patients re-enter the clinic for
reexamination at the first week, and every one month.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 10, 2022</start_date>
<completion_date type="Anticipated">October 30, 2025</completion_date>
<primary_completion_date type="Anticipated">October 2023</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>gut microbiome</measure>
<time_frame>Baseline</time_frame>
<description>Fecal microbiome will be analyzed by metagenome sequencing</description>
</primary_outcome>
<primary_outcome>
<measure>gut microbiome</measure>
<time_frame>The first week</time_frame>
<description>Fecal microbiome will be analyzed by metagenome sequencing</description>
</primary_outcome>
<primary_outcome>
<measure>gut microbiome</measure>
<time_frame>The first month</time_frame>
<description>Fecal microbiome will be analyzed by metagenome sequencing</description>
</primary_outcome>
<primary_outcome>
<measure>gut microbiome</measure>
<time_frame>The second month</time_frame>
<description>Fecal microbiome will be analyzed by metagenome sequencing</description>
</primary_outcome>
<primary_outcome>
<measure>gut microbiome</measure>
<time_frame>The third month</time_frame>
<description>Fecal microbiome will be analyzed by metagenome sequencing</description>
</primary_outcome>
<primary_outcome>
<measure>The change of postprandial blood glucose</measure>
<time_frame>Up to three months</time_frame>
<description>Fingertip blood glucose was used to detect postprandial blood glucose. The change of postprandial blood glucose among the three months will be measured</description>
</primary_outcome>
<secondary_outcome>
<measure>Saliva microbiota</measure>
<time_frame>Baseline</time_frame>
<description>Saliva microbiota will be analyzed by metagenome sequencing</description>
</secondary_outcome>
<secondary_outcome>
<measure>Saliva microbiota</measure>
<time_frame>The first week</time_frame>
<description>Saliva microbiota will be analyzed by metagenome sequencing</description>
</secondary_outcome>
<secondary_outcome>
<measure>Saliva microbiota</measure>
<time_frame>The first month</time_frame>
<description>Saliva microbiota will be analyzed by metagenome sequencing</description>
</secondary_outcome>
<secondary_outcome>
<measure>Saliva microbiota</measure>
<time_frame>The second month</time_frame>
<description>Saliva microbiota will be analyzed by metagenome sequencing</description>
</secondary_outcome>
<secondary_outcome>
<measure>Saliva microbiota</measure>
<time_frame>The third month</time_frame>
<description>Saliva microbiota will be analyzed by metagenome sequencing</description>
</secondary_outcome>
<secondary_outcome>
<measure>Fecal metabolomics</measure>
<time_frame>Baseline</time_frame>
<description>Targeted or untargeted fecal metabolomics are performed</description>
</secondary_outcome>
<secondary_outcome>
<measure>Fecal metabolomics</measure>
<time_frame>The first week</time_frame>
<description>Targeted or untargeted fecal metabolomics are performed</description>
</secondary_outcome>
<secondary_outcome>
<measure>Fecal metabolomics</measure>
<time_frame>The first month</time_frame>
<description>Targeted or untargeted fecal metabolomics are performed</description>
</secondary_outcome>
<secondary_outcome>
<measure>Fecal metabolomics</measure>
<time_frame>The second month</time_frame>
<description>Targeted or untargeted fecal metabolomics are performed</description>
</secondary_outcome>
<secondary_outcome>
<measure>Fecal metabolomics</measure>
<time_frame>The third month</time_frame>
<description>Targeted or untargeted fecal metabolomics are performed</description>
</secondary_outcome>
<secondary_outcome>
<measure>Serum metabolomics</measure>
<time_frame>Baseline</time_frame>
<description>Targeted or untargeted serum metabolomics are performed</description>
</secondary_outcome>
<secondary_outcome>
<measure>Serum metabolomics</measure>
<time_frame>The first week</time_frame>
<description>Targeted or untargeted serum metabolomics are performed</description>
</secondary_outcome>
<secondary_outcome>
<measure>Serum metabolomics</measure>
<time_frame>The first month</time_frame>
<description>Targeted or untargeted serum metabolomics are performed</description>
</secondary_outcome>
<secondary_outcome>
<measure>Serum metabolomics</measure>
<time_frame>The second month</time_frame>
<description>Targeted or untargeted serum metabolomics are performed</description>
</secondary_outcome>
<secondary_outcome>
<measure>Serum metabolomics</measure>
<time_frame>The third month</time_frame>
<description>Targeted or untargeted serum metabolomics are performed</description>
</secondary_outcome>
<enrollment type="Anticipated">2000</enrollment>
<condition>Diabetes</condition>
<biospec_retention>Samples With DNA</biospec_retention>
<biospec_descr>
<textblock>
Biospecimen including fecal, saliva, fasting boold, and fasting urine samples will be
collected
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
Diabetes who are volunteer to participate and sign the informed consent form, and without
special diseases, such as mental system diseases or other cognitive impairment, cancer and
other malignant wasting diseases.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Comply with the diagnosis of diabetes in western medicine and the diagnostic criteria
of type 2 diabetes in the "Guiding Principles for Clinical Research of New Chinese
Medicines"; volunteer to participate and sign the informed consent form.

Exclusion Criteria:

- Major special diseases, such as mental system diseases or other cognitive impairment,
cancer and other malignant wasting diseases.
</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>Westlake University</name>
<address>
<city>Hangzhou</city>
<state>Zhejiang</state>
<zip>310024</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Ju-Sheng Zheng, PhD</last_name>
<phone>86-0571-86915303</phone>
<email>zhengjusheng@westlake.edu.cn</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>December 2, 2021</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>June 26, 2023</last_update_submitted>
<last_update_submitted_qc>June 26, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 28, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Diabetes</keyword>
<keyword>Nutrition</keyword>
<keyword>Gut microbiome</keyword>
<keyword>Metabolomics</keyword>
<keyword>Traditional Chinese medicine</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Diabetes Mellitus</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This is a prospective cohort study that takes place in a clinic of Hangzhou, China. The aim
of this study is to explore the molecular mechanism of special Chinese medicine formula
combined with personalized nutrition to assist the treatment of diabetes from the aspect of
multi-omics view. This study also aims to explore the relationship between gut microbiome and
blood glucose in the process of personalized diet intervention.
Traditional Chinese medicine has a history of more than two thousand years in China for
treating diabetes based on the theory of "medicine and food homology". Modern pharmacological
research and clinical research have shown that proprietary Chinese medicines and Chinese
herbal decoctions have the advantages of overall regulation and fewer side effects for the
treatment of type 2 diabetes and its complications. Meanwhile, dietary intervention is
essential for the treatment of diabetes. In a clinic of Hangzhou, China, Chinese medicine
doctors use a special Chinese medicine formula combined with dietary intervention to treat
diabetes, and achieve good therapeutic effects without obvious adverse effects. The diet
treatment plan is based on the results of the patient's food tolerance test, and dietary
recommendations are provided based on the food glycemic index. In the first week of the
treatment, patients are limit carbohydrate intake. Patients are evaluated every one month,
and are instructed to choose foods rich in fiber and low glycemic index to reduce blood sugar
fluctuations. Every patient is followed by one nutritionist, who provides dietary
instructions for the patient. Patients use fingertip blood glucose to detect postprandial
blood glucose. One course of treatment is three months, all patients will be treated for one
course in this study. During the treatment, the dosage of western medicine hypoglycemic drugs
was adjusted according to the Chinese Diabetes Prevention and Control Guidelines. Both
Chinese medicine prescriptions and nutrition prescriptions were followed for the treatment to
work towards the direction of drug injections-only oral drugs-drug reduction-drug
discontinuation-drug discontinuation and stability-cure. Baseline information of demography,
lifestyle, diet, physical activity, comorbidity, medication history, and so on is collected
when patients enter the clinic to receive treatments. Meanwhile, the saliva, stool, fasting
blood, fasting urine samples are collected. During the treatment, the dietary information is
collected through photos taken by patients themselves. The saliva, stool, fasting blood,
fasting urine samples are also collected when the patients re-enter the clinic for
reexamination at the first week, and every one month.
Biospecimen including fecal, saliva, fasting boold, and fasting urine samples will be
collected
Diabetes who are volunteer to participate and sign the informed consent form, and without
special diseases, such as mental system diseases or other cognitive impairment, cancer and
other malignant wasting diseases.
Inclusion Criteria:
- Comply with the diagnosis of diabetes in western medicine and the diagnostic criteria
of type 2 diabetes in the "Guiding Principles for Clinical Research of New Chinese
Medicines"; volunteer to participate and sign the informed consent form.
Exclusion Criteria:
- Major special diseases, such as mental system diseases or other cognitive impairment,
cancer and other malignant wasting diseases.
|
NCT0531xxxx/NCT05312463.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/NCT05312463</url>
</required_header>
<id_info>
<org_study_id>2021XLA117-3</org_study_id>
<nct_id>NCT05312463</nct_id>
</id_info>
<brief_title>Assessment on Effects of Tongjiang Granule in Treating Nonerosive Reflux Disease Overlapping Epigastric Pain Syndrome</brief_title>
<official_title>Randomized Double-Blind Clinical Trial of Tongjiang Granule in the Treatment of Patients With Overlapping Gastrointestinal Symptoms of Nonerosive Reflux Disease(NERD) and Epigastric Pain Syndrome(EPS)</official_title>
<sponsors>
<lead_sponsor>
<agency>Xiyuan Hospital of China Academy of Chinese Medical Sciences</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>First Affiliated Hospital of Heilongjiang Chinese Medicine University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Yueyang Hospital of Integrated Traditional Chinese and Western Medicine</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Liuzhou Hospital of Traditional Chinese Medicine</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Xiyuan Hospital of China Academy of Chinese Medical Sciences</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Overlapping gastrointestinal symptoms of functional gastrointestinal diseases (FGIDs) is an
internationally recognized problem in modern medical diagnosis and treatment. Such patients
show more physical symptoms and worse quality of life, resulting in a huge economic burden.
At present, FGIDs gastrointestinal symptoms overlap, lack of effective and systematic
treatment, and the treatment goal is to improve symptoms.The study plans to carry out a multi
center and large sample RCT clinical study of Tongjiang granule in the treatment of
overlapping gastrointestinal symptoms of non erosive reflux disease(NERD)and epigastric pain
syndrome（EPS, so as to provide high-level evidence-based evidence for the treatment of
overlapping symptoms of FGIDs and form a diagnosis and treatment scheme that can be
popularized.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Overlapping gastrointestinal symptoms of functional gastrointestinal diseases (FGIDs) is an
internationally recognized modern medical treatment problem. More than 40.7% of people
worldwide suffer from more than one FGIDs.Gastroesophageal reflux disease (GERD) and
functional dyspepsia (FD) are common FGIDs. Clinically, the symptom overlap between GERD and
FD is very common. Some studies show that 31.32% of FD and 41.15% of FD overlap GERD overlaps
with FD, and the presence of FD reduces the response of GERD patients to proton pump
inhibitors (PPIs).At present, the pathogenesis of gastrointestinal symptoms overlap in FGIDs
is not clear, and there is a lack of effective and systematic treatment. Non erosive reflux
disease (NERD) and epigastric pain syndrome (EPS) are common subtypes of GERD and FD. Nerd
accounts for about 70% of GERD patients and EPS accounts for more than 50% of FD patients.
Long-term use of PPI can lead to many side effects, even dependency. The treatment of
traditional Chinese medicine compound has the characteristics of individualized syndrome
differentiation and the advantage of "treating different diseases at the same time". It has a
significant effect on the overlap of gastrointestinal symptoms in clinic.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 26, 2022</start_date>
<completion_date type="Anticipated">October 2024</completion_date>
<primary_completion_date type="Anticipated">October 2023</primary_completion_date>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Visual Analogue Scale（VAS）scores of main symptoms （heartburn, reflux, epigastric pain, epigastric burning sensation）</measure>
<time_frame>10 weeks</time_frame>
<description>Observe the changes of VAS scores of main symptoms（heartburn, reflux, epigastric pain, epigastric burning sensation） at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal，If the score descends, it indicates that the patient's condition has improved.</description>
</primary_outcome>
<secondary_outcome>
<measure>Visual Analogue Scale（VAS）scores of Atypical symptoms and other symptom scores （chest pain, pharyngeal foreign body sensation, cough, etc）</measure>
<time_frame>10 weeks</time_frame>
<description>Observe the changes of VAS scores of Atypical symptoms and other symptom scores（chest pain, pharyngeal foreign body sensation, cough, etc） at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal,If the score descends, it indicates that the patient's condition has improved.</description>
</secondary_outcome>
<secondary_outcome>
<measure>the MOS item short from health survey (SF-36 scale)</measure>
<time_frame>10 weeks</time_frame>
<description>Observe the changes of SF-36 scale at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal,if the score descends, it indicates that the patient's condition has improved.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Patient-Reported Outcome (Pro scale)</measure>
<time_frame>10 weeks</time_frame>
<description>Observe the changes of Pro scale at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal,if the score descends, it indicates that the patient's condition has improved.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Hospital Anxiety and Depression Scale (HAD)</measure>
<time_frame>10 weeks</time_frame>
<description>Observe the changes of Hospital Anxiety and Depression Scale (had) at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal,if the score descends, it indicates that the patient's condition has improved.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Visceral Sensitivity Scale (VSI)</measure>
<time_frame>10 weeks</time_frame>
<description>Observe the changes of Visceral Sensitivity Scale (VSI) at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal,if the score descends, it indicates that the patient's condition has improved.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">228</enrollment>
<condition>Gastroesophageal Reflux</condition>
<condition>Functional Dysphonia</condition>
<arm_group>
<arm_group_label>Tongjiang granule group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Experiment group: oral administration of Tongjiang granule with warm water after meal for 1 bag each time for three times a day. The medication period was 4 weeks.</description>
</arm_group>
<arm_group>
<arm_group_label>Tongjiang granule simulant group</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Control group:oral administration of Tongjiang granule simulant with warm water after meal for 1 bag each time for three times a day. The medication period was 4 weeks.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Tongjiang granule</intervention_name>
<description>Tongjiang granules, 1 bag / time, 3 times / day.</description>
<arm_group_label>Tongjiang granule group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Tongjiang granule simulant</intervention_name>
<description>Tongjiang granule simulant,1 bag / time, 3 times / day.</description>
<arm_group_label>Tongjiang granule simulant group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. It meets the diagnostic criteria of nonerosive reflex disease(NERD)and epigastric pain
syndrome(EPS)

2. It meets the diagnostic criteria of liver-stomach depression-heat syndrome of
traditional Chinese medicine

3. Age between 18 and 70 years old

4. Patients have informed consent and are willing to receive corresponding treatment

Exclusion Criteria:

1. Patients with active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of
gastric mucosa or suspected malignant change, achalasia or postoperative achalasia

2. There are other organic diseases of the digestive system (such as acute and chronic
pancreatitis, cirrhosis, etc.), or systemic diseases that affect the gastrointestinal
motility, such as hyperthyroidism, diabetes mellitus over 10 years, chronic renal
insufficiency, spirit (the score of SAS and SDS shows severe anxiety or depression),
nervous system diseases, etc

3. Patients with severe organ diseases such as heart, liver and kidney (such as ALT, AST
more than 2 times of normal value), hematopoietic system diseases and tumors

4. HP infection was positive (bacterial culture, histological examination, urea breath
test, rapid urease test and fecal antigen test were positive);

5. People with a history of gastric / abdominal surgery (excluding appendectomy);

6. Pregnant and lactating women;

7. People with a history of allergies to all the test drugs

8. Subjects who are participating in other clinical trials or have participated in other
clinical trials within 4 weeks

9. Other situations that reduce the possibility of enrollment or complicate enrollment
according to the judgment of the researcher, such as frequent changes in working
environment and other situations that are easy to cause loss of follow-up.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Fengyun Wang, professor</last_name>
<phone>010-62835610</phone>
<email>wfy811@163.com</email>
</overall_contact>
<location>
<facility>
<name>Xiyuan Hospital of China Academy of Chinese Medical Sciences</name>
<address>
<city>Beijing</city>
<state>Beijing</state>
<zip>100091</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Fengyun Wang, professor</last_name>
<phone>+86(010)62835610</phone>
<email>wfy811@163.com</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 3, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>April 1, 2022</last_update_submitted>
<last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 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>Gastroesophageal Reflux</mesh_term>
<mesh_term>Dysphonia</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Overlapping gastrointestinal symptoms of functional gastrointestinal diseases (FGIDs) is an
internationally recognized problem in modern medical diagnosis and treatment. Such patients
show more physical symptoms and worse quality of life, resulting in a huge economic burden.
At present, FGIDs gastrointestinal symptoms overlap, lack of effective and systematic
treatment, and the treatment goal is to improve symptoms.The study plans to carry out a multi
center and large sample RCT clinical study of Tongjiang granule in the treatment of
overlapping gastrointestinal symptoms of non erosive reflux disease(NERD)and epigastric pain
syndrome（EPS, so as to provide high-level evidence-based evidence for the treatment of
overlapping symptoms of FGIDs and form a diagnosis and treatment scheme that can be
popularized.
Overlapping gastrointestinal symptoms of functional gastrointestinal diseases (FGIDs) is an
internationally recognized modern medical treatment problem. More than 40.7% of people
worldwide suffer from more than one FGIDs.Gastroesophageal reflux disease (GERD) and
functional dyspepsia (FD) are common FGIDs. Clinically, the symptom overlap between GERD and
FD is very common. Some studies show that 31.32% of FD and 41.15% of FD overlap GERD overlaps
with FD, and the presence of FD reduces the response of GERD patients to proton pump
inhibitors (PPIs).At present, the pathogenesis of gastrointestinal symptoms overlap in FGIDs
is not clear, and there is a lack of effective and systematic treatment. Non erosive reflux
disease (NERD) and epigastric pain syndrome (EPS) are common subtypes of GERD and FD. Nerd
accounts for about 70% of GERD patients and EPS accounts for more than 50% of FD patients.
Long-term use of PPI can lead to many side effects, even dependency. The treatment of
traditional Chinese medicine compound has the characteristics of individualized syndrome
differentiation and the advantage of "treating different diseases at the same time". It has a
significant effect on the overlap of gastrointestinal symptoms in clinic.
Inclusion Criteria:
1. It meets the diagnostic criteria of nonerosive reflex disease(NERD)and epigastric pain
syndrome(EPS)
2. It meets the diagnostic criteria of liver-stomach depression-heat syndrome of
traditional Chinese medicine
3. Age between 18 and 70 years old
4. Patients have informed consent and are willing to receive corresponding treatment
Exclusion Criteria:
1. Patients with active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of
gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
2. There are other organic diseases of the digestive system (such as acute and chronic
pancreatitis, cirrhosis, etc.), or systemic diseases that affect the gastrointestinal
motility, such as hyperthyroidism, diabetes mellitus over 10 years, chronic renal
insufficiency, spirit (the score of SAS and SDS shows severe anxiety or depression),
nervous system diseases, etc
3. Patients with severe organ diseases such as heart, liver and kidney (such as ALT, AST
more than 2 times of normal value), hematopoietic system diseases and tumors
4. HP infection was positive (bacterial culture, histological examination, urea breath
test, rapid urease test and fecal antigen test were positive);
5. People with a history of gastric / abdominal surgery (excluding appendectomy);
6. Pregnant and lactating women;
7. People with a history of allergies to all the test drugs
8. Subjects who are participating in other clinical trials or have participated in other
clinical trials within 4 weeks
9. Other situations that reduce the possibility of enrollment or complicate enrollment
according to the judgment of the researcher, such as frequent changes in working
environment and other situations that are easy to cause loss of follow-up.
|
NCT0531xxxx/NCT05312476.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/NCT05312476</url>
</required_header>
<id_info>
<org_study_id>R/R B-NHL 02</org_study_id>
<nct_id>NCT05312476</nct_id>
</id_info>
<brief_title>Clinical Study on CAR-T Targeting Igβ Targets in Refractory Relapsed Non-Hodgkin's Lymphoma</brief_title>
<official_title>Clinical Study of the Safety, Tolerability and Preliminary Efficacy of Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets in Patients With Igβ-positive Refractory Relapsed Non-Hodgkin's Lymphoma</official_title>
<sponsors>
<lead_sponsor>
<agency>The First Affiliated Hospital of Soochow University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>The First Affiliated Hospital of Soochow University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Aim of this study will evaluate the safety, tolerability and preliminary efficacy of chimeric
antigen receptor T cells (CAR-T) targeting Igβ targets in patients with Igβ-positive
refractory relapsed non-Hodgkin's lymphoma.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Non-Hodgkin's lymphoma is a group of malignant neoplasms of the lymphatic system originating
from B or T cells, of which 60-70% of patients have B-cell-derived lymphoma (B-NHL). Although
rituximab in combination with chemotherapy has significantly improved the prognosis of B-cell
lymphoma, some patients still have primary resistance or relapse. In recent years,
breakthroughs have been made in the treatment of B-cell tumors with Chimeric Antigen
Receptor-Modified T Cells (CART), the investigators therefore constructed CAR-T cells
targeting Igβ to investigate the safety and efficacy of CAR-T cells with this target for the
treatment of r/r B-NHL.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">February 10, 2022</start_date>
<completion_date type="Anticipated">February 10, 2025</completion_date>
<primary_completion_date type="Anticipated">February 10, 2025</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>DLT</measure>
<time_frame>Measured from start of treatment until 28 days after last dose</time_frame>
<description>DLT occurring within 28 days of the last dose.</description>
</primary_outcome>
<primary_outcome>
<measure>Adverse events profile</measure>
<time_frame>Measured from start of treatment until 28 days after last dose</time_frame>
<description>Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated.</description>
</primary_outcome>
<secondary_outcome>
<measure>Objective Response Rate</measure>
<time_frame>up to 3 months</time_frame>
<description>Proportion of CR and PR subjects will be assessed at 3 months post-infusion.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of Response</measure>
<time_frame>up to 12 months</time_frame>
<description>Duration of overall response will be assessed from the first chimeric antigen receptor T cells (CAR-T) targeting Igβ targets given to progression, death or last follow-up.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Progression-free survival</measure>
<time_frame>up to 12 months</time_frame>
<description>To measure the duration of response to chimeric antigen receptor T cells (CAR-T) targeting Igβ targets over a follow-up period of 12 months.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Overall Survival</measure>
<time_frame>up to 12 months</time_frame>
<description>OS will be assessed from the first chimeric antigen receptor T cells (CAR-T) targeting Igβ targets given to death or last follow-up.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Peak Plasma Concentration</measure>
<time_frame>Measured from start of treatment until 28 days after last dose</time_frame>
<description>the peak amplification of Igβ-CART in peripheral blood.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time to Peak Amplification</measure>
<time_frame>Measured from start of treatment until 28 days after last dose</time_frame>
<description>the time to peak amplification of Igβ-CART in peripheral blood.</description>
</secondary_outcome>
<secondary_outcome>
<measure>AUC0-28</measure>
<time_frame>Measured from start of treatment until 28 days after last dose</time_frame>
<description>the area under the curve (AUC0-28) obtained by plotting the number of CAR-T cells in serum against the visit time from 0 to 28 days after reinfusion.</description>
</secondary_outcome>
<secondary_outcome>
<measure>PD</measure>
<time_frame>Measured from start of treatment until 28 days after last dose</time_frame>
<description>Pharmacodynamics is the peripheral blood B-cell ratio.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">12</enrollment>
<condition>Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma</condition>
<arm_group>
<arm_group_label>Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Chimeric antigen receptor T cells targeting Igβ targets (CAR-T)</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets</intervention_name>
<description>Dose escalation studies:3 dose groups in total: expect 3-6 cases in each group, and dose set at 1×106/kg，3×106/kg，6×106/kg.
Dose extension study:3 cases (1 dose group).</description>
<arm_group_label>Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets</arm_group_label>
<other_name>Chimeric antigen receptor-modified T (CAR-T) cell therapy</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Voluntary signing of informed consent and good compliance.

2. Age ≥ 6 years.

3. Previously treated with 2 or more lines of therapy.

4. Has a measurable target lesion.

5. ECOG 0-1#.

6. Have appropriate organ function, subject to the following criteria (except for
abnormal liver function due to tumor infiltration): AST≤3 times upper limit of
normal#ALT≤3 times upper limit of normal# TB≤2 times ULN, unless combined with
Gilbert's syndrome #Patients with Gilbert's syndrome with TB≤ 3 times ULN and DB≤ 1.5
times ULN can be include # Scr ≤1.5 times ULN or CCr≥60 ml/min# Lung function≤Level 1;
dyspnea(CTCAE v5.0),and blood oxygen saturation without oxygen absorption> 91%#
INR≤1.5 times ULN# aPTT≤1.5 times ULN.

7. negative blood/urine pregnancy test in women of childbearing age within 7 days prior
to cell infusion, and any male and female patients of childbearing potential must
agree to use an effective method of contraception throughout the study and for at
least six months after the study treatment is administered.

8. Pass the T-cell amplification test.

9. Have adequate venous access to single or venous blood and no other contraindications
to leukocyte isolation.

10. Estimated survival time ≥3 months.

Exclusion Criteria:

1. Prior malignancy (other than Relapsed Refractory B-cell Non-Hodgkin's Lymphoma),
except for cured malignant tumors with no active lesions for 3 years; Adequate
treatment of inactive lesions in non-melanoma skin cancer, malignant tonsilloma or
carcinoma in situ.

2. Have used immunosuppressants or hormones within 2 weeks prior to signing informed
consent, or plan to have to use immunosuppressants or high-dose hormones (e.g.
prednisone >15mg) after signing informed consent, specifically systemic treatment,
excluding treatment with topical or inhaled corticosteroids.

3. The presence of bacterial, fungal, viral, mycoplasma or other types of infection that,
in the judgment of the investigator, are difficult to control.

4. HIV, Syphilis or COVID-19 infection.

5. Active hepatitis B or active hepatitis C.

6. Previous or current CNS disease other than this disease, such as seizures,
cerebrovascular ischaemia/hemorrhage, dementia, cerebellar disease or any CNS-related
autoimmune disease.

7. A history of cardiac angioplasty or stent placement within 12 months prior to signing
the informed consent form, or a history of myocardial infarction, unstable angina or
other clinically significant heart disease.

8. Patients with primary immunodeficiency.

9. Have had a severe tachyphylaxis to any of the drugs to be used in this study.

10. Live vaccination within 6 weeks prior to screening.

11. Pregnant or breasting-feeding women.

12. Active autoimmune diseases.

13. Active acute or chronic graft-versus-host disease (GVHD) at the time of signing the
informed consent form.

14. Received an allogeneic hematopoietic stem cell transplant within 6 months prior to
signing the informed consent form.

15. Participated in an investigational clinical trial of any other drug within 30 days
prior to signing the informed consent form.

16. Conditions deemed by the researcher to be inappropriate for participation in this
clinical trial.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>6 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Depei Wu, M.D</last_name>
<role>Study Chair</role>
<affiliation>The First Affiliated Hospital of Soochow University</affiliation>
</overall_official>
<overall_contact>
<last_name>Caixia Li, M.D</last_name>
<phone>+86 512 67781856</phone>
<email>licaixia@suda.edu.cn</email>
</overall_contact>
<location>
<facility>
<name>The First Affiliated Hospital of Soochow University</name>
<address>
<city>Suzhou</city>
<state>Jiangsu</state>
<zip>215000</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Caixia Li, M.D</last_name>
<phone>+86 512 67781856</phone>
<email>licaixia@suda.edu.cn</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 21, 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 3, 2022</last_update_submitted>
<last_update_submitted_qc>April 3, 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>
<keyword>CAR-T Cells targeting Igβ targets</keyword>
<keyword>Relapsed Refractory B-cell Non-Hodgkin's Lymphoma</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Lymphoma</mesh_term>
<mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
<mesh_term>Lymphoma, B-Cell</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Aim of this study will evaluate the safety, tolerability and preliminary efficacy of chimeric
antigen receptor T cells (CAR-T) targeting Igβ targets in patients with Igβ-positive
refractory relapsed non-Hodgkin's lymphoma.
Non-Hodgkin's lymphoma is a group of malignant neoplasms of the lymphatic system originating
from B or T cells, of which 60-70% of patients have B-cell-derived lymphoma (B-NHL). Although
rituximab in combination with chemotherapy has significantly improved the prognosis of B-cell
lymphoma, some patients still have primary resistance or relapse. In recent years,
breakthroughs have been made in the treatment of B-cell tumors with Chimeric Antigen
Receptor-Modified T Cells (CART), the investigators therefore constructed CAR-T cells
targeting Igβ to investigate the safety and efficacy of CAR-T cells with this target for the
treatment of r/r B-NHL.
Inclusion Criteria:
1. Voluntary signing of informed consent and good compliance.
2. Age ≥ 6 years.
3. Previously treated with 2 or more lines of therapy.
4. Has a measurable target lesion.
5. ECOG 0-1#.
6. Have appropriate organ function, subject to the following criteria (except for
abnormal liver function due to tumor infiltration): AST≤3 times upper limit of
normal#ALT≤3 times upper limit of normal# TB≤2 times ULN, unless combined with
Gilbert's syndrome #Patients with Gilbert's syndrome with TB≤ 3 times ULN and DB≤ 1.5
times ULN can be include # Scr ≤1.5 times ULN or CCr≥60 ml/min# Lung function≤Level 1;
dyspnea(CTCAE v5.0),and blood oxygen saturation without oxygen absorption> 91%#
INR≤1.5 times ULN# aPTT≤1.5 times ULN.
7. negative blood/urine pregnancy test in women of childbearing age within 7 days prior
to cell infusion, and any male and female patients of childbearing potential must
agree to use an effective method of contraception throughout the study and for at
least six months after the study treatment is administered.
8. Pass the T-cell amplification test.
9. Have adequate venous access to single or venous blood and no other contraindications
to leukocyte isolation.
10. Estimated survival time ≥3 months.
Exclusion Criteria:
1. Prior malignancy (other than Relapsed Refractory B-cell Non-Hodgkin's Lymphoma),
except for cured malignant tumors with no active lesions for 3 years; Adequate
treatment of inactive lesions in non-melanoma skin cancer, malignant tonsilloma or
carcinoma in situ.
2. Have used immunosuppressants or hormones within 2 weeks prior to signing informed
consent, or plan to have to use immunosuppressants or high-dose hormones (e.g.
prednisone >15mg) after signing informed consent, specifically systemic treatment,
excluding treatment with topical or inhaled corticosteroids.
3. The presence of bacterial, fungal, viral, mycoplasma or other types of infection that,
in the judgment of the investigator, are difficult to control.
4. HIV, Syphilis or COVID-19 infection.
5. Active hepatitis B or active hepatitis C.
6. Previous or current CNS disease other than this disease, such as seizures,
cerebrovascular ischaemia/hemorrhage, dementia, cerebellar disease or any CNS-related
autoimmune disease.
7. A history of cardiac angioplasty or stent placement within 12 months prior to signing
the informed consent form, or a history of myocardial infarction, unstable angina or
other clinically significant heart disease.
8. Patients with primary immunodeficiency.
9. Have had a severe tachyphylaxis to any of the drugs to be used in this study.
10. Live vaccination within 6 weeks prior to screening.
11. Pregnant or breasting-feeding women.
12. Active autoimmune diseases.
13. Active acute or chronic graft-versus-host disease (GVHD) at the time of signing the
informed consent form.
14. Received an allogeneic hematopoietic stem cell transplant within 6 months prior to
signing the informed consent form.
15. Participated in an investigational clinical trial of any other drug within 30 days
prior to signing the informed consent form.
16. Conditions deemed by the researcher to be inappropriate for participation in this
clinical trial.
|
NCT0531xxxx/NCT05312489.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/NCT05312489</url>
</required_header>
<id_info>
<org_study_id>Vascular Trauma</org_study_id>
<nct_id>NCT05312489</nct_id>
</id_info>
<brief_title>Outcomes of Traumatic Arterial Injuries in Upper vs. Lower Extremities</brief_title>
<official_title>Outcomes of Traumatic Arterial Injuries in Upper vs. Lower Extremities</official_title>
<sponsors>
<lead_sponsor>
<agency>Assiut University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Assiut University</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to identify and compare the causes of vascular trauma at the
extremities, injury characteristics, types of vascular surgical interventions, and the
outcomes of traumatic vascular injuries between the upper and lower extremities.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
1. Primary patient assessment Patients will be clinically assessed on presentation, and
resuscitation protocols will be initiated if signs of hypovolemic shock are present
according to Advanced Trauma Life Support guidelines.

2. History and physical examination are the most important components of the diagnostic
protocol The presence of hard signs of arterial injury

- Absent or diminished pulses

- Active haemorrhage

- Large, expanding, or pulsatile hematoma

- Bruit or thrill

- Distal ischemia is considered an indication for surgery, and no further specific
investigative measures will be taken.

Soft signs of vascular trauma should be noted as well including

- Small, stable hematoma

- Unexplained hypotension

- History of haemorrhage that is no longer present

- Proximity of injury to major vessels

3. Investigations including:

- The use of a hand-held Doppler examination as a diagnostic aid

- Duplex US and CTA for imaging.

- Lab investigations: Complete blood picture, Coagulation profile and Kidney function
tests.

Options of intervention:

All vascular trauma patients will be admitted for operative management and follow up. The
specific surgical intervention will be determined by the vascular surgeon according to type,
site, and extent of the injury, ranging from ligation of the injured vessel to vascular graft
interposition.

An injury to a peripheral artery that does not result in complete transection can be repaired
depending on luminal diameter with an interrupted or continuous suturing technique. A
complete transection of a peripheral artery is first managed with minimal debridement back to
healthy intima at both ends then an end-to-end anastomosis or with an interposition graft of
autogenous vein or prosthetics arterial graft.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">June 1, 2022</start_date>
<completion_date type="Anticipated">June 1, 2024</completion_date>
<primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Other</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Presence of distal pulse or signals by doppler ultrasound</measure>
<time_frame>Intraoperative</time_frame>
<description>Presence of distal pulse or signals by doppler ultrasound which indicates technical success of the surgery and patency of the affected artery</description>
</primary_outcome>
<secondary_outcome>
<measure>Type of the injury in the upper extremities compared with the lower extremities</measure>
<time_frame>Preoperative</time_frame>
<description>blunt or penetrating injury by history and clinical examination</description>
</secondary_outcome>
<secondary_outcome>
<measure>Presentation of the injury in the upper extremities compared with the lower extremities</measure>
<time_frame>Preoperative</time_frame>
<description>Bleeding or ischemia by clinical examination.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Presence of injury related complications in the upper extremities compared with the lower extremities</measure>
<time_frame>Preoperative</time_frame>
<description>Presence of complications(or not) like compartment syndrome, hematoma or/and associated nerve deficit by clinical examination.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Presence of postoperative complications in the upper extremities compared with the lower extremities</measure>
<time_frame>Postoperative for 10 days</time_frame>
<description>Presence of complications(or not) like thrombosis of the repaired vessel, pseudoaneurysm formation or/and deep vein thrombosis by clinical examination and Duplex ultrasound evaluation.
Presence of complications(or not) like surgical site infection or/and wound dehiscence by clinical examination and culture and sensitivity.</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">65</enrollment>
<condition>Vascular Trauma</condition>
<arm_group>
<arm_group_label>Upper extremity arterial trauma</arm_group_label>
<description>Vascular traumatic injuries of the arterial system of the upper limbs.</description>
</arm_group>
<arm_group>
<arm_group_label>Lower extremity arterial trauma</arm_group_label>
<description>Vascular traumatic injuries of the arterial system of the lower limbs.</description>
</arm_group>
<eligibility>
<study_pop>
<textblock>
All patients fulfilling the previous criteria who are operated at Assiut University
Hospital - Department of Vascular and Endovascular Surgery.
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- All peripheral arterial injuries of one or more of the extremities.

Exclusion Criteria:

- Vascular injuries limited to the venous system only.

- Vascular injuries limited to thoracic, abdominal, or neck vessels.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Mohamed A Mubarak</last_name>
<role>Study Director</role>
<affiliation>Assiut University</affiliation>
</overall_official>
<overall_official>
<last_name>Ashraf G Taha</last_name>
<role>Study Director</role>
<affiliation>Assiut University</affiliation>
</overall_official>
<overall_official>
<last_name>Osman M Ahmed</last_name>
<role>Study Director</role>
<affiliation>Assiut University</affiliation>
</overall_official>
<overall_official>
<last_name>Abanoub E Mousa</last_name>
<role>Principal Investigator</role>
<affiliation>Assiut University</affiliation>
</overall_official>
<overall_contact>
<last_name>Abanoub E Mousa</last_name>
<phone>+20882056361</phone>
<email>abanob.12167701@med.au.edu.eg</email>
</overall_contact>
<reference>
<citation>Gallo LK, Ramos CR, Rajani RR, Benarroch-Gampel J. Management and Outcomes after Upper Versus Lower Extremity Vascular Trauma. Ann Vasc Surg. 2021 Oct;76:152-158. doi: 10.1016/j.avsg.2021.05.007. Epub 2021 Jun 18.</citation>
<PMID>34153492</PMID>
</reference>
<reference>
<citation>Feliciano DV, Moore FA, Moore EE, West MA, Davis JW, Cocanour CS, Kozar RA, McIntyre RC Jr. Evaluation and management of peripheral vascular injury. Part 1. Western Trauma Association/critical decisions in trauma. J Trauma. 2011 Jun;70(6):1551-6. doi: 10.1097/TA.0b013e31821b5bdd. No abstract available.</citation>
<PMID>21817992</PMID>
</reference>
<reference>
<citation>Feliciano DV, Moore EE, West MA, Moore FA, Davis JW, Cocanour CS, Scalea TM, McIntyre RC Jr. Western Trauma Association critical decisions in trauma: evaluation and management of peripheral vascular injury, part II. J Trauma Acute Care Surg. 2013 Sep;75(3):391-7. doi: 10.1097/TA.0b013e3182994b48.</citation>
<PMID>23928739</PMID>
</reference>
<reference>
<citation>Huber GH, Manna B. Vascular Extremity Trauma. 2023 Apr 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536925/</citation>
<PMID>30725610</PMID>
</reference>
<verification_date>April 2022</verification_date>
<study_first_submitted>February 16, 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 3, 2022</last_update_submitted>
<last_update_submitted_qc>April 3, 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>Assiut University</investigator_affiliation>
<investigator_full_name>Abanoub Emad Mousa Daniel</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to identify and compare the causes of vascular trauma at the
extremities, injury characteristics, types of vascular surgical interventions, and the
outcomes of traumatic vascular injuries between the upper and lower extremities.
1. Primary patient assessment Patients will be clinically assessed on presentation, and
resuscitation protocols will be initiated if signs of hypovolemic shock are present
according to Advanced Trauma Life Support guidelines.
2. History and physical examination are the most important components of the diagnostic
protocol The presence of hard signs of arterial injury
- Absent or diminished pulses
- Active haemorrhage
- Large, expanding, or pulsatile hematoma
- Bruit or thrill
- Distal ischemia is considered an indication for surgery, and no further specific
investigative measures will be taken.
Soft signs of vascular trauma should be noted as well including
- Small, stable hematoma
- Unexplained hypotension
- History of haemorrhage that is no longer present
- Proximity of injury to major vessels
3. Investigations including:
- The use of a hand-held Doppler examination as a diagnostic aid
- Duplex US and CTA for imaging.
- Lab investigations: Complete blood picture, Coagulation profile and Kidney function
tests.
Options of intervention:
All vascular trauma patients will be admitted for operative management and follow up. The
specific surgical intervention will be determined by the vascular surgeon according to type,
site, and extent of the injury, ranging from ligation of the injured vessel to vascular graft
interposition.
An injury to a peripheral artery that does not result in complete transection can be repaired
depending on luminal diameter with an interrupted or continuous suturing technique. A
complete transection of a peripheral artery is first managed with minimal debridement back to
healthy intima at both ends then an end-to-end anastomosis or with an interposition graft of
autogenous vein or prosthetics arterial graft.
All patients fulfilling the previous criteria who are operated at Assiut University
Hospital - Department of Vascular and Endovascular Surgery.
Inclusion Criteria:
- All peripheral arterial injuries of one or more of the extremities.
Exclusion Criteria:
- Vascular injuries limited to the venous system only.
- Vascular injuries limited to thoracic, abdominal, or neck vessels.
|
NCT0531xxxx/NCT05312502.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/NCT05312502</url>
</required_header>
<id_info>
<org_study_id>0000-0002</org_study_id>
<nct_id>NCT05312502</nct_id>
</id_info>
<brief_title>Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor</brief_title>
<official_title>Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor: A Randomized Controlled Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Selcuk University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Selcuk 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>
H0: There is no difference between birth satisfaction and pain levels of pregnant women who
used and did not use a birth ball during labor.

H1: There is a difference between birth satisfaction and pain levels of pregnant women who
used and did not use a birth ball during the birth process.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">March 1, 2020</start_date>
<completion_date type="Actual">December 1, 2022</completion_date>
<primary_completion_date type="Actual">June 1, 2021</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>The sample size was 106 pregnant women, 53 in each group, with a known score using the G*Power 3.1.7 program (intervention group=29.19±5.86-control group=26.51±5.13) with 85% power, 0.48 effect size and 0.15 error. was calculated as. Considering data loss, it is planned to reach 10% more pregnant women. Intervention group=57, control group=54 pregnants, and the study was terminated. The women were divided into two groups using the random numbers table in the simple random sampling method. Single blinding was performed on the women participating in the study. However, in order to prevent bias, the researcher who collected the data gave codes to the questionnaire forms of the pregnant women.</intervention_model_description>
<primary_purpose>Supportive Care</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Introductory Information Form</measure>
<time_frame>pre-intervention</time_frame>
<description>The form consisting of 13 questions was prepared by the researcher in order to describe the sociodemographic characteristics and current health status of women.</description>
</primary_outcome>
<primary_outcome>
<measure>Birth Process Follow-up Form</measure>
<time_frame>during the intervention</time_frame>
<description>It was created by the researcher in order to obtain information about the progress of birth and the characteristics of the fetus during the birth process of the pregnant. In the form, there are questions including the hour and subsequent follow-up hours when the vaginal opening is 4 cm, dilatation, fetal heartbeat, whether there is oxytocin administration, the duration and frequency of contractions, and the characteristics of the amniotic fluid.</description>
</primary_outcome>
<secondary_outcome>
<measure>Visual Analog Scale (VAS)</measure>
<time_frame>during the intervention</time_frame>
<description>It is a measurement usually used to evaluate pain from 0 (no pain) to 10 (unbearable pain). A 10 cm vertical form was used in the study. Pain level was evaluated with VAS during each follow-up of the pregnant woman.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Birth Satisfaction Scale-Short Form (DME-F)</measure>
<time_frame>in the first hour in postpartum period</time_frame>
<description>The short form of the scale was revised by Martin et al. in 2016 to evaluate the birth satisfaction levels of women (Martin et al., 2016). The Turkish validity and reliability study was conducted by Serhatlıoğlu et al. in 2018 (Göncü Serhatlıoğlu et al., 2018). The scale consists of 10 items and a minimum of 0 and a maximum of 40 points can be obtained. The items of the scale are in a 5-point Likert type and are scored as Strongly agree (4 points)-Strongly Disagree (0 points).</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">111</enrollment>
<condition>Pain</condition>
<condition>Labor Pain</condition>
<condition>Satisfaction</condition>
<arm_group>
<arm_group_label>Experimental: Birth Ball</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>In the second stage, the birth ball application was made and followed. Pregnant women with a vaginal opening of 4 cm admitted to the delivery room were instructed to sit on the delivery ball for a total of 30 minutes. A stopwatch clock was used to determine these 30 minutes. The pregnant woman was not asked to sit on the ball all the time, and she could take a break for rest or other needs. The birth ball, which is suitable for women's use, was preferred in 45 cm dimensions, and the pilates circle was used as a stabilizer. Under the supervision of the researcher, the pregnant women sat upright on the ball and began to rock back and forth. Meanwhile, the researcher held the pregnant woman's hand. In order for the pregnant woman not to lose her balance, the birth ball was placed on a pilates circle and she was supported by the researcher in making the movements.</description>
</arm_group>
<arm_group>
<arm_group_label>Control</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>A routine care was performed.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Birth Ball</intervention_name>
<description>During labour, the pregnant woman was positioned using a birth ball.</description>
<arm_group_label>Experimental: Birth Ball</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- the consent of the pregnant women to participate in the study,

- have signed the informed consent form,

- be over the age of 18,

- Vaginal opening was determined as 4 cm

Exclusion Criteria:

- Having a psychologically diagnosed disorder

- Pregnant women diagnosed with risky pregnancy
</textblock>
</criteria>
<gender>Female</gender>
<gender_based>Yes</gender_based>
<minimum_age>19 Years</minimum_age>
<maximum_age>47 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Dr. Ali Kemal Belviranlı Gynecology and Pediatrics Hospital</name>
<address>
<city>Konya</city>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 21, 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>May 24, 2023</last_update_submitted>
<last_update_submitted_qc>May 24, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 25, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Selcuk University</investigator_affiliation>
<investigator_full_name>Yasemin ERKAL AKSOY</investigator_full_name>
<investigator_title>Asistant Prof. Dr.</investigator_title>
</responsible_party>
<keyword>Birth ball</keyword>
<keyword>birth satisfaction</keyword>
<keyword>pain</keyword>
<keyword>midwifery care</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Labor Pain</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
H0: There is no difference between birth satisfaction and pain levels of pregnant women who
used and did not use a birth ball during labor.
H1: There is a difference between birth satisfaction and pain levels of pregnant women who
used and did not use a birth ball during the birth process.
Inclusion Criteria:
- the consent of the pregnant women to participate in the study,
- have signed the informed consent form,
- be over the age of 18,
- Vaginal opening was determined as 4 cm
Exclusion Criteria:
- Having a psychologically diagnosed disorder
- Pregnant women diagnosed with risky pregnancy
|
NCT0531xxxx/NCT05312515.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/NCT05312515</url>
</required_header>
<id_info>
<org_study_id>0000-0002-7453-1205</org_study_id>
<nct_id>NCT05312515</nct_id>
</id_info>
<brief_title>The Effect of Hot Bag/Warm Application on Feet After Cesarean Delivery on Postpartum Comfort, Pain and Flatus</brief_title>
<official_title>The Effect of Hot Bag/Warm Application on Feet After Cesarean Delivery on Postpartum Comfort, Pain and Flatus</official_title>
<sponsors>
<lead_sponsor>
<agency>Selcuk University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Selcuk University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The postpartum period is a process in which both physical (bleeding, infection, anemia) and
emotional (delay in breastfeeding and mother-baby relationship) problems occur in women.
Among the conditions that physically affect the woman who has had a cesarean section, a
decrease in bowel movements is often seen and this decrease can last for 24 hours or longer.
Initiation of bowel movements after surgery, time of first flatulence and defecation are
important factors that determine postoperative patient comfort.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Pain after cesarean section is usually associated with incision site and uterine
contractions. There are various medical treatment and midwifery applications for the
resolution of pain and gas output after cesarean section. Recently, it has been stated that
in addition to the treatments applied after surgery, non-drug methods should be used to
increase the effectiveness of recovery. These methods include applications such as hot
application, abdominal massage, music therapy, chewing gum. The effect of hot application in
patients with post-operative gas problems is the acupuncture points of the foot, warm and
moist heat stimulation and the small intestine, colon, anus and other reflective areas.
activates blood circulation. It is predicted that postpartum comfort will increase in the
postpartum postpartum, whose pain decreases with postpartum heat application and intestinal
mobility returns to normal. The aim of this study is to determine the effect of applying heat
to the feet after cesarean section on postpartum comfort, pain and gas output.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 1, 2021</start_date>
<completion_date type="Actual">December 30, 2022</completion_date>
<primary_completion_date type="Actual">March 1, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>In order to ensure randomization in the study, a random numbers table was created by dividing into two groups out of 238 samples by taking 10% more than the number of samples determined on the site https://www.randomizer.org/. In order to avoid bias, the assignment of women to the intervention and control groups according to the randomization list will be determined by a midwife working in the clinic, who is not one of the study authors. In the study, the CONSORT scheme will be followed during the application.</intervention_model_description>
<primary_purpose>Supportive Care</primary_purpose>
<masking>Triple (Participant, Care Provider, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Introductory Information Form</measure>
<time_frame>at the beginning of the study</time_frame>
<description>It was prepared by the researcher to describe the sociodemographic characteristics and current health status of women. The group of women will be marked as Intervention or Control.</description>
</primary_outcome>
<primary_outcome>
<measure>Post Cesarean Section Follow-up Form-First follow up</measure>
<time_frame>application after 30 minute</time_frame>
<description>In this form, the time the patient was taken into surgery; length of stay in the recovery unit; time of service; the type of anesthesia administered; It was created by the researcher in order to obtain information about the hot water bag application time and the first gas removal time.</description>
</primary_outcome>
<primary_outcome>
<measure>Post Cesarean Section Follow-up Form-Second follow up</measure>
<time_frame>application after 60 minute</time_frame>
<description>In this form, the time the patient was taken into surgery; length of stay in the recovery unit; time of service; the type of anesthesia administered; It was created by the researcher in order to obtain information about the hot water bag application time and the first gas removal time.</description>
</primary_outcome>
<primary_outcome>
<measure>Post Cesarean Section Follow-up Form-Third follow up</measure>
<time_frame>application after 120 minute</time_frame>
<description>In this form, the time the patient was taken into surgery; length of stay in the recovery unit; time of service; the type of anesthesia administered; It was created by the researcher in order to obtain information about the hot water bag application time and the first gas removal time.</description>
</primary_outcome>
<secondary_outcome>
<measure>Visual Pain Scale (VAS)-First follow up</measure>
<time_frame>application after 30 minute</time_frame>
<description>It is a measurement usually used to evaluate pain from 0 (no pain) to 10 (unbearable pain). In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers. The number expressed by the patient is accepted as the intensity of pain felt at that moment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Visual Pain Scale (VAS)-Second follow up</measure>
<time_frame>application after 60 minute</time_frame>
<description>It is a measurement usually used to evaluate pain from 0 (no pain) to 10 (unbearable pain). In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers. The number expressed by the patient is accepted as the intensity of pain felt at that moment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Visual Pain Scale (VAS)-Third follow up</measure>
<time_frame>application after 120 minute</time_frame>
<description>It is a measurement usually used to evaluate pain from 0 (no pain) to 10 (unbearable pain). In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers. The number expressed by the patient is accepted as the intensity of pain felt at that moment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Postpartum Comfort Scale-First follow up</measure>
<time_frame>application after 30 minute</time_frame>
<description>Postpartum Comfort Scale: It is a scale that can be used to measure the postpartum comfort of mothers who delivered vaginally or by cesarean section. The PCS consists of a 5-point Likert-type scale scoring system and 34 items. I totally agree with positive sentences shows the best comfort (5 points), and negative sentences show low comfort (1 point). Accordingly, the lowest score to be taken from the scale is 34, and the highest score is 170. The average value is determined by dividing the total score obtained from the scale by the number of items, and the result is shown in the 1-5 distribution.High scores on the scale indicate increased comfort.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Postpartum Comfort Scale -Second follow up</measure>
<time_frame>application after 60 minute</time_frame>
<description>Postpartum Comfort Scale: It is a scale that can be used to measure the postpartum comfort of mothers who delivered vaginally or by cesarean section. The PCS consists of a 5-point Likert-type scale scoring system and 34 items.I totally agree with positive sentences shows the best comfort (5 points), and negative sentences show low comfort (1 point). Accordingly, the lowest score to be taken from the scale is 34, and the highest score is 170. The average value is determined by dividing the total score obtained from the scale by the number of items, and the result is shown in the 1-5 distribution.High scores on the scale indicate increased comfort.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Postpartum Comfort Scale -Third follow up</measure>
<time_frame>application after 120 minute</time_frame>
<description>Postpartum Comfort Scale: It is a scale that can be used to measure the postpartum comfort of mothers who delivered vaginally or by cesarean section. The PCS consists of a 5-point Likert-type scale scoring system and 34 items. I totally agree with positive sentences shows the best comfort (5 points), and negative sentences show low comfort (1 point). Accordingly, the lowest score to be taken from the scale is 34, and the highest score is 170. The average value is determined by dividing the total score obtained from the scale by the number of items, and the result is shown in the 1-5 distribution. High scores on the scale indicate increased comfort.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">108</enrollment>
<condition>Cesarean Section Complications</condition>
<condition>Pain</condition>
<condition>Postpartum Anxiety</condition>
<arm_group>
<arm_group_label>Warm Application to Feet and Follow-up After Cesarean Section</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Warm application will be applied to the feet of women who come to the surgical service after cesarean delivery, 3 hours after they are admitted to the service. For hot application, a hot water bag will be used, the temperature of the water to be placed in the hot water bag is max. It will be set by the researcher to be 44°C. Since the temperature of the water (max. 44°C) does not create a risk of burns, no additional precautions were required. A stopwatch clock will be used to track the duration of the application. After the application will be done for 30 minutes, a hot water bag will be taken. Hot application will be done once. During the application, the researcher will be with the women, will check whether any complications have developed, and if complications or discomfort develop, the application will be terminated.</description>
</arm_group>
<arm_group>
<arm_group_label>Control</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>The control group will be given routine post-operative care without any intervention and data collection tools will be applied at the same time as the intervention group. In addition, the patient and his family will be informed to write it down with the watch if there is gas after the procedure when the researcher is not with them.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Warm Application to Feet</intervention_name>
<description>Warm Application to Feet after Cesarean Section</description>
<arm_group_label>Warm Application to Feet and Follow-up After Cesarean Section</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- over 18 years old

- Can read and understand Turkish

- No history of any medical illness

- Singular pregnancy

- No complications during or after surgery

- Those who have not had any problems during pregnancy

- giving birth to a live baby

- No diagnosed psychological disorder

- Women who do not pass gas before applying heat

Exclusion Criteria:

- From gas before hot application

- Hearing loss

- The baby is in intensive care

- Women with vascular diseases

- Women who were taken to the intensive care unit after surgery due to any complications
</textblock>
</criteria>
<gender>Female</gender>
<gender_based>Yes</gender_based>
<minimum_age>18 Years</minimum_age>
<maximum_age>50 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Dr. Ali Kemal Belviranlı Gynecology and Pediatrics Hospital</name>
<address>
<city>Konya</city>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<reference>
<citation>Büyükkayacı Duman N, Karataş N. Sezaryen Sonrası Erken Taburcu Olan Kadınlara Verilen Evde Bakım Hizmetinin Anne Sağlığına Ve Öz Bakım Gücüne Etkisi. Sağlık Bil Derg 2011, 20(1):54-67.</citation>
</reference>
<reference>
<citation>Ciardulli A, Saccone G, Di Mascio D, Caissutti C, Berghella V. Chewing gum improves postoperative recovery of gastrointestinal function after cesarean delivery: a systematic review and meta-analysis of randomized trials. J Matern Fetal Neonatal Med. 2018 Jul;31(14):1924-1932. doi: 10.1080/14767058.2017.1330883. Epub 2017 Jun 6.</citation>
<PMID>28502203</PMID>
</reference>
<reference>
<citation>Sutton CD, Carvalho B. Optimal Pain Management After Cesarean Delivery. Anesthesiol Clin. 2017 Mar;35(1):107-124. doi: 10.1016/j.anclin.2016.09.010. Epub 2016 Dec 12.</citation>
<PMID>28131114</PMID>
</reference>
<results_reference>
<citation>Sell SE, Beresford PC, Dias HHZR, Garcia ORZ, Santos EKA. Looks and knowledge: experiences of mothers and nursing staff regarding post-caesarean section pain. Text Context Nurs., 2012, 21(4): 766-74.</citation>
</results_reference>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 23, 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>May 24, 2023</last_update_submitted>
<last_update_submitted_qc>May 24, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 25, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Selcuk University</investigator_affiliation>
<investigator_full_name>Yasemin ERKAL AKSOY</investigator_full_name>
<investigator_title>Asistant Prof. Dr.</investigator_title>
</responsible_party>
<keyword>Cesarean Section</keyword>
<keyword>Pain</keyword>
<keyword>Postpartum Comfort</keyword>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The postpartum period is a process in which both physical (bleeding, infection, anemia) and
emotional (delay in breastfeeding and mother-baby relationship) problems occur in women.
Among the conditions that physically affect the woman who has had a cesarean section, a
decrease in bowel movements is often seen and this decrease can last for 24 hours or longer.
Initiation of bowel movements after surgery, time of first flatulence and defecation are
important factors that determine postoperative patient comfort.
Pain after cesarean section is usually associated with incision site and uterine
contractions. There are various medical treatment and midwifery applications for the
resolution of pain and gas output after cesarean section. Recently, it has been stated that
in addition to the treatments applied after surgery, non-drug methods should be used to
increase the effectiveness of recovery. These methods include applications such as hot
application, abdominal massage, music therapy, chewing gum. The effect of hot application in
patients with post-operative gas problems is the acupuncture points of the foot, warm and
moist heat stimulation and the small intestine, colon, anus and other reflective areas.
activates blood circulation. It is predicted that postpartum comfort will increase in the
postpartum postpartum, whose pain decreases with postpartum heat application and intestinal
mobility returns to normal. The aim of this study is to determine the effect of applying heat
to the feet after cesarean section on postpartum comfort, pain and gas output.
Inclusion Criteria:
- over 18 years old
- Can read and understand Turkish
- No history of any medical illness
- Singular pregnancy
- No complications during or after surgery
- Those who have not had any problems during pregnancy
- giving birth to a live baby
- No diagnosed psychological disorder
- Women who do not pass gas before applying heat
Exclusion Criteria:
- From gas before hot application
- Hearing loss
- The baby is in intensive care
- Women with vascular diseases
- Women who were taken to the intensive care unit after surgery due to any complications
|
NCT0531xxxx/NCT05312528.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/NCT05312528</url>
</required_header>
<id_info>
<org_study_id>2018.01.1.01.001</org_study_id>
<nct_id>NCT05312528</nct_id>
</id_info>
<brief_title>Evaluation of New Biomarkers in Stage 3 and 4 Endometriosis</brief_title>
<official_title>Diagnostic Value of Annexin V, sVCAM-1, sICAM-1, Vascular Endothelial Growth Factor, TNF Alpha and Interleukin-6 in Ovarian and Deep Infiltrating Endometriosis, the Changes of These Markers in the Postoperative Period</official_title>
<sponsors>
<lead_sponsor>
<agency>Bagcilar Training and Research Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Bagcilar Training and Research Hospital</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The diagnostic value of Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and
Proinflammatory cytokines (TNF-a and interleukin-6) in ovarian endometriosis and deep
infiltrating endometriosis, their levels in organ-specific involvement, their relationship
with symptoms, and the changes of these markers in the postoperative period will be
evaluated.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Serum Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and proinflammatory
cytokines (TNF-a and interleukin-6) values were studied by taking blood samples from all
patients before and three months after the operation.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 1, 2018</start_date>
<completion_date type="Actual">March 1, 2019</completion_date>
<primary_completion_date type="Actual">February 1, 2019</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Diagnostic value of serum Annexin V in endometriosis</measure>
<time_frame>Up to 4 months</time_frame>
<description>To determine whether serum Annexin V levels (ng/mL) can be used as diagnostic markers of endometriosis disease.</description>
</primary_outcome>
<primary_outcome>
<measure>Diagnostic value of serum sVCAM-1 in endometriosis</measure>
<time_frame>Up to 4 months</time_frame>
<description>To determine whether serum sVCAM-1(ng/mL) levels can be used as diagnostic markers of endometriosis disease.</description>
</primary_outcome>
<primary_outcome>
<measure>Diagnostic value of serum sICAM-1 in endometriosis</measure>
<time_frame>Up to 4 months</time_frame>
<description>To determine whether serum sICAM-1(ng/mL) levels can be used as diagnostic markers of endometriosis disease.</description>
</primary_outcome>
<primary_outcome>
<measure>Diagnostic value of serum Vascular Endothelial Growth Factor in endometriosis</measure>
<time_frame>Up to 4 months</time_frame>
<description>To determine whether serum Vascular Endothelial Growth Factor (pg/mL) levels can be used as diagnostic markers of endometriosis disease.</description>
</primary_outcome>
<primary_outcome>
<measure>Diagnostic value of serum TNF-alpha in endometriosis</measure>
<time_frame>Up to 4 months</time_frame>
<description>To determine whether serum TNF-alpha (pg/mL) levels can be used as diagnostic markers of endometriosis disease.</description>
</primary_outcome>
<primary_outcome>
<measure>Diagnostic value of serum Interleukin-6 in endometriosis</measure>
<time_frame>Up to 4 months</time_frame>
<description>To determine whether serum Interleukin-6 (pg/mL) levels can be used as diagnostic markers of endometriosis disease.</description>
</primary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Actual">79</enrollment>
<condition>Endometriosis</condition>
<arm_group>
<arm_group_label>Study Group</arm_group_label>
<description>Stage 3 and 4 endometriosis patients</description>
</arm_group>
<arm_group>
<arm_group_label>Control Group</arm_group_label>
<description>Patients without endometriosis, who required surgery for tubal ligation, benign ovarian cysts or uterine fibroids were included.</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>endometriosis surgery</intervention_name>
<description>Laparoscopy was performed in the follicular phase of the woman's menstrual cycle and all recognizable endometriotic lesions were treated by bipolar coagulation, resection of endometriotic nodules and ovarian cystectomy.</description>
<arm_group_label>Study Group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>other benign condition surgeries</intervention_name>
<description>ovarian cystectomy, bilateral tubal ligation, myomectomy etc.</description>
<arm_group_label>Control Group</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Stage III and IV endometriosis patients aged 18-50 years requiring surgery for chronic
pelvic pain or suspected malignancy
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. Stage III and IV endometriosis patients requiring surgery due to chronic pelvic pain or
suspected malignancy

Exclusion Criteria:

1. Malignant disease

2. Ovarian failure

3. Acute pelvic inflammatory disease

4. Smokers

5. Pregnancy

6. Chronic autoimmune disease
</textblock>
</criteria>
<gender>Female</gender>
<gender_based>Yes</gender_based>
<minimum_age>18 Years</minimum_age>
<maximum_age>50 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Evrim Ebru Kovalak, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Bagcilar Training and Research Hospital</affiliation>
</overall_official>
<location>
<facility>
<name>Bagcilar Teaching and Research Hospital</name>
<address>
<city>Istanbul</city>
<state>Bagcilar</state>
<zip>34200</zip>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<link>
<url>https://pubmed.ncbi.nlm.nih.gov/22736326/</url>
<description>Based on the above publication</description>
</link>
<results_reference>
<citation>Vodolazkaia A, El-Aalamat Y, Popovic D, Mihalyi A, Bossuyt X, Kyama CM, Fassbender A, Bokor A, Schols D, Huskens D, Meuleman C, Peeraer K, Tomassetti C, Gevaert O, Waelkens E, Kasran A, De Moor B, D'Hooghe TM. Evaluation of a panel of 28 biomarkers for the non-invasive diagnosis of endometriosis. Hum Reprod. 2012 Sep;27(9):2698-711. doi: 10.1093/humrep/des234. Epub 2012 Jun 26.</citation>
<PMID>22736326</PMID>
</results_reference>
<verification_date>March 2022</verification_date>
<study_first_submitted>February 23, 2022</study_first_submitted>
<study_first_submitted_qc>March 26, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 5, 2022</study_first_posted>
<last_update_submitted>March 26, 2022</last_update_submitted>
<last_update_submitted_qc>March 26, 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>Bagcilar Training and Research Hospital</investigator_affiliation>
<investigator_full_name>Evrim Ebru Kovalak</investigator_full_name>
<investigator_title>Medical Doctor, Obstetrician and Gynecologist</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Endometriosis</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The diagnostic value of Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and
Proinflammatory cytokines (TNF-a and interleukin-6) in ovarian endometriosis and deep
infiltrating endometriosis, their levels in organ-specific involvement, their relationship
with symptoms, and the changes of these markers in the postoperative period will be
evaluated.
Serum Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and proinflammatory
cytokines (TNF-a and interleukin-6) values were studied by taking blood samples from all
patients before and three months after the operation.
Stage III and IV endometriosis patients aged 18-50 years requiring surgery for chronic
pelvic pain or suspected malignancy
Inclusion Criteria:
1. Stage III and IV endometriosis patients requiring surgery due to chronic pelvic pain or
suspected malignancy
Exclusion Criteria:
1. Malignant disease
2. Ovarian failure
3. Acute pelvic inflammatory disease
4. Smokers
5. Pregnancy
6. Chronic autoimmune disease
|
NCT0531xxxx/NCT05312541.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/NCT05312541</url>
</required_header>
<id_info>
<org_study_id>N-2-2022</org_study_id>
<nct_id>NCT05312541</nct_id>
</id_info>
<brief_title>A Comparative Study Between Analgesic Effect of Opioid Free and Opioid Based Anesthesia in Radical Nephrectomy Surgery</brief_title>
<official_title>A Comparative Study Between Analgesic Effect of Opioid Free and Opioid Based General Anesthesia Technique in Patients Undergoing Open Radical Nephrectomy Surgery.A Prospective Randomized Controlled Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Kasr El Aini Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Cairo University</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Kasr El Aini Hospital</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
Patients undergoing nephrectomy have a high incidence of postoperative pain. In the
perioperative period, these patients are often treated with patient-controlled opioids,
epidural analgesia, or both. While effective, both of these treatment modalities carry risk,
ie, opioids have a side effect profile including pruritus, nausea,vomiting, increase the risk
of oversedation and apnea in patients at risk (eg, those with sleep apnea), difficulty in
voiding, and ileus. These complications may lead to a prolonged hospital stay. High dose
opioids can also cause acute opioid tolerance and hyperalgesia. Epidurals have been
associated with hypotension, post dural puncture headaches, changes in management of
anticoagulation Opioid free anesthesia (OFA) is a technique in which no intraoperative opioid
administered through any route, including systemic, neuraxial, or tissue infiltration.Opioid
free anesthesia has many advantages especially avoiding opioid overdose and opioid-induced
hyperalgesia. The most important advantage of OFA seems to be the potential improvement of
recovery profile in obese patients. OFA depends on combinations of non-opioid agents and
adjuncts, including propofol, lidocaine, magnesium, dexmedetomidine, and ketamine to produce
anesthesia, and analgesia.

Aim of the work our study aim to compare the analgesic effect of OFA and opioid based general
anesthesia using pre emptive wound infiltration in patients undergoing open radical
nephrectomy surgery.

Objectives:

1. To evaluate analgesic effect of each group intra operative {heart rate, and systolic and
diastolic blood pressure }

2. To evaluate analgesic effect of each group post operative [total opioid consumption in
24h postoperative , Postoperative VAS , hemodynamic).

3. To estimate the incidence of early postoperative complication in both groups
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This a randomized control trial is designed to include (74) patients ASA physical status II
patients ranging from(18) to(70)years old scheduled for open radical nephrectomy

Patients meeting the inclusion criteria will be randomly assigned to receive either :

Group I :Opioid Based Anesthesia (n=37) GroupII: Opioid Free Anesthesia:(n=37) Anesthesia
management

Preoperative procedures:

Full history and investigation will be taken in the form of complete blood count , blood
sugar,liver function tests. Kidney function tests ,electrolytes and coagulation profile. Pre
induction of general anesthesia with gabapentin 300 mg tab or placebo 1 h before surgery
while gabapentin in (Opioid free Anesthesia) and placebo in (Opioid Based Anesthesia) . After
securing IV access by 20G cannula, all patients will receive 0.05mg/kg midazolam for anxiety.
Ranitidine 50mg, metoclopramide 10mg and antibiotic 50mg/kg as a premedication.Intraoperative
monitoring includes ASA standard monitoring Electrocardiography (ECG), noninvasive blood
pressure, pulse oximetry for O2 saturation, end-tidal carbon dioxide (CO2) values by
capnography.

Intraoperative procedures:

Induction of general anesthesia in both groups will be done by 2mg \kg propofol, and 0.5mg\kg
atracurium. to facilitate endotracheal intubation, with fentanyl1ug/kg/ iv then infusion of 1
ug/kg/h in group I (Opioid Based Anesthesia) and with ketamine 0.5 mg/kg iv, Lidocaine 1
mg/kg iv then continuous infusion with 2 mg/kg/hr, dexamethasone 0.1 mg/kg.iv, magnesium
sulfate 20 mg/kg.iv in group II (Opioid Free Anesthesia) after induction.

Anesthesia maintenance will be achieved in both group with endotracheal tube (ETT) with
suitable size, 1.2 minimium alveolar concentration of isoflurane, volume controlled mode
ventilation, respiratory rate will be adjusted according to Et CO2 to range between 35-40
mmHg, a tidal volume of 6-8 ml/kg and mixture of gases in proportion 50% oxygen and 50% air,
with positive end expiratory pressure (PEEP) 5 cm H2O and0.1 mg\kg atracurium every 30 min.

Intervention Before skin incision by 15 min the surgeon will infiltrate the wound by syringe
containing 20 ml mixture of (10 ml xylocaine 2%and 10 ml bupivacaine 0. 5%) in both groups.
By the end of surgery, anaesthesia will be discontinued ,patient will be reversed by
neostigmine 0.05mg\kg and atropine0.02mg\kg, extubation will be done and patient will be
transferred to post anaesthesia care unit (PACU).

Postoperative

1. The pain assessment after full recovery will be performed using a 10 cm visual analog
scale (VAS) (0- no pain and 10 cm maximum pain) .Postoperative pain assessments using
VAS at 0 point (the full recovery state which is defined as a state of consciousness of
individual when he is awake or easily arousable and aware of his surroundings and
identity, 2 hr, 6 hr, 12 hr, and at 24 hr. IV paracetamol 1 g every 6 hours will be
administered for both groups.

The time to first request of postoperative analgesic is defined as( the time interval
from tracheal extubation to first dose of morphine adminstration) will be recorded
.Rescue postoperative analgesic will be administrated if VAS ≥ 4 at rest or on patient's
demand with IV morphine sulphate 0.03 mg/kg with maximum dose 20 mg per day in both
groups .the total amount of morphine in the first postoperative 24 hours will be
calculated in both groups.

2. Post operative hemodynamic will be assessed(heart rate ,systolic and diastolic blood
pressure at the same time point)

3. Incidence of complication will be assessed:

- Nausea and vomiting

- Respiratory complications(bronchospasm , laryngospasm , respiratory depression)

Measurement tools

1. Patients demographic data will be collected; age, gender, and duration of anesthesia

2. Intraoperative hemdynamic (Heart rate ,systolic and diastolic blood pressure).

3. Postoperative pain assessments using VAS at at 0 point (the full recovery state), 2 hr,
6 hr, 12 hr, and at 24 hr

4. Time to first request of rescue postoperative analgesic

5. Total opioid consumption in 24 h postoperative

6. Postoperative hemdynamic (Heart rate ,systolic and diastolic blood pressure at the same
time point)
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 10, 2022</start_date>
<completion_date type="Anticipated">September 2022</completion_date>
<primary_completion_date type="Anticipated">September 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Prevention</primary_purpose>
<masking>Double (Investigator, Outcomes Assessor)</masking>
<masking_description>Randomization will be done by computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelopes will be opened by the nurse, the card inside will determine the patient group.</masking_description>
</study_design_info>
<primary_outcome>
<measure>The Time to first request of opioid analgesia</measure>
<time_frame>it will be measured from tracheal extubation to first request of postoperative analgesia in the first 24 hours postoperative and it will be expressed in minutes</time_frame>
<description>the time interval between tracheal extubation and the first request to postoperative analgesia</description>
</primary_outcome>
<secondary_outcome>
<measure>Total opioid consumption</measure>
<time_frame>the total amount of morphine in the first postoperative 24 hours will be calculated</time_frame>
<description>total amount of morphine in the first postoperative 24 hours</description>
</secondary_outcome>
<secondary_outcome>
<measure>Postoperative VAS score</measure>
<time_frame>Postoperative pain assessments using VAS at 0 point (the full recovery state ), 2 hours, 6 hours, 12 hours,and at 24 hours postoperative.</time_frame>
<description>The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">74</enrollment>
<condition>Opioid Free Anesthesia</condition>
<arm_group>
<arm_group_label>Opioid Based Anesthesia</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Pre induction of general anesthesia with placebo 1 h before surgery. induction of general anesthesia with fentanyl1ug/kg/ iv then infusion of 1 ug/kg/h</description>
</arm_group>
<arm_group>
<arm_group_label>opioid free anesthesia</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Pre induction of general anesthesia with gabapentin 300 mg tab 1 h before surgery. induction of general anesthesia with ketamine 0.5 mg/kg iv, Lidocaine 1 mg/kg iv then continuous infusion with 2 mg/kg/hr, dexamethasone 0.1 mg/kg.iv, magnesium sulfate 20 mg/kg.iv</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>pre emptive local anaesthetic wound infiltration</intervention_name>
<description>Before skin incision by 15 min the surgeon will infiltrate the wound by syringe containing 20 ml mixture of (10 ml xylocaine 2%and 10 ml bupivacaine 0. 5%) in both groups</description>
<arm_group_label>Opioid Based Anesthesia</arm_group_label>
<arm_group_label>opioid free anesthesia</arm_group_label>
<other_name>xylocaine and bupivacaine local anaesthetic mixture</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Gender both males and females

2. ASA Class II

3. Age 18-70 years

4. Patients undergoing open radical nephrectomy

Exclusion Criteria:

1. Allergy to local anesthetic

2. Infection of the skin at the site of local infiltration

3. Cvs problem(ischemic heart disease,arrhythmias{heart block, supraventricular
tachyarrhythmia (SVT),atrial fibrillation (AF),multiple extra systole)

4. Liver and renal impairment(elevated liver enzymes (ALT, AST two to three fold),
chronic renal failure (CRF) )
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Heba ismail, professor</last_name>
<role>Study Director</role>
<affiliation>Anesthesia department , Cairo university</affiliation>
</overall_official>
<overall_contact>
<last_name>Ahmed nabih, lecturer</last_name>
<phone>01002773488</phone>
<phone_ext>202</phone_ext>
<email>nabihomar100@yahoo.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>mohamed abdel ghany, lecturer</last_name>
<phone>01016109777</phone>
<phone_ext>202</phone_ext>
<email>dr.mohmed.elshazly8686@gmail.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Kasr Alainy, Cairo University</name>
<address>
<city>Cairo</city>
<zip>202</zip>
<country>Egypt</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Ahmed nabih, lecturer</last_name>
<phone>01002773488</phone>
<phone_ext>202</phone_ext>
<email>nabihomar100@yahoo.com</email>
</contact>
</location>
<location_countries>
<country>Egypt</country>
</location_countries>
<verification_date>May 2022</verification_date>
<study_first_submitted>March 12, 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>May 7, 2022</last_update_submitted>
<last_update_submitted_qc>May 7, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">May 10, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
<investigator_full_name>Ahmed nabih youssef</investigator_full_name>
<investigator_title>Lecturer of anesthesia</investigator_title>
</responsible_party>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Bupivacaine</mesh_term>
<mesh_term>Anesthetics, Local</mesh_term>
<mesh_term>Anesthetics</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Patients undergoing nephrectomy have a high incidence of postoperative pain. In the
perioperative period, these patients are often treated with patient-controlled opioids,
epidural analgesia, or both. While effective, both of these treatment modalities carry risk,
ie, opioids have a side effect profile including pruritus, nausea,vomiting, increase the risk
of oversedation and apnea in patients at risk (eg, those with sleep apnea), difficulty in
voiding, and ileus. These complications may lead to a prolonged hospital stay. High dose
opioids can also cause acute opioid tolerance and hyperalgesia. Epidurals have been
associated with hypotension, post dural puncture headaches, changes in management of
anticoagulation Opioid free anesthesia (OFA) is a technique in which no intraoperative opioid
administered through any route, including systemic, neuraxial, or tissue infiltration.Opioid
free anesthesia has many advantages especially avoiding opioid overdose and opioid-induced
hyperalgesia. The most important advantage of OFA seems to be the potential improvement of
recovery profile in obese patients. OFA depends on combinations of non-opioid agents and
adjuncts, including propofol, lidocaine, magnesium, dexmedetomidine, and ketamine to produce
anesthesia, and analgesia.
Aim of the work our study aim to compare the analgesic effect of OFA and opioid based general
anesthesia using pre emptive wound infiltration in patients undergoing open radical
nephrectomy surgery.
Objectives:
1. To evaluate analgesic effect of each group intra operative {heart rate, and systolic and
diastolic blood pressure }
2. To evaluate analgesic effect of each group post operative [total opioid consumption in
24h postoperative , Postoperative VAS , hemodynamic).
3. To estimate the incidence of early postoperative complication in both groups
This a randomized control trial is designed to include (74) patients ASA physical status II
patients ranging from(18) to(70)years old scheduled for open radical nephrectomy
Patients meeting the inclusion criteria will be randomly assigned to receive either :
Group I :Opioid Based Anesthesia (n=37) GroupII: Opioid Free Anesthesia:(n=37) Anesthesia
management
Preoperative procedures:
Full history and investigation will be taken in the form of complete blood count , blood
sugar,liver function tests. Kidney function tests ,electrolytes and coagulation profile. Pre
induction of general anesthesia with gabapentin 300 mg tab or placebo 1 h before surgery
while gabapentin in (Opioid free Anesthesia) and placebo in (Opioid Based Anesthesia) . After
securing IV access by 20G cannula, all patients will receive 0.05mg/kg midazolam for anxiety.
Ranitidine 50mg, metoclopramide 10mg and antibiotic 50mg/kg as a premedication.Intraoperative
monitoring includes ASA standard monitoring Electrocardiography (ECG), noninvasive blood
pressure, pulse oximetry for O2 saturation, end-tidal carbon dioxide (CO2) values by
capnography.
Intraoperative procedures:
Induction of general anesthesia in both groups will be done by 2mg \kg propofol, and 0.5mg\kg
atracurium. to facilitate endotracheal intubation, with fentanyl1ug/kg/ iv then infusion of 1
ug/kg/h in group I (Opioid Based Anesthesia) and with ketamine 0.5 mg/kg iv, Lidocaine 1
mg/kg iv then continuous infusion with 2 mg/kg/hr, dexamethasone 0.1 mg/kg.iv, magnesium
sulfate 20 mg/kg.iv in group II (Opioid Free Anesthesia) after induction.
Anesthesia maintenance will be achieved in both group with endotracheal tube (ETT) with
suitable size, 1.2 minimium alveolar concentration of isoflurane, volume controlled mode
ventilation, respiratory rate will be adjusted according to Et CO2 to range between 35-40
mmHg, a tidal volume of 6-8 ml/kg and mixture of gases in proportion 50% oxygen and 50% air,
with positive end expiratory pressure (PEEP) 5 cm H2O and0.1 mg\kg atracurium every 30 min.
Intervention Before skin incision by 15 min the surgeon will infiltrate the wound by syringe
containing 20 ml mixture of (10 ml xylocaine 2%and 10 ml bupivacaine 0. 5%) in both groups.
By the end of surgery, anaesthesia will be discontinued ,patient will be reversed by
neostigmine 0.05mg\kg and atropine0.02mg\kg, extubation will be done and patient will be
transferred to post anaesthesia care unit (PACU).
Postoperative
1. The pain assessment after full recovery will be performed using a 10 cm visual analog
scale (VAS) (0- no pain and 10 cm maximum pain) .Postoperative pain assessments using
VAS at 0 point (the full recovery state which is defined as a state of consciousness of
individual when he is awake or easily arousable and aware of his surroundings and
identity, 2 hr, 6 hr, 12 hr, and at 24 hr. IV paracetamol 1 g every 6 hours will be
administered for both groups.
The time to first request of postoperative analgesic is defined as( the time interval
from tracheal extubation to first dose of morphine adminstration) will be recorded
.Rescue postoperative analgesic will be administrated if VAS ≥ 4 at rest or on patient's
demand with IV morphine sulphate 0.03 mg/kg with maximum dose 20 mg per day in both
groups .the total amount of morphine in the first postoperative 24 hours will be
calculated in both groups.
2. Post operative hemodynamic will be assessed(heart rate ,systolic and diastolic blood
pressure at the same time point)
3. Incidence of complication will be assessed:
- Nausea and vomiting
- Respiratory complications(bronchospasm , laryngospasm , respiratory depression)
Measurement tools
1. Patients demographic data will be collected; age, gender, and duration of anesthesia
2. Intraoperative hemdynamic (Heart rate ,systolic and diastolic blood pressure).
3. Postoperative pain assessments using VAS at at 0 point (the full recovery state), 2 hr,
6 hr, 12 hr, and at 24 hr
4. Time to first request of rescue postoperative analgesic
5. Total opioid consumption in 24 h postoperative
6. Postoperative hemdynamic (Heart rate ,systolic and diastolic blood pressure at the same
time point)
Inclusion Criteria:
1. Gender both males and females
2. ASA Class II
3. Age 18-70 years
4. Patients undergoing open radical nephrectomy
Exclusion Criteria:
1. Allergy to local anesthetic
2. Infection of the skin at the site of local infiltration
3. Cvs problem(ischemic heart disease,arrhythmias{heart block, supraventricular
tachyarrhythmia (SVT),atrial fibrillation (AF),multiple extra systole)
4. Liver and renal impairment(elevated liver enzymes (ALT, AST two to three fold),
chronic renal failure (CRF) )
|
NCT0531xxxx/NCT05312554.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/NCT05312554</url>
</required_header>
<id_info>
<org_study_id>21CT(CN)</org_study_id>
<nct_id>NCT05312554</nct_id>
</id_info>
<brief_title>Safety and Efficacy of IrisFIT™ Patent Foramen Ovale Occluders</brief_title>
<official_title>A Prospective, Multi-Center, Single-Group Goal Value Clinical Trial to Revaluate the Safety and Efficacy of Patent Foramen Ovale Occluders</official_title>
<sponsors>
<lead_sponsor>
<agency>Lifetech Scientific (Shenzhen) Co., Ltd.</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Lifetech Scientific (Shenzhen) Co., Ltd.</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
To evaluate the performance of patent foramen ovale (PFO) device developed by Lifetech
Technology (Shenzhen) Co., LTD
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The purpose of this prospective, multi-center, single-group target value premarket clinical
trial was to evaluate the safety and efficacy of a patent foramen ovale (PFO) occlator
developed by Lifetech Technology (Shenzhen) Co., LTD for the treatment of cryptogenic stroke
complicated with patent foramen ovale. The study required the implant to follow instructions
strictly.
</textblock>
</detailed_description>
<overall_status>Withdrawn</overall_status>
<why_stopped>
Company policy
</why_stopped>
<start_date type="Actual">April 12, 2022</start_date>
<completion_date type="Anticipated">March 31, 2028</completion_date>
<primary_completion_date type="Anticipated">December 25, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Accurate success rate</measure>
<time_frame>6 month</time_frame>
<description>180 days after the operation, transthoracic echocardiography (TTE) showed that the position and shape of the occluders were normal, and no horizontal atrial shunt was observed. Re-examination by chest echocardiographic contrast echocardiography (cTTE) showed no or only a small amount of right-to-left shunt, that is, no microvesicles or less than 10 microvesicles/frame in left heart cavity after resting state and Valsalva action.</description>
</primary_outcome>
<secondary_outcome>
<measure>Success rate of occluder implantation technology</measure>
<time_frame>one week after surgery</time_frame>
<description>The success of occluder implantation technology is defined as successful intraoperative implantation of occluder and immediate postoperative hypersurgery It was confirmed that the shape and position of the sealing device were appropriate, no new pericardial effusion or valve regurgitation was found, and the perioperative patients survived.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Success rate of occluder implantation</measure>
<time_frame>one week after surgery</time_frame>
<description>Successful occluder implantation was defined as successful implantation of occluder and routine postoperative hospitalization There were no serious adverse events related to surgery</description>
</secondary_outcome>
<secondary_outcome>
<measure>Success rate of complete occlusion</measure>
<time_frame>180 days after surgery</time_frame>
<description>Complete occlusion was defined as the transthoracic echocardiography (TTE) showing occlusion 180 days after surgery The position and shape of the apparatus were normal, and no horizontal atrial shunt was observed. The results of chest echocardiographic contrast echoography (cTTE) were reviewed There was no right-to-left shunt, that is, no microbubbles in the left heart cavity after Valsalva and resting state.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Effective plugging success rate</measure>
<time_frame>360 days after surgery</time_frame>
<description>Effective occlusion was defined as: transthoracic echocardiography (TTE) showed the position and shape of the occluder 360 days after the operation Normal condition, no horizontal atrial shunt; Reexamination by chest echocardiographic contrast echocardiography (cTTE) showed no or few results In other words, there were no microbubbles or less than 10 microbubbles in the left heart cavity after Valsalva and resting state</description>
</secondary_outcome>
<secondary_outcome>
<measure>Recurrence or incidence of cryptogenic stroke during follow-up</measure>
<time_frame>360 days, 2 years, 3 years, 4 years, 5 years after surgery</time_frame>
<description>Cryptogenic stroke was defined as a new focal cerebral ischemia confirmed by neuroimaging (cranial MRI or CT), which was performed After extensive vascular, cardiac, and blood evaluation, non-atherosclerotic, cardiogenic, or arteriolar obliterators were identified Cerebral infarction caused by the diagnosis of exclusion.</description>
</secondary_outcome>
<secondary_outcome>
<measure>All-cause mortality rate</measure>
<time_frame>360 days, 2 years, 3 years, 4 years, 5 years after surgery</time_frame>
<description>All-cause death is defined as death from any cause during the follow-up period.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of new atrial fibrillation and atrial flutter during follow-up period</measure>
<time_frame>360 days, 2 years, 3 years, 4 years, 5 years after surgery</time_frame>
<description>A prospective, multi-center, single-group goal value clinical trial to evaluate the safety and efficacy of patent foramen ovale occluders</description>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of device-related serious adverse events during follow-up (including device-related thrombosis, embolic stroke, and peripheral stroke)</measure>
<time_frame>360 days, 2 years, 3 years, 4 years, 5 years after surgery</time_frame>
<description>Arterial embolism, III degree ATrioventricular block, heart abrasion, infective endocarditis, severe hemolytic anemia, etc.);</description>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of device defects.</measure>
<time_frame>360 days, 2 years, 3 years, 4 years, 5 years after surgery</time_frame>
<description>Device defects refer to unreasonable risks that may endanger human health and safety under normal use of medical devices in clinical trials, such as label errors, quality problems and failures</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">0</enrollment>
<condition>Patent Foramen Ovale</condition>
<condition>Cryptogenic Stroke</condition>
<arm_group>
<arm_group_label>Intervention arm</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients with cryptogenic stroke complicated with patent foramen ovale,and passed the screening and signed the informed consent form</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Iris FIT™ PFO closure system</intervention_name>
<description>Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with the Iris Patent foramen ovale occluder according to the INSTRUCTIONS for Use (IFU)</description>
<arm_group_label>Intervention arm</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Patients aged 18-60 years;

2. Be able to understand the purpose of the experiment, voluntarily participate in the
experiment and sign the informed consent;

3. Patent foramen ovale was confirmed by chest ultrasound (TTE) or esophageal ultrasound
(TEE);

4. The presence of a large right-to-left shunt was confirmed by right aspiration
angiography (cTTE or cTCD);

5. It meets the clinical status of patent foramen ovale plugging indication, and at least
one of the following conditions exists:

1. Cryptogenic stroke complicated with patent foramen ovale, combined with one or
more clinical risk factors;

2. Cryptogenic stroke complicated with patent foramen ovale, combined with one or
more anatomical risk factors of patent foramen ovale;

3. Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein
thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy;

4. Cryptogenic stroke complicated with patent foramen ovale, but still recurred with
antiplatelet or anticoagulant therapy.

Exclusion Criteria:

1. Carotid atherosclerotic stenosis was determined by the investigator based on CT or
vascular ultrasound (> 50%);

2. Large cerebral infarction occurred within 4 weeks (MR/CT or DWI image ASPECTS score <6
points or infarction volume ≥70 ml or infarction area > 1/3 middle cerebral artery
blood supply area);

3. intracardiac thrombosis or tumor, intracardiac neoplasm;

4. acute myocardial infarction or unstable angina within 6 months;

5. Left ventricular aneurysm formation or left ventricular wall movement disorder;

6. Mitral/aortic disease: including mitral stenosis or severe mitral regurgitation of any
cause, severe aortic stenosis or severe aortic regurgitation, mitral or aortic valve
vegetations or prior valve replacement surgery;

7. Dilated cardiomyopathy, LVEF < 35%, or other severe heart failure;

8. Patients with right-to-left shunt due to other causes, including atrial septal defect
or perforated diaphragm;

9. Atrial fibrillation/atrial flutter (chronic or intermittent);

10. pregnant or planning to become pregnant during the trial;

11. Patients with active endocarditis or other untreated infections or other hemorrhagic
diseases;

12. Pulmonary hypertension or patent foramen ovale was a special channel;

13. liver and kidney function impairment (ALT or AST > 3 times the upper limit of normal
value, serum creatinine (Cr) > 2 times the upper limit of normal value);

14. Uncontrolled hypertension (> 180/100 mmHg);

15. Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding
within 3 months, obvious retinopathy, history of other intracranial bleeding, and
obvious intracranial diseases;

16. Coronary heart disease, hypertension, diabetes and other vascular diseases that are
poorly controlled by drugs or other means;

17. The investigator determined that the patient was not suitable for implantation of PFO
occluder (for example, the diameter of the base of the atrial septal tumor ≥25mm and
the size of the foramen ovale ≥5mm) or the patient has contraindications for
implantation of PFO occluder;

18. Thrombosis exists at the location or route of implantation;

19. Malignant neoplasms or other diseases with a life expectancy of less than 2 years;

20. Patients who could not be followed up during the trial;

21. Participate in clinical trials of other drugs or medical devices within three months.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Xiangbin Pan, Doctor</last_name>
<role>Principal Investigator</role>
<affiliation>Fuwai Yunnan Cardiovascular Hospital</affiliation>
</overall_official>
<location>
<facility>
<name>Fuwai Yunnan Cardiovascular Hospital</name>
<address>
<city>Kunming</city>
<state>Yunnan</state>
<country>China</country>
</address>
</facility>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>March 2023</verification_date>
<study_first_submitted>March 24, 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>March 10, 2023</last_update_submitted>
<last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 14, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ischemic Stroke</mesh_term>
<mesh_term>Foramen Ovale, Patent</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
To evaluate the performance of patent foramen ovale (PFO) device developed by Lifetech
Technology (Shenzhen) Co., LTD
The purpose of this prospective, multi-center, single-group target value premarket clinical
trial was to evaluate the safety and efficacy of a patent foramen ovale (PFO) occlator
developed by Lifetech Technology (Shenzhen) Co., LTD for the treatment of cryptogenic stroke
complicated with patent foramen ovale. The study required the implant to follow instructions
strictly.
Inclusion Criteria:
1. Patients aged 18-60 years;
2. Be able to understand the purpose of the experiment, voluntarily participate in the
experiment and sign the informed consent;
3. Patent foramen ovale was confirmed by chest ultrasound (TTE) or esophageal ultrasound
(TEE);
4. The presence of a large right-to-left shunt was confirmed by right aspiration
angiography (cTTE or cTCD);
5. It meets the clinical status of patent foramen ovale plugging indication, and at least
one of the following conditions exists:
1. Cryptogenic stroke complicated with patent foramen ovale, combined with one or
more clinical risk factors;
2. Cryptogenic stroke complicated with patent foramen ovale, combined with one or
more anatomical risk factors of patent foramen ovale;
3. Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein
thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy;
4. Cryptogenic stroke complicated with patent foramen ovale, but still recurred with
antiplatelet or anticoagulant therapy.
Exclusion Criteria:
1. Carotid atherosclerotic stenosis was determined by the investigator based on CT or
vascular ultrasound (> 50%);
2. Large cerebral infarction occurred within 4 weeks (MR/CT or DWI image ASPECTS score <6
points or infarction volume ≥70 ml or infarction area > 1/3 middle cerebral artery
blood supply area);
3. intracardiac thrombosis or tumor, intracardiac neoplasm;
4. acute myocardial infarction or unstable angina within 6 months;
5. Left ventricular aneurysm formation or left ventricular wall movement disorder;
6. Mitral/aortic disease: including mitral stenosis or severe mitral regurgitation of any
cause, severe aortic stenosis or severe aortic regurgitation, mitral or aortic valve
vegetations or prior valve replacement surgery;
7. Dilated cardiomyopathy, LVEF < 35%, or other severe heart failure;
8. Patients with right-to-left shunt due to other causes, including atrial septal defect
or perforated diaphragm;
9. Atrial fibrillation/atrial flutter (chronic or intermittent);
10. pregnant or planning to become pregnant during the trial;
11. Patients with active endocarditis or other untreated infections or other hemorrhagic
diseases;
12. Pulmonary hypertension or patent foramen ovale was a special channel;
13. liver and kidney function impairment (ALT or AST > 3 times the upper limit of normal
value, serum creatinine (Cr) > 2 times the upper limit of normal value);
14. Uncontrolled hypertension (> 180/100 mmHg);
15. Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding
within 3 months, obvious retinopathy, history of other intracranial bleeding, and
obvious intracranial diseases;
16. Coronary heart disease, hypertension, diabetes and other vascular diseases that are
poorly controlled by drugs or other means;
17. The investigator determined that the patient was not suitable for implantation of PFO
occluder (for example, the diameter of the base of the atrial septal tumor ≥25mm and
the size of the foramen ovale ≥5mm) or the patient has contraindications for
implantation of PFO occluder;
18. Thrombosis exists at the location or route of implantation;
19. Malignant neoplasms or other diseases with a life expectancy of less than 2 years;
20. Patients who could not be followed up during the trial;
21. Participate in clinical trials of other drugs or medical devices within three months.
|
NCT0531xxxx/NCT05312567.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/NCT05312567</url>
</required_header>
<id_info>
<org_study_id>2021-FERV</org_study_id>
<nct_id>NCT05312567</nct_id>
</id_info>
<brief_title>FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms</brief_title>
<official_title>Randomized, Double-Blind, Plac.-Controlled Clinical Study to Compare the Efficacy of FP-101 60mg b.i.d. vs. Placebo for the Treatment of Moderate-to-Severe Hot Flashes in Peri- and Post-menopausal Women Over a Period of 1-Week.</official_title>
<sponsors>
<lead_sponsor>
<agency>Fervent Pharmaceuticals</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
<collaborator>
<agency>ICON plc</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>Fervent Pharmaceuticals</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This Phase II proof of concept study is designed to assess the safety and efficacy of FP-101
(60mg b.i.d.), an extended-release oral tablet product, compared to a matching placebo in the
treatment of moderate-to-severe hot flashes in peri- and post-menopausal women over a period
of 1-week.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This randomized, double-blind, parallel-group, placebo-controlled, clinical trial is designed
to compare patient-reported changes in Vasomotor Symptoms (VMS) for FP-101 vs. placebo in
peri- and post-menopausal women. The study will be run as a fully decentralized clinical
trial (DCT), by use of components such as electronic Consent (eConsent), mobile/tele health
visits, electronic Patient Reported Outcomes (ePROs), and direct-to-participant shipping of
the (investigational medicinal product (IMP). The DCT approach to this study will rely on a
digital platform through which subjects can consent, enroll, and interact with the PI and
study staff. Proper regulatory framework and technology use will ensure compliance with Good
Clinical Practice (GCP), ethics & legal/regulatory requirements.

Healthy peri- and post-menopausal women (>45 years of age) suffering from VMS will be
recruited if they have >=7- 8 moderate to severe hot flushes per day at baseline. After
meeting all eligibility criteria subjects will be enrolled and start a 1-week run-in period
to identify/eliminate placebo responders, as well as to exclude subjects who have difficulty
completing the eDiary. Any Adverse Events (AEs) during the run-in period will serve as
baseline for the safety assessments at the end of the treatment period.

Eligible subjects will undergo a tele health baseline visit during which the criteria for
inclusion in the treatment period will be confirmed. Over a 1-week treatment period, subjects
will complete a daily electronic Diary (eDiary) to record any AEs and the frequency and
severity of hot flashes during the past 12hr interval. In the morning, subjects will record
the number of awakenings during the past night and the number of night sweats.

The PI will conduct an end-of-study visit with each of the subjects randomized to the study
medications to review safety and efficacy data, complete a Patient Global Improvement Scale,
and clarify any open issues with the subjects.

------------------------------
</textblock>
</detailed_description>
<overall_status>Active, not recruiting</overall_status>
<start_date type="Actual">March 24, 2021</start_date>
<completion_date type="Anticipated">September 30, 2023</completion_date>
<primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Randomized, double-blind, parallel-group, placebo-controlled study to compare patient-reported changes in VMS for the IMP vs. placebo. The study will be run as a fully decentralized clinical trial.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
<masking_description>Matching placebo tablets. Double-blind treatment packaging and dispensation.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Change in the frequency (average daily number) of moderate-to-severe hot flashes.</measure>
<time_frame>Recorded every 12 hrs over a 1-week treatment period.</time_frame>
<description>Subjects use a digital platform to record hot flash frequency in a daily eDiary.</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in the severity (average daily rating) of moderate-to-severe hot flashes.</measure>
<time_frame>Recorded every 12 hrs over a 1-week treatment period.</time_frame>
<description>Subjects use digital platform to record hot flash severity (3-point scale) in a daily eDiary.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in nighttime awakenings (average daily number) with or without night sweats.</measure>
<time_frame>Recorded every morning over a 1-week treatment period.</time_frame>
<description>Subjects use daily eDiary to record nighttime awakenings & night sweats frequency.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluate the clinical meaningfulness of VMS changes after 1-week of treatment.</measure>
<time_frame>After 1 week of treatment at the end-of-study visit.</time_frame>
<description>Completing validated Patient Global Improvement Scale (7-point) with PI.</description>
</secondary_outcome>
<other_outcome>
<measure>Any Adverse Events and Concomitant Medications</measure>
<time_frame>Recorded as needed/every 12 hrs over a 1-week treatment period.</time_frame>
<description>Subjects will use daily eDiary to record any AEs and concomitant medications</description>
</other_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">105</enrollment>
<condition>Vasomotor Symptoms</condition>
<condition>Menopause</condition>
<arm_group>
<arm_group_label>Active Treatment (FP-101)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>White to off-white extended-release, round tablets containing FP-101.</description>
</arm_group>
<arm_group>
<arm_group_label>Matching placebo</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>White to off-white round tablets without the active ingredient but otherwise matching in size and appearance.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>FP-101</intervention_name>
<description>daily oral tablet administration (b.i.d.)</description>
<arm_group_label>Active Treatment (FP-101)</arm_group_label>
<arm_group_label>Matching placebo</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Peri- and Post-Menopausal female subjects (>45 yrs) experiencing a min of 7-8 moderate
to severe hot flashes per day

- Able/willing to provide informed consent.

- Able/willing to complete all study procedures and visits.

- Able/willing to not use any over-the-counter (OTC) cough & cold medications that
contain the IMP active during the study.

Exclusion Criteria:

- Subject exhibits positive home pregnancy test at screening or any time during study

- Subject currently taking any form of Hormone Therapy (HT), including local estrogen
therapies

- Subject currently taking tamoxifen, other selective estrogen receptor modulators, or
other hormone deprivation therapy.

- Subject with history of serotonergic syndrome

- Subject is currently taking monoamine oxidase inhibitors (MAOIs) (or for 2 weeks after
stopping the MAOI drug), antidepressants, thioridazine, pimozide, cannabidiol,
opioids, antipsychotic agents, antiretroviral agents, quinidine, quinine, or other
medications for VMS such as Brisdelle® (paroxetine mesylate), clonidine and
gabapentin.

- Subject is currently taking a dietary/herbal supplement(s) to manage VMS, such as soy
isoflavones or black cohosh.

- Subject has uncontrolled diabetes, a history of hypertension & is not on a stable dose
of antihypertensive medications for at least 30 days prior to screening.

- Subject has clinically unstable cardiac disease, including atrial fibrillation,
symptomatic brady- or tachy-arrhythmias, congestive heart failure (NYHA class II, III,
and IV), or symptomatic atherosclerotic cardiovascular disease (coronary artery
disease, carotid artery disease or peripheral artery disease) or history of myocardial
infarction or stroke within 2 years of enrolment in the study.

- Subject reports medical history suggestive of impaired liver/kidney function or, in
the PI's opinion, exhibits liver/kidney function impairment to the extent that the
subject should not participate in the study.

- Subject has biliary tract disease, adrenal cortical insufficiency, or any other
medical condition that, in the PI's opinion (and after discussion with the medical
monitor), is considered inadequately treated and precludes entry into the study.

- Subject has thyroid disease, unless subject is clinically stable with normal thyroid
indices and is on maintenance thyroid medication (e.g., levothyroxine or liothyronine)
for ≥6 months prior to screening.

- Subject has a history of, or is currently presenting with, substance use disorder as
defined by the 5th Edition of the Diagnostic and Statistical Manual of Mental
Disorders (DSM). Subject has a history of psychiatric disorders, including a lifetime
history of major depressive disorder, bipolar disorder, panic disorder, generalized
anxiety, psychotic disorders, suicidality or suicidal ideation, or post-traumatic
stress disorder.

- Subject is currently participating in another clinical trial

- Subjects who were determined to be placebo responders or non-compliant during the
1-week run-in period.
</textblock>
</criteria>
<gender>Female</gender>
<gender_based>Yes</gender_based>
<gender_description>Peri- and Post-menopausal women</gender_description>
<minimum_age>46 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Helmut H Albrecht, MD</last_name>
<role>Study Director</role>
<affiliation>Lumanity</affiliation>
</overall_official>
<location>
<facility>
<name>Torrance Clinical Research Institute</name>
<address>
<city>Lomita</city>
<state>California</state>
<zip>90717</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Long Beach Clinical Trial Services</name>
<address>
<city>Long Beach</city>
<state>California</state>
<zip>90806</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Provideré Research Inc.</name>
<address>
<city>West Covina</city>
<state>California</state>
<zip>91790</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Inpatient Research Clinic</name>
<address>
<city>Hialeah</city>
<state>Florida</state>
<zip>33013</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Angel Medical Research Corporation</name>
<address>
<city>Miami Lakes</city>
<state>Florida</state>
<zip>33016</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Suncoast Clinical Research - Pasco County</name>
<address>
<city>New Port Richey</city>
<state>Florida</state>
<zip>34652</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Cary Medical Group</name>
<address>
<city>Cary</city>
<state>North Carolina</state>
<zip>27518</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Raleigh Medical Group</name>
<address>
<city>Raleigh</city>
<state>North Carolina</state>
<zip>27609</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Clinical Research of Philadelphia</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19114</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Coastal Carolina Research Center</name>
<address>
<city>North Charleston</city>
<state>South Carolina</state>
<zip>29405</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>ICON Early Phase Services</name>
<address>
<city>San Antonio</city>
<state>Texas</state>
<zip>78209</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Discovery Clinical Trials - Stone Oak</name>
<address>
<city>San Antonio</city>
<state>Texas</state>
<zip>78258</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 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>May 24, 2023</last_update_submitted>
<last_update_submitted_qc>May 24, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 25, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>No plans to share data with other researchers</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This Phase II proof of concept study is designed to assess the safety and efficacy of FP-101
(60mg b.i.d.), an extended-release oral tablet product, compared to a matching placebo in the
treatment of moderate-to-severe hot flashes in peri- and post-menopausal women over a period
of 1-week.
This randomized, double-blind, parallel-group, placebo-controlled, clinical trial is designed
to compare patient-reported changes in Vasomotor Symptoms (VMS) for FP-101 vs. placebo in
peri- and post-menopausal women. The study will be run as a fully decentralized clinical
trial (DCT), by use of components such as electronic Consent (eConsent), mobile/tele health
visits, electronic Patient Reported Outcomes (ePROs), and direct-to-participant shipping of
the (investigational medicinal product (IMP). The DCT approach to this study will rely on a
digital platform through which subjects can consent, enroll, and interact with the PI and
study staff. Proper regulatory framework and technology use will ensure compliance with Good
Clinical Practice (GCP), ethics & legal/regulatory requirements.
Healthy peri- and post-menopausal women (>45 years of age) suffering from VMS will be
recruited if they have >=7- 8 moderate to severe hot flushes per day at baseline. After
meeting all eligibility criteria subjects will be enrolled and start a 1-week run-in period
to identify/eliminate placebo responders, as well as to exclude subjects who have difficulty
completing the eDiary. Any Adverse Events (AEs) during the run-in period will serve as
baseline for the safety assessments at the end of the treatment period.
Eligible subjects will undergo a tele health baseline visit during which the criteria for
inclusion in the treatment period will be confirmed. Over a 1-week treatment period, subjects
will complete a daily electronic Diary (eDiary) to record any AEs and the frequency and
severity of hot flashes during the past 12hr interval. In the morning, subjects will record
the number of awakenings during the past night and the number of night sweats.
The PI will conduct an end-of-study visit with each of the subjects randomized to the study
medications to review safety and efficacy data, complete a Patient Global Improvement Scale,
and clarify any open issues with the subjects.
------------------------------
Inclusion Criteria:
- Peri- and Post-Menopausal female subjects (>45 yrs) experiencing a min of 7-8 moderate
to severe hot flashes per day
- Able/willing to provide informed consent.
- Able/willing to complete all study procedures and visits.
- Able/willing to not use any over-the-counter (OTC) cough & cold medications that
contain the IMP active during the study.
Exclusion Criteria:
- Subject exhibits positive home pregnancy test at screening or any time during study
- Subject currently taking any form of Hormone Therapy (HT), including local estrogen
therapies
- Subject currently taking tamoxifen, other selective estrogen receptor modulators, or
other hormone deprivation therapy.
- Subject with history of serotonergic syndrome
- Subject is currently taking monoamine oxidase inhibitors (MAOIs) (or for 2 weeks after
stopping the MAOI drug), antidepressants, thioridazine, pimozide, cannabidiol,
opioids, antipsychotic agents, antiretroviral agents, quinidine, quinine, or other
medications for VMS such as Brisdelle® (paroxetine mesylate), clonidine and
gabapentin.
- Subject is currently taking a dietary/herbal supplement(s) to manage VMS, such as soy
isoflavones or black cohosh.
- Subject has uncontrolled diabetes, a history of hypertension & is not on a stable dose
of antihypertensive medications for at least 30 days prior to screening.
- Subject has clinically unstable cardiac disease, including atrial fibrillation,
symptomatic brady- or tachy-arrhythmias, congestive heart failure (NYHA class II, III,
and IV), or symptomatic atherosclerotic cardiovascular disease (coronary artery
disease, carotid artery disease or peripheral artery disease) or history of myocardial
infarction or stroke within 2 years of enrolment in the study.
- Subject reports medical history suggestive of impaired liver/kidney function or, in
the PI's opinion, exhibits liver/kidney function impairment to the extent that the
subject should not participate in the study.
- Subject has biliary tract disease, adrenal cortical insufficiency, or any other
medical condition that, in the PI's opinion (and after discussion with the medical
monitor), is considered inadequately treated and precludes entry into the study.
- Subject has thyroid disease, unless subject is clinically stable with normal thyroid
indices and is on maintenance thyroid medication (e.g., levothyroxine or liothyronine)
for ≥6 months prior to screening.
- Subject has a history of, or is currently presenting with, substance use disorder as
defined by the 5th Edition of the Diagnostic and Statistical Manual of Mental
Disorders (DSM). Subject has a history of psychiatric disorders, including a lifetime
history of major depressive disorder, bipolar disorder, panic disorder, generalized
anxiety, psychotic disorders, suicidality or suicidal ideation, or post-traumatic
stress disorder.
- Subject is currently participating in another clinical trial
- Subjects who were determined to be placebo responders or non-compliant during the
1-week run-in period.
|
NCT0531xxxx/NCT05312580.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/NCT05312580</url>
</required_header>
<id_info>
<org_study_id>FCRE-220105_ATK</org_study_id>
<nct_id>NCT05312580</nct_id>
</id_info>
<brief_title>PMCF Study for Peripheral Arteries Above the Knee (ATK)</brief_title>
<official_title>A Retrospective PMCF Study Evaluating the Safety and Clinical Performance of the S.M.A.R.T. Flex Stent Iliac, S.M.A.R.T. Flex SFA/PP, S.M.A.R.T. Control Nitinol Stent, S.M.A.R.T. Nitinol Stent, PALMAZ Blue .018 Peripheral Stent on Slalom, PALMAZ Genesis .035 Peripheral Stent on Opta Pro, SABER OTW PTA Catheter, SABERX PTA Dilatation Catheter and PowerFlex Pro PTA Catheter for the Endovascular Interventions in the Ilio-femoropopliteal Vessels</official_title>
<sponsors>
<lead_sponsor>
<agency>Cordis Corporation</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
<collaborator>
<agency>FCRE (Foundation for Cardiovascular Research and Education)</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Cordis Corporation</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The rationale of this study is to confirm and support the clinical safety and performance of
the products in a real-word population of 350 patients who underwent an endovascular
intervention within standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least
1 of the products (named above) from Cordis US Corp.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">June 1, 2022</start_date>
<completion_date type="Actual">November 7, 2022</completion_date>
<primary_completion_date type="Actual">October 7, 2022</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Retrospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Freedom from Serious Adverse Events</measure>
<time_frame>30 days</time_frame>
<description>Acute primary Safety Endpoint:
Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effect (SADEs) during the procedure and up to 30 days after the procedure.</description>
</primary_outcome>
<primary_outcome>
<measure>Freedom from Serious Adverse Events</measure>
<time_frame>12 months</time_frame>
<description>Primary Safety Endpoint:
Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effect (SADEs) up to 12 months after the procedure.</description>
</primary_outcome>
<primary_outcome>
<measure>Technical success rate</measure>
<time_frame>During the procedure</time_frame>
<description>Acute Primary Efficacy Endpoint:
Technical success rate defined as successful crossing, introduction, deployment (stents)/deflation (balloon catheter) and a <30% residual stenosis on visual assessment of S.M.A.R.T. Flex Stent Iliac, S.M.A.R.T. Flex SFA/PP, S.M.A.R.T. Control Nitinol Stent, S.M.A.R.T. Nitinol Stent, PALMAZ Blue .018 Peripheral Stent on Slalom, PALMAZ Genesis .035 Peripheral Stent on Opta Pro, SABER OTW PTA Catheter, SABERX PTA Dilatation Catheter and PowerFlex Pro PTA Catheter according to the respective IFU.</description>
</primary_outcome>
<primary_outcome>
<measure>Freedom from clinically-driven target lesion revascularization</measure>
<time_frame>12 months</time_frame>
<description>Primary Efficacy Endpoint:
The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any reintervention at the target lesion due to symptoms.</description>
</primary_outcome>
<secondary_outcome>
<measure>Technical success rate</measure>
<time_frame>During the procedure</time_frame>
<description>Technical success rate defined as successful crossing, introduction, deployment and successful completion of the procedure of the Cordis guidewires (Emerald, ATW, Stablizer, Storq, SV 0.018", Wizdom) and/or the Cordis guiding catheters (Adroit, Vista Brite Tip) and/or the Cordis diagnostic catheters (Super Torque, Super Torque MB, Super Torque Plus, Infiniti 4F/5F/6F, Tempo 4F, Tempo Aqua, High Flow, Pigtail Straightener) and/or the Cordis vascular access devices (Avanti+, Brite Tip, Vista Brite IG, vessel dilator) and/or the Cordis vascular closure devices (MynxGrip and Mynx Control) and/or the Cordis OUTBACK CTO catheters according to the respective IFU.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Technical success rate</measure>
<time_frame>Day of procedure</time_frame>
<description>Technical success rate defined as successful hemostasis without conversion to manual/mechanical compression of the Cordis vascular closure devices (MynxGrip and Mynx Control) according to the respective IFU.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Freedom from CD-TLR</measure>
<time_frame>36- and 60-months</time_frame>
<description>Freedom from clinically-driven target lesion revascularization (CD-TLR) at 36- and 60-months, defined as any reintervention at the target lesion due to symptoms.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Stent fracture rate</measure>
<time_frame>Up to 30 days post-procedure, 12-, 36- and 60-months</time_frame>
<description>Stent fracture rate assessed at up to 30 days post-procedure, 12-, 36- and 60-months.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Stent migration rate</measure>
<time_frame>Up to 30 days post-procedure, 12-, 36- and 60-months</time_frame>
<description>Stent migration rate assessed at up to 30 days post-procedure, 12-, 36- and 60-months.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of Ankle Brachial Index</measure>
<time_frame>Up to 30 days post-procedure, 12-, 36- and 60-months</time_frame>
<description>Change of Ankle Brachial Index (ABI) assessed at up to 30 days post-procedure, 12-, 36- and 60-months compared to baseline ABI.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time-to-hemostasis</measure>
<time_frame>Day of procedure</time_frame>
<description>Time-to-hemostasis assessed for the Cordis vascular closure devices (MynxGrip and Mynx Control). Categorized as Hemostatic time category (HTC) ≤2, HTC >2 to ≤4, HTC >4 to ≤5, HTC >5 to ≤7, HTC >7 to ≤10 min.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time-to-ambulation</measure>
<time_frame>Day of procedure</time_frame>
<description>Time-to-ambulation assessed for the Cordis vascular closure devices (MynxGrip and Mynx Control) defined as time between end of the procedure and ambulation in hours.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Rate of Major Amputation free survival</measure>
<time_frame>Up to 30 days post-procedure, 12-, 36- and 60-months</time_frame>
<description>Rate of Major Amputation free survival defined as any amputation above the knee assessed at up to 30 days post-procedure, 12-, 36- and 60-months.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Clinical success</measure>
<time_frame>Up to 30 days post-procedure, 12-, 36- and 60-months</time_frame>
<description>Clinical success at up to 30 days post procedure, 12-, 36- and 60-months, defined as an improvement of the Rutherford Classification of one class or more, as compared to the pre-procedure Rutherford Classification.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Vessel perforation/dissection</measure>
<time_frame>During the procedure</time_frame>
<description>Vessel perforation/dissection during the procedure.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs)</measure>
<time_frame>36- and 60-months</time_frame>
<description>Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) at 36- and 60-months after the procedure.</description>
</secondary_outcome>
<secondary_outcome>
<measure>All cause of mortality</measure>
<time_frame>procedure through study completion (12 months)</time_frame>
<description>All cause of mortality through life of the study.</description>
</secondary_outcome>
<enrollment type="Actual">387</enrollment>
<condition>Peripheral Arterial Disease</condition>
<condition>Femoropopliteal Stenosis</condition>
<condition>Angiopathy, Peripheral</condition>
<eligibility>
<study_pop>
<textblock>
Patient who underwent endovascular procedure of the ilio-femoropopliteal vessel with at
least one of the above mentioned study devices.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. Patient is >18 years old at conduction of the procedure.

2. Patient who underwent endovascular procedure of the ilio-femoropopliteal vessel with
at least one of the following the S.M.A.R.T. Flex Stent Iliac and/or S.M.A.R.T. Flex
SFA/PP and/or S.M.A.R.T. Control Nitinol Stent and/or S.M.A.R.T. Nitinol Stent and/or
PALMAZ Blue .018 Peripheral Stent on Slalom and/or PALMAZ Genesis .035 Peripheral
Stent on Opta Pro and/or SABER OTW PTA Catheter and/or SABERX PTA Dilatation Catheter
and/or PowerFlex Pro PTA Catheter as described in the IFU of the devices.

3. Target Lesion is located in the ilio-femoropopliteal vessels.

Exclusion Criteria:

1. Anatomy or size of vessels that did not allow appropriate usage of the devices,
following IFU of the devices.

2. Known contraindication and/or allergy to (a component of) the device as described in
the IFU of the devices.

3. Women who were pregnant or lactating at the time of the procedure.

4. Life expectancy of less than 12 months at the time of procedure.

5. Any patient who was hemodynamically unstable at onset of procedure.
</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>Medizinische Universität Innsbruck</name>
<address>
<city>Innsbruck</city>
<zip>6020</zip>
<country>Austria</country>
</address>
</facility>
</location>
<location>
<facility>
<name>KABEG-Klinikum Klagenfurt am Wörthersee</name>
<address>
<city>Klagenfurt am Wörthersee</city>
<zip>9020</zip>
<country>Austria</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Universitätsklinikum St. Pölten - Lilienfeld</name>
<address>
<city>St.Pölten</city>
<zip>3100</zip>
<country>Austria</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Medizinische Universität WienMedizinische Universität Wien</name>
<address>
<city>Wien</city>
<zip>1090</zip>
<country>Austria</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Public health establishment, Arras Hospital</name>
<address>
<city>Arras</city>
<zip>31059</zip>
<country>France</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital de la Timone</name>
<address>
<city>Marseille</city>
<zip>13354</zip>
<country>France</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Public Hospital, Centre Hospitalier Universitaire de Toulouse</name>
<address>
<city>Toulouse</city>
<zip>31059</zip>
<country>France</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Clinique River Gauche</name>
<address>
<city>Toulouse</city>
<zip>31300</zip>
<country>France</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Leiden University Medical Center (LUMC)</name>
<address>
<city>Leiden</city>
<zip>2333</zip>
<country>Netherlands</country>
</address>
</facility>
</location>
<location_countries>
<country>Austria</country>
<country>France</country>
<country>Netherlands</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 26, 2023</last_update_submitted>
<last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">July 27, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Peripheral Arterial Disease</mesh_term>
<mesh_term>Peripheral Vascular Diseases</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The rationale of this study is to confirm and support the clinical safety and performance of
the products in a real-word population of 350 patients who underwent an endovascular
intervention within standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least
1 of the products (named above) from Cordis US Corp.
Patient who underwent endovascular procedure of the ilio-femoropopliteal vessel with at
least one of the above mentioned study devices.
Inclusion Criteria:
1. Patient is >18 years old at conduction of the procedure.
2. Patient who underwent endovascular procedure of the ilio-femoropopliteal vessel with
at least one of the following the S.M.A.R.T. Flex Stent Iliac and/or S.M.A.R.T. Flex
SFA/PP and/or S.M.A.R.T. Control Nitinol Stent and/or S.M.A.R.T. Nitinol Stent and/or
PALMAZ Blue .018 Peripheral Stent on Slalom and/or PALMAZ Genesis .035 Peripheral
Stent on Opta Pro and/or SABER OTW PTA Catheter and/or SABERX PTA Dilatation Catheter
and/or PowerFlex Pro PTA Catheter as described in the IFU of the devices.
3. Target Lesion is located in the ilio-femoropopliteal vessels.
Exclusion Criteria:
1. Anatomy or size of vessels that did not allow appropriate usage of the devices,
following IFU of the devices.
2. Known contraindication and/or allergy to (a component of) the device as described in
the IFU of the devices.
3. Women who were pregnant or lactating at the time of the procedure.
4. Life expectancy of less than 12 months at the time of procedure.
5. Any patient who was hemodynamically unstable at onset of procedure.
|