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#Study Description
Brief Summary
The investigators have developed self-help booklets specifically for adults with PH who are experiencing difficulties with depression. The self-help booklets are based on a type of psychological treatment called Cognitive Behavioural Therapy or CBT for short.
* CBT looks at the way people think and what they do, and how this affects their mood.
* It involves making changes to thoughts and behaviours.
* CBT can help people develop more helpful ways of coping with depression.
* CBT is one of the most effective therapies for depression, this means it works well.
There are four booklets that participants will work though weekly in their own time and at home. The aim of this study is to test whether the self-help booklets are helpful in reducing depression in people with pulmonary hypertension.
Those taking part will be asked to complete a series of questions asking about themselves including whether they are experiencing any difficulties such as depression and anxiety.
They will then be allocated at random to one of two groups. Group one will receive the self-help booklets, called the intervention group. Group two, or the wait list group, will receive the intervention at a later date if it is found to be helpful. Having two groups is very important as it will allow us to see whether benefits associated with taking part in the project was because of the self-help booklets or something else.
Participants in group one will also be contacted partway through the intervention to ask about their experiences of taking part.
Both groups will be asked to complete a series of questionnaires four weeks later and then again in one month. Participants in group one will be contacted again to find out more about their experiences of the project.
Detailed Description
Previous research has demonstrated high rates of depression in people with pulmonary hypertension (PH). The psychological interventions that support people with depression are not made specific to people with PH and may not be relevant for them, and there is limited evidence examining psychological treatments for depression in people with PH. The aim of this study is to develop and test a self-help psychological intervention for depression based on cognitive behavioural therapy (CBT), which has been developed specifically for individuals with PH. When participants have agreed to take part, they will be allocated at random into an intervention or wait-list group. The self-help materials will be provided online (for people outside of the UK) or posted in paper form (for those living in the UK) and will take four weeks to complete at home. Both groups will complete questionnaires at the same time points (before starting the study, after four weeks and after eight weeks (pre-, post-intervention and one-month follow up). In addition, the intervention group will be contacted after two weeks of their participation and asked about their experiences of the intervention and participation in the study - measuring acceptability of the intervention. The intervention group will also be asked to complete a feedback questionnaire after completing the intervention to further examine acceptability. Analysis will be conducted by the researcher to examine whether the self-help intervention reduced depression in individuals with PH, compared to those with PH who did not receive the intervention. The potential benefit of the study includes a new intervention for depression in people with PH. When the study is completed, if the intervention is found to be helpful and safe, then the people who took part in the study and did not receive the intervention will be offered the intervention.
#Intervention
- OTHER : Self-help materials for depression
- Self-help materials for depression based on cognitive behavioural therapy have been created and tailored to those with PH by researchers involved in this project, using the evidence base and theory plus clinical experience. The Medical Research Council Frameworks for complex interventions (Craig et al., 2008; Skivington et al., 2021) have been followed as well as the quality appraisal tool for self-help interventions in depression (Cape, 2015). The self-help materials will be shared for feedback with a readership panel of people with PH and caregivers who are members of Pulmonary Hypertension Association UK (a charity for people with PH) prior to being given to participants. The self-help materials will be provided online or posted in paper form to the intervention group and will take four weeks for the person to complete at home (one booklet per week).
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of pulmonary hypertension
* Over the age of 18 years
* Able to complete questionnaires without help from others
* Can understand English
* They will read all study documents in detail and ask the researcher any questions they have. Based on this, they could provide informed consent to take part if they are eligible.
* Feels like they have difficulties with depression, low mood or negative thoughts.
* Not currently experiencing thoughts of self-harm or suicide. This means that they have not had thoughts of self-harm or suicide within the last month.
Exclusion criteria:
* Current thoughts of self-harm or suicide.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05726669
|
{
"brief_title": "Self-help Booklets for Depression in Adults With Pulmonary Hypertension.",
"conditions": [
"Pulmonary Hypertension",
"Depression"
],
"interventions": [
"Other: Self-help materials for depression"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05726669",
"official_title": "Randomised Controlled Trial of Self-help Cognitive Behavioural Therapy for Depression in Adults With Pulmonary Hypertension.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-03-12",
"study_completion_date(actual)": "2024-03-12",
"study_start_date(actual)": "2023-06-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-20",
"last_updated_that_met_qc_criteria": "2023-02-03",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-02-14",
"first_submitted": "2023-02-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to estimate the time to disease progression when everolimus and pasireotide are given together in patients with advanced or metastatic HCC who have not had any prior systemic therapy.
Detailed Description
This open label, single-arm Phase II study will assess time to progression (TTP) and safety of everolimus and pasireotide in patients with advanced or metastatic hepatocellular carcinoma (HCC) and limited prior systemic therapy. Should this regimen demonstrate efficacy, this will support a Phase III randomized clinical trial of this combination therapy. At least 30 patients will be enrolled into this Phase II study. Additionally, given the potential importance of the RAS/RAF/MEK/ERK and RAS/pAKT pathways, we propose to correlate outcomes with baseline pAKT, p-S6, somatostatin receptor tumor expression, and serum VEGF expression. We anticipate these exploratory analyses will increase understanding of the molecular pathways and their inhibition in this disease. The study will be performed as a University of North Carolina-coordinated, multicenter study.
#Intervention
- DRUG : Everolimus
- Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.
- Other Names :
- Afinitor, RAD001
- DRUG : Pasireotide
- Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity.
- Other Names :
- SOM230, Pasireotide LAR, Pasireotide s.c.
|
#Eligibility Criteria:
Inclusion Criteria:
* Each subject must meet all of the following inclusion criteria to participate in this study:
1. Advanced or metastatic hepatocellular carcinoma (stage C per the BCLC criteria, see Appendix A). HCC may be diagnosed by tissue diagnosis or Alpha-fetoprotein (AFP) >400 ng/mL with compatible mass on Magnetic Resonance Imaging Scan (MRI). Cat Scan (CT) abdomen with 3-phase contrast with arterial phase enhancement is acceptable, although MRI is preferred (imaging should be done within 4 weeks of study initiation). Recurrences of previously resected HCC will not require tissue confirmation if there is clear radiographic recurrence in the judgment of the investigator. Disease must not otherwise be amenable to local therapy.
2. Maximum Childs-Pugh score 6 (see Appendix A) with no active encephalopathy
3. Prior systemic therapy limited to sorafenib that was discontinued due to intolerance. Patients must undergo at least a 4-week washout prior to enrollment.
4. Eastern Cooperative Oncology Group (ECOG) PS of 0 <= age <= 2
5. Life expectancy of >12 weeks
6. Age >=18 years
7. Patients who have received previous local therapy, such as surgery, radiotherapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous injection, or cryoablation, will be eligible for enrollment in the study provided that there is documented progression and disease is not amenable to further local therapies. Therapy must be completed >4 weeks prior to study initiation (Day 1 of everolimus and pasireotide administration).
8. Minimum of 4 weeks since any major surgery
9. No active serious infection or other comorbid illness which would impair ability to participate in the trial.
10. International Normalized Ratio (INR) <=1.5. (Anticoagulation is allowed if target INR <=2.0 on a stable dose of warfarin or on a stable dose of low molecular weight heparin (LMWH) for >2 weeks at time of enrollment).
11. Fasting serum cholesterol <=300 mg/dL OR <=7.75 mmol/L AND fasting triglycerides (TGs) <=2.5 x upper limit of normal (ULN). NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
12. Patients must have adequate organ function as evidenced by:
* Absolute neutrophil count (ANC) >=1.5 x 109/L
* Platelet count >=50 x 109/L
* Hemoglobin (Hg) >9 g/dL
* Bilirubin <=2 x ULN
* Aspartate transaminase (AST) or Alanine transaminase (ALT) <=5 x ULN
* Serum creatinine <=1.5 x ULN OR creatinine clearance >=50 mL/min (estimated by Cockcroft Gault or measured)
13. Serum magnesium and serum potassium within institutional normal limits (patients may be on replacement)
14. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test performed within 7 days prior to Day 1 of everolimus and pasireotide administration.
15. WOCBP and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men and women should use adequate birth control for at least 8 weeks after the last administration of study drugs. (Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions and are therefore not considered effective for this study.)
16. Signed, Institutional Review Board (IRB) approved written informed consent
Exclusion Criteria:
* Patients meeting any of the following exclusion criteria at baseline will be excluded from study participation:
1. Patients who have received prior treatment with an mTOR inhibitor (e.g., sirolimus, temsirolimus, everolimus) or somatostatin analog (e.g. octeotride)
2. Chronic treatment with systemic steroids (except for intermittent topical, local injection, or eye drops) or another immunosuppressive agent. NOTE: This restriction regarding systemic steroids does not apply should patient need course of glucocorticoid for treatment of non-infectious pneumonitis during study (see Section 4.5.2).
3. Patients with a known hypersensitivity to everolimus or other rapamycins (e.g., sirolimus, temsirolimus) or to its excipients
4. Patients with a known hypersensitivity to somatostatin or to its excipients
5. Concurrent or planned radiation, hormonal, chemotherapeutic, experimental, or targeted biologic therapy
6. Prior treatment with any investigational drug within the preceding 4 weeks
7. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
* Symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV)
* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
* Severely impaired lung function as defined as spirometry and diffusing capacity for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
* Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN or Glycated hemoglobin (HbA1c) >8.0% (Note: at the principle investigator's discretion, ineligible patients can be re-screened after adequate medical therapy has been instituted.)
* Active (acute or chronic) or uncontrolled severe infections. NOTE: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. Hepatitis B viral deoxyribonucleic acid (HBV DNA) and Hepatitis C viral ribonucleic acid (HCV RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection. See Section 4.2 for further information.
8. Clinically significant third space fluid accumulation (i.e., ascites requiring paracentesis despite use of diuretics) or pleural effusion that either requires thoracentesis or is associated with shortness of breath
9. Risk factors for prolongation of Corrected QT Interval (QTc)* including:
* QTc at screening >450 msec
* History of syncope or family history of idiopathic sudden death
* Sustained or clinically significant cardiac arrhythmias
* Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block
* Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes or Parkinson's disease), human immunodeficiency virus (HIV), uncontrolled hypothyroidism, or cardiac failure
* Concomitant medication(s) known to increase QT interval (See Appendix B)
* University of North Carolina at Chapel Hill (UNC) uses GE electrocardiogram (ECG) carts which use the Bazett formula for QTc.
10. Patients should not receive immunization with attenuated live vaccines within 1 week of study entry or during study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guérin (BCG), yellow fever, varicella, and TY21a typhoid vaccines.
11. Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
12. Symptomatic cholelithiasis
13. Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
14. A known history of HIV seropositivity (HIV testing is not mandatory)
15. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection.)
16. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except warfarin as long as the goal INR is <=1.5). Low-molecular-weight heparin (LMWH) is permitted (see Section 3.1.10.)
17. Unable or unwilling to discontinue use of prohibited fruit (or its juices) and/or prohibited medications listed in Appendix B for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
18. Male patient whose sexual partner(s) are WOCBP who are not willing to use adequate contraception during the study and for 8 weeks after the end of treatment
19. Active alcohol intake of 80 grams or more per day. For reference, one portion of alcohol (one glass of wine, one can or bottle of beer, or one ounce of hard liquor) contains approximately 15 grams of ethanol.
20. Inability to comply with study and/or follow-up procedures
21. History of noncompliance to medical regimens
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01488487
|
{
"brief_title": "Everolimus and Pasireotide (SOM230) in Patients With Advanced or Metastatic Hepatocellular Carcinoma",
"conditions": [
"Advanced Adult Hepatocellular Carcinoma"
],
"interventions": [
"Drug: Everolimus",
"Drug: Pasireotide"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01488487",
"official_title": "Phase II Single Arm Study of Everolimus and Pasireotide (SOM230) in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-03",
"study_completion_date(actual)": "2015-03",
"study_start_date(actual)": "2011-12"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-04-07",
"last_updated_that_met_qc_criteria": "2011-12-07",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-12-08",
"first_submitted": "2011-12-06",
"first_submitted_that_met_qc_criteria": "2016-03-08"
}
}
}
|
#Study Description
Brief Summary
Children with pneumonia presenting to the emergency department at Monroe Carell Jr. Children's Hospital at Vanderbilt or Children's Hospital of Pittsburgh will be potentially eligible for study. During intervention periods, providers caring for enrolled children will be presented with a detailed decision support strategy that emphasizes management in accordance with national guideline recommendations. The anticipated study duration is 24 months and, as this study does not include direct contact with enrolled subjects, there is no anticipated follow up.
Detailed Description
Pneumonia is the most common serious infection in childhood. In the United States (US), pneumonia accounts for 1-4% of all emergency department (ED) visits in children (3-28 per 1,000 US children per year) and ranks among the top 3 reasons for pediatric hospitalization with \>100,000 hospitalizations per year (15-22 per 100,000 US children per year). Pneumonia also accounts for more days of antibiotic use in US children's hospitals than any other condition.
Emergency care for childhood pneumonia, including hospitalization rates, varies widely across the nation. A study examining hospital admission rates at 35 US children's hospitals from 2009-12 showed marked differences in severity-adjusted pneumonia hospital admission rates (median 31%; range 19-69%). Provider preferences and inaccurate risk perceptions contribute to these differences in hospitalization rates. Within the Intermountain Healthcare System in Utah, Dean et al. exposed large differences in admission rates (range 38-79%) among 18 individual ED providers providing care for \>2,000 adults with pneumonia. Differences were not explained by patient characteristics or illness severity and higher rates of hospitalization did not reduce hospital readmissions or mortality. In another multicenter study of 472 adults with pneumonia at \<4% risk of 30-day mortality estimated using objective severity scores, providers overestimated the risk of mortality in 5% of outpatients (range across institutions 0-12%) and 41% of inpatients (range across institutions 36-48%). These studies suggest that risk perceptions are often inaccurate, and potentially lead to unnecessary or prolonged hospitalizations and intensive therapies. Similar studies have not been performed in children because no valid prognostic tools exist to reliably predict pediatric pneumonia severity.
#Intervention
- BEHAVIORAL : Clinical Decision Support
- For enrolled subjects assigned to the decision support arm, providers will receive prognostic information derived using our previously validated and best performing model. The decision support application will automatically calculate predicted risk for moderate (intensive care) and severe (respiratory failure or shock) outcomes using the parameters derived from the prognostic tool's regression equation. Outcome probabilities will be integrated into the decision support application and displayed within the EHR.
|
#Eligibility Criteria:
Inclusion Criteria:
* Six months to <18 years
* Radiographic evidence of pneumonia in ED
* Provider-confirmed diagnosis of pneumonia
Exclusion Criteria:
* Children with tracheostomy, cystic fibrosis, immunosuppression
* Inter-hospital transfers
* Hospitalization within preceding 7 days
* Previously enrolled within preceding 28 days
* Provider preference for any reason
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06033079
|
{
"brief_title": "Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP2)",
"conditions": [
"Pneumonia Childhood"
],
"interventions": [
"Behavioral: Clinical Decision Support"
],
"location_countries": [
"United States"
],
"nct_id": "NCT06033079",
"official_title": "Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP1): Prognostic Decision Support",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-30",
"study_completion_date(actual)": "2022-11-30",
"study_start_date(actual)": "2020-11-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-12-05",
"last_updated_that_met_qc_criteria": "2023-09-07",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-09-13",
"first_submitted": "2023-08-23",
"first_submitted_that_met_qc_criteria": "2023-11-13"
}
}
}
|
#Study Description
Brief Summary
The purpose of this research study is to learn more about cognitive deficits in people with certain mood disorders. The mood disorders are Major Depressive Disorder (MDD) and Bipolar disorder, depressed type.
Cognitive deficits are problems with things like thinking and memory. People with cognitive deficits may have problems concentrating and paying attention. When talking, they may have trouble recalling a word they want to say. They may think slowly and have problems remembering things. These deficits can affect an individual's ability to work and function socially. Cognitive deficits that occur with depression may increase the risk of a relapse of major depressive disorder.
We want to study the course of cognitive impairment in subjects as they are receiving treatment for their depression. We want to find out if their cognitive deficits get better, worse, or stay the same.
We also want to learn more about a stress hormone called cortisol that is produced in the body. We want to study the relationship between cortisol and cognitive impairment. Recent research has shown that cognitive impairment may be more severe in people who have high levels of cortisol in their blood.
We will also measure the levels of a protein in your blood called brain-derived neurotrophic factor (BDNF). BDNF helps the growth of new brain cells. It appears that the growth of new brain cells lessens when people are depressed. Treatment with antidepressant medications may cause BDNF levels to increase and return to normal. We are interested in studying the relationship between BDNF levels and cognitive impairment throughout treatment.
#Intervention
- OTHER : Prevalence
- Mood and cognitive assessments
|
#Eligibility Criteria:
Inclusion Criteria:
* Eligible subjects will be inpatients admitted to the Massachusetts General Psychiatric inpatient service, Blake 11 with diagnoses of MDD with and without psychotic features and BPDD with and without psychotic features.
* Subjects will include men and women aged 18 <= age <= 85.
* Competent to give informed consent.
Exclusion Criteria:
* Patients with illnesses that impair cognitive functioning including: vascular dementia, and neurological illnesses including Parkinson's Disease, Huntington's Disease, multiple sclerosis, and Alzheimer's Disease.
* The following DSM-IV diagnoses: schizophrenia, schizoaffective disorder, delusional disorder, organic mental disorder, substance use disorders including alcohol, active within the past 6 months, acute bereavement, and psychotic disorder not elsewhere classified.
* Pregnant women
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00844974
|
{
"brief_title": "Cognitive Deficits in Major Depressive Disorder and Bipolar Disorder, Depressed Type: Prevalence and Improvement With Treatment of Depressive Symptoms",
"conditions": [
"Major Depression",
"Bipolar Disorder"
],
"interventions": [
"Other: Prevalence"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00844974",
"official_title": "Cognitive Deficits in Major Depressive Disorder and Bipolar Disorder Depressed Type: Prevalence and Symptoms With Treating of Depressive Symptoms",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2007-12"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-11-18",
"last_updated_that_met_qc_criteria": "2009-02-12",
"last_verified": "2013-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-02-16",
"first_submitted": "2008-05-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Vital pulp therapy (VPT) is a general term for multiple procedures (indirect pulp cap, direct pulp cap and pulpotomy) all directed toward preserving pulp vitality and enable complete root development in immature teeth. The aim of this study is to evaluate the clinical, radiographic and histologic (if any teeth later are doomed for extraction for orthodontic or other reasons) success rate of VPT on treating cariously exposed permanent teeth with developmental defects of enamel. This will be a a prospective case series study including children between 6-16 years old having tooth with enamel hypomineralization defect with deep caries, restorable teeth , and no signs of infection. The teeth will be followed up both clinically and radiographically for 1 year after treatment. It is expected that the teeth will maintain vitality with resolution of symptoms (if present) and completion of root development in immature teeth after vital pulp therapy.
Detailed Description
Background: One of the greatest challenges that may affect the integrity of teeth is dental caries. If left untreated, pulpal involvement may occur leading to irreversible damage and eventually necrosis. This risk is greatly increased in the presence of developmental defects affecting tooth enamel such as molar-incisor hypomineralization (MIH). Despite having high success rate, root canal treatment will lead to loss of proprioceptive function, loss of stress-reducing damping property and tooth sensitivity in developed teeth and will also inhibit complete root formation in immature permanent teeth. Vital pulp therapy (VPT) is a general term for multiple procedures (indirect pulp cap, direct pulp cap and pulpotomy) all directed toward preserving pulp vitality and enable complete root development in immature teeth. So, it has been advocated as a better alternative for pulpectomy/root canal treatment in deep carious vital permanent teeth.
Aim: To evaluate the clinical, radiographic and histologic (if any teeth later are doomed for extraction for orthodontic or other reasons) success rate of VPT on treating cariously exposed permanent teeth with developmental defects of enamel.
Materials and methods: The study will be a prospective case series study including children between 6-16 years old. Inclusion criteria include patients having tooth with enamel hypomineralization defect with deep caries. Teeth should be restorable tooth. No soft tissue swellings, mobility or tenderness to percussion should be present. In cases of pulpotomy, bleeding from all canals should be present after opening the access. Tooth should be diagnosed with reversible / irreversible pulpitis (as indicated by positive response to cold testing).
Medically compromised patients will be excluded from the study. Also any tooth that is non-restorable, having sinus tract or periodontally compromised will be excluded. The procedure involves taking preoperative compete records (radiograph, vitality tests, percussion, mobility and photographs). After administration of anesthetic agent, rubber dam will be placed, caries is removed and appropriate dressing pulp material will be placed and then the final restoration is placed. A post-operative x-ray will be taken. The teeth will be followed up both clinically and radiographically for 1 year after treatment.
Expected Results: It is expected that the teeth will maintain vitality with resolution of symptoms (if present) and completion of root development in immature teeth after vital pulp therapy.
#Intervention
- PROCEDURE : IPT (Indirect pulp treatment)
- Indirect pulp treatment involves complete caries excavation from the dentin-enamel junction using a round bur. Caries near the pulp is removed with caution using spoon excavator until the remaining dentine shows increased resistance to manual instrumentation. A layer of resin-modified glass ionomer (RMGI) dressing material is placed, followed by resin-modified glass ionomer (RMGI) build-up material, and the final restoration; a preformed Stainless Steel Crown (SSC).
- Other Names :
- Indirect pulp capping
- PROCEDURE : Cvek/partial pulpotomy
- Cvek/partial pulpotomy involves removal of inflamed pulp tissue to depth until healthy pulp tissue is reached (depth of 2-4 mm), as indicated by healthy bleeding and arrest of hemorrhage upon pressure with a cotton pellet moistened with 2.5% NaOCl for 2-5 minutes and repeated for two times if required. Gray MTA will be placed in the pulp chamber in 2-3 mm thickness, moist cotton pellet will be placed to ensure setting and the tooth will be temporized with IRM, the patient will be reviewed after 1 week. If the tooth is asymptomatic, final restoration with RMGIC and stainless steel crown will be placed , and a post-operative radiograph will be taken.
- PROCEDURE : Cervical pulpotomy
- Cervical pulpotomy involves removal of inflamed pulp tissue from all pulp chamber as indicated by healthy bleeding and arrest of hemorrhage upon pressure with a cotton pellet moistened with 2.5% NaOCl for 6 minutes and repeated for two times if required. Gray MTA will be placed in the pulp chamber (2-3mm) thickness, moist cotton pellet will be placed to ensure setting and the tooth will be temporized with IRM, the patient will be reviewed after 1 week. If the tooth is asymptomatic, final restoration with RMGIC and stainless steel crown will be placed , and a post-operative radiograph will be taken.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy patient between 6 <= age <= 16 years.
* Tooth with enamel hypomineralization defect
* Molar tooth with deep caries
* Restorable molar tooth
* No soft tissue swellings, mobility or tenderness to percussion
* Bleeding from all canals (when performing cervical pulpotomy)
* Reversible / Irreversible pulpitis (as indicated by positive response to pulp testing using cold test)
Exclusion Criteria:
* Medically compromised patient
* Non-restorable tooth
* Presence of dental abcess / sinus tract
* Periodontally compromised teeth
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03735069
|
{
"brief_title": "Vital Pulp Therapy in Carious Teeth With Hypomineralization",
"conditions": [
"Dental Caries Extending to Pulp",
"Molar Incisor Hypomineralization"
],
"interventions": [
"Procedure: Cvek/partial pulpotomy",
"Procedure: Cervical pulpotomy",
"Procedure: IPT (Indirect pulp treatment)"
],
"location_countries": [
"Jordan"
],
"nct_id": "NCT03735069",
"official_title": "Outcome of Vital Pulp Therapy in Carious Teeth With Hypomineralization Defects: a Clinical Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-15",
"study_completion_date(actual)": "2020-01-30",
"study_start_date(actual)": "2017-09-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-02-12",
"last_updated_that_met_qc_criteria": "2018-11-06",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-08",
"first_submitted": "2018-11-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The six-minute walk test (6MWT) is a well established field exercise test to assess the functional exercise capacity in chronic obstructive pulmonary disease (COPD). The objective of this study is to assess the impact of walking behind the patient on 6MWT distance in patients with COPD.
Detailed Description
In a single-center, randomized crossover study, the investigators aim to elucidate whether there is a difference in the 6MWT distance when the assessor walks behind the patient compared to the patient walking alone.
Patients with COPD referred for pulmonary rehabilitation will be invited to perform an accompanied 6MWT (assessor walks behind the patient) and unaccompanied 6MWT (assessor does not walk behind the patient) in random order.
The tests will be performed at the end of a pulmonary rehabilitation program, after patients are familiarised with the 6MWT testing procedure and learning effects can be excluded.
#Intervention
- OTHER : 6MWT - accompanied
- Assessor walks behind the patient
- OTHER : 6MWT - not accompanied
- Assessor does not walk behind the patient
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of COPD according to GOLD II-IV (FEV1/FVC < 0.7, FEV1%Norm < 80%)
Exclusion Criteria:
* Inability to perform a 6MWT when arriving at the clinic (e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations)
* Inability to understand the instructions of the 6MWT, either of language or cognitive reasons
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04033783
|
{
"brief_title": "Impact of Walking Behind the COPD Patient on 6MWD",
"conditions": [
"COPD"
],
"interventions": [
"Other: 6MWT - not accompanied",
"Other: 6MWT - accompanied"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT04033783",
"official_title": "The Impact of Walking Behind the Patient on Six-Minute Walk Test Distance in Chronic Obstructive Pulmonary Disease: a Randomized Cross-over Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-16",
"study_completion_date(actual)": "2019-12-16",
"study_start_date(actual)": "2019-09-18"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-12-20",
"last_updated_that_met_qc_criteria": "2019-07-25",
"last_verified": "2019-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-26",
"first_submitted": "2019-07-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.
#Intervention
- DRUG : Artemether-lumefantrine
|
#Eligibility Criteria:
Inclusion Criteria:
* male or female infants and children <=12 years
* body weight of >=5 kg and <35 kg,
* with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite
Exclusion Criteria:
* complicated malaria
* persistent vomiting
* malaria due to parasites other than P. falciparum
* antimalarial treatment received in the past 2 weeks
* known chronic disease e.g. positive HIV status, severe cardiac, renal, or hepatic disease
Sex :
ALL
Ages :
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00386763
|
{
"brief_title": "Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.",
"conditions": [
"Malaria",
"Falciparum"
],
"interventions": null,
"location_countries": [
"Benin",
"Kenya",
"Tanzania",
"Mali",
"Mozambique"
],
"nct_id": "NCT00386763",
"official_title": "A Randomized, Investigator-Blinded, Multicenter, Parallel-Group Study to Compare Efficacy, Safety and Tolerability of Arthemeter/ Lumefantrine Dispersible Tablet Formulation vs. Artemether/ Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants and Children.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2007-03",
"study_start_date(actual)": "2006-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-03-12",
"last_updated_that_met_qc_criteria": "2006-10-11",
"last_verified": "2009-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-10-12",
"first_submitted": "2006-10-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Orthognathic surgery, one kind of Oro-maxillofacial surgery, is a complicate surgery that undergoes several hours with nasotracheal intubation general anesthesia. To limit blood loss during operation, the patients are often under intentional hypotension. However, the intentional hypotension may confuse with hypovolemic induced low blood pressure. The hypothesis is using flotrac (to measure stroke volume variation) to keep the patients hemodynamics stable under Tridil and propofol infusion and avoid over-infusion of crystalloid or colloid and prevent hypovolemia induced postoperative nausea and vomiting.
Detailed Description
Orthognathic surgery, one kind of oro-maxillofacial surgery, is a complicated surgery that undergoes several hours with nasotracheal intubation general anesthesia. Patients without premedication undergo orthognathic surgery with nasotracheal intubation general anesthesia.
Patients without premedications Monitoring of patients with entropy for consciousness, ECG, with noninvasive BP and invasive blood pressure through redial artery, train-of-four monitor, target controlled infusion of propofol, infusion Tridil, and sevoflurane for mainly anesthesia maintenance. Ventilator setting as volume control (8-12ml/kg), frequency respiratory rate (8-12/min), I/E ratio: 1/2, positive end expiratory pressure: 4 mmHg, Fraction inspiratory O2: 60%.
To maintain the MAP \>60-55 mmHg, urine output 0.5-1ml/kg, and body core temperature \> 36 Celsius degree.
Closely observation of patients postoperatively for adverse events or complications.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients undergo orthognathic surgery, ASA I~III, 20 <= age <= 65 old, no mouth limitation
Exclusion Criteria:
* ankylosing spondylitis, limited mouth opening < 3 cm, liver or renal disease, obese patients (BMI>35kg/m2), patients refused
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03086694
|
{
"brief_title": "Goal-Directed Fluid Therapy for Patients Undergoing Oro-Maxillofacial Surgery",
"conditions": [
"Blood Pressure, Low"
],
"interventions": null,
"location_countries": [
"Taiwan"
],
"nct_id": "NCT03086694",
"official_title": "Kaohsiung Medical University Chung-Ho Memorial Hospital",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-25",
"study_completion_date(actual)": "2019-08-31",
"study_start_date(actual)": "2017-04-05"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-21",
"last_updated_that_met_qc_criteria": "2017-03-15",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-03-22",
"first_submitted": "2017-02-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)
Detailed Description
The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet compared to placebo in children (5-11 years of age) with House Dust Mite allergic rhinitis based on the total combined rhinitis symptoms and medication score during the last 8 weeks of treatment.
In addition, the trial will evaluate safety and tolerability of the treatment, and assess whether treatment has an impact on asthma symptoms and medication use, immunological parameters, and rhinoconjunctivitis quality of life (QoL).
The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 1 year.
#Intervention
- BIOLOGICAL : Sublingual allergy immunotherapy tablet
- For daily administration (1 tablet per day)
- Other Names :
- Acarizax, Odactra
- OTHER : Placebo
- For daily administration (1 tablet per day)
- Other Names :
- Placebo sublingual tablet
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects aged 5 <= age <= 11 years
* A clinical history of HDM AR/C (Allergic rhinitis/rhinoconjunctivitis) (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening
* Have a certain level of AR (Allergic rhinitis) symptoms on at least 8 of the last 14 days of the baseline period
* Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period
* Positive skin prick test (SPT) and IgE (Immunoglobulin E) to D. pteronyssinus or D. farinae at screening
* Lung function >= 70% of predicted value
Exclusion Criteria:
* Sensitised and regularly exposed to perennial allergens
* Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation
* Asthma requiring treatment with high dose of inhaled corticosteroid
* A relevant history of systemic allergic reaction
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 11 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04145219
|
{
"brief_title": "House Dust Mite Allergy Trial In Children",
"conditions": [
"Allergic Rhinitis Due to Dermatophagoides Farinae",
"Allergic Rhinitis Due to Dermatophagoides Pteronyssinus",
"Allergic Rhinitis Due to House Dust Mite"
],
"interventions": [
"Other: Placebo",
"Biological: Sublingual allergy immunotherapy tablet"
],
"location_countries": [
"France",
"Lithuania",
"Slovakia",
"Ukraine",
"United States",
"Poland",
"Germany",
"Canada",
"Russian Federation",
"Spain",
"Bulgaria"
],
"nct_id": "NCT04145219",
"official_title": "A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-04-01",
"study_completion_date(actual)": "2023-04-21",
"study_start_date(actual)": "2019-10-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-12",
"last_updated_that_met_qc_criteria": "2019-10-28",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-30",
"first_submitted": "2019-10-11",
"first_submitted_that_met_qc_criteria": "2024-06-11"
}
}
}
|
#Study Description
Brief Summary
International, Multicenter, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad combined with Allopurinol in Heart Failure with Preserved Ejection Fraction
Detailed Description
Evidence shows independent associations between hyperuricaemia and the risk of cardio-renal conditions, including heart failure (HF). Serum uric acid (sUA) is also a strong prognostic factor and correlates with other markers of poor prognosis in HF patients with preserved ejection fraction (HFpEF), and an estimated 1/2-2/3 of HFpEF patients have hyperuricaemia. HFpEF is a microvascular disease likely partly driven by endothelial dysfunction and inflammation in coronary vessel walls. Uric acid crystals have been identified in coronary vessel walls in some hyperuricaemic patients.
Uric acid transporter 1 (URAT1) is responsible for reabsorption of uric acid (UA) in the proximal tubule. Inhibition of URAT1 results in increased urinary excretion of UA and lowering of uric acid in the blood. Verinurad is a novel URAT1 inhibitor in Phase 2 development for chronic kidney disease (CKD) and HF. Verinurad combined with the xanthine oxidase (XO) inhibitors (XOI) febuxostat or allopurinol has been shown to lower sUA in patients with recurrent gout in Phase 2 studies by up to approximately 80%.
The primary objective of this Phase 2 study is to assess the effect of a combination of verinurad and allopurinol on exercise capacity in patients with HFpEF.
The secondary objectives are to assess effect of combination of verinurad and allopurinol in comparison to allopurinol monotheraphy on excercise capacity dwhich will be measured in peak VO2 as well as effect of verinurad and allopurinol compared to placebo and to allopurinol monotheraphy on Kansas City cardiomyopathy questionnaire (KCCQ)-total symptom score (TSS). A sub-study aims to investigate the relationship between UA crystals and inflammation.
#Intervention
- DRUG : Verinurad
- The treatment will be titrated in 3 steps for target low dose (3 mg), intermediate dose (7.5 mg) and high dose (12mg) of verinurad.
Drug: Allopurinol The treatment will be titrated in 3 steps. Low dose (100mg), intermediate (200mg) and high dose (300mg) of allopurinol.
- Other Names :
- verinurad titration 3 - 7.5 - 12mg, allopurinol titration 100 - 200 - 300 mg
- DRUG : Allopurinol
- Study treatments will be titrated in 3 steps: Low dose (100mg), intermediate (200mg) and high dose (300mg) of allopurinol
- Other Names :
- allopurinol titration 100 - 200 - 300 mg
- DRUG : Placebo for verinurad
- Matching Capsule
- Other Names :
- Placebo
- DRUG : Placebo for allopurinol
- Matching tablet
- Other Names :
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient must be >= 40 years at the time of signing the ICF
* Patients with hyperuricaemia defined as sUA level of > 6 mg/dL.
* Patients with documented diagnosis of symptomatic HFpEF according to all of the following criteria:
1. Have NYHA functional class II-III at enrolment
2. Have medical history of typical symptoms/signs of HF > 6 weeks before enrolment
3. LVEF >= 45%
4. NT-proBNP >= 125 pg/mL (>= 14.75 pmol/L) at Visit 1 for patients without ongoing atrial fibrillation/flutter.
* Patients able to exercise to near exhaustion during a CPET as exhibited by RER
>= 1.05 during CPET conducted during screening. If patient does not achieve RER >= 1.05 the CPET may be repeated once, at least 48 hours but less than 2 weeks (but before randomisation) after the initial test; in such cases the second test will serve as baseline.
* Male or female
Exclusion Criteria:
* eGFR < 30ml/min/1.73m2 (based on CKD-EPI formula)
* Presence of any condition that precludes exercise testing
* Known history of a documented LVEF < 40%
* Probable alternative or concomitant diagnoses which in the opinion of the Investigator could account for the patient's HF symptoms and signs (eg, anaemia, hypothyroidism)
* Known carrier of the Human Leukocyte Antigen-B (HLA-B) *58:01 allele: HLA-B
*58:01 genotyping is mandatory prior to randomization for all patients.
* Patients diagnosed with tumor lysis syndrome or Lesch-Nyhan syndrome
* Patients who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the patients' tasks associated with the protocol
* Presence of any condition which, in the opinion of the investigator, places the patient at undue risk or potentially jeopardises the quality of the data to be generated
* Current acute decompensated HF or hospitalisation due to decompensated HF < 4 weeks prior to enrolment
* Myocardial infarction, unstable angina, coronary revascularisation (percutaneous coronary intervention or coronary artery bypass grafting), ablation of atrial flutter/fibrillation, valve repair/replacement, implantation of a cardiac resynchronisation therapy device, stroke or transient ischemic attack within 6 months prior to enrolment.
* Planned coronary revascularisation, ablation of atrial flutter/fibrillation and/or valve repair/replacement
* Atrial fibrillation with persistent resting heart rate > 110 beats per minute.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 130 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04327024
|
{
"brief_title": "Study of Verinurad in Heart Failure With Preserved Ejection Fraction",
"conditions": [
"Heart Failure With Preserved Ejection Fraction (HFpEF)"
],
"interventions": [
"Drug: Verinurad",
"Drug: Placebo for allopurinol",
"Drug: Placebo for verinurad",
"Drug: Allopurinol"
],
"location_countries": [
"Slovakia",
"Mexico",
"United States",
"Poland",
"Germany",
"Canada",
"Austria",
"Russian Federation",
"Australia",
"Bulgaria",
"Argentina",
"Korea, Republic of"
],
"nct_id": "NCT04327024",
"official_title": "A Phase 2, Multicentre, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad Combined With Allopurinol in Heart Failure With Preserved Ejection Fraction",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-29",
"study_completion_date(actual)": "2022-04-29",
"study_start_date(actual)": "2020-05-19"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-29",
"last_updated_that_met_qc_criteria": "2020-03-27",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-30",
"first_submitted": "2020-03-13",
"first_submitted_that_met_qc_criteria": "2023-06-12"
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to determine whether allogenic bone marrow stem cell transplant is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic limbus stem cell transplant.
#Intervention
- PROCEDURE : Stem Cell with Amniotic Membrane Transplant
- Single stem cell expansion in amniotic membrane transplant
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or Female older than 18 years.
* Signed Informed consent
* Negative pregnancy test at inclusion for any potential childbearing female.
* Compromise of contraceptive method during all trial for any potential childbearing female.
* Diagnosis of Ocular Surface Failure due to Limbus Insufficiency Syndrome, based in any of the published characteristics as corneal surface neovascularization, loss of corneal transparency, epithelial irregularities, history of punctate keratitis, erosions or repetitive ulcers and presence of symptoms and confirmed by the presence of epithelial phenotype cells assessed with conjunctival impression cytology.
* Availability for all the scheduled visits during the study
Exclusion Criteria:
* Uncontrolled systemic disease (e.g. hypertension or diabetes) or any disease that under medical decision might put the patient at risk during the surgery or follow-up examinations or may cause any hazard in data analysis.
* Active ocular infection in any eye. If the infection can be cured, inclusion can be considered after 30 days of inactive infection since its end.
* Alterations in lid statics / dynamics or any other pathology (e.g. severe dry eye syndrome) except the one that originated the Limbus Insufficience that under medical opinion might alter the results. Any of these must be corrected 3 months prior to patient inclusion, before reconsidering rescreening.
* Limbus insufficiency syndrome which has not been previously treated with all medical (not surgical) procedures available.
* No availability for all scheduled visits during the study.
* Any other circumstance under investigator´s opinion that prevents patient inclusion even though normal inclusion and exclusion criteria are met.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01562002
|
{
"brief_title": "Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome",
"conditions": [
"Limbus Corneae Insufficiency Syndrome"
],
"interventions": [
"Procedure: Stem Cell with Amniotic Membrane Transplant"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT01562002",
"official_title": "Advanced Therapy for Ocular Surface Reconstruction. Allogenic Limbus Epithelial Stem-cell Transplant vs Bone Marrow Mesenchymal Stem-cell Transplant in Limbus Insufficiency Syndrome. Double-masked Randomized Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-12",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2012-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-01-08",
"last_updated_that_met_qc_criteria": "2012-03-22",
"last_verified": "2015-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-03-23",
"first_submitted": "2012-03-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Trial purpose: For infants born \<28 weeks of age, can initial respiratory resuscitation with new system (low imposed work of breathing and prongs) reduce the frequency of delivery room intubations compared to standard treatment with T-piece resuscitator system (high imposed work of breathing and face mask)?
Trial summary: This is a randomised controlled trial of delivery room intubation rates comparing a new system and T-piece resuscitation system for initial stabilisation of infants born \<28 weeks.
Detailed Description
The study is a two arm randomised comparison of two systems (T-piece device and the new system) for respiratory support after delivery of an infant born less than 28 weeks gestational age (GA). This multicentre trial will start at Karolinska University Hospital and other sites can join throughout the study period. The trial is academic with the coordinating investigator as sponsor. No company funding will be considered.
The new device has been designed for neonatal resuscitation and CE-marked for this intended use. The device is operated/handled in a similar way to existing devices and can provide support according to resuscitation guidelines.
During spontaneous breathing the continuous positive airway pressure (CPAP) provided with the new system is more pressure stable and has low imposed work of breathing. The benefits of decreased imposed work of breathing during resuscitation have not previously been investigated. The new system has the option of using prongs as the patient interface. Prongs have shown promising results in trials and have theoretical benefits. We hypothesis that the combined use of prongs and low imposed work of breathing could reduce the number of infants that need mechanical ventilation.
Screening for eligibility and consent will be performed on mothers with threatening delivery of an extremely premature infant (\<28 weeks gestational age). There is no lower gestational age limit but patients should not be included if there is a decision to intubate prior to delivery or treatment limitations.
After a patient has been enrolled the randomisation will be on hold until delivery is imminent. Randomisation will be stratified on centre, gestational age and antenatal steroid treatment. The interventions cannot be blinded.
The management of respiratory support is according to international guidelines and a detailed description is provided in the clinical management appendix. The intervention is respiratory support for the first 10-30 minutes of life and will begin after birth when the infant is transferred to the resuscitation team. The intervention ends 1) when an infant is intubated (primary outcome), 2) after a minimum of 10 minutes support, with the randomized system, the patient is stable and breathing adequately, 3) at 30 minutes when the respiratory support can continue as decided by the clinicians (cross-over not allowed).
Apart from the system used for respiratory support all patients will receive standard care. No assessments or investigations of the trial subjects are planned. Data will be reported by the resuscitation team and collected from records.
The primary outcome is delivery room intubation or death. The secondary outcomes include time to intubation, use of surfactant, use of positive pressure ventilation, respiratory support at 72 hours and temperature on intensive care admission. Safety variables include pneumothorax, intraventricular haemorrhage and problems with ventilation and equipment.
All analysis will be on intention to treat and p\<0.05 considered statistically significant. The primary outcome variable (delivery room intubation or death) will represent a 2x2 cross table and analysed with Pearson chi-square test. The secondary outcomes include Kaplan Meier analysis of time to intubation and comparisons of means for continuous variables. There are no predetermined subgroups. Subgroup analysis will be used to describe the population and to generate hypotheses.
#Intervention
- DEVICE : T-piece used for respiratory support (several manufacturers)
- Infants will receive support by a standard T-piece resuscitator system (manufacturer not dictated in protocol). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)
- Other Names :
- Neopuff™ Infant T-Piece Resuscitator, T-piece Disposable Circuit Kit (GE Healthcare), Other T-piece manufacturers
- DEVICE : New system used for respiratory support
- Infants will receive support by the new system (manufactured by Inspiration Healthcare, UK). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)
- Other Names :
- Manufacturing and CE-marking by Inspiration Healthcare, UK
|
#Eligibility Criteria:
Inclusion Criteria:
* Born <28 weeks gestational age at a university hospital
* Delivery can be vaginal or with caesarean section and steroid prophylaxis to mother can be complete, incomplete or not given
Exclusion Criteria:
* Decision on treatment limitations before randomisation
* Decision to intubate infant made before delivery (for example local routine for infants born before 23 weeks GA)
* Known airway, pulmonary, cardiac, gastro-intestinal tract malformations
* Known neuromuscular disease
* No study neonatologist available
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02563717
|
{
"brief_title": "Comparison Of Respiratory Support After Delivery on Infants Born Before 28 Weeks Gestational Age",
"conditions": [
"Respiration; Insufficient or Poor, Newborn",
"Infant, Premature, Diseases"
],
"interventions": [
"Device: New system used for respiratory support",
"Device: T-piece used for respiratory support (several manufacturers)"
],
"location_countries": [
"Lithuania",
"Sweden",
"Poland",
"Norway",
"Iceland"
],
"nct_id": "NCT02563717",
"official_title": "A Randomised Controlled Trial of Delivery Room Intubation Rates Comparing a New System and T-piece Resuscitation System for Initial Stabilisation of Infants Born <28 Weeks",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-05-15",
"study_completion_date(actual)": "2020-05-18",
"study_start_date(actual)": "2016-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-06-01",
"last_updated_that_met_qc_criteria": "2015-09-28",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-30",
"first_submitted": "2015-09-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The effect of expiratory muscle strength training (EMST) on sleep quality, disease severity, and respiratory muscle strength has been previously investigated in OSA syndrom. Only the effects of the high-intensity short-term EMST study in moderate OSAS patients were studied. High intensity and low intensity EMST has advantages and disadvantages.The study aims to compare the effects of high (60% MEP) and low (30% MEP) expiratory muscle strength training (EMST) on disease severity, sleep efficiency, snoring, fatigue severity and quality of life in severe OSAS patients.
Detailed Description
Ahi Evren Chest Cardiovascular Surgery Training Research Hospital In sleep lab, polysomnography will be directed to the physiotherapist by the pulmonologist with severe OSAS patients. Patients will be divided into two groups by block randomization method. The study was planned as double-blind. Patients will not know what treatment they are receiving, the doctor does not know what treatment the patient is receiving, and technicians who take and analyze polysomnography will not know what treatment the patients are receiving.
Severe OSAS patients with MEP 30% (low intensity) to the first group, MEP 60% (high intensity) to the second group with expiratory muscle training device, 7 days / week, 25 breaths per day, 1 minute rest for 5 breaths will be run with the cycle. The training will take a total of 8 weeks. The follow-up of the patients will be done remotely by phone. MEP measurements will be repeated every 2 weeks in the hospital and the new training workload will be calculated.
#Intervention
- OTHER : Expiratory muscle trainig
- This exercise will be used to strengthen forced expiratory muscles.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with severe OSAS by Polysomnography in Ahi Evren Chest, Cardiovascular Surgery Training and Research Hospital Sleep Center will be included.
* General health condition is stable
Exclusion Criteria:
* Passed stroke,
* Neurological disease and psychological disease
* Cardiac disease
* Hypothyroidism
* Serious obstructive nasal disease,
* A history of infection in the past month.
* Previous oroferengeal surgery history
* With a BMI of 40 kg / m2 or more,
* Using substance, alcohol, sedative and hypnotic drugs
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04454242
|
{
"brief_title": "High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome",
"conditions": [
"Obstructive Sleep Apnea Syndrome"
],
"interventions": [
"Other: Expiratory muscle trainig"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04454242",
"official_title": "Comparison of the Effects of High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-30",
"study_completion_date(actual)": "2022-06-01",
"study_start_date(actual)": "2021-06-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-12-20",
"last_updated_that_met_qc_criteria": "2020-06-30",
"last_verified": "2022-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-01",
"first_submitted": "2020-06-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if progesterone treatment safely reduces brain swelling and damage after injury.
Detailed Description
Title: Progesterone Treatment of Blunt Traumatic Brain Injury Principal Investigator(s): Arthur Kellermann, M.D., M.P.H. Institution: Emory University Biostatistician: Vicki Hertzberg, Ph.D. Institution: Emory University Project phase or primary methodology: Phase II pilot, double blind, 4:1 randomized controlled, clinical trial Target disease: Blunt traumatic brain injury Intervention: Intravenous progesterone infused over three days Number of patients to be enrolled: 100 Number of clinical centers: One (Grady Memorial Hospital) Primary Hypothesis: Dose: Intravenous infusion of progesterone at a dose of 0.5 mg/kg/hr produces a steady state of 450 +/- 100 nmol/L in male and female subjects.
Safety: Compared to study subjects who receive placebo, subjects who receive IV progesterone do not have an increased risk of mortality or an increased incidence of adverse effects.
Efficacy: Administering IV progesterone shortly following TBI produces any or all of the following effects, including:
* Reduction of the intracranial pressure therapeutic intensity level (ICP-TIL).
* Decreased duration of coma.
* Decreased inpatient mortality.
* Improved neurological outcome one month post-injury.
Secondary Hypotheses: Benefit: The benefits of IV progesterone for TBI are evident across a range of clinically relevant treatment subgroups, regardless of:
* Time from injury to drug administration: (i.e., \<2 hrs. vs. 2-4 hrs. vs. 4-6 hrs.).
* Victim gender.
* Presence or absence of severe extracranial trauma.
* Presence or absence of premorbid confounders of outcome (e.g., alcohol intoxication, alcoholism, stroke, etc.).
* Incidence or lack of confounding neurological insults (e.g., hypoxemia, hypotension).
* Severity of the traumatic brain injury - moderate (index GCS 9-12) versus severe (index GCS 4-8).
* Severity of non-brain injuries (AIS, ISS scores).
Description of methodology and design: Double blind randomized controlled, clinical trial. Block randomization will be used to insure that moderate and severely injured patients of both genders and races (black and nonblack) have an equal chance of allocation to either treatment group.
Patient selection criteria: Age \> 18; blunt traumatic brain injury; moderate to severe brain injury (iGCS 4-12); arrival \< 11 hours after Injury
Description of pre-randomization procedures or process: Potential study subjects will be identified by Emergency Medical Service (EMS) personnel and Emergency Medicine attending physicians and residents in the ECC of GMH. EMS (ambulance) personnel will notify ECC personnel that they are bringing a blunt trauma patient with a Glasgow Coma Score (iGCS) of 12 or less. On arrival, the attending emergency physician on duty will conduct a primary and secondary trauma survey and note the patient's post initial resuscitation or i GCS. If the patient has a iGCS of 4 - 12 and meets criteria for presumptive eligibility, the ECC attending will page the investigator on-call (IOC) and ask Hospital Social Services to initiate aggressive efforts to contact the patient's family. To insure prompt administration of progesterone/placebo, a 'door to needle time' of ≤ 2 hours has been established as our performance goal. To meet this deadline, a member of the research team will immediately respond to the ECC and determine if the patient meets the inclusion and exclusion criteria. Time from injury will be established as clearly as possible from the EMS report, police report or witness interview. Block randomization will be used to insure that moderate and severely injured patients of both genders and races (black and nonblack) have an equal chance of allocation to either treatment group. To accomplish this goal, the GMH pharmacy will be given block sets of randomly ordered packets with sequential study numbers for subjects with moderate TBI (presenting GCS 9-12) and severe TBI (presenting GCS 4-8). Inside each packet will be instructions to prepare an infusion of progesterone or a comparable volume of placebo. When the pharmacist receives a copy of the randomization request, he/she will open the next packet in sequence based on the patient's severity of brain injury (moderate versus severe), gender, and race. Following treatment group assignment, the pharmacist will record the patient's name, medical record number, dose, and time the medication was prepared in a confidential log for use by the Safety Committee.
Precise treatment dose description for protocol: Our goal is to initiate treatment within 2 hours of injury as documented from an EMS report, police report or witness interview. We will accept patients up to 11 hours post-injury. We will attempt to achieve serum levels of progesterone in human subjects that are similar to those normally observed in the third trimester of pregnancy (i.e., 450 +/- 100 nmol/L).
To determine the infusion rate needed to achieve a SSSPC of progesterone of 450 +/- 100nmol/L, we will conduct a dose-escalation study. The first 12 subjects randomized to progesterone will receive a loading dose of 0.714 mg/kg over 60 minutes followed by a continuous infusion of 0.50 mg/kg/hr for three days. Because study personnel will be blinded to group assignment, an unblinded pharmacologist will analyze the SSSPC data from these 12 patients. If the target concentration of 450 +/- 100nmol/L is not achieved in 90% of these subjects, the infusion rate will be modified and applied to the next ten subjects randomized to progesterone therapy. This will be performed a third time if necessary. If pharmacokinetic variability precludes the achievement of the target concentration in 90% of subjects using a fixed infusion, we will adopt an individualized dosing strategy based on real-time serum concentration data. If this is required, adjustments will be made to the placebo infusions as well to maintain blinding of the study investigators. The total dose given to any patient over the three day dosing period should not exceed 7.5 grams.
Plan for Follow-up:
The GOS, DRS, and GOAT will be assessed at one month post-injury. At the time of hospital discharge, each patient's disposition will be noted (morgue, nursing home, rehabilitation facility, another acute care hospital, patient's home, relative's home), so plans can be made for a follow-up exam one month post-injury. Subjects who are still hospitalized at GMH, an inpatient rehabilitation facility, a skilled nursing home, or an acute care hospital other than GMH one month post-injury will be tested on site. We will visit patients who are homebound at the time of follow-up. All other subjects will be asked to come to a study clinic at GMH for testing. Patients who are too severely impaired to test at one month post-injury will be classified as 'not testable'. This category will be considered a surrogate marker for a poor outcome. We will utilize reliability codes to record all possible reasons for the non-administration of a particular measure, such as physical impairment (e.g., hemiparesis) cognitive impairment (e.g., did not understand instructions), or intoxication.
During the follow-up visit, the study subject (or a proxy respondent) will be asked questions about their physical and mental health, any medical complications (e.g., seizure disorder, and headaches), their functional status, their occupational status, their level of sexual function, and their current living situation. Information on other variables that influence outcome, such as access to rehabilitation services, will be collected as well. To encourage participation, subjects will be reimbursed $25 for the follow-up visit, plus additional money for travel-related expenses.
Extent and type of blinding/masking: Hospital pharmacy personnel will know each patient's group assignment, but this information will be withheld from the patient, the study team, and the clinical team responsible for the patient's care. Both study drug and placebo will be suspended in a lipid base, and will be indistinguishable by color or injection characteristics.
Endpoints and outcomes: Four measures will be used to monitor each patient's clinical response to treatment. The first three will be tracked daily by our study nurses. The fourth will be assessed one month post-injury. These four measures are:
1. Reduction in ICP, reflected by a decline in the patient's therapeutic intensity level (ICP-TIL) a measure of the intensity of treatment needed to reduce increased intracranial pressure;
2. Duration of coma (i.e., total hours from injury to awakening);
3. Death prior to hospital discharge;
4. Neurological outcome at one month post -injury, as measured by the Glasgow Outcome Scale (GOS), the Disability Rating Scale (DRS), and the Galveston Orientation and Amnesia Test (GOAT).
Statistical design and sample size calculations: Our data analysis strategy is designed to accomplish our three primary and one secondary goals: 1) achieve and maintain a predetermined steady state concentration of progesterone in 90% of our study patients, 2) confirm the safety of the study drug, 3) test the hypothesis that administration of progesterone within 6 hours of TBI improves clinical and neurological outcomes, and the secondary; determine if the benefit of IV progesterone is equally evident across a range of clinically relevant treatment subgroups. In the process of achieving these goals, we will quantify our ability to identify and enroll TBI patients, administer the study drug within strict time restraints, and adhere to the study protocol.
To assess the efficacy of progesterone for treatment of TBI, we will employ a systematic statistical analysis strategy. Our first analytic step will be to compile descriptive statistics (e.g., mean, median, standard deviation, range, proportion) of patient demographics. This activity, while not directly addressing any of the study hypotheses, will serve to describe the central tendencies and variability of the outcome variables and covariables.
The second step will be to compare treatment groups with respect to suspected important covariates, specifically patient age, gender, cause and type of brain injury, presence or absence of intracranial mass lesions, presence/absence of extracranial trauma, presence/absence of premorbid confounders (e.g., alcohol intoxication, alcoholism, stroke, etc.), presence/absence of confounding neurological insults (e.g., hypoxemia, hypotension), severity of TBI, and time to initial drug administration. This will assess the balance achieved through randomization. The third step will be to analyze the data according to our specific aims.
To estimate the sample size needed to establish efficacy, we needed to specify the effect size to be detected by our outcome measures. We do not have any human data to definitively establish the effect size expected as a result of treatment. Based on animal models, we conservatively posit that progesterone will improve neurological outcome (i.e., dichotimized GOS, DRS, GOAT at one month post-injury) by 25%. We expect to enroll 100 subjects at a 4:1 randomization (80 treated and 20 controls) into our pilot study. With respect to duration of coma, the number of patients that would allow us to achieve 80% power to detect a difference of at least 0.6 standard deviation between treatment groups at the two-sided 0.05 significance level was 50 treated and 50 controls. For this outcome, a difference of 0.6 standard deviation units translates into a difference of + 1.1 days, or 29%, based on the findings of Stambrook, et al.6 However, since we have changed our protocol to a 4:1 randomization, we no longer have the power to detect this difference. Similarly, in the subgroup of patients monitored for differences in the ICP-TIL, in the original 1:1 randomization scheme we would have been able to achieve 80% power to detect a difference of at least 1.0 standard deviation between treatment groups at the two-sided 0.05 significance level, but with the 4:1 scheme no longer have the power to detect a difference. With respect to mortality, our pilot will have insufficient power (\<50%) to definitively detect an effect size equal to 25% reduction in the rate of death. Similarly there is insufficient power to detect a 'good' neurological outcome at hospital discharge or at one month post-injury using a dichotomized GOS (good or moderate recovery versus severe disability), with the expectation of 50% with good outcome in the placebo group, based on the findings of Levin, et al. However, this study should allow us to perceive trends in the data as well as determine the range and prevalence of outcomes that we might anticipate for a multi-center study of this therapy. This will allow us to refine our future power calculations appropriately.
Initially, there will be a dose escalation component within the progesterone group, but the differences in the level of circulating progesterone between the subgroups will be minimal compared to the control group. Hence, all progesterone treated patients are assumed to respond similarly to the treatment. (2) At the completion of the pilot phase at least 100 patients will be randomized into this study. GMH's trauma registry indicates that at least 145 potentially eligible TBI patients (age ≥ 18, GCS 4-12, blunt mechanism, and \<11 hours from injury) will come to GMH during the study interval. Every effort will be made to obtain informed consent from a proxy in order to administer the study drug within the specified time limit (2 hours).
Proposed safety and efficacy monitoring boundaries:
Data Safety and Monitoring Board (DSMB): In accordance with standard procedures for NIH sponsored clinical trials, the DSMB chair and members have been selected by the NIH-NINDS. This committee will be informed of each subject's group assignment (A versus B), but will be blinded with respect to which group received the study drug.
This committee will have three responsibilities: 1) monitor identification, enrollment, and randomization procedures to detect any evidence of bias; 2) monitor adverse events to determine if they occur disproportionately in one group, and 3) monitor key clinical outcomes to determine if one group does significantly better than the other. To assist the DSMB in its work, our statistician, Vicki Hertzberg, will monitor the progress of the study on a monthly basis. The DSMB will have no role in the day-to-day conduct of the trial. The study statistician will report to the DSMB at quarterly meetings.
Safety Monitoring: A study nurse and/or the research program coordinator will round on subjects daily to track their clinical progress and the occurrence of any serious adverse events (SAE) or adverse events (AE). All SAEs will be reported to the IRB, DSMB, and FDA within 24 hours. All other adverse events will be reported to the PI, IRB, and FDA on a weekly basis. Specific events potentially related to the study drug, based on prior knowledge of the pharmacology of progesterone, combination agents that include progesterone, and the Intralipid carrier, will be closely monitored by the study team. These events include: a) phlebitis at the injection site; b) sedation unexplained by administration of other CNS medications; c) an increase in liver enzymes; d) unexplained hyperglycemia; e) hypotension or hypertension not known to be associated with increased intracranial pressure; f) unexplained fever; g) thromboembolic disease; and h) sepsis. Baseline metabolic parameters will be determined from the initial blood draw prior to study drug administration. Blood sampling will be performed at least once per day during drug administration for monitoring. In addition, hourly vital sign measurements and other parameters will be obtained from ICU charting forms. Patients will be examined daily by team members for any signs of adverse reactions. Team members will also review charting, laboratory reports and treating physician notes daily. In addition, all trauma deaths are reviewed by an interdisciplinary Trauma Outcome Review Committee (TORC) to determine if the death was non-preventable, potentially preventable, or preventable. A member of our study team will attend all of these meetings. If/when TORC reviews a death involving a participant in the study, their findings will be shared with the DSMB as well as the P.I. and co-P.I. The DSMB will closely monitor the incidence of death and other serious adverse events such as sepsis or thromboembolic disease. If they have concerns about the incidence of any of these events as linked to the study drug, they will immediately report these concerns to the National Institute for Neurological Disorders and Stroke (NINDS), as well as to the Emory IRB. Furthermore, all occurrences of death (regardless of cause) and unexpected serious adverse events will be reported to the Food and Drug Administration (FDA).
Efficacy: To assess the efficacy of the drug on an interim basis, there will be a comparison of the study groups with respect to the endpoints (mortality, duration of coma, ICP-TIL, and neurological status indicators at one month) at the time when 12, 24, and 48 patients have been entered into the trial. Comparisons at these interim points which exceed a z-score of 2.782 (associated p-value of 0.0054) will be considered significant, using the O'Brien-Fleming procedure.
To determine if one treatment group does better than the other, the team's study nurses will obtain the following outcome measures: 1) ICP-TIL, 2) duration of coma, 3) in-hospital mortality, 4) Glasgow Outcome Score, 5) Disability Rating Scale, and 6) Galveston Orientation and Amnesia Test. The DSMB will monitor these outcomes by treatment group (A versus B) in order to promptly identify any between-group differences. If significant differences are noted, the code will be broken and our findings will be immediately reported to the Emory IRB, the FDA, the NINDS and DSMB.
Patient accrual plan:
We will enroll the first 100 eligible patients over a two year enrollment period.
Ethical and consent considerations:
Since our study involves treatment of patients with acute neurological impairment, they are not competent to give informed consent. We will therefore seek proxy consent from the patient's family or next-of-kin or legally authorized representative (LAR). If an LAR is subsequently located that objects to the study, the process will be halted and the patient's participation will be terminated. Only the IOCs, or the study coordinator, will be permitted to approach family members to request consent.
A written form that complies with the polices and procedures of Emory University's IRB has been developed and approved. This form includes the following elements: title of the protocol, the name of the PI, study objectives and purpose, a detailed description of the procedure and interventions, explanation of the responsibilities of the subject and of the family member(s) who act as proxy respondents during follow-up interviews, any and all foreseeable risks, anticipated benefits, available alternatives, an explicit statement of confidentiality, non-compensation for participation, the right to withdraw at any time, a signature section, and a number to contact the PI or a member of the study team with any questions.
Given the sudden, unanticipated nature of traumatic brain injury, and the potential time delays involved in getting a family member to the hospital, we have been authorized by the IRB to obtain proxy consent for participation over the telephone. When this is necessary, the on-call investigator will contact the family member, provide a brief explanation of the situation, read the consent form verbatim, and request verbal consent over the telephone. A third party will listen in to confirm that the family member understands and has provided proxy consent. On the signature line of the form, the witness will print the name of the consenting proxy, write their own name immediately below this name, note the time and date of the telephone call, and check a box labeled 'telephone consent'.
Before recruiting the first patient in this study, we will undertake a comprehensive process to notify and consult the target communities that use GMH as their trauma center. The Emory University News and Information office has pledged its support. On the advice of Emory Healthcare marketing, we have allocated $40,000 to support marketing and community outreach activity during the first 6 months of the study. Lesser amounts have been allocated to keep the community informed in years 2 and 3. An independent interdisciplinary Safety Committee has been created to provide additional monitoring for study safety.
In addition to designating a Safety Committee, we will convene an independent citizen advisory committee. Two influential Atlantans have agreed to co-chair this group. One is Rev. Gerald Durley, Pastor of Providence Missionary Baptist Church, one of Atlanta's largest African-American congregations. Rev. Durley is also a key member of Concerned Black Clergy, a local activist group. The other co-chair is Sandy Teepen, a TBI survivor, safety advocate, and wife of a national newspaper columnist and former editorial page editor for the Atlanta Constitution, the largest circulation newspaper in the Southeastern United States.
Progesterone has been used for many years to treat a variety of medical conditions. Side effects ascribed to its use alone are minimal. Minor adverse reactions include temperature elevations of 1 degree Fahrenheit, mood changes (depression following drug withdrawal), vaginal, cervical and uterine lining changes, irregular vaginal bleeding or amenorrhea, hyperventilation, mild fluid retention, a transient increase in low density lipoprotein (LDL), a transient decrease in high density lipoprotein (HDL), interference with lactation during breast feeding, nausea, abdominal cramping, dizziness, headaches, breast pain, and a delay in fertility. Most of these effects are associated with prolonged administration of progesterone (i.e., weeks to months). They are unlikely to be experienced during short-course administration (i.e., 3 days).
Throughout the pilot trial, subjects will be monitored for potential side effects of drug therapy (i.e. hyperglycemia, hypertension unexplained by increases in ICP, unexplained fever, local phlebitis, thromboembolic disease, abnormal vaginal bleeding). The Safety Committee will meet quarterly to review group-specific clinical outcomes and side effects. If they are concerned that one group is doing significantly better (or worse) than the other, they have the authority to break the code and order premature termination of the trial.
Participating pharmaceutical or device manufacturing company: None
Proposed sponsor or funding agencies: NINDS NIH
Significance of the Research and Impact on Medical Care: If the therapeutic benefits observed in animals are replicated in humans, administration of intravenous progesterone should produce several benefits, including: a) reduction of intracerebral pressure; b) decreased duration of coma; c) decreased mortality; and d) improved neurological function at one month post-injury. If these findings are verified, it will represent a major advance in the treatment of traumatic brain injury.
#Intervention
- DRUG : IV Progesterone
|
#Eligibility Criteria:
Inclusion Criteria:
* Blunt head trauma occuring within 11 hours
* Ages 18 years and older (or Tanner Score of 5)
* Index GCS between 4 and 12
Exclusion Criteria:
* Spinal cord injury
* Penetrating head trauma
* Cardiopulmonary arrest upon ECC arrival
* Status Epilepticus upon ECC arrival
* Systolic BP < 90mmHG upon ECC arrival
* Pulse Ox of < 90 (or pO2 < 60)
* Prisoners or incarcerated individuals
* Past Hx of significant intercranial pathology
* Pregnant females
* Blood alcohol level > 250 mg/dl
* Non-English speakers (a Spanish version of the ICF is currently being developed)
* Allergy(s) to soy, egg, or progesterone
* Active breast or reproductive organ cancer(s)
* Previous head injury or stroke within the past 6 weeks
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00048646
|
{
"brief_title": "Progesterone Treatment of Blunt Traumatic Brain Injury",
"conditions": [
"Traumatic Brain Injury"
],
"interventions": [
"Drug: IV Progesterone"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00048646",
"official_title": "ProTECT: Single Center, Phase II (Pilot), Double Blind, 4:1 Randomized, Placebo Controlled Clinical Trial for Progesterone Treatment of Moderate and Severe Blunt TBI",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-09",
"study_completion_date(actual)": "2005-09",
"study_start_date(actual)": "2002-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "QUADRUPLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-09-19",
"last_updated_that_met_qc_criteria": "2002-11-05",
"last_verified": "2014-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2002-11-06",
"first_submitted": "2002-11-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients with critical limb ischaemia (CLI) are at risk of losing their limb and/or life and therefore have no option but to undergo bypass or amputation surgery. This presents a major physical challenge to the body and patients with low fitness will struggle to overcome the effects of the surgical trauma. Currently there is a high risk of a poorer outcome for CLI patients than with most other surgical procedures, as demonstrated by high rates of complications (20-46%) and 30 day mortality (7.5-13.5%). Up to 30% of people will die within the first year. Exercise and respiratory muscle training, before surgery, has shown a reduction in complications in other surgical specialties.
Around 50% of CLI patients present as an emergency, meaning training before admission is not feasible, so the Investigator proposes to see if training during the hospital stay will aid a better recovery. However, as this has not been done in vascular surgical patients the investigator needs to initially test if this intervention is possible in this patient group in an acute hospital setting.The aim of this proof of concept single cohort study is to assess whether an exercise intervention, started on hospital admission and continued post-surgery, for the duration of the hospital admission, is safe, acceptable, well tolerated and feasible to run in an acute ward setting.
The exercise regime will include daily upper limb aerobic (hand bike) and inspiratory muscle training (POWERbreathe) and upper body strength training every second day until discharge. The Investigator will assess safety by recording adverse events and acceptability by adherence to exercise programme and qualitative interviews. The Investigator will evaluate processes and completeness of data collection and describe before and after measures of physical fitness.
#Intervention
- OTHER : Exercise
- The exercise regime will include daily upper limb aerobic (hand bike) and inspiratory muscle training (POWERbreathe) and upper body strength training every second day until discharge.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years or over
* Willing to participate and able to give written informed consent
* Clinical diagnosis of critical limb ischaemia or Fontaine Class III-IV or Rutherford Class 4 <= age <= 6
* Admitted to the vascular surgical ward for lower limb surgery
Exclusion Criteria:
* Patients presenting who have diabetes are presenting with acute limb ischaemia with no history of PAD
* Cognitive Impairment as demonstrated by not being able to safely follow instructions.
* Unable to understand or read English
* Absolute contraindications to exercise including:-
* Acute MI
* Ongoing unstable angina
* Uncontrolled cardiac arrhythmia with hemodynamic compromise
* Active endocarditis
* Symptomatic severe aortic stenosis
* Decompensated heart failure
* Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
* Acute myocarditis or pericarditis
* Acute aortic dissection
* Physical disability that precludes safe and adequate exercise as determined by the clinical team
* Contraindications to IMT including:-
* A history of spontaneous pneumothrorax (ie not due to traumatic injury)
* A pneumothorax due to traumatic injury that has not fully healed
* A burst eardrum that has not fully healed or any other condition of the eardrum
* Unstable asthma and abnormally low perception of dyspnoea
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04043078
|
{
"brief_title": "Exercise In Critical Limb Ischaemia Patients Having Surgery Proof of Concept",
"conditions": [
"Critical Limb Ischemia"
],
"interventions": [
"Other: Exercise"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04043078",
"official_title": "Exercise In Critical Limb Ischaemia Patients Having Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-07-31",
"study_completion_date(actual)": "2020-07-31",
"study_start_date(actual)": "2019-08-03"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-08-31",
"last_updated_that_met_qc_criteria": "2019-08-01",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-08-02",
"first_submitted": "2019-07-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main purpose of this study is to find out if scanning the foot using a 3D scanner influences the effectiveness of custom made insoles, compared to the more traditional approach of taking a foam-box impression cast of the foot. Both of these methods are currently used as standard care in the NHS Greater Glasgow and Clyde (GGC) Orthotic Department. In this study, insoles will be manufactured either from a direct 3D scan of the foot, or from a foam-box impression cast, and a series of questionnaires will be used to measure any changes in foot pain and foot function. The results from this study will be used to develop an information resource for both patients and Orthotists which will fill gaps in our current knowledge and hopefully guide us further in providing the best possible care for future patients who require insoles.
Detailed Description
A single centre, double blinded, randomised controlled trial. Interventional, equivalence Trial design.
Participants will be asked to attend 2 face-to-face appointments for assessing and fitting of insoles, which is standard practice in the NHS GGC Orthotic Department. Each face-to-face appointment will take approximately 40 minutes. Following the fitting of the insoles, participants will be asked to participate in 3 telephone calls over 12-weeks, during which they will be asked to answer questions from two questionnaires (the 'Foot Health Status Questionnaire', and the 'Orthotic and Prosthetic User Survey'). Each telephone appointment will take approximately 15 minutes. Once participants receive their insoles, they will also be asked to keep a diary detailing the number of hours that they wore the insoles each day over 12-weeks. This information will be collected by the Orthotist involved with the trial during the telephone review appointments.
#Intervention
- DEVICE : CAD/CAM insoles
- computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
#Eligibility Criteria:
Inclusion Criteria:
* Are aged 18 years or above
* Are referred to the NHS GGC Orthotic service requiring a new assessment for insoles
* are deemed suitable for CAD/CAM insoles as assessed by the PI or Co-I on clinical assessment
* Are able to commit to five appointments over a 16-week period (two Face-to-Face appointments, three Telephone Appointments)
* Have suitable own footwear that can accommodate a CAD/CAM insole as assessed by the PI or Co-I, and as per standard practice can wear these for 12-weeks
* Is willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
* An adequate understanding of written and verbal information in English in order to provide informed consent and answer the study questionnaires
Exclusion Criteria:
* Scheduled elective surgery or other procedures which is likely to affect mobility during the trial.
* Scheduled steroid injection of the foot or ankle up to 3 months prior to joining the trial, or during participation in the trial
* Age <18 years
* Adult with Incapacity, under The Adults with Incapacity (Scotland) Act 2000
* Participant unable or unwilling to consent
* Medial longitudinal Arch height of the foot exceeds depth of EVA blank (35mm)
* Clinical assessment concludes that the participant requires an insole material other than EVA
* Clinical assessment concludes that the participant does not require or will be unlikely to benefit from CAD/CAM insoles.
* The participant is unable to commit to the trial conditions.
* Peripheral Neuropathy present
* Active foot ulceration present
* Participant with life expectancy of less than 6 months.
* Any other significant disease or disorder which, in the opinion of the PI or Co-I, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Participants who have participated in another research trial involving an investigational foot orthosis in the past 12 weeks.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05444192
|
{
"brief_title": "Comparing Clinical Outcomes Using Two Insole Manufacture Techniques",
"conditions": [
"Foot Injury",
"Foot Deformity",
"Foot Sprain",
"Feet, Flat",
"Foot Ankle Injuries"
],
"interventions": [
"Device: CAD/CAM insoles"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05444192",
"official_title": "Comparing the Effectiveness of Computer-aided-design Computer-aided-manufacture (CAD/CAM) Insoles Manufactured From Foam-box Cast vs Direct Scan on Patient Reported Outcome Measures: A Double-blinded, Randomised Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-24",
"study_completion_date(actual)": "2023-11-24",
"study_start_date(actual)": "2022-09-29"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-16",
"last_updated_that_met_qc_criteria": "2022-06-30",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-05",
"first_submitted": "2022-06-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of nasal glucagon (AMG504-1) in treating episodes of hypoglycemia. The population will be enriched to include participants who suffer from impaired hypoglycemia awareness.
Detailed Description
This study is designed to evaluate the effectiveness of nasal glucagon (NG) administered under clinical use conditions in treating episodes of hypoglycemia in persons with T1D.
This study also aims to assess the ease with which caregivers can administer the experimental medication in treatment of hypoglycemic events.
The study will also generate data on the participants' assessment of local tolerability and provide information on immunogenicity of nasal glucagon with regards to the potential development of anti-glucagon antibodies.
#Intervention
- DRUG : Nasal Glucagon
- 3 mg nasal glucagon powder
- Other Names :
- Dry-Mist Nasal Glucagon, AMG504-1, LY900018
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or Female Person with diabetes (PWD) lives with or is in frequent contact with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia
* With a history of type 1 diabetes >1 year
* At least 18 years but not older than 75 years
* Body mass index (BMI) greater than or equal to 18.50 and below 35.00 kg/m2.
* PWD will be otherwise healthy according to medical history, general physical examination (including vital signs), nasal examination, and laboratory tests (biochemistry, hematology, and urinalysis).
* For female subjects, a urine pregnancy test must be negative.
Exclusion Criteria:
* Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
* Use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02171130
|
{
"brief_title": "Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia",
"conditions": [
"Hypoglycemia",
"Diabetes Mellitus",
"Drug-Specific Antibodies"
],
"interventions": [
"Drug: Nasal Glucagon"
],
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT02171130",
"official_title": "A Multiple Center, Open Label, Prospective, Observational Study to Evaluate the Effectiveness and Ease-of-Use of AMG504-1 Administered in the Home or Work Environments for Treating Episodes of Hypoglycemia in Patients With Type 1 Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-08",
"study_completion_date(actual)": "2015-08",
"study_start_date(actual)": "2014-05"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-15",
"last_updated_that_met_qc_criteria": "2014-06-20",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-06-24",
"first_submitted": "2014-06-12",
"first_submitted_that_met_qc_criteria": "2019-09-27"
}
}
}
|
#Study Description
Brief Summary
More adolescents and young adults are surviving cancer than ever before. Many endure negative effects related to their cancer and its treatment, which reduces their quality of life and functioning. Physical activity is one strategy that has been shown to promote quality of life amongst cancer survivors. However, very little research has focused on adolescent and young adult cancer survivors. Therefore, the purpose of this pilot randomized controlled trial is to explore the feasibility, safety, and potential benefits of a 12-week home-based physical activity intervention in adolescent and young adult cancer survivors.
#Intervention
- BEHAVIORAL : Physical Activity
- Participants will receive a 12-week home-based physical activity program that has been individualized using their baseline assessment results. The program will be comprised of aerobic training (2 days/week) and resistance training (2 days/week). The aerobic training will be performed unsupervised. The resistance training will be performed under the supervision of a study team member (who will visit participants homes) for the first 6 weeks to ensure proper form and safety.
|
#Eligibility Criteria:
INCLUSION CRITERIA:
* Have been diagnosed with cancer for the first time between the ages of 15 and 39 years;
* Have completed cancer treatment within 5 years;
* Currently between the ages of 15 <= age <= 44;
* Have no current evidence of progressive disease, secondary cancer (i.e., cancer cells that have spread from the primary cancer), or second cancers (i.e., a new different cancer);
* Live within 100 km of the University of Ottawa;
* Be inactive or insufficiently active as determined by a single item screening question (i.e., participants must respond 'no' to the following question: are you currently engaging in moderate physical activity, defined as activity that increases your heart rate and causes you to sweat, on 3 or more days a week?). Screening participants based on their level of physical activity will ensure only those individuals for whom the intervention will have the largest effect are recruited;
* Able to read, understand, and provide informed consent in English;
* Ready for physical activity as indicated by answering Physical Activity Readiness Questions (PAR-Q). If participants are not ready for physical activity as determined by the PAR-Q they will need to complete a Physical Activity Readiness Medical Examination Form.
EXCLUSION CRITERIA:
* Physical impairments precluding participation in physical activity;
* Unwilling or unable to sign the Participant Informed Consent Form;
* Received a diagnosis of brain cancer or thyroid cancer. Brain cancer survivors will be excluded as a function of the cognitive impairments associated with their diagnosis and treatment and thyroid cancer survivors will be excluded due to the vastly different treatment regimens. That is, both of these cancers may result in different physical, psychological/emotional, and social effects that could impact the outcomes of interest.
Eligible participants who want to participate in the other pre-specified outcome measures to assess cognitive functioning must also meet the following additional inclusion/exclusion criteria.
ADDITIONAL INCLUSION CRITERIA:
* Right-handedness, because language is lateralized and has been shown to be left side dominant (for right handers) during fMRI tasks;
* Able to read, understand, and provide informed consent in English for the additional assessments.
ADDITIONAL EXCLUSION CRITERIA:
* Metal implants (e.g., pacemaker) or metal dental work (aside from fillings) that would preclude scanning;
* Claustrophobia;
* Poor eyesight (not correctable with contact lenses) that precludes viewing stimuli presented in the scanner;
* Lower back pain that would preclude a person from lying relatively still for one hour;
* Substance use disorder as assessed by a single item question (i.e., participants must respond 'no' to the following question: Have you been told, in the last five years, by your healthcare provider that you have a substance use disorder?).
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Maximum Age : 44 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03016728
|
{
"brief_title": "Physical Activity for Adolescent and Young Adult Cancer Survivors",
"conditions": [
"Adolescent and Young Adult Cancer Survivors"
],
"interventions": [
"Behavioral: Physical Activity"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03016728",
"official_title": "Exploring the Feasibility, Safety, and Potential Benefits of a 12-week Home-based Physical Activity Intervention",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-16",
"study_completion_date(actual)": "2019-05-05",
"study_start_date(actual)": "2017-09-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-31",
"last_updated_that_met_qc_criteria": "2017-01-06",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-01-11",
"first_submitted": "2016-12-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To understand how AKI (Acute Kidney Injury) leads to chronic kidney disease so therapies can be found to alter the progression of events thereby significantly impacting the long-term outcomes of children who develop AKI.
Detailed Description
This research study is designed to study what happens to the kidneys after they have an injury. There is some evidence that even if there appears to be great improvement of kidney function, an injury can put patients at risk for long-term problems with their kidney function and increase their risk to have high blood pressure. We want to collect information from participants to help explain why this injury can cause future problems, including Chronic Kidney Disease (CKD) which may help us prevent these health problems.
|
#Eligibility Criteria:
Inclusion Criteria:
* Children between age 2 <= age <= 20
* Decrease in renal function by 25% or greater
* Renal function has returned to normal
Exclusion Criteria:
* History of chronic disease
* Cancer
* Congenital heart disease
* Organ Transplantation
* Liver disease
* Pulmonary disease
* Diabetes other primary metabolic condition
* Severe neurologic impairments
* Hypertension
* Auto-immune
* Infectious disease or renal disease
* Smokers
* Renal disease w/primary cause i.e. - HUS or Glomerulonephritis
* severe allergies including allergy to seafood and/or iodine
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00358306
|
{
"brief_title": "The Role of Endothelium Dysfunction in Progression of CKD (Chronic Kidney Disease) After AKI (Acute Kidney Injury)",
"conditions": [
"Acute Renal Failure",
"Chronic Kidney Failure",
"Endothelial Dysfunction",
"Hemolytic-uremic Syndrome (HUS)"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00358306",
"official_title": "The Role of Endothelium Dysfunction in Progression of CKD (Chronic Kidney Disease) After AKI (Acute Kidney Injury)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-07",
"study_completion_date(actual)": "2009-07",
"study_start_date(actual)": "2008-04"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-05-14",
"last_updated_that_met_qc_criteria": "2006-07-28",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-07-31",
"first_submitted": "2006-07-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Use of the Chartis® Assessment System prior to EBV Treatment
Detailed Description
This is a multi-center study which will enroll up to 120 patients. Subjects will undergo a Chartis Assessment prior to EBV treatment. The Chartis assessment will determine the presence or absence of collateral ventilation, a potential determining factor in the success of EBV therapy. This study is not randomized; all subjects are eligible to receive EBV Treatment, regardless of Chartis Assessment outcome. Follow-up data will only be collected on those patients that meet the Chartis inclusion criteria.
#Intervention
- DEVICE : Chartis System
- The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways.
- DEVICE : Endobronchial Valve (EBV) Treatment
- The endobronchial valve is designed to induce target lobe volume reduction.
|
#Eligibility Criteria:
Inclusion Criteria:
* Heterogeneous emphysema
* Able to obtain a Chartis value during Assessment
Exclusion Criteria:
* Any co-existing major medical problems that would not make it possible for the subject to tolerate a bronchoscopic procedure.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01101958
|
{
"brief_title": "A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR)",
"conditions": [
"Emphysema"
],
"interventions": [
"Device: Endobronchial Valve (EBV) Treatment",
"Device: Chartis System"
],
"location_countries": [
"Germany",
"Netherlands"
],
"nct_id": "NCT01101958",
"official_title": "A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR) in Subjects With Heterogeneous Emphysema",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-03",
"study_completion_date(actual)": "2013-03",
"study_start_date(actual)": "2012-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-12",
"last_updated_that_met_qc_criteria": "2010-04-08",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-04-12",
"first_submitted": "2010-04-08",
"first_submitted_that_met_qc_criteria": "2013-12-04"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is:
To determine the rate and routes of excretion of BIA 3-202 and the mass balance in urine and faeces To determine the kinetics of total radioactivity in blood To determine the kinetics of total radioactivity in plasma To determine the kinetics of BIA 3-202 and its metabolites in plasma
Detailed Description
Monocentre, open, non-placebo-controlled, single-group, single-dose study. Safety measurements (12-lead ECG, vital signs, blood chemistry and haematology) were conducted before and after the study, adverse events were monitored throughout the study.
Each subject was to receive a single oral dose of 2.5 MBq \[14C\]-labelled BIA 3-202 (200 mg). This was the intended radiolabelled dose without any losses; the actual administered dose was of 2.29 MBq \[14C\]-labelled BIA 3-202 (200 mg). Subjects were hospitalized the day before the administration until 264 hours thereafter.
Whole blood samples (2 mL) for total radioactivity analysis, plasma samples (1.5 mL) for total radioactivity analysis, and plasma samples (7 mL) for analysis of BIA 3-202 and its metabolites were collected at the following times: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose.
Urine was sampled before the drug administration (pre-dose), then it was collected from 0-4, 4-8, 8-24, 24-48, 48-72, 72-120, 120-168, 168-216, and 216-264 hours post-dose.
Aliquots of each sample were taken for liquid scintillation counting by the investigator.
Aliquots were separated for determination of parent drug and metabolite patterns.
A baseline faeces sample was obtained during the screening or baseline period. Following dose, each faeces sample was collected in a separate container during the 264 hours post-dose period.
Vomitus (if produced) was collected.
#Intervention
- DRUG : BIA 3-202 (200 mg)
- 200 mg powder for oral use of unlabelled BIA 3-202
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male subject, 40 <= age <= 55 years. Take only Caucasians.
* Clinically acceptable sitting blood pressure and pulse rate , i.e.: BP: 110 <= age <= 160 mmHg systolic, 65 <= age <= 95 mmHg diastolic and pulse rate: 50 <= age <= 100 bpm. Blood pressure and pulse will be measured after 3 minutes resting in a sitting position.
* Subject body weight must be between 50 and 95 kg and within -10% / +20% of normal for their height and frame size (according to Metropolitan Life Insurance Table, see Appendix 1&2 of the Study Protocol). Frame size will be determined using elbow breadth measurement.
* Normal 12-lead ECG.
* Ability to communicate well with the investigator and comply with the requirements of the entire study.
* The subject has given his written informed consent to participate in the study.
Exclusion Criteria:
* History of serious adverse reactions or hypersensitivity to any drug.
* Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
* History of alcohol or drug abuse in the last 5 years.
* Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
* Need of any prescription medication within 14 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug.
* Participation in other clinical trials during the previous month in which an investigational drug or a commercially available drug was tested.
* Loss of 500 mL blood or more during the 3 month period before the study, e.g., as a donor.
* Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e., impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.
* Symptoms of a significant somatic or mental illness in the 4 week period preceding drug administration.
* History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
* Positive results from the HIV serology.
* Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation, however, liver parameters (SGPT, SGOT) and CK values must be within the normal range.
* Positive results of the drug screening.
* Known hypersensitivity to BIA 3 <= age <= 202.
* Heavy smokers, i.e., more than 10 cigarettes per day.
* Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray investigation).
* Subject who had more than 4 flights (with more than 2 hours flight time) within the last year prior to the administration of the drug.
Sex :
MALE
Ages :
- Minimum Age : 40 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02772614
|
{
"brief_title": "Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites",
"conditions": [
"Parkinson's Disease"
],
"interventions": [
"Drug: BIA 3-202 (200 mg)"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT02772614",
"official_title": "An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites Following a Single-dose Oral Administration",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-02",
"study_completion_date(actual)": "2006-02",
"study_start_date(actual)": "2006-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-05-13",
"last_updated_that_met_qc_criteria": "2016-05-12",
"last_verified": "2016-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-05-13",
"first_submitted": "2016-05-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The long-term goal of this research is to increase breast cancer screening rates in NYC Chinese immigrants. The researchers plan to accomplish this objective by developing and testing a culturally- and linguistically-adapted Witness Project program for Chinese immigrants. To inform the intervention development, the study team will identify barriers and facilitators to breast cancer screening in Chinese immigrants through individual qualitative interviews.
A total of 156 participants will be recruited during the entire study.
In Aim 1 which started in July 2021, 60 women were recruited for in-depth interviews to assess their breast cancer knowledge, perceived barriers and benefits/risks to completing mammography, perceived susceptibility to breast cancer, fatalism, screening intention, acculturation, language preference, and health literacy.
In Aim 2, 96 women will be recruited to participate in the pilot testing of the intervention. Recruitment will take place at community sites that serve Chinese immigrants in New York City. Enrollment for Aim 2 is anticipated to start in March of 2022.
#Intervention
- BEHAVIORAL : Narrative breast health education
- Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community
|
#Eligibility Criteria:
Inclusion Criteria:
* >= 40 years
* female
* born in China
* read and speak Cantonese, Mandarin, or English
Exclusion Criteria:
* none
Sex :
FEMALE
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05089292
|
{
"brief_title": "Increasing Breast Cancer Screening in Chinese Immigrants",
"conditions": [
"Screening Mammogram"
],
"interventions": [
"Behavioral: Narrative breast health education"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05089292",
"official_title": "Increasing Breast Cancer Screening in Chinese Immigrants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-13",
"study_completion_date(actual)": "2022-12-13",
"study_start_date(actual)": "2021-07-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-10",
"last_updated_that_met_qc_criteria": "2021-10-15",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-10-22",
"first_submitted": "2021-10-15",
"first_submitted_that_met_qc_criteria": "2024-06-06"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if the use of breast MRI in detecting breast malignancies in survivors of Hodgkin's disease is more successful than the traditional mammogram.
Detailed Description
* The screening breast MRI and mammography will be performed 6 months or longer after the last mammogram. For pre-menopausal women, the screening will be performed during the second week of the menstrual cycle to reduce cycle-related breast changes. As much as possible, the breast MRI and mammogram are to be performed on the same day.
* On the day of the breast imaging studies, the patient will also be asked to fill out a baseline breast health questionnaire, which includes questions on time since radiation therapy, prior screening history, history of prior benign breast biopsies, menopausal status, prior hormonal therapy use, etc.
* In patients with suspicious findings or findings highly suggestive of malignancy, the abnormal findings will be reviewed with the patient and recommendations will be made for a biopsy.
#Intervention
- PROCEDURE : breast MRI
- Repeated once a year for three years
- PROCEDURE : Mammogram
- Repeated once a year for three years
|
#Eligibility Criteria:
Inclusion Criteria:
* Female patients treated with radiation therapy to the chest area for Hodgkin's disease
* Age between 12 and 35 at initial treatment
* Eight years or longer after initial treatment
* Pre-approval from the participant's insurance company for the breast imaging studies
Exclusion Criteria:
* Pregnant or lactating women
* Post Bilateral mastectomy
* Currently undergoing breast cancer therapy
* Known metastatic cancer
* Patients with contraindications for undergoing an MRI: cardiac pacemaker, known metallic objects in body e.g. metallic clips, bullets, shrapnel or buckshots.
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00165412
|
{
"brief_title": "Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease",
"conditions": [
"Breast Cancer",
"Hodgkin's Disease"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00165412",
"official_title": "Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-05",
"study_completion_date(actual)": "2010-05",
"study_start_date(actual)": "2005-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-02",
"last_updated_that_met_qc_criteria": "2005-09-09",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-14",
"first_submitted": "2005-09-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Correlation between colposcopist findings and digital cervicography employing Gynescope system
Detailed Description
Up to 30 women that will be referred for colposcopy examination at the standard indications will also undergo a colposcopy examination of the cervix by a gynescope. The physicain performing the optical test will record the findings in accordance with the International Federation for Cervical Pathology and Colposcopy (IFCPC) terminology. Categorical variable will be included in every record. At later stage, the images obtained by the cervicography will be evaluated and recorded in accordance with the IFCPC terminology. Correlation between the categorical findings in both assesments will be compared. The correlation measure will be performed by Kappa test according to the categorial result of both measurements.
#Intervention
- DIAGNOSTIC_TEST : Digital cervicography
- Colposcopist findings and digital cervicography employing Gynescope system
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients reffered for colposcopy
Exclusion Criteria:
Patient refusion
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03840187
|
{
"brief_title": "Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System",
"conditions": [
"Cervical Dysplasia"
],
"interventions": null,
"location_countries": [
"Israel"
],
"nct_id": "NCT03840187",
"official_title": "Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-15",
"study_completion_date(actual)": "2020-01-15",
"study_start_date(actual)": "2019-03-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-18",
"last_updated_that_met_qc_criteria": "2019-02-12",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-15",
"first_submitted": "2019-02-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Open-heart surgery causes injury of the heart muscle. Although this is usually mild, temporary and reversible, if it is severe it can endanger life and require additional high cost care. During surgery, techniques are used to protect the heart from injury, but these remain imperfect. This study assesses the effect of facilitating sugar metabolism (a more efficient fuel) by the heart muscle using the drug Perhexiline given before the operation. This treatment has a sound experimental basis for improving outcome. If this improvement is confirmed surgical results could be improved. The investigators will be studying heart function, heart muscle energy stores and chemicals which quantify the amount of heart muscle injury. The investigators' hypothesis is that Perhexiline will improve the protection of the heart by decreasing damage that may occur during heart surgery.
#Intervention
- DRUG : Perhexiline
- Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
- Other Names :
- PEXSIG
- DRUG : Placebo marked PEXSIG
- Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult
* First-time
* Isolated coronary artery bypass surgery
Exclusion Criteria:
* Diabetes Mellitus
* Renal impairment with Creatinine greater than or equal to 200micromol/L
* Atrial fibrillation
* Amiodarone therapy, recent (in last month) or current
* Hepatic impairment, significant preoperative
* Peripheral neuropathy
* Pregnancy or breast-feeding
* Emergency surgery or required on clinical grounds within 5 days of referral
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00845364
|
{
"brief_title": "Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery",
"conditions": [
"Myocardial Reperfusion Injury",
"Cardiac Output, Low"
],
"interventions": [
"Drug: Placebo marked PEXSIG",
"Drug: Perhexiline"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00845364",
"official_title": "Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-04",
"study_completion_date(actual)": "2010-04",
"study_start_date(actual)": "2007-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-05-20",
"last_updated_that_met_qc_criteria": "2009-02-17",
"last_verified": "2010-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-02-18",
"first_submitted": "2009-02-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a randomized, double-blind, vehicle-controlled, parallel group dose response study evaluating the safety and effectiveness of 2 concentrations of NFX-179 Gel in subjects with cutaneous neurofibromas. At Visit 1, the investigator will identify 10 Target cNFs that fulfil the enrollment criteria. The Target cNFs must be located on the subject's face, anterior trunk, or upper extremities. Two Target cNFs must be on the face and 8 must be on the anterior trunk or upper extremities. The study medication will be applied topically QD to the Target cNFs for 182days (26 weeks). During the duration of the study subjects will be evaluated for safety and efficacy.
#Intervention
- DRUG : NFX-179 gel
- NFX-179 topical gel is the active investigational product being studied
- Other Names :
- NFX-179 topical gel
- DRUG : Vehicle gel
- NFX-179 vehicle gel is the placebo comparator for this study
- Other Names :
- NFX-179 vehicle gel
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is at least 18 years
* Subject must provide written informed consent prior to any study procedures
* Subject must have a clinical diagnosis of NF1
* Subject has 10 clinically diagnosed Target cNFs with preferably 2 Target cNFs located on the face and 8 Target cNFs located on the anterior trunk or upper extremities. Alternatively, at least 1 Target cNF is located on the face, in which case 9 Target cNFs must be located on the anterior trunk or upper extremities. Each Target cNF must meet the following criteria:
* Has, in the investigator's opinion, a clinically typical appearance
* Is not within 1 cm of the orbital rim
* Is not covered with hair that might, in the investigator's opinion, interfere with obtaining photographs or impair evaluation of the cNF
* Has a Physician's Tumor Assessment grade >=2
* Is dome shaped
* Is not pedunculated
* Is a discrete cNF surrounded by sufficient non-affected skin that, in the investigator's opinion:
* The dimensions can be measured
* The perimeter can be outlined in the study photographs
* Is not irritated (e.g., bleeding, inflamed)
* Is not in an area subject to repeated trauma (e.g., area that is shaved, on the beltline, under a bra strap, etc.)
* Does not have an active cutaneous infection
* Target cNFs on the face must have the following tumor dimensions:
* Has a length that is >=5mm and <=14mm
* Has a width that is >=5mm and <=14mm
* Has a height that is >=2mm.
* Target cNFs on the anterior trunk or upper extremities must have the following tumor dimensions:
* Has a length that is >=7mm and <=14mm
* Has a width that is >=5mm and <=14mm
* Has a height that is >=2mm.
* Subject agrees to avoid exposure of Target cNFs to excessive sunlight and to use her/his routine sunscreen if excessive exposure cannot be avoided
* Subject agrees NOT to use tanning beds
* Subject is willing to forego treatment of each Target cNF, except protocol specified therapy, during the study
* Female subjects who are women of childbearing potential must have a negative urine pregnancy test result and be willing to use a protocol approved, contraceptive method for the duration of the study
* Subject is willing and able to follow all study instructions and to attend all study visits.
Exclusion Criteria:
* Subject has used any of the following topical therapies within the specified period prior to Visit 1 on or in proximity to any Target cNF that, in the investigator's opinion, impairs evaluation of any the cNFs or which exposes the subject to an unacceptable risk by study participation:
* Corticosteroids; 30 days
* Prescription retinoids (e.g., tazarotene, tretinoin, adapalene); 30 days
* > 5% of an alpha-hydroxy acid (e.g., glycolic acid, lactic acid); 30 days
* Fluorouracil; 30 days
* Imiquimod; 30 days
* LASER, light (e.g., intense pulsed light [IPL], photo-dynamic therapy [PDT]) or other energy-based therapy; 180 days
* MEK inhibitor or BRAF inhibitor; ever.
* The subject has used any of the following systemic medications therapies within the specified period prior to Visit 1:
* Retinoids (e.g., etretinate, isotretinoin); 90 days
* MEK inhibitors; 180 days
* BRAF inhibitors; 180 days
* Subject has a history of hypersensitivity to any of the ingredients in the study medications
* Subject has any known intercurrent illness or physical condition that would, in the investigator's opinion, impair evaluation of a Target cNF or which exposes the subject to an unacceptable risk by study participation
* Subject has, in the investigator's opinion, clinically relevant history of liver disease, including viral hepatitis, current alcohol abuse, or cirrhosis
* Subject has a history of metastatic disease, or active cancer (excluding nonmelanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or Stage 0 chronic lymphocytic lymphoma) within the previous 5 years
* Subject has any condition (e.g., other skin conditions or diseases, metabolic dysfunction, physical examination findings, clinical laboratory findings) or situation (e.g., vacation, scheduled surgery) that would, in the investigator's opinion, impair evaluation of a Target cNF or which exposes the subject to an unacceptable risk by study participation
* Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within the previous 30 days
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05005845
|
{
"brief_title": "NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)",
"conditions": [
"Cutaneous Neurofibroma",
"Neurofibromatosis 1"
],
"interventions": [
"Drug: NFX-179 gel",
"Drug: Vehicle gel"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05005845",
"official_title": "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Phase 2 Dose-Response Study to Determine Safety and Effectiveness of Two Concentrations of NFX-179 Gel in Subjects With Cutaneous Neurofibromas",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-04",
"study_completion_date(actual)": "2023-10-04",
"study_start_date(actual)": "2021-09-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-18",
"last_updated_that_met_qc_criteria": "2021-08-11",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-16",
"first_submitted": "2021-08-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Lipedema which causes excessive accumulation of fat in the subcutaneous tissue, is a rare, progressive disease. This disease generally affects women, following puberty or early adulthood and usually results in the slow increase of the circumference of the legs and/or arms, bilaterally. In a typical presentation of lipedema, the enlargement of the lower extremities is disproportionately greater than that of the trunk and upper extremities When first described in 1940, lipedema was thought to exclusively affect the lower extremities. However, as the disease has been recognized over the years, lipedema has been reported to affect the upper extremities. Upper extremity lipedema, with no involvement of the lower extremities is an extremely rare incident.
Detailed Description
Due to the hypertrophy in adipose tissue, the link between lymphatic dysfunction and the progression to lipo-lymphedema, lipedema is conservatively treated with physiotherapy, manual lymph drainage and compression, also known as complex decongestive physiotherapy. Furthermore, the consensus of the International Society of Lymphology has stated that intermittent pneumatic compression is an optional treatment which may be applied as an adjuvant therapy to complex decongestive physiotherapy. All participants included in the study were included in a treatment protocol consisting of complex decongestive physiotherapy and intermittent pneumatic compression. The Perometer was used in the measurement of upper extremity volume and circumference before and after treatment.
#Intervention
- PROCEDURE : Complex decongestive physiotherapy
- Each patient received a treatment protocol of Complex decongestive physiotherapy for 5 days a week until they were discharged from the clinic. All patients fully completed all components of the treatment routine daily. The treatment was performed by a physiotherapist who was certified with Manual Lymph Drainage Combined Decongestive Physiotherapy. After the daily treatment protocol was completed, patients wore standard or individually sized compression grade II or III medical compression stockings for the rest of the day.
|
#Eligibility Criteria:
Inclusion Criteria:
* being between the ages of 18 <= age <= 65,
* having a diagnosis of upper extremity lipedema
* being willing to participate in the study
Exclusion Criteria:
* accompanying diagnosis of lymphedema,
* deep vein thrombosis
* disease which causes edema in the upper extremities
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04643392
|
{
"brief_title": "Physiotherapy Applications in Upper Extremity Lipedema",
"conditions": [
"Lipedema"
],
"interventions": [
"Procedure: Complex decongestive physiotherapy"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04643392",
"official_title": "The Effects of Complex Decongestive Physiotherapy Applications on Upper Extremity Circumference and Volume in Patients With Lipedema",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-03",
"study_completion_date(actual)": "2020-05-04",
"study_start_date(actual)": "2019-09-02"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-25",
"last_updated_that_met_qc_criteria": "2020-11-18",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-11-25",
"first_submitted": "2020-11-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this study, the effect of nurse-led empowerment training given to patients with Type 2 Diabetes on clinical findings and empowerment behaviors will be investigated.
Detailed Description
The research is a randomized controlled design research that includes a pre-test/post-test design. The primary outcome expected in the research; change in empowerment behaviors as a result of the training given; secondary outcomes are changes in clinical findings.
The research universe; All Type 2 diabetes patients who applied to the endocrinology polyclinic of a private hospital in Eskisehir city center between March-July 2019 consisted of. In the study, the sample was randomly selected, and it was aimed to reach all patients with Type 2 diabetes who were 18 years of age and older, with a diagnosis period of one year or more.
In the study, patients were randomly assigned to the intervention group, which included 6 weeks of training, or to the control group, which was on a 6-week waiting list. It used a question-based format to address the educational, behavioral, and psychosocial needs of patients within the scope of a 12-hour empowerment program that lasted for 6 weeks, 2 hours a week.
Education (DSMS (Developing Empowerment-Based Diabetes Self-Management Support)) is planned as stated literature.
Purpose of education: Empowerment as a philosophy of care emphasizes a collaborative approach to facilitating behavior change for patients themselves. Empowerment approach; Goal setting is a five-step process that provides patients with the knowledge and clarity they need to develop and achieve their diabetes and lifestyle goals. The first two steps are to identify the problem and identify patients' beliefs, thoughts, and feelings that may support or hinder their efforts. The third step is to determine the long-term goals expected from patients. In this step, patients are then expected to make a behavioral change that will help them achieve their long-term goals. The last step is for patients to evaluate their efforts and determine what they have learned in the process. Empowerment training was determined within the framework of this process.
#Intervention
- BEHAVIORAL : Diabetes self- management education (DSME) program
- We offered a two-hour course each week, comprising of two sessions of lectures (40 minutes each), two breaks (10 min each) and interactive session (20 min). In the interactive session, patients could communicate with each other in groups or raise any questions to the investigators.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with Type 2 Diabetes Mellitus diagnosed more than 1 year ago
Exclusion Criteria:
* Mental retardation
* Dementia
* Deafness
* Blindness
* Psychiatric illness
* Steroid use
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05680207
|
{
"brief_title": "Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings",
"conditions": [
"Diabetes Mellitus, Type 2",
"Empowerment",
"Patient Empowerment"
],
"interventions": [
"Behavioral: Diabetes self- management education (DSME) program"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05680207",
"official_title": "The Effect of Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-30",
"study_completion_date(actual)": "2019-08-30",
"study_start_date(actual)": "2019-03-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-11",
"last_updated_that_met_qc_criteria": "2023-01-08",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-01-11",
"first_submitted": "2022-12-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the D4325C00007 study is to identify and characterise patients with known or newly diagnosed CKD for possible participation in future renal clinical studies and to obtain an overview on current treatment choices for this patient group in different regions.
#Intervention
- PROCEDURE : assessment
- 2 ml volume of blood withdrawal
|
#Eligibility Criteria:
Inclusion criteria:
* Male or female aged >= 18 years at the time of signing the informed consent
* Express interest to participate in a future CKD clinical study
* eGFR >= 20 to < 90 mL/min/1.73 m2 (eGFRcr[AS], Section 8.2.1) (Delgado et al 2022, Inker et al. 2021)
* UACR >= 700 mg/g or UPCR >= 1000 mg/g based on urine sample at time of screening visit
* Receiving RAS inhibitor therapy (ACEi or ARB) that has been at stable dosing for at least 4 weeks. Exceptions from this requirement will be made for participants who are unable to tolerate RAS inhibitor therapy
* Provision of signed and dated written informed consent before any study-specific procedures
Exclusion criteria:
* Known NYHA class III or class IV Congestive Heart Failure at the time of enrolment
* Known T1DM
* Known history of any life-threatening cardiac dysrhythmia (continuous or paroxysmal)
* Known history of solid organ transplantation
* Known history or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2i (eg, dapagliflozin, canagliflozin, empagliflozin) or endothelin receptor antagonists (eg, ambrisentan, atrasentan, bosentan)
* Known blood-borne diseases such as specified in Appendix B (category A and B)
* Known pregnancy at the time for the visit or have an intention to become pregnant
* Lupus nephritis, anti-neutrophil cytoplasmic autoantibody vasculitis, minimal change disease, autosomal dominant polycystic kidney disease (polycystic kidney disease), Alport syndrome, patients on renal replacement therapy, or clinical nephrotic syndrome with problematic oedema
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 130 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05967806
|
{
"brief_title": "A Study to Identify and Characterise Patients With Chronic Kidney Disease and Proteinuria",
"conditions": [
"Renal Disease"
],
"interventions": null,
"location_countries": [
"India",
"Slovakia",
"Sweden",
"China",
"United States",
"Poland",
"Taiwan",
"South Africa",
"Thailand",
"Canada",
"Vietnam",
"Brazil",
"Argentina",
"Turkey"
],
"nct_id": "NCT05967806",
"official_title": "An International, Non-randomised, Non-interventional, Multicentre Study to Identify and Characterise Patients With CKD and High Proteinuria for Possible Participation in Future Renal Clinical Studies.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-30",
"study_completion_date(actual)": "2024-08-30",
"study_start_date(actual)": "2023-07-31"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-29",
"last_updated_that_met_qc_criteria": "2023-07-20",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-01",
"first_submitted": "2023-07-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This pilot study will determine the feasibility and effectiveness of implementing video plethysmography (PPG) for contactless vital signs and str5ess index measurements from surgical patients in preoperative care. Our primary objective is to determine the feasibility and validity of using video PPG to collect contactless BP, HR and RR measurements when compared medical-grade instruments. Our secondary objective is to validate the use of video PPG in measuring HRV and stress index when compared to a validated stress questionnaire.
Detailed Description
The huge impact of the COVID-19 pandemic on global healthcare systems has given rise to an increased need for virtual care. This pilot study will determine the feasibility and effectiveness of implementing video plethysmography (PPG)for contactless vital signs measurements such as blood pressure (BP), heartrate (HR), respiratory rate (RR) and heart rate variability (HRV) from surgical patients in preoperative care. We also aim to validate the use of video PPG in measuring HRV and stress index when compared to a validated stress questionnaire.
This study aims to assess how video PPG technology can be implemented in a clinical and telemedicine. If proven to be effective, this technology can be integrated into any smartphone or tablet and will allow users to monitor their vital signs with just a 1.5-minute video.
#Intervention
- DEVICE : Video PPG
- Contactless vital signs and stress measurement using video PPG technology. An iPad will be used to record a video of the participant's, which can then be converted to vital signs using a specialized algorithm.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients undergoing elective ambulatory surgery with general and/or regional anesthesia;
* >= 18 years;
* able to comprehend study instructions in English
Exclusion Criteria:
* refusal to consent for the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05165381
|
{
"brief_title": "Contactless Vital Signs Measurement",
"conditions": [
"Blood Pressure, Heart Rate, Respiratory Rate, Heart Rate Variability, Stress Index, Vital Signs Monitoring",
"Vital Signs Monitoring"
],
"interventions": [
"Device: Video PPG"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT05165381",
"official_title": "Video Plethysmography for Contactless Vital Signs Measurement: A Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-15",
"study_completion_date(actual)": "2023-12-15",
"study_start_date(actual)": "2022-02-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-12-19",
"last_updated_that_met_qc_criteria": "2021-12-10",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-12-21",
"first_submitted": "2021-12-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study is intended to explore changes in the composition and quantity of gut bacteria subject to treatment with strong pain medication. Two pain medications will be compared (OXN PR and OxyPR). Other gastrointestinal parameters will be assessed.
Detailed Description
Patients who require around-the-clock opioid therapy and show symptoms of constipation secondary to opioid treatment will be randomised to receive either OXN PR followed by OxyPR, or vice versa. Each treatment takes 24days. The study is composed of three phases, a pre-randomisation phase, a double-blind phase and a Follow-up phase.
#Intervention
- DRUG : OXN PR followed by OxyPR tablets
- DRUG : OxyPR followed by OXN PR tablets
|
#Eligibility Criteria:
Inclusion Criteria:
Subjects who are receiving WHO step II/III opioid analgesic medication for the treatment of non-malignant pain and who require daily opioid treatment for pain with WHO step III opioid therapy for the duration of the study, based on Investigator's judgement.
Documented history of non-malignant pain that requires around-the-clock opioid therapy (20 - 50 mg oxycodone PR equivalent per day for a minimum of study duration).
Subjects with constipation caused or aggravated by opioids:
* Subject's medical need of regular intake of laxatives to have at least 3 bowel evacuations per week, or having less than 3 bowel evacuations when not taking a laxative.
* In the opinion of the subject and investigator confirm that the subject's constipation is induced, or worsened by the subject's prestudy opioid medication (present at Screening).
Exclusion Criteria:
Any contraindication to oxycodone, naloxone, or any non-investigational medicinal products (NIMPs) that will be used by subjects during the study.
Continuous systemic use of antibiotics and/or steroids within the last 4 weeks prior to the start of the Screening Period and during the study period.
Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01915147
|
{
"brief_title": "A Study to Explore the Influence of Two Opioid Pain Medications on Bacterial Composition in the Gut and Other Gastrointestinal Aspects",
"conditions": [
"Severe Chronic Pain"
],
"interventions": [
"Drug: OXN PR followed by OxyPR tablets",
"Drug: OxyPR followed by OXN PR tablets"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01915147",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-02",
"study_completion_date(actual)": "2015-09",
"study_start_date(actual)": "2013-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-12-14",
"last_updated_that_met_qc_criteria": "2013-07-31",
"last_verified": "2015-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-08-02",
"first_submitted": "2013-06-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study in order to evaluate the effect of virtual reality glasses during splint in children on pain and anxiety due to the procedure.
Detailed Description
The study was carried out as a randomized controlled experimental study in order to evaluate the effect of virtual reality glasses during splint in children aged 6-12 years on pain and anxiety due to the procedure.
The sample of the research consisted of 80 childrens who came to Karabuk University Training and Research Hospital orthopedic policlinic and emergency between 1 May and 31 October 2021 for the splint application. In the study, two groups consisted of experimental group (n=40) and control group (n=40) were determined.
The 'Participant Information Form', the 'Wong Baker Pain Scale', the 'State Anxiety Inventory for Children', virtual reality glasses and pulse oximeter were used to collect data. The pain, anxiety and vital signs of the children in the experimental and control groups were recorded before, during and after the splint.
The video chosen by the children in the experimental group was shown with virtual reality glasses during the splint application. In the control group a video wasn't shown during the splint application. Chi square, Mann Whitney U, Bonferroni and Friedman tests were used in the analysis of data.
#Intervention
- OTHER : The group using virtual reality glasses
- The video chosen by the children in the experimental group was started 1-2 minutes before the splint with virtual reality glasses and watched for an average of 7 minutes.
|
#Eligibility Criteria:
Inclusion Criteria:
* The child should be between the ages of 6 and 12 age old.
* Acceptance of the research and giving written consent by the family and the child.
* Ability of the family and child to speak Turkish.
* The child should not wear glasses.
* The child should be at a cognitive level able to choose videos.
Exclusion Criteria:
* The child should have chronic diseases.
* The child should take analgesics with in the last 24 hours.
* The child should have physical, mental and neurological disabilities.
* The child has a febrile illness.
* Fainting of the child during the procedure.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05281133
|
{
"brief_title": "Effect Of Virtual Reality Glasses Used During Splint Application On Children's Pain And Anxiety Levels.",
"conditions": [
"Pain, Acute",
"Anxiety Acute",
"Fractures, Bone"
],
"interventions": [
"Other: The group using virtual reality glasses"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05281133",
"official_title": "Effect Of Virtual Reality Glasses Used During Splint Application On Children's Pain And Anxiety Levels.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-10-31",
"study_completion_date(actual)": "2021-10-31",
"study_start_date(actual)": "2021-05-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-03-16",
"last_updated_that_met_qc_criteria": "2022-03-10",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-16",
"first_submitted": "2022-03-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this administrative survey is to inform health system logistics by assessing the attitudes towards towards the bivalent COVID-19 boosters held by healthcare workers (HCWs) at a large, rural health system. It will also test, prospectively, the effect on interest in the bivalent COVID-19 booster of different framing approaches in a survey question sent to employees of a large, rural health system.
Detailed Description
The Food and Drug Administration has authorized two bivalent COVID-19 boosters with the expectation that the Centers for Disease Control will soon recommend them. The researchers plan to survey the HCWs at a large, rural health system on their attitudes on the bivalent booster.
This survey will gather data on HCWs' interest in a bivalent booster, reasons for hesitancy, risk perception about COVID-19 infection and its complications, and prior COVID-19 infection and vaccination.
Respondents will also be randomly assigned to see different versions of the question asking if they are interested in a bivalent booster with different framing approaches, such as protection of the self or protection of patients (for patient-facing employees). Information on prior vaccination and perceptions of risk will also be gathered and used as covariates in the analysis.
#Intervention
- BEHAVIORAL : Salience of Omicron variant
- The message mentions the Omicron variant, which can be a fear appeal or make salient the reason for the new booster
- BEHAVIORAL : Self-protection message
- The message makes a reference to protecting one's self
- BEHAVIORAL : Other-protection message
- The message makes a reference to protecting others (patients)
|
#Eligibility Criteria:
Inclusion Criteria:
* Employee at the health system
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05529030
|
{
"brief_title": "COVID-19 Booster Readiness Survey",
"conditions": [
"Vaccination Refusal"
],
"interventions": [
"Behavioral: Other-protection message",
"Behavioral: Self-protection message",
"Behavioral: Salience of Omicron variant"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05529030",
"official_title": "COVID-19 Booster Readiness Survey",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-15",
"study_completion_date(actual)": "2022-09-15",
"study_start_date(actual)": "2022-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-09-30",
"last_updated_that_met_qc_criteria": "2022-09-01",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-09-06",
"first_submitted": "2022-09-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Therapeutic plasma exchange (TPE) is an established treatment modality for the acute removal of pathophysiological relevant mediators in various diseases. Adipokines have recently been found to play an important role in a variety of immunologic diseases. However, in many of these disease states cardiac and inflammatory involvement is common and biomarkers are routinely used for diagnosis or assessment of therapeutic success. The effect of TPE on biomarkers used in the clinical routine has not been investigated. The aim of this study is to determine adipokine and cardiac biomarker removal during TPE therapy.
Detailed Description
We performed a observational prospective single-centered study. Every patient received two consecutive therapeutic plasma exchange (TPE) sessions during the study. Plasma exchange therapy was performed using either the Spectra Optia® or the Octo Nova® apheresis system. Anticoagulation was applied either by heparin or citrate. The prescribed dose of exchange volume of every TPE treatment was 1.1-times the individual calculated total plasma volume, using the Nadler-Allen equation. A substitute fluid with 5% albumin concentration was used in every treatment. Blood samples for measurement of different adipokines (resistin, leptin, soluble ICAM-1, soluble CD40 ligand, monocyte chemoattractant protein-1 (MCP-1), soluble tumor necrosis factor receptor (sTNF-R) as well as cardiac and inflammatory biomarkers and routine chemistry were drawn before (pre-TPE) and at the end (post-TPE) of the first and second TPE session.
|
#Eligibility Criteria:
Inclusion Criteria:
* indication for TPE
* age between 18 and 80 years
* written informed consent
Exclusion Criteria:
* need for fresh-frozen plasma as replacement fluid
* participation in another study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02533596
|
{
"brief_title": "Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange",
"conditions": [
"Antibody-mediated Rejection",
"Autoimmune Reaction Mediated by Immune Complex"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT02533596",
"official_title": "Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-12",
"study_completion_date(actual)": "2011-03",
"study_start_date(actual)": "2010-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-08-27",
"last_updated_that_met_qc_criteria": "2015-08-24",
"last_verified": "2015-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-08-27",
"first_submitted": "2015-02-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of a structured nursing intervention (PCE), including two types of intervention defined in the literature (coping strategies promoting social support and empowerment through health education), which has an effect on the perceived quality of life for the caregiver, when compared with conventional intervention or non-support.
Detailed Description
Aim: to compare the effectiveness of a standardized care plan (SCP) compared to the usual nursing intervention to improve the quality of life for primary caregivers over 65 years old measured through points change with the EuroQol-5D (EQ-5D) scale.
Secondary objectives:
Evaluate the influence of prognostic variables on quality of life of caregiver. Describe the level of caregiver burden. Describe the socio-demographic profile of the dependent person and caregiver.
Method:
Design: cluster randomized trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service. Subjects: unit of randomization: primary healthcare centres. Analysis unit: caregivers over 65 years old.
Intervention: The SCP in the treatment group and the usual intervention in the control group.
Sample size adjusted for design effect= 218 (109 in each arm). Main response variable: perceived quality of life (EQ-5D). Secondary response variables: nursing diagnosis, Zarit Caregiver Burden Interview, objective overload level.
Prognostic variables:Dependent person-related: dependence level (Barthel, Lawton-Brody), cognitive dysfunction (Pfeiffer).
Caregiver-related: depression scale (Yesavage), anxiety level (Goldberg), family function (family Apgar). Sociodemographic variables.
Data Analysis: Analysis of main effectiveness by intention to treat, comparing the difference in units on the EQ-5D scale before and post- intervention in both groups at 0, 6, 12 and 18 months. The estimation adjusted, using logistic regression with aleatory effects, those data that can act as confounding factors or change the effect.
#Intervention
- BEHAVIORAL : CuidaCare Intervention
- Nursing intervention address to Caregiver Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education
- Other Names :
- Nursing intervention, Primary Health care, Caregiver, Strain, Quality of life, Standardized care plan (PCE)
- OTHER : Control Group/Usual Care:
- Control Group/Usual Care:
Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education
|
#Eligibility Criteria:
Inclusion Criteria:
* Not psychological treatment or social support during the study period.
* Be able to follow the trial's demands.
* Experience of caring for at least 6 months in a year.
* Caregivers who consent to take part.
Exclusion Criteria:
* Caregivers of patients hospitalized during the initial data collection.
* Caregivers of institutionalized patients.
* Severe psychiatric conditions including depression and major affective pictures.
* Paid caregivers.
* Experience as a caregiver for less than a month.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01478295
|
{
"brief_title": "Effectiveness of Nursing Intervention on Caregivers",
"conditions": [
"Quality of Life"
],
"interventions": [
"Behavioral: CuidaCare Intervention",
"Other: Control Group/Usual Care:"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT01478295",
"official_title": "Effectiveness of Nursing Intervention on Quality of Life of Older Caregivers: Clinical Trial Randomised by Clusters",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2013-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-11",
"last_updated_that_met_qc_criteria": "2011-11-21",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-11-23",
"first_submitted": "2011-11-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This project will provide new insights concerning how to reduce dengue transmission by means of cost-effective and sustainable implementation strategies of vector control methods.
The research will assess key strategies which deliver new vector control tools with respect to their cost-effectiveness, acceptability and sustainability in contrasting environments.
#Intervention
- OTHER : Insecticide treated curtains and insecticide treated covers
- The study is comparing the introduction of two new vector control tools (insecticide treated curtains and insecticide treated covers) through two different distribution strategies. These tools are curently not in use in the routine programmes of the concerned countries.
|
#Eligibility Criteria:
Inclusion Criteria:
* No patients, but communities were included, with as inclusion criteria: neighborhoods of Lam Chabang, Thailand and Valera and San Rafael de Carvajal, Venezuela after obtaining community approval
Exclusion Criteria:
* Neighborhoods without community approval
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00883441
|
{
"brief_title": "Implementation Research of New Dengue Vector Control Tools",
"conditions": [
"DENGUE"
],
"interventions": [
"Other: Insecticide treated curtains and insecticide treated covers"
],
"location_countries": [
"Venezuela",
"Thailand"
],
"nct_id": "NCT00883441",
"official_title": "Implementation Research of New Dengue Vector Control Tools",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-02",
"study_completion_date(actual)": "2009-12",
"study_start_date(actual)": "2006-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-01-08",
"last_updated_that_met_qc_criteria": "2009-04-16",
"last_verified": "2013-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-04-17",
"first_submitted": "2009-04-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to evaluate the comparative effectiveness of a high-fidelity, low-resource, and feasible model versus a standardized brief intervention that mimics usual care to deliver tailored inhaler technique education to children with asthma via a randomized clinical trial. We have already conducted a trial of V-TTG among elementary school-aged children hospitalized in the inpatient setting and we now aim to test this tool in the outpatient clinic setting among a broader pediatric patient population.
Detailed Description
Asthma is the most common chronic childhood condition and has significant adverse consequences. One in 12 United States children has asthma, resulting in 13.4 million missed school days, 1 million emergency department visits, and 140,000 hospitalizations annually. Urban, minority, and underserved youth are disproportionally affected. On Chicago's South Side, one-in-five children have an asthma diagnosis; over half visit an urgent care or emergency department (55%), miss school (51.2%), or require parents to miss work annually due to asthma (56.1%).
Effective self-management is crucial to optimize asthma care and improve outcomes. A key barrier to self-management is the improper use of respiratory inhalers, which limits disease control. Better inhaler technique is associated with improved asthma outcomes for children. Assessment and education of inhaler technique are recommended at all healthcare encounters; however, it is limited in practice because it is resource-intensive (both personnel and time) and lacks fidelity. Thus, low-resource interventions that accurately teach inhaler skills are needed to impact pediatric asthma outcomes.
Teach-to-Goal (TTG) is a patient-centered strategy that uses tailored rounds of teaching and assessments to ensure mastery of inhaler technique. Studies show it is effective but resource-intensive. A 'virtual TTG' (V-TTG) intervention represents an opportunity to deliver inhaler technique education with a high-fidelity, low-resource, and feasible strategy. The module utilizes innovative learning technology with video demonstrations and assessment questions to tailor education to each user; the cycles of assessment and education continues until satisfactory mastery is achieved. Our team developed a V-TTG intervention for adults with demonstrated efficacy. It remains unknown whether this interactive and adaptive module will be feasible and effective in the pediatric population due to varied developmental levels and parental involvement in care.
Virtual Teach-to-Goal (V-TTG) holds the potential to improve inhaler technique in children; however, because learning theory indicates children and adults learn differently, the same learning module cannot be utilized. We have already constructed V-TTG for children with feedback from children with asthma, parents, and healthcare professionals. The learning module is tailored for age by using developmentally and age-appropriate vocabulary, concepts, format, and pacing.
#Intervention
- BEHAVIORAL : Virtual Teach to Goal
- Participants will complete inhaler education on a tablet device.
- BEHAVIORAL : Brief Instruction
- Participants will be read out loud instruction on how to use their inhaler.
|
#Eligibility Criteria:
Inclusion Criteria:
* Families will be included in the study if:
1. The child is between the ages of 6 <= age <= 17 years
2. The child has a diagnosis of asthma, wheezing, or bronchospasm
3. The child has been or is seen in general pediatrics, pediatric pulmonary, or pediatric allergy clinic at the University of Chicago Medical Center
4. The child is taking medication for asthma, wheezing, or bronchospasm (either a controller medication or a quick-relief medication)
5. The family has acess to wifi and/or data that supports virtual video-based platforms (if study is done virtually)
Exclusion Criteria:
* Families will be excluded from the study if:
1. The child/parent decline or unable to provide consent/assent
2. The child/parent does not speak/read English
3. The child cannot use an inhaler by themselves without a mask
4. The child previously participated in this study
5. The family does not have access to wifi and/or data that supports virtual video-based platforms (if study done virtually)
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04470180
|
{
"brief_title": "Virtual Teach to Goal vs. Brief Intervention Inhaler Study-outpatient",
"conditions": [
"Asthma in Children"
],
"interventions": [
"Behavioral: Brief Instruction",
"Behavioral: Virtual Teach to Goal"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04470180",
"official_title": "An RCT of Virtual Teach-to-Goal Versus Brief Instruction for Children With Asthma in Clinics",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-11-05",
"study_completion_date(actual)": "2021-11-05",
"study_start_date(actual)": "2020-08-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-02-18",
"last_updated_that_met_qc_criteria": "2020-07-13",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-14",
"first_submitted": "2020-04-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a two part study. Part I is designed to test single doses of GSK678586A in healthy volunteers. Part II is designed to test repeat doses (two doses) of GSK679586A in patients with mild asthma. Both parts are designed to investigate the safety, tolerability and the way the body absorbs GSK679586A when given by intravenous infusion (through a vein in your arm).
#Intervention
- DRUG : GSK679586
- Active Drug
- DRUG : Placebo
- Saline
- Other Names :
- Saline
|
#Eligibility Criteria:
Inclusion criteria:
* Men aged 18 - 65 years inclusive, or women aged 18 - 50 years inclusive.
* Female subjects must be of non-childbearing potential,
* Male subjects must agree to abstain from sexual intercourse or use adequate contraception during sexual intercourse with pregnant or lactating females, in addition to their female partner using another form of contraception. This criterion must be followed from the time of the first dose of study medication until 84 days after the last dose of study medication.
* Body weight >= 50 kg and BMI within the range 19 - 29.9 kg/m2.
* Non-smoker as verified by urinary cotinine levels below 300 ng/mL at screening or ex-smokers who have given up smoking for >12 months with a history <10 pack years [Pack yrs = (No of cigarettes/day x No of years smoked)/20]
* Available to complete all study measurements.
* Able to read, comprehend, and write English at a sufficient level to complete study related materials.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Additional Inclusion Criteria for Subjects in Part I
* Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
Additional Inclusion Criteria for Subjects in Part II
* History of asthma for at least 6 months prior to the screening visit currently requiring no treatment or intermittent treatment with inhaled short-acting beta2-agonist only. Subject must not have received low dose inhaled corticosteroids within three months prior to Day 0.
* Pre-bronchodilator FEV1 >70% but <90% of predicted at screening with >=12% reversibility after short-acting beta2-agonist or If the subject has a pre-bronchodilator FEV1 >=90% at screening but has a history of asthma or if the subject meets the FEV1 criteria but does not demonstrate >=12% reversibility after short-acting beta2-agonist administration, then the subject may be considered eligible if a Bronchial Provocation Test for asthma is positive (and after consultation with Medical Monitor and Principal Investigator). The bronchial provocation will be considered positive when the standard criteria for a positive response with the given challenge agent are met.
* Skin prick test positive for an allergen that is appropriate for nasal challenge
Exclusion criteria:
* As a result of medical interview, physical examination or screening investigations, the responsible physician deemed the subject unsuitable for the study.
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
* Previous exposure to humanised antibody therapy for any reason.
* A strong family history of Th1 cytokine-related inflammatory disorders, including but not limited to, Type I diabetes mellitus, multiple sclerosis, Crohn's disease, rheumatoid arthritis, sarcoidosis.
* Known history of active or latent tuberculosis, or recent (within 6 months of study enrolment) exposure to a person with active tuberculosis. Previous medical history and letter from the subject's physician (GP) should exclude this.
* A history of chronic urogenital infections or other chronic infections.
* Subjects who have received any type of vaccination in the last two months.
* The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication
* Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John'sWort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
* History of alcohol/drug abuse or dependence within 12 months of the study:
* Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* A positive test for human immunodeficiency virus (HIV) antibodies.
* The subject has a positive pre-study urine drug/ urine alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
* ECG that is outside of ranges as defined by the protocol
* Those who, in the opinion of the Investigator, have a risk of non-compliance with study procedures.
* The subject has a history of confirmed or active parasitic infection.
* The subject is unable to refrain from travelling to countries with a high prevalence of infectious (especially parasitic) disease from when the first dose is administered until the expected washout period is complete (plasma levels below LLQ) or the last follow-up visit, which ever is later
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00411814
|
{
"brief_title": "A Study Of GSK679586A When Infused Into Healthy And Mild Asthmatic Volunteers",
"conditions": [
"Asthma"
],
"interventions": [
"Drug: Placebo",
"Drug: GSK679586"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT00411814",
"official_title": "A Dose-escalating Study of the Safety and Pharmacokinetics of GSK679586A in Healthy Volunteers and Mild Asthmatics.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-02",
"study_completion_date(actual)": "2008-02",
"study_start_date(actual)": "2006-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-03-19",
"last_updated_that_met_qc_criteria": "2006-12-14",
"last_verified": "2012-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-12-15",
"first_submitted": "2006-12-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The PATRIOT study will evaluate a risk-based personalized behavioral intervention to improve foot self-care, self-monitoring, and modifiable risks for amputation such as blood glucose, blood pressure and cholesterol in order to prevent diabetic foot ulcers in patients at higher than normal risk for amputation. This novel intervention aims to improve self-care and early detection of foot abnormalities in at-risk patients with diabetes and poor foot self-care using advanced behavioral approaches to target adherence to multiple health behaviors, including foot self-care, self-monitoring, medication adherence, dietary adherence, and physical activity simultaneously. If this promising behavioral theory-driven approach delivered using common technology (phone) to the patient at home can work in a setting where improvements in foot care are so urgent, it will be an important scientific contribution.
Detailed Description
Amputation is a devastating complication of diabetes that is preceded in \> 80% of cases by foot ulcers. Veterans with diabetes are at risk for incident foot ulcers, particularly if they have neuropathy, vascular disease or anatomic abnormalities. This risk is worsened if they have poor foot self-care, poor foot self-monitoring and/or poor control of A1c and other risk factors. It is important to activate at-risk Veterans to improve self-care and self-monitoring, and lower other amputation risks.
The PATRIOT study is a randomized controlled trial (RCT) testing the effectiveness of a personalized behavioral intervention (PBI) aimed to improve foot self-care, foot self-monitoring, and modifiable risks for amputation such as A1c, BP, LDL and smoking using behavioral counseling combined with dermal thermometry. The primary specific aim is to evaluate the effect of PBI on the proportion of foot lesions (ulcerative or non-ulcerative) compared to current best practice (CBP) care for diabetes. The secondary specific aims are to evaluate the impact of PBI on foot self-care skills, foot education and adherence, A1c, BP and LDL, and quality of life at 6 months as well as its longer-term effects at 12 months; and cost-effectiveness compared to CBP. The will also examine the effect of PBI and CBP on demonstrated foot self-care, plantar pressures, inflammation, satisfaction and intervention acceptability.
The investigators will randomize 404 adults with diabetes who are at higher than normal risk of foot ulcers \[Risk score of 1, 2 or 3 (with no history of ulcers or amputations)\] to the PBI and CBP equally. The PBI is a cohesive, personalized intervention targeting foot self-care and self-monitoring that includes dermal thermometry, diet, exercise, and medication-taking incorporating self-regulatory theory, the Transtheoretical Model and Prospect Theory and delivered using Motivational Interviewing principles and the teach back method. The interventions will be standardized and fidelity of the intervention will be maintained. Through a blinded RCT, the investigators will test the effect of PBI in relation to CBP. Key outcomes are non-ulcerative and ulcerative lesions, foot-care skills, foot care education, adherence to diet and medication, general and foot health-specific quality of life, A1c, BP, and LDL. Outcomes will be measured at baseline, 6 and 12 months. All analyses will be intent-to-treat.
This study will evaluate a cohesive risk-stratified personalized behavioral intervention aimed to improve self-care, enhance self-monitoring and reduce incident ulcers in adults without a previous diabetic foot ulcer. This study applies established behavioral theories combined with new technology to intervene and improve care for adults with diabetes who are at risk for amputation. If this promising theory-driven primary prevention approach to prevent foot lesions can work in a clinical setting where improvements in foot care are urgently needed, it will be an important scientific contribution that could lower the risk of amputation in adults with diabetes.
#Intervention
- BEHAVIORAL : Personalized Behavioral Intervention
- The PBI is based on self-regulation theory, the Transtheoretical Model and Prospect Theory, and will be delivered using Motivational Interviewing principles and the teach-back method. Participants will receive monthly calls targeting foot self-care, foot self-monitoring, diet, medication and physical activity for 6 months. Call/mailing frequency during the next 6 months will depend on adherence level to foot self-care and self-monitoring at 6 months.
- Other Names :
- PBI
- BEHAVIORAL : Current Best Practice
- CBP will include monthly calls from a counselor focusing on preventing conditions like colorectal cancer, flu, insomnia, vision problems, memory loss and oral disease for the first 6 months. Frequency of calls and mailings from counselors during the next 6 months will be determined by level of adherence to preventive strategies during the first 6 months.
- Other Names :
- CBP
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults with diabetes and PAVE score 1, 2 or 3, drug therapy for > 6 months
* An available phone
* At least 2 primary care visits in the previous 1.5 years at the recruitment site
Exclusion Criteria:
* Patients with acute CVD events < 3 months ago
* 86 poor estimated short-term survival (< 1 year)
* Recent major surgery (< 3 months)
* Inability to exercise
* Prior toe or foot amputation
* Prior foot ulcer
* Temporary residence in the area
* Inability to provide consent will be excluded
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02356757
|
{
"brief_title": "Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy",
"conditions": [
"Diabetes",
"Foot Ulcer"
],
"interventions": [
"Behavioral: Personalized Behavioral Intervention",
"Behavioral: Current Best Practice"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02356757",
"official_title": "Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-30",
"study_completion_date(actual)": "2021-09-30",
"study_start_date(actual)": "2015-08-24"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-10-22",
"last_updated_that_met_qc_criteria": "2015-02-02",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-02-05",
"first_submitted": "2015-02-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to investigate the effect of training with the Gait Enhancing and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor function in adults. The investigator hypothesizes that long-term GEMS-H use would improve locomotor function. Specifically, individuals in the GEMS-H group will show faster gait speed compared to those in the control group.
Detailed Description
The GEMS-H is a hip-type assist device developed by Samsung Electronics. The GEMS-H is worn around the waist and fastened at the waist and thighs by a set of belts with velcro to assist motion at the hip joints. The device weighs 2.1kg, and has 2 brushless direct current motors running on a rechargeable lithium ion battery. The normal operation time for the device is 2 hours. It is controlled through a custom built application on a hand held tablet.
The purpose of this study is to investigate the effect of training with the Gait Enhancing and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor function in adults. The investigator hypothesizes that long-term GEMS-H use would improve locomotor function. Specifically, individuals in the GEMS-H group will show faster gait speed compared to those in the control group.
Participants will be scheduled for 18 sessions of training (randomly placed either in GEMS-H training group or traditional training group without the GEM-H) plus 5 sessions of testing (pre-training, mid-test after the 9 sessions of training, post-training, 1 month follow-up and 3 month follow-up after the 18 sessions training completed).
#Intervention
- DEVICE : with Gait Enhancing and Motivating System-Hip (GEMS-H)
- The intensity of training: between 12 and 16 in borg's rating of perceived exertion scale.
Assessments consist of gait function, cardiopulmonary metabolic energy cost, physical performance, balance, physical level, pain, fall efficacy, depression, quality of life and activities of daily living.
- OTHER : without Gait Enhancing and Motivating System-Hip (GEMS-H)
- The intensity of training: between 12 and 16 in borg's rating of perceived exertion scale.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age: 19 - 84 years
* No history of central nervous system related disease
Exclusion Criteria:
* Difficulty in walking due to conditions such as poor vision or fractures
* Height is less than 140cm or more than 185cm.
* Body mass index (BMI) greater than 35.
* Difficulty understanding and participating in the study such as those with cognitive problems or dementia.
* Subject who is at risk of falling during walking due to severe dizziness
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 84 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03962517
|
{
"brief_title": "Effect of GEMS-H on Locomotor Function in Adults",
"conditions": [
"Adults",
"Middle Age",
"Aged",
"Aged, 80 and Over"
],
"interventions": [
"Device: with Gait Enhancing and Motivating System-Hip (GEMS-H)",
"Other: without Gait Enhancing and Motivating System-Hip (GEMS-H)"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03962517",
"official_title": "Effect of GEMS-H on Locomotor Function in Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-05",
"study_completion_date(actual)": "2020-02-05",
"study_start_date(actual)": "2019-05-28"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-02",
"last_updated_that_met_qc_criteria": "2019-05-22",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-24",
"first_submitted": "2019-05-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study will seek to explore the possibility of developing post-traumatic stress disorder following a violent offense commited, among the population of prisoners of the Bordeaux-Gradignan penitentiary center.
Detailed Description
The overrepresentation of psychiatric disorders among prisoners has been the subject of numerous studies and the significant increase in the number of prisoners over the past 3 decades, make research in prisons a major public health issue.
Recent studies have been able to highlight an over-representation of post-traumatic stress disorder in the prison population. Leading to questionning the factors that could explain the overrepresentation of this disorder in prison with various hypotheses raised. Among these hypotheses, the possibility of developing post-traumatic stress disorder following a violent offense commited has been proposed.
The study will thus seek to explore the development of a Post-traumatic Stress Disorder following a violent act committed using the PCL-5 questionnaire
Study design :Observational, descriptive, monocentric study with completion of an anonymous self-questionnaire.
Participation in the study is voluntary and anonymous with signature of a non-opposition form.
Expected outcomes : better knowledge of this disorder in detention and a hypothesis to explain its overrepresentation. Earlier detection of this pathology in prison could thus be considered, in particular by improving the identification of people at risk according to the presence of contributing factors. More specific support and improved access to care for inmates could be considered, allowing early treatment and thus avoiding progression to other co-morbidities or risk of recidivism.
|
#Eligibility Criteria:
Inclusion Criteria
* Aged over 18
* Have as a reason for imprisonment one of the following: Homicide and willful violence resulting in death, Rape or sexual assault, Violence and other personal injury.
* Having signed and duly completed the Non-Objection form for participation in the study
* Mastery of the French language
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05026450
|
{
"brief_title": "Exploring the Psycho-traumatic Impact of a Violent Act Commited at the Bordeaux-Gradignan Penitentiary Center",
"conditions": [
"Post Traumatic Stress Disorder",
"Offensive Aggression",
"Violent Behavior"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT05026450",
"official_title": "Exploring the Psycho-traumatic Impact of a Violent Act Commited - Study Among Inmates of the Bordeaux-Gradignan Penitentiary Center",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-30",
"study_completion_date(actual)": "2022-09-30",
"study_start_date(actual)": "2022-03-21"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-18",
"last_updated_that_met_qc_criteria": "2021-08-23",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-30",
"first_submitted": "2021-08-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type 2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will receive placebo.
Detailed Description
Glucokinase (GK, also called hexokinase IV or D) can phosphosphorylate glucose to glucose-6-phosphate (G-6-P) in pancreatic β-cells and liver cells, which represents the first step of glucose metabolism. GK also acts as a glucose sensor and exerts a key role in maintaining glucose homeostasis. HMS5552 is a 4th-generation GK agonist or activator (GKA), which was originally licensed from Roche and subsequently developed by Hua Medicine. HMS5552 has been shown to activate GK in pancreatic beta cells, liver and intestinal epithelial cells. It regulates systemic blood glucose through a variety of mechanisms including directly enhancing insulin release (pancreas), inhibiting production of endogenous glucose (liver) and by indirectly promoting GLP-1 release (enteroendocrine L-cells).
#Intervention
- DRUG : HMS5552
- 75mgQD
- Other Names :
- GKA
- DRUG : HMS5552
- 100mgQD
- Other Names :
- GKA
- DRUG : HMS5552
- 50mgBID
- Other Names :
- GKA
- DRUG : HMS5552
- 75mgBID
- Other Names :
- GKA
- OTHER : Placebo
- QD/BID
|
#Eligibility Criteria:
Inclusion Criteria:
* Male & female, 40~75 years
* T2DM patients，anti-hyperglycemic drug-naïve and on diet & exercise for at least 3 months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone
* HbA1c 7.5~10.5% at screening and pre-randomization
* Fasting plasma glucose (FPG)7.0~11.1 millimole/liter (mmol/L, local lab) at screening, and 7.0~13.3 millimole/liter (mmol/L, central lab) at pre-randomization
* BMI: 19~30kg/m^2 & TG<5.5mmol/L
Exclusion Criteria:
* T1D，secondary DM, pre-DM
* kidney diseases or eGFR MDRD<60ml/min/1.73m^2
* unstable CVDs
* liver diseases
* mental or CNS diseases
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02561338
|
{
"brief_title": "A Multi-center 12-week Study of HMS5552 in T2DM",
"conditions": [
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Other: Placebo",
"Drug: HMS5552"
],
"location_countries": [
"China"
],
"nct_id": "NCT02561338",
"official_title": "A Multi-center, Randomized, Double-blind, Placebo-controlled, 12-week Phase II Study to Evaluate the Safety, Tolerability, Efficacy and Population PK of HMS5552 in Type 2 Diabetic Adult Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-09",
"study_completion_date(actual)": "2016-09",
"study_start_date(actual)": "2015-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-10",
"last_updated_that_met_qc_criteria": "2015-09-24",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-28",
"first_submitted": "2015-09-23",
"first_submitted_that_met_qc_criteria": "2020-02-25"
}
}
}
|
#Study Description
Brief Summary
To evaluate the Sun Protection Factor efficacy on human skin.
#Intervention
- DRUG : BAY987517
- Each 50 cm\*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm\*2 test application. (Formulation Code: Z12-030)
|
#Eligibility Criteria:
Inclusion Criteria:
* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18 <= age <= 70 years.
* Good health as determined from the HRL SHF (Subject History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)
Exclusion Criteria:
* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02822339
|
{
"brief_title": "Sun Protection Factor Assay",
"conditions": [
"Sunscreening Agents"
],
"interventions": [
"Drug: BAY987517"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02822339",
"official_title": "Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-29",
"study_completion_date(actual)": "2016-06-29",
"study_start_date(actual)": "2016-06-23"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-12-13",
"last_updated_that_met_qc_criteria": "2016-06-30",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-04",
"first_submitted": "2016-06-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Study will examine the metabolic, physiological and cardiovascular changes by intake of New Zealand blackcurrant extract at rest and during moderate-intensity treadmill walking in healthy males.
Detailed Description
The investigators will examine effects of acute intake, intermittent intake and chronic intake of New Zealand blackcurrant extract using indirect calorimetry and hemodynamic measurements.
#Intervention
- DIETARY_SUPPLEMENT : New Zealand blackcurrant extract
- Capsules taken daily or intermittent
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy
* Non-smokers
* Not taking any supplements
* No known allergy to berries or berry products
Exclusion Criteria
* Sedentary
* Known high blood pressure
* Smoking
* On medication
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05067062
|
{
"brief_title": "Intake Duration Effects of Blackcurrant on Cardiovascular and Metabolic Responses",
"conditions": [
"no Conditions"
],
"interventions": [
"Dietary Supplement: New Zealand blackcurrant extract"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05067062",
"official_title": "Effects of Intake Duration of New Zealand Blackcurrant Extract on Physiological, Cardiovascular and Metabolic Responses at Rest and During Moderate-intensity Exercise in Healthy Males",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09-01",
"study_completion_date(actual)": "2018-09-01",
"study_start_date(actual)": "2017-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-10-04",
"last_updated_that_met_qc_criteria": "2021-10-01",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-10-04",
"first_submitted": "2021-09-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).
#Intervention
- BIOLOGICAL : RSV Vaccine
- Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
- OTHER : Placebo
- Participants will receive a single IM injection of placebo on Day 1.
|
#Eligibility Criteria:
Inclusion Criteria:
* In the investigator's clinical judgment, participants must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and symptoms are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)
* A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
* Agree to not donate blood from the time of vaccination until 3 months after vaccination
* Have a body mass index (BMI) less than (<) 40 kilogram per meter square (kg/m^2)
* Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study
Exclusion Criteria:
* Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders)
* Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
* History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis
* Has hepatitis B or C infection, including history of treated hepatitis C infection
* Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04453202
|
{
"brief_title": "A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults",
"conditions": [
"Healthy"
],
"interventions": [
"Biological: RSV Vaccine",
"Other: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04453202",
"official_title": "A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels of an Ad26.RSV.preF-based Vaccine in Adults Aged 60 Years and Older",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09-24",
"study_completion_date(actual)": "2021-04-09",
"study_start_date(actual)": "2020-07-16"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-01",
"last_updated_that_met_qc_criteria": "2020-06-29",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-01",
"first_submitted": "2020-06-29",
"first_submitted_that_met_qc_criteria": "2023-10-02"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to develop, deliver and evaluate a provider intervention for mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in the children and appropriate cervical cancer screening in the mothers.
Detailed Description
In this study the investigators utilized Community Based Participatory Research approaches in combination with our previous and ongoing research, patient and provider education materials available from professional organizations, and qualitative information obtained from provider in-depth interviews and parent/daughter focus groups to develop a provider intervention to encourage receipt of the HPV vaccine, and appropriate cancer screening in African Americans and Hispanics. A focus of the study was the formation of a Community Advisory Board (CAB) which provided input into the development and modification of the provider intervention. Safety net clinics in Nashville and Memphis served as intervention sites, and in Chattanooga and Nashville (Meharry) served as control sites. Mothers and children at the intervention sites viewed a 5-minute video in the exam room during any visit type before seeing the provider, and received an information sheet with a list of suggested questions to ask the provider. Mothers and children at the control sites received usual care. The selected study sites identified cervical cancer screening as a priority area based on the needs assessments conducted as part of the Meharry Medical College Community Health Center-Community Network Program (CHC-CNP). The investigators conducted pre- and post-intervention quantitative surveys with mothers and their children to evaluate whether the provider intervention was effective in improving HPV vaccination coverage, and cervical cancer screening rates. The investigators abstracted medical records and have indicated this in the HIPAA privacy form. After conducting pre- and post-intervention surveys and abstracting medical records, the investigators found that increasing HPV vaccine uptake requires more intensive, multicomponent interventions.
#Intervention
- BEHAVIORAL : Educational materials
- 5-minute video and information sheet with a list of suggested questions to ask the provider
|
#Eligibility Criteria:
Inclusion Criteria:
* Being seen as a pediatric patient at a study clinic on the day of enrollment
* Self-identified African American or Hispanic
* Aged 9 <= age <= 18 years (mother accompanying child to clinic visit had no age limit)
* Had received no doses of HPV vaccine or received one shot and was overdue for the second dose (three or more months after the first dose was given) prior to the clinic visit
Exclusion Criteria:
* Already having received two or more doses of HPV vaccine
* Mother or female guardian (referred to as 'mother' henceforth) not accompanying the child
* Plans to move away from the clinic catchment area within the next 12 months
* Not completing the baseline assessment prior to entering the exam room
* Mother not providing or unable to give consent
* Child not giving assent.
Sex :
ALL
Ages :
- Minimum Age : 9 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02808832
|
{
"brief_title": "An HPV Vaccine Provider Intervention in Safety Net Clinics",
"conditions": [
"Human Papillomavirus",
"Uterine Cervical Neoplasms"
],
"interventions": [
"Behavioral: Educational materials"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02808832",
"official_title": "Development of an HPV Vaccine and Cervical Cancer Screening Provider Intervention",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-03",
"study_completion_date(actual)": "2016-08",
"study_start_date(actual)": "2010-09"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-09-14",
"last_updated_that_met_qc_criteria": "2016-06-17",
"last_verified": "2016-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-22",
"first_submitted": "2016-06-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Interaction of GLP-1 and PYY3-36 in the inhibition of food intake in healthy subjects
Detailed Description
PYY3-36 and GLP-1 are two classical gastrointestinal peptides, which are released into the circulation during meals from L-cells of the distal gut; there is compelling evidence that each participates in the control of appetite regulating individual meal sizes in healthy subjects, but also in patients with obesity or diabetes type II. The regulation of human eating habits is, however, highly complex and our understanding of appetite control is far from complete. In many areas our knowledge is rather rudimentary; little is known, to give an example, about the importance of individual signals and their interactions.
From studies in animals and humans it is known that individual satiety signals can interact: contributions of glucagon and CCK produced functionally synergistic inhibitions of feeding in rats, that is, simultaneous injection of the two peptides inhibited feeding significantly more than the sum of their individual effects. In contrast, we have been unable to show in healthy volunteers any interaction between GLP-1 and CCK33; the simultaneous infusion of CCK33 and GLP-1 resulted in an infra-additive reduction in meal size, which led us to suggest that the two peptides could even interact antagonistically.
To further explore potential interactions between these two well-known satiety signals, we plan to investigate the effects of individual doses of PYY3-36 and GLP-1, and their interaction in the control of food intake and satiety in healthy male subjects.
#Intervention
- DRUG : Placebo tablet
- Control arm
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy male subjects
* no evidence of disease
* no history of gastrointestinal or endocrine disorders
Exclusion Criteria:
* alcohol and drug abuse
* history of gastrointestinal or endocrine disorders
* female subjects
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00822705
|
{
"brief_title": "Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36",
"conditions": [
"Anti Obesity Agent"
],
"interventions": [
"Drug: Placebo tablet"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT00822705",
"official_title": "Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36: a Phase 1 Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-11",
"study_completion_date(actual)": "2009-01",
"study_start_date(actual)": "2008-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-01-14",
"last_updated_that_met_qc_criteria": "2009-01-13",
"last_verified": "2009-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-01-14",
"first_submitted": "2009-01-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Lower limb orthopedic surgery is commonly realized under spinal anesthesia. This loco-regional anesthesia induces a peripheral vascular resistance decrease by vasodilatation resulting in hypotension. A severe and prolonged hypotension can compromise regional perfusion and worse outcome especially in very elderly patients. Moreover the venous vasodilatation observed after spinal anesthesia decreases cardiac preload resulting in a cardiac output decrease. Several authors had identified the prevention of hypotension as a key role during spinal anesthesia although none prophylactic treatment has been identified. Spinal anesthesia single injection (SA) with low dose of local anesthetic or continuous spinal anesthesia with very low dose bolus injections cause fewer episodes of hypotension. Despite these techniques, hypotension can occur. Phenylephrine is an alpha adrenergic agonist and cause vasoconstriction preventing hypotension. Prophylactic phenylephrine infusion for preventing hypotension has been demonstrated during spinal anesthesia for cesarean delivery. The investigators want to assess for the first time the prophylactic phenylephrine infusion for preventing hypotension in elderly patients undergoing orthopedic lower limb surgery under spinal anesthesia single injection.
Detailed Description
The aim of this study is to assess the prophylactic phenylephrine infusion for preventing hypotension in elderly patients.
This prospective double blinded randomized control trial will include elderly patients over 60 years undergoing orthopedic lower limb surgery under spinal anesthesia single injection (10 mg of Bupivacaine 0,5% with 5 µg of Sufentanyl). We define 4 groups: (1) Patients from 60 to 75 years receiving 100 µg/min of phenylephrine infusion; (2) patients from 60 to 75 years receiving saline infusion; (3) patients over 75 years receiving 100 µg/min of phenylephrine infusion; (4) patients over 75 years receiving saline infusion. Standard monitoring is applied including noninvasive arterial blood pressure, electrocardiography and pulse oximetry. The vasopressor solution and the saline solution will be prepared in identical 50 mL syringes by an investigator not involved in patient care. The investigator administering the solution and the patient are blinded to the content of the syringe. The velocity of infusion will be the same between groups (1ml/min) and the infusion will start once the spinal anesthesia realized. Arterial blood pressure measurements are realized each 1 minute for the first 20 minutes and then each 5 minutes until the end of surgery. After each measurement of MAP, the infusion is stopped if the MAP is more than baseline, and it is continued or restarted if the MAP is less than or equal to baseline. Anyway the infusion is stopped at the end of motor block. Hypotension is defined as a 20% decrease of mean arterial pressure (MAP). Severe hypotension is defined as a 30% decrease of MAP. Hypertension is defined as MAP \> 120% of baseline. Each time there is a MAP measurement showing hypotension while patients are under infusion, a 1 mL IV bolus of phenylephrine 100µg/ml is injected by the anesthesiologist involved in patient care. The total volume of study solution given by infusion and the total volume of phenylephrine given by bolus are recorded.
We want to demonstrate fewer episodes of hypotension and fewer post operatory cardiovascular and neurologic events in the groups receiving prophylactic phenylephrine infusion.
#Intervention
- DRUG : phenylephrine infusion
- patients from 60 to 75 years receiving 100micrograms of phenylephrine infusion
- DRUG : patients receiving saline infusion
- patients more than 60 years receiving 100micrograms of saline infusion
|
#Eligibility Criteria:
Inclusion Criteria:
* > 60 years
* informed consent
* lower limb orthopaedic surgery
* spinal anesthesia
Exclusion Criteria:
* dementia
* anemia less than 10grams per deciliter
* hypertension
* hemostasis disorders
* infection at the puncture
* allergy to local anesthetic,
* patient under anticoagulant.
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01533662
|
{
"brief_title": "Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia",
"conditions": [
"Orthopedic Surgery of Lower Limb"
],
"interventions": [
"Drug: patients receiving saline infusion",
"Drug: phenylephrine infusion"
],
"location_countries": [
"France"
],
"nct_id": "NCT01533662",
"official_title": "Phase 2 Study Evaluating the Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Lower Limb Orthopedic Surgery in the Elderly Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-05",
"study_completion_date(actual)": "2013-09",
"study_start_date(actual)": "2011-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-06-23",
"last_updated_that_met_qc_criteria": "2012-02-10",
"last_verified": "2014-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-15",
"first_submitted": "2011-06-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research is to evaluate the immunogenicity of a single dose of Influenza Vaccines (0.5mL or 0.25mL) in healthy children aged up to 35 months or 36 up to 48 months. To evaluate the safety and tolerability of a single 0.25mL IM of injection influenza vaccines in healthy children aged up to 35 months; to evaluate the safety and tolerability of a single 0.50mL IM injection of influenza vaccines in healthy children aged up to 48 months.
#Intervention
- BIOLOGICAL : Influenza Trivalent Inactivated Vaccines
- This phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age.
Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial.
Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm.
- BIOLOGICAL : Influenza Trivalent Inactivated Vaccines
- This phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age.
Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial.
Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm.
|
#Eligibility Criteria:
Inclusion Criteria:
* children up to 48 months of age, who received both doses of one of the two study vaccines in the previous V70P2 trial, whose parents/legal guardians have given written informed consent prior to study entry,
* in good health as determined by:medical history, physical examination, clinical judgment of the investigator.
Exclusion Criteria:
* Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start;
* Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 15 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable);
* Fever (defined as axillary temperature >= 38.0°C/rectal temperature >= 38.5°C) within the 7 days before enrolment;
* Any serious disease including, for example:cancer,autoimmune disease (including rheumatoid arthritis),diabetes mellitus,chronic pulmonary disease,acute or progressive hepatic disease,acute or progressive renal disease;
* Known or suspected impairment/alteration of immune function, for example, resulting from:receipt of immunosuppressive therapy (corticosteroid - except topical or inhaled steroids - or cancer chemotherapy),receipt of immunostimulants,receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,high risk for developing an immunocompromising disease;
* Bleeding diathesis;
* History of hypersensitivity to any component of the study medication or chemically related substances;
* History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component;
* Laboratory confirmed influenza disease in the past 6 months;
* Surgery planned during the study period;
* Receipt of another investigational vaccine or any investigational agent within 30 days prior to study start. All routine vaccines should be given according to local recommendations: routine vaccines or any other vaccines not foreseen in the protocol can be given after the active trial phase (i.e. 4 weeks after last vaccination in the respective season) has been concluded;
* Participation to another trial of an investigational agent within 90 days of enrolment;
* Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Sex :
ALL
Ages :
- Minimum Age : 16 Months
- Maximum Age : 48 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00644540
|
{
"brief_title": "Immunogenicity and Safety Following a Single Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine (an Adjuvanted Sub-unit Influenza Vaccine and a Non-adjuvanted Split Virion Influenza Vaccine) in the Previous V70P2 Study",
"conditions": [
"FLU"
],
"interventions": [
"Biological: Influenza Trivalent Inactivated Vaccines"
],
"location_countries": [
"Finland"
],
"nct_id": "NCT00644540",
"official_title": "A Phase II, Observer-Blind, Parallel Groups, Single Center, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine in the Previous V70P2 Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-01",
"study_completion_date(actual)": "2008-06",
"study_start_date(actual)": "2007-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-12-01",
"last_updated_that_met_qc_criteria": "2008-03-25",
"last_verified": "2014-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-03-27",
"first_submitted": "2008-03-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
TEst the effect of 'Tailored Physical Activity' or 'Chronic Pain Self-management Program' on Returning to Work in Sicklisted Citizens With Chronic Pain Related to the Spine or Upper Body
Detailed Description
Pain affects quality of life and it's important for the individual who experience chronic pain to find strategies to prevent or reduce pain. In some situations pain can't be reduced and the individual has to master pain by learning to live with it. Pain can lead to a loss of functions which may change one's roles both in relation to the family as to colleagues, for example sick leave from work.
Limited evidence is available on the effects of interventions to sick-listed citizens with chronic musculoskeletal pain.
This study test the effect of either 'tailored physical activity or 'Chronic Pain Self-management Program' on returning to work and the parameters pain, function and quality of life respectively on the body function and participation level of sick-listed people with chronic musculoskeletal pain related to columna and the upper body.
Citizens in DK-Sønderborg Municipality sick-listed for a maximum of 9 weeks will be invited. Participants will be randomized for either tailored physical activity, 'Chronic Pain Self-Management Program' or reference group.
Primary endpoint is 3 months and 12 months follow-up.
#Intervention
- OTHER : Tailored Physical Activity
- Health counselling (1,5h) and graded physical activity (3×50 min/week in 10 weeks)
- BEHAVIORAL : "Chronic Pain Self-management Programme"
- Health counselling (1,5h) and 'Chronic Pain Self-management Program' (2,5h in 6 weeks)
- BEHAVIORAL : Health counselling
- Health guidance (1,5h)
|
#Eligibility Criteria:
Inclusion Criteria:
* Sick-listed with musculoskeletal pain related to columna or the upper body for a maximum period of 9 weeks in DK-Sønderborg Municipality
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 66 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01356784
|
{
"brief_title": "Returning to Work. Efficacy of 'Tailored Physical Activity or' 'Chronic Pain Self-management Program' in Sicklisted Citizens With Chronic Musculoskeletal Pain",
"conditions": [
"Musculoskeletal Pain"
],
"interventions": [
"Behavioral: 'Chronic Pain Self-management Programme'",
"Other: Tailored Physical Activity",
"Behavioral: Health counselling"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT01356784",
"official_title": "Efficacy of 'Tailored Physical Activity or' 'Chronic Pain Self-management Program' on Returning to Work: a Randomized Controlled Trial in Sicklisted Citizens With Chronic Pain Related to the Spine or Upper Body",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-07",
"study_completion_date(actual)": "2014-04",
"study_start_date(actual)": "2011-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-04-24",
"last_updated_that_met_qc_criteria": "2011-05-18",
"last_verified": "2014-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-19",
"first_submitted": "2011-05-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study will evaluate how the ovaries may be functioning while using the the Implanon®/Nexplanon® during the three years beyond the FDA approved duration. Ovarian function will be assessed with weekly serum progesterone levels. Participants will undergo weekly venipuncture for a total of four draws. Participants will be followed for 30 days.
Detailed Description
This prospective cohort will evaluate the ovarian function of 210 ENG users during the three years beyond the FDA approved duration. Participants enrolled in the current study, EPIC (Evaluating the Prolonged Use of IUD and Implant for Contraception, NCT02267616), will be contacted via telephone, screened and scheduled to enroll in person. After the signed consent is obtained participants will be asked to complete a brief questionnaire on demographic information and bleeding patterns. Participants will undergo a blood draw to assess serum etonogestrel and serum progesterone levels.
Follow up visits will include a weekly blood draw for three weeks to assess serum progesterone levels. Participants will also complete a bleeding diary to assess daily bleeding patterns for the 30 day study period.
The investigators will enroll participants at seven time points; at method expiration (3 years of use), and in six-month intervals through six years of use.
#Intervention
- DEVICE : Etonogestrel Implant
- Ovarian function will be assessed with weekly serum progesterone levels. Participants will undergo weekly venipuncture for a total of four draws over a 30 day period. Participants will also complete a bleeding diary to assess daily bleeding patterns for the 30 day study period.
- Other Names :
- Subdermal arm implant
|
#Eligibility Criteria:
Inclusion Criteria:
* Enrolled in the prospective EPIC Prolonged Use Study
* 18 <= age <= 45 years
* At expiration or beyond the end of the FDA-approved duration of use of the etonogestrel-releasing subdermal implant (ENG implant =3 years)
* Ability to consent in English
* Willing and able to complete required follow-up for the study.
Exclusion Criteria:
* Have history of female sterilization procedure
* Desire for conception in the next 12 months
* Had their ENG implant removed
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03058978
|
{
"brief_title": "Assessing Ovarian Function During Prolonged Implant Use",
"conditions": [
"Contraception"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT03058978",
"official_title": "Assessing Ovarian Function During Prolonged Implant Use",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-30",
"study_completion_date(actual)": "2021-12-30",
"study_start_date(actual)": "2017-03-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-12",
"last_updated_that_met_qc_criteria": "2017-02-16",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-23",
"first_submitted": "2017-02-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is a randomized, cross-over, dietary intervention research design comprising a 5-day run-in period, two 3-day dietary interventions, and a 7-day washout period. Participants (mother-offspring dyads) will be randomly assigned to order of interventions. Participants will be recruited as a convenience sample from mother-offspring dyads in the greater Moscow, Idaho and Boise, Idaho areas. The purpose of this study is to to learn more about the use of an allergen test strip to detect cow's milk and soy food allergen proteins in human milk, to explore the impact of maternal bovine milk and soy milk consumption on human milk and maternal/infant gastrointestinal microbiomes and to examine maternal stress during periods of dietary elimination and re-introductions periods.
Detailed Description
The current estimated prevalence of Immunoglobulin E-mediated childhood food allergy is \~8% with up to 11% of caregivers reporting food allergy symptoms. Research also suggests that 40% of children with food allergy report food allergy to multiple food allergens. Infant food allergy can result in multiple physical symptoms including colic, vomiting, reflux, bloody stool, failure to thrive, and eczema, and has been associated with a decreased quality of life in infants and their caregivers. Treatment options for infant food allergies are currently limited. In most situations, mothers must choose between continuing to breastfeed while attempting to avoid potential food allergens or ending breastfeeding and providing expensive hydrolyzed infant formula.
Breastfeeding affects mortality in children under the age of 5 years old reducing episodes of diarrhea and respiratory infections, and decreasing hospital admissions by up to 70%. The Lancet series on breastfeeding quantified the global economic health impact of breastfeeding on healthcare due to infant illness and mortality. Of the estimated 130 million live births per year globally, 820,000 infant deaths, 87% of which are under 6 months old, could be mitigated with improved breastfeeding practices. The Lancet report projects that a 10% increase in exclusive breastfeeding up to 6 months would translate to an estimated $312 million in healthcare savings in the US alone. Long-term (up to 2 years), additional breastfeeding benefits would impact treatment costs for infants and toddlers as much as $2.45 billion in the US.
Many breastfeeding women are led to believe that they should not eat certain foods (e.g., dairy) because this might lead to food intolerance in their infants. Without a method to directly test human milk, mothers will methodically cut out whole food groups (most of them extremely healthy) without realizing that the true problem is going undetected. This often starts with dairy and quickly spirals until her diet is very limited. A total elimination diet is typical for this community. Many women reduce their intake down to as few as five foods (i.e., chicken, mango, coconut oil, spinach, and potato). This extreme dietary restriction puts mothers and infants at risk for nutritional deficiencies with potential life-long effects.
Currently, there is no mechanism available for mothers to know what allergens are present in their milk. Food diaries are inadequate as dietary protein only enters breastmilk a portion of the time and is present in the milk for a variable amount of time depending on several factors including metabolism, nursing schedule and unknown individual characteristics. A simple at-home test strip would empower women to continue breastfeeding by removing the mystery of the allergens present. Mothers and pediatricians could use this information to determine what is causing reactions and then follow up to determine if informed dietary elimination made mom's milk safe. Women could then enjoy their favorite foods and be confident in feeding their infant.
Free to Feed has developed a first-in-class solution using patent-pending technology to detect food allergen proteins in human milk. With this knowledge, mothers would be able to identify the culprit and remove the food from their diets or wait for the allergen to clear from their milk prior to feeding through repeated testing. This technology hopes to empower mothers to breastfeed longer, giving both mom and baby lifelong benefits, while relieving the stress of inducing unknown effects.
Previous research has identified the presence of specific nonhuman proteins found in human milk. While an abundance of information exists on bovine proteins in human milk, very limited research exists examining the presence of soy proteins in human milk. Furthermore, there is no notable existing research validating the use of strips or other tools to detect food allergens in human milk.
The first aim of this research is to validate the use of this patent-pending technology, Freedom Strips, to detect bovine and soy-based food allergen proteins in human milk with the goal that women will be able to test their milk for common antigens (e.g., dairy) and make informed decisions as to whether the milk should be fed to their infants. This will benefit mothers and babies on a global scale as it will enable women to quickly and easily determine if their milk is safe to feed their infants.
One hypothesis explaining the discomfort and increasingly distressed behavior of infants when consuming human milk containing food allergens relates to potential changes in the gastrointestinal microbiome. There is limited information on the relationship between maternal cow's milk and soy consumption and the gastrointestinal microbiome of mothers and their offspring. Therefore, the second aim of this study is to explore the impact of maternal cow's milk and soy consumption on breastmilk and maternal/infant gastrointestinal microbiomes.
Furthermore, elimination diets, dietary challenges and food reintroduction can put a significant amount of stress on mothers of children with infant food allergies. More research is needed examining how maternal stress levels might change throughout this process. A third aim of this study is to examine and compare maternal stress levels during dietary elimination and food challenge periods.
The proposed research study will build upon previous literature by increasing our knowledge related to the detection and identification of nonhuman proteins, specifically bovine and soy, in human milk. This study is unique because it will include a dietary intervention with increasing doses of soy or bovine milk examining how the amount of intake of a food allergen may impact protein detection. It also unique because it includes the investigation of maternal stress and maternal/infant GI microbiomes, both of which may provide more insight on the mechanisms and outcomes of infant food allergies. While our research lab has experience in investigating a variety of factors related to human milk and the microbiome, this study is unique from all other studies currently being done at the University of Idaho.
This study will consist of a randomized, cross-over, dietary intervention research design comprising a 5-day run-in period, two 3-day dietary interventions with a 7-day washout period between them, and a final 2-day washout period after the 2nd intervention. 40 mother-offspring dyads will be recruited to participate. Participants will be randomly assigned to order of intervention. Demographic and health data will be collected at baseline (d0) as will information related to typical infant crying patterns and maternal stress (Perceived Stress Scale). Baseline data collection will also include collection of a human milk sample (approximately 10 mL), a maternal stool sample, and an infant stool sample. Participants will complete two 24-hour dietary recalls during baseline collection (day 0) rather than one to obtain typical dairy and soy intake.
Run-in elimination period: After baseline collection, both groups will undergo a 5-day run-in period during which time half the subjects will eliminate soy and the other half will eliminate cow's milk. Participants will be provided with a list of foods and ingredients to avoid during this time facilitated by a registered dietitian. During these 5 days, participants will complete a daily compliance check and indicate any soy or bovine products/foods that they may or may not have consumed. On d5 of this run-in period, participants will again provide samples of milk and maternal and infant stool and will complete the Perceived Stress Scale.
Dietary intervention period I: After completing the run-in period, the women will consume 200 mL, 300 mL, and 400 mL of bovine milk or soy milk during d1, d2, and d3 (respectively). During each dietary intervention period, participants will provide 3 samples of milk (approximately 10 mL each) each of the 3 days (12 samples total), 1 maternal stool sample, and 1 infant stool sample. Daily logs will be kept to ascertain dairy and soy intake compliance, infant crying and fussiness, and maternal/infant stooling patterns. On the third day of the dietary intervention, mothers will again complete the Perceived Stress Scale.
Washout period I: The first dietary intervention period will be followed by a 7-day washout period during which time the product that was not eliminated the first time will be eliminated from the diet. On the last day of this washout period, participants will provide an optional maternal and/or infant stool sample; they will also complete the Perceived Stress Scale. Infant crying and fussiness will also be monitored and recorded daily during the first two days of the washout period.
Dietary intervention period II: After this, each subject will consume 200 mL, 300 mL, and 400 mL of bovine milk or soy milk (which ever they did not consumer in the first intervention period) during d1, d2, and d3 (respectively). Data and samples collected during intervention I will be collected during intervention II.
Washout period II: The second dietary intervention period will be followed by a 2-day washout period during which time they will continue to eliminate the food produce eliminated in intervention period II. On the last day of this washout period, subjects will provide a milk sample (approximately 10 mL), a maternal stool sample, and an infant stool sample. Infant crying and fussiness will also be monitored and recorded daily.
#Intervention
- OTHER : Cow's Milk
- Participants will consume 200 mL, 300 mL, and 400 mL of 1% bovine milk during the diet challenge which occurs on three consecutive days of the study. The first day of the diet challenge participants consume 200 mL, the second day 300 mL and the third day 400 mL.
- OTHER : Soy Milk
- Participants will consume 200 mL, 300 mL, and 400 mL of soy milk during the diet challenge which occurs on three consecutive days of the study. The first day of the diet challenge participants consume 200 mL, the second day 300 mL and the third day 400 mL.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy women aged >= 18 years
* Ability to drive to Boise, Idaho or Moscow, Idaho or New York, New York
* Must be currently lactating or breastfeeding
* Mothers of infants aged 0 <= age <= 12 months
* Willing to provide samples of human milk
* Willing to consume 1 <= age <= 2 cups of soy milk and cow's milk daily for 3 days each
Exclusion Criteria:
* Individuals who are unable or unwilling to consume bovine or soy milk
* Individuals unwilling or unable to provide samples of human milk
* Individuals unable to speak and read English
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04851340
|
{
"brief_title": "Investigating the Detection of Bovine and Soy Proteins in Human Milk",
"conditions": [
"Microbiome",
"Stress",
"Food Allergy in Infants"
],
"interventions": [
"Other: Cow's Milk",
"Other: Soy Milk"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04851340",
"official_title": "Validation of a Proprietary Test Strip for the Detection of Bovine and Soy Proteins in Human Milk: A Randomized Crossover Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-07-31",
"study_completion_date(actual)": "2021-08-31",
"study_start_date(actual)": "2020-11-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-03-03",
"last_updated_that_met_qc_criteria": "2021-04-16",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-20",
"first_submitted": "2020-12-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Pulse pressure variation (PPV) is a well-known and widely used dynamic preload indicator based on heart-lung interaction to predict fluid responsiveness. Generally, patients are considered to be fluid-responsive when the PPV value larger than 11-13%. However, several previous researches demonstrated that there is a zone of uncertainty (grey zone) in PPV. To predict fluid-responsiveness accurately in the patients with PPV within grey zone (9-13%), the investigators would evaluate the augmented PPV using augmented ventilation.
#Intervention
- OTHER : Augmented ventilation
- When the patient's PPV is within grey zone, patient's tidal volume is maintained with augmented tidal volume of 12 ml/kg (from normal ventilation of 8ml/kg) for 2min duration.
- OTHER : Fluid loading
- We record the stroke volume index (SVI) values before and after volume expansion with 6ml/kg of balanced crystalloid
- Other Names :
- Balanced crystalloid infusion
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients undergoing elective open laparotomy surgery.
Exclusion Criteria:
* Irregular heart beats,
* cardiac arrhythmia,
* moderate or severe valvular heart disease,
* preoperative left ventriular ejection fraction less than 40%,
* moderate t severe obstructive pulmonary disease,
* preoperative need of inotropics infusion,
* preoperative serum Cr > 1.3ml/dl,
* moderate to severe renal or liver disease,
* acute lung injury or acute lung problem,
* coexisting open chest condition,
* severe bradycardia,
* patients with spontaneous breathing
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02653469
|
{
"brief_title": "Augmented Pulse Pressure Variation to Predict Fluid Responsiveness in Open Laparotomy",
"conditions": [
"Gynecologic Neoplasms",
"Abdominal Neoplasms"
],
"interventions": [
"Other: Fluid loading",
"Other: Augmented ventilation"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT02653469",
"official_title": "Pulse Pressure Variation With Augmented Ventilation to Predict Fluid Responsiveness in the Patients Undergoing Open Laparotomy Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02",
"study_completion_date(actual)": "2016-02",
"study_start_date(actual)": "2015-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-04",
"last_updated_that_met_qc_criteria": "2016-01-09",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-01-12",
"first_submitted": "2015-10-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Cervicogenic headache (CGH) manifests as unilateral neck pain referred from the neck's soft tissues or bony structures. The aim of this study will be to compare the effectiveness of Shi style cervical mobilization versus Sustained Natural Apophyseal Glides on pain, strength and functional disability in patients with Cervicogenic Headache.
Detailed Description
A Randomized Clinical Trial will be conducted at Jinnah hospital Lahore through consecutive sampling technique on 40 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with shi style mobilizations with 6 sesions over 4 weeks for 20minutes. Group B will be treated with Sustained Natural Apophyseal Glides with Number of repetitions are increased gradually from 6 to 10 and end physiological movement is maintained for 10seconds. Outcome measures will be conducted through NPRS for pain , Deep Neck flexors strength by pressure Biofeedback, Dizziness Handicap Inventory for pain and change in dizziness, NDI for functional impairments and SF 36 for quality of life.Data will be analyzed through SPSS software version 25 .
#Intervention
- OTHER : shi style mobilization
- Step 1 soothing tendon stepTherapist will aerate patient's neck 3 to 6 times.Step 2 moblization step Therapist will apply low velocity small amplitude oscillatory movement without thrust. Head will be in 45 degrees of flexion or extension. Repeat this for 3 to 6 times. Then distraction force is applied to the cervical. Step 3 dredging collateral step Therapist holds thenar and hypothenar muscles of patient's hand on affected side and gently shook the upper limb ebb and flow with small shaking and high frequency. Repeat the procedure 3 times 6 sesions over 2 weeks for 20minutes
- OTHER : SNAGS
- Patient will receive sustained natural apophyseal glides as described by brian mulligan. Patient position will be upright sitting when therapist will apply a sustained passive assesory glide while patient moves actively through available physiological range of motion in the direction in which symptoms are produced. the headache SNAG technique will be performed with the patient sitting on a chair in the erect posture. The therapist will handle C2 spinous process with the middle phalanx of one hand. With the other hand, he will perform ventral gliding on C2 for 10 repetitions holding for 10 seconds in each glide with a rest time of 30 seconds in between. Patient will be asked to report dizziness or any other symptom after procedure. If patient reports symptom then angle of application is changed to ensure symptom free treatment in all patientsNumber of repetitions are increased gradually from 6 to 10 and end physiological movement is maintained for 10second
|
#Eligibility Criteria:
Inclusion Criteria:
* Age:18 <= age <= 65.
* Both male and females.
* Unilateral dominant headache.
* Positive International Headache Society Diagnostic Criteria (IHS) for cervicogenic headache.
* Decrease strength deep neck flexors by pressure biofeedback.
* Tenderness of the upper 3 cervical spine joints.
Exclusion Criteria:
*
* Patients who received any treatment for CGH within the previous 3 months that would interfere with this study.
* Pregnant females.
* Inflammatory conditions in which manual therapy is contraindicated(29).
* Cancer or brain diseases.
* Recent fracture or injuries.
* Congenital conditions of the cervical spine.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06459726
|
{
"brief_title": "Effects of Shi Style Cervical Mobilization Versus SNAGS in Patients With Cervicogenic Headache",
"conditions": [
"Cervicogenic Headache"
],
"interventions": [
"Other: SNAGS",
"Other: shi style mobilization"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT06459726",
"official_title": "Effects of Shi Style Cervical Mobilization Versus Sustained Natural Apophyseal Glides on Pain,Strength and Functional Disability in Patients With Cervicogenic Headache.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-07-01",
"study_completion_date(actual)": "2024-08-30",
"study_start_date(actual)": "2024-05-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-27",
"last_updated_that_met_qc_criteria": "2024-06-11",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-06-14",
"first_submitted": "2024-06-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI) in HSV-2 seronegative ethnic Japanese adults aged 18-40 years.
#Intervention
- BIOLOGICAL : HSVTI Formulation 1
- This investigational intervention will be administered intramuscular as 2 doses to HSVTI_F1 Group.
- BIOLOGICAL : HSVTI Formulation 2
- This investigational intervention will be administered intramuscular as 2 doses to HSVTI_F2 Group.
- BIOLOGICAL : Placebo
- This intervention will be administered intramuscular as 2 doses to Placebo group.
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
* Written informed consent obtained from the participant prior to performance of any study-specific procedure.
* Healthy participants as established by medical history and physical examination, at the discretion of the investigator, before entering into the study.
* Man or woman aged 18 <= age <= 40, included, at the time of screening.
* Japanese ethnic origin (defined as having been born in Japan with 4 ethnic Japanese grandparents and able to speak Japanese).
* Women of non-childbearing potential may be enrolled in the study.
* Women of childbearing potential may be enrolled in the study, if the participant:
* Has practiced highly effective contraception for 1 month prior to study intervention administration, and
* Has a negative pregnancy test result at the Screening visit and on the day of each study intervention administration, and
* Has agreed to continue highly effective contraception until Day 118, approximately 3 months post-Dose 2.
Blood sample for simultaneous FSH and estradiol levels may be collected and tested locally at the discretion of the investigator to confirm non-reproductive potential according to local laboratory reference range.
* Seronegative for HSV-2 as determined by Western blot performed at the Screening visit.
Exclusion Criteria:
Medical conditions:
* Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Clinically significant abnormalities may include but are not limited to: evidence of cardiac damage, heart failure categorized as class II or greater according to the New York Heart Association functional classification, heart valve disease, pulmonary uncontrolled persistent asthma despite treatment, uncontrolled diabetes, or disease or disorder that may put the participant at risk or influence study results.
* Participants with a controlled underlying chronic co-morbidity may be enrolled, provided there have been no changes to their medication within 3 months prior to the Screening visit.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study or that would interfere with the immunogenicity assessments planned in this study.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
* Any confirmed or suspected immunosuppressive or immunodeficient condition or documented or suspected HIV infection, based on medical history and physical examination (no laboratory testing required).
Hypersensitivity to latex.
* Recurrent history of or uncontrolled neurological disorders or seizures.
* At the screening visit: hematological parameters (hemoglobin level, white blood cell, platelet) and/or biochemical parameters (ALT, AST, creatinine, blood urea nitrogen) outside the normal laboratory ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator.
* Body mass index =18 kg/m2 or =35 kg/m2.
* History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications (including meningitis, encephalitis, radiculopathy, myelitis).
Prior/Concomitant therapy:
* Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning as of the Screening visit, or their planned use during the study period.
* Planned administration or administration of a vaccine* in the period starting 15 days* before each dose and ending 15 days* after each dose of study intervention administration**.
* In case of adjuvanted and live-attenuated vaccines, this time window is to be increased to 30 days before and after each dose.
* In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
* Administration or planned administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study intervention or planned administration during the study period.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose. For corticosteroids, this will mean prednisone equivalent =20 mg/day for adult participants. Inhaled, intra articular and topical steroids are allowed.
* Prior receipt of a vaccine containing HSV antigens.
Prior/Concurrent clinical study experience:
* Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug or invasive medical device).
Other exclusions:
* Pregnant or lactating woman. Woman planning to become pregnant or planning to discontinue contraceptive precautions before Day 118 (approximately 3 months post-Dose 2).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05989672
|
{
"brief_title": "A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years",
"conditions": [
"Herpes Simplex"
],
"interventions": [
"Biological: Placebo",
"Biological: HSVTI Formulation 1",
"Biological: HSVTI Formulation 2"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT05989672",
"official_title": "A Phase 1, Observer-blind, Randomized, Placebo-Controlled Study to Evaluate Reactogenicity, Safety and Immune Response of an HSV-targeted Immunotherapy in HSV-2 Seronegative Japanese Participants Aged 18-40 Years",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-29",
"study_completion_date(actual)": "2024-04-24",
"study_start_date(actual)": "2023-08-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-30",
"last_updated_that_met_qc_criteria": "2023-08-04",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-14",
"first_submitted": "2023-08-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device. The study aimed to determine whether the novel formulation (Simoon) had a similar profile to that of the established formulation (Concept1).
Detailed Description
This study was double-blind with regards to the Concept1, where placebo for the lactose-blended indacaterol was available. However, with regards to the Simoon, neither the subject nor the investigator was blinded due to lack of a placebo to the PulmoSphere formulation. Hence, the overall designation of the study was partially-blind.
#Intervention
- DRUG : Indacaterol 150 μg via the Concept1 dry-powder inhaler
- Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler.
- DRUG : Indacaterol 60 μg via the Simoon dry-powder inhaler
- Indacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.
- DRUG : Indacaterol 120 μg via the Simoon dry-powder inhaler
- Indacaterol 120 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.
- DRUG : Placebo to indacaterol via the Concept1 dry-powder inhaler
- Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.
|
#Eligibility Criteria:
Inclusion criteria:
* Patients with persistent asthma with a forced expiratory volume in 1 second (FEV1) >= 50%
* Patients using inhaled corticosteroid (with or without long-acting beta agonist)
Exclusion criteria:
* Asthma exacerbations in previous 6 months
* Chronic obstructive pulmonary disease (COPD) or other pulmonary disease
* Excessive use of short-acting beta agonists
Other protocol-defined inclusion/exclusion criteria applied to the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01012739
|
{
"brief_title": "Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices",
"conditions": [
"Asthma"
],
"interventions": [
"Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler",
"Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler",
"Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler",
"Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler"
],
"location_countries": [
"Germany",
"Netherlands",
"United Kingdom"
],
"nct_id": "NCT01012739",
"official_title": "A Randomized, Partially-blinded, Single-dose, 4-way Cross-over Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Maleate Administered Via the Concept1 Device or Via the Simoon Device",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-03",
"study_completion_date(actual)": "2010-03",
"study_start_date(actual)": "2009-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-08-29",
"last_updated_that_met_qc_criteria": "2009-11-12",
"last_verified": "2011-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-11-13",
"first_submitted": "2009-11-12",
"first_submitted_that_met_qc_criteria": "2011-07-22"
}
}
}
|
#Study Description
Brief Summary
There is a strong association between smoking and schizophrenia with prevalence rates ranging from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number of hypotheses have been proposed to explain the relationship between high smoking rates and schizophrenia, mostly relating to self-medication primarily for the negative symptoms of schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower than for other psychiatric disorders. The negative health effects of smoking increase the morbidity and mortality in schizophrenic patients. Currently, the efficacy of bupropion HCl in the treatment of smoking by schizophrenic subjects is inconclusive, and there have not been any published studies of the efficacy of varenicline in schizophrenic subjects. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be useful to expand these studies to examine its effects in schizophrenic patients. Identifying effective and safe means of smoking cessation for this vulnerable population has the potential to reduce morbidity and mortality among individuals with schizophrenia.
Detailed Description
There is a strong association between smoking and schizophrenia with prevalence rates ranging from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number of hypotheses have been proposed to explain the relationship between high smoking rates and schizophrenia, mostly relating to self-medication primarily for the negative symptoms of schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower than for other psychiatric disorders. The negative health effects of smoking increase the morbidity and mortality in schizophrenic patients. The smoking cessation agent bupropion HCl has been tested in schizophrenics, but the results on its efficacy are inconclusive. Recent works by different laboratories have shown the safety and efficacy of varenicline, a partial alpha4beta2 and full alpha7 nicotinic acetylcholine receptor agonist, as a smoking cessation agent. However, to date, no published studies have tested the safety and efficacy of varenicline in treatment of nicotine dependence in schizophrenic patients. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be beneficial to examine its effects in schizophrenic patients. The central hypothesis of this application is that treatment with varenicline will safely increase smoking abstinence rates in schizophrenic patients when compared to those receiving placebo. This central hypothesis will be tested and the objectives of this application accomplished by pursuing two Specific Aims: 1) Treatment with varenicline or bupropion HCl for a period of three months will increase smoking abstinence rates in schizophrenic patents when compared to placebo; and 2) Treatment with varenicline or bupropion HCl for a period of three months will not increase psychosis in schizophrenic patients when compared to placebo. For our General Investigational Plan, we will employ a double-blind randomized placebo controlled study to assess varenicline's safety and efficacy. It is our expectation that we will demonstrate that varenicline is safe and effective in decreasing smoking rates in schizophrenic patients without exacerbating psychotic symptoms. Such outcomes will be significant, because they will offer a new treatment for smoking cessation in this vulnerable population.
#Intervention
- OTHER : Sugar Pill
- Sugar pill created and masked by the pharmacy to be used as a control.
- DRUG : Varenicline
- Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
- Other Names :
- Chantix
- DRUG : Bupropion HCl
- in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
- Other Names :
- Wellbutrin, Zyban
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects, 18 <= age <= 75 years
* Diagnosis of schizophrenia or schizoaffective disorder based on Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria
* Smoking at least 10 cigarettes per day
* Weight of at least 100 lbs (45.4 kg)
* Motivation to quit smoking
* Stabilized psychotic symptoms
* Provision of informed consent for testing and treatment
Exclusion Criteria:
* Serious cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorder
* Seizure disorder, recent withdrawal from alcohol or anxiolytics
* History of bulimia nervosa, anorexia nervosa, or dementia
* History of depression, panic, or bipolar disorders
* Pregnancy or lactation
* Prior use of varenicline or bupropion HCl within three months prior to initiation of the study
* Current use of other smoking cessation treatments
* Regular use of non-cigarette tobacco products (> than once/week)
* Past substance abuse (alcohol or non-nicotine containing drugs) in the preceding 6 months
* Patients with suicidal ideations or plans
* Florid psychosis or increasing psychosis following varenicline or bupropion HCl treatment
* History of, or current, alcohol dependence/abuse
* Current use of monoamine oxidase inhibitors (MAOI)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01111149
|
{
"brief_title": "Varenicline and Smoking Cessation in Schizophrenia",
"conditions": [
"Schizophrenia",
"Smoking Cessation"
],
"interventions": [
"Other: Sugar Pill",
"Drug: Varenicline",
"Drug: Bupropion HCl"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01111149",
"official_title": "Varenicline and Smoking Cessation in Schizophrenia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-08",
"study_completion_date(actual)": "2012-08",
"study_start_date(actual)": "2009-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-07-17",
"last_updated_that_met_qc_criteria": "2010-04-26",
"last_verified": "2014-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-04-27",
"first_submitted": "2010-04-23",
"first_submitted_that_met_qc_criteria": "2014-06-02"
}
}
}
|
#Study Description
Brief Summary
The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.
#Intervention
- DRUG : AZD1222
- For subjects in part 1 will have that route of Administration as Intramuscular, 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) on V2
- DRUG : 0.9% (w/v) saline
- For subjects in placebo will have that route of Administration as Intramuscular 0.9% (w/v) saline on V2 and V6.
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants aged 18 <= age <= 55 (Cohort A and C), aged 56 <= age <= 69 (Subcohorts B1 and D1), or aged >= 70 years (Subcohorts B2 and D2)
Exclusion Criteria:
* Known past laboratory-confirmed SARS-CoV-2 infection
* Positive SARS-CoV-2 RT PCR test at screening
* Seropositivity to SARS-CoV-2 at screening.
* Significant infection or other illness, including fever > 37.8°C on the day prior to or day randomization
* History of Guillain-Barré syndrome
* Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting <= 14 days)
* History of allergy to any component of the vaccine
* Any history of angioedema
* Any history of anaphylaxis
* Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and uterine cervical carcinoma in situ)
* History of serious psychiatric condition likely to affect participation in the study
* Bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
* Suspected or known current alcohol or drug dependency
* Any other significant disease, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study or impair interpretation of the study data
* Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04568031
|
{
"brief_title": "Study of AZD1222 for the Prevention of COVID-19 in Japan",
"conditions": [
"COVID-19"
],
"interventions": [
"Drug: AZD1222",
"Drug: 0.9% (w/v) saline"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT04568031",
"official_title": "A Phase I/II Randomized, Double-blind, Placebo-controlled Multicentre Study in Participants Aged 18 Years or Older to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-11-22",
"study_completion_date(actual)": "2021-11-22",
"study_start_date(actual)": "2020-08-23"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-01",
"last_updated_that_met_qc_criteria": "2020-09-25",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-29",
"first_submitted": "2020-08-21",
"first_submitted_that_met_qc_criteria": "2023-08-04"
}
}
}
|
#Study Description
Brief Summary
Autoimmune Addison's disease (AAD) is a rare and debilitating disease in which an autoimmune attack progressively destroys the adrenal cortex. Untreated it is universally fatal and treated people are absolutely dependent upon steroid medications lifelong, with a consequent excess in morbidity and mortality. A key feature of the adrenal cortex is that its cells are responsive to changes in circulating adrenocorticotrophic hormone (ACTH) concentration. This study aims to regenerate adrenocortical steroidogenic cell function in patients with established autoimmune Addison's disease (AAD) by stimulating proliferation and differentiation of their progenitor cells, the adrenocortical stem cells (ACSCs) (1,2). Using daily subcutaneous ACTH, administered according to two different regimens over 20 weeks, we will investigate whether regeneration of adrenal steroidogenic function through revival of ACSC activity is a realistic possibility.
#Intervention
- DRUG : depot tetracosactide
- 1mg, 3x weekly by sc injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Established autoimmune adrenal failure for >1yr age 16 to 65
Exclusion Criteria:
* Significant cardio-respiratory, chronic renal or non-autoimmune liver disease; malignancy
* Asthma, current infectious disease, recent live vaccination, acute psychosis, peptic ulcer disease
* Pregnancy, breast feeding or plan for pregnancy within 9 months
* Known non-autoimmune cause for adrenal failure (haemorrhage, adrenoleukodystrophy etc.)
* Known hypersensitivity or allergy to Synacthen
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 66 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01371526
|
{
"brief_title": "Revival of Stem Cells in Addison's Study",
"conditions": [
"Adrenal Failure"
],
"interventions": [
"Drug: depot tetracosactide"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT01371526",
"official_title": "Revival of Autochthonous Adrenocortical Stem Cells in Autoimmune Addison's Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-09",
"study_completion_date(actual)": "2012-09",
"study_start_date(actual)": "2010-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-02-06",
"last_updated_that_met_qc_criteria": "2011-06-09",
"last_verified": "2013-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-06-13",
"first_submitted": "2011-03-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compare disease response of Albumin-bound paclitaxel (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC).
#Intervention
- DRUG : Albumin-bound paclitaxel
- Administered by intravenous infusion.
- Other Names :
- ABI-007, ABRAXANE®, nab®-paclitaxel
- DRUG : Paclitaxel
- Administered by intravenous infusion.
- Other Names :
- Taxol®
- DRUG : Carboplatin
- Administered by intravenous infusion. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). For the purposes of this protocol, the GFR is considered to be equivalent to creatinine clearance (calculated by the method of Cockcroft and Gault, 1976).
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)
* Male or non-pregnant and non-lactating female, and equal or greater than age 18
* If a female patient is of child-bearing potential, as evidence by regular menstrual periods, she must have a negative serum pregnancy test (beta human chorionic gonadotropin [βhCG]) documented within 72 hours of the first administration of study drug
* If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator
* No other current active malignancy
* Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion)
* Patients must have received no prior chemotherapy for the treatment of metastatic disease. Adjuvant chemotherapy permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study
* Patient has the following blood counts at baseline:
* Absolute neutrophil count (ANC) greater than or equal to 1.5x10^9/L
* Platelets greater than or equal to 100x10^9/L
* Hemoglobin (Hgb) greater than or equal to 9 g/dL
* Patient has the following blood chemistry levels at baseline:
* Aspartate aminotransferase (SGOT), alanine aminotransferase (SGPT) less than or equal to 2.5 x upper limit of normal range (ULN) or less than or equal to 5.0 x ULN if liver metastases;
* Total bilirubin less than or equal to ULN
* Creatinine less than or equal to 1.5 mg/dL
* Expected survival of greater than 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities
Exclusion Criteria:
* Evidence of active brain metastases, including leptomeningeal involvement. Prior evidence of brain metastasis permitted only if treated and stable and off therapy for greater than or equal to 1 month
* The only evidence of disease is non-measurable
* Patient has pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events [CTCAE] Version 3).
* Patient received radiotherapy in the last 4 weeks, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed
* Patient has a clinically significant concurrent illness
* Patient has received treatment with any investigational drug within the previous 4 weeks
* Patient has a history of allergy or hypersensitivity to any of the study drugs
* Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug
* Patient is enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00540514
|
{
"brief_title": "Albumin-bound Paclitaxel (ABI-007) for Patients With Advanced Non-Small Cell Lung Cancer",
"conditions": [
"Non-Small Cell Lung Carcinoma"
],
"interventions": [
"Drug: Albumin-bound paclitaxel",
"Drug: Carboplatin",
"Drug: Paclitaxel"
],
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT00540514",
"official_title": "A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared With Taxol and Carboplatin as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-10-01",
"study_completion_date(actual)": "2013-02-01",
"study_start_date(actual)": "2007-11-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-29",
"last_updated_that_met_qc_criteria": "2007-10-05",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-10-08",
"first_submitted": "2007-10-04",
"first_submitted_that_met_qc_criteria": "2013-08-16"
}
}
}
|
#Study Description
Brief Summary
We retrospectively review a single-center cohort of gallbladder polyps from January 2015 to May 2020. Univariate and multivariable analyses were performed to extract potential risky factors of neoplastic polyps. Also, a comparison was conducted between laparoscopic cholecystectomy (LC) and laparoscopic polypectomy (LP) to explore factors affecting surgeons' decision on LC or LP.
#Intervention
- OTHER : Non
- This is a retrospective study, without intervention.
|
#Eligibility Criteria:
Inclusion Criteria:
Surgical indications for LC included polyp diameter over 10 millimeters, or polyps accompanied by GB stones, or consideration of neoplastic polyps. Surgical indications for GB-preserving surgery included GB with normal emptying function and polyp diameter smaller than 10 millimeters, or consideration of benign non-neoplastic polyps, or asymptomatic polyps.
Exclusion Criteria:
Those do not fit for laparoscopic surgery.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04762797
|
{
"brief_title": "Management Strategy of Polypoid Lesions of the Gallbladder",
"conditions": [
"Polyp Gallbladder"
],
"interventions": [
"Other: Non"
],
"location_countries": [
"China"
],
"nct_id": "NCT04762797",
"official_title": "Management Strategy of Polypoid Lesions of the Gallbladder: a Single-center Retrospective Cohort Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-05-31",
"study_completion_date(actual)": "2020-12-31",
"study_start_date(actual)": "2015-01-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-02-21",
"last_updated_that_met_qc_criteria": "2021-02-17",
"last_verified": "2015-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-21",
"first_submitted": "2021-02-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Background: There is a need for projects that link work closer to the rehabilitation chain to further understand risk factors for sick-leave. The new aspect of this project is that it combines work place intervention with individualized physiotherapy, based on validated standardized tests and a classification based treatment system.
Aim: The aim is to expand the knowledge and understanding of complex causes of musculoskeletal pain, particularly low back pain (LBP). The main aim is to examine if cognitive functional therapy (CFT) can further reduce sick-leave and pain, and increase function and well-being.
Material and methods: To ensure good recruitment we have collaboration with the Department for Health and social services in the county of Bergen, which has a sickness absence above average among their health workers.
We will invite those with LBP problems to be included in an RCT and receive CFT in a physiotherapy clinic (usually offered 5 to 12 visits). The comparison group will receive a series with cognitive patient education and physiotherapy (COPE-PT) given by a physiotherapist. All participants will be followed by their workplace leaders. All patients who enter the RCT will be re-examined at 3 and 12 months and the predictors for sick-leave, function and coping in different sub-groups of patients with NSLBP will be studied.
Detailed Description
Musculoskeletal complaints: Function, activity and work
1. Introduction and relevance
Causes of sick-leave are multidimensional, and even if a sick-listed person has physical pain and/or functional problems, treatment models that focus only on these aspects are often not successful. In fact a sole focus on physical impairment may even medicalize the problem and increase a person's dependency on care professionals. Current knowledge suggests it is necessary to combine cognitive, functional and organizational strategies which include the workplace leader in order to reduce sick-leave absence. High quality clinical studies set in a Norwegian workplace that take all these aspects into consideration are scarce, and there is a need for research in which multiple dimensions are integrated in the management of persons who are, or are about to become sick-listed.
Musculoskeletal complaints and particularly non-specific low back pain (NSLBP) is a common reason for sick-leave in Norway. Risk profiling and stratification of workers with NSLBP is central in this project. Differences in functional capacity and requirements, particularly at work and in activities of daily living, means that workers with similar medical diagnoses may need different treatments. This research project proposes a several stages process. In the first stage, those workers who become sick-listed, or who are on the brink of becoming so, due to musculoskeletal complaints, including NSLBP, will be closely supported by specially trained workplace leaders with a focus on preventing medicalization of the problem and promoting activity. It is a legal responsibility for every workplace in Norway to take care of workers with health problems, but this has in many work-places not been optimized. In the next stage those who have musculoskeletal complaints will be invited to undergo a functional evaluation 4 weeks after their first day of sick-leave or start of their complaint. This functional evaluation can be used in the communication between the patient, their work leader and/or their primary health caretaker. Those with LBP will be invited to test an intervention model that builds on recent knowledge about sub-classification of NSLBP to reduce sick-leave, improve function and coping. This treatment is called cognitive functional therapy (CFT), will be tested in a randomized, controlled trial (RCT). There will be a comparison group in the RCT who will get a series with cognitive patient education and physiotherapy (COPE-PT) by specially trained physiotherapists. All participants will be followed by their work leaders. To enhance understanding about the causes and mechanisms of sick-leave, and to understand workers experience of treatments as well as the work leaders experience of the educational courses and their use of the functional evaluation, a parallel qualitative process evaluation will take place. The project intends to increase our knowledge of risk factors for sickness absence and how to improve the communication between the patient, their workplace and caretakers.
2 Stratification of back pain has received increased attention the last few years. There is increasing evidence that interventions based on a multidimensional understanding of patients with back- and pelvic related problems allowing more targeted intervention and can have implications for the treatment effect (Main \& Watson 1996; O'Sullivan 1997; Linton 2000; Skouen et al. 2002; Fritz et al. 2003; Fersum et al. 2009). It is important that the multidimensional intervention takes place within a bio-psycho-social perspective, enabling targeted intervention towards the underlying mechanisms of pain and disability.
Cognitive patient education (COPE) for patients with musculoskeletal pain problems, including LBP, has for the last few years become an element, either alone or as part of multidisciplinary pain programs (Moseley et al. 2004; Werner et al 2010).
3. Methods and material
This study is a RCT for patients with NSLBP. Those with remaining LBP complaints at this stage will be randomized to either targeted cognitive functional therapy (CFT) intervention taking place in a physiotherapy clinic or to a comparison group with cognitive patient education and physiotherapy (COPE-PT). All will be followed by their workplace leader at their individual workplace.
Research questions:
RCT study: Persons with 4-8 weeks of sick-leave and/or who has remaining NSLBP at this stage: Do workers receiving cognitive functional therapy (CFT) combined with workplace intervention, have reduced sick-leave, improved function and coping, compared to those receiving cognitive patient education and physiotherapy (COPE-PT), in combination with workplace intervention, at 3 and 12 months after the intervention?
Material, design and outcome measures
Study
Cognitive functional therapy (CFT) compared to cognitive patient education and physiotherapy (COPE-PT) for patients with non-specific chronic low back pain (NSCLBP):
Participants with NSCLBP will be recruited as part of another study related to the FAkta project. Before randomization all patients will be examined with standardized tests as well as with a short walking test with the use of an accelerometer.
Workers with NSLBP will be randomized to either CFT (O'Sullivan, 2000, 2005) or to a comparison group with COPE-PT. All participants will be followed by their workplace leaders. Persons who randomly are allocated to either the CFT intervention group or comparison group COPE-PT will be offered treatment by specially trained physiotherapists at a physiotherapy clinic, based on the multidimensional understanding of their complaints.
Outcome measures: The primary outcome measure in the RCT is sick-leave, measured by number of days absence from work. The participants in this study will, in addition to the questionnaires mentioned above, have the the Roland Morris questionnaire as secondary outcome measure. The project will start at the beginning of 2012, and persons will be included until the end of 2013, with the last follow-up at the end of 2014.
Power calculation: In a former study (Steenstra et al. 2006) where a similar model for workplace intervention was evaluated, an average of 100 days (SD=96.0) of sick-leave was found for back patients who received intervention, compared to 130 days (SD=70.0) in those who received treatment-as-usual. A sample size of 123 participants in each group gives a power of 80 % to detect an effect of this magnitude with significance level at 0.05.
However, a recent power calculation based on the recent results from Fersum et al. (2013) where CFT was compared to manual therapy indicate that it should be sufficient with 30 participants in each group. The results have still not been published internationally, but measured in effect size (ES), the difference between the new CFT compared to today's usual practice with manual therapy and exercise was around 1 ES on most measures, in favor of the CB-CFT, reflecting both a statistical and clinical significant difference. The participant in this new study will, however, probably have more problems compared to the previous RCT. This has enabled us to aim for intervention group and one comparison group with at least 50, but hopefully close to 70 in each group. This sample size will give adequate power to detect sick-leave differences of this magnitude, even allowing for a substantial attrition rate.
Personal resources in the study : All PTs that will take part in study will receive an instructional course covering subjects like work life, optimal cognitive approach for the patients, and strategies to ensure optimal co-operation between the workplace and the worker. Three of these experienced therapists will have specialized training in the CFT intervention, which they have already utilized in participation in a similar, recent RCT. The 4-5 PTs in the second intervention group will not be familiar with CFT, but they will receive much training in cognitive coping techniques after the COPE-PT LBP trial principles (Werner et al. 2010). The educational part of the COPE-PT for new instructors with a PT background takes 2 days supervised by Werner and his group, with regular follow-up meeting with the project leaders, together with a psychologist trained in cognitive therapy (Minna Hynninen).
The CFT is adjusted to the individual, with minimum duration of 45 minutes each session, and 4 - 8 treatments during a period of 8 - 12 weeks (average 7-8 treatments). Follow-up will take place after the intervention period (at 3 months) and will include a physical examination and questionnaires. The next follow-up will be at 12 months and by questionnaires only. The participants in COPE-PT will receive one weekly session 4 times, and the follow-up examination will also be at 3 and 12 months, similar to the CFT group.
The person in charge of the RCT is researcher Kjartan Vibe Fersum, who will assist in the project co-ordination and CFT treatment. Alice Kvåle will together with the research fellow Tove Ask be an assessor of all patients who enter the project at 4-6 weeks. Only Kvåle will do the re-examination at 3 months of patients who have entered the RCT and she will be blinded for group belonging.
4. Organization, budget and relevance
Project management, organisation and cooperation The Physiotherapy research group, unit for Musculoskeletal complaints, at the Department of Public Health and Primary Health Care, University of Bergen (UiB) is responsible for managing and organizing the project, in cooperation with the Department of Health- and Social Services at Bergen County. This department has documented above average sick-leave among their health service employees, and both the management and the political leaders of the department aim to reduce this.
Budget This project has got Nkr. 4.700.000,- from the Norwegian Fund for Postgraduate Training in Physiotherapy to cover expenses for Kjartan Vibe Fersum and Tove Ask in the time period 2011 to 2015. Other resources are either part of our research positions at UiB or have been/will be applied for. Details are found in Appendix IV. The Department of Health and Social Services at Bergen County has agreed to let the workplace leaders and union leaders have paid leave when participating in the education courses and/or in the focus group interviews.
Compliance with strategic documents At the Department of Public Health and Primary Health Care, UiB, we have many resource persons who have musculoskeletal pain as their major area of interest, which is reflected both in the departments' research and teaching. One major goal is to further enhance knowledge and understanding regarding the complex causes and mechanisms of musculoskeletal pain and disability, as well as to examine the effect of a targeted functional approach in combination with focus on the workplace, evaluated both on the individual and the societal level. Part of this project aims to identify subgroups of workers with non-specific low back pain who just have been sick-listed or who are about to be so. This allows workers to be classified in such a way that they will respond to targeted treatment and get substantial improved effect of the intervention in comparison to what is usual today. The project will be performed in close co-operation with the Department of Health and Social Services, Bergen County.
Relevance to society In a recent reform for interaction between the municipalities and secondary health services in Norway ('Samhandlingsreformen' 2010), the importance of increased focus on health promotion and rehabilitation within the local councils has been underlined. A more efficient system of management and treatment within the primary health care system should prevent more extensive and chronic complaints. Recognition of the early signs and risk factors of musculoskeletal complaints in a bio-psycho-social perspective in different subgroups of workers is of great importance. Health promotion and rehabilitative measures must recognize the different needs of different groups ('Rett behandling, på rett sted, til rett tid' - Jfr. St.m.47). Effective communication between the worker, the workplace and the treating PTs/MTs in the municipality are central. The workers who are recruited to the project are themselves all workers within the Department of Health and Social Services. Their work is often quite physically demanding, and they have an above average percentage of sick-leave. It is challenging to try to improve function in workers with heavy workloads in order to reduce sick-leave, for the benefit of the individual and for society.
The project is likely to have important consequences regarding how workers at risk are cared for in the workplace, potentially highlighting the need for the right actions to the right time. The results of this study may lead to better interaction between health personnel (here mainly PTs/MTs), the work place and the occupational health services. The RCT will clarify whether classification based CFT results in greater improvements in function and working ability, than treatment-as-usual. The qualitative part of the project will give insight into the mechanisms for sick-leave, and give additional information as far as aspects that can be improved in to enhance workplaces effectiveness in dealing with musculoskeletal complaints, especially with reference to workers with back problems.
Environmental perspectives By means of the RCT the aim is to test if the new treatment model of CFT combined with focus on the workplace, will lead to improved function and less sickness absence, in comparison to a cognitive treatment strategy without hands-on.
5. Ethics
Ethical aspects There is no harm related to participation in the project. The participants will get written and verbal information about the project via their workplace leader (head nurse/department leader). Pamphlets will also be distributed with information at the different workplaces. Interested participants with musculoskeletal complaints will then directly book an appointment. An informed consent will be made separately for Study II, and a new one for Study III and IV. According to current rules and regulations regarding responsibility for employees, each work place should maintain regular contact with sick-listed workers and try to include them at work ('Avtale om Inkluderende arbeidsliv'). The additional part will be to fill in questionnaires and agree to a physical examination 4-6 weeks later. Participants will, when included into the RCT in Study III, be asked if they want to take part in the focus group interviews in Study IV. An application for the complete project will be sent to Regional Ethical Committee.
Gender equality and gender perspectives More women than men are working in health care and have a higher percentage of sick-leave, although both gender will be invited to participate. The project will focus on identifying mechanisms for sick-leave absence in a bio-psycho-social perspective, and the gender perspective, both organizational and physical, will be focused on.
6. Communication with users and utilization of results
Communication with users Central users in this project are health workers in the primary health care system and representatives from them have been involved in planning of the project and will continue to be so. The research results will be mediated in meetings with the work group leaders and head nurses and in courses arranged for the employees. The workplace leaders will meet the research team and the appointed course instructors to exchange experience several times throughout the project period.
Dissemination plan The research material will be analyzed and disseminated in articles published in relevant, national and international referee based journals. Furthermore, information will be disseminated by courses and lectures to health workers employed in primary health care facilities, as well as to physiotherapists/manual therapists working in physiotherapy clinics, based on the results of the different studies. It is anticipated that the workplace contacts will continue for workers at risk for becoming sick-listed also after the project has ended, if the study has shown positive results.
#Intervention
- BEHAVIORAL : Physical Therapy
- Other Names :
- Cognitive functional therapy and Cognitive patient education
|
#Eligibility Criteria:
Inclusion Criteria:
* NSLBP for > 3 months, and reported that their pain was provoked by postures, movement and daily activities.
* Pain intensity measured with a numerical rating scale (NPRS) over the last 14 days >3/10
* Roland Morris Disability Questionnaire (RMDQ) >= 7 was necessary to be admitted to the study.
* Ørebro Musculoskeletal Pain Questionnaire-short form (ØMPQ-SF) was used to examine the participants risk profile pre-treatment, and had to be >= 30, on a scale from 0 <= age <= 100.
Exclusion Criteria:
* Continuous sick-leave duration >= 4 months
* Acute exacerbation of LBP a
* Specific LBP diagnosis - radicular pain, disc herniation, spondylolisthesis, stenosis, Modic changes
* Any low limb surgery in the last 3 months; surgery involving the lumbar spine;
* Pregnancy
* Diagnosed psychiatric disorder
* Active rheumatologic disease, progressive neurological disease
* Serious cardiac or other internal medical condition
* Malignant diseases, acute traumas, infections, or acute vascular catastrophes.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 67 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03952741
|
{
"brief_title": "Cognitive Functional Therapy Compared to Cognitive Patient Education and Physiotherapy for Patients With Low Back Pain",
"conditions": [
"Low Back Pain"
],
"interventions": [
"Behavioral: Physical Therapy"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT03952741",
"official_title": "Cognitive Functional Therapy (CFT) Compared to Cognitive Patient Education and Physiotherapy (COPE-PT) for Patients With Non-specific Chronic Low Back Pain (NSCLBP)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12",
"study_completion_date(actual)": "2017-11",
"study_start_date(actual)": "2012-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-16",
"last_updated_that_met_qc_criteria": "2019-05-14",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-16",
"first_submitted": "2017-11-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A clinical trial to compare the efficacy of azithromycin (Arm 1) vs. doxycycline (Arm 2) administered per CDC's STD Treatment Guidelines for rectal Chlamydia trachomatis (CT) in men who have sex with men (MSM). Subjects will be males aged = / \> 18 years with a microbiologically confirmed diagnosis of rectal CT and at least one male sex partner in the past 12 months. The trial will be conducted at two sites in the US and will enroll up to 274 total subjects to achieve 246 subjects who contribute to the primary analysis. The duration of this study will be approximately 16 months 22 months with subject participation duration 29 days. The primary objective of this study is to compare the efficacy of azithromycin vs. doxycycline for treatment of rectal CT infection in MSM based on microbiologic cure (negative NAAT) at Day 29.
Detailed Description
A Phase 4, multi-center, randomized, double-blinded, placebo-controlled trial to compare the efficacy of azithromycin (Arm 1) vs. doxycycline (Arm 2) administered per CDC's STD Treatment Guidelines for rectal Chlamydia trachomatis (CT) in men who have sex with men (MSM). The effect of Lymphogranuloma Venereum (LGV) infection on microbiologic cure in MSM with rectal CT will also be assessed. Arm 1 will comprise of subjects receiving 1 gram of Azithromycin (4 capsules of 250 mg) orally as a single dose, and Doxycycline placebo (1 capsule) orally twice daily for 7 days. Arm 2 will comprise of subjects receiving 100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days, and Azithromycin placebo (4 capsules) administered orally as a single dose. Subjects will be males aged = / \>18 years with a microbiologically confirmed diagnosis of rectal CT and at least one male sex partner in the past 12 months. The trial will be conducted at two sites in the US and will enroll up to 274 total subjects to achieve 246 subjects who contribute to the primary analysis. The duration of this study will be approximately 22 months with subject participation duration 29 days. The primary objective of this study is to compare the efficacy of azithromycin vs. doxycycline for treatment of rectal CT infection in MSM based on microbiologic cure (negative NAAT) at Day 29. The secondary objectives are: 1) to assess the effect of LGV infection on microbiologic cure in MSM with rectal CT at Days 15 and 29 and 2) to compare the efficacy of azithromycin vs. doxycycline for treatment of rectal CT in MSM based on microbiologic cure at Day 15.
#Intervention
- DRUG : Azithromycin
- Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.
- DRUG : Doxycycline
- Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.
- OTHER : Placebo
- Azithromycin placebo (4 capsules), administered orally as a single dose; Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Willing and able to understand and provide written informed consent before initiation of any study procedures.
* Willing and able to comply with planned study procedures for all study visits.
* Male sex at birth and aged = / > 18 years with valid contact information.
* At least one male sex partner (oral or anal) in the past 12 months.
* Untreated rectal CT diagnosed by a positive NAAT result.
* Willingness to abstain from condomless receptive anal sex during the trial.
* Willingness to complete a 7-day study drug regimen.
Exclusion Criteria:
* Current clinical diagnosis of acute proctitis per the CDC's 2015 STD Treatment Guidelines: symptoms of anorectal pain, tenesmus, and/or rectal discharge with anoscopy findings confirming inflammation.
* Concomitant untreated gonorrhea (rectal, pharyngeal, or urethral) or known exposure to gonorrhea in the time between CT testing and study enrollment.
* Clinical diagnosis of concomitant untreated primary or secondary syphilis.
* Known allergy to tetracyclines or macrolides.
* Received antimicrobial therapy active against C. trachomatis within 21 days of positive rectal CT NAAT result, or between the positive CT NAAT result and study enrollment*.
*This includes subjects treated empirically on the day of testing due to known exposure to gonorrhea or chlamydia, as well as enrollment in another study using antimicrobial therapy active against C. trachomatis, or planned enrollment in such a study during their time in this trial. Specifically, use of the following antibiotics is an exclusion criterion: azithromycin and other macrolides, doxycycline and related tetra- or glycylcyclines, fluoroquinolones, rifampin, quinupristin-dalfopristin, and linezolid.
* Plans to move to another location that would preclude study follow-up appointments in clinic or by mail-in in the next 30 days.
* Use of any investigational drug contraindicated to treatment with azithromycin or doxycycline within 7 days before enrollment.
* Previous enrollment in this trial.
* Any other condition that, in the opinion of the investigator, would interfere with participation in the trial.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03608774
|
{
"brief_title": "Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM",
"conditions": [
"Anal Chlamydia Infection"
],
"interventions": [
"Drug: Azithromycin",
"Other: Placebo",
"Drug: Doxycycline"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03608774",
"official_title": "A Phase 4, Randomized, Double-Blinded, Placebo-Controlled Trial of Azithromycin Versus Doxycycline for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-21",
"study_completion_date(actual)": "2020-02-21",
"study_start_date(actual)": "2018-07-13"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-01-07",
"last_updated_that_met_qc_criteria": "2018-07-30",
"last_verified": "2019-01-25"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-08-01",
"first_submitted": "2018-06-28",
"first_submitted_that_met_qc_criteria": "2020-12-10"
}
}
}
|
#Study Description
Brief Summary
This pilot study will use a hybrid reciprocal peer support and peer coach model to initiate and sustain heart-healthy behavioral changes in Veterans. Veterans who are at-risk for cardiovascular disease (CVD) will be enrolled in the study and paired with another Veteran to receive and provide social support around engaging in CVD risk reduction behaviors. Enrolled participants will be offered a series of 3 group sessions focused on CVD risk reduction, goal setting and action plan development. Between group sessions, peer partners will be asked to have weekly calls to discuss action plan challenges, explore options for problem solving, and provide encouragement and accountability for personal goals. Participants who do not engage in the group sessions or weekly phone calls, or who request additional help, will receive support from trained peer coaches. The goal of this pilot study is to evaluate the proof of concept for a hybrid reciprocal peer support (RPS) and peer coach intervention to improve heart healthy behaviors among Veterans at risk for CVD.
Detailed Description
A total of 24 Veterans enrolled at the Durham Veterans Affairs Medical Center will be screened and enrolled. Eligible Veterans are 35-64 years old, with at least one uncontrolled or poorly controlled risk factor for CVD. In addition, 3-6 veterans will be enrolled and trained as heart health peer coaches, with eligibility being 35-64 years old, with at least one documented CVD factor who have sustained improvement in physical activity or dietary change in the previous 3-6 months. All participants complete a baseline assessment, three structured group meetings, and a 12 week post-intervention assessment. At the first group, each participant creates a behavioral goal, and peer partners are paired with another Veteran based on behavioral goal and gender. They are expected to call their peer once a week to discuss progress or difficulty with their action plan and support each other with problem solving. Post enrollment and prior to the first group meeting, Peer coaches will have 3-5 hours of motivational and communication training with study staff focusing on skills such as active listening, non-directive support, eliciting change-talk, promoting incremental change, and patient confidentiality. Peer coaches will interact with peer buddies during a) group sessions, b) at a 6 week phone check-in, and c) on-going support if needed. Additional support will be initiated if there are no phone calls between pairs, there is a lack of participant engagement in calls to partner or attending group sessions, or upon request by the peer. There are two Aims of the current pilot study. Aim 1: examine the feasibility and acceptability of a 12-week hybrid peer coach-reciprocal peer support intervention. Feasibility will be evaluated by ease of recruitment, and enrollment and retention rates. Acceptability will be assessed by self-report of amount, frequency and modality of contacts, participation rates for group sessions, and through post-intervention qualitative interviews.
Aim 2: explore gender differences in feasibility/acceptability of the hybrid peer support model. Gender differences will be evaluated through qualitative comparison of participant reported experiences with intervention content as well as peer and group interactions by gender; and, quantitatively via exploration of differences in enrollment, retention, refusal reasons and frequency of peer contacts.
#Intervention
- BEHAVIORAL : reciprocal peer support and non reciprocal coach support
- Peers and peer coaches provide mutual or one-way support to initiate and sustain behavioral improvements for cardiovascular health, with additional education from study staff.
|
#Eligibility Criteria:
Inclusion Criteria:
Peer partners and peer coaches:
* Enrolled in a Durham Veterans Administration Health Care System primary care clinic (including the women's health clinic)
* At risk for cardiovascular disease as defined by having at least one of the following:
* Uncontrolled hypertension
* history of obesity defined as (BMI >30)
* uncontrolled non-insulin dependent diabetes mellitus
* In addition, Peer coaches have made and sustained a behavioral change in past 3 <= age <= 6 months to improve heart health
* English as preferred language
* no significant hearing impairment
* lives approximately 30 minutes from the Durham Veterans affairs Medical Center
* agrees to attend regular visits per study protocol
* no contraindication to engage in at least moderate physical activity
* willing to use personal phone for peer and coach contacts
Exclusion Criteria:
* insulin-dependent diabetes
* serious mental illness defined as schizophrenia, bipolar disorder, dementia, active psychosis psychiatric hospitalization within the last 12 months or current high-risk suicide flag in their electronic medical record
* active substance use as documented in electronic or positive screening during telephone screening
* limited Life expectancy (<6 months) or severely ill defined as enrolled in hospice or actively undergoing chemotherapy or radiation therapy for cancer
* currently pregnant or planning to become pregnant in next 6 months
Sex :
ALL
Ages :
- Minimum Age : 35 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03646656
|
{
"brief_title": "Heart Health Buddies: Peer Support to Decrease CVD Risk",
"conditions": [
"Cardiovascular Disease"
],
"interventions": [
"Behavioral: reciprocal peer support and non reciprocal coach support"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03646656",
"official_title": "Heart Health Buddies: Peer Support to Decrease Cardiovascular Risk (CDA 13-263)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-15",
"study_completion_date(actual)": "2019-03-15",
"study_start_date(actual)": "2018-09-26"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-27",
"last_updated_that_met_qc_criteria": "2018-08-23",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-08-24",
"first_submitted": "2018-08-23",
"first_submitted_that_met_qc_criteria": "2020-03-06"
}
}
}
|
#Study Description
Brief Summary
Minimally invasive thoracic surgery is increasingly popular. Recently, a new minimally invasive thoracic approach, robotic-assisted thoracic surgery (RATS) has been developed. RATS presents some advantages compared to VATS such as three-dimensional view of the surgical field, its precisions facilitates the navigation in difficult to access spaces and eliminates tremor which reduces learning curve and it may have a reduction of complications.
During RATS and differently from VATS, not only one lung ventilation (OLV) is needed but also a continuous tension capnothorax. CO2 insufflation with intrathoracic positive pressure has a potential negative impact on the cardiorespiratory physiology. Moreover, CO2 insufflation and one lung ventilation can produce ventilation induced lung injury which are related to pulmonary postoperative complications (PPC).
In order to reduce PPC and ventilation induced lung injury, lung protective strategies are used which reduce atelectrauma and overdistension. These strategies consist of three main pillars: use of low tidal volumes, performance of recruitment maneuvers and application of optimal positive end-expiratory pressure (PEEP).
However, optimal PEEP levels and actual effects of PEEP are not clear. Several clinical studies with one-lung ventilation have reported improved oxygenation and ventilation when an alveolar recruitment maneuver is performed with a standardized PEEP of 5 to 10 cm·H2O. Nevertheless, other studies observe during one-lung ventilation improvements in oxygenation and lung mechanics with individualized PEEP determined by using a PEEP decrement titration trial after an alveolar recruitment maneuver. The effect of a tension capnothorax during RATS may modify pulmonary compliance and optimal PEEP may be different from patients having VATS resection.
Even though both methods are habitual in the clinical practice, there are no studies of the effect of an alveolar recruitment maneuver with individualized PEEP during one-lung ventilation in Robotic-Assisted Thoracic Surgery (RATS). The investigators hypothesized that such a procedure would improve oxygenation and lung mechanics during one-lung ventilation in RATS compared with the establishment of a standardized PEEP. The investigators perform a descriptive observational prospective study to test this hypothesis.
Detailed Description
Minimally invasive thoracic surgery is increasingly popular thanks to its potential benefits, including less pain, reduced surgical stress and systemic inflammatory response and reduced length of stay. In fact, video-assisted thoracoscopic surgery (VATS), is recommended for lung resection in early stages in ERAS Guidelines. Recently, a new minimally invasive thoracic approach, robotic-assisted thoracic surgery (RATS) has been developed. Its main indications are lung resection, diaphragmatic repair, esophagectomy and resection of mediastinal tumor. RATS presents some advantages compared to VATS such as three-dimensional view of the surgical field, its precisions facilitates the navigation in difficult to access spaces, it improves work ergonomics and eliminates tremor which reduces learning curve and it may have a reduction of complications.
During RATS and differently from VATS, not only one lung ventilation (OLV) is needed but also a continuous tension capnothorax. Intrathoracic CO2 insufflation aims both to retract tissues and expand the surgical field which gives a better view of intrathoracic structures but also to facilitate anatomical dissection. Nevertheless, CO2 insufflation with intrathoracic positive pressure has a potential negative impact on the cardiorespiratory physiology: it may increase respiratory airway pressure, it may cause hypercapnia and respiratory acidosis and can compromise the hemodynamics induced by the compression of the mediastinal vessels. Moreover, CO2 insufflation and one lung ventilation can produce ventilation induced lung injury which are related to pulmonary postoperative complications (PPC).
In order to reduce PPC and ventilation induced lung injury, lung protective strategies are used which reduce atelectrauma and overdistension. These strategies consist of three main pillars: use of low tidal volumes, performance of recruitment maneuvers and application of optimal positive end-expiratory pressure (PEEP).
However, optimal PEEP levels and actual effects of PEEP are not clear. Several clinical studies with one-lung ventilation have reported improved oxygenation and ventilation when an alveolar recruitment maneuver is performed with a standardized PEEP of 5 to 10 cm·H2O. Nevertheless, other studies observe during one-lung ventilation improvements in oxygenation and lung mechanics with individualized PEEP determined by using a PEEP decrement titration trial after an alveolar recruitment maneuver. The effect of a tension capnothorax during RATS may modify pulmonary compliance and optimal PEEP may be different from patients having VATS resection.
Even though both methods are habitual in the clinical practice, there are no studies of the effect of an alveolar recruitment maneuver with individualized PEEP during one-lung ventilation in Robotic-Assisted Thoracic Surgery (RATS). The investigators hypothesized that such a procedure would improve oxygenation and lung mechanics during one-lung ventilation in RATS compared with the establishment of a standardized PEEP. The investigators perform a descriptive observational prospective study to test this hypothesis.
An individualized open lung approach which will consist in an alveolar recruitment maneuver followed by a positive end-expiratory pressure adjusted to best respiratory system compliance will be performed before and after capnothorax establishment.
The main expected benefits will be improvement of oxygenation, ventilation and lung mechanics.
Recruitment maneuvers are part of daily practice during mechanical ventilation. During OLV, they are done systematically, but little is known of optimal PEEP after it. When performed correctly, considering its contraindications and appropriate monitoring they are safe technique (9)
This is a single center (Hospital Clínic de Barcelona), prospective, intraoperative descriptive study. The hypothesis is to demonstrate the change in individualized optimal PEEP before and after capnothorax during OLV and the improvement of ventilation and lung mechanics. The primary objective is to assess the improvement of oxygenation, ventilation and lung mechanics in patients ventilated with individualized PEEP during capnothorax.The secondary objectives is to report the incidence of associated perioperative complications. With the purpose of standardizing the optimal respiratory management of patients that undergo robotic-assisted thoracic surgery (RATS).
Based on previous studies, it was estimated that a total of 30 patients will be needed to detect at least a 10% of static compliance during the establishment of capnothorax in one-lung ventilation, with a 5% significance level and 80% power.
Candidates for this study will be identified at the scheduled visit, prior to surgery, with one of the anaesthetists of the Cardiothoracic Anaesthesia section of our hospital. This visit is usually carried several days or weeks before surgery. Once a potential participant has been identified, the main investigator (R.N.) will offer the possibility to explain the study during the same scheduled visit and they will also provide written information regarding our study. Those who, subsequently, express their potential desire to participate in the study will also be offered an informed consent sheet for their signature. For those still willing to consider their participation but not ready to decide whether to accept or not their inclusion as part of the study, a second visit will be done once the patient is admitted to the hospital the day before the surgery.
The inclusion criteria are patients with ASA physical status I to III admitted to Hospital Clínic de Barcelona undergoing elective RATS lung resection who agree to participate in the study and sign the written consent form.
The exclusion criteria are patients with age \<18 years, ASA physical status IV, pneumonectomy, New York Heart Association III to IV, and preoperative hemoglobin \<10 mg/dL will be excluded from the study. Moreover, patients in which recruitment maneuvers are contraindicated will also be excluded from the study. Contraindications for recruitment maneuvers are: history of pneumothorax, contralateral pulmonary bulla, hemodynamic instability, lung emphysema, COPD, bronchopleural fistula, acute cor pulmonale or intracranial hypertension .
Data will be inspected and tested for distribution according to Kolmogorove Smirnov test. Normally distributed data were compared between study arms using the unpaired T-student test, whereas non-normally distributed data were compared using the Mann Whitney U test. All data were summarised as mean or median as appropriate. Fisher's exact test was used for comparing categorical data.
All patients included in the study will be assigned an identification code. In a separated database, the main investigator will have the relation between the identification code and the patient's clinical record number. All investigators of the study will have access to the coded number database that will be stored in a shared Drive document, and the main investigator will be responsible for it. Both database will be stored 5 years after study completion.
Individual data, such as participant baseline medical conditions, type of surgery, respiratory parameters, results from arterial gasometries samples and postoperative pulmonary complications until the 7th day from the admission will be recorded in order to assess the benefit of optimal PEEP before and after capnothorax stablishment.
|
#Eligibility Criteria:
Inclusion Criteria:
* ASA physical status I to III
* Admitted to Hospital Clínic de Barcelona
* Undergoing elective RATS lung resection
* Who agree to participate in the study and sign the written consent form.
Exclusion Criteria:
* Patients with age <18 years
* ASA physical status IV
* Pneumonectomy
* New York Heart Association III to IV
* Preoperative hemoglobin <10 mg/dL will be excluded from the study.
* Patients in which recruitment maneuvers are contraindicated (history of pneumothorax, contralateral pulmonary bulla, hemodynamic instability, lung emphysema, COPD, bronchopleural fistula, acute cor pulmonale or intracranial hypertension).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 120 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06026670
|
{
"brief_title": "Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery",
"conditions": [
"Ventilator-Induced Lung Injury"
],
"interventions": null,
"location_countries": [
"Spain"
],
"nct_id": "NCT06026670",
"official_title": "Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-02-20",
"study_completion_date(actual)": "2024-02-26",
"study_start_date(actual)": "2023-07-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-28",
"last_updated_that_met_qc_criteria": "2023-09-04",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-09-07",
"first_submitted": "2023-07-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control
#Intervention
- DRUG : Empagliflozin
- DRUG : Placebo
- DRUG : Placebo
- For blinding purposes
|
#Eligibility Criteria:
Inclusion criteria:
* Diagnosis of type 2 diabetes mellitus
* Patients on diet and exercise regimen who are pre-treated with any insulin therapy alone or in combination with 1 oral antidiabetic drug for at least 12 weeks prior to screening
* Fasting C-peptide must be > 0.5 ng/mL
* HbA1c at screening in Patients who are treated with insulin alone must be >=7.5% and <=10.0%
* HbA1c in Patients who are treated with insulin with 1 oral antidiabetic drug (OAD) must be >=7.0% and <=9.5% at screening, and >=7.5% and <=10.0% at placebo run-in period
* Age at informed consent must be >=20 and <75 years
* BMI at screening must be >22 and <=40 kg/m2
* Further inclusion criteria apply
Exclusion criteria:
* Patients who experience uncontrolled hyperglycaemia before randomization
* Patients who are treated with sulfonylurea whose dose is more than a half of daily maximum approval dose, glucagon-like peptide-1 (GLP-1) analogue, thiazolidinedione and sodium-glucose co-transporter 2 (SGLT-2) inhibitor
* Patients with recent cardiovascular and/or stroke events
* Patients with hepatic and/or renal dysfunction
* Patients who received anti-obesity drugs or other treatment leading to unstable body weight
* Patients who have known allergy or hypersensitivity to insulin and/or empagliflozin
* Pre-menopausal women who are nursing or pregnant
* Further exclusion criteria apply
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02589639
|
{
"brief_title": "Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus",
"conditions": [
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: Placebo",
"Drug: Empagliflozin"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT02589639",
"official_title": "A 52-week Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Empagliflozin Once Daily, as an add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-04-18",
"study_completion_date(actual)": "2018-01-05",
"study_start_date(actual)": "2015-10-28"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-27",
"last_updated_that_met_qc_criteria": "2015-10-27",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-28",
"first_submitted": "2015-10-27",
"first_submitted_that_met_qc_criteria": "2018-12-11"
}
}
}
|
#Study Description
Brief Summary
Objective: Implant surface topography is a key element in achieving osseointegration. Nanostructured surfaces have shown promising results in accelerating and improving bone healing around dental implants. The main objective of the present clinical study is to compare, at 4 and 6w, bone-to-implant contact in implants having either machined surface (MAC), SLA medium roughness surface or a Nanostructured Calcium-Incorporated surface (XPEED®). Thirty five mini-implants with 3 different surface treatments (XPEED® (n=16) - SLA (n=13) - Machined (n=6)), were placed in the posterior maxilla of 11 patients then retrieved at either 4 or 6w in a randomized split-mouth study design.
#Intervention
- PROCEDURE : Implant placement
- Implant placement with different surface types
|
#Eligibility Criteria:
Inclusion Criteria:
*
* Height of the residual bone crest in the programmed implant site >= 9 mm and thickness >= 7mm.
* Availability, in each sector, of sufficient mesio-distal space allowing placement of 2 standard-sized implants and at least 2 mini-implants (3.5x8.5mm) for retrieval.
* Healed bone crest (>= 3 months elapsed after extraction or tooth loss).
* Age > 18 years.
* Ability to examine and fully understand the study protocol.
Exclusion Criteria:
*
* Myocardial infarction within the past 6 months.
* Poorly controlled diabetes (HBA1c > 7.5%).
* Coagulation disorders.
* Radiotherapy to the head/neck area within the past two years.
* Present or past treatment with intravenous bisphosphonates.
* Immunocompromised patients.
* Psychological or psychiatric problems.
* Alcohol or drug abuse.
* Poor oral hygiene and motivation (full mouth plaque score > 30% and/or full mouth bleeding score > 20%).
* Uncontrolled periodontal disease.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05558800
|
{
"brief_title": "Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants With Different Surfaces.",
"conditions": [
"Implant Geometry"
],
"interventions": [
"Procedure: Implant placement"
],
"location_countries": [
"Lebanon"
],
"nct_id": "NCT05558800",
"official_title": "Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants Having Either Machined, SLA Medium Roughness, Nanostructured Calcium-Incorporated or Plasma Reactivated Nanostructured Calcium-Incorporated Surface: A Histologic Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-30",
"study_completion_date(actual)": "2022-07-30",
"study_start_date(actual)": "2018-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-30",
"last_updated_that_met_qc_criteria": "2022-09-25",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-09-28",
"first_submitted": "2022-09-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will examine the incremental benefit of animal-assisted therapy (AAT) as an adjunct intervention when combined with Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for the treatment of maltreated youth. In addition, the development of therapeutic rapport and the intensity of stress experienced during treatment sessions will be examined as mediational mechanisms of treatment outcome. This project will help determine whether a larger study to test the beneficial effects of AAT for maltreated youth is feasible and warranted.
Detailed Description
The eventual goal of this line of research is to determine whether, and through what mechanisms, Animal-Assisted Therapy (AAT) is beneficial for the treatment of maltreated youth. The current project is a feasibility study to determine if larger clinical trials are warranted. The specific aims of the current study are (1) to examine whether the integration of AAT into standard Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) enhances treatment effectiveness, (2) to evaluate the tolerability and feasibility of AAT when integrated into TF-CBT, and (3) to evaluate hypothesized mediational processes that may explain observed positive effects for the integration of AAT. Maltreated youth may display myriad emotional and behavioral symptoms; prominent among these is posttraumatic stress (PTS). TF-CBT is a well-established evidence-based treatment for PTS and other symptoms subsequent to child maltreatment and, therefore, is a suitable intervention for this trial. Sixty (60) maltreated youth (ages 6-17) displaying elevated PTS will be assigned to receive TF-CBT or TF-CBT+AAT using a blocked randomization procedure. The TF-CBT protocol is the standard twelve 90-minute sessions typically used in research trials. Youth in the TF-CBT+AAT condition will receive the standard protocol with a certified service dog present in the room for each session and the youth will be allowed to interact with the dog during session. A pre-post design will be used to ascertain whether the addition of AAT prompts greater PTS reduction as well as greater improvements in other outcomes, including internalizing symptoms, externalizing symptoms, and emotion regulation. Outcome metrics include caregiver and youth-reported objective measures, and respiratory sinus arrhythmia (RSA) assessed via an electrocardiogram (ECG) during both a resting and stress reactivity paradigm. Feasibility metrics assessed include treatment satisfaction, ability to implement the TF-CBT techniques with a dog in the room, treatment disrupting events attributable to the dogs, and whether the dogs experience significant stress as a result of their participation. Stress experienced by the dog will be determined through RSA, salivary cortisol, and behavioral responses. Two prominent hypotheses regarding the mechanism of effect for AAT will be examined. First, therapeutic rapport will be assessed at multiple increments to determine whether the presence of the dog improved the quality or efficiency of development of rapport. Second, RSA will be recorded for the youth during treatment sessions to determine if the presence of the dog yielded a lower intensity of stress during the sessions. Both therapeutic rapport and level of in-session stress will be examined as mediating variables to determine whether either explained enhanced treatment outcomes. To improve the methodological rigor of the study, data will be collected by research assistants blinded to the youth's treatment condition and the same clinicians will implement both treatment conditions, thereby eliminating clinician-specific effects on outcomes.
#Intervention
- BEHAVIORAL : TF-CBT
- TF-CBT is typically described as including 3 phases, each focusing on a common goal and encompassing a third of treatment (4 sessions). The first phase focuses on skills-building and includes psychoeducation, parenting skills training, relaxation skills training, affect modulation skills training, and cognitive coping skills training. The second phase involves focused gradual exposure activities, including construction of a narrative account of the child's maltreatment experiences and cognitive processing of maladaptive thoughts. The third phase emphasizes the child's mastery over environmental reminders of the maltreatment and includes sharing the trauma narrative with the caregiver, in vivo exposure to physical stimuli, and enhancing future development.
- BEHAVIORAL : TF-CBT+AAT
- TF-CBT, as described in the other arm, with animal-assisted therapy as an adjunct intervention. During the administration of TF-CBT, a certified service dog will be in the room and the participant may elect to interact with the dog as various points throughout the sessions.
|
#Eligibility Criteria:
Inclusion Criteria:
* A caregiver willing to participate with the youth
* An allegation of child maltreatment investigated by child protective services (CPS) or the police
* A raw score of >= 39 (borderline or clinical elevation) on the caregiver- report version of the UCLA PTSD Reaction Index for the DSM-5.
Exclusion Criteria:
* Severe developmental delays and/or psychiatric problems that necessitate a higher level of care for the child. An allegation of child maltreatment investigated by child protective services (CPS) or the police
* Intellectual deficits for the child (IQ < 80 on a cognitive screener)
* Caregiver inability to complete assessment measures due to psychiatric, cognitive, or other limitation
* The available caregiver is suspected or known to have perpetrated maltreatment
* A fear of dogs, a dog allergy, or any prior history of aggression toward animals for the child and/or caregiver
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03135119
|
{
"brief_title": "Integrating Animal-Assisted Therapy Into Trauma-Focused Cognitive-Behavioral Therapy for Maltreated Youth",
"conditions": [
"Child Abuse",
"Posttraumatic Stress"
],
"interventions": [
"Behavioral: TF-CBT",
"Behavioral: TF-CBT+AAT"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03135119",
"official_title": "Integrating Animal-Assisted Therapy Into Trauma-Focused Cognitive-Behavioral Therapy for Maltreated Youth: A Randomized Feasibility Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-18",
"study_completion_date(actual)": "2020-03-18",
"study_start_date(actual)": "2017-11-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-05-18",
"last_updated_that_met_qc_criteria": "2017-04-28",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-01",
"first_submitted": "2017-04-20",
"first_submitted_that_met_qc_criteria": "2022-05-16"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study was to evaluate no less therapeutic efficacy and safety of the Angal, lozenges \[Menthol\], 1 mg + 5 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, lozenges, 0,2 mg + 2 mg + 50 mg (LLC 'Valeant', Russia) in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat.
#Intervention
- DRUG : Angal, lozenges [menthol],
- Angal, administered per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution.
- DRUG : ANTI-ANGIN® FORMULA
- 0,2 mg + 2 mg + 50 mg (LLC 'Valeant', Russia). Administered per 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution.
|
#Eligibility Criteria:
Inclusion Criteria:
* Voluntarily signed informed consent for participation in this clinical study; 18 <= age <= 45 old inclusive, male and female;
* Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat;
* Onset of first symptoms of the uncomplicated acute infectious and inflammatory diseases of the pharynx (pharyngitis and/or tonsillitis) less than 48 hours prior to inclusion into the study;
* Baseline TSS score (Tonsillopharyngitis Severity Score) >= 5 (total score);
Exclusion Criteria:
* Use of analgesics within <12 hours prior to the study start or/and inability to cancel them during the study;
* Use of antibiotics within <48 hours prior to the study start or/and inability to cancel them during the study;
* Use of local therapy (sprays, rinses, lozenges) to pharynx within <12 hours before study start or/and inability to cancel them, besides study medications.
* Use systemic or inhaled corticosteroids within <=1 months prior to the study start and planned therapy of them during the study (besides skin means).
* Presence of symptoms of primary bacterial pharyngitis or secondary bacterial infection (including fever over 37,5 ° C, the presence of purulent raids in the throat, severe intoxication, leukocytosis, neutrophilia, shift leukocyte left (increasing the percentage of neutrophils sticks appearance younger forms of neutrophils), increased ESR 30 mm/hr);
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03095521
|
{
"brief_title": "A Local Clinical Study for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol] and ANTI-ANGIN® FORMULA, Lozenges, in Treatment of Patients With a Sore Throat",
"conditions": [
"Sore Throat"
],
"interventions": [
"Drug: Angal, lozenges [menthol],",
"Drug: ANTI-ANGIN® FORMULA"
],
"location_countries": [
"Russian Federation"
],
"nct_id": "NCT03095521",
"official_title": "A Prospective, Multi-center, Open, Randomized Clinical Study in Parallel Groups, for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol], 1 mg + 5 mg (Sandoz d.d., Slovenia), and ANTI-ANGIN® FORMULA, Lozenges, 0,2 mg + 2 mg + 50 mg (LLC 'Valeant', Russia) in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-05-07",
"study_completion_date(actual)": "2017-05-07",
"study_start_date(actual)": "2017-02-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-22",
"last_updated_that_met_qc_criteria": "2017-03-24",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-03-29",
"first_submitted": "2017-03-21",
"first_submitted_that_met_qc_criteria": "2018-12-14"
}
}
}
|
#Study Description
Brief Summary
The primary aim of this single site study was to assess the feasibility of implementing a staff/parent communication intervention within 72 hours of the parents making an end-of-life decision on behalf of their child.
Detailed Description
Parents/guardians of children with incurable cancer face end-of-life decisions on behalf of their child including whether or not to enroll their child in a Phase I study, whether or not to agree to a 'do not resuscitate' status, or to begin terminal care. Descriptive research to date indicates that one of the factors that most helps parents to make these decisions and to remain satisfied with the decision afterward is their perception that they decided as a 'good parent' would decide. Parents define being a 'good parent' as making a decision that is in the best interest of their child. Parents' perception of their success in being a good parent is influenced by their interactions with the child's health care providers. Health care providers who are not fully informed about the decision and the parents' rationale for the decision are likely to convey doubt about the decision to parents and to other health care providers. Parents interpret this doubt as staff questioning the parents' ability to make good decisions. Lack of adequate information also creates staff tension. This single-site feasibility study will implement and evaluate a two-part communication intervention designed to identify parents' definition of being a good parent, and to communicate this definition and the rationale for the parents' decision to staff. The intervention will be implemented in 60 to 80 end-of-life clinical care situations in which parents have made a decision on behalf of a child who is still living. The feasibility study is guided by the Pediatric Quality of Life at End of Life model. The parent/guardian intervention includes a face-to-face interview with parents regarding their definition of a 'good parent' and their basis for the decision they made. Parents/guardians will be interviewed within 72 hours after making the end of life decision and again 1 to 3 weeks after making the decision. Health care professionals assigned to the terminally ill child will receive the communication intervention within hours of the parent interview, and will evaluate its usefulness 1 to 2 weeks after receiving it.
1.1 To assess the feasibility of delivering the two-part communication intervention. The definition of feasible is that 50% of all interventions are successfully implemented.
1.1.1 To identify all three types of difficult treatment decisions within the defined time frame (thus identifying eligible parents/guardians and obtaining consent within 72 hours after the decision was made), document the study team's ability to successfully implement the intervention before the child's death (obtaining the parent/guardian information and sharing that with the defined staff such that the family achieves the definition of being fully evaluable as a study participant), and document the participation rate by tracking the number of eligible parents/guardians who agree to participate, decline to participate or withdraw from the study.
1.2: To assess staff perceptions of the impact of the communication intervention on staff 1 to 2 weeks after the intervention.
1.2.1 to measure: a) staff recall of the definition of a good parent and the rationale for the decision; b) staff perception of how this knowledge influenced their care for the family; c) staff satisfaction with the verbal and written communication intervention forms; and d) the impact of the communication intervention on team tension and team communication about the parents' decisions.
1.3: To assess the impact of the communication on parents/guardians by recording their perceptions of the positive and negative aspects of the intervention at the time of the intervention and 1 to 3 weeks after the decision making.
#Intervention
- OTHER : Parent Interview
- To include the PI, Nursing Research Specialist,Clinical Research Associate or Clinical Nurse Specialist
|
#Eligibility Criteria:
Inclusion Criteria:
* Eligible parents/guardian can be enrolled only one time and will be:
* 21 years and older.
* This study will enroll only parents/guardians who are 21 years and older. The investigators clinical experience is that when the parent/guardian is younger, additional adult members of the family are involved in the decision making and that asking a single person to identify him or herself as the primary parent/guardian creates difficulties for the family.
* As a result, no parent/guardian younger than age 21 will be enrolled in this study.
* English-speaking.
* Willing to give written consent to participate.
* The parents/guardians of a child with incurable cancer or a fatal cancer-related condition who is being treated at St. Jude Children's Research Hospital
* The parents/guardians who made an end-of-life decision on behalf of the seriously ill child within the previous 72-hours.
* Eligible staff can be enrolled more than one time and will be:
* English-speaking
* Willing to give written consent to participate
Exclusion Criteria:
* Parents/guardians who meet the above criteria but are identified by their attending or social support staff member (an assigned social worker or psychologist at St. Jude Children's Research Hospital) as emotionally or mentally unable to participate in the informed consent process will not be approached about participating in the study.
* Parents who are identified by their attending or social support staff member as likely to find the study too burdensome because of their emotional or mental state.
* Parents who did not make the end-of-life decision (i.e., when the patient made the decision).
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00827437
|
{
"brief_title": "Family-Staff Communication Intervention at the Time of Difficult Treatment Decision Making",
"conditions": [
"Difficult Decision Making"
],
"interventions": [
"Other: Parent Interview"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00827437",
"official_title": "Family-Staff Communication Intervention at the Time of Difficult Treatment Decision Making",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-11",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2004-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-04-23",
"last_updated_that_met_qc_criteria": "2009-01-21",
"last_verified": "2011-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-01-22",
"first_submitted": "2008-08-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
BACKGROUND: Musculoskeletal side effects related to isotretinoin are frequently reported. This study aimed to investigate the effect of oral isotretinoin treatment on muscle strength. Our second aim was to evaluate whether there was a correlation between the serum creatine phosphokinase (CPK) level, a specific marker of muscle breakdown, and muscle strength.
METHODS: This study included 30 patients who presented to our hospital and were started on oral isotretinoin treatment for acne vulgaris and 30 patients in the control group who were given local treatment. Age, gender, height and weight of the patients were recorded, and the body mass index (BMI) was calculated. The hamstring and quadriceps muscle strengths of the non-dominant side were evaluated in all patients using an isokinetic dynamometer, and the peak torque (PT) values were recorded. In the isotretinoin group, isokinetic measurements were performed again in those that completed six-month drug treatment and compared with the initial PT values.
Detailed Description
BACKGROUND: Musculoskeletal side effects related to isotretinoin are frequently reported. This study aimed to investigate the effect of oral isotretinoin treatment on muscle strength. Our second aim was to evaluate whether there was a correlation between the serum creatine phosphokinase (CPK) level, a specific marker of muscle breakdown, and muscle strength.
METHODS: This study included 30 patients who presented to our hospital and were started on oral isotretinoin treatment for acne vulgaris and 30 patients in the control group who were given local treatment. Age, gender, height and weight of the patients were recorded, and the body mass index (BMI) was calculated. The hamstring and quadriceps muscle strengths of the non-dominant side were evaluated in all patients using an isokinetic dynamometer, and the peak torque (PT) values were recorded. In the isotretinoin group, isokinetic measurements were performed again in those that completed six-month drug treatment and compared with the initial PT values.
#Intervention
- DEVICE : Isokinetic device (Biodex System 4)
- The measurement of muscle strength with isokinetic device
- Other Names :
- serum creatinine phosphokinase level
|
#Eligibility Criteria:
Inclusion Criteria:
* being aged 18 <= age <= 45 years
* receiving isotretinoin treatment for the isotretinoin group
* not having used isotretinoin within the last year for the control group
Exclusion Criteria:
* chronic kidney or liver disease,
* uncontrolled hypertension, heart failure,
* malignancy,
* thyroid and bone diseases (e.g., hyperparathyroidism and osteomalacia),
* use of drugs that may affect skeletal metabolism (e.g., corticosteroids, heparin, and anticonvulsants),
* a history of trauma and/or surgery in the lower extremities.
* Patients who discontinued or terminated their isotretinoin treatment were not included in the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04626817
|
{
"brief_title": "Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study",
"conditions": [
"Muscle Strength"
],
"interventions": [
"Device: Isokinetic device (Biodex System 4)"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04626817",
"official_title": "Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-01",
"study_completion_date(actual)": "2019-10-01",
"study_start_date(actual)": "2018-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-13",
"last_updated_that_met_qc_criteria": "2020-11-06",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-11-13",
"first_submitted": "2020-11-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. Approximately 9 % of those who use cannabis will become addicted. The number goes up to about 1 in 6 among those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis daily. The consequences of cannabis abuse in the most prone population (14-25 years of age) are extremely serious, and may include addiction, altered brain development, poorer educational outcomes, cognitive impairment, lower income, greater welfare dependence, unemployment and lower relationship and life satisfaction. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority.
The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders. The purpose of this research is to study how AEF0117 influences the subjective effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis's effects.
This will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day 1. On the morning of Day 1, all subjects will receive a single oral dose of 2 mg containing approximately 100 μCi of \[4-14C\]AEF0117 approximately 1 hour after completion of a low fat breakfast.
Detailed Description
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. Approximately 9 % of those who use cannabis will become addicted. The number goes up to about 1 in 6 among those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis daily. The consequences of cannabis abuse in the most prone population (14-25 years of age) are extremely serious, and may include addiction, altered brain development, poorer educational outcomes, cognitive impairment, lower income, greater welfare dependence, unemployment and lower relationship and life satisfaction. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority.
The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders. The purpose of this research is to study how AEF0117 influences the subjective effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis's effects.
The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date.
The purpose of this study is to determine the absorption, metabolism, and excretion of \[4 14C\]AEF0117 and to characterize and determine the metabolites present in plasma, urine, and, where possible, feces in healthy male subjects following a single oral administration. Knowledge of the metabolism and excretion of parent drug and its metabolites is useful for evaluating the Metabolites in Safety Testing requirements elucidated in the Food and Drug Administration (FDA) Guidance and International Conference on Harmonisation (ICH) M3 and the likelihood of effects of renal or hepatic impairment on the disposition of AEF0117 and the likelihood for drug-drug interactions with AEF0117.
This will be a Phase 1, open-label, nonrandomized, single dose study in healthy male subjects.
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Up to 8 subjects will be enrolled to ensure that 6 subjects complete the study. Subjects will be admitted into the study site on Day 1. On the morning of Day 1, all subjects will receive a single oral dose of 2 mg containing approximately 100 μCi of \[4-14C\]AEF0117 approximately 1 hour after completion of a low fat breakfast.
Subjects will reside at the study site from Day -1 through Day 28 and will be discharged on Day 28. If the following criteria are not met by Day 28, subjects will continue study participation and will be asked to return for a residential visit on Day 35 to allow for continuation of the 24-hour collection (urine, blood, and feces) for total radioactivity:
* plasma radioactivity levels below the limit of quantitation for 2 consecutive collections,
* ≥90% mass balance recovery, and
* ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods.
If the following criteria are not met at the Day 35 visit, then the subjects will be required to come back on Day 42 to allow for continuation of the 24-hour collection (urine, blood, and feces) for total radioactivity:
* plasma radioactivity levels below the limit of quantitation for 2 consecutivecollections, and
* ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 24-hour period.
Subjects will be discharged from the study at the latest discharge day of Day 43, unlessotherwise agreed upon by the sponsor and investigator.
Up to 8 subjects will be enrolled to ensure that 6 subjects complete the study.
#Intervention
- DRUG : AEF0117
- 2 mg AEF0117 containing approximately 100 μCi of \[4-14C\]AEF0117
- Other Names :
- 3ß-(4-methoxybenzykoxy)pregn-5-en-20-one t)
|
#Eligibility Criteria:
Inclusion Criteria:
* Males, of any race, between 18 and 65 years, inclusive, at screening.
* Body mass index between 18.0 and 30.0 kg/m2, inclusive.
* In good health, determined by no clinically significant findings from medical history,12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in and from the physical examination at check-in, as assessed by the investigator (or designee).
* Males will agree to use contraception
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
* History of a minimum of one bowel movement per day.
Exclusion Criteria:
Medical conditions
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
* History of significant hypersensitivity, intolerance, or allergy to corn products/oil, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). Cholecystectomy is not allowed.
* Confirmed vital signs measurements below:
* systolic blood pressure >140 or <90 mmHg, systolic blood pressure >160 or <90 mmHg for male volunteers between 60 and 65 years
* diastolic blood pressure >90 or <50 mmHg, and
* pulse rate >100 or <40 beats per minute. Minor deviations from the normal range may be allowed if deemed by the investigator to have no clinical significance, after discussion with medical monitor.
* Positive hepatitis panel and/or reactive human immunodeficiency virus test
* Positive coronavirus disease 2019 (COVID-19) test less than 30 days prior to screening and/or experiencing symptoms.
Prior/concomitant therapy
* Administration of a COVID-19 vaccine in the past 30 days prior to dosing.
* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, and/or use or intend to use any drugs known to induce or inhibit CYP isozymes, within 30 days prior to check-in, unless deemed acceptable by the investigator (or designee) and accepted by sponsor's medical monitor.
* Use or intend to use any prescription medications/products within 14 days prior to check-in, and any medication with an elimination half-life of >60 hours (time since last dose of at least 6 times the elimination half-life), unless deemed acceptable by the investigator (or designee) and with consultation with sponsor's medical monitor.
* Use or intend to use slow-release medications/products considered to still be activewithin 14 days prior to check-in, unless deemed acceptable by the investigator (or designee) and accepted by sponsor's medical monitor.
* Use or intend to use any nonprescription medications/products including vitamins,minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days priorto check-in, unless deemed acceptable by the investigator (or designee) and with consultation with sponsor's medical monitor.
Prior/concurrent clinical study experience
* Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known) prior to dosing, and if the elimination half-life is >60 hours (time since last dose of at least 6 times the elimination half-life), following agreement between investigator (or designee) and sponsor's medical monitor.
* Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months (previous study to be at least 4 months prior to check-in to the study site where exposures are known to the investigator or 6 months prior to check-in to the study site for a radiolabeled drug study where exposures are not known to the investigator). The total 12-month exposure from this study and a maximum of 2 other previous radiolabeled studies within 4 to 12 months prior to this study will be within the Code of Federal Regulations (CFR) recommended levels considered safe, per the US Title 21 CFR 361.1.
* Have previously completed or withdrawn from this study or any other study investigating AEF0117 and have previously received AEF0117.
Diet and lifestyle
* Alcohol consumption of >21 units per week for males. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
* Positive urine drug screen at screening or check-in or positive urine alcohol test result at check-in.
* History of alcoholism or drug/chemical abuse (as defined by the current Diagnostic and Statistical Manual of Mental Disorders) within 2 years prior to check-in.
* Use of tobacco- or nicotine-containing products within 3 months prior to check-in or positive cotinine at screening or check-in.
Other exclusions
* Receipt of blood products within 2 months prior to check-in.
* Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
* Poor peripheral venous access.
* Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
* Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05554926
|
{
"brief_title": "Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects",
"conditions": [
"Marijuana Abuse"
],
"interventions": [
"Drug: AEF0117"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05554926",
"official_title": "A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-24",
"study_completion_date(actual)": "2023-02-24",
"study_start_date(actual)": "2022-12-16"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-04-07",
"last_updated_that_met_qc_criteria": "2022-09-22",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-09-26",
"first_submitted": "2022-09-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Introduction: This study investigated the efficacy of sacral erector spinae plane block (ESPB) for managing postoperative pain and reducing opioid consumption in patients undergoing hemorrhoid and pilonidal sinus (PS) surgery.
Detailed Description
Introduction: This study investigated the efficacy of sacral erector spinae plane block (ESPB) for managing postoperative pain and reducing opioid consumption in patients undergoing hemorrhoid and pilonidal sinus (PS) surgery.
#Intervention
- PROCEDURE : sacral ESPB
- sacral ESPB
|
#Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologists (ASA) I-II patients undergoing hemorrhoid and pilonidal sinus surgery
Exclusion Criteria:
* patients with coagulopathies, pregnant women, patients with significant cardiovascular, hepatic, or renal disease, patients who declined spinal anesthesia or were contraindicated for it, and patients who had previously undergone the same surgery
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06459739
|
{
"brief_title": "Effect of Sacral Erector Spinae Plane Block on Hemorrhoid and Pilonidal Sinus Surgery",
"conditions": [
"Pain, Acute Post-Operative",
"Pilonidal Sinus",
"Hemorrhoids",
"Anesthesia"
],
"interventions": [
"Procedure: sacral ESPB"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06459739",
"official_title": "Effect of Sacral Erector Spinae Plane Block on Hemorrhoid and Pilonidal Sinus Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-03-01",
"study_completion_date(actual)": "2024-04-01",
"study_start_date(actual)": "2023-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-14",
"last_updated_that_met_qc_criteria": "2024-06-10",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-06-14",
"first_submitted": "2024-06-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the effect of Leukocyte Platelet Rich Fibrin and freeze-dried bone allograft in a layered technique on the bone quantity and quality following socket grafting in preparation for endosseous implant placement.
Pre (baseline)- and post-grafting (3 months) clinical as well as 2- and 3-dimensional radiographic measurements will be used to evaluate the dimensional ridge changes between sites grafted with L-PRF/FDBA layered technique vs. L-PRF/FDBA and L-PRF alone.
Histological analysis will be performed by a bone biopsy taken at time of surgical re-entry (after 3 months) of grafted sites to place the dental implant and assessed for differences in new bone formation between the three types of graft.
Detailed Description
This study is a prospective, three-arm randomized trial that will evaluate and compare the bone healing following ridge preservation of extraction sockets using either L-PRF/FDBA layered technique or L-PRF/FDBA or L-PRF alone in a total of 30 patients (10 in each arm).
Qualifying participants and defects will be randomized following a computerized permutation block to receive either technique on day of surgery. Tooth extraction will be performed with a flapless minimally invasive technique, followed by socket grafting with a randomized graft.
The mineralized cortico-cancellous bone allograft that will be used in this study will be obtained from the same donor, lot and tissue bank to account for variation in age, race, gender and related healing potential of different graft sources.
Bone core biopsies will be harvested at time of implant placement 3 months following socket grafting. Bone cores will then undergo histological and histomorphometrical analyses to determine qualitative and quantitative healing differences between three treatment groups.
Clinical measurements are gathered at 2 time points (grating and implant placement) at all defects and will be compared for differences.
Cone beam computed tomography (CBCT) initial scans are conducted immediately following socket grafting and second scans obtained prior to implant placement. Virtual implant planning software will be utilized to assess and compare the 2- and 3-dimensional changes for all defects.
#Intervention
- PROCEDURE : Ridge preservation using L-PRF/FDBA layered technique
- Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique
- PROCEDURE : Ridge preservation using L-PRF/FDBA
- Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA
- PROCEDURE : Ridge preservation using L-PRF
- Atraumatic tooth extraction following by socket grafting using L-PRF
|
#Eligibility Criteria:
Inclusion Criteria:
* English speaking and able to read and understand English informed consent document
* At least 18 years.
* Must be a patient at the UAB School of Dentistry
* Patient is willing and able to comply with all steps of the study
* Hopeless single-rooted tooth planned to be replaced with a dental implant and with healthy adjacent teeth not planned for extraction.
Exclusion Criteria:
* Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
* Pregnant women
* Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04133363
|
{
"brief_title": "To Compare Ridge Preservation Technique Using Leukocyte Platelet Rich Fibrin (L-PRF) and Freeze-dried Bone Allograft (FDBA) Layered Technique vs L-PRF/FDBA and L-PRF Alone in Influencing Quantity and Quality of New Bone Formation in Grafted Extraction Sockets",
"conditions": [
"Ridge Preservation"
],
"interventions": [
"Procedure: Ridge preservation using L-PRF/FDBA",
"Procedure: Ridge preservation using L-PRF",
"Procedure: Ridge preservation using L-PRF/FDBA layered technique"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04133363",
"official_title": "Clinical, Radiographic, and Histomorphometric Outcomes Following Ridge Preservation Using Leukocyte Platelet Rich Fibrin (L-PRF) and Freeze-Dried Bone Allograft (FDBA) Layered Technique: A Prospective, Randomized Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-10-27",
"study_completion_date(actual)": "2023-01-31",
"study_start_date(actual)": "2020-06-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-26",
"last_updated_that_met_qc_criteria": "2019-10-17",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-21",
"first_submitted": "2019-10-17",
"first_submitted_that_met_qc_criteria": "2024-06-12"
}
}
}
|
#Study Description
Brief Summary
This randomized clinical trial studies how well a computerized cognitive behavior therapy program works in treating depression in patients with cancer. The cognitive behavior therapy program uses a series of internet-delivered sessions intended to help patients identify and change problematic patterns of thinking and behavior that maintain depression.
Detailed Description
PRIMARY OBJECTIVES:
I. Establish the efficacy of computerized cognitive behavior therapy ('Beating the Blues') in reducing symptoms of depression and remission of major depressive disorder (MDD) in cancer patients.
II. Test the feasibility of implementation and patient acceptability of online computerized cognitive behavior therapy for cancer patients with major depressive disorder (MDD).
III. Test moderators (cancer specific stress, MDD history, anxiety disorder comorbidity, and homework compliance) of treatment outcome.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (IMMEDIATE TREATMENT): Patients undergo computerized cognitive behavior therapy consisting of 45-60 minute sessions once per week for 8 weeks. Patients also complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD7) at weeks 1, 3, 5, 7 and 8 and complete other questionnaires for 15-30 minutes each that assess psychosocial and physical symptoms.
GROUP II (WAIT-LIST): Patients are placed on an 8-week wait-list and then undergo computerized behavior therapy and receive questionnaires as in Group I.
After completion of study intervention, patients are followed up at 2, 4, and 6 months.
#Intervention
- BEHAVIORAL : Computerized Cognitive Behavior Therapy
- Undergo computerized cognitive behavior therapy
- Other Names :
- cCBT, cognitive behavior therapy, Beating the Blues, CBT
|
#Eligibility Criteria:
Inclusion Criteria:
* A current/prior cancer diagnosis
* A principal diagnosis of major depressive disorder (MDD)
* Able and willing to give informed consent
* Have access to a computer with an internet connection at home
Exclusion Criteria:
* History of bipolar affective disorder or psychosis
* History of substance dependence in the past six months
* Subnormal intellectual potential (intelligence quotient [IQ] below 80)
* Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis
* Inability to read and write English
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02837887
|
{
"brief_title": "Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer",
"conditions": [
"Major Depressive Disorder"
],
"interventions": [
"Behavioral: Computerized Cognitive Behavior Therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02837887",
"official_title": "A Computerized Cognitive Behavioral Therapy for Cancer Patients With Major Depressive Disorder",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-31",
"study_completion_date(actual)": "2018-03-29",
"study_start_date(actual)": "2016-07-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-06-22",
"last_updated_that_met_qc_criteria": "2016-07-15",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-20",
"first_submitted": "2016-07-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study evaluates the endotracheal tube cuff pressure of a taper-guard cuffed tube during tympanoplasty with ipsilateral rotation of head, compared to the contralateral rotation of head.
The investigators will performed the ipsilateral rotation of head against the fixed tube in half of participants or the contralateral rotation of head in the other half.
Detailed Description
The inflation of the endotracheal tube cuff is very useful to prevent aspiration of contaminated substances into lung past endotracheal tube and leakage of gas during positive pressure ventilation. However, excessive inflation of endotracheal tube cuff frequently causes tracheal mucosal damage, which can increase the incidence of sore throat, hoarseness, and coughing after surgery.
Taper-guard cuffed tube was newly developed. Taper-guard endotracheal tube is more effective in providing a sealing effect than a cylindrical endotracheal tube in an in vitro study. However, recently, it was reported that the cuff pressure of a Taper-guard endotracheal tube significantly increased after a positional change from the supine to the lateral flank position, compared to that of a cylindrical endotracheal tube. However, during tympanoplasty, the investigators need to rotate head for proper position.
In this study, therefore, the investigators investigate the difference of the endotracheal tube cuff pressure of a taper-guard cuffed tube between ipsilateral and contralateral rotation of head against the fixed tube during tympanoplasty.
#Intervention
- PROCEDURE : Ipsilateral rotation of head
- Ipsilateral rotation of head against fixed tube
- PROCEDURE : Contralateral rotation of head
- Contralateral rotation of head against fixed tube
|
#Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologists physical status classification I-III for a tympanoplasty under general anesthesia
Exclusion Criteria:
* history of difficult intubation, limited neck movement, respiratory diseases, and body mass index >35kg/m2
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03524586
|
{
"brief_title": "Comparison of the Cuff Pressure of a Taper-guard Cuffed Tube Between Ipsilateral and Contralateral Rotation of Head",
"conditions": [
"Anesthesia, Endotracheal",
"Airway Management"
],
"interventions": [
"Procedure: Contralateral rotation of head",
"Procedure: Ipsilateral rotation of head"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03524586",
"official_title": "Comparison of the Endotracheal Tube Cuff Pressure of a Taper-guard Cuffed Tube Between Ipsilateral and Contralateral Rotation of Head During Tympanoplasty; Prospective Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-05",
"study_completion_date(actual)": "2018-05-01",
"study_start_date(actual)": "2018-01-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-05-17",
"last_updated_that_met_qc_criteria": "2018-05-02",
"last_verified": "2018-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-05-15",
"first_submitted": "2018-05-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study investigates the effect of high-intense aerobe exercise training (HIIT) and aerobe exercise of low intensity on clinical and physiological parameters (anxiety, activity, cortisol, alpha amylase, heart rate, heart rate variability, spiroergometry) in patients with Music Performance Anxiety (MPA). Half of the patients will receive HIIT, while the other half will receive aerobe exercise of low intensity.
Detailed Description
In this study, 20 patients with MPA will receive a high-intensive aerobe training (HIIT, 6 HIIT-sessions of 20 minutes within a period of 12 days). Additionally, 20 MPA-patients will undergo a less intense aerobe training matched regarding frequency and duration of sessions. Prior to the first training session, after completing the training (day 12) and 10 days after the Training (day 22), symptoms of anxiety and will be assessed by using questionnaires. Moreover, heart rate and heart rate variability will be obtained and activity level is measured using accelerometers. Before and after the training there will be an assessment of saliva samples for measuring cortisol and alpha amylase.
Furthermore, a standardized performance situation is established before and after the Training. Before, during and after the performance anxiety ratings, cortisol, alpha amylase, heart rate and heart rate variability are assessed.
The investigators hypothesize, that patients with MPA which undergo HIIT, will show a stronger and more sustained improvement of both, clinical symptoms and physiological measures. Specifically, a decreased heart rate, higher heart rate variability and decreased endocrinological parameters.
#Intervention
- OTHER : high-intensive aerobe exercise
- Aerobe bicycle ergometer training within 77-95% of maximum oxygen consumption; duration of each training session: 20 minutes; frequency of training: 6 sessions within 12 days
- OTHER : low-intensive aerobe exercise
- Aerobe training below 70% of maximum oxygen consumption (including light stretching and simple exercises adapted from yoga figures); duration of training session: 20 minutes; frequency of training: 6 sessions within 12 days
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of social anxiety disorder, Performance only subtype due to DSM-5
* Appropriate abilities to communicate and to complete the questionnaires
* Written informed consent
* Possibility of regular attendance at the training sessions
* Participant is a classical instrumentalist
Exclusion Criteria:
* Other severe mental conditions than MPA (e.g. schizophrenia, severe depressive episode, addiction)
* Acute suicidality
* Epilepsy or other disorders of the central nervous system (e.g. tumor, encephalitis)
* Contraindications to aerobe exercise Training
* Start or modification of an anxiolytic pharmacotherapy or other therapy within the last four weeks
* Current psychotherapy
* no sufficient capability to consent to trial
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03562312
|
{
"brief_title": "Performance Anxiety Changes With Exercise",
"conditions": [
"Performance Anxiety"
],
"interventions": [
"Other: high-intensive aerobe exercise",
"Other: low-intensive aerobe exercise"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT03562312",
"official_title": "Clinical, Neuroendocrine and Physiological Effects of Exercise in Patients With Music Performance Anxiety",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-14",
"study_completion_date(actual)": "2020-04-14",
"study_start_date(actual)": "2018-05-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-15",
"last_updated_that_met_qc_criteria": "2018-06-07",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-19",
"first_submitted": "2018-05-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an open-label, single-dose study of the plasma pharmacokinetics (PK), safety, and tolerability of islatravir (ISL, MK-8591), and the intracellular PK of ISL triphosphate (ISL-TP) in male and female adult participants with moderate hepatic impairment and in healthy matched control participants.
#Intervention
- DRUG : Islatravir
- Two ISL 30 mg capsules taken by mouth.
- Other Names :
- MK-8591
|
#Eligibility Criteria:
Inclusion Criteria:
Healthy Control Participants:
* Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed prior to randomization
* Is in good health based on laboratory safety tests obtained at the screening visit and prior to administration of the initial dose of study drug.
* Has a body mass index (BMI) >=18.5 and <=40 kg/m2
Hepatic Impairment Participants:
* Has a diagnosis of chronic (> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology
* Has a score on the Child-Pugh scale ranging from 7 to 9 (moderate hepatic insufficiency) at screening
* With the exception of hepatic impairment, is in generally good health
* Has a BMI >= 18.5 and <= 40 kg/m2
Healthy and Hepatic Impairment Participants:
* Males : uses contraception according to local regulations
* Females: is not pregnant or breastfeeding and one of the following applies:
* Is not a woman of childbearing potential (WOCBP) OR
* Is a WOCBP and uses an acceptable contraceptive method
* A WOCBP with negative highly sensitive pregnancy test within 24 hours of study intervention
Exclusion Criteria:
* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
* Has a history of cancer (malignancy)
* Has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or non-prescription drugs or food
* Has known hypersensitivity to the active substance or any of the excipients of the study drug
* Is positive for hepatitis B surface antigen, hepatitis C antibodies, HIV-1 or HIV-2
* Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit
* Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to study drug administration, throughout the study, until the poststudy visit
* Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit
* Has a QTc interval >470 for males or >480 ms for females, has a history of risk factors for Torsades de Pointes (eg, heart failure/cardiomyopathy or family history of long QT syndrome), has uncorrected hypokalemia or hypomagnesemia, is taking concomitant medications that prolong the QT/QTc interval
* Is not considered low risk of having HIV infection
* Is a smoker or user of electronic cigarettes and/or has used nicotine or nicotine-containing products (eg, nicotine patch) within 3 months of screening
* Consumes greater than 3 glasses of alcoholic beverages per day
* Consumes more than 6 caffeinated beverages per day
* Is a regular user of illicit drugs or has a history of drug abuse within 2 years
* Presents any concern to the investigator regarding safe study participation
* Is unwilling to comply with study restrictions
* Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04515641
|
{
"brief_title": "Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030)",
"conditions": [
"Human Immunodeficiency Virus (HIV) Infection"
],
"interventions": [
"Drug: Islatravir"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04515641",
"official_title": "An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Islatravir (MK-8591) in Participants With Moderate Hepatic Impairment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-09-13",
"study_completion_date(actual)": "2021-09-13",
"study_start_date(actual)": "2020-11-05"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-03",
"last_updated_that_met_qc_criteria": "2020-08-14",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-17",
"first_submitted": "2020-08-14",
"first_submitted_that_met_qc_criteria": "2022-07-25"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of an investigational therapeutic agent (Cvac) in ovarian cancer patients in first or second remission and to determine its ability to prevent cancer from returning.
Study objectives
Primary objectives:
* To confirm the safety of administering Cvac in this population.
* To determine the effects of Cvac on progression-free survival (PFS).
Secondary objectives:
* To determine overall survival (OS) for ovarian cancer patients who receive Cvac after achieving remission in the first or second-line setting.
* Evaluation of host immunologic response to Cvac administration.
Detailed Description
An initial cohort of 7 patients were treated with Cvac in an open-label phase to confirm the safety and consistency of manufacturing between Cvac drug product manufactured in the United States (US) and Australia. After the manufacturing characteristics of Cvac were confirmed to be consistent and each patient in the initial cohort had completed 1 injection cycle of Cvac with no serious or treatment-related Grade 3 or 4 adverse events (AEs), 56 patients were enrolled and randomized (1:1) to either Cvac or observational standard of care (OSC).
#Intervention
- BIOLOGICAL : Cvac
- Cvac consists of autologous dendritic cells (DCs) incubated with the antigen, mannosylated fusion protein (M-FP), to target the DCs to the specific mucin 1 antigen.
|
#Eligibility Criteria:
Inclusion Criteria:
* Female subjects >= 18 years with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer who have previously undergone surgical cytoreduction and received first or second line conventional chemotherapy and are currently in complete remission (based on clinical and radiologic studies).
* Cancer antigen (CA)-125 <= upper limit of normal with a prior history of an elevated CA-125.
* Able and willing to undergo mononuclear cell collection.
* Not more than 12 weeks between enrollment and the last dose of chemotherapy that resulted in complete remission.
* No prior surgery to the peritoneum or pleural space within 28 days of enrollment, excluding removal of catheters used for chemotherapy administration.
* No prior treatment with an investigational product within 30 days of enrollment.
* Baseline electrocardiogram within normal limits or any abnormalities deemed not indicative of cardiac disease for which intervention is required.
* Serum creatinine <= 2 mg/dL.
* Serum aspartate aminotransferase or serum alanine aminotransferase <= 2.5x the upper limit of normal or serum total bilirubin <= 1.5x the upper limit of normal.
* White blood cell count >= 3.0 K/µL; absolute neutrophil count >= 1.5K/µL; hemoglobin >= 9.0 g/dL, and platelets >= 100,000/mm^3. (These complete blood count results are required for enrollment. It should be noted that complete blood count results, including monocyte count >= 0.2 × 10^9/L, will be needed prior to leukapheresis to determine if sufficient dendritic cells can be obtained for Cvac™ manufacture.)
* Life expectancy of at least 12 months.
* Eastern Cooperative Oncology Group Performance Status of 0 <= age <= 1.
* All toxicities from prior therapies, excluding alopecia, must have resolved to Common Terminology Criteria for Adverse Events Grade <= 1.
* Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion.
* Able to provide written informed consent.
Exclusion Criteria:
* Coexisting or other malignancies unless in complete remission for not less than 3 years. Does not include in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin for which no restrictions apply, assuming they have been adequately treated.
* Ovarian germ cell, sarcoma, or mixed Mullerian tumors.
* Prior cancer vaccine or cellular therapy.
* Active uncontrolled infections or any organ system toxicity >= Grade 2 by Common Terminology Criteria for Adverse Events criteria.
* Inability to provide informed consent or to comply with study-related procedures.
* Concurrent systemic treatment with steroids or other immunosuppressive agents.
* Diagnosed immunodeficiency and/or autoimmune disorders.
* Myocardial infarction in the past 6 months and/or clinically significant heart disease.
* Infection with human immunodeficient virus (HIV), hepatitis B or C virus.
* Pregnant or breastfeeding.
* Evidence or history of central nervous system metastases.
* Full dose anticoagulation therapy administered within 7 days of leukapheresis procedure.
* Hematopoietic growth factors administered within 14 days of enrollment.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01068509
|
{
"brief_title": "Ovarian Cancer Vaccine for Patients in Remission",
"conditions": [
"Epithelial Ovarian Cancer"
],
"interventions": [
"Biological: Cvac"
],
"location_countries": [
"Australia",
"United States"
],
"nct_id": "NCT01068509",
"official_title": "A Randomized, Open-label Phase IIb Trial of Maintenance Therapy With a MUC1 Dendritic Cell Vaccine (Cvac™) for Epithelial Ovarian Cancer Patients in First or Second Remission",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-08",
"study_completion_date(actual)": "2015-04",
"study_start_date(actual)": "2010-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-11",
"last_updated_that_met_qc_criteria": "2010-02-11",
"last_verified": "2016-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-02-15",
"first_submitted": "2010-02-10",
"first_submitted_that_met_qc_criteria": "2016-06-23"
}
}
}
|
#Study Description
Brief Summary
Background: Bleeding and coagulopathy still accounts for the majority of early in-hospital deaths following trauma. There have been lately several published studies suggesting that higher transfusion ratios of fresh frozen plasma (FFP), platelets (PTL) and cryoprecipitate (CRYO) to red blood cell (RBC) are associated with survival advantages. However, the evidence comes from retrospective data limited by a significant number of unaddressed confounders. In addition, the use of blood products bears known and important risks of complications.
Hypothesis: The adoption of a formula-driven transfusion practice with pre-defined ratios of FFP to PTL to RBC transfusion (1:1:1) is feasible and superior to current laboratory-guided transfusion practice in treating and/or preventing early coagulopathy improving survival rates in massively bleeding trauma patients .
Objective: To exam the feasibility of implementing a pre-defined ratio of FFP to PTL to RBC (1:1:1) transfusion protocol and its impact on a population of bleeding trauma patients.
Design: A two-year pilot feasibility randomized control trial at Sunnybrook Health Sciences Centre. Randomization: 70 patients are expected to be randomized to lab-driven or to formula-driven massive transfusion protocol and followed-up to 28 days or hospital discharge.
Study outcomes: protocol violation; in-hospital mortality by exsanguination; death at 28 days; coagulation competence defined by current standard coagulation tests (INR \& PTT \< 1.5 times normal; PTL ≥ 50 and Fibrinogen ≥ 1.0) or clotting factor levels ≥ 30%; correlation of current standard coagulation tests with clotting factors levels; cessation of bleeding; incidence of ALI, sepsis, MOF, transfusion-related circulatory overload, transfusion reactions; Ventilator-free days; ICU \& Hospital LOS; thromboembolic events.
Intervention protocol: Transfusion of pre-defined ratios of FFP and PTL to RBC (1:1:1) (formula-driven) for the first 12h of hospitalization without coagulation tests guidance while patient is hemorrhaging or before if bleeding stops.
Statistical analysis: protocol compliance rate and in-hospital mortality rates within 24h and at 28 days will be assessed using Chi-square test. ROC analysis will be used to analyze coagulation competence.
Main expected outcomes: implementation of a formula-driven transfusion protocol is feasible and coagulation competence will be achieved faster and more efficiently in the study group.
#Intervention
- OTHER : Massive transfusion protocol
- Patients randomized to this arm will be transfused based on a pre-defined massive transfusion protocol. Blood bank will release blood a pre-defined packages. Blood will be received in aliquots containing 4 units off FFP, 1 pool of buffy coat platelet (4 units) and 4 units of RBC. As discussed previously, this would correspond to an FFP:RBC transfusion ratio of 1:1.
Patients randomized to the study protocol will be receiving the FFP and PTL at pre-defined ratios to RBC (1:1:1) up to 12h of hospitalization or earlier if cessation of the massive transfusion requested at the discretion of the treating physicians.
- Other Names :
- Early and aggressive FFP transfusion, 1:1, FFP:RBC transfusion, Damage Control Resuscitation, Hemostatic Resuscitation, Early use of FFP
- OTHER : Standard of care
- Patients randomized to this arm will be treated as per Sunnybrook's current standard of care massive transfusion protocol. Crystalloid and red cell transfusions are performed to maintain volume status, and to maintain haemoglobin levels above 70 g/L. FFP is transfused based in 3-4 unit aliquots, for INR\>1.5. Platelets are transfused 1 pool at a time (4 units Buffy coat platelets) to maintain platelet counts above 50 x 109/mL. Cryoprecipitate is transfused 8-12 units at a time to keep fibrinogen above 0.8 gram/L.
|
#Eligibility Criteria:
Inclusion Criteria
Patients were eligible for this study if they:
i) were adult trauma patients assessed by the trauma team; and ii) suffered either penetrating or blunt mechanism of injury; and
* were bleeding and expected to require massive transfusion (either 4 units within the next 2 hours or >= 10 units of RBC in 24 h) or required transfusion of un-cross matched emergency stock red blood cells; and
* had an episode of hypotension (systolic bp <= 90mmHg).
Exclusion Criteria
Patients were excluded if:
i) they were assessed in the trauma room more than six hours after injury; or ii) they received more than two units of RBC transfusion prior to arrival; or iii) they had suffered a concomitant severe brain injury (defined as any of the following: Glasgow Coma Scale of 3 due to severe traumatic brain injury; clear indication of immediate neurosurgical intervention based on clinical findings, mechanism of trauma associated with focal signs (anisocoria, CT evidence of intracranial bleeding with mass effect); or iv) they had evidence of having a catastrophic head injury (such as transcranial gunshot wound, open skull fracture with exposure/loss of brain tissue, or expert opinion by either the trauma team leader or neurosurgical consultant based on initial clinical or initial CT findings); or v) they had evidence that their shock state was unrelated to hemorrhage (ie cardiogenic, septic, anaphylactic, acute adrenal insufficiency, neurogenic, or obstructive (cardiac tamponade, tension pneumothorax and massive pulmonary emboli); or vi) they had a known hereditary or acquired coagulopathy unrelated to the trauma resuscitation (for example: hemophilia, hepatic insufficiency, or anti-coagulant medications); or vii) they were moribund with evidence of unsalvageable injuries.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00945542
|
{
"brief_title": "The Trauma- Formula-Driven Versus Lab-Guided Study (TRFL Study)",
"conditions": [
"Hemorrhagic Shock",
"Trauma Coagulopathy"
],
"interventions": [
"Other: Standard of care",
"Other: Massive transfusion protocol"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00945542",
"official_title": "Formula-driven vs Laboratory-guided Transfusion Practices in Bleeding Trauma Patients: A Feasibility Randomized Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2009-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-12-02",
"last_updated_that_met_qc_criteria": "2009-07-23",
"last_verified": "2011-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-07-24",
"first_submitted": "2009-07-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To present the first admission chest computed tomography (CT) findings of patients followed up with a diagnosis of COVID-19, and to compare the two classification systems by evaluating these findings according to the BSTI and RSNA guidelines.
Detailed Description
A total of 764 adult patients who were diagnosed with COVID-19 inpatient of researchers' hospital 2020 were included in this study. The findings were recorded as typical, indeterminate, and atypical by the RSNA guidelines and as classical COVID-19, possible COVID-19, indeterminate, and non-COVID-19 by the BSTI classification. The data obtained according to both classification systems were compared with each other.
|
#Eligibility Criteria:
Inclusion Criteria:
* Who had single negative RT-PCR
* Non-optimal chest CT , insufficient data
* <18 age of year
* Thoracic trauma
* Chest CT Negative
Exclusion Criteria:
* RT-PCR positive and chest CT positive findings
* At least two RT-PCR negative and chest CT positive findings
* >18 age of year
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04754633
|
{
"brief_title": "Comparison of Chest CT Findings Related to COVID-19 With RSNA and BSTI Guidelines",
"conditions": [
"Covid19",
"Infection Viral",
"CT Scan"
],
"interventions": null,
"location_countries": [
"Turkey"
],
"nct_id": "NCT04754633",
"official_title": "Comparison of Chest CT Findings Related to COVID-19 With RSNA and BSTI Guidelines: Correlation Between Radiologists",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-07-20",
"study_completion_date(actual)": "2020-07-20",
"study_start_date(actual)": "2020-07-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-02-15",
"last_updated_that_met_qc_criteria": "2021-02-12",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-15",
"first_submitted": "2021-02-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants with the pneumococcal study vaccines.
Detailed Description
The purpose of this study is to assess the immunogenicity of the two formulations of GSK Biologicals' pneumococcal vaccine 2830929A (11-valent vaccine or 11Pn vaccine) and 2830930A (12-valent vaccine or 12Pn vaccine), when administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life, when compared to immune responses to the licensed vaccines Synflorix™ and Prevnar 13™, and to assess the reactogenicity and safety of these two same investigational formulations when administered according to this schedule. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine will be co-administered in infants with the pneumococcal study vaccines.
#Intervention
- BIOLOGICAL : Pneumococcal conjugate vaccine GSK2830929A
- Intramuscular injection
- BIOLOGICAL : Pneumococcal conjugate vaccine GSK2830930A
- Intramuscular injection
- BIOLOGICAL : Synflorix™
- Intramuscular injection
- BIOLOGICAL : Prevnar 13™
- Intramuscular injection
- BIOLOGICAL : Infanrix hexa™
- Intramuscular injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.
* A male or female between, and including 6 to 12 weeks (42 <= age <= 90 days) of age at the time of the first vaccination. In addition, the first pneumococcal and DTPa-HBV-IPV/Hib vaccination should be given in accordance with the official national recommendations for the immunisation schedule of infants.
* Written informed consent obtained from the parents/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of at least 36 weeks.
Exclusion Criteria:
* Child in care.
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/administration of a vaccine containing diphtheria toxoid, tetanus toxoid (except MenC-TT in Spain) or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the following exceptions:
* Licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines.
* Licensed rotavirus vaccines are allowed if administered at least 7 days before or after each dose of study of vaccines.
* Licensed MenC-TT vaccine is allowed in Spain and should be concomitantly administered with the study vaccine at around 2, 4 and 12 <= age <= 15 months of age.
* In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organised by the public health authorities, outside the routine immunization program, that vaccine can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product .
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness, including Kawasaki's syndrome.
* History of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile).
* Acute disease and/or fever at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during study period.
* Previous vaccination against diphtheria, tetanus, pertussis, polio, H. influenzae type b.
* Previous vaccination against S. pneumoniae.
* History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b disease.
* Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
Sex :
ALL
Ages :
- Minimum Age : 6 Weeks
- Maximum Age : 12 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01616459
|
{
"brief_title": "Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants",
"conditions": [
"Infections, Streptococcal"
],
"interventions": [
"Biological: Pneumococcal conjugate vaccine GSK2830930A",
"Biological: Infanrix hexa™",
"Biological: Prevnar 13™",
"Biological: Pneumococcal conjugate vaccine GSK2830929A",
"Biological: Synflorix™"
],
"location_countries": [
"Germany",
"Spain",
"Czechia",
"Poland"
],
"nct_id": "NCT01616459",
"official_title": "Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-04-25",
"study_completion_date(actual)": "2014-01-22",
"study_start_date(actual)": "2012-07-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-16",
"last_updated_that_met_qc_criteria": "2012-06-07",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-06-11",
"first_submitted": "2012-06-07",
"first_submitted_that_met_qc_criteria": "2014-05-15"
}
}
}
|
#Study Description
Brief Summary
This study seeks to determine if photobiomodulation (PBM, or low level laser light) affects the growth and distribution of nerves int he skin. Our previous study demonstrated that the treatment we use here was effective at reducing the symptoms of neuropathy (as measured by the modified total neuropathy score) in patients who had been treated with chemotherapy. The current effort is designed to repeat this confirm this observation using a more extensive battery of survey as well as to begin to elucidate the mechanism through which photobiomodulaiton produces the effect. WE will also be attempting to determine if diabetic patients differ in terms of response from chemotherapy patients
Detailed Description
Consenting patients with self-reported neuropathy following either diabetes or administration of chemotherapy, will undergo sensory testing and skin biopsies of the the foot and leg prior to initiating treatment. They will undergo PBM 3 times weekly for 6 weeks with with a follow-up biopsy performed at the conclusion of therapy and sensory testing throughout. Patients will have one remote evaluation at 26 weeks to determine whether the effect, if any extinguishes.
#Intervention
- DEVICE : Realief Therapy
- Patients will be treated using class IV laser using a proprietary algorithm developed by REALief neuropathy centers
- Other Names :
- biopsies (skin, diagnostic not therapeutic)
|
#Eligibility Criteria:
Inclusion Criteria: self reported neuropathy following exposure to diabetes or chemotherapy
* willingness to undergo biopsies and 6 weeks of therapy
Exclusion Criteria:
* pregnancy
* active cancer treatment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03195868
|
{
"brief_title": "Photobiomodulation Therapy and Nerve Density for Patients With Diabetic or Chemotherapy-associated Neuropathy",
"conditions": [
"Neuropathy",
"Neuropathy, Diabetic",
"Neuropathy Toxic"
],
"interventions": [
"Device: Realief Therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03195868",
"official_title": "A Comparative Analysis of Changes in Peripheral Nerve Density and Structure Following Photobiomodulation Therapy Using the REALief Therapy System for Patients With Diabetic or Chemotherapy-associated Neuropathy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-21",
"study_completion_date(actual)": "2021-01-21",
"study_start_date(actual)": "2019-09-30"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-06-09",
"last_updated_that_met_qc_criteria": "2017-06-21",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-22",
"first_submitted": "2017-06-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to investigate additional clinical uses for the polymer, which is a FDA approved, 510k, medical device, but has not been approved for use on patients with pin track sites as a way to lower the infection rate and is investigational for this purpose. The approved uses include wound care and post-operative care.
About 13 subjects will take part in this study.
Detailed Description
Study Objectives Research participants eligible for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant.
It is a 510K FDA cleared medical device indicated for providing a covering over minor wounds and scrapes that are clean and dry. The microbicidal liquid solution consists of organic polymer dissolved in methylene chloride organic solvent. The unique formulation eradicates any organisms (bacteria, fungi, viruses) it comes in contact with. This is a result of the methylene chloride's activity against an infinite number of organisms. The methylene chloride evaporates leaving a clear, elastomeric, non-odorous film for covering minor wounds. The film protects the wound against entry of water, dirt, and germs. The film is elastomeric and protects in difficult regions where flexing, bending and creasing skin occurs. The clear film forms in less than a minute. Application is commonly accomplished using a cotton tip applicator. The liquid is applied on and around the wound extending at least an inch and a quarter beyond the edges of the wound. Momentary stinging may occur upon initial application. The film commonly remains intact for one to three days or longer depending on exposure to rubbing, flexing, or soap and water. This film is resistant to degradation by water alone, but can be easily removed with the combination of soap and water or it can be gently peeled off starting at the outer edges. It is for external use only. It is not intended for use on deep or infected wounds or puncture wounds, or for use near the eyes, mouth, or nose. Intentional inhaling of the contents may be harmful or fatal. The bottle should be tightly capped after each use to prevent evaporation of the solvent.7
This Principle Investigator has previously utilized and topically applied the product as an additional step in the treatment protocol for pin site care for several reconstructive surgery patients (approximately 25) with over 200 pin sites with only 2 pin site infections. This represents a significant reduction from the average incidence of pin site infections reported in the literature (\<1% vs 27% on a per research participant basis). A recently published retrospective case series evaluating this microbicidal polymer dressing reported 6 patients and 66 pins had no infections when Duraderm® was used as part of their pin site care regimen.8
This study was undertaken to formally evaluate whether this microbial liquid po used on pin sites leads to a reduction in pin track infections when compared to a control group as well as the reported average incidence in the literature.
#Intervention
- DEVICE : Novel Microbicidal Liquid Polymer
- The polymer is a 510K FDA cleared medical device indicated for providing a covering over minor wounds and scrapes that are clean and dry. The microbicidal liquid solution consists of organic polymers . The unique formulation eradicates any organisms (bacteria, fungi, viruses) it comes in contact with. This is a result of the solvent's activity against an infinite number of organisms After eradication is complete, the solvent then transitions into a clear, elastomeric, non-odorous film for covering disrupted tissue. The film protects the wound against entry of water, dirt, and germs. The film is elastomeric and protects in difficult regions where flexing, bending and creasing skin occurs. The clear film forms in less than a minute.6 DuraDerm® should not be used to the treat deep infected wounds. DuraDerm® can be used to protect disrupted skin surface of wounds that are clean and dry.
|
#Eligibility Criteria:
Inclusion Criteria:
* Deformity correction, traumatic provisional fixation
* All pin sites are stable
* 18 years or greater
* No known contraindication to receive product
Exclusion Criteria:
* Age less than 18 years
* Known allergy to Methylene Chloride
* Known sensitivity to organic polymers
* Non-clean, dry wound at pin
* Vulnerable research participants (Institutionalized, students, employees, prisoners, or those with decisional incapacity, etc.)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03756506
|
{
"brief_title": "The Use of a Novel Microbicidal Liquid Polymer for the Reduction of Pin Track Infection",
"conditions": [
"Infection",
"Post-operative Care"
],
"interventions": [
"Device: Novel Microbicidal Liquid Polymer"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03756506",
"official_title": "An Evaluation of the Use of a Novel Microbicidal Liquid Polymer for the Reduction of Pin-tract Infection in Research Participants Receiving External Fixation Following Deformity Correction and Traumatic Provisional Fixation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-30",
"study_completion_date(actual)": "2019-09-30",
"study_start_date(actual)": "2018-11-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-30",
"last_updated_that_met_qc_criteria": "2018-11-26",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-28",
"first_submitted": "2018-11-26",
"first_submitted_that_met_qc_criteria": "2020-06-29"
}
}
}
|
#Study Description
Brief Summary
The Children's Hospital of Philadelphia's ambulatory network uses an electronic health record (EHR) to document clinical information. Using the EHR, a clinical decision support tool will be designed to help the primary care physician's in caring for children with asthma. The goal will be to improve the primary care physician's use of the national Institutes of Health guidelines for the best care for asthma. To study this EHR decision support tool, it will be introduced into 5 practices while 5 other practices will have the existing asthma care information. It will be determined whether the physicians in the practices with the decision support tool are better at following the asthma guidelines. If the decision support tool works...then it will be offered to others to use with their EHR systems.
Detailed Description
National Asthma Education and Prevention Program guidelines (NAEPP) exist, but are under used in Primary Care. In addition, implementation of the guidelines has been shown to be vary according to the location of practice and other contextual factors.
The Children's Hospital of Philadelphia Pediatric Research Consortium (PeRC), a practice-based research network will determine whether an innovative clinical decision support system embedded in an existing electronic health record (EHR) will improve provider adherence to the existing NAEPP guidelines.
After receiving a standardized education module based on NAEPP guidelines, 10 primary care pediatric practices (both urban and suburban) will be randomized to receive either a passive EHR (control sites) or an interactive decision support sytem (intervention sites).
The primary outcome of interest will be the proportion of patient son appropriate asthma controller medication compared over time. Secondary outcomes include the proportion of asthma patients with: 1) an updated asthma action plan 2) documentation of spirometry performed (6 to 17years) and 3) an updated problem list reflecting current asthma severity. After hours calls to providers and types of office visits related to to asthma will be tracked. Contextual factors at the clinic and patient level will be examined to assess their association with the outcomes of interest. In addition, measurement of asthma-related quality of life and missed school and work in a sample of 200 subjects from each group will be performed
If shown to be successful, this type of clinical decision support, embedded within the EHR, has the potential to be a powerful tool to improve the implementation of asthma guidelines and clinical practice guidelines for other conditions and illnesses.
#Intervention
- BEHAVIORAL : Computerized Decision support
- Using a clustered randomized method, computerized decision support, embedded in the electronic health record, was offered to selected primary care practices and outcomes of asthma care were compared to those practices without the computerized decision support.
- Other Names :
- electronic health record
|
#Eligibility Criteria:
Inclusion Criteria:
* Children with the diagnosis of asthma
* Children enrolled in one of 10 selected primary care practices in the PeRC practice-based research network
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01522144
|
{
"brief_title": "An Electronic Decision Support Tool to Improve Outpatient Asthma Care",
"conditions": [
"Asthma"
],
"interventions": [
"Behavioral: Computerized Decision support"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01522144",
"official_title": "EHR Decision Support to Improve Outpatient Asthma Care",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-04",
"study_completion_date(actual)": "2008-08",
"study_start_date(actual)": "2006-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-01-31",
"last_updated_that_met_qc_criteria": "2012-01-27",
"last_verified": "2012-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-01-31",
"first_submitted": "2012-01-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Pulmonary dysfunction after cardiac surgery with CPB remains to be a problem complicating the postoperative course of the patients. The investigators hypothesized that RIPCcom, combined intervention of remote ischemic preconditioning and remote ischemic postconditioning, would confer beneficial influence on inflammatory response and resultant postoperative pulmonary dysfunction after CPB in patients undergoing complex valvular heart surgery who are at increased risk of postoperative pulmonary dysfunction.The aim of this study was to evaluate the lung-protective effect of combined remote ischemic pre- and post-conditioning in patients undergoing complex valvular heart surgery.
#Intervention
- PROCEDURE : remote ischemic pre and postconditioning (RIPC)
- RIPCcom group: combined intervention of remote ischemic pre- and postconditioning consisted of three 10-minute cycles of right lower limb ischemia, which was induced with an automated cuff-inflator placed on the right upper leg and inflated to 250 mmHg, with an intervening 10 minute of reperfusion during which the cuff was deflated. This intervention were performed at 10 minutes after induction of anesthesia and then 10 min after weaning from CPB.
- Other Names :
- combined intervention of remote ischemic preconditioning and remote ischemic postconditioning.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients undergoing valvular heart surgery.
* Age: 20~80.
Exclusion Criteria:
* Emergency operation.
* patients with peripheral vascular disease.
* Patients with a known history or clinical evidence of chronic obstructive pulmonary disease.
* Patients with hepatic or renal dysfunction
* Patients with acute myocardial infarction within 1 week before surgery
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01427621
|
{
"brief_title": "Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery",
"conditions": [
"Heart Valve Diseases"
],
"interventions": [
"Procedure: remote ischemic pre and postconditioning (RIPC)"
],
"location_countries": null,
"nct_id": "NCT01427621",
"official_title": "Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-11",
"study_completion_date(actual)": "2011-05",
"study_start_date(actual)": "2010-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-09-01",
"last_updated_that_met_qc_criteria": "2011-08-31",
"last_verified": "2011-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-09-01",
"first_submitted": "2011-08-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective is to evaluate the effect of MBS treatment in human subjects, and to validate its impact on intestinal flora and diabetes symptoms on diabetic patients undertaking metformin. The scientific data collected will be referenced for future product development.
#Intervention
- DIETARY_SUPPLEMENT : MBS oral solution
- Oral BIDAC, twice a day before breakfast and dinner times
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female subject who aged from 20 to 70.
* BMI in between 18.5 and 35 kg/m2 inclusively.
* Fasting blood sugar >= 126 mg/dL, and confirmed diagnosis of type-II diabetes.
* 30 days prior to the screening visit (V1), HbA1c is steadily maintained in between 7 <= age <= 10% by medication.
* Prior to the screening visit (V1), subjects have been regularly taken 500 <= age <= 200 mg/day for at least 90 days.
Exclusion Criteria:
* Pregnant or breastfeeding women or female subjects plan to enter pregnancy during study period.
* Subjects who are allergic to soy or products containing it.
* At investigator's discretion, subjects are unlikely to comply with study procedures due to a history of alcohol or drug addiction.
* Subjects on vegetarian diet or other special diets (eg. Ketogenic or gluten-free diets).
* Subjects have ongoing participation in another clinical trial that involves the use of investigational drugs, medical devices, dietary supplements, and/or cosmetics.
* Subject with impaired renal function confirmed by Serum Total Bilirubin >= 1.5 upper limit of normal [ULN], Aspartate Transaminase/ Alanine Transaminase (AST/ALT) >= 2 ULN, Creatinine >= 2 ULN or eGFR <60 mL/min/1.73 m^2.
* Subjects who have been diagnosed with malignant tumors within five (5) years before the screening visit (V1) with exception to subjects with topical cancer but show significant recovery following investigator's assessment, such as basal or squamous cell skin cancer, superficial bladder cancer, or prostate or cervix or carcinoma in situ of the breast.
* 30 days prior to screening visit (V1), subjects have taken antibiotics, synthetic drugs (Sulfonamides, Fluoroquinolone, etc.), anti-fungal or anti-viral medication but not limited to topical forms for use in skin application.
* Within 14 days prior to screening visit (V1), subjects have taken products or supplements that contain probiotics or prebiotics.
* Within 14 days prior to screening visit (V1), subjects experience diarrhea caused by gastrointestinal infection (3 times of watery stool within 24 hours).
* Within14 days prior to screening visit (V1), subjects have taken steroids, immunosuppressant, and/or inflammatory medicines.
* Subjects took or intend to take medications other than metformin that may affect intestinal flora within 30 days prior to screening visit, during screening period or whole trial period. Examples of this kind of medication include DPP-4 inhibitors, GLP-1 receptor agonists, acarbose, hypoglycemic sulfonamides, thiazolidinediones, SGLT2 inhibitors, and insulin.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04639492
|
{
"brief_title": "Postbiotic MBS and Metformin Combination in Patients With T2DM",
"conditions": [
"Type-II Diabetes"
],
"interventions": [
"Dietary Supplement: MBS oral solution"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT04639492",
"official_title": "Evaluating the Effect and Safety of Postbiotic MBS and Metformin Combination on Gut Microbiota and Symptom in Patients With Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-30",
"study_completion_date(actual)": "2022-09-23",
"study_start_date(actual)": "2020-11-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-05",
"last_updated_that_met_qc_criteria": "2020-11-19",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-11-20",
"first_submitted": "2020-11-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main objective of this study is to assess the effectiveness of low dose Vitamin K1 (200 micrograms per day) at improving anticoagulation control in unstable patients on warfarin. This study will also aim to look at effectiveness in the context of genes known to influence warfarin metabolism, variability in the consumption of Vitamin K rich foods, and patient knowledge about warfarin anticoagulation -- factors which have been associated with anticoagulation control and which can influence the effectiveness of this intervention in clinical practice.
Detailed Description
A double-blinded placebo controlled pilot RCT assessing the effectiveness of daily supplementation with low dose Vitamin K1 (200 micrograms per day) against placebo at improving anticoagulation control. Previous studies assessing the efficacy of this intervention have been small and further trials are required to evaluate the true effectiveness and safety profile. Furthermore the impact of genetic polymorphisms, known to impact warfarin metabolism, on the effectiveness/safety of this intervention will also be assessed in this study. Demographic and clinical variables as well as potential confounding variables such as variable dietary Vitamin K intake, concomitant interacting medications, and anticoagulation knowledge will be assessed in this study. Given that this is a pilot study we will be looking at recruitment numbers and necessary parameter estimates to determine the number of patients available at our institution for the study. Power analysis will be performed to evaluate the treatment effect size between the placebo and intervention groups.
#Intervention
- DIETARY_SUPPLEMENT : Vitamin K1 (Phytonadione)
- Vitamin K1 tablets (100 micrograms per tablet) will be taken by patients randomized to the Vitamin K arm. Dosage is two tablets per day (200 micrograms per day) to be taken with warfarin for the 6 month study period.
- DIETARY_SUPPLEMENT : Placebo
- Lactose-based placebo tablets (identical in appearance to the Vitamin K1 tablets) will be taken by patients randomized to the placebo arm. Dosage is two tablets per day to be taken with warfarin for the 6 month study period.
|
#Eligibility Criteria:
Inclusion Criteria:
* >= 18 years
* Have been on warfarin anticoagulation for at least 9 months
* Have an INR target range of 2.0 <= age <= 3.0
* Have 'unstable' anticoagulation control, defined as in the preceding 6 months having at least 3 INRs out of range (>= 3.2 or =<1.8) or at least 3 warfarin dose changes
* Have anticoagulation managed by the Ottawa Hospital Thrombosis Clinic
* Able to provide written, informed consent
Exclusion Criteria:
* Anticipated interruption or termination of warfarin anticoagulation in the next six months for a period of 1 week or greater
* Patient instability in the preceding six months suspected to be due to a) Interruption of warfarin therapy for a period of 1 week or more or b) Significant non-compliance (assessed from patient record)
* Possess a known allergy to Vitamin K or lactose based placebos
* Unable/Refusal to provide written, informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00794755
|
{
"brief_title": "Low Dose Supplementation to Improve Anticoagulation Control With Oral Vitamin K as an Adjuvant to Warfarin Therapy",
"conditions": [
"Coagulation"
],
"interventions": [
"Dietary Supplement: Placebo",
"Dietary Supplement: Vitamin K1 (Phytonadione)"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00794755",
"official_title": "A Phase III Pilot RCT (Randomized, Controlled Trial) to Assess the Effectiveness of Low Dose Vitamin K1 (200 Micrograms Per Day) on Improving Anticoagulation Control in Unstable Patients on Warfarin",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-04",
"study_completion_date(actual)": "2010-04",
"study_start_date(actual)": "2008-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-07-27",
"last_updated_that_met_qc_criteria": "2008-11-19",
"last_verified": "2011-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-11-20",
"first_submitted": "2008-11-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
State-of-the-art documents like ARIA and european position paper on rhinosinusitis (EPOS) provide clinicians with evidence-based treatment algorithms for allergic rhinitis (AR) and chronic rhinosinusitis (CRS) respectively (1)(2) . The currently available medications can alleviate symptoms associated with AR and RS, and most patients with RS benefit from endoscopic sinus surgery (ESS). In real life, a significant percentage of patients with AR and CRS continue to experience bothersome symptoms despite adequate treatment. This group with so-called severe chronic upper airway disease (SCUAD) represents a therapeutic challenge (3).
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients that have undergone bilateral ESS for inflammatory sinonasal disease, without additional sino-nasal surgery after the ESS.
* Age > 18 and < 75 years.
* Written informed consent
* Dutch, French or English speaking patients
Exclusion Criteria:
* Unilateral ESS
* Benign and malignant tumor disease
* Patient with a psychiatric, addictive, or any disorder of which the investigators feel at the time of evaluation for participation in the study that this may compromise the ability to give truly informed consent for participation in this study or provide reliable information on the questionnaire
* Lack of knowledge of Dutch, French or English
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01777425
|
{
"brief_title": "Long-term Control in Rhinosinusitis After Functional Endoscopic Sinus Surgery (FESS)",
"conditions": [
"Condition of Patient 3 Years After FESS-operation"
],
"interventions": null,
"location_countries": [
"Belgium"
],
"nct_id": "NCT01777425",
"official_title": "Long-term Control in Rhinosinusitis After FESS: Cross-sectional Observational Study on Control in Rhinosinusitis at a Mean Interval of 3 Years After FESS",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-05",
"study_completion_date(actual)": "2013-05",
"study_start_date(actual)": "2012-12"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-03-05",
"last_updated_that_met_qc_criteria": "2013-01-23",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-01-28",
"first_submitted": "2013-01-23",
"first_submitted_that_met_qc_criteria": "2014-01-17"
}
}
}
|
#Study Description
Brief Summary
This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.
#Intervention
- BEHAVIORAL : Enhanced Internet DA
- BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
- BEHAVIORAL : Internet DA
- BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support. This intervention is designed to provide education regarding the available risk management options.
- BEHAVIORAL : Enhanced Print DA
- BRCA1/2 carriers randomized to this arm will receive print-based decision support materials which include a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
- BEHAVIORAL : Print DA
- BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.
- BEHAVIORAL : Inconclusive Results DA
- Women who receive uninformative BRCA1/2 results randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
|
#Eligibility Criteria:
Inclusion Criteria:
* Undergo BRCA1/2 genetic counseling and testing at one of four study sites
* Receive positive or uninformative test results
* English speaking
Exclusion Criteria:
* Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment
* Previous bilateral mastectomy
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02133703
|
{
"brief_title": "Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility",
"conditions": [
"Breast Cancer",
"Ovarian Cancer"
],
"interventions": [
"Behavioral: Enhanced Internet DA",
"Behavioral: Print DA",
"Behavioral: Inconclusive Results DA",
"Behavioral: Enhanced Print DA",
"Behavioral: Internet DA"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02133703",
"official_title": "Decision Making Interventions for Women Receiving Uninformative BRCA1/2 Test Results or Positive BRCA1/2 Test Results",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-01",
"study_completion_date(actual)": "2022-07-01",
"study_start_date(actual)": "2015-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-14",
"last_updated_that_met_qc_criteria": "2014-05-06",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-05-08",
"first_submitted": "2014-04-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).
#Intervention
- OTHER : Study Formula (SF)
- New infant formula for term infants fed ad lib
- OTHER : Comparator Formula (CF)
- Commercially available infant formula for term infants fed ad lib
|
#Eligibility Criteria:
Inclusion Criteria:
* Term (no less than 37 weeks, 0 days and less than 42 weeks, 0 days), singleton infant.
* Birth weight of greater than or equal to 2500 grams.
* Designated healthy by a physician.
* Less than or equal to 14 days of age at enrollment.
* If formula fed, exclusively consuming and tolerating a cow's milk infant formula at enrollment and have a parent who agrees to feed the study formula as a sole source of nutrition for a minimum of 16 weeks.
* If human milk fed, predominantly consuming and tolerating human milk and have a mother/parent who plans to predominantly feed human milk as sole source of nutrition for a minimum of 16 weeks.
* Weight for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
* Length for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
* Head circumference for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
* Weight for length greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
* Not currently receiving and have a parent/guardian who does not plan to give pre- and/or pro-biotics for the full duration of the study.
* Not currently participating in an interventional clinical trial and have a parent(s) or legal guardian(s) who agree not to enroll the infant in an interventional clinical trial while participating in this trial.
* Have parent(s) or legal guardian(s) who are capable of completing the written records, questionnaires, and study procedures required by the protocol.
* Have a parent(s) or legal guardian(s) who have read and voluntarily signed the Institutional Review Board Informed Consent prior to study participation.
Exclusion Criteria:
* Evidence of any anatomic or physiologic condition that would interfere with normal growth, development, or feeding.
* Infants required to take medications know to influence growth and development.
* Maternal history with known adverse effects on the fetus and/or the newborn infants.
* Family history of cow milk protein allergy or soy intolerance/allergy.
* Infants receiving any amount supplemental human milk with infant formula or visa-versa at time of enrollment.
* Infants from a multiple birth.
Sex :
ALL
Ages :
- Minimum Age : 0 Days
- Maximum Age : 14 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04218929
|
{
"brief_title": "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants",
"conditions": [
"Infants",
"Newborn"
],
"interventions": [
"Other: Study Formula (SF)",
"Other: Comparator Formula (CF)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04218929",
"official_title": "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-11",
"study_completion_date(actual)": "2021-06-11",
"study_start_date(actual)": "2019-12-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-06-30",
"last_updated_that_met_qc_criteria": "2020-01-02",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-06",
"first_submitted": "2019-12-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.
Detailed Description
Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.
#Intervention
- DEVICE : Kalifilcon Toric Lens
- Kalifilcon A Daily Disposable Toric for Ametropia
- DEVICE : Total1 for Astigmatism
- Total1 for Astigmatism
- DEVICE : Precision1 for Astigmatism
- Precision1 for Astigmatism
- DEVICE : MyDay Toric
- MyDay Toric
|
#Eligibility Criteria:
Inclusion Criteria:
* Be >= 18 years on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Have no active ocular disease or allergic conjunctivitis.
* Not be using any topical ocular medications.
* Be willing and able to follow instructions.
* Have signed a statement of informed consent.
Exclusion Criteria:
* Participating in a conflicting study in the opinion of the Investigator.
* Considered by the Investigator to not be a suitable candidate for participation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06098937
|
{
"brief_title": "Kalifilcon A Toric Compared to Commercially Available Lenses",
"conditions": [
"Astigmatism"
],
"interventions": [
"Device: MyDay Toric",
"Device: Kalifilcon Toric Lens",
"Device: Total1 for Astigmatism",
"Device: Precision1 for Astigmatism"
],
"location_countries": [
"United States"
],
"nct_id": "NCT06098937",
"official_title": "Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Commercially Available Daily Disposable Toric Contact Lenses",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-27",
"study_completion_date(actual)": "2023-09-27",
"study_start_date(actual)": "2023-09-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-10",
"last_updated_that_met_qc_criteria": "2023-10-23",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-25",
"first_submitted": "2023-09-29",
"first_submitted_that_met_qc_criteria": "2024-12-05"
}
}
}
|
#Study Description
Brief Summary
Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS).
Detailed Description
Introduction: Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS). Objective: To evaluate the synergistic effect of hypnotic analgesia associated with tDCS under metabolites parameters and pain levels in healthy individuals before a nociceptive stimulation pattern. Methods: it will be performed a blinded crossover sham controlled randomized clinical trial. It will be included 32 woman healthy subjects, Susceptible to the hypnosis technique according to the Scale of Hypnotic Susceptibility (WSGC) Scale of Hypnotic Scale score. aged 18 to 65. They will be allocated in one of the following groups: active tDCS + hypnotic analgesia, sham tDCS + hypnotic analgesia, hypnotic analgesia and tDCS . After a 7 days interval, the groups will be crossed in order to receive the opposite intervention of the first week. The primary endpoints will be the electrophysiological brain parameters, such as changes in the Theta, Alpha and Gamma waves, as measured by EEG. The secondary endpoints will be the level of pain, measured against nociceptive induced by the cold test and stimuli standardized pressure through algometry pressure and power down system modulatory pain, pain using the subject test - CPM - task. The intra and inter-group comparisons will be made by means of two-way ANOVA followed by Bonferroni. A p significance level of \<0.05 was established. Expected results: This study hypothesizes that a synergistic effect of analgesic techniques in pain levels in healthy subjects compared to isolated character.
#Intervention
- BEHAVIORAL : Hypnotic analgesia
- Subjects will receive hypnotic analgesia during 20 minutes
- DEVICE : a-tDCS
- Subjects will receive transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes
- OTHER : Hypnotic analgesia + a-tDCS
- Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes
- DEVICE : s-tDCS
- Subjects will receive sham transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 0mA, 20 minutes
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy
* Female
* 11 years of schooling
* 12 cut-off at Waterloo-Stanford Group C (WSGC)
Exclusion Criteria:
* hearing loss subjects
* formal contraindication to tDCS (pregnancy, deep brain device, epilepsy, seizure)
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03744897
|
{
"brief_title": "Effect of Hypnosis Combined to Transcranial Direct Stimulation in Pain",
"conditions": [
"Pain Perception",
"Pain Acute"
],
"interventions": [
"Behavioral: Hypnotic analgesia",
"Device: s-tDCS",
"Device: a-tDCS",
"Other: Hypnotic analgesia + a-tDCS"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT03744897",
"official_title": "Effect of Hypnosis Combined to Transcranial Direct Stimulation in Cortical Activity and Pain Perception in Healthy Females",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-01",
"study_completion_date(actual)": "2018-11-01",
"study_start_date(actual)": "2017-07-18"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-11-26",
"last_updated_that_met_qc_criteria": "2018-11-14",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-19",
"first_submitted": "2017-09-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study evaluates the corneal features using anterior segment - optical coherence tomography in patients affected by type 2 diabetes mellitus
Detailed Description
To investigate the potential role of anterior segment-optical coherence tomography (AS-OCT) in identifying the corneal changes (in particular in total corneal, epithelial and stromal thicknesses) in patients affected by type 2 diabetes mellitus, without signs of diabetic retinopathy at fundus examination.
The AS-OCT could represents a valid early biomarker in these patients.
#Intervention
- DIAGNOSTIC_TEST : Anterior segment-optical coherence tomography
- Each subject underwent anterior segment -optical coherence tomography to evaluate the total corneal, epthelium and stromal thicknesses.
|
#Eligibility Criteria:
Inclusion Criteria:
* age older than 50 years
* diagnosis of previous type 2 diabetes mellitus
* absence of signs of diabetic retinopathy
* absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* absence of significant lens opacities, low-quality OCT and OCT-A images
Exclusion Criteria:
* age younger than 50 years
* absence of previous diagnosis of type 2 diabetes mellitus
* presence of signs of diabetic retinopathy
* presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* presence of significant lens opacities, low-quality OCT and OCT-A images.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04992325
|
{
"brief_title": "AS-OCT Study in Diabetic Retinopathy",
"conditions": [
"Diabetes Mellitus"
],
"interventions": [
"Diagnostic Test: Anterior segment-optical coherence tomography"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT04992325",
"official_title": "Anterior Segment- Optical Coherence Tomography as Early Biomarker in Diabetic Retinopathy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-04-25",
"study_completion_date(actual)": "2021-04-30",
"study_start_date(actual)": "2020-07-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-08-05",
"last_updated_that_met_qc_criteria": "2021-07-29",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-05",
"first_submitted": "2021-07-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed to test the safety and efficacy of Colflex, an oral spray created by Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and sore throats, as well as dental and oral health changes.
|
#Eligibility Criteria:
Inclusion Criteria:
* availability to give written consent
* age 18 <= age <= 60, men and women (who are not pregnant or nursing)
* people in good health
* able to follow protocol
* must be experiencing a sore throat or cold at least once a year
Exclusion Criteria:
* smokers
* liver and kidney disease
* inflammatory bowel disease
* pancreatitis
* gallbladder or biliary disease
* neurolgical/psychological disease
* bleeding disorders
* platelet abnormatilies
* gastrointestinal disorders that could interfere with fat absorption
* serum triglycerides > 500 mg/dL and/or total cholesterol > 300 mg/dL
* hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 Hg
* BMI >30
* consume or planned to consume anticoagulant, hypertension, or lipid lowering medications
* reported consumption of more than 2 alcoholic drinks/day or history of alcoholism or drug dependence
* reported use of experimental medication within 1 month prior to the trial
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02011035
|
{
"brief_title": "Evaluating the Clinical Efficacy and Safety of Colflex",
"conditions": [
"Personal Satisfaction"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT02011035",
"official_title": "Evaluating the Clinical Efficacy and Safety of Colfelx",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-03",
"study_completion_date(actual)": "2014-03",
"study_start_date(actual)": "2013-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-26",
"last_updated_that_met_qc_criteria": "2013-12-09",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-13",
"first_submitted": "2013-09-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This single-center study will be conducted in 3 phases: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-dose phase (up to 5 cohorts, 9 subjects/cohort), and a midazolam drug-drug interaction phase (one cohort of 8 subjects).
Detailed Description
The single-dose phase initiates with ascending doses of an oral solution followed by a 3-way crossover food effect and bioavailability (capsule formulation) cohort. Serum IGF-1 levels and GHRH-analog stimulated GH levels will be assessed as pharmacodynamics measures.
The first multiple-dose (7 days dosing) cohort will be initiated after the PK and safety data are available from the single-dose phase. Subsequent multiple-dose cohorts will have 10 days of dosing. Serum IGF-1 level and GH levels will be assessed as pharmacodynamics measures.
The last cohort in the study is midazolam drug-drug interaction study. The dose will be selected based on review of all pharmacokinetic and safety data for the single-dose and multiple-dose cohorts completed. On Day 1, 8 subjects will receive a single oral 2 mg dose of midazolam. Starting on Day 3 through Day 8, subjects will receive daily doses of CRN00808. On Day 9, subjects will be administered CRN00808 and 2 mg midazolam together.
#Intervention
- DRUG : CRN00808
- Investigational drug
- DRUG : Placebo Oral Solution
- Placebo
- DRUG : Midazolam oral solution
- Midazolam as part of the drug-drug interaction arm of the study
- DRUG : Placebo oral capsule
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* BMI 18 to 30 kg/m2
* Females postmenopausal or surgically sterile
Exclusion Criteria:
* Any uncontrolled or active major systemic disease including, but not limited to: acromegaly (with or without pituitary surgery or radiation therapy), cardiac, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential
* History or presence of malignancy within the past 5 years. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
* Use of any investigational drug within the past 60 days or 5 half-lives, whichever is longer
* Have a medically significant abnormality observed during screening or the admission physical examination or in any other baseline measurements
* Use of any prior medication without approval of the investigator within 14 days prior to admission
* Tested positive at screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
* History of alcohol or substance abuse in the past 6 months
* Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03276858
|
{
"brief_title": "Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Drug: Placebo Oral Solution",
"Drug: CRN00808",
"Drug: Placebo oral capsule",
"Drug: Midazolam oral solution"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT03276858",
"official_title": "A Double-Blind, Randomized, Placebo-Controlled, Single- And-Multiple-Dose Study to Evaluate the Safety, PK, and PD of CRN00808 in Healthy Volunteers and to Determine the Effect of CRN00808 on Midazolam PK",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-30",
"study_completion_date(actual)": "2018-04-30",
"study_start_date(actual)": "2017-09-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-29",
"last_updated_that_met_qc_criteria": "2017-09-07",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-09-08",
"first_submitted": "2017-09-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Pressure ulcers (PrUs) are the most frequent significant medical complication after spinal cord injury (SCI). PrU prevalence, morbidity, mortality, and recurrence rates are high, and most persons with SCI will have at least one serious PrU during their lifetime. VA costs of treating the almost 3,500 unique Veterans with SCI and a severe ulcer at an SCI Center in FY10 was just under $400 million.
Detailed Description
Background:
Pressure ulcers (PrUs) are the most frequent significant medical complication after spinal cord injury (SCI). PrU prevalence, morbidity, mortality, and recurrence rates are high, and most persons with SCI will have at least one serious PrU during their lifetime. VA costs of treating the almost 3,500 unique Veterans with SCI and a severe ulcer at an SCI Center in 2010 was just under $400 million.
Objectives:
The primary objective of this randomized clinical trial (RCT) was to determine whether a multi-component self-management (SM) intervention increases the use of skin-protective behaviors and reduces skin worsening in Veterans with SCI, compared to an education control (ED) intervention. Secondary outcomes included PrU knowledge, self-management skills, communication with providers, self-efficacy, community integration and days on bedrest. Another objective was to conduct focus group interviews with patients and providers and to analyze transcripts of SM group sessions to determine barriers and facilitators with regard to spinal cord injury and pressure ulcer prevention.
Methods:
This was a multi-site efficacy intervention study with a single blind prospective randomized design. Descriptive statistics were used to summarize demographic and key variables. Supplemental focus group interviews were conducted with patients with SCI (n=35) and SCI providers (n=39). Focus group interviews and SM group calls were transcribed verbatim and analyzed using constant comparative techniques.
Study participants included Veterans hospitalized for Stage III/IV PrUs at or below the level of injury, from six VA SCI Centers around the country (Long Beach, Houston, Milwaukee, Augusta, Hines and St. Louis). Prior to discharge, PrU risk factors were identified and 1:1 PrU education was provided. Randomization and the behavioral interventions began at discharge. The number of randomized subjects were 72 in the ED group and 72 in the SM group (n=144). The analytic sample included subjects with complete data (n=92).
The intervention included 8 site coordinator-initiated calls using didactic (ED) or Motivational Interviewing (MI) strategies to address PrU risk factors. The second component included telephone group calls that included either didactic information about SCI or SM skills including: 1) knowledge about the medical condition; 2) self-monitoring; 3) problem-solving skills; 4) skill for managing the effects of the condition; 5) adherence to necessary health behaviors; and 6) self-advocacy with health care providers. ED subjects received general health information and were not instructed in any specific problem solving, self-monitoring or SM techniques. The ED intervention was comparable to the SM with respect to natural history/ time, dosing, measurement processes, attention, therapeutic alliance, social support, and in receiving a manualized treatment with specific therapist procedures. Self-reported outcome data were obtained by phone at 3 and 6 months, and from mailed photos of study ulcers.
Status:
Study is complete. Additional analyses are ongoing and future manuscripts are planned.
#Intervention
- BEHAVIORAL : Self Management (SM)
- Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology.
- BEHAVIORAL : Motivational Interviewing (MI)
- Self Management and Motivational Interviewing (SM+MI) participants were assigned to both a self-management and motivational interview group. An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures.
- BEHAVIORAL : Education (ED)
- The ED intervention differs only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
|
#Eligibility Criteria:
Inclusion Criteria:
* > 18 years,
* SCI of at least six month's duration,
* hospitalized for a Stage III or IV PrU,
* cognitively intact,
* available for telephone follow-up, and
* discharged to a community setting or able to direct own care.
Exclusion Criteria:
We excluded patients with a terminal diagnosis, severe psychiatric comorbidities (eg, current psychosis), cognitive impairments that limited their ability to consent or participate, severe hearing loss, and wounds not expected to heal. People discharged to nursing homes unable to direct their own care were also excluded.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00763282
|
{
"brief_title": "Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)",
"conditions": [
"Pressure Ulcers",
"Spinal Cord Injuries"
],
"interventions": [
"Behavioral: Motivational Interviewing (MI)",
"Behavioral: Self Management (SM)",
"Behavioral: Education (ED)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00763282",
"official_title": "Self-Management to Prevent Ulcers in Veterans With Spinal Cord Injury",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2008-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-04-27",
"last_updated_that_met_qc_criteria": "2008-09-29",
"last_verified": "2014-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-30",
"first_submitted": "2008-09-26",
"first_submitted_that_met_qc_criteria": "2015-01-07"
}
}
}
|
#Study Description
Brief Summary
The uptake of vaccines for Human Papillomavirus (HPV) in the U.S. is far below recommended levels, particularly for adolescent boys and especially among minority families. Proposed here is a mobile web application ('mobile web app') for personal computers, smart phones, and tablet computers that will accurately inform parents and adolescent boys about the HPV vaccination and address unique concerns about its safety and effectiveness for boys. The BoyVac mobile web app will be evaluated for its ability to improve vaccine outcomes in a randomized efficacy trial with parents and adolescent boys aged 11-13 years.
Detailed Description
The President's Cancer Advisory Board and the Centers for Disease Control have called for renewed efforts in promoting vaccination for Human Papillomavirus (HPV), including vaccination for adolescent boys, because the uptake of this new vaccine remains alarmingly low. Currently, less than 15% of adolescent boys have received the HPV vaccine; thus, most of this population remains at risk for oropharyngeal, anal, and penile cancers. Many parents remain unconvinced of the safety and effectiveness of HPV vaccines, so effective and accessible messaging to improve decision-making on this vaccine is needed. Parents of adolescent boys also have different concerns about HPV vaccination than for adolescent girls, creating a need for unique health communication interventions to promote vaccine uptake among boys. Interventions also need to address the unique challenges of minority populations and populations for whom English is not the first language. A novel digital intervention will be produced and evaluated for its ability to improve HPV vaccine outcomes. Specifically, a mobile responsive web application ('mobile web app') will be created that performs similar to a mobile app but runs on a variety of computing platforms from personal desktop and laptop computers to the latest smart phones and tablet computers. Mobile web app content will be targeted to parents and adolescent boys aged 11-13 years. The specific aims are to: 1) carefully and systematically develop a mobile web app (BoyVac) for smart phones, tablet computers, and personal computers that will utilize Diffusion of Innovations principles to provide targeted information concerning HPV vaccine adoption to adolescent males and their parents, particularly minority adolescents and parents; 2) implement a comprehensive and rigorous test of the impact of the BoyVac mobile web app intervention on HPV vaccine adoption outcomes via a randomized efficacy trial (BoyVac v. usual and customary care); and 3) examine the dose-response relationships between mobile web app usage and vaccine outcomes within a components analysis. A group-randomized pretest-posttest controlled design will be implemented, recruiting 1800 pairs of parents and adolescent boys from 30 pediatric clinics (n=60 parents and boys per clinic). Parents will be surveyed at baseline, a 3-month follow-up, and a 9-month follow-up and records HPV vaccination adoption for the boys will be obtained from the clinics' medical records at the 9-month follow-up. Analyses will test the hypotheses that 1) more 11-13 year old boys in the intervention group (BoyVac mobile web app) will adopt the HPV vaccine than boys in the usual and customary care comparison group and 2) adoption of HPV vaccine will be mediated by improvements in theoretical mediators among parents in the intervention compared to the usual and customary care comparison group.
#Intervention
- BEHAVIORAL : Web App Intervention Group
- All baseline and follow-up data collection will be conducted via online surveys and a customized web portal and include parent self-reports and clinic records of vaccination of boys
- BEHAVIORAL : Usual Customary Care Group
- Participants randomized to the usual and customary care (UC) group will receive a website with a pamphlet on HPV vaccination from the Centers for Disease Control and Prevention (CDC) in Portable Document Format (PDF) format.
- Other Names :
- UC
|
#Eligibility Criteria:
Inclusion Criteria:
Adolescent boys:
* being male
* being 11 <= age <= 13 years
* being a patient at a participating University of New Mexico (UNM) Hospital's Envision pediatric practice
* parental consent for testing, and
* child assent for testing
Parents/Guardians:
* being a parent/guardian of an eligible and participating 11 <= age <= 13 year old boy
* demonstrated ability to comprehend study requirements, and
* providing informed consent for oneself and assent for their youth's participation
Exclusion Criteria:
Adolescent boys:
* another immediate family member is participating in the project (i.e., a sibling)
* the participant has already received any or all doses for the HPV vaccine, or
* the participant refuses to assent.
Parents/Guardians:
* under the age of 18, or
* another immediate family member is participating in the project (i.e., another parent).
Sex :
ALL
Ages :
- Minimum Age : 11 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03000998
|
{
"brief_title": "Web App Technology for Boys and Parents: Improving HPV Vaccine Uptake",
"conditions": [
"Human Papillomavirus Virus",
"HPV"
],
"interventions": [
"Behavioral: Usual Customary Care Group",
"Behavioral: Web App Intervention Group"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03000998",
"official_title": "Web App Technology for Boys and Parents: Improving HPV Vaccine Uptake",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-30",
"study_completion_date(actual)": "2022-06-30",
"study_start_date(actual)": "2017-01-31"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-02-06",
"last_updated_that_met_qc_criteria": "2016-12-19",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-22",
"first_submitted": "2016-11-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A randomised controlled trial to investigate three methods to reduce early mortality in adults, adolescents and children aged 5 years or older starting antiretroviral therapy (ART) with severe immuno-deficiency. The three methods are:
(i) increasing the potency of ART with a 12 week induction period using 4 antiretroviral drugs from 3 classes
(ii) augmented prophylaxis against opportunistic/bacterial infections and helminths for 12 weeks
(iii) macronutrient intervention using ready-to-use supplementary food for 12 weeks.
Detailed Description
REALITY is a open-label randomised trial of 1800 adults, adolescents and children aged 5 years or more with low CD4 counts about to initiate ART.
The trial will have a factorial design with 3 randomisations, each to address one of the potential approaches to reduce early mortality in adults and children initiating ART with low CD4, namely:
1. Raltegravir for 12 weeks from ART initiation in addition to 3 standard ART (3-drug 2-class) versus standard of care first-line 3-drug 2-class ART (choice according to national guidelines for ART initiation);
2. Immediate enhanced opportunistic infections (OI) prophylaxis with isoniazid/pyridoxine and cotrimoxazole, plus 12 weeks fluconazole, 5 days azithromycin and a single dose of albendazole versus cotrimoxazole prophylaxis alone for the first 12 weeks followed by isoniazid and any prophylaxis and/or treatment prescribed at screening
3. supplementation with Ready to Use Supplementary Food (RUSF) for 12 weeks versus standard of care nutritional support to those with poor nutritional status according to local guidelines.
All participants will receive cotrimoxazole throughout the trial.
The primary objective of the trial is to identify effective, safe and acceptable interventions to reduce early mortality (all-cause) in HIV-infected adults, adolescents, and older children (5 years or more) initiating ART.
#Intervention
- DRUG : Raltegravir
- 400mg twice daily for the first 12 weeks only in addition to 3 standard ARVs
- DRUG : Fluconazole
- 100mg once daily for 12 weeks
- DRUG : Azithromycin
- 500mg once daily for 5 days
- DRUG : Albendazole
- a single dose 400mg
- DRUG : Isoniazid
- 300mg taken immediately in combination with cotrimoxazole
- DIETARY_SUPPLEMENT : Ready to Use Supplementary Food
- 2x92g packets daily of high energy, low protein lipid-based paste for 12 weeks
- Other Names :
- RUSF
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged >= 5 years
* Documented HIV infection by HIV ELISA or HIV rapid test
* Naive to ART
* CD4 T-cell count <100 cells/mm3 on blood test taken at screening for REALITY
* Results of screening haematology and biochemistry tests available and no contraindications to planned ART according to national guidelines
* Patient/carer provide informed consent (and children <18 years assent, as appropriate according to their age and knowledge of HIV status)
The lower age limit is because CD4 counts are less reliable predictors of immunodeficiency under 5 years: CD4 counts are recommended by guidelines in older children.
No patient with a CD4 count above 100 cells/mm3 should have ART delayed in order to subsequently meet eligibility criteria. Rather, patients eligible for REALITY will be those testing HIV positive for the first time with a low CD4 count (i.e. those delaying presentation to care), or those who have defaulted before initiating ART and only return to care at an advanced stage of immuno-deficiency.
Exclusion Criteria:
* Contraindications to any proposed antiretroviral drugs (including integrase inhibitors), isoniazid, fluconazole, albendazole or azithromycin
* Pregnant or breastfeeding or intending to become pregnant during the first 12 weeks of the study
* Ever known to have previously received single-dose nevirapine for prevention of mother-to-child transmission (mother or child).
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01825031
|
{
"brief_title": "Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy",
"conditions": [
"Human Immunodeficiency Virus"
],
"interventions": [
"Drug: Azithromycin",
"Drug: Isoniazid",
"Drug: Raltegravir",
"Dietary Supplement: Ready to Use Supplementary Food",
"Drug: Fluconazole",
"Drug: Albendazole"
],
"location_countries": [
"Kenya",
"Malawi",
"Uganda",
"Zimbabwe"
],
"nct_id": "NCT01825031",
"official_title": "Reduction of Early mortALITY in HIV-infected African Adults and Children Starting Antiretroviral Therapy: a Randomised Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-03",
"study_completion_date(actual)": "2016-03",
"study_start_date(actual)": "2013-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-04-20",
"last_updated_that_met_qc_criteria": "2013-04-02",
"last_verified": "2016-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-04-05",
"first_submitted": "2013-01-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
An exploratory, double-arm, 4-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia.
Detailed Description
The purpose of the proposed study is to evaluate the overall effects of use of an abbreviated version of CT-156 (the Study App) in participants aged 18 years or older with schizophrenia.
#Intervention
- DEVICE : CT-156-C-001
- CT-156 is a digital therapeutic (DTx) under development to treat patients 18 years of age and older with a diagnosis of schizophrenia under standard of care therapy who are on antipsychotic medication and not currently experiencing acute hallucinations or delusions.
|
#Eligibility Criteria:
Inclusion Criteria:
* A participant will be eligible for entry into the study if all of the following criteria are met:
1. Willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
2. Is an adult at least 18 years at the time of informed consent.
3. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
4. Lives in the United States.
5. Meets diagnostic criteria for a primary diagnosis of schizophrenia as defined in the International Classification of Diseases, Eleventh Edition (ICD-11) or Diagnostic Statistical Manual, Fifth Edition (DSM-5) for at least 6 months prior to screening.
6. Has outpatient treatment status at the time of screening, with no psychiatric inpatient hospitalization within 13 weeks (3 months) prior to screening.
7. Is currently prescribed at least one typical and/or atypical antipsychotic medication, and has been on the same antipsychotic medication(s) for at least 13 weeks (3 months) prior to randomization (Day 1). Dose adjustments are permitted during the study as outlined in the respective package insert(s).
8. Has an average score of >2 in at least 2 domains of Understanding and communicating, Getting Along with People, Life Activities - Household, or Participation in Society on the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0).
9. Participant is the only user of an iPhone with iPhone operating system (iOS) version 14 or later or a smartphone with an Android operating system (OS) version 11 or later and agrees to download and use the digital mobile application as required by the protocol.
10. Is willing and able to receive SMS text messages and push messages on their smartphone.
11. Is the owner of and has regular access to an email address.
12. Has regular access to the internet via cellular data plan and/or wi-fi.
13. Has stable housing and has remained at the same residence for at least 13 weeks (3 months) prior to screening, and does not anticipate housing changes for the duration of the study.
14. Understands the use of the Study App during the screening period and at the Baseline Visit, per investigator judgment.
Exclusion Criteria:
* A participant will not be eligible for study entry if any of the following criteria are met:
1. Has acute prominent positive symptoms that, in the opinion of the investigator, would preclude effective engagement with the app
2. Is currently receiving or has received concomitant therapy, defined as individual or group-based structured treatment (e.g., Cognitive Behavioral Therapy, Social Skills Training, Motivational Interviewing, or Vocational/Occupational Therapy), within 6 months (26 weeks) prior to screening per investigator assessment.
3. Is currently treated with more than two antipsychotic medications (including more than 2 dosage forms).
4. Is currently treated with clozapine, or was treated with clozapine within 5 years of the Screening Visit.
5. Meets ICD-11 or DSM-5 criteria for diagnoses not under investigation that will impact compliance to the protocol, including schizophreniform, schizoaffective, or psychosis non-specific disorders (post-traumatic stress disorder [PTSD], bipolar disorder, major depressive disorder, developmental disorders).
6. Meets ICD-11 or DSM-5 criteria for a current episode of depression, mania or hypomania.
7. Meets ICD-11 or DSM-5 criteria for a current substance or alcohol use disorder (excluding caffeine and nicotine) within 26 weeks (6 months) of the Screening Visit. Diagnoses classified as in sustained remission are permitted.
8. In the investigator's opinion, currently needs or will likely require prohibited concomitant medications and/or therapy during the study.
9. Is at risk for suicide, as defined by any of the following:
1. A 'yes' response to either item 4 or 5 on the C-SSRS Suicidal Ideation Items within the last 13 weeks (3 months) prior to screening or at the Baseline Visit.
2. A 'yes' response on the C-SSRS Suicidal Behavior Items within the last 26 weeks (6 months) prior to screening or at the Baseline Visit.
3. In the opinion of the investigator, presents a serious risk of suicide.
10. Has participated in another clinical study (interventional or observational) in the last 26 weeks (6 months).
11. Has previously participated in study CT-155-C-001, CT-155-C-002, CT-155-C-003, CT-155-P-00x, or CT-155-A-001.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06136936
|
{
"brief_title": "A Study to Evaluate the Overall Effects of Treatment With Abbreviated CT-156 in People With Schizophrenia",
"conditions": [
"Schizophrenia"
],
"interventions": [
"Device: CT-156-C-001"
],
"location_countries": [
"United States"
],
"nct_id": "NCT06136936",
"official_title": "A Multicenter, Exploratory, Randomized, Double-Arm, 4-week Study to Evaluate the Overall Effects of Treatment With Abbreviated CT-156 in People With Schizophrenia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-18",
"study_completion_date(actual)": "2024-02-22",
"study_start_date(actual)": "2023-09-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-08",
"last_updated_that_met_qc_criteria": "2023-11-13",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-11-18",
"first_submitted": "2023-11-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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