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#Study Description
Brief Summary
Shock is a condition of reduced tissue perfusion, resulting in the inadequate delivery of oxygen and nutrients that are necessary for cellular function. The current resuscitative agents can extend patient's life to a limited extent. Centhaquin (PMZ-2010) in very low doses reduced blood lactate levels, improved blood pressure, cardiac output, survival and proved to be a highly effective resuscitative agent. The investigators are conducting a phase I clinical study in humans to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of centhaquin citrate in normal healthy volunteers.
Detailed Description
Shock is a condition of reduced tissue perfusion, resulting in the inadequate delivery of oxygen and nutrients that are necessary for cellular function. Common causes of shock are hypovolemia (excessive blood or fluid loss), sepsis, cardiac failure, dengue and neuroendocrine dysfunction. The current resuscitative measures include administration of crystalloid solutions (e.g., 0.9% saline, Ringer's lactate, or hypertonic saline) or colloid solutions (e.g., hydroxyethyl starch, albumin, or dextrans). These agents can extend patient's life to a limited extent. Centhaquin (PMZ-2010) in very low doses reduced blood lactate levels, improved blood pressure, cardiac output, survival and proved to be a highly effective resuscitative agent. The investigators are conducting a phase I clinical study in humans to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of centhaquin citrate in normal healthy volunteers. Successful completion of phase I studies will lead to efficacy studies in patients with hypovolemic shock.
#Intervention
- DRUG : PMZ-2010 (Centhaquin)
- As per the randomization schedule, injection of PMZ-2010 or placebo (100 ml normal saline) will be administered to each subject under supervision of investigator as an intravenous infusion over one hour. PMZ-2010 will be dissolved in normal saline (100 ml) before administration.
- Other Names :
- Placebo (normal saline)
|
#Eligibility Criteria:
Inclusion Criteria: Subjects to be enrolled in this trial must fulfill all of these criteria:
* Sex: male
* Age: 18 <= age <= 60 yr old, both inclusive
* Having a Body Mass Index (BMI) between 18.5 <= age <= 28 kg / m2 (both inclusive) and body weight not less than 45 kg
* Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; and to comply with the requirements of the entire study
* Voluntarily given written informed consent to participate in this study
* Be of normal health as determined by the principal investigator from medical history, physical examination and laboratory investigations, 12-lead ECG and X-ray chest of the subjects performed within 10 days prior to the admission of the study
* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, 'power drinks') and grapefruit (juice) from 48 h prior to each admission until study completion
Exclusion Criteria: Subjects meeting any of these criteria will not be enrolled in the study:
* Employees of JCDC or Pharmazz India Private Limited
* Not willing to use contraceptives (preferably condoms) during sexual activity for the period of 3 months from the date of check-in
* History of hypersensitivity and / or intolerance to Centhaquin or any other related compounds.
* History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study.
* Clinically abnormal ECG and Chest X-ray.
* Physical findings: clinically relevant abnormal physical findings (including body temperature) suggesting underlying pathologies or those which could interfere with the objectives of the study.
* Subjects with impaired renal function as measured by glomerular filtration rate <90 mL/min/1.73m2 estimated using the modification of diet in renal disease (MDRD) formula [GFR for Male =186 × (Serum Creatinine)-1.154 × Age-0.203 ]12
* Laboratory values that are significantly different than the normal reference range and/or are deemed to be of clinical significance by the investigator
* Presence of reactive disease markers of HIV 1 and II, HBsAg, HCV or VDRL.
* Positive for alcohol breath test and/or urine drug screen (barbiturates, benzodiazepines, amphetamine, cocaine, opiates, tetra-hydro cannabinol).
* Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
* Diseases: relevant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine, neurological or gastrointestinal diseases. History of depression, psychosis, schizophrenia or any other severe psychiatric diseases, or epilepsy, or any other illness that may interfere with the aim of the study. History of any significant illness in the 4 weeks preceding the screening
* Medications: history of intake of any medications including over the counter medications (OTC) and any herbal agents at least 4 weeks period prior to study drug administration.
* Investigational drug trials: participation in the evaluation of any drug in the 3 months prior to the start of the study (dosing with IMP).
* Blood donation: Subjects who, through completion of this study, would have donated and/or lost more than 300 mL of blood in the past 12 weeks Note: In case the blood loss is <= 200 mL; subject may be dosed 60 days after blood donation or last sample of the previous study
* Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
* History of drug dependence or alcoholics
Sex :
MALE
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
|
NCT02408731
|
{
"brief_title": "A Study to Determine the Safety, Tolerability and Pharmacokinetics of PMZ-2010 (Centhaquin) in Healthy Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: PMZ-2010 (Centhaquin)"
],
"location_countries": [
"India"
],
"nct_id": "NCT02408731",
"official_title": "A Randomized, Double-blind, Placebo-controlled Phase I Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of PMZ-2010 (Centhaquin) in Healthy Male Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": "2015-04",
"study_start_date(actual)": "2014-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-04-28",
"last_updated_that_met_qc_criteria": "2015-03-31",
"last_verified": "2015-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-04-03",
"first_submitted": "2015-03-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to test the effectiveness of albuterol versus placebo with the following specific aims: a) Treatment of brain dead organ donors with albuterol will reduce pulmonary edema, improve donor oxygenation, and increase the number of lungs available for transplantation, b) Developing a blood test to predict the development of primary graft dysfunction in lung transplant recipients, and c) treating brain dead organ donors with albuterol will decrease markers of primary graft dysfunction and lead to improved lung transplant recipient outcomes and to higher rates of lungs suitable for transplantation.
Detailed Description
The donor lung utilization rate in the United States remains less than 15%, and the demand for donor lungs far exceeds the available supply. The most common reasons for failure to utilize donor lungs are donor hypoxemia and/or pulmonary infiltrates. Since pulmonary edema is a common, reversible cause of hypoxemia and infiltrates in patients with brain injury, strategies to treat pulmonary edema in organ donors should lead to improved donor oxygenation and higher rates of donor lung utilization. Inhaled beta-2 agonists increase the rate of alveolar fluid clearance and reduce pulmonary edema in both animal and human lungs. In addition, our group has recently reported that the majority of human donor lungs that are rejected for transplantation have measurable pulmonary edema and respond to beta-2 agonists with increased rates of alveolar fluid clearance. Based on this compelling scientific evidence, we propose to test the efficacy of an inhaled beta-2 agonist to increase the rate of alveolar fluid clearance and reduce pulmonary edema in brain dead organ donors with the following specific aims:
Specific Aim 1: To test the effect of aerosolized albuterol on donor oxygenation in a multicenter, randomized, double-blinded, placebo-controlled trial in 500 brain dead organ donors managed over a 2 year period by the California Transplant Donor Network (CTDN).
Hypothesis 1a: Treatment of brain dead organ donors with aerosolized albuterol will improve donor oxygenation and increase the donor lung utilization rate compared to treatment with placebo.
Hypothesis 1b: Treatment of brain dead organ donors with aerosolized albuterol will reduce the severity of pulmonary edema in procured lungs compared to treatment with placebo.
Specific Aim 2: To develop and validate a panel of biological markers that can predict and diagnose acute lung injury due to primary graft dysfunction in lung transplant recipients.
Hypothesis 2a: A panel of plasma biological markers measured in brain dead organ donors that includes markers of inflammation, coagulation, endothelial injury and lung epithelial injury will predict the development of primary graft dysfunction in the lung recipient.
Hypothesis 2b: Treatment of brain dead organ donors with inhaled beta-2 agonists will lead to reductions in levels of a panel of biological markers of inflammation, coagulation, endothelial injury, and lung epithelial injury that will be associated with increased donor lung utilization and improved recipient outcomes.
#Intervention
- DRUG : Albuterol
- 5 mg nebulized q4h
- Other Names :
- salbutamol
- DRUG : Saline
- 1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
- Other Names :
- placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Brain death
* Consent for lung donation and donor research
* Release from coroner or medical examiner
Exclusion Criteria
* Age less than 14 years
Sex :
ALL
Ages :
- Minimum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00310401
|
{
"brief_title": "The Effect of Nebulized Albuterol on Donor Oxygenation",
"conditions": [
"Brain Death",
"Organ Donor",
"Pulmonary Edema"
],
"interventions": [
"Drug: Saline",
"Drug: Albuterol"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00310401",
"official_title": "The Effect of Nebulized Albuterol on Donor Oxygenation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-05",
"study_completion_date(actual)": "2011-06",
"study_start_date(actual)": "2007-04"
},
"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)": "2018-03-16",
"last_updated_that_met_qc_criteria": "2006-03-31",
"last_verified": "2018-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-04-03",
"first_submitted": "2006-03-01",
"first_submitted_that_met_qc_criteria": "2013-06-24"
}
}
}
|
#Study Description
Brief Summary
Objective
The primary objective is to evaluate the efficacy of a multi-faceted, clinical decision support intervention aimed at improving the quality of decisions about Cardio Pulmonary Resuscitation (CPR) for seriously ill, elderly patients in hospital.
The hypothesis is that fewer patients in the intervention group will have a documented order for CPR and they will have greater satisfaction with decision making about CPR than patients in the control group.
Detailed Description
Methodological Approach
The study will be a randomized controlled trial comparing a multi-faceted decision support intervention to usual care for hospitalized patients. The primary objective of this study is to determine if our multifaceted intervention changes decisions about CPR. The components of the multifaceted intervention have already been evaluated for feasibility and acceptability in the hospital setting. The intervention has two parts: the first is a values clarification exercise, and the second part is a CPR video decision aid that explains the risks and benefits of CPR as well as the reasons a patient may choose to receive CPR or not. From previous research it is known that many hospitalized patients have prescribed orders for CPR despite expressing a preference not to have CPR when asked. Furthermore patients often have expressed values that are not concordant with their expressed wishes regarding resuscitation. Therefore it is hypothesized that fewer patients in the intervention group will have a documented order for CPR and they will have greater satisfaction with decision making about CPR than patients in the control group.
We will conduct sensitivity analyses to investigate whether the intervention is more effective among patients who remain in hospital longer after enrollment. We will measure the intervention effect among patients who remained in hospital for fewer than three days after enrollment, among patients who were in hospital for 3-7 days after enrollment, and among patients who remained in hospital for longer than 7 days post-enrollment.
#Intervention
- BEHAVIORAL : Decision Support
- A two-part intervention to help patients make better decisions about CPR
|
#Eligibility Criteria:
Inclusion Criteria:
* Eligible to receive CPR
* Satisfying at least one of the following criteria groups
1. 55 years or older with one or more of the following diagnoses:
* Chronic obstructive lung disease (2 of the 3 of: baseline PaCO2 of > 45 torr, cor pulmonale; respiratory failure episode within the preceding year; forced expiratory volume in 1 sec <0.5 L)
* Congestive heart failure (New York Heart Association class IV symptoms and left ventricular ejection fraction < 25%)
* Cirrhosis (confirmed by imaging studies or documentation of esophageal varices and one of three conditions; hepatic coma, child's class C liver disease, or child's class B liver disease with gastrointestinal bleeding)
* Cancer (metastatic cancer or stage IV lymphoma)
* End-stage dementia (inability to perform all ADLs, mutism or minimal verbal output secondary to dementia, bed-bound state prior to acute illness).
2. 80 years or older and admitted to hospital from the community for an acute medical or surgical condition.
3. If none of the above criteria are met, any patient whose death within the next 6 months would not surprise any member of their care team.
4. At least 55 years and predicted risk of death in the next 12 months of >=10% as calculated with the HOMR Now! Score
Exclusion Criteria:
* Patients or SDMs who do not speak English.
* Patients or SDMs who do not provide informed consent.
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03287895
|
{
"brief_title": "Improving Decisions About CPR",
"conditions": [
"CPR Decision-Making"
],
"interventions": [
"Behavioral: Decision Support"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03287895",
"official_title": "A Multifaceted Tool to Improve Decision Making About Cardio-Pulmonary Resuscitation (CPR) for Hospitalized Patients Who Are Seriously Ill",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-22",
"study_completion_date(actual)": "2018-10-22",
"study_start_date(actual)": "2017-10-01"
},
"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)": "2018-12-26",
"last_updated_that_met_qc_criteria": "2017-09-15",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-09-19",
"first_submitted": "2017-08-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
It is estimated that over 1 million people in the United States have HIV infection. While HIV is treatable, there are still high rates of HIV-associated neurocognitive disorder (HAND). HAND is defined by low scores on memory testing. To meet the criteria for HAND, an HIV-infected individual has to have a low score on at least two different memory tests. It is estimated that 20-50% of people living with HIV have HAND. It is therefore still a common problem. While individuals with HAND typically improve on antiretroviral therapy for HIV, often this improvement is incomplete. Also, there are over 20 antiretroviral medications approved for HIV in the US. It is not clear if the specific choice of antiretroviral medication makes a difference in the improvement of HAND.
The investigators have designed a small preliminary study in which subjects with and without HAND who have never been on treatment for HIV or have been off treatment for at least 6 months are followed for the first 12 months after starting antiretroviral therapy.The investigators will enroll a maximum of 46 subjects (23 subjects in each arm). Subjects will also be followed by their primary HIV medical provider. For the study, subjects will be followed for 48 weeks. There are three followup visits: 12 weeks, 24 weeks, and 48 weeks. Memory testing will be performed at baseline and each followup visit. Blood will also be taken at baseline and the three followup visits to measure changes in inflammation. A lumbar puncture will be performed at baseline and at 24 weeks to measure changes in inflammation and amount of HIV virus in the spinal fluid. There is also an optional lumbar puncture at the last study visit of 48 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Confirmed HIV infection (HAART naïve), subjects 18 <= age <= 59 of age
* Negative serum cryptococcal antigen if CD4+ T-cell count <100 cells/microliter, normal serum thyroid stimulating hormone level, negative serum rapid plasma reagin (RPR) (Can have positive RPR <=1:4 if treated for syphilis by CDC guidelines at least 6 months prior to enrollment, had no signs/symptoms of neurosyphilis, and RPR titer decreased at least 4-fold by 6 months after treatment).
Exclusion Criteria:
* Ongoing heavy alcohol use (more than 2 drinks per day) or ongoing illicit drug use
* Schizophrenia or other psychotic disorder, bipolar disorder, or uncontrolled depression as reported by the subject or medical provider.
3 Neoplasm of the CNS OR history of traumatic brain injury with loss of consciousness > 30 minutes OR CNS infection in the last 6 months.
* Pregnancy or incarceration
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 59 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT01966094
|
{
"brief_title": "Observational Study of HIV-associated Neurocognitive Disorder",
"conditions": [
"HIV Associated Neurocognitive Disorder",
"Human Immunodeficiency Virus"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01966094",
"official_title": "Observational Study of HIV-associated Neurocognitive Disorder",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-06-05",
"study_completion_date(actual)": "2018-06-05",
"study_start_date(actual)": "2013-10"
},
"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)": "2018-07-19",
"last_updated_that_met_qc_criteria": "2013-10-16",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-10-21",
"first_submitted": "2013-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This project is intended to provide a rigorous test of the Turtle Program, an early intervention program for behaviorally inhibited preschoolers. The proposed project will extend promising pilot study findings by: (a) evaluating the integrated intervention in a larger sample (n = 150) of 45-64 month children and their parents, which will allow for an examination of mediators and moderators of treatment effects; (b) comparing the Turtle Program to the best available treatment for preschool behavioral inhibition, the Cool Little Kids (CLK) parent psychoeducation group; (c) examining heart rate reactivity and regulation as both baseline moderators of treatment response and as outcome measures; (d) examining parent anxiety disorders as a moderator of treatment response; (e) including a mid-treatment assessment and extending follow-up to one year.
#Intervention
- BEHAVIORAL : Turtle Program
- BEHAVIORAL : Cool Little Kids
|
#Eligibility Criteria:
Inclusion Criteria:
* child must be attending preschool; child must score within top 15% on parent-rated Behavioral Inhibition Questionnaire
Exclusion Criteria:
* child has a diagnosis of pervasive developmental disorder, selective mutism, or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety; child does not have a custodial parent who has also consented to participate
Sex :
ALL
Ages :
- Minimum Age : 45 Months
- Maximum Age : 64 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02308826
|
{
"brief_title": "Multi-Component Early Intervention for Socially Inhibited Preschool Children",
"conditions": [
"Behavioral Inhibition",
"Anxiety"
],
"interventions": [
"Behavioral: Turtle Program",
"Behavioral: Cool Little Kids"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02308826",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06",
"study_completion_date(actual)": "2019-06",
"study_start_date(actual)": "2014-12"
},
"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)": "2023-05-10",
"last_updated_that_met_qc_criteria": "2014-12-02",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-04",
"first_submitted": "2014-12-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus
#Intervention
- DRUG : ipragliflozin
- Oral
- Other Names :
- ASP1941
- DRUG : Placebo
- Oral
|
#Eligibility Criteria:
Inclusion Criteria:
* Established diagnosis of type 2 diabetes mellitus
* Fasting serum C-peptide level > 0.6 ng/mL
* HbA1c between 7.0 and 10.0%
* Body Mass Index between 20 and 45 kg/m2
Exclusion Criteria:
* Serum creatinine > upper limit of normal
* Proteinuria (albumin/creatinine ratio > 300 mg/g)
* Dysuria and/or urinary tract infection
* Significant renal, hepatic or cardiovascular diseases
* Ketosis
* Hypertension
* Severe gastrointestinal diseases
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00621868
|
{
"brief_title": "A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus",
"conditions": [
"Diabetes Mellitus"
],
"interventions": [
"Drug: ipragliflozin",
"Drug: Placebo"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT00621868",
"official_title": "ASP1941 Phase II Clinical Study - A Double-blind, Placebo-controlled, Parallel-group, Dose-response Study in Patients With Type 2 Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-03-14",
"study_completion_date(actual)": "2009-03-14",
"study_start_date(actual)": "2008-03-26"
},
"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)": "2024-11-12",
"last_updated_that_met_qc_criteria": "2008-02-13",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-22",
"first_submitted": "2008-02-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will be an open-label, cross-over study as subjects will be studied under both study conditions - suspension of subcutaneous insulin infusion via pump during treatment with insulin alone (control) vs. suspension of subcutaneous insulin via pump during treatment with insulin and canagliflozin.
Detailed Description
The study will consist of 4 visits: an enrollment/screening visit, a control visit with pump suspension prior to treatment with canagliflozin, a visit with pump suspension while on canagliflozin and an end of study visit. Each of the pump suspension visits will be approximately 20-hour overnight admissions to the Hospital Research Unit (HRU).
#Intervention
- DRUG : canagliflozin
- basal interruption with canagliflozin
- Other Names :
- Invokana
- OTHER : basal interruption without canagliflozin
- basal interruption
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 45 years
* Clinical diagnosis of T1D (type 1 diabetes) (formal antibody and/or genetic testing will not be required)
* Duration of T1D >= 1 year
* HbA1c <= 9 %
* Treated with continuous subcutaneous insulin infusion (with or without adjunctive treatment with a SGLT2 inhibitor) for at least 3 months
* Body weight > 40 kg
* Be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
* Normal hematocrit
* Able to give consent
* Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods.
Exclusion Criteria:
* Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
* Renal impairment, determined as eGFR < 60 ml/minute/1.73m2
1. History of unstable or rapidly progressing renal disease
2. Conditions of congenital renal glucosuria
3. Renal allograft
4. Recurrent UTI (urinary tract infection)
5. History of Vesico-ureteral-reflux disease
* Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
* Use of metformin, thiazolidinedione or GLP1 agonist within 1 month prior to screening visit. For those subjects on canagliflozin or other SGLT2 inhibitors, an alternate study procedure may be utilized as described above
* Use of any medications (besides insulin or SGLT2 inhibitor) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed as long as not given within 2 weeks of the closed loop admissions. Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites
* History of hypoglycemic seizure within last 3 months
* History of diabetic ketoacidosis (DKA) requiring medical intervention (ie. emergency room visit and/or hospitalization) within 1 month prior to the screening visit
* Allergies or contraindication to the contents of canagliflozin tablets or insulin
* Volume depleted subjects. Subjects at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics who cannot carefully monitor their volume status should be excluded from the study
* Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
* Recurrent GU (genitourinary) infections
* Uncircumcised males secondary to increased risk of development of GU infections
* History of hypotension, defined as blood pressure (BP) <10th% for age and sex
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
|
NCT02673138
|
{
"brief_title": "Effect of Canagliflozin in T1DM (Type 1 Diabetes Melitus) After Interruption of Continuous Subcutaneous Insulin Infusion",
"conditions": [
"Type 1 Diabetes"
],
"interventions": [
"Other: basal interruption without canagliflozin",
"Drug: canagliflozin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02673138",
"official_title": "Effect of Canagliflozin in T1DM After Interruption of Continuous Subcutaneous Insulin Infusion",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-01",
"study_completion_date(actual)": "2017-07",
"study_start_date(actual)": "2016-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-10-13",
"last_updated_that_met_qc_criteria": "2016-02-01",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-02-03",
"first_submitted": "2016-02-01",
"first_submitted_that_met_qc_criteria": "2018-11-01"
}
}
}
|
#Study Description
Brief Summary
This retrospective multicenter observational study will provide real-life efficacy and tolerance data for patients with relapsed multiple myeloma (RMM) treated with carfilzomib in the context of nominative expanded access and compassionate use in France, and will allow to evaluate healthcare practices from data obtained during the use of carfilzomib for routine care. Nominative expanded access was open in February 2014 and stopped in march 2016, then relayed by the compassionate program (march 2016- February 2017).
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female patients over the age of 18 years
* Patients beginning carfilzomib treatment in the framework of expanded access or compassionate use in France (KRd or Kd regimen)
* Patients who received carfilzomib in first or second MM relapse
* Patients receiving at least one complete course of carfilzomib
Exclusion Criteria:
* Patients already included in an interventional research protocol using carfilzomib at the time of treatment initiation
* Patients refusing to allow the computerization of their data
* Patients for whom hospital medical records are not accessible
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
|
NCT04811508
|
{
"brief_title": "Retrospective Study to Describe Carfilzomib Use on Patients With Relapsed Multiple Myeloma in France in the Context of Carfilzomib Nominative Expanded Access and Compassionate Use",
"conditions": [
"Relapsed Multiple Myeloma"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT04811508",
"official_title": "Retrospective Study to Describe Carfilzomib Use on Patients With Relapsed Multiple Myeloma in France in the Context of Carfilzomib Nominative Expanded Access and Compassionate Use",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-31",
"study_completion_date(actual)": "2021-12-31",
"study_start_date(actual)": "2020-08-04"
},
"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)": "2022-03-09",
"last_updated_that_met_qc_criteria": "2021-03-19",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-23",
"first_submitted": "2021-03-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.
#Intervention
- DRUG : OTO-201
|
#Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:
* Subject is a male or female aged 6 months to 17 years, inclusive
* Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)
* Subject's caregiver is willing to comply with the protocol an attend all study visits
Exclusion Criteria includes, but is not limited to:
* Subject has a history of sensorineural hearing loss
* Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation
* Subject has a history of known immunodeficiency disease
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02408796
|
{
"brief_title": "Open-Label Study of OTO-201 for Treatment of AOMT",
"conditions": [
"Acute Otitis Media",
"AOMT"
],
"interventions": [
"Drug: OTO-201"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02408796",
"official_title": "A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Supra-Tympanostomy Tube Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-05",
"study_completion_date(actual)": "2015-05",
"study_start_date(actual)": "2015-03"
},
"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)": "2020-10-19",
"last_updated_that_met_qc_criteria": "2015-04-02",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-04-03",
"first_submitted": "2015-03-27",
"first_submitted_that_met_qc_criteria": "2020-09-01"
}
}
}
|
#Study Description
Brief Summary
Expanded access, open label study at a single dose level in patients with CED that in the opinion of the investigators might benefit from TTHX1114
#Intervention
- DRUG : TTHX1114
- engineered FGF-1
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 years or older
* Subjects who are women of childbearing potential (WOCBP) must be using an acceptable method of birth control (See Section 6.4.3)
* Proposed Study Eye that has been diagnosed with an ocular condition that, in the opinion of the Investigator, could possibly benefit from TTHX1114 administration, and has a measurable efficacy endpoint
* Fellow Eye with 20/100 BCVA or better
* No concurrent ocular or medical condition that would impair the assessment of safety and efficacy
Exclusion Criteria:
* Prior exposure to TTHX1114
* Intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance (Note: This includes all components and excipients of the study drug)
* Current or recent (e.g., the 28 days prior to Study Day 0) participation in any other, interventional clinical research study
* History of:
* Ocular cancer (including melanoma)
* Herpetic keratitis
* Documented and repeated elevated IOP in either eye
* Posterior Polymorphous Corneal Dystrophy (PPCD; aka Schlichting dystrophy)
* Uveitis
* Use of any concomitant medications that may interfere with the assessment of safety and efficacy
* Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with 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
|
NCT04812067
|
{
"brief_title": "A Safety and Efficacy Trial of TTHX1114 in People With CED",
"conditions": [
"Corneal Endothelial Dystrophy"
],
"interventions": [
"Drug: TTHX1114"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04812067",
"official_title": "A Phase 2 Clinical Trial to Assess the Safety and Observe the Potential Benefit of TTHX1114 Delivered Via Intra-Cameral (IC) Injection",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-08-29",
"study_completion_date(actual)": "2023-10-31",
"study_start_date(actual)": "2021-11-30"
},
"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)": "2023-11-07",
"last_updated_that_met_qc_criteria": "2021-03-19",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-23",
"first_submitted": "2021-03-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To compare the number of breakthrough bleeds under tailored prophylaxis with Human cell line recombinant factor FVIII (Human-cl rhFVIII) with the historical bleeding rate from patients who received Human-cl rhFVIII as on demand treatment.
Detailed Description
There were 3 phases in this study: (1) An initial pharmacokinetic (PK) assessment in which participants received a single infusion of 60±5 IU/kg of Human-cl rhFVIII; blood samples were collected for 72 hours following the infusion. (2) Prophylactic Treatment-Phase I during which participants received infusions of 30-40 IU/kg of human-cl rhFVIII every other day or 3x/week for 1-3 months. (3) Prophylactic Treatment-Phase II during which the dose and dosing interval were determined individually from data gathered in the initial PK assessment. The maximum dosing interval with a dose of ≤ 60-80 IU/kg that maintains a trough level of ≥ 0.01 IU/mL was determined. Participants were treated for 6 months.
#Intervention
- BIOLOGICAL : Human-cl rhFVIII
- Human-cl rhFVIII was provided as a freeze-dried concentrate to be reconstituted in water for injection.
|
#Eligibility Criteria:
Inclusion Criteria:
* Severe haemophilia A (FVIII:C < 1%) according to medical history.
* Male patients >= 18 years.
* Previous treatment with a FVIII concentrate (regular prophylaxis with good compliance or on-demand treatment) for at least 150 exposure days (EDs).
* Good documentation regarding dosing and bleeding frequency in the 6 months preceding study start.
* Immunocompetence (CD4+ count > 200/microliter).
* HIV-negative, if positive, viral load < 200 particles/microliter or < 400,000 copies/mL.
* Freely given written informed consent
Exclusion Criteria:
* Any coagulation disorder other than haemophilia A.
* Present or past FVIII inhibitor activity (> 0.6 Bethesda Unit [BU])
* Severe liver or kidney disease.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01863758
|
{
"brief_title": "Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A",
"conditions": [
"Severe Haemophilia A"
],
"interventions": [
"Biological: Human-cl rhFVIII"
],
"location_countries": [
"Slovakia",
"Poland",
"Germany",
"Romania",
"Austria",
"Bulgaria",
"Hungary",
"United Kingdom"
],
"nct_id": "NCT01863758",
"official_title": "Prospective, Open-label, Multicenter Phase 3b Study to Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Previously Treated Adult Patients With Severe Haemophilia A",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-01",
"study_completion_date(actual)": "2015-01",
"study_start_date(actual)": "2013-08"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-01-30",
"last_updated_that_met_qc_criteria": "2013-05-23",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-05-29",
"first_submitted": "2013-05-23",
"first_submitted_that_met_qc_criteria": "2017-07-05"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to examine prospectively the safety and efficacy of alefacept in the treatment of subjects with severe alopecia areata of the scalp. Common features between psoriasis and alopecia areata, including immunologic and therapeutic aspects, suggest that alefacept, which has been shown to be a safe and statistically significant beneficial therapeutic modality for the treatment of psoriasis, may have therapeutic value in alopecia areata.
Detailed Description
Alopecia areata (AA) is an autoimmune condition characterised by a T-cell mediated attack on the hair follicle. The inciting antigenic stimulus is unknown. A dense peribulbar lymphocytic infiltrate and reproducible immunologic abnormalities are hallmark features of the condition. The cellular infiltrate primarily consists of activated T-lymphocytes and antigen-presenting Langerhans cells. T-lymphocytes play a critical role in the pathogenesis of disease. The observance of hair regrowth in those with alopecia areata who are treated with cyclosporine, a known inhibitor of T-cell function, further confirms the central role of the T-lymphocytes in the development of the disease.
Activation of T-cells is initiated by interaction of the T-cell receptor with the antigen/major histocompatibility complex on the antigen-presenting cells. Co-stimulatory interactions occur secondarily, including binding of the T-cell CD2 receptor to the antigen-presenting cell ligand LFA-3 (lymphocyte function-associated antigen-3 CD58). Induction of a molecular signaling cascade with resultant T-cell activation and proliferation ensues. Abrogation of this activation may result in diminished or aborted expression of disease, and thus suggests a potential therapeutic role for alefacept in the treatment of alopecia areata. Alefacept is a bioengineered LFA-3/Immunoglobulin fusion protein that binds to the CD2 T-cell receptor and interferes with the ligation of LFA-3. Binding of the immunoglobulin portion of the fusion protein to the FCy receptor on antigen-presenting cells potentiates apoptosis of CD-2 T-cells to thereby reduce the population of activated T-cells.
Psoriasis is a T-cell mediated disorder that shares many immunologic features with alopecia areata. Accordingly, treatments that are effective in psoriasis often prove to be beneficial in alopecia areata. Anthralin, topical and intralesional steroids and cyclosporine are among several therapeutic agents that have efficacy in both disorders. Based on the impressive therapeutic responses seen in those with psoriasis treated with alefacept, a similarly beneficial outcome is tentatively anticipated with treatment of those with alopecia areata.
#Intervention
- DRUG : Alefacept
- Study participants will receive weekly IM administration of placebo or 15 mg of alefacept for 12 weeks, to be followed by a 12-week post-treatment period during which the safety, efficacy, and durability of effect in treatment responders will be assessed on weeks 2, 4, 8 and 12.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects must give written informed consent and candidates in the US must authorize the release and use of protected health information (PHI)
* Subjects must be between the ages of 18 and 65 inclusive at the time of informed consent
* Must have a diagnosis of scalp alopecia areata as determined by the study investigator
* Must have 50 <= age <= 95% patchy scalp hair loss due to alopecia areata of at least one year duration
* Must have CD4+ T-lymphocyte counts at or above the lower limit of normal as determined by a local laboratory.
Exclusion Criteria:
* History of systemic or cutaneous malignancy other than treated basal cell carcinomas or 3 or less squamous cell carcinomas.
* Nevi or cutaneous lesions currently undiagnosed but suspicious for malignancy.
* Evidence of immunocompromise.
* Advanced or poorly controlled diabetes.
* Unstable cardiovascular disease.
* Clinically significant medical or psychiatric disease as determined by the investigator.
* History of alcohol or drug abuse within 2 years of assessment for study enrollment.
* Serious local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) within 3 months prior to the first dose of investigational drug.
* Positive PPD history of incompletely treated or untreated tuberculosis.
* Abnormal T-lymphocyte count, and/or liver function tests.
* If female, serum hemoglobin level greater than 1 unit below accepted limit for normal or otherwise abnormal.
* Male subjects with an abnormal serum hemoglobin.
* Known positivity for hepatitis C antigen or hepatitis B surface antigen.
* Known positivity for HIV antibody.
* Diagnosis of diffuse alopecia areata.
* Coexistent androgenetic alopecia which, in males is Norwood-Hamilton stage VI or greater, or in females, Ludwig stage III.
* Prior treatment with alefacept.
* Treatment with another investigational drug within 4 weeks prior to anticipated first treatment dose.
* Unable to practice effective contraception for the duration of the study.
* Females who are nursing, pregnant or planning to become pregnant while in the study.
* Those who have donated blood within a month of date of screening evaluation.
* Concomitant enrollment in other investigational drug study.
* Unwilling to maintain a consistent hair style and to eschew shaving of scalp hair throughout the course of the study.
* Unable to comply with the protocol.
* Other unspecified reasons that contraindicate enrollment in the study, as determined by the study investigator.
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
|
NCT00167102
|
{
"brief_title": "Alefacept in Patients With Severe Scalp Alopecia Areata",
"conditions": [
"Alopecia Areata"
],
"interventions": [
"Drug: Alefacept"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00167102",
"official_title": "A Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Evaluate The Safety and Therapeutic Efficacy of Intramuscular Administration of Alefacept in Patients With Chronic, Severe Scalp Alopecia Areata",
"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)": "2005-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-22",
"last_updated_that_met_qc_criteria": "2005-09-12",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-14",
"first_submitted": "2005-09-09",
"first_submitted_that_met_qc_criteria": "2013-02-27"
}
}
}
|
#Study Description
Brief Summary
The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most reported side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody against vascular endothelial growth factor, hypertension had an overall incidence up to 32%. The increase in blood pressure occurs early in treatment. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this side effect is essential for optimal treatment with this class of drugs.
The primary objective is to explore the effect of bevacizumab infusion on endothelium-dependent vasodilation of forearm resistance arteries.
#Intervention
- DRUG : Acetylcholine
- Intra-arterial infusion
- DRUG : Nitroprusside
- Intra arterial infusion
- DRUG : Bevacizumab
- Intra arterial infusion
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 50 years
* Male
* Results of serum glucose, lipids and creatinine should be within the laboratory's reference ranges.
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
Exclusion Criteria:
* Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
* History of or current abuse of drugs, alcohol or solvents.
* History of malignant disease.
* First degree relatives with a history of cancer before the age of 50
* First degree relatives with a history of premature cardiovascular disease before the age of 50
* Current use of medication.
* Clinical evidence of cardiac or pulmonary disease
* Hypertension ( systole >140mmHG, diastole >90mmHg)
* Diabetes mellitus
* Smoking
* Any clinically relevant abnormality on ECG.
* A history of thrombosis or first degree family members with a history of recurrent thrombosis
* Inability to understand the nature and extent of the trial and the procedures required.
* Previous participation in a study with bevacizumab
Sex :
MALE
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
|
NCT01125943
|
{
"brief_title": "Bevacizumab and Endothelium Dependent Vasodilation",
"conditions": [
"Hypertension",
"Cancer",
"Endothelial Dysfunction"
],
"interventions": [
"Drug: Nitroprusside",
"Drug: Acetylcholine",
"Drug: Bevacizumab"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT01125943",
"official_title": "Bevacizumab and Endothelium Dependent Vasodilation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-10",
"study_completion_date(actual)": "2011-11",
"study_start_date(actual)": "2010-06"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-01-10",
"last_updated_that_met_qc_criteria": "2010-05-17",
"last_verified": "2013-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-19",
"first_submitted": "2010-05-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to compare the therapeutic efficacy, safety, cost-effectiveness and maintenance effect between Chinese herbal formula and lactulose on chronic constipation in long-term care.
Detailed Description
Although many people regard regular defecation as important factor to maintain healthy, constipation is still a common problem in general population. According to some surveys, constipation affects approximately 50% to 73% of nursing home residents. Because the symptoms cause serious impairment of life quality, laxatives are commonly prescribed for people and over-prescribing of laxatives is also common. Despite the large sums spent on laxatives, there have been few advances in laxative treatment in the last 50 years and there have been minimal research addressing the problem. Therefore constipation was labeled as 'the neglected symptoms'.
There is unsatisfactory effect by currently pharmacologic therapies and preventive strategies for constipation. Contrarily, they had abundant clinical experiences and medical records for constipation in traditional Chinese medicine. So we follow the worldly trend to do the research of integrative Chinese medicine and Western medicine since WHO launched the first global strategy on traditional and complementary/alternative medicine (TM/CAM) to assist countries to create a stronger evidence base of the TM/CAM products and practices.
The study will be performed under randomized, double-blind, placebo controlled, parallel design. The object of this study is the residents in nursing homes. After intake of Chinese herb, improving constipation and care quality, decreasing the need of enema or digital maneuver, minimizing the dosage of rescue laxatives and saving the medical expenditure will be expected.
#Intervention
- DRUG : Chinese herbal formula (CCH1)
- initial dose of 1.5/3.0/4.5gm herbal powder with 15/30/45ml placebo of duphalac, respectively, per day for mild/moderate/severe constipation, then titrated
- Other Names :
- TCM
- DRUG : Duphalac
- initial dose of 15/30/45ml duphalac with 1.5/3.0/4.5gm placebo of herbal powder, respectively, per day for mild/moderate/severe constipation, then titrated
- Other Names :
- Laxative
|
#Eligibility Criteria:
Inclusion Criteria:
* men and non-pregnant women who are at least 20 years
* patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication
* the one who meet any one of the following three criteria: 1.RomeIII criteria; 2.at least once a week of enema/suppository use/digital maneuver in past three months; 3.laxative use in more than half time of last three months
Exclusion Criteria:
* known severe renal or hepatic insufficiency,
* known colorectal cancer, anal abscess, anal fistula, anal fissure, rectocele, inflammatory bowel diseases, or gastrointestinal obstruction;
* unknown cause of gastrointestinal bleeding or acute infection
* neuromuscular dystrophy or spinal cord injury induced constipation
* history of drug abuser
* unstable psychiatric disorders
* women who are pregnant, as determined by a urine pregnancy test
* use of an investigational drug (within 30days prior to enrolled)
* known allergies to the component of study medication
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00745147
|
{
"brief_title": "Comparison of TCM and Laxatives for Adults With Chronic Constipation",
"conditions": [
"Chronic Constipation"
],
"interventions": [
"Drug: Chinese herbal formula (CCH1)",
"Drug: Duphalac"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT00745147",
"official_title": "Comparison of Chinese Herbal Formula and Lactulose for Adults With Chronic Constipation-a Randomized ,Double-Blind, Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-10",
"study_completion_date(actual)": "2010-04",
"study_start_date(actual)": "2008-07"
},
"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)": "2010-05-04",
"last_updated_that_met_qc_criteria": "2008-08-31",
"last_verified": "2010-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-03",
"first_submitted": "2008-08-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes
#Intervention
- DRUG : semaglutide
- Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.
- DRUG : liraglutide
- Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.
- DRUG : placebo
- Administered subcutaneously ( s.c., under the skin) once daily.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female, age at least 18 years at the time of signing informed consent.
* Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening
* HbA1c (glycosylated haemoglobin): 53 <= age <= 86 mmol/mol (7.0 <= age <= 10.0%) (both inclusive)
* BMI: 25.0 - 40.0 kg/m^2 (both inclusive)
Exclusion Criteria:
* Simultaneous participation in any other clinical trial of an investigational medicinal product
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days)
* Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
* History of pancreatitis (acute or chronic)
* Screening calcitonin above or equal to 50 ng/L
* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
* Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology)
* Within the past 180 days before screening any of the following: Myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
* Currently planned coronary, carotid or peripheral artery revascularisation
* Patients presently classified as being in New York Heart Association (NYHA) Class III or IV
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
|
NCT02461589
|
{
"brief_title": "Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes",
"conditions": [
"Diabetes",
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: liraglutide",
"Drug: semaglutide",
"Drug: placebo"
],
"location_countries": [
"United States",
"Germany",
"South Africa",
"Canada",
"Austria",
"Malaysia",
"Russian Federation",
"Serbia",
"Czechia",
"United Kingdom"
],
"nct_id": "NCT02461589",
"official_title": "Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-10-13",
"study_completion_date(actual)": "2016-10-13",
"study_start_date(actual)": "2015-09-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-31",
"last_updated_that_met_qc_criteria": "2015-06-01",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-06-03",
"first_submitted": "2015-06-01",
"first_submitted_that_met_qc_criteria": "2017-12-21"
}
}
}
|
#Study Description
Brief Summary
Using an adult lung bench model of non invasive ventilation, the aim of the study is to compare an experimental system of breath-synchronized vibrating mesh nebulizer to a conventional vibrating mesh nebulizer during non invasive ventilation in terms of inhaled and lost doses.
#Intervention
- DRUG : Nebulization of Amikacin during NIV (RR: 15 cycles/minute)
- 500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds. The NIV is set with an IPAP of 15 cmH2O and EPAP of 5 cmH2O. The lung model is simulated with a respiratory rate of 15 cycles/minute
- Other Names :
- Amikacine sulfate
- DRUG : Nebulization of Amikacin during NIV (RR: 25 cycles/minute)
- 500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds. The NIV is set with an IPAP of 15 cmH2O and EPAP of 5 cmH2O. The lung model is simulated with a respiratory rate of 25 cycles/minute
- Other Names :
- Amikacine sulfate
|
#Eligibility Criteria:
Inclusion Criteria:
* Not applicable (in vitro study)
Exclusion Criteria:
* hypersensitivity (allergic) reactions to aminoglycosides
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02084043
|
{
"brief_title": "In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation",
"conditions": [
"Respiratory Diseases",
"Lung Diseases",
"Cystic Fibrosis",
"COPD",
"Asthma"
],
"interventions": [
"Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute)",
"Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT02084043",
"official_title": "In Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-06",
"study_completion_date(actual)": "2015-06",
"study_start_date(actual)": "2014-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-06-08",
"last_updated_that_met_qc_criteria": "2014-03-08",
"last_verified": "2015-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-03-11",
"first_submitted": "2014-03-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to perform biopsies of one of the glands that make saliva. The biopsied tissue will then be analyzed to see if it has changes that occur in Parkinson's disease. This study will determine whether it is possible to do a second biopsy a few years after a previous biopsy and determine whether there are changes in the biopsy that would allow for analysis of disease progression.
Detailed Description
Tissue biopsies documenting the presence and density of Lewy type synucleinopathy (LTS) in living patients with probable Parkinsons disease (PD) would be extremely valuable as a diagnostic test, as a marker of molecular therapeutic target engagement and as a progression marker. Based on recent data from our group with both early and advanced PD patients, we propose to perform a second transcutaneous submandibular gland (SMG) needle core biopsy in 12 patients who have previously been biopsied and had LTS present in their SMG tissue.
#Intervention
- PROCEDURE : Submandibular gland biopsy
- Needle biopsies of the right and left submandibular glands
|
#Eligibility Criteria:
Inclusion criteria
* PD patients ages up to age 85.
* Previous participation in a SMG biopsy study at Mayo Clinic Arizona with a positive biopsy being reported
Exclusion criteria
* Evidence for dementia that would preclude the patient from signing informed consent
* History of bleeding diathesis or hematologic disorders
* Medically unable to undergo a core needle biopsy of the submandibular gland
* Prior treatment of the submandibular gland with botulinum toxin injections.
* History of past or current acute infection or abscess of the submandibular gland.
* History of past or current neoplastic process within the submandibular gland.
* History of peripheral neuropathy.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03359226
|
{
"brief_title": "Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease",
"conditions": [
"Parkinson Disease"
],
"interventions": [
"Procedure: Submandibular gland biopsy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03359226",
"official_title": "Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson&Apos;s Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-31",
"study_completion_date(actual)": "2018-05-31",
"study_start_date(actual)": "2017-11-21"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-11-06",
"last_updated_that_met_qc_criteria": "2017-11-29",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-12-02",
"first_submitted": "2017-11-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Ivory Dentin Graft is at least as good as the competitor treatment group (OsteoBiol Gen Os) for alveolar ridge preservation following tooth extraction.
The non-inferiority endpoints will be achieved if the competitor treatment group will not be statistically better than the Ivory Graft treatment.
Detailed Description
Device Description - Investigational Medicinal Product Ivory Dentin Graft is a bone graft material for the repair or augmentation of bone defects in dental procedures. It consists of sterile 300 - 900 μm porous particles of hydroxyapatite which retain the natural form of the source porcine dentin.
Ivory Dentin Graft is intended to be used as a bone graft material for the repair or augmentation of bone defects in dental procedures.
OsteoBiol Gen Os. - Comparator control device A natural replicate of autologous bone, Gen-Os® conserves the same intimate structures (matrix and porous form) and presents a highly osteoconductive properties. Gen-Os® is gradually resorbable and provides support in bone neoformation helping to preserve the original graft shape and volume.
Study Design: The Ivory Dentin Graft study is a prospective, randomized, semi double blinded with blinded assessments study comparing patients grafted with Ivory Dentin Graft (Investigational group) and patients grafted with OsteoBiol Gen Os (comparator group) for alveolar ridge preservation following tooth extraction.
Study Population and Justification: A total of 44 adult patients in 2 study groups scheduled to undergo at least one dental implant placement of mandibular premolar or molar are planned to be enrolled. The patients will be randomized into two treatment groups: One group is to be grafted with Ivory Dentin Graft while the second group will be grafted with OsteoBiol Gen Os, randomization ratio of 1:1 between the experimental and control group.
Sample size Justification and Statistical Analysis Plan: The rationale for sample size calculation is based on demonstrating non-inferiority in the study primary endpoint between the tested and the reference treatment groups.
The calculations assume a difference of up to 30% (percent as in unit of measure and not of relative difference) woven bone between the treatments, which will be considered equivalent (non-inferiority) and standard deviation of 32%.
In a sample of 15 patients per group, a difference of up to 30% in the mean woven bone between the treatment groups will be considered equivalent with 5% significance level and 80% statistical power. Assuming expected dropout rate of \~30%, 44 patients (22 per group) will be recruited in order to ensure final sample size of 30 study completers (15 per group). All tests will be two-tailed, and a p value of 5% or less will be considered statistically significant. The data will be analysed using the R version 4.0.1 (R development Core Team. Vienna, Austria).
Primary Endpoints: 95% Confidence Interval of the Differences between the treatments (Mean Ivory Graft - Mean Comparator) in woven bone ratio at 4 months after grafting will be applied. The non-inferiority endpoint will be achieved if the lower limit of the confidence interval will be higher than -30 (meaning that the comparator is less than 30 points better than Ivory Graft or not better at all).
Secondary Endpoints: Differences in categorical secondary endpoints will be tested for significance using Chi-Square test or Fisher's Exact test (as appropriate) Differences in numeric secondary endpoints will be tested for significance using the two-sample T-test or Non-parametric Wilcoxon-Mann-Whitney Rank sum test for independent samples (as is appropriate).
Exploratory Endpoints: Usability, defined as ease of procedure using 10-points satisfaction scale, will be summarized in appropriate tables by treatment.
The percent of teeth which require additional grafting at implant placement will be summarized and compared using Chi-square test or Fisher's exact test (as is appropriate).
Handling of Participant Withdrawals: Participants who leave the study prematurely will be replaced. A patient discontinuing the study before grafting of Ivory Dentin Graft (Visit 2) will be followed for safety. Each case of premature withdrawal will be properly recorded in the Screening Failure Log as deemed necessary.
Patient Screening: Prior to any study-related screening procedure, delegated study team members will approach potentially eligible adult patients who are waiting to be scheduled for tooth extraction and grafting for necessary titanium implant placement. Patients who do not meet inclusion criteria or who are for any other reason determined to be unsuitable for inclusion in the study, or who decline to participate in the study, will be considered and recorded as 'screening failure' and receive standard and appropriate treatment.
Informed Consent: The informed consent document will be signed and dated for screening and enrollment and each patient consenting will be documented in the patient medical binder. The patient will be given a copy of the consent form together with the study doctor's letter at the time of enrollment. The clinician will ask the patient about his plans and his willingness to attend all scheduled follow-up visits.
Randomization will be done by Castor EDC web-software. The patients will be randomized into two treatment groups: One group is to be grafted with Ivory Dentin Graft while the second group will be grafted with OsteoBiol Gen Os, randomization ratio of 1:1 between the experimental and control group.
TRIAL PROCEDURES: After informed consent is obtained, a case record form including all aspects listed below will be recorded. Eligible patients will be enrolled into the study and be treated according to standard treatment protocols for tooth extraction, grafting, implant placement, dental biopsy and dental radiographic procedures and with the standard protocol for local anesthetic.
Visit 1: Screening and Enrolment, as part of pre-operative visit (0-90 days before grafting procedure ) The following assessments will be performed: Demographics, Medical history, Vital signs, Current medications. A CT scan will be performed in order to verify patient eligibility and graft procedure preparation Visit 2: Randomization and extraction socket graft filling by Ivory Dentin Graft or Gen Os after tooth extraction.
The designated randomization groups (Ivory Dentin Group and Gen Os) will be:
1. Recorded in the patient CRF
2. A sticker of the used study item and the used package will be achived in the patient binder- this will be used as source to verify correct allocation.
All patients will be operated by study delegated physicians using the same method.
Socket debridement and cleaning: After exposure of the defect the sounding walls should be debrided by surgical curette and all granulation tissue removed.
The extraction site will be graft filled either using Ivory Dentin Graft or OsteoBiol Gen-Os according to the respective Instructions for Use using either vial or syringe applicators with dental membrane. Only the graft performing sub-investigator and the study coordinator will be un-blinded to the patient allocation. All efforts and measures would be taken by the study team to keep the patient and blinded assessors blinded of allocation- semi double blinded study.
Periapical x-ray imaging will be performed on each enrolled patient once completing the graft filling in order to validate the bone grafting procedure.
The following assessments will be performed following the procedure:
1. Extraction socket grafting Physician usability Form
2. Study Patient Discharge form. Patients will be monitored for short-term follow-up (1 week, 1 and 4 months following their extraction socket grafting procedure) and for long-term follow-up and will be evaluated for their medical and dental conditions. Implantation of titanium implants will be conducted 4 months following the grafting procedure at grafted site of each enrolled patient.
Short-term Visit 3: Follow up 1 week following grafting procedure The patient will be asked to report any dental complication- all will be investigated by the sub-investigator using Visit 3 safety Follow Up Form. In addition, vital signs will be taken by study investigator.
Visit 4: Follow up 1 month following grafting procedure The patient will be asked to report any dental complication- all will be investigated by the sub-investigator using Visit 4 safety Follow Up Form. In addition, vital signs will be taken by study investigator.
A Computerized Tomography (CT) will be performed prior to visit 5 Visit 5: Follow up 4 months following grafting procedure and dental Implant placement (Short-term Termination visit)
Prior to the procedure, the patient will be asked to report any dental complication. The following assessments will be conducted during the visit:
1. Vital Signs
2. Implant placement Physician usability Form
3. Study Patient Discharge form.
4. Short-term termination visit The alveolar bone strength (torque measurement) will be measured by torque measurement.
Adequacy of bone graft (need for additional grafting at implant placement) will be evaluated by the study investigator based on the clinical examination, torque measurement and CT scan, and will be specified and justified in the Case Report Form.
Un-scheduled visit: The study investigator will instruct the patient to immediately contact the study team in case of: Implant failure, loose graft particles, loss of grafting material, graft site infection, insufficient healing of graft site, excessive bleeding and wound dehiscence. The patient must call the study nurse to schedule an un-scheduled visit which may only be performed by the principal Investigator.
Post-Market Clinical Follow-up: Patients will be monitored also for long-term follow-up (6 and 10 months, 2.5 and 5 years following their extraction socket grafting procedure) and will be evaluated by the study nurse for their medical and dental conditions.
Data Monitoring and Quality Control:The investigator, through an appointed Clinical Research Associate (CRA), will be responsible for implementing and maintaining quality assurance and quality control systems with written Standard Of Procedures to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s), including ISO 14155.
The investigator will be responsible for ensuring direct access to all trial related sites, source data/documents, and reports for the purpose of monitoring and auditing by the hospital, and inspection by Israeli regulatory authorities.
Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.
The study CRA will verify that (a) The rights and well-being of human patients are protected, (b) The reported trial data are accurate, complete, and verifiable from source documents and (c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s) (including ISO 14155). The full responsibilities of the trial monitor appear in full in the ICH-GCP. The monitor(s) should follow Ivory Graft (or their CRO representative) written for monitoring the specific trial. The monitor will submit a written report after each trial-site visit or trial-related communication. A report should include the date, site, name of the monitor, and name of the investigator or other individual(s) contacted. A report should include a summary of what the monitor reviewed and the monitor's statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and/or actions recommended to secure compliance.
To ensure compliance of this investigator initiated trial with current national regulations and the ICH guidelines, data generated by this study will be available for inspection upon request by representatives of the local health authorities- IRB or the national authorities - MOH, or any entity providing support for this trial. Routine monitoring or audit activities for this study will be conducted by authorized representatives. The general scope of such visits would be to inspect study data (regulatory requirements), source documentation and CRF completion in accordance with current GCP, the ICH guidelines and the respective local and national government regulations and guidelines.
#Intervention
- DEVICE : Graft Matrix
- Both Graft matrix products are supplied sterile, for single use only and packed in vials or a syringe-like applicator. All products consist of the same bone graft particles with the only variants being due to different amounts per package or different containers.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female patient 18 up to 80 years.
* Patient requiring at least one implant placement following mandibular pre-molar or molar tooth extraction.
* Alveolar mandibular ridge (empty socket):
* Height: not less than 10 mm, from the gingival margin to the mandibular nerve canal - as seen in the screening CT scan.
* Width: not less than 5 mm, from buccal to lingual cortical plates - as seen in the screening CT scan.
* Ability to give informed consent for the study by patient or legal guardian.
* Willingness to undergo all follow up visits, as well as unscheduled sick visits.
Exclusion Criteria:
* Pregnancy (all women of child-bearing age would be questioned and told by the consenting physician regarding that criteria).
* Known or suspected hypersensitivity to the constituents of the bone graft material (for example porcine collagen)
* Pathologies or conditions contraindicating surgery or presenting with active acute or chronic infections excluding periapical granuloma (for example osteomyelitis, sinusitis), uncontrolled diabetes
* Immunologic disorders or auto-immune pathologies, in particular elderly
* Serious bone diseases of endocrine aetiology
* Serious disturbances of bone metabolism
* Ongoing treatment with gluco- or mineralocorticoids, or with agents affecting calcium metabolism (e.g. calcitonin, bisphosphonates)
* Irradiation therapy, chemotherapy or immunosuppressive therapy in the last 5 years
* Malignancies
* Severe Parafunction (bruxism and clenching)
* Poor oral hygiene or active periodontitis
* Heavy tobacco smoking habit (> 10 cigarettes per day)
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:
Yes
|
NCT03150472
|
{
"brief_title": "Safety and Efficacy Evaluation of the Ivory Dentin Graft Device",
"conditions": [
"Deficiency of Alveolar Ridge (Disorder)",
"Alveolar Bone Grafting",
"Mandibular Prosthesis User"
],
"interventions": [
"Device: Graft Matrix"
],
"location_countries": [
"Israel"
],
"nct_id": "NCT03150472",
"official_title": "Safety and Efficacy Evaluation of the Ivory Dentin Graft Device",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09-09",
"study_completion_date(actual)": "2020-09-09",
"study_start_date(actual)": "2017-11-07"
},
"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)": "2020-09-11",
"last_updated_that_met_qc_criteria": "2017-05-09",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-12",
"first_submitted": "2017-05-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
For many years, researchers and doctors have studied different kinds of treatments to improve the survival of men with testicular cancer. However, recent research has shown that many years later, men who had testicular cancer appear to be at higher risk for developing heart disease (heart attack or heart failure), especially if they received chemotherapy. Since these studies were done many years after men received treatment, there was no way to know if other factors contributed to the health problems they experienced. This study is being done because it would be helpful to study heart function and cardiovascular disease risk factors of men who have been diagnosed with testicular cancer, before and after they receive chemotherapy treatment compared to men who receive treatment with surgery alone.
Detailed Description
The aim of this pilot study is to examine global and regional LV systolic and diastolic function, cardiac output, cardiac reserve, VO2peak and CVD risk profile in males recently diagnosed with testicular cancer treated with surgery alone or surgery and chemotherapy.
|
#Eligibility Criteria:
Inclusion Criteria:
* surgery and surveillance
* surgery and multi-cycle chemotherapy
* both good and intermediate prognosis seminoma and non-seminomatous germ cell testicular tumors
* Karnofsky performance index > 70%
* no contraindications to cardiopulmonary testing
Exclusion Criteria:
* documented cardiovascular disease or evidence of myocardial ischemia on the incremental exercise (VO2peak) test.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00705094
|
{
"brief_title": "Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients",
"conditions": [
"Testicular Cancer",
"Seminoma",
"Non-seminomatous"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT00705094",
"official_title": "Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-05",
"study_completion_date(actual)": "2012-07",
"study_start_date(actual)": "2008-09"
},
"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)": "2014-10-01",
"last_updated_that_met_qc_criteria": "2008-06-24",
"last_verified": "2014-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-06-25",
"first_submitted": "2008-06-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
General Investigational Plan
Study Objectives The goal of this proposal is to determine whether enhancing brain glucose utilization minimizes cognitive decline in patients with Amnestic Mild Cognitive Impairment (AMCI) or mild Alzheimer's disease (AD) dementia. We propose a proof of concept double-blind, placebo controlled pilot study to determine if increasing brain thiamine availability with the investigational new drug benfotiamine, will minimize the decline in glucose utilization and slow the cognitive decline associated with the progression AMCI/AD dementia.
Specifically, our objectives are two-fold:
* To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).
* To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients as measured with Fluorodeoxyglucose Positron Emission Tomography(FGPET) in the posterior cingulate.
We will also carry out the following secondary objectives:
* Assess if there are differences in secondary clinical outcome measures (NPI, ADCSADL, CDR, Buschke) between benfotiamine and placebo groups and whether specific cognitive domains (ie: activities of daily living, learning and memory verbal memory, behavioral, etc.) are driving these changes.
* Compare ADAS-COG change scores in the benfotiamine and placebo groups within and between strata that were defined by initial cognitive impairment, to attempt to identified the population that most benefits from benfotiamine.
* Compare changes in glucose utilization between the benfotiamine and placebo groups in secondary Regions of Interest (ROIs) including the hippocampus, prefrontal regions and entorhinal cortex.
* Compare changes in whole brain glucose utilization between the benfotiamine and placebo groups using statistical parametric mapping (SPM).
* Assess the correlation between changes in glucose utilization with changes in ADAS Cog.
* Determine if ApoE4 genotype alters the response to benfotiamine.
Detailed Description
Study Design
This study will be conducted at the Burke Rehabilitation Hospital under an IRB protocol. Wplan to accrue a total of 76 male and/or female patients (\> 65 years) with a diagnosis of AMCI/AD dementia that are also amyloid positive by PET scan. Patients will be randomized and blinded to either a benfotiamine or placebo group. Because it is unknown whether there will be differential responses to treatment according to initial cognitive impairment, participants will be stratified according to the median MMSE cut-off score of our historical METS population who are \> 65 years old and have an MMSE \>21.
In this double-blind study, patients and their caregivers, as well as all physicians, clinicians, coordinators and investigators interacting with the patients, will be unaware of the treatment assignments. Treatment assignments will be available to the safety-monitoring physician, Dr. Michael Reding, who will have no unnecessary subject contact. If necessary, the code will be revealed to Dr. Reding by the pharmacist, Dr. Thomas Grandville.
Each patient will make six visits to the Memory Evaluation and Treatment Service (METS) clinic at Burke Rehabilitation Hospital. Information on medication use, vital signs, outcome measures, compliance and safety/tolerability will be collected at each time point. The screening visit (visit 1) will take place within 30 days prior to baseline visit (visit 2). Informed consent/assent will be obtained from each subject or his/her caregiver prior to conducting any study related procedures. During the screening visit a review of inclusion/exclusion criteria will be completed along with the collection of demographic data, disease history, and information about prior and concomitant medications. A complete medical history, physical examination, neurological examination, including the MMSE, CDR, CSDD and vital signs, will be collected. Blood will be drawn to assess blood glucose Patients that are diagnosed as likely Alzheimer patients that are not hyperglycemic will then have an amyloid PET scan. Only patients with a diagnosis of AD and a positive amyloid scan will be included. Prior to baseline (visit 2), FDGPET studies will be completed for each subject. At the baseline visit (visit 2) blood will be drawn to determine APOE and thiamine (vitamin B1 status). At visits 2-6, information on concomitant medications will be updated, vitals will be taken, medication compliance will be assessed and the following study measures will be administered: Alzheimer's Disease Assessment Scale (ADASCog), Buschke SRT, Neuropsychological Inventory (NPI), Clinical Dementia Rating Scale (CDR) and Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADLs). The final PET scan will be conducted approximately one week prior to the last visit. In addition to safety assessments at time of each visit, each patient will receive a call from the clinical coordinator at weeks 2 and 6 to assess for adverse events.
The benfotiamine and placebo will be dispensed by the pharmacy at Burke under the direction of Thomas Grandville, D. Pharm. The caregiver will administer the drug since patients with memory problems may forget to take it on a regular basis. In the placebo group, the active compound benfotiamine will be replaced with microcrystalline cellulose. The other components, shape and color are identical to the treatment. Caregivers will be instructed to oversee the administration of the study medication as prescribed to ensure compliance. A record of the number of capsules dispensed, number returned, and actual number taken will be recorded at scheduled visits. Each patient will be treated for 12 months.
The study cognitive measures include: the ADAS-Cog (our primary outcome measure), Alzheimer's Disease Cooperative Study-Activities of Daily Living, Neuropsychiatric Inventory, Clinical Dementia Rating Scale, Buschke Selective Reminding Test (SRT). is a standard diagnostic tool in the assessment of verbal memory. The Biological/Mechanistic Outcome Measures will be FDG-PET Scanning Procedures
Data Analysis Preliminary analyses will be conducted to describe the study sample and to confirm the relationship between level of glucose utilization and severity of cognitive impairment. For continuous variables (eg cognitive function, glucose utilization), we will first examine distributions to assess normality assumptions. We will perform transformations as needed to stabilize the variance, and to reduce skewness and kurtosis. We will use means (sd) and proportions n (%) to characterize the study sample. T-tests and Chi-square, or Wilcoxon rank sum test and Fisher, where appropriate, will be used to assess for any differences in patient characteristics according to treatment group. We will use spearman correlation coefficients and linear regression, unadjusted and adjusted for covariates, to assess the relationship between FDG-PET and MMSE in the whole population as well as in MMSE stratified groups to examine the relationship between initial MMSE score and glucose uptake.
All analyses to test study hypotheses will be run as intention to treat (ITT). Missing observations will be addressed by using the method of last observation carried forward (LOCF).
#Intervention
- DRUG : Benfotiamine
- * To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).
* To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients as measured with Fluorodeoxyglucose Positron Emission Tomography(FGPET) in the posterior cingulate.
- Other Names :
- S-[2-{[(4-amino-2- methylpyrimidin-5-yl)methyl] (formyl)amino}-5-(phosphonooxy)pent-2-en-3-yl] benzenecarbothioate
|
#Eligibility Criteria:
Inclusion Criteria:
* 60 years or older
* Clinical diagnosis of AMCI by the Peterson criteria or probable AD dementia according to the National Institute of Neurological Disorders and stroke and the Alzheimer's Disease related Disorders Association (NINCDS/ADRDA)
* MMSE score > or equal to 21
* CDR score > or equal to 0.5 and < or equal to1
* Cornell Scale for Depression in Dementia(CSDD) score <10.
* Ambulatory or ambulatory with aide
* Have a caregiver willing to accompany the patient to each visit, accept responsibility for supervising treatment and provided input to clinical outcome assessments
* Reside at home
* Speak English
* Amyloid positive PET-scan
* If they are on AD medications they must be stable on AD medications for at least three months prior to baseline
* Subjects ore willing/able to provide informed consent.
Exclusion Criteria:
* Patients with significant neurological disorder other than AD including hypoxia, stroke, traumatic brain injury
* A current psychiatric disorder according the DSM-IV diagnosis of major depression unless successfully treated on a stable dose of an antidepressant for at least 4 weeks and continues on stable dose throughout the study
* Any other DSM-IV Axis l diagnosis including other primary neurodegenerative dementia schizophrenia or bipolar depression
* A current diagnosis of uncontrolled diabetes mellitus (glucose values > 200 mg/ml).
* Patients with uncontrolled diabetes will be excluded because high glucose will alter the FDG-PET studies. The clinic that does PET (Columbia University Medical Center) excludes patients if glucose values exceed 200 mg/ml.
* A current diagnosis of active, uncontrolled seizure disorder
* A current diagnosis of probable or possible vascular dementia according to NINDS-AIREN
* An investigational drug during the previous 4 weeks
* A current diagnosis of severe unstable cardiovascular disease
* A current diagnosis of acute severe, or unstable asthmatic condition (e.g., severe chronic obstructive pulmonary disease (COPD),
* A current diagnosis of cardiac, renal or hepatic disease
* History of alcoholism, current or within past 5 years
* A disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty)
* A1C less than or equal to 8
* Current diagnosis of cancer/active treatments
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
|
NCT02292238
|
{
"brief_title": "Benfotiamine in Alzheimer's Disease: A Pilot Study",
"conditions": [
"Alzheimer's Disease"
],
"interventions": [
"Drug: Benfotiamine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02292238",
"official_title": "Benfotiamine in Alzheimer's Disease: A Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-07-20",
"study_completion_date(actual)": "2020-09-08",
"study_start_date(actual)": "2015-02-15"
},
"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)": "2022-06-28",
"last_updated_that_met_qc_criteria": "2014-11-14",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-11-17",
"first_submitted": "2014-11-10",
"first_submitted_that_met_qc_criteria": "2022-06-02"
}
}
}
|
#Study Description
Brief Summary
By confirming the incidence of biliary tract complications in adult patients aged 18 years or older who received extracorporeal membrane oxygenation , and measuring the duration of application of extracorporeal membrane oxygenation, drugs administered during the application period of extracorporeal membrane oxygenation, duration of fasting period, duration of total intravenous nutrition, and plasma bilirubin concentration, the researchers will try to find risk factors of biliary tract complications in patients receiving extracorporeal membrane oxygenation. Clinically, the researchers will check whether there are modifiable risk factors in patients receiving extracorporeal membrane oxygenation.
Detailed Description
Extracorporeal membrane oxygenation is an important method for the management of severe refractory heart and lung dysfunction, and improvements in extracorporeal membrane oxygenation equipment and increased experience have made it possible to use it for a long time. However, complications following extracorporeal membrane oxygenation are very common, and mortality and morbidity are high. When extracorporeal membrane oxygenation is applied, gastrointestinal bleeding may occur due to stress, ischemia, or bleeding tendency, and direct secondary bilirubin elevation and gallstone formation may occur secondary to long-term fasting, total intravenous nutrition, hemolysis, and diuretics. In intensive care patients, acalculous cholecystitis can progress with multiple organ failure and is known to be associated with prolonged ICU stay and high mortality. However, there is no report on whether the incidence of cholecystitis, risk factors, direct elevation of bilirubin, and cholelithiasis in patients receiving extracorporeal membrane oxygenation progresses to symptomatic cholecystitis.
#Intervention
- OTHER : extracorporeal membrane oxygenation therapy
- Extracorporeal membrane oxygenation for the management of severe refractory heart and lung dysfunction
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients over the age of 18 who have received extracorporeal membrane oxygenation therapy
Exclusion Criteria:
* None.
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
|
NCT04963322
|
{
"brief_title": "The Incidence and Risk Factors of Biliary Complications in Patients With ECMO",
"conditions": [
"Patients With Extracorporeal Membrane Oxygenation"
],
"interventions": null,
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT04963322",
"official_title": "The Incidence and Risk Factors of Biliary Complications in Patients With Extracorporeal Membrane Oxygenation: a Retrospective Observational Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-29",
"study_completion_date(actual)": "2021-06-29",
"study_start_date(actual)": "2021-05-21"
},
"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)": "2021-07-15",
"last_updated_that_met_qc_criteria": "2021-07-07",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-07-15",
"first_submitted": "2021-06-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Premature and accelerated brain aging trajectories have been observed among people with metabolic dysfunction, but mechanisms of these altered trajectories are not understood. Insulin resistance (IR) is known to change with age and affect cognition in older and elderly adults as well as in patients with mood disorders. The main purpose of the study is to describe the developmental trajectory of cognitive and neural biomarkers across the spectrum of metabolic dysfunction in overweight/obese adults younger than 50 years of age. The innovative study design will allow the investigators to examine cognitive outcome development over a 25-year span without an investment into the longitudinal observation of changes in cognition and neural function.
Detailed Description
Premature and accelerated brain aging trajectories started to be recognized in cognitive and neural responses, but specific mechanisms for the course of cognitive aging remain to be elucidated. Insulin resistance (IR) is known to change with age, affect cognition in older and elderly adults as well as in patients with affective disorders. It is unknown whether IR can predict cognitive decline in individuals younger than age 50 without overt mental illness. Studies in younger adults afford a unique opportunity to assess whether IR mediates cognitive and correlating neural processes decades before the manifestation of cognitive decline. The investigators propose to use an innovative accelerated longitudinal design (ALD) to characterize trajectories of cognitive and neural biomarkers and to: 1) describe baseline cognitive and neural biomarkers of brain function across the spectrum of IR in persons ages 25-50; 2) assess how the baseline IR and change in IR at a younger age affects the pattern of decline in cognitive and neural biomarkers and 3) explore the effects of baseline IR on changes in cognitive and neural variables of interest as moderated by non-modifiable risk factors for cognitive decline (gender, and APOE4/family history of AD). The current proposal aims to describe the developmental trajectory of cognitive and neural biomarkers across the spectrum of metabolic dysfunction in overweight/obese adults younger than 50 years of age. Utilizing an accelerated longitudinal design (ALD) we will recruit overweight/obese individuals (total N=160) aged 25-50. Based on semi-longitudinal data, this design will allow us to examine outcome development over 25 years between ages 25-50 after 3-year follow-up. All subjects will undergo baseline qualitative measure of IR, cognitive assessments and multimodal magnetic resonance imaging (MMRI). Neuropsychological evaluation will focus on cognitive flexibility/set shifting tests reflecting hippocampal connectivity to the medial prefrontal region. MMRI will include memory-related hippocampal function and connectivity (measured with task- and resting-state fMRI) and hippocampal volumes. The ALD design will allow investigation of the relation between cognitive performance and a corresponding neural response across the IR spectrum over a long period of time and the predictive value of IR of long-term trajectories of change in cognitive and neural biomarkers over span of 25 years.
|
#Eligibility Criteria:
Inclusion Criteria:
* Between 25 and 50 years
* BMI of 25 to 33 kg/m^2
* At least 12 years of education
* All subjects will be medically stable (i.e. no uncontrolled or poorly controlled medical illnesses), cognitively intact as defined by Mini Mental Status Exam (MMSE) score of > 27, and will have adequate visual and auditory acuity to allow for cognitive testing. Glycemic history will be collected together with other pertinent medical information from primary care providers.
Exclusion Criteria:
* Diagnosis of possible or probably dementia, MCI, or any other dementia
* Evidence of cognitive decline by MMSE < 27 or self-reported significant decline in memory within the past year (per the Memory Function Questionnaire)
* History of Type 1 or Type 2 Diabetes
* Fasting plasma glucose > 126 mg/dL
* History of significant cardiovascular disease or myocardial infarction, cerebrovascular/pulmonary disease, cancer, untreated hypothyroidism, unstable or untreated hypertension, history of head trauma, MRI-contraindications (i.e. metal in body, claustrophobia), premature birth (which may affect MRI findings), history of neurological disorder (ischemic attacks, carotid bruits, or lacunes upon MRI scan), or evidence of neurological or other physical illness that could produce cognitive deterioration
* Use of any drug that may significantly affect the SSPG or cognitive testing results (specifically: centrally active beta-blockers, narcotics, clonidine, antipsychotics, benzodiazepines, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anti-convulsants, anti-diabetics, or anti-cholesterol medications)
* Drug or alcohol abuse or dependence within the past 6 months, or positive urine toxicology screen for illicit substances at eligibility screening
* History of mental illness, with the exception of past mood disorder, or evidence of acute depression as determined by a 17-item Hamilton Depression Rating Scale (HDRS-17) score of 8 or more
* Participants with history of mood disorder must be in remission for at least 6 months prior to study entry
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03039647
|
{
"brief_title": "Insulin Resistance and Accelerated Cognitive Aging",
"conditions": [
"Insulin Resistance"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT03039647",
"official_title": "Insulin Resistance and Accelerated Cognitive Aging",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-01",
"study_completion_date(actual)": "2022-05-01",
"study_start_date(actual)": "2017-01-01"
},
"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)": "2022-05-09",
"last_updated_that_met_qc_criteria": "2017-01-30",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-01",
"first_submitted": "2017-01-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed to provide efficacy and safety data for certoparin in the prophylaxis of venous thromboembolism in immobilized, acutely ill medical patients.
#Intervention
- DRUG : Certoparin
- 3000 U anti XA of certoparin in 0.3 ml solution, once daily
- Other Names :
- Sandoparin, Embolex, low molecular weight heparin
- DRUG : Unfractionated Heparin
- solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily
|
#Eligibility Criteria:
Inclusion Criteria:
* Hospitalized medical patients 70 years or older
* Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
* written informed consent
Exclusion Criteria:
* immobilization longer than 3 days prior to randomization
* prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
* expected major surgical or invasive procedure within the next 3 weeks after randomization
* LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
* immobilization due to cast or fracture
* indication for anticoagulatory or thrombolytic therapy
* acute symptomatic DVT / PE
* known hypersensitivity to any of the study drugs or drugs with similar chemical structures
* Acute or history of heparin induced thrombocytopenia type II (HIT II)
Other protocol-defined inclusion/exclusion criteria may apply
Sex :
ALL
Ages :
- Minimum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00451412
|
{
"brief_title": "A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients",
"conditions": [
"Thromboembolism"
],
"interventions": [
"Drug: Unfractionated Heparin",
"Drug: Certoparin"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT00451412",
"official_title": "A Randomized, Double-blind, Multi-center Comparison of the Efficacy and Safety of Certoparin (3000 U Anti-Xa o.d.) With Unfractionated Heparin (5000 IU t.i.d.) in the Prophylaxis of Thromboembolic Events in Acutely Ill Medical Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-06",
"study_completion_date(actual)": "2009-06",
"study_start_date(actual)": "2007-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-07-25",
"last_updated_that_met_qc_criteria": "2007-03-22",
"last_verified": "2012-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-03-23",
"first_submitted": "2007-03-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Obesity affects one in five children in the UK and undoubtedly causes increased ill health with rising levels of childhood and adolescent diabetes, obesity induced liver disease and increased risk of early heart disease. There are few clinics offering effective treatment for childhood obesity. However, the clinic for childhood obesity at Bristol Royal Hospital for Children (BCH) has been successful in around 83% of cases. This pilot study aims to examine the feasibility of transferring the success of the hospital clinic to primary care in preparation for a full RCT. The study will entail training a practice nurse, community dietician and exercise specialist to deliver the same clinical service in primary care as that offered in BCH. Initial work will gather the views of staff delivering the hospital service and those of patients and parents to identify the crucial components of the intervention that are likely to be needed in primary care and to then to refine the intervention.A pilot trial will examine how feasible it is to recruit patients into the service and get some initial idea as to whether weight management is equally good, patient satisfaction and retention improves and what data needs to be collected for a full economic assessment. If found to be effective, the next step will be to use knowledge gained in this study to design and undertake a more extensive, formal study across Bristol in various primary care settings.This larger study will address how such a service can be delivered across a complete spectrum of primary care populations, so that similar services could be developed across the country.
Detailed Description
The care of childhood obesity clinic (COCO) at Bristol Royal Hospital for Children (BCH) provides a proven and effective treatment service for childhood obesity and is one of only a few specialist centres in the UK. The clinic service is based around a multidisciplanary team comprising: consultant; specialist nurses; dietitian: exercise specialist. This pilot study examines the feasibility of transferring the hospital clinic to a nurse led primary care setting in preparation for a full RCT. The study involves training a practice nurse to deliver the service in primary care alongside a dietitian and exercise specialist. Initial work will collect the views of staff delivering the hospital service and patients and parents which will enable us to identify the components of the service that will be needed to run a primary care based service. As a pilot we will focus on: (a) whether weight management is equally good in primary care; (b) whether recruitment, patient retention and satisfaction can be improved in primary care and (c) what data need to be collected for a full economic assessment.
Children will be recruited to the trial by GP via electronic referral form designed by the study team. Families of children fulfilling recruitment criteria (age: 5-16, BMI≥98th centile) will be sent a study pack and reply form, all those who do not respond will be contacted by the COCO consultant to clarify willingness to participate. Families declining participation will follow usual care pathway. Recruited families will be randomised to one of two primary care clinics or COCO clinic.
#Intervention
- BEHAVIORAL : Obesity management framework
- Treatment in primary care will be compared to treatment in a secondary hospital setting. Treatment in both cases will be provided by a multi-disciplinary team of: obesity or practice nurse, dietitian, exercise specialist with some input from medical team.
|
#Eligibility Criteria:
Inclusion Criteria:
* 5 to <18 yrs old on day of recruitment
* Children consulting their general practitioner or other primary care professional with a weight > 95th percentile
Exclusion Criteria:
* Suspected underlying pathology or syndrome on primary consultation
* Severe learning difficulties
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00536536
|
{
"brief_title": "Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study",
"conditions": [
"Childhood Obesity"
],
"interventions": [
"Behavioral: Obesity management framework"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00536536",
"official_title": "Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": "2010-06",
"study_start_date(actual)": "2008-04"
},
"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)": "2019-04-09",
"last_updated_that_met_qc_criteria": "2007-09-27",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-09-28",
"first_submitted": "2007-09-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the effects of CPAP treatment on blood pressure in patients with sleep apnea syndrome (SAS) and refractory arterial hypertension (RAH).
Also, some of the mechanisms mediating SAS and RAH (systemic inflammation, oxidative stress, sympathetic hyperactivity) will be analyzed.
#Intervention
- DEVICE : CPAP
- continuous positive airways pressure
- DEVICE : Control
- Patients are 3 months without any change in their treatment, and are in the waiting list to come into the CPAP procedure after that time
|
#Eligibility Criteria:
Inclusion Criteria:
* refractory arterial hypertension and sleep apnea with apnea-hypopnea index over 15
Exclusion Criteria:
* excessive sleepiness
* professional drivers
* secondary arterial hypertension
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
|
NCT00863135
|
{
"brief_title": "Effect of CPAP on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension",
"conditions": [
"Obstructive Sleep Apnea",
"Refractory Arterial Hypertension"
],
"interventions": [
"Device: CPAP",
"Device: Control"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT00863135",
"official_title": "Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-07",
"study_completion_date(actual)": "2016-07",
"study_start_date(actual)": "2008-12"
},
"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)": "2017-02-09",
"last_updated_that_met_qc_criteria": "2009-03-16",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-03-17",
"first_submitted": "2009-03-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of the study is to find out whether a high fat meal increases blood lipids and causes monocyte (white blood cell) activation, and whether blueberry intake at the same meal lessens monocyte activation in healthy people.
Detailed Description
This study was designed as a single blind, placebo-controlled crossover study. Subjects were never told what dose of blueberry powder was given. Researchers handling samples and data did not know what dose of blueberry powder subjects received on test day 2 or 3. The frozen blueberry yogurt supplemented with either control or blueberry powder was coded by letter, and samples were coded by test day: since the control powder was given on the first day to all subjects, the laboratory staff analyzing the samples would have known that the first day samples were from the subjects receiving the control powder.The provision of the control powder on the first day to all subjects was done to mitigate potential carry over effects of the blueberry powder.The randomization plan for the two doses (two vs four servings) of blueberry powder was uploaded into a spreadsheet of which only the registered dietitian, the Human Studies Manager, and the Metabolic Kitchen and Human Feeding Laboratory staff had access. Subjects were instructed by a registered dietitian to follow a low polyphenol and omega-3 diet and limit consumption of fruits, vegetables, soy, fatty fish (e.g. salmon), whole grains, nuts, coffee, tea, and chocolate starting 3 days prior to each test day. The night before each test day, subjects were required to eat a standardized dinner provided by the WHNRC. Since a previous meal may impact the postprandial response of the next, subjects were fed a dinner that consisted of a burrito with tortilla, chicken, cheese, oil, and pinto beans as well as yogurt and lemonade. On each test day, subjects arrived at the WHNRC after a 12-hour overnight fast. Subjects had their body temperature, blood pressure, and weight measured, and then had blood withdrawn. Subjects were fed the MHF breakfast supplemented with a frozen yogurt containing either control or blueberry powder. Subjects were given 20 minutes to consume the entire breakfast. Subjects were instructed not to eat or drink anything other than plain water. Three and one-half hours following consumption of the test meal each subject returned to the WHNRC for a postprandial blood draw. Postprandial hypertriglyceridemia peaks on average 3.5 hours after the consumption of a high fat breakfast, thus the 3.5 hour blood draw provides the highest concentration of TGRL. Subjects were allowed to return to their normal activities after the morning meal before the postprandial blood draw. Following the postprandial blood draw, subjects were allowed to return to their normal dietary habits until three days prior to their next test day. Subjects were fed the control powder on their first test day. On the second and third test days subjects were fed varying amounts of the blueberry powder that were equivalent to two or four servings of fresh blueberries (24.1 g and 48.2 g of blueberry powder, respectively) in a random order.
#Intervention
- OTHER : Breakfast meal with placebo powder
- Zero serving equivalents (1 serving equivalent = ½ cup fresh raw blueberries) of blueberries in the form of a mixed side dish comprising frozen yogurt, sugar, and placebo powder.
- OTHER : Breakfast meal with 2 serving equivalents of blueberries
- Two serving equivalents (1 serving equivalent = ½ cup fresh raw blueberries) of blueberries in the form of a mixed side dish comprising frozen yogurt, sugar, and freeze-dried blueberry powder.
- OTHER : Breakfast meal with 4 serving equivalents of blueberries
- Four serving equivalents (1 serving equivalent = ½ cup fresh raw blueberries) of blueberries in the form of a mixed side dish comprising frozen yogurt, sugar, and freeze-dried blueberry powder.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adults
* Able to complete study procedures
* Body Mass Index 18 - 24.9 kg/m2
Exclusion Criteria:
* Diabetes mellitus
* Kidney disease
* Liver disease
* Thyroid disease
* Bleeding disorders
* Autoimmune diseases and other inflammatory disease
* Cancer, unless in remission for > 5 years
* Blood cell counts outside the normal range for age and gender
* Blood chemistry panels outside the normal range for age and gender
* Blood cholesterol greater than 240 mg/dL
* Blood triacylglycerol greater than 300 mg/dL
* Hemoglobin less than 11.5 g/dL
* Hypertension, blood pressure greater than 140/90 mmHg
* Follow a vegetarian diet
* Smoke or use tobacco products
* Drink more than one alcoholic beverage per day
* Taking cholesterol-lowering or blood pressure medication
* Daily or regular use of antihistamines
* Use of nonsteroidal anti-inflammatory drugs (NSAIDs)
* Use of steroids for asthma or other inflammatory diseases
* Use of thyroid-regulating drugs
* Use of over the counter weight loss products
* Known allergies or sensitivities to food ingredients in the test meals
* Taking fish or algal oil supplements and unwilling to stop
* Pregnant and lactating women
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
|
NCT01594008
|
{
"brief_title": "The Effects of Antioxidants in Blueberry Powder on Inflammation Induced by a Single High Fat Meal.",
"conditions": [
"Inflammation"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01594008",
"official_title": "Does Blueberry Intake Alleviate Postprandial Lipemia-induced Inflammation?",
"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)": "2012-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-24",
"last_updated_that_met_qc_criteria": "2012-05-04",
"last_verified": "2013-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-08",
"first_submitted": "2012-05-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
During the past several years，MCE（magnet controlled endoscopy）has made great process in detecting lesions of gastric as well as screening. Compared with conventional endoscopy, magnetically controlled capsule endoscopy can be further optimized in gastric examination. So we make an AI for operators to help improve the quality of MCE and record the mucosa visibilty of gastirc.
Detailed Description
We developed a new artificial intelligence for quality improving during the operation of magnet controlled endoscopy. The AI can help operators screen every part of gastric and then evaluate the visibilty of gastic. Also, It can be record time of the opration. Other than that ,we compared the performancce of AI with experts.
#Intervention
- OTHER : AI-Box
- AI-box is a system fixed adjacent to magnet controlled capsule endoscopy. Patients who accept the check of magnet controlled capsule endoscopywill be enrolled .
|
#Eligibility Criteria:
Inclusion Criteria:
* patients between 18 and75
* patients who can sign informed consent
Exclusion Criteria:
* patients who are unsuitable to accept the check
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
|
NCT04278196
|
{
"brief_title": "Computer Assisted Quality-monitoring for Magnet-controlled Capsule Endoscopy: a Prospective Case-control Study.",
"conditions": [
"Magnet Controlled Capsule Endoscopy"
],
"interventions": null,
"location_countries": [
"China"
],
"nct_id": "NCT04278196",
"official_title": "Computer Assisted Quality-monitoring for Magnet-controlled Capsule Endoscopy: a Prospective Case-control Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-10-01",
"study_completion_date(actual)": "2020-11-30",
"study_start_date(actual)": "2020-01-01"
},
"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)": "2021-05-11",
"last_updated_that_met_qc_criteria": "2020-02-19",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-20",
"first_submitted": "2020-02-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to find out if androgen deprivation therapy affects insulin, cardiac risk factors such as cholesterol level, and body fat and muscle.
Detailed Description
* This is a non-treatment study. This study has no effect on the care the participant will receive.
* In addition to the participants routine standard medical appointments they will need to make 2 additional outpatient visits for special testing over 12 weeks. These 2 additional outpatient visits will include the following: 1) urine and blood tests, 2) Oral Glucose Tolerance Test (OGTT) 3) Body measurements with a tape measure of your arms, legs, and waist and 4) x-ray evaluations (CT scan and bone density test).
#Intervention
- DRUG : Androgen deprivation therapy
- According to standard medical care
|
#Eligibility Criteria:
Inclusion Criteria:
* Adenocarcinoma of the prostate, clinical stage M0
* About to initiate GnRH agonist therapy
* Karnofsky Performance Status 90 or 100
* Serum creatinine < 2.0mg/dl
Exclusion Criteria:
* Hormone therapy within 12 months
* History of diabetes mellitus or glucose intolerance
* Anabolic agents or metabolic agents known to affect insulin or glucose levels
* Prior hormone therapy within the past 12 months and planned hormone therapy during the 12 week study (Group 2)
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00455624
|
{
"brief_title": "Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer",
"conditions": [
"Prostate Cancer"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00455624",
"official_title": "Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-05",
"study_completion_date(actual)": "2006-05",
"study_start_date(actual)": "2002-11"
},
"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)": "2013-07-11",
"last_updated_that_met_qc_criteria": "2007-04-02",
"last_verified": "2013-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-04-04",
"first_submitted": "2007-04-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).
#Intervention
- BIOLOGICAL : Pembrolizumab
- Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
- Other Names :
- KEYTRUDA®
- DRUG : Placebo
- Normal saline or dextrose solution administered as an IV infusion Q3W
- DRUG : Cisplatin
- 100 mg/m\^2 administered as an IV infusion Q3W
- Other Names :
- Platinol®, Platinol®-AQ
- RADIATION : Accelerated Fractionation (AFX) Radiotherapy
- 70 Gray (Gy) given in 35 fractions over 6 weeks
- RADIATION : Standard Fractionation (SFX) Radiotherapy
- 70 Gy given in 35 fractions over 7 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Has a pathologically proven new diagnosis of oropharyngeal p16 positive, oropharyngeal p16 negative, or larynx/hypopharynx/oral cavity (independent of p16) squamous cell carcinoma. Participants with oral cavity tumors need to have unresectable disease. Participants with multiple synchronous tumors are not eligible for the study.
* Has provided tissue for Programmed Cell Death Receptor Ligand 1 (PD-L1) biomarker analysis from a core or excisional biopsy. If an excisional or incisional biopsy has been performed, participants remain eligible for the study provided the residual disease meets the staging criteria required for the trial (e.g., excisional biopsy of a lymph node with residual T4 primary). Prior surgical debulking, including tonsillectomy, for the head and neck cancer under study is not allowed.
* Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan or magnetic resonance imaging, based on RECIST version 1.1
* Is eligible for definitive CRT and not considered for primary surgery based on investigator decision
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days prior to receiving the first dose of study therapy
* Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
* Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy
Exclusion Criteria:
* Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study therapy
* Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-PD-L1, anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in clinical studies with pembrolizumab
* Has received a live vaccine within 30 days prior to the first dose of study therapy
* Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer
* Has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical surgery for head and neck cancer under study
* Has not recovered from major surgery prior to starting study therapy
* Has known active Hepatitis B or C
* Has known history of Human Immunodeficiency Virus (HIV)
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy
* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
* Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.
* Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has had previous allogeneic tissue/solid organ transplant
* Has active infection requiring systemic therapy
* Has a history of severe hypersensitivity reaction to pembrolizumab, Cisplatin or radiotherapy or their analogs
* Is pregnant or breast feeding or expecting to conceive or father children throughout the study period and for up to 180 days after the last dose of study therapy
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
|
NCT03040999
|
{
"brief_title": "Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)",
"conditions": [
"Head and Neck Neoplasms"
],
"interventions": [
"Biological: Pembrolizumab",
"Radiation: Accelerated Fractionation (AFX) Radiotherapy",
"Drug: Cisplatin",
"Radiation: Standard Fractionation (SFX) Radiotherapy",
"Drug: Placebo"
],
"location_countries": [
"Colombia",
"United States",
"Netherlands",
"Germany",
"Poland",
"Austria",
"Czechia",
"United Kingdom",
"France",
"Japan",
"Israel",
"Taiwan",
"Australia",
"Italy",
"Turkey",
"New Zealand",
"Brazil",
"Korea, Republic of",
"Canada",
"Spain",
"Belgium"
],
"nct_id": "NCT03040999",
"official_title": "A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-31",
"study_completion_date(actual)": "2024-08-21",
"study_start_date(actual)": "2017-04-05"
},
"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)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2017-02-01",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-02",
"first_submitted": "2017-02-01",
"first_submitted_that_met_qc_criteria": "2023-05-12"
}
}
}
|
#Study Description
Brief Summary
This study will explore the safety, tolerability and efficacy of litoxetine in men and women who suffer from urinary incontinence
Detailed Description
This is a double blind randomized placebo controlled study which will explore the safety, tolerability and efficacy of oral litoxetine, a highly selective SSRI, provided by dose titration to subjects suffering from urinary incontinence
#Intervention
- DRUG : Litoxetine
- oral study medication provided in a dose titration manner
- DRUG : placebo
- placebo medication provided in a dose titration manner
|
#Eligibility Criteria:
Inclusion Criteria:
All subjects aged 18 to 70 will be eligible for inclusion in this study if all of the following criteria apply:
* Willing to provide written informed consent
* Have symptoms of urinary incontinence for at least 3 consecutive months
* For male subjects: Undergone prostatectomy at least 6 months prior to inclusion
* Have at least 7 incontinence episodes per week in the diary entries for the Screening Placebo Run In Period
* Subject is ambulatory and able to use the toilet independently
* If subjects use pelvic floor exercises, subjects must have been on a stable exercise and activity regime for at least 3 months prior to screening and that regime must remain stable during the treatment period
* Subject has a body mass index (BMI) >= 19 kg/m2 but <= 35 kg/m2 BMI=weight [kg] / height [m2}
* Subjects must have a pre-dose mean systolic/diastolic blood pressure of <= 140/90 mmHg before randomization can occur
* For female subjects: Must not be pregnant, lactating, or actively trying to become pregnant, Subjects who are premenopausal and of childbearing potential must have a negative pregnancy test at Screening (serum) and at Day 0 (urine) and must use a medically acceptable and effective method of birth control for the duration of the study, which can include:
1. Having a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
2. Use of double-barrier methods of contraception; condoms with the use of caps (with spermicide) and intra-uterine devices are acceptable
3. Use of hormonal contraceptives (oral, depots, patches, etc.) with double-barrier methods of contraception as outlined above
4. True abstinence: When this is in line with the preferred and usual lifestyle of the subject (period abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
* Subjects taking oral contraceptives or hormone replacement therapy (women) or hormone adjuvant therapy (men) must have a stable dose and regimen for >= 3 months prior to entry into the study
Exclusion Criteria:
A subject will not be eligible to participate in the study if they meet any of the following criteria:
* History of anti-incontinence surgery in past 12 months
* Use of Botox for the treatment of urinary incontinence in the past 12 months
* Current or recent (3 months) use of any pharmacologic agent used to treat symptoms of urinary incontinence
* For women: Grade III/IV pelvic organ prolapse; defined per clinical practice
* For women: History of pelvic prolapse repair or urethral diverticulectomy within 12 months of Screening.
For men: urethral surgery within 6 months of Screening
* History of interstitial cystitis or bladder-related pain
* Subjects with concurrent (at Screening), recent (within 30 days), chronic, or recurrent (> 4 per year) urinary tract infections (positive dipstick for urinary tract infection and abnormal microscopic evaluation, signs and symptoms) or unevaluated microhematuria
* History of diagnosed gastrointestinal obstructive disorders
* Chronic severe constipation
* History of radiation cystitis or history of pelvic irradiation
* Electrostimulation, biofeedback, or bladder training therapy (behavioural therapy), during the previous month prior to Screening, or the intention to initiate such therapies during the study period. Pessaries and implants are also excluded.
* Postvoid residual (PVR) urine volume > 150 mL
* Diagnosis of dementia
* Diagnosis of epilepsy
* Diagnosis of acute narrow-angle glaucoma
* History of mania or diagnosis of bipolar disorder and/or seizures
* Subjects with uncontrolled hypertension
* Documented history of myocardial infarction, unstable angina, and/or has undergone coronary artery bypass surgery and/or percutaneous transluminal coronary angioplasty in the past year
* Congestive heart failure (New York Heart Association Class III or IV heart failure; Appendix 3)
* Any concurrent condition or any clinically significant abnormality on the Screening physical examination, laboratory tests, electrocardiogram (ECG; including ischemic heart disease), Hepatitis B or C, which, in the opinion of the Investigator, may affect the interpretation of safety or efficacy data, or which otherwise contraindicates participation in a clinical study with litoxetine:
1. Hypersensitivity to litoxetine or any of its ingredients
2. History of clinically significant drug hypersensitivity
3. Subjects with current (within 2 years) urogenital neoplasms or malignancies including bladder, uterine or cervical cancer (not applicable to male subjects with prostate cancer in whom a prostatectomy has been performed)
4. Subjects with neuropathology that could affect the lower urinary tract or nerve supply, including but not limited to multiple sclerosis, stroke, Parkinsonism, or spinal cord injury
5. Subjects with diabetes insipidus
6. Clinically significant or unstable, endocrine, hepatic, renal, immunologic, or lung disease (ie, active chronic obstructive pulmonary disease), or malignancy other than non-melanomatous skin cancer
* Severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73m2)
* Severe hepatic impairment (Child-Pugh B or greater)
* Current or recent (6 months) treatment for depression, or a current diagnosis of depression or have a state of depression or suicidality at Screening.
* History of current or recent (6 months) suicidal ideation and behaviour (SIB), or history of any suicide attempt in the past 12 months.
* History of an addiction to drugs or alcohol within 5 years prior to screening, or of alcohol or substance abuse within the past year, as determined by the Investigator. 26. Current use of the following medications:, any serotonergic medication, nonselective irreversible monoamineoxidase inhibitors (MAOIs), cytochrome P450 (CYP)1A2 inhibitors (such as fluvoxamine, ciprofloxacin, or enoxacin), cytochrome P450 (CYP) 2D6 inhibitors (bupropion, fluoxetine, metoclopromide, paroxetine, quinidine), pimozide and thioridazine, and any other medication that would be considered a safety risk for co-administration with litoxetine (See Section 5.7.2 Prohibited Medications)
* Participation in a clinical study within the month prior to Screening, or exposure to an investigational drug which has not washed out for at least 5 half-lives since its last administration, prior to Screening.
* In the opinion of the Investigator, is at risk of non-compliance with study procedures, or cannot read, understand, or complete study-related materials (including electronic diaries), particularly informed consent.
* Participation in any clinical study of an investigational drug that may affect urinary function within 3 months prior to Screening
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
|
NCT03397771
|
{
"brief_title": "DBPC Trial to Evaluate the Safety, Tolerability and Efficacy of Oral Litoxetine in Subjects With Urinary Incontinence",
"conditions": [
"Urinary Incontinence"
],
"interventions": [
"Drug: Litoxetine",
"Drug: placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03397771",
"official_title": "A Double-Blind Randomised Placebo-Controlled Phase I/IIa Dose Titration Trial to Evaluate the Safety, Tolerability and Efficacy of Oral Litoxetine up to 30 mg vs Placebo BID in Subjects With Urinary Incontinence",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-30",
"study_completion_date(actual)": "2019-05-30",
"study_start_date(actual)": "2018-04-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-06-11",
"last_updated_that_met_qc_criteria": "2018-01-05",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-12",
"first_submitted": "2017-12-20",
"first_submitted_that_met_qc_criteria": "2020-06-09"
}
}
}
|
#Study Description
Brief Summary
The percentage of hypertension among adults aged 18 is relatively high which is about 30% in Malaysia. Uncontrolled hypertension will increase the risk of diseases especially cardiovascular disease. However, adults still lack awareness about the importance of knowledge of hypertension. In between, online health information seeking and the use of social media to gather health information have been quite a norm among students. The wide use of this platform has been proven in various researches and studies.
This study will be conducted among the undergraduate students in FMHS, UPM to look at the various socio-demographic factors associated with their level of knowledge on hypertension. Therefore, this may lead to a need to plan awareness programs on hypertension and to increase the knowledge of hypertension among health science students in the future. A cross-sectional study design will be done for this study. All undergraduate students in FMHS, UPM will be selected through simple random sampling. Online questionnaires will be given via the selected student email platform.
However, there are limitations for this study where we only focus on the students of FMHS, UPM. Hence, the results of this study may be limited to them only. The causal relationship cannot be determined by this study design as well. The purpose of this study is to determine the social media use, online health information seeking practices with knowledge on hypertension among undergraduate students in FMHS, UPM, and its associated factors
Detailed Description
BACKGROUND Hypertension is a medical condition that acts as an important public health problem worldwide. It contributes to the disease which is mostly seen in primary health care settings such as cardiovascular disease, stroke, kidney failure, and premature death if it is not diagnosed as soon as possible. The World Health Organization (WHO) significantly mentions that an estimation of 1.13 billion people worldwide from poor countries where the healthcare system is weak have been detected with hypertension. Hypertension also puts an enormous financial pressure towards individuals and medical services via utilizing limited resources . Hypertension is predisposed to multiple factors. Such factors vary from country to country and there is also a disparity between urban and rural areas of the same location.
In Malaysia, 30% of adults above 18 have hypertension. Based on another study, it was proven that adults with uncontrolled hypertensive portrayed a higher risk of CVD mortality when compared to normotensive adults. It was reported that there were 3550 of them all caused hypertensive death and based on that 1027 are caused by cardiovascular disease; 771 are caused by heart-specific diseases and 256 by a cerebrovascular specific disease. However, untreated hypertension was stated to be the high risk of all caused death.
Based on a study by Grad I. et al, global knowledge on hypertension among adults is relatively low which is almost 49.2%. Whereas for medium knowledge on hypertension has 38% and only reported that 13% has higher knowledge on hypertension
. Besides, adults also have insufficient knowledge on epidemiology, method of treatment, and avoidance of hypertension(6).In addition, a good understanding of hypertension has also been linked with enhanced compliance with medications and good control of blood pressure.
According to Loiselle (1995), health information behavior is basically defined as a self-regulatory technique used by patients to coordinate transactions between self-related and health-related settings with the goal of balancing instrumental benefits and informative subjective costs. The students use electronic health knowledge to take some essential health-related decisions and actions. Students reported using the health details gathered more as a guide for lifestyle changes (72.4%) and the rest is dealing with healthcare practitioners online about the change in medication and guide of lifestyle changes.
WHO states that many people, primarily in the developing world, have access to online medical information, engage in online groups, buy well-being goods and services.
From the other side, hospital reports are often linked up by health agencies. The search for online health information has been on the increase and the knowledge gained has diverse influences on the healthcare outcomes of human beings. Based on a study conducted on 4504 respondents about mobile health use and perception among Malaysians in Selangor, only 1 in 5 respondents reported using some health-related application or mobile health device. The analysis of the health details that Malaysia is pursuing is still limited. From the point of view of scientific research, not much study has been done on different problems that occurred in the sense of finding health knowledge.
One of the interventional strategies to the elimination of health inequalities is by utilizing social media as a popular way to get health information. Depending on the concepts of loyalty and mutuality, social media promotes the sharing of life-enhancing services, such as health-related knowledge and social ties. In fact, social media sites are activating feedback systems that result in an enhanced degree of self-efficacy, which is vital in sustaining healthier behaviors and adhering to treatment. It becomes a mixture of direct contact and mainstream media which is personalized and responsive. Social networking media, including Facebook, one of the social media networking platforms, has such connectivity features in their architecture. As of 2004, it has been extremely popular with more than 350 million users around the world.
Non-communicable diseases constitute a worldwide crisis that contributes to more than 36 million (63 %) of all mortality globally. Almost 29 million (80%) of such deaths arise in low-and middle-income nations. Increasing use of social media implies a strategy to achieve scalability or even overcome barriers that often impede public health measures. For example, a smartphone-based home glucose monitoring service has been implemented through which community health professionals have given clinical advice for diabetic patients through smartphones.
The social media use, health information seeking, and knowledge on hypertension in Malaysia are not well studied. It is beneficial to have an overview of the social media use, health information seeking and knowledge on hypertension among the students of Faculty of Medicine and Health Science (FMHS), UPM because they are individuals who will work in a healthcare setting in the near future.
In conclusion, knowledge of hypertension is relatively very important to reduce the prevalence of hypertension and to create more awareness among the public. Ways of getting knowledge and online health information like social media are important as it is becoming a popular form of information. This study will be conducted among the students in FMHS, UPM because of the variety of sociodemographic factors present that will be a platform to see the association between the factors and their level of knowledge on hypertension. Moreover, this may be a good start to plan an awareness program on Hypertension and also initiate programs to increase the knowledge of hypertension among the students.
STUDY OBJECTIVE General Objective To determine the social media use, online health information seeking and knowledge on hypertension among students in FMHS, UPM.
Specific Objective I. To determine the socio-demographic factors (age, gender, race, family income status, undergraduate course and year of study) of students of FMHS, UPM. II. To determine the social media use of students among FMHS, UPM. III. To determine the online health information-seeking behavior on hypertension among students of FMHS, UPM. IV. To determine the level of knowledge on hypertension among students of FMHS, UPM. V. To study the association of socio-demographic factors, social media use and online health information seeking on the knowledge of hypertension.
STUDY INSTRUMENTS Study instruments include a questionnaire adapted from a previously published questionnaire. The questionnaire to assess the social media use and health information seeking was adapted from a study about Health Information Seeking and Social Media Use on the Internet among people with Diabetes. The hypertension knowledge questionnaire was adapted from a tool developed to assess hypertension knowledge among urban patients. This questionnaire is prepared in English and is divided into four parts.
|
#Eligibility Criteria:
Inclusion Criteria:
All undergraduate students in the Faculty of Medicine and Health Science (FMHS), Universiti Putra Malaysia (UPM).
Exclusion Criteria:
* Students who are on long leave
* Students who have dropped out of the course.
* Students who are acutely unwell
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04451876
|
{
"brief_title": "Social Media Use ,Online Health Information Seeking and Knowledge on Hypertension",
"conditions": [
"Hypertension",
"Knowledge, Attitudes, Practice",
"Social Behavior"
],
"interventions": null,
"location_countries": [
"Malaysia"
],
"nct_id": "NCT04451876",
"official_title": "Social Media Use ,Online Health Information Seeking and Knowledge on Hypertension Among Undergraduate Students of Faculty of Medicine and Health Sciences (FMHS), Universiti Putra Malaysia (UPM)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-24",
"study_completion_date(actual)": "2020-10-30",
"study_start_date(actual)": "2020-08-17"
},
"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)": "2020-11-10",
"last_updated_that_met_qc_criteria": "2020-06-25",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-30",
"first_submitted": "2020-06-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The increase in the tension of the soft tissues around a nerve restricts the movement, affects the function of the nerve, and makes the nerve vulnerable to entrapment. Even a mild nerve compression can cause entrapment and lead to neuroinflammation. It is known that inflammatory mediators amplify axonal sensitivity. Although the spontaneous discharge potential of visceral afferents is quite low under normal conditions, neuroinflammation increases the excitability of these fibers. With this mechanism, hyperalgesia may develop in sensory fibers in neuroinflammation. This may cause pathologies in the organs innervated by the relevant nerve.
The fascia and muscles of the cervical region surround the vagus nerve. There are two main fascial compartments in the cervical region. The SCM and trapezius muscle fascias join to the most superficial fascia of the deep cervical fascia and they together form these compartments. These fasciae superiorly attach to the cranium and inferiorly to the pectoral region. The vagus nerve emerges from the jugular foramen together with the 9th and 11th cranial nerves. It then continues through the carotid sheath in the cervical region. The carotid sheath is in contact with the SCM muscle. For this reason, it can be thought that SCM muscle tension or thickness may affect the carotid sheath and thus the function of the vagus nerve passing through it.
In summary, deterioration in vagus nerve activity plays a role in pathologies of the organs innervated by the vagus. Although the relationship between vagal dysfunction and gastrointestinal system symptoms is clear, the mechanisms affecting vagus nerve function have not yet been clarified. It has been reported in the literature that some maneuvers from the cervical region are also effective on the vagus nerve. Also, according to investigators' clinical experience, gastrointestinal symptoms are frequently observed in patients with increased cervical soft tissue tension. However, there are not enough studies investigating whether the cervical region soft tissue tension can affect the gastrointestinal system via the vagus nerve. Therefore, this study was planned to examine the relationship of cervical soft tissue tension with vagus nerve function and gastrointestinal symptoms in asymptomatic individuals and individuals with neck pain.
#Intervention
- OTHER : VAGUS-NDT
- Neurodynamic test for vagus nerve
|
#Eligibility Criteria:
Inclusion Criteria:
* Being 18 <= age <= 50 of age,
* Having less than 30 body mass index,
* Being a volunteer
Exclusion Criteria:
* Having any type of malign disease,
* Being diagnosed with a systemic disease (cardiologic, gastrointestinal, rheumatological, neurological, etc.),
* Having any type of surgery within the last 6 months,
* Being diagnosed with Whiplash syndrome
* Having an unhealed fracture
* Pregnancy
* Using prescribed medicine for the gastrointestinal system
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
|
NCT05325879
|
{
"brief_title": "Relationship of Cervical Region Tension With Vagal Function",
"conditions": [
"Gastrointestinal Diseases",
"Autonomic Nervous System Disease"
],
"interventions": [
"Other: VAGUS-NDT"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05325879",
"official_title": "Investigation of the Relationship of Cervical Region Tension With Vagal Function and Gastrointestinal Symptoms",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-15",
"study_completion_date(actual)": "2023-09-15",
"study_start_date(actual)": "2022-08-15"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-18",
"last_updated_that_met_qc_criteria": "2022-04-06",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-13",
"first_submitted": "2022-04-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a research study to look at how Dichloroacetate (DCA), and investigational drug and chloral hydrate are broken down in the body. The purpose of the study is to better understand how humans metabolize these two common chemicals that are widely present in the environment. The study focuses on how the drug chloral hydrate is broken down and how it effects DCA
Detailed Description
The subject's general health is assessed by a history and physical exam and routine blood work. I normal the individual undergoes five nights of receiving 1.5ug/kg of chloral hydrate. On day 6 the individual receives 2.5 micrograms/kg of Dichloroacetate (DCA) and kinetics are drawn. After 30 days the subject comes back and receives 1.5ug/kg of chloral hydrate for five nights and has kinetics drawn on night one and five. On days 6-9 the subject returns for a blood draw. After 30 days the same process as above is done except the subject receives 1gram of chloral hydrate for five nights and 25mg/kg of Dichloroacetate one day then 30 days later the subject receives 1gram of chloral hydrate for five nights and has kinetics done on night one and five and blood samples drawn on days 6-9
#Intervention
- DRUG : Dichloroacetate environmental dose
- On day 6 they receive Dichloroacetate 2.5 ug/kg orally times 1 and have pharmacokinetics.
- Other Names :
- DCA
- DRUG : Chloral Hydrate environmental dose
- Study subjects are given 1.5 ug/kg of Chloral Hydrate for 5 nights and pharmacokinetics are done on night 1 and 5.
- DRUG : Dichloroacetate therapeutic dose
- Subjects receive 25 mg/kg DCA on Day 6. Pharmacokinetics are done on nights 1 and nights 5.
- Other Names :
- DCA
- DRUG : Chloral Hydrate therapeutic dose
- Subject is given 25 mg/kg of Chloral Hydrate for five nights.
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy
* normal screening labs
Exclusion Criteria:
* no gastrointestinal surgery
* no smoking
* no medication
* not pregnant
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01128270
|
{
"brief_title": "Pharmacotoxicology of Trichloroethylene Metabolites",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Dichloroacetate therapeutic dose",
"Drug: Chloral Hydrate environmental dose",
"Drug: Dichloroacetate environmental dose",
"Drug: Chloral Hydrate therapeutic dose"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01128270",
"official_title": "Pharmacotoxicology of Trichloroethylene Metabolites Aim 3",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-10",
"study_completion_date(actual)": "2012-10",
"study_start_date(actual)": "2010-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-05-07",
"last_updated_that_met_qc_criteria": "2010-05-20",
"last_verified": "2014-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-21",
"first_submitted": "2010-05-20",
"first_submitted_that_met_qc_criteria": "2014-04-08"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess whether methylphenidate affects time of emergence from isoflurane general anesthesia. Time to emergence was defined as the time from termination of isoflurane to extubation. After stopping isoflurane infusion, when the patient breaths spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.
Detailed Description
Based on this significant arousal stimulatory effect, the investigators hypothesize that methylphenidate (inhibitor of dopamine and norepinephrine transporters) decreases the emergence time from isoflurane general anesthesia.
PRIMARY OBJECTIVE:
To assess whether methylphenidate affects time of emergence from isoflurane general anesthesia. Time to emergence was defined as the time from termination of isoflurane to extubation. After stopping isoflurane infusion, when the patient breaths spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.
SECONDARY OBJECTIVES:
* To assess the efficacy of methylphenidate in preventing post operative nausea and vomiting (PONV) by limited opioids consumption: PONV verbal response scale on a 0 to 10 verbally elicited scale: 0 (no nausea) to 10 (nausea as bad as it could be)
* To assess the efficacy of methylphenidate in preventing opioids dose escalation (fast cognitive improvement with efficient pain control -Postoperative Pain Numeric Rating Scale: O=None; (1-3)=Mild; (4-6)= Moderate; (7-10)=Severe).
Study Population: Adult patients at Ohio State University Wexner Medical Center - Sports Medicine, aged between 18-65 years, with an American Society of Anesthesiologists (ASA) physical status of I (normal healthy patient) or II (patients with mild systemic disease; no functional limitation) who are scheduled to undergo hip arthroscopic surgery - same day discharge - under isoflurane general anesthesia.
Single-center, prospective, randomized, double-blind, placebo-controlled trial involving 54 subjects scheduled to undergo arthroscopic orthopedic surgery under isoflurane general anesthesia at The Ohio State University Wexner Medical Center (OSUWMC) - University Hospital East. Eligible subjects that provide voluntary and written informed consent will be included in this study.
#Intervention
- DRUG : Methylphenidate HCl
- Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)
- Other Names :
- Concerta, Daytrana, Methylin, Ritalin
- DRUG : Placebo
- 20 mg of placebo (PO) will be given 2 hours prior to surgery
- Other Names :
- Placebo (PO)
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 <= age <= 65 of age
* ASA I or II
* Capable and willing to consent
* Participants literate in English language
Exclusion Criteria:
* ADHD with current use of methylphenidate
* Hypersensitivity to methylphenidate
* ASA III, IV or V
* Patients with severe visual or auditory disorder
* Illiteracy
* Presence of a clinically diagnosed anxiety, agitation, major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
* Tics or Tourette's syndrome
* Glaucoma
* Hypertension, history of atrial arrhythmias (atrial fibrillation, atrial flutter), myocardial infarction
* Taking or have taken within the past 14 days a monoamine oxidase inhibitor or MAOI (Selegiline)
* Subjects who have participated or are currently participating in a clinical trial of an investigational drug within 30 days prior to surgery
* Any condition, which in the opinion of the investigator would make subject ineligible for participation in the study such as history of unstable cardiovascular, pulmonary, renal, hepatic, neurologic (seizures), hematologic or endocrine abnormality (hyperthyroidism, unstable Diabetes type I/II)
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
|
NCT02327195
|
{
"brief_title": "General Anesthesia Emergence Induced by Methylphenidate",
"conditions": [
"Delayed Emergence From Anesthesia"
],
"interventions": [
"Drug: Placebo",
"Drug: Methylphenidate HCl"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02327195",
"official_title": "Active Emergence of From Isoflurane General Anesthesia Induced by Methylphenidate",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-01",
"study_completion_date(actual)": "2018-01",
"study_start_date(actual)": "2014-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-12",
"last_updated_that_met_qc_criteria": "2014-12-23",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-30",
"first_submitted": "2014-12-16",
"first_submitted_that_met_qc_criteria": "2022-03-02"
}
}
}
|
#Study Description
Brief Summary
1. ry outcome includes the correlation between lymphocyre /neurtophll ratio (LNR) and mortality rate during hospital stay in the ICU admitted COVID 19 patients.
2. ry outcome(s) include the LNR and its correlation with ICU stay, the need for mechanical ventilation, renal impairment.
Detailed Description
In December 2019,the COVID-19 virus has been mainly breaking out in Wuhan in China as pneumonia affecting patients . Common clinical features During hospitalization started to appear including acute respiratory infection , inflammatory reaction , fever, pneumonia, cough, fatigue , anosmia .
The patient known suspected if he has a clinical picture of viral pneumonia, exposure history, and radiographic findings \[CT\] or \[MRI\] chest consistent with COVID-19 pneumonia. the gold standard and the Final diagnosis (PCR) positivity for the presence of coronavirus .
The immune response to respiratory infection causes neutrophils to collect inside the lung especially the alveoli. Neutrophils aggregation may lead to collateral tissue damage and cytotoxicity. According to Previous studies apoptosis of lymphocytes occurred due to the release of anti-inflammatory cytokines resulting in lymphopenia. high levels of circulating neutrophils have been demonstrated in COVID-19 patients(
A lot of literatures and studies have demonstrated the value of what is called neutrophil/ lymphocyte ratio (LNR) as a simple prognostic ratio correlated to morbidity and mortality. Up to our knowledge, there is no study utilized such ratio in COVID-19 ICU admitted patients, so that, this study has been built
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients (aged >=18 years)
* Patients who need non-invasive ventilation (NIV or CPAP) or invasive ventilation (intubation)
Exclusion Criteria:
* Previous diagnosis of severe liver or kidney failure.
* Patients with Human Immunodeficiency Virus (HIV) infection.
* Patients with previous hematological diseases (Leukemia) that condition alterations in blood counts.
* Consumption of treatments with any type of immunosuppressants prior to admission that conditions low lymphocytes.
* Patients with bone marrow depression.
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
|
NCT04817397
|
{
"brief_title": "The Lymphocyte/Neutrophil Ratio as a Prognostic Index for Short Term Outcome in the ICU Admitted COVID-19 Adult Patients",
"conditions": [
"Covid19"
],
"interventions": null,
"location_countries": [
"Egypt"
],
"nct_id": "NCT04817397",
"official_title": "The Lymphocyte/Neutrophil Ratio as a Prognostic Index for Short Term Outcome in the ICU Admitted COVID-19 Adult Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-07-30",
"study_completion_date(actual)": "2021-08-30",
"study_start_date(actual)": "2021-03-20"
},
"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)": "2021-10-12",
"last_updated_that_met_qc_criteria": "2021-03-25",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-26",
"first_submitted": "2021-03-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.
#Intervention
- DRUG : Cisplatin + etoposide
- Cisplatin 90 mg/m² day 1, every 3 weeks
Etoposide 100 mg/m² days 1-3, every 3 weeks
- DRUG : Epirubicin + ifosfamide + etoposide
- Epirubicin 60 mg/m² day 1, every 3 weeks
Ifosfamide (+ uromitexan) 1.5 g/m² days 1-3, every 3 weeks
Etoposide 100 mg/m² days 1-3, every 3 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological diagnosis of small-cell lung cancer
* Extensive disease (i.e. a disease with distant metastases or that cannot be included in a single irradiation field incorporating primary tumour, mediastinum and supraclavicular lymph node(s))
* Availability for participating in the detailed follow-up of the protocol
* Presence of an evaluable or measurable lesion
* Informed consent
Exclusion Criteria:
* Prior treatment with chemotherapy, radiotherapy or surgery
* Performance status < 60 on the Karnofsky scale
* A history of prior malignant tumor, except non-melanoma skin cancer or in situ carcinoma of the cervix or a cured cancer (defined as a disease-free interval > 5 years)
* White blood cells < 4000/mm3
* Platelets < 100000/mm3
* Serum bilirubin > 1.5 mg/100 ml
* Serum creatinine > 1.3 mg/100 ml and creatinine clearance <60 ml/min
* Recent myocardial infarction (less than 3 months prior to date of diagnosis)
* Congestive cardiac failure or cardiac arrhythmia uncontrolled by medical treatment
* Uncontrolled infectious disease
* Serious medical or psychological factors which may prevent adherence to the treatment schedule
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
|
NCT00658580
|
{
"brief_title": "Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer",
"conditions": [
"Small Cell Lung Carcinoma, Extensive Disease"
],
"interventions": [
"Drug: Cisplatin + etoposide",
"Drug: Epirubicin + ifosfamide + etoposide"
],
"location_countries": [
"France",
"Spain",
"Belgium",
"Greece"
],
"nct_id": "NCT00658580",
"official_title": "A Phase III Randomized Study Comparing A Chemotherapy With Cisplatin And Etoposide To A Etoposide Regimen Without Cisplatin For Patients With Extensive Small-Cell Lung Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-12",
"study_completion_date(actual)": "2015-02",
"study_start_date(actual)": "2000-04"
},
"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)": "2015-02-12",
"last_updated_that_met_qc_criteria": "2008-04-14",
"last_verified": "2015-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-04-15",
"first_submitted": "2008-04-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older . The objective of the study is to evaluate the safety and tolerability of PCV24. The trial is a single-center, randomized, blind,parallel-controlled design I clinical trial.
Detailed Description
Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older. The objective of the study is to evaluate the safety and tolerability of PCV24. The active control vaccine is a 23-valent pneumococcal polysaccharide vaccine (23-valent pneumococcal polysaccharide vaccine, PPSV23) produced by the Chengdu Institute of Biological Products. The placebo is aluminum phosphate adjuvant (aluminum content 0.25mg/dose), sodium chloride, succinic acid, polysorbate 80, and water for injection except for antigen components in 24-valent pneumococcal polysaccharide conjugate vaccine developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Vinorelite Biopharmaceutical Co., Ltd.
A total of at least 240 participants will be enrolled, including 84 adults aged 18-60years and 120 elderly people aged ≥61 years. Participants will be randomized in a 1:1:1:1 ratio to receive one dose of PCV24 formulation 1, PCV24 formulation 2, PPSV23 or placebo.
#Intervention
- BIOLOGICAL : Reinovax PCV24 formulation 1
- One dose of Reinovax PCV24 formulation 1（0.5mL）
- BIOLOGICAL : Reinovax PCV24 formulation 2
- One dose of Reinovax PCV24 formulation 1（0.5mL）
- BIOLOGICAL : PPSV23
- One dose of PPSV23 (0.5 mL) contains 1、2、3、4、5、6B、7F、8、9N、9V、10A、11A、12F、14、15B、17F、18C、19A、19F、20、22F、23F and33F saccharides.
- BIOLOGICAL : Placebo
- One dose of 0.5 mL placebo is aluminum phosphate adjuvant (aluminum content 0.25mg/dose), sodium chloride, succinic acid, polysorbate 80, and water for injection except for antigen components in 24-valent pneumococcal polysaccharide conjugate vaccine
|
#Eligibility Criteria:
Inclusion Criteria:
* Volunteers over the age of 18 on the day of screening, and can provide legal identification;
* Informed consent must be obtained from the volunteer and signed informed consent form;
* Volunteers are able and willing to comply with the requirements of the clinical trial protocol and can attend all visits;
* Armpit body temperature <= 37.0 °C on the day of enrollment.
Exclusion Criteria:
* Previous pneumococcal vaccination, or history of invasive disease caused by pneumococcal in the past;
* Have any previous history of severe allergies to vaccines or drugs, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Athus reaction), etc.;
* Have been diagnosed with congenital or acquired immunodeficiency, or have recently received immunosuppressant therapy, such as systemic glucocorticoid therapy such as prednisone or similar drugs > 5 mg/day for more than 2 consecutive weeks in 1 month before vaccination (Note: the use of topical and inhaled/nebulized steroids can participate);
* Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (when measured on site: systolic blood pressure >= 160 mmHg, diastolic blood pressure >=100 mmHg), etc.;
* Suffering from acute febrile illness or infectious diseases, such as tuberculosis, viral hepatitis, etc.;
* History of nervous system damage, severe congenital malformations, severe developmental disabilities, severe genetic defects, severe malnutrition, etc.;
* Have a history or family history of epilepsy, encephalopathy, or psychiatric disorders;
* Those who have been diagnosed with thrombocytopenia, any abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities, etc.) or contraindications to intramuscular injection such as anticoagulant therapy;
* asplenia, functional asplenia, and asplenia or splenectomy due to any cause;
* Suffering from severe chronic diseases or conditions that cannot be controlled smoothly in the advanced stage, such as diabetes, thyroid disease, etc.;
* Have received blood or blood-related products or immunoglobulins within 3 months;
* Received live attenuated vaccine within 14 days;
* Received other vaccines within 7 days;
* Received other investigational drugs or vaccines within 1 month;
* Is participating in or plans to participate in clinical studies of other drugs or vaccines during the study period;
* Any other condition that, in the opinion of the investigator, may interfere with the study evaluation;
* Those who have abnormal laboratory tests such as blood routine, blood biochemistry, and urine routine that are clinically significant and cannot be enrolled according to the comprehensive judgment of the investigator;
* Exclusion Criteria for Partial Populations:
Females of childbearing potential (18~49 years): positive urine pregnancy test on the day of enrollment, lactation, or pregnancy plans within 6 months.
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
|
NCT06678607
|
{
"brief_title": "Phase I Clinical Trial of PCV24 in People Aged 18 Years and Older",
"conditions": [
"Pneumococcal Infectious Disease"
],
"interventions": [
"Biological: PPSV23",
"Biological: Reinovax PCV24 formulation 2",
"Biological: Reinovax PCV24 formulation 1",
"Biological: Placebo"
],
"location_countries": [
"China"
],
"nct_id": "NCT06678607",
"official_title": "Phase I Clinical Trial to Evaluate the Safety and Tolerability of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-07-28",
"study_completion_date(actual)": "2024-07-28",
"study_start_date(actual)": "2023-11-19"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-07",
"last_updated_that_met_qc_criteria": "2024-11-05",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-11-07",
"first_submitted": "2024-11-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
People of low socioeconomic status are more inclined to incur poor health than those of high socioeconomic status. Different factors have been attributed to contributing to such health inequalities, including differences in modifiable lifestyle factors. For example, people of high socioeconomic status are more likely to engage in greater levels of physical activity, and are more inclined to adhere and take up population-level behaviour change interventions. Subsequently, there has been a call to create more targeted interventions designed to especially target people with low socioeconomic status.
Socioeconomic status represents availability and access to resources, and measures that are broadly divided into individual measures such as income, education and occupational status, and area-level or neighbourhood deprivation measures. However, while socioeconomic status is a multifaceted concept, there is a tendency in research to use a single measure (such as either income or education level) interchangeably to capture the full scope of socioeconomic status. This is based upon the assumption that one socioeconomic measure taps into the underlying features of another aspect of socioeconomic status, despite little being known about the effect each socioeconomic status measure has upon physical activity intervention outcomes.
Therefore the purpose of this study is to consider the effect the different measures of socioeconomic status, specifically income, occupational status, education and area deprivation, have upon the effectiveness of an established implementation intentions-based intervention (the volitional helpsheet) designed to increase physical activity.
Detailed Description
Detailed Description A health gap exists such that people of low socioeconomic status are more inclined to incur poor health than those of high socioeconomic status (Marmot, 2005). Differences in modifiable lifestyle factors between high- and low-socioeconomic groups, such as differences in physical activity levels, have been implemented in contributing to this health gap. Additionally, interventions created to redress this health gap can unintentionally have the reverse effect of increasing health inequalities as more affluent individuals are more likely to take up and adhere to behaviour change interventions, thus creating intervention-generated inequalities (White et al., 2009). Subsequently, there has been an increased call for interventions designed to promote healthy lifestyle behaviours, including physical activity, to be targeted towards specific groups of individuals including people with low-socioeconomic status (White et al., 2009). However, socioeconomic status is typically operationalised using a single measure such as educational status, yet socioeconomic status represents availability of and access to resources (Psaki et al., 2014), including those that access physical activity.
Socioeconomic measures can broadly be categorised as individual level factors, such as income, education and occupation, and area-level indicators or neighbourhood deprivation indices (Galobardes et al., 2006a, 2006b) such as the Index of Multiple Deprivation. While each measure captures a specific aspect of socioeconomic status, having its own relative strengths and limitations, there is a tendency in research to use a single measure (such as either income or education level) interchangeably to capture the full scope of socioeconomic status (Geyer et al., 2006). This is based upon the assumption that one socioeconomic measure taps into the underlying features of another aspect of socioeconomic status, despite little being known about the effect each socioeconomic status measure has upon physical activity intervention outcomes.
The purpose of this study is to consider the effect the different measures of socioeconomic status, specifically income, occupational status, education and area deprivation, have upon the effectiveness of an established implementation intentions-based intervention (the volitional help sheet) designed to increase physical activity and which has been shown to increase physical activity among manual workers (Armitage \& Arden, 2010).
This study will seek to address the following research questions;
1. Does the volitional help sheet (VHS) increase gym attendance among new gym registrants?
2. Does the way in which socioeconomic status is measured moderate the effects of the volitional help sheet on gym attendance between low and high -income, - education, -occupation and -area deprivation groups?
Method A two-armed randomised controlled trial design was used. Participants were randomised into either the intervention or control condition using an online random number generator.
Participants A sample size calculation was conducted using evidence from Belanger-Gravel et al., (2013) in their meta-analysis examining the effects of implementation intentions on physical activity. Assuming an effect size of 0.24 (α = 0.05), the study was powered to 90%, giving a desired sample size of 786 participants (384 participants per group). However, the desired sample size was not achieved. Subsequently, a total of 118 adult participants (aged 18 years or older) were recruited from leisure centres in deprived areas of a city located in the North West of England. The final total sample size was 98 due to issues associated with missing values of some key socioeconomic status variables.
Procedure New leisure centre members were invited to take part in the study by either the researcher or a staff member. Each participant was provided with a participant information sheet, and asked to complete a consent form before completing the questionnaire which had been randomised in advance. It was explained to each participant in writing that their gym attendance was be tracked for 12-months using their electronic gym entry swipes. Each questionnaire was identical, differing only in the instructions on how to complete the volitional help sheet.
Intervention The volitional help sheet is a psychological tool based on implementations intentions, which helps the formation of 'if-then' plans. This helps individuals to translate motivation into behavioural action. 'If-then' plans are created when an individual links a critical situation in memory ('if') with an appropriate behavioural response ('then') (Armitage and Arden, 2010). In this way 'if-then' plans enable an individual to automatically initiate the specified behavioural response when the environmental cue is encountered (Armitage and Arden, 2010). The volitional help sheet is comprised of two lists; one of critical situations that challenge participants to being physically active (e.g. 'If I'm tempted not to go to the gym because it's cold outside'), and the other appropriate behavioural solutions (e.g. 'then I will make myself go to the gym anyway because I know I will feel better afterward'. In the present study, the intervention group participants are required to draw a line to between relevant critical situations and solutions to create 'if-then' plans. The control group receive the exact same volitional help sheet, the only difference being that participants are instructed to tick relevant critical situations and solutions.
Measures Demographic information including gender, age and ethnicity was taken in addition to the following measures.
Gym attendance - Gym attendance for each participant was measured electronically by tracking gym entry swipes. Gym attendance was obtained for 12-months from when the baseline questionnaire was completed. As each participant is required to attend a mandatory induction session to access the gym suite, this session was discounted from the total attendance.
Physical activity - The short form International Physical activity Questionnaire (IPAQ-SF) (Craig et al., 2003) was used to obtain a self-reported measure of physical activity.
The following socioeconomic status measures were taken; Area deprivation - Each participants post-code was used to obtain an area deprivation score using the English Indices of Multiple Deprivation (IMD, 2015) which was then grouped to obtain a decile ranking.
Household Income - was assessed using the Living Costs and Food survey (LCFS, 2014). Accordingly, participants were asked to select which income band from eleven represents there household income. Income bands increase by £100 increments and range from 'Less than £100 per week' to 'Over £1000 per week'.
Occupational Status - An adapted version of the National Statistics Socioeconomic Classification NS-SEC method (NS-SEC 2010) was used to obtain a measure of occupational status for each participant. Participants were initially asked to indicate their employments status from six options including 'employed', 'self-employed' and 'student', and to state their most recent or current job role and what it entails. Participant job titles were then mapped onto the NS-SEC coding framework to derive an occupation code, which was used to establish an NS-SEC analytic and operational category for each participant.
Education - was measured using the qualification questions obtained from the UK Census 2011. Participants were required to indicate, from a list of qualifications ('1 - 4 O levels / CSEs / GCSEs (any grade), Entry Level, Foundation Diploma', 'Apprenticeship', 'Degree (for example BA, BSc), higher degree (for example MA, PhD, PGCE' and 'No qualifications') every qualification that applied to them from the list. Participants were instructed to tick the nearest equivalent qualification if their UK qualification was not listed. For those participants who had acquired qualifications outside of the UK, they were instructed to tick 'Foreign Qualifications' and then the nearest UK equivalent qualification, if known.
Statistical Analysis Randomisation success of the total sample was evaluated using multivariate analysis of variance (MANOVA).
A one-way between groups analysis of variance (ANOVA) was used to assess the effectiveness of the volitional help sheet upon total gym attendance during the 12-month study period between the experimental and control groups. Two way between-group ANOVA's were used to evaluate the direct and indirect effects of each socioeconomic measure of income, education, occupation and area deprivation upon gym attendance between both the experimental and control conditions.
#Intervention
- OTHER : Volitional help sheet
- Other Names :
- VHS
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 or over
* Newly registered gym members
* Be able to speak English
Exclusion Criteria:
* Adults with an obvious learning difficulty that means they were unable to understand the purpose of the study and what was asked of them as they would not be able to provide informed consent.
* Adults who have been a gym member in the past 12 months preceding 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:
Yes
|
NCT04325399
|
{
"brief_title": "A Randomised Controlled Trial of a Brief Planning Intervention to Promote Physical Activity",
"conditions": [
"Physical Activity"
],
"interventions": [
"Other: Volitional help sheet"
],
"location_countries": null,
"nct_id": "NCT04325399",
"official_title": "A Randomised Controlled Trial of a Brief Planning Intervention to Promote Physical Activity",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-11-02",
"study_completion_date(actual)": "2016-11-02",
"study_start_date(actual)": "2016-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-27",
"last_updated_that_met_qc_criteria": "2020-03-25",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-27",
"first_submitted": "2020-03-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor, with activity against numerous beta-lactamases, including class A extended spectrum betalactamases (ESBLs), class C cephalosporinases, and extended spectrum class D oxacillinases (OXA) that can hydrolyze cephalosporins and can be found in Enterobacteriaceae and Pseudomonas aeruginosa (P. aeruginosa). QPX7728 is also a potent inhibitor of carbapenemases from all molecular classes, such as class A Klebsiella pheumoniae carbapenemase (KPC), class B New-Dehli Metalo-beta-lactamase (NDM) and Verona integron-encoded metallo-betalactamase (VIM), and class D OXA-48 that are found in carbapenem resistant Enterobacteriaceae, and also class D carbapenemases such as OXA-23 that are found in carbapenem resistant Acinetobacter baumannii.
Detailed Description
The Centers for Disease Control (CDC) has listed carbapenem-resistant Enterobacteriaceae and Acinetobacter as urgent threats and multidrug resistant Pseudomonas, and extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae as serious threats \[CDC, 2019\]. Consistent with the global nature of these resistant bacteria, the World Health Organization (WHO) has designated carbapenem-resistant, ESBL-producing Enterobacteriaceae, carbapenem-resistant Acinetobacter baumannii, and carbapenem-resistant Pseudomonas aeruginosa as pathogens for which new agents are critically needed \[WHO, 2017\]. Qpex Biopharma is developing a fixed combination antibiotic of QPX2014 plus an ultra-broad spectrum beta-lactamase inhibitor, QPX7728.
#Intervention
- DRUG : QPX7728
- beta lactamase inhibitor
- Other Names :
- IV
- DRUG : QPX2014
- antibiotic
- Other Names :
- IV
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adult males and/or females of non-childbearing potential, 18 <= age <= 55 of age (inclusive) at the time of screening.
* Body mass index (BMI) >= 18.5 and <= 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive) at the time of screening.
* Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, electrocardiograms [ECGs], physical examination) as assessed by the PI.
* Voluntarily consent to participate in the study.
* Male volunteers must agree to be sexually abstinent or agree to use a condom when engaging in any sexual activity from study check-in (on Day -1) through 30 days following the last administration of the study drug, and to not donate sperm during this same period of time. If engaging in sexual activity with a female partner of childbearing potential, an additional method of birth control must be used.
Approved additional methods of birth control include:
1. Intrauterine device (IUD) in place for at least 3 months prior to Day 1 through 30 days following the final dosing of the study drug.
2. Barrier method (diaphragm) for at least 14 days prior to Day 1 through 30 days following dosing of the study drug.
3. Stable hormonal contraceptive for at least 3 months prior to Day 1 through 30 days following dosing of the study drug.
4. Surgical sterilization (vasectomy) at least 6 months prior to Day 1.
* Females of non-childbearing potential must be either postmenopausal (defined as 12 months spontaneous amenorrhea) with a serum FSH >= 40 mIU/mL or have undergone one of the following sterilization procedures at least 6 months prior to Day 1 (and is documented):
1. Bilateral tubal ligation;
2. Hysterectomy;
3. Hysterectomy with unilateral or bilateral oophorectomy;
4. Bilateral oophorectomy.
Exclusion Criteria:
* History or presence of significant (based on the PI assessment) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Positive pregnancy test at screening or check-in (Day 1) for women.
* Positive urine drug/alcohol testing at screening or check-in (Day -1). A repeat test may be performed at the Investigator's discretion in circumstances where a positive result is suspected to be caused by consumption of non-illicit substances.
* Positive pregnancy test at screening or check-in (Day 1) for women.
* Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
* History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
* Use of more than an average of 5 packs/week of tobacco/nicotine-containing product within 6 months prior to Day 1. Subjects must agree to refrain from smoking within 48 hours prior to confinement and for the duration of the study.
* Excessive intake of alcohol, defined as an average daily intake of greater than 2 standard drinks for women and 4 standard drinks for men, (1 bottle of beer (375mL) is equivalent to approximately 1.4 standard drinks, 1 glass of spirits (30mL) is equivalent to approximately 1 standard drink and 1 glass (150mL) of wine is equivalent to approximately 1.5 standard drinks).
* Use of any prescription medication (with the exception of hormone replacement therapy for females) within 14 days prior to Day 1.
* Use of any over-the-counter (OTC) medication, including herbal products, probiotics and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
* Use of antacids, H2 receptor blockers or proton pump inhibitors within 3 days prior to Day 1.
* Documented hypersensitivity reaction or anaphylaxis to any medication, including beta-lactam antibiotics.
* Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day 1.
* Plasma donation within 7 days prior to Day 1.
* Participation in another investigational clinical trial within 30 days prior to Day 1 or within 5 half-lives of the previous investigational drug, whichever is longer.
* Surgery within the past three months prior to Day 1 determined by the PI to be clinically relevant. Minor surgeries allowed include laser vision, minor dental and tooth extraction, mole or basal cell skin removal, endoscopy, and biopsy.
* Any significant acute illness (based on the PI assessment) within 30 days prior to Day 1.
* QTcF interval >450 msec for males and >470 msec for females or history of prolonged QT syndrome at screening or check-in (Day -1).
* Calculated creatinine clearance less than 80 mL/min (Cockcroft- Gault method) at screening or check-in (Day -1).
* Subjects who have any clinically significant laboratory value abnormalities at screening or check-in (Day -1), in particular:
1. White blood cell count < 3,000/mm3, hemoglobin < 11g/dL.
2. Absolute neutrophil count < 1,200/mm3 or platelet count < 120,000/mm3.
* Liver function abnormalities at screening or check-in (Day -1) (defined by an elevation in bilirubin, AST or ALT > ULN for subjects based on age and sex).
* Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study.
* Participation in a previous QPX7728 or QPX7831 study.
* Participation of research site staff, their close family, or significant others.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05072444
|
{
"brief_title": "Drug-Drug Interaction Study of IV QPX2014 Combined With QPX7728 in Healthy Adult Subjects",
"conditions": [
"Bacterial Infections"
],
"interventions": [
"Drug: QPX2014",
"Drug: QPX7728"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05072444",
"official_title": "A Phase 1, Randomized, Double-Blind, Single-Dose, Drug-Drug Interaction Study to Determine the Impact of Co-administration of QPX7728 on the Pharmacokinetics of QPX2014 in Healthy Adult Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-11-23",
"study_completion_date(actual)": "2021-11-23",
"study_start_date(actual)": "2021-11-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-10",
"last_updated_that_met_qc_criteria": "2021-09-28",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-10-11",
"first_submitted": "2021-09-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Adolescence and emerging adulthood are critical periods during which health outcomes may be imperiled for youth with Type 1 Diabetes (T1D). Due to the strong presence of alcohol use in the college environment, college students with T1D may be especially vulnerable to these risks.
Our goal is to develop preliminary evidence in support of a scalable intervention targeting diabetes health management and alcohol use avoidance for college youth with T1D. For this project the investigators will engage at least 120 youth with T1D in college. The study sample will be drawn from two national, non-profit, peer support based groups: the College Diabetes Network (CDN) and the TuDiabetes Network.
The study aims to 1) develop and pilot and educational video intervention; 2) determine the acceptability and efficiency of various web platforms for engaging college students in completing a survey about their health and alcohol use and to; 3) compare effectiveness of delivery of a brief intervention delivered by a peer versus a provider. The investigators plan to engage 120 college youth with T1D in completing a survey about their health knowledge and alcohol use behaviors.
Baseline survey items will ask participants about knowledge, attitudes, and practices/plans for diabetes self-management and alcohol use in college. In response to survey items, participants will provide information on topics including general and disease-specific health information, as well as attitudes, behavior, beliefs, and knowledge related to alcohol use. Participants will also respond to questions relating to social support, mental health, and perseverance and commitment to long term goals.
Following the baseline survey, participants will be presented with a brief educational video about diabetes self-management and alcohol use risks. Participants will be randomized to receive one of two educational video interventions. One version will be framed and delivered from a peer-based source and the other from a provider, content will otherwise be identical. Participants will receive 2 follow-up surveys; one immediately following viewing the video and the second two weeks later. Both the immediate follow-up and the 2-week follow-up survey will test salience, recall, and effects on health knowledge, beliefs and behavioral intentions.
While the main purpose of the pilot is to ascertain preferences in the absence of preliminary data, our a priori hypothesis is that peer delivery will have greater impact for this population.
#Intervention
- BEHAVIORAL : Peer-Based Web-Based Health Information
- The intervention will be a brief vignette to present educational content about alcohol use risks for Type 1 Diabetes; framed and delivered from a peer-based source. The content for the intervention will be drawn on existing theories of behavior change, including the concepts of 'consciousness raising', 'self-reevaluation' and 'helping relationships'. The intervention will comprise of PowerPoint slides for final implementation as a narrated video that can be posted to a website for participant viewing.
- BEHAVIORAL : Provider-Based Web-Based Health Information
- The intervention will be a brief vignette to present educational content about alcohol use risks for Type 1 Diabetes; framed and delivered from a provider-based source. The content for the intervention will be drawn on existing theories of behavior change, including the concepts of 'consciousness raising', 'self-reevaluation' and 'helping relationships'. The intervention will comprise of PowerPoint slides for final implementation as a narrated video that can be posted to a website for participant viewing.
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants will be eligible to be included given: self-report of medical diagnosis of Type 1 diabetes, membership in a college diabetes network (CDN) chapter or TuDiabetes (the sampling frame), attendance/matriculation in college, ability to read and understand English (the language of the surveys and the educational vignettes), access to the Internet, ages 17 <= age <= 25 years. Participants must consent to participation in the study and consent to be re-contacted for the two-week follow up assessment, and provide a valid e-mail address for re-contact.
Exclusion Criteria:
* Participants who do not report a diagnosis of T1D, those who are unable to speak/read English at a middle school reading level, use a computer keyboard and/or complete a web-based questionnaire will be excluded. Patients who do not consent to the 2-week follow up or do not provide a valid e-mail address for re-contact will also be excluded.
Sex :
ALL
Ages :
- Minimum Age : 17 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02883829
|
{
"brief_title": "Effects of Web-Based Health Information on Risk Behavior for Youth With Type 1 Diabetes in College",
"conditions": [
"Diabetes Mellitus, Type 1"
],
"interventions": [
"Behavioral: Provider-Based Web-Based Health Information",
"Behavioral: Peer-Based Web-Based Health Information"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02883829",
"official_title": "Health Promotion in Transition: Effects of Web-Based Health Information on Disease Management and Risk Behavior for Youth With Type 1 Diabetes in College",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-05-10",
"study_completion_date(actual)": "2017-05-10",
"study_start_date(actual)": "2017-04-04"
},
"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)": "2017-11-17",
"last_updated_that_met_qc_criteria": "2016-08-25",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-08-30",
"first_submitted": "2016-08-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to reduce the incidence of postoperative constipation by systematic nurse assessment, interventions and evaluation, in the first month after thoracic surgery.
#Intervention
- PROCEDURE : Degree of constipation
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients admitted for planned lung surgery
* Patients are capable
* Able to talk and understand Danish
Exclusion Criteria:
* Patients with colostomy and / or ileostomy
* Neurological or abdominal diseases
* Feed through a tube
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
|
NCT00364169
|
{
"brief_title": "Prevention of Constipation: Systematic Nursing Interventions to Reduce Postoperative Constipation After Thoracic Surgery",
"conditions": [
"Postoperative Constipation"
],
"interventions": null,
"location_countries": [
"Denmark"
],
"nct_id": "NCT00364169",
"official_title": "Systematic Nursing Interventions to Reduce Postoperative Constipation After Thoracic Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-12",
"study_completion_date(actual)": "2006-12",
"study_start_date(actual)": "2006-09"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-07-01",
"last_updated_that_met_qc_criteria": "2006-08-11",
"last_verified": "2008-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-08-15",
"first_submitted": "2006-08-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to verify the effectiveness of tDCS combined with foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild and moderate compromise.
#Intervention
- DEVICE : Foot Drop Stimulatio - Neuro Orthosis
- Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.
- DEVICE : Transcranial direct brain stimulation
- Transcranial direct brain stimulation on motor cortex
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects with ischemic or hemorrhagic stroke diagnosis.
* Mild, moderate or severe hemiparesis (chronic stroke - at least 6 months)
* Minimal cognitive ability to understand commands
* Able to walk 10 meters unassisted or with minimal assistance
Exclusion Criteria:
* No current use of antiepileptic drugs for seizures
* Secondary musculoskeletal disorder involving the lower limb
* Contraindication for electrical stimulation
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:
Yes
|
NCT04077814
|
{
"brief_title": "Association Between the tDCS and FDS for Gait Rehabilitation After Stroke",
"conditions": [
"Stroke"
],
"interventions": [
"Device: Foot Drop Stimulatio - Neuro Orthosis",
"Device: Transcranial direct brain stimulation"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT04077814",
"official_title": "Association Between the Transcranial Direct Current Stimulation (tDCS) and Foot Drop Stimulation (FDS) for Gait Rehabilitation After Stroke - A Randomized Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-20",
"study_completion_date(actual)": "2020-09-30",
"study_start_date(actual)": "2019-09-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-02-11",
"last_updated_that_met_qc_criteria": "2019-08-31",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-04",
"first_submitted": "2019-06-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Objective:
Due to high mortality rates the capillary leakage and the acute abdomen are important risk factors of the probability of survival. The aim of an optimal therapy of the acute abdomen within the neonatal period is beside the cure of the underlying disease the prophylaxis of capillary leakage with the help of optimised intra- and postoperative volume therapy.
Question:
Do the neonates with very low birth weight and a surgery therapy of acute abdomen benefit from early increase of the haemoglobin/haematocrit by optimised volume therapy with crystalloid and colloidal volume as prophylaxis of the capillary leakage?
|
#Eligibility Criteria:
Inclusion criteria:
* All Children with very low birth weight who have undergone surgery of acute abdomen within the neonatal period between 2001 and 2011 on 'Campus Charité Mitte' or 'Charité Virchow - Klinikum'.
* Neonates (calculated date of birth + 4 weeks)
Exclusion criteria:
* Birth weight > 1500g
Sex :
ALL
Ages :
- Minimum Age : 1 Minute
- Maximum Age : 4 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01817062
|
{
"brief_title": "Neonates With Very Low Birth Weight and Surgery Therapy of Acute Abdomen",
"conditions": [
"Very Low Birth Weight"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT01817062",
"official_title": "Retrospective Analysis of Intraoperative Volume Administration in Neonates Without Congenital Malformations With Very Low Birth Weight and Acute Abdomen.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2013-03",
"study_start_date(actual)": "2001-01"
},
"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)": "2013-05-08",
"last_updated_that_met_qc_criteria": "2013-03-21",
"last_verified": "2013-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-03-22",
"first_submitted": "2013-03-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in liver cancer could play an important role in diagnosis, predicting the risk for tumor recurrence, and providing novel target therapy biomarkers. In view of these facts, the investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of liver cancer in normal peripheral blood after cryosurgery with or without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR) method.
Detailed Description
1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately 17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with liver cancer and healthy volunteers. The blood of the healthy volunteers will be used to evaluate the sensitivity and specificity and as negative control cells. To avoid contamination with skin cells, 2 mL blood will be discarded before the study samples will be taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for 20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR. Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to choose an adequate therapy.
#Intervention
- OTHER : Flow cytometry (FCM)
- Use FCM to test PBMCs/CTCs from volunteers/patients.
- OTHER : RT-PCR
- Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age:18 <= age <= 75
* Karnofsky performance status >60
* Diagnosis of liver cancer based on histology or the current accepted radiological measures.
* Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
* Will receive cryosurgery and/or DC-CIK treatment
* Life expectancy: Greater than 3 months
* Patients' routine blood test, liver function and kidney function have no obvious abnormalities
* Ability to understand the study protocol and a willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with other primary tumor except liver cancer
* History of coagulation disorders or anemia
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02416635
|
{
"brief_title": "The Detection of Circulating Tumor Cells (CTCs) in Patients With Liver Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment",
"conditions": [
"Neoplastic Cells, Circulating"
],
"interventions": [
"Other: Flow cytometry (FCM)",
"Other: RT-PCR"
],
"location_countries": [
"China"
],
"nct_id": "NCT02416635",
"official_title": "The Detection of Circulating Tumor Cells (CTCs) in Patients With Liver Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment",
"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": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-12-30",
"last_updated_that_met_qc_criteria": "2015-04-10",
"last_verified": "2015-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-04-15",
"first_submitted": "2015-04-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of our study is to investigate the effects of Kinesio Taping application, which is applied before the training period, on postural stability in young soccer players.
#Intervention
- DEVICE : Kinesio Taping application
- Therapeutic taping application applied to skin affecting muscle, fascia, circulation, ligaments, tendons and joints.
- Other Names :
- Kinesio Tex Gold, Kinesio Tex FP
|
#Eligibility Criteria:
Inclusion Criteria:
* Soccer players aged between 12 <= age <= 16
Exclusion Criteria:
* Players who had lower extremity injury previously
Sex :
MALE
Ages :
- Minimum Age : 12 Years
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02683434
|
{
"brief_title": "Effects of Kinesio Taping on Postural Stability in Young Soccer Players",
"conditions": [
"Increasing Performance of Healthy Athlete"
],
"interventions": [
"Device: Kinesio Taping application"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT02683434",
"official_title": "Effects of Kinesio Taping on Postural Stability in Young Soccer Players",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-02",
"study_completion_date(actual)": "2017-02",
"study_start_date(actual)": "2016-01"
},
"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)": "2017-07-14",
"last_updated_that_met_qc_criteria": "2016-02-11",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-02-17",
"first_submitted": "2016-01-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Lasers are the treatment modality of choice for Port Wine Stain birthmarks.The epidermis is not totally spared due to partial absorption of energy therein by melanin that presents an optical barrier through which the light must pass to reach the underlying blood vessels. Absorption of laser energy by melanin causes localized heating in the epidermis, which may, if not controlled, produce permanent complications such as hypertrophic scarring or dyspigmentation.
Detailed Description
The researchers want to establish a correlation between non-invasive skin temperature measurements and the minimum laser energy during skin laser treatment using cryogen spray cooling.
This study would eliminate the need for test pulses to estimate the safe and acceptable radiant exposure prior to laser treatment.
#Intervention
- PROCEDURE : cooling spray during laser treatment
- skin temperature measurement
- Other Names :
- laser treatment
|
#Eligibility Criteria:
Inclusion Criteria:
* 7 years and older with diagnosis of port wine stain birthmark
* 18 years and older with no port wine stain
* non-pregnant women
* apparent good health
Exclusion Criteria:
* age less than 7 years
* pregnant women
* history of photodermatoses or skin cancer
* current use of photosensitizing drugs
Sex :
ALL
Ages :
- Minimum Age : 7 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00540917
|
{
"brief_title": "Measurement Skin Temperature During Pulsed Laser Exposure",
"conditions": [
"Port-Wine Stain"
],
"interventions": [
"Procedure: cooling spray during laser treatment"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00540917",
"official_title": "Phase II Clinical Trial is to Compare Epidermal Temperature Measurements During 1.Laser Treatment at Standard Treatment Energies 2.Cryogen Spray Cooling (CSC) Plus Laser Treatment. 3.Contact Cooling Plus Laser Treatment.",
"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)": "2002-07"
},
"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)": "2022-11-01",
"last_updated_that_met_qc_criteria": "2007-10-04",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-10-08",
"first_submitted": "2007-10-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Laminoplasty and laminectomy have been used for decades for the treatment of intraspinal space occupying lesions, spinal stenosis, disc herniation, injuries, etc. After these procedures, patients often experience severe postoperative pain at the surgical site. However, current methods of pain control are mostly insufficient. At present, several pain controlling methods are available, to reduce postoperative pain after laminoplasty or laminectomy. Methods for systemic administration include: oral analgesics, intermittent intravenous, intramuscular injections, patient- controlled intravenous analgesia, etc. However, the aforementioned methods may have a lot of side effects, and are usually used after the occurrence of pain and the analgesic effects are sometimes inadequate. Topical administration options use a lower dose of drugs and therefore have less systemic side effects. Pre-emptive injection of local anesthetics can significantly reduce postoperative pain during rest and movement, however, the analgesic effect is maintained for a relatively short period of time. It is necessary to use more cases to explore the other compatibility of drugs with longer duration of action and stronger analgesic effect. Betamethasone as the stereoisomer of dexamethasone is a long-acting corticosteroid, which has long lasting anti-inflammatory properties. Whether betamethasone combined with local anesthetic for laminoplasty or laminectomy has better short-term and long-term effects than the local anesthetic alone has not been reported yet. Therefore, a prospective, randomized, controlled, blinded-endpoint study is needed to compare the postoperative analgesic efficacy of preemptive wound infilteration of ropivacaine alone and betamethasone plus ropivacaine for laminectomy or laminoplasty.
#Intervention
- DRUG : The Treatment group
- The local infiltration solution in the treatment group will consist of betamethasone and ropivacaine. For local infiltration, a total of 30 ml solution will be prepared for each group, which will include 0.5ml of compound betamethasone injection(betamethasone propionate 5mg and betamethasone sodium phosphate 2mg per 1ml) added to 14.5ml of saline and 15ml of 1% ropivacaine. The surgeon will perform wound infiltration after induction of anesthesia and before surgery. A total of 10 ml of solution will be injected into each level. The study solution will be injected into the subcutaneous tissue, paravertebral muscles, along with the posterior area around the spinous process, lamina, transverse process and the facet joints, along both sides of the planned incision. The epidural space and intrathecal space will not be infiltrated.
- DRUG : The Control group
- The local infiltration solution in the control group will consist of ropivacaine. For local infiltration, a total of 30 ml solution will be prepared for each group, which will include 15ml of ropivacaine added to 15 ml of saline for the Control group. The surgeon will perform wound infiltration after induction of anesthesia and before surgery. A total of 10 ml of solution will be injected into each level. The study solution will be injected into the subcutaneous tissue, paravertebral muscles, along with the posterior area around the spinous process, lamina, transverse process and the facet joints, along both sides of the planned incision. The epidural space and intrathecal space will not be infiltrated.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients scheduled for surgery under general anaesthesia for laminectomy or laminoplasty;
* American Society of Anaesthesiologists (ASA) classification of I or II;
* Age 18 <= age <= 64;
* Participates with an anticipated full recovery within 2 hours postoperatively.
Exclusion Criteria:
* Patient refusal;
* Participants who cannot use a patient-controlled analgesia (PCA) device and cannot understand the instructions of a Visual Analogue Score (VAS);
* Previous history of spinal surgery;
* Allergy to opioids, betamethasone or ropivacaine;
* Peri-incisional infection;
* History of stroke or a major neurological deficit;
* Trauma, deformity;
* Psychological problems;
* Extreme body mass index (BMI) (< 15 or > 35);
* History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
* Patients using systemic steroids;
* Pregnant or breastfeeding;
* Preoperative Glasgow Coma Scale < 15;
* Participants who have received radiation therapy or chemotherapy preoperatively, or with a high probability to require a postoperative radiation therapy or chemotherapy according to the preoperative imaging.
* Not able to give written informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04153396
|
{
"brief_title": "Preemptive Infiltration With Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy",
"conditions": [
"Pain, Postoperative",
"Neurosurgery"
],
"interventions": [
"Drug: The Control group",
"Drug: The Treatment group"
],
"location_countries": [
"China"
],
"nct_id": "NCT04153396",
"official_title": "Preemptive Infiltration With Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-03",
"study_completion_date(actual)": "2022-06-03",
"study_start_date(actual)": "2021-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-03-14",
"last_updated_that_met_qc_criteria": "2019-11-04",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-11-06",
"first_submitted": "2019-11-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Non-inferiority randomized trial of 5,500 women with a cesarean delivery randomized prior to discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.
Detailed Description
This was a non-inferiority multi-center unblinded randomized trial of 5,500 women undergoing a cesarean delivery who were randomized before discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg. The primary endpoint was the presence/absence of moderate to severe pain at 1 week after discharge. Moderate to severe pain was defined as a value of 4 or higher on the Brief Pain Inventory worst pain scale (0 to 10) in the last 24 hours. Consenting women were assigned in a 1:1 ratio to one of the two arms using a secure internet based randomization system maintained centrally by the Data Coordinating Center (DCC). Randomization was stratified by site. Women were followed through 90 days postpartum.
#Intervention
- DRUG : 0 to 20 tablets of oxycodone 5mg
- Individualized opioid prescription protocol (IOPP) that includes shared decision making
- DRUG : Fixed opioid prescription
- 20 tablets of oxycodone 5mg
|
#Eligibility Criteria:
Inclusion Criteria:
* Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible)
* Singleton, twin or triplet gestation
Exclusion Criteria:
* An opioid prescription filled during the current pregnancy
* Known history of opioid use disorder, by medical record review
* Contraindication to opioids (oxycodone)
* Contraindications to both acetaminophen and ibuprofen
* Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain trajectory will be completely different
* Fetal or neonatal death prior to randomization
* Inability to randomize within 1 day before planned discharge from the hospital
* Inability to participate in shared decision making as assessed by research staff
* Language barrier (non-English or Spanish speaking)
* Participation in this trial in a previous pregnancy
* Participation in another intervention study that influences the primary outcome in this trial
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04296396
|
{
"brief_title": "Opioid Prescription After Cesarean Trial",
"conditions": [
"Pregnancy Related",
"Opioid Use",
"Pain"
],
"interventions": [
"Drug: 0 to 20 tablets of oxycodone 5mg",
"Drug: Fixed opioid prescription"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04296396",
"official_title": "Prescription After Cesarean Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-07",
"study_completion_date(actual)": "2022-07-08",
"study_start_date(actual)": "2020-09-21"
},
"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)": "2023-10-03",
"last_updated_that_met_qc_criteria": "2020-03-04",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-05",
"first_submitted": "2020-03-03",
"first_submitted_that_met_qc_criteria": "2023-09-06"
}
}
}
|
#Study Description
Brief Summary
The objectives of the study were to evaluate the efficacy, safety, and tolerability of valdecoxib 10 mg once daily (QD) or naproxen 500 mg twice daily (BID) versus placebo, and to assess the efficacy of valdecoxib 10 mg QD versus naproxen 500 mg BID, in treating the signs and symptoms of rheumatoid arthritis (RA) in a severe Rheumatoid Arthritis population.
#Intervention
- DRUG : valdecoxib
- valdecoxib 10 mg tablet once daily for 12 weeks
- DRUG : naproxen
- naproxen 500 mg capsule twice daily for 12 weeks
- DRUG : placebo
- placebo tablet every morning and capsule every evening for 12 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* A diagnosis of severe rheumatoid arthritis (RA) for at least 6 months
* The Rheumatoid Arthritis must have been treated with a stable regimen including a non-steroidal anti-inflammatory drug (NSAID), as well as methotrexate for at least 12 weeks -OR- an NSAID (for at least 12 weeks plus a tumor necrosis factor inhibitor (i.e., adalimumab [Humira®] for a minimum of 5 doses on a regular schedule, etanercept [Enbrel®] for 6 weeks, infliximab (Remicade®) for 3 doses and currently on a stable regimen of infusions not more than every 8 weeks)
Exclusion Criteria:
* A diagnosis of any other inflammatory arthritis or a secondary, noninflammatory type of arthritis (eg, osteoarthritis (OA) or fibromyalgia) that, in the investigator's opinion, was symptomatic enough to interfere with the evaluation of the effect of valdecoxib on the patient's primary diagnosis of Rheumatoid Arthritis were excluded from 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
|
NCT00650455
|
{
"brief_title": "Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients",
"conditions": [
"Arthritis, Rheumatoid"
],
"interventions": [
"Drug: placebo",
"Drug: naproxen",
"Drug: valdecoxib"
],
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT00650455",
"official_title": "Clinical Protocol for a Multicenter, Double-Blind, Randomized, Placebo Controlled, Comparison of the Efficacy and Safety of Bextra® (Valdecoxib) 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe RA Population",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-01",
"study_completion_date(actual)": "2005-01",
"study_start_date(actual)": "2003-02"
},
"study_design": {
"allocation": null,
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-07-21",
"last_updated_that_met_qc_criteria": "2008-03-28",
"last_verified": "2008-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-04-01",
"first_submitted": "2008-03-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A study to evaluate the effect of SB-656933-AAA on the body after a single dose in subjects who have been challenged with ozone.
#Intervention
- DRUG : SB-656933-AAA
- SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.
- DRUG : Placebo
- Placebo tablets will be intended to be administered orally.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects between 18 <= age <= 50 years.
* Females should be of non-child bearing potential.
* Non-smoking for at least 12 months.
* Normal lung function.
* Subjects should be able to produce acceptable sputum samples.
Exclusion Criteria:
* Any serious medical condition.
* Hepatitis B or C and/or HIV positive.
* Currently on regular medication except paracetamol.
* Body Mass Index <20 or >30.
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
|
NCT00551811
|
{
"brief_title": "Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone",
"conditions": [
"Pulmonary Disease, Chronic Obstructive"
],
"interventions": [
"Drug: Placebo",
"Drug: SB-656933-AAA"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT00551811",
"official_title": "A Dose Ranging Study to Assess the Effect of Pre-treatment With a Single Dose of Oral SB656933 on Lung Inflammation Following Challenge With Inhaled Ozone and Intermittent Exercise in Healthy Volunteers, Relative to Placebo",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-07-22",
"study_completion_date(actual)": "2008-07-22",
"study_start_date(actual)": "2007-10-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": null,
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-08-07",
"last_updated_that_met_qc_criteria": "2007-10-29",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-10-31",
"first_submitted": "2007-10-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease surrogate markers of bone metabolism and early cardiovascular disease in individuals with moderate to severe airflow obstruction and a chronic bronchitis phenotype.
Detailed Description
Study participants will be given Roflumilast 500 micrograms daily for 30 days. At baseline, prior to drug administration, blood samples will be collected for analysis of markers of bone metabolism (C-terminal telopeptide of Type I Collagen (CTx), Amino-terminal Propeptide of Type-1 Procollagen (P1NP) and participants will undergo measurement of endothelial function with measurement of brachial flow mediated dilation. After completion of one month of Roflumilast therapy, participants will have a repeat blood collection for measurement of CTx and P1NP and repeat measurement of brachial flow mediated dilation testing.
#Intervention
- DRUG : Roflumilast
- Other Names :
- Daxas, Daliresp
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects between the ages of 50 and 70 with a minimum of ten-pack years of tobacco exposure, airflow obstruction (FEV1/FVC < 0.70) with an FEV1 < 70%
* baseline sputum production at least some of the time as reported on the Saint George's Respiratory Questionnaire, and at least one exacerbation within the past year
Exclusion Criteria:
* Subjects with chronic prednisone use, antiresorptive therapy use (bisphosphonates, calcitonin, parathyroid hormone)
* Subjects with a body mass index less than 18 or greater than 34
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01745848
|
{
"brief_title": "Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD",
"conditions": [
"Chronic Obstructive Pulmonary Disease"
],
"interventions": [
"Drug: Roflumilast"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01745848",
"official_title": "Effect of Roflumilast on Systemic Markers of Bone Metabolism and Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06",
"study_completion_date(actual)": "2016-06-30",
"study_start_date(actual)": "2013-02"
},
"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)": "2017-08-29",
"last_updated_that_met_qc_criteria": "2012-12-07",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-12-10",
"first_submitted": "2012-12-06",
"first_submitted_that_met_qc_criteria": "2017-07-27"
}
}
}
|
#Study Description
Brief Summary
The investigators of this study have developed a standardized counseling aid using an electronic mobile device to help women learn about what to expect during labor and subsequent vaginal delivery or cesarean delivery, specifically regarding pain expectations. Half of women will complete the counseling aid and the other half will receive standard counseling and care. The study aims to determine if the counseling aid improves patient satisfaction and perception of pain control.
Detailed Description
A. Objective To compare perception of postpartum pain and patient satisfaction between women who receive routine obstetric care to those who receive routine obstetric care and complete a standardized counseling aid antepartum.
B. Background Enhanced Recovery After Surgery (ERAS) is a standardized, evidenced-based method for the perioperative management of surgical patients. ERAS protocols have been well studied in several surgical specialties, including gynecologic oncology and benign gynecology, and have been shown to reduce hospital length of stay and costs without increasing rates of complications or readmission.
The use of ERAS in obstetrics is also growing. Recent studies have shown that an enhanced recovery pathway after cesarean delivery can decrease hospital stay and cost and reduce opioid use. Guidelines have been developed for evidence-based recommendations for preoperative, intraoperative and postoperative phases of care.
An important component of any ERAS protocol is pre-operative counseling. Postoperative pain management starts with counseling prior to surgery. Guidelines suggest that preoperative counseling should include patient-centered education on the options for management of pain. This process also allows an opportunity to engage patients in the decision making process. Previous studies have shown that counseling on pain expectations can improve patient outcomes.
The aim of our study is to develop a standardized antepartum counseling aid and improve postpartum pain perceptions and patient experience.
C. Study Methodology
1. Study Design The study is a randomized control trial. Patients will be assigned 1:1 to the study group and control group.
2. Comparison Groups:
1: Group 1:
* Study Group: Women will watch an educational video regarding expectations for delivery and postpartum care in addition to receiving standard care and counseling.
2: Group 2:
* Control Group: Women will receive standard care and counseling.
3. Procedures:
Identification of Potentially Eligible Patients
1. Potentially eligible patients will be identified through screening of clinic patients at time of routine prenatal visit at the Prisma Health OBGYN Center between 35 to 41 weeks gestation.
Study Enrollment
2. Investigators will review charts of women scheduled for routine obstetric appointments and screen for eligibility. Eligible women will be contacted at the time of their prenatal appointment.
3. Study fliers advertising the study will also be posted in OB clinics at the OBGYN Center.
4. Women who are interested in enrollment will be counseled and consented by study personnel at their scheduled appointment.
5. The enrollment process involves a face-to-face interview with one of the study investigators for verification of study eligibility and counseling regarding study procedures as well as potential benefits and risks prior to obtaining written consent.
Treatment Allocation
6. On day of enrollment, patients will be randomized into the treatment group or the control group using a computer-generated randomization scheme.
7. Randomization will be stratified by plan for delivery with plan for vaginal delivery versus plan for cesarean delivery, as content of the educational videos will be geared towards mode of delivery.
8. Randomization assignment will not be blinded.
9. All participants will complete an initial demographic questionnaire immediately following randomization via self- administered assessments within the test application using a mobile tablet.
10. Subjects allocated to Group 1: will:
A. Complete the demographic questionnaire, the survey questions, and then complete the counseling aid.
B. Prior to discharge after delivery, study personnel will administer the postpartum questionnaire via a mobile tablet. The questionnaire is programmed into the study application.
11. Subjects allocated to Group 2: will:
A. Complete the demographic questionnaire and survey questions without watching the educational video.
B. Prior to discharge after delivery, study personnel will administer the postpartum questionnaire via a mobile tablet. The questionnaire is programmed into the study application.
12. Research staff will complete chart reviews to confirm delivery information and other study related data.
4. Outcomes:
1. Primary: What is the impact of a standardized antepartum counseling aid on patient satisfaction with pain expectations during hospital admission for labor and delivery compared to women who do not use the counseling aid and receive routine counseling only? Satisfaction will be measured using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R). The APS-POQ-R is designed for use in adult hospital pain management QI activities and measures 6 aspects of quality including: (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) helpfulness of information about pain treatment; (5) ability to participate in pain treatment decisions; and (6) use of nonpharmocological strategies.
2. Secondary outcomes: Perception of pain control intrapartum and postpartum based on postpartum questionnaires, expectations of what type and how much pain medication at time of discharge, use of narcotics postpartum as determined by chart review, pain perceptions in patients with history of mood disorder as determined by questionnaire, pain perceptions in patients with history of substance abuse as determined by questionnaire.
#Intervention
- OTHER : Counseling Aid
- Women will watch an educational video regarding expectations for delivery and postpartum care in addition to receiving standard care and counseling.
|
#Eligibility Criteria:
Inclusion Criteria:
* Pregnant women > 18 years
* Gestational age 35 weeks to 41 weeks
* English or Spanish speaking
* Plan for vaginal delivery or cesarean delivery at Greenville Memorial Hospital
* Singleton or twin gestation
Exclusion Criteria:
* Non-English or Non-Spanish speaking patients
* Inability to read English, inability to read Spanish
* Pregnancy diagnosed with fetal anomalies
* Intrauterine fetal demise
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
|
NCT04822493
|
{
"brief_title": "Improving Pain Perceptions After Initiating a Delivery Application",
"conditions": [
"Postoperative Pain",
"Pain"
],
"interventions": [
"Other: Counseling Aid"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04822493",
"official_title": "Improving Pain Perceptions After Initiating a Delivery Application",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-08-31",
"study_completion_date(actual)": "2021-08-31",
"study_start_date(actual)": "2021-01-01"
},
"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)": "2022-06-02",
"last_updated_that_met_qc_criteria": "2021-03-29",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-30",
"first_submitted": "2020-09-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Pilot study with healthy subjects to test the in vivo potential colonization ability of S. dentisani. Phase I, exploratory, prospective, mechanistic pilot clinical trial with two parallel follow-up groups. Probiotic will be applied topically as an adhesive gel with a dental splint under different dosing regimes. Saliva and plaque samples will be obtained at day 0, 14 and 28.
Detailed Description
Phase I study, exploratory, prospective, mechanistic, to evaluate the capacity of
Streptococcus dentisani CECT 7746 of colonizing the tooth surface. The study will be carried out with 10 healthy subjects divided into two groups (n = 5 per group) that differ in the number of applications of probiotic:
Group A: participants who will receive a single application of the product during the initial visit Group B: participants who will receive 7 applications on consecutive days, with the first in the start visit. Probiotic will be applied topically as an adhesive gel with a dental splint under different dosing regimes.The total dose received will be the same for both groups, and the total duration of the follow-up will be of 4 weeks from the first application also for both groups.
On day 0: Participants who meet the inclusion and exclusion criteria will be randomized in one of the two groups. Saliva and plaque samples will be obtained by the dentist, and all the participants will receive an professional teeth cleaning in one half of the mouth (quadrants 1-4). Afterwads, treatment will be applied by the dentist according to assigned group, and the randomized participants in the multiple-dose group will be explained how to perform the six successive applications at home every 24 hours.
On day 14: follow-up visit, saliva and plaque samples will be obtained from all participants. Patient assigned to the multi-dose group will return the used material On day 28th: final visit, saliva and plaque samples will be obtained.
#Intervention
- OTHER : Streptococcus dentisani CECT7746
- Treatment will be applied topically as an adhesive gel with a dental splint
|
#Eligibility Criteria:
Inclusion Criteria:
* Absence of serious periodontal diseases (eg gingivitis, periodontitis)
* Ability to understand the requirements and implications of the study
Exclusion Criteria:
* Antibiotic consumption during the 30 days prior to the initiation of the study.
* Oral probiotics consumption during the 30 days before the start of the study
* Pregnant or lactating women
* Chronic diseases (eg, diabetes, kidney problems, cancer) or diseases that could affect salivary flow.
* Chronic treatment or medication that could reduce salivary flow, such as antidepressants or psychotropic drugs.
* Allergy to any of the product composition ingredients
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
|
NCT03522363
|
{
"brief_title": "Streptococcus Dentisani Colonization Capacity in a Split Mouth Model",
"conditions": [
"Oral Health"
],
"interventions": [
"Other: Streptococcus dentisani CECT7746"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT03522363",
"official_title": "Study of Streptococcus Dentisani Capacity to Colonize Supragingival Plaque in a Split Mouth Model",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-03-11",
"study_completion_date(actual)": "2016-09-20",
"study_start_date(actual)": "2016-02-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-05-11",
"last_updated_that_met_qc_criteria": "2018-05-10",
"last_verified": "2018-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-05-11",
"first_submitted": "2018-02-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Objective To investigate the effectiveness of the use of the QMD Helios Laser device in association with standard rehabilitation therapy in reducing inflammatory symptoms in patients following total knee replacement.
Design Randomized controlled trial. Setting Rehabilitation structure, inpatient Main outcome measures Pain subscale of the WOMAC and Lequesne's Algo-Functional Index (LIKERT scale), knee circumference (measured at the middle line of the knee joint space) and knee flexion /extension range of motion by goniometer.
Detailed Description
As life expectancy increases, more and more people are afflicted with degenerative joint diseases. Knee osteoarthritis is a pathology typical of old age (over 60 years), but it can also occur in younger people (aged 40-50 years) and is more prevalent in women (11%) than men (7%). Total knee replacement surgery is becoming increasingly frequent.In the immediate post-operative period, the main problems encountered by patients are: inflammation, edema and, above all, pain. These can strongly influence the restoring of a correct muscle-joint function and hence the time needed for a return to normal activities of daily living (ADLs).Post-operative rehabilitation is now a fundamental part of the functional recovery of patients after knee replacement surgery. Traditional rehabilitation programs are mainly focused on improving joint mobility, reducing musculotendinous retractions, increasing muscle strength and establishing a correct gait pattern. Over the years, in addition to the manual rehabilitative techniques, the use of instrumental methods to stimulate the healing processes and speed up recovery times has become a frequent practice, especially for the management of post-operative pain and inflammation. One of these methods is laser therapy, which consists of light radiation composed of a beam of photons with specific physical characteristics that interacts with living tissue to produce an anti-inflammatory, analgesic and biostimulation effect. Another form of instrumental therapy used in rehabilitation for the management of pain/edema resulting from an inflammatory process is the application of cold (cryotherapy) or heat (thermotherapy) or both together in combination (contrast therapy). Cryotherapy is a type of physical therapy that produces temporary anesthesia of the part undergoing treatment.Thermotherapy consists of the application of heat to stimulate a biological process inducing the release of chemotactic substances and growth factors, which have a powerful regenerative and reparative action. An innovative device that combines the therapeutic advantages of these different forms of physical therapy is QMD Helios (Hakomed, Egna, BZ, Italy), designed to provide cryo-thermal and laser treatment. The device is equipped with a high-power diode laser. This therapeutic laser can work at 3 different wavelengths (808 nm,1064 nm, 1120 nm). The wavelengths are each individually controlled and can be delivered in various modes: continuous wave, pulsed mode, super pulse, and Harmonic pulsation (laser wave emission with a variable frequency - determined by means of a scan performed by the device - suited to the tissue to be treated). This innovative triple-wavelength emission represents the most versatile solution when one wishes to obtain different therapeutic effects at the same time. In addition to the use of laser, the device allows the application of cryo-thermal therapy, simultaneously or separately. Simultaneous administration promotes thermal shock, a basic principle of contrast therapy characterized by a marked variation of temperature (30-40 degrees) within a short space of time (30-60 seconds) inducing vasodilation through the heat and vasoconstriction through the cold. Thermal shock is effective in the early stages of rehabilitation for a rapid resolution of pain and swelling.Although in recent years instrumental therapy has come to play a very important role in rehabilitation medicine in the management of pain/inflammation in the acute patient, there is lack of reported evidence in the literature on the use of laser therapy in patients after knee replacement surgery. The aim of this study is to evaluate the effectiveness of the use of the QMD Helios laser device in association with standard rehabilitation therapy in reducing edema and pain symptoms in patients following total knee replacement.
#Intervention
- PROCEDURE : Laser therapy-cryo thermal therapy
- 5 days per week, 3 weeks, sessions including laser therapy + cryo therapy followed by usual rehabilitation
- PROCEDURE : Usual care
- 5 days per week, 3 weeks, sessions of usual rehabilitation
|
#Eligibility Criteria:
Inclusion Criteria:
* good general physical conditions
* first total knee replacement
Exclusion Criteria:
* diabetic neuropathy
* renal or hearth disease
* allergic reactions
* Reynaud's disease
* lupus
* rheumatoids arthritis
* peripheral vascular disease
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04183673
|
{
"brief_title": "Laser + Cryo-thermal Therapy Following Total Knee Replacement Surgery",
"conditions": [
"Knee Arthropathy"
],
"interventions": [
"Procedure: Usual care",
"Procedure: Laser therapy-cryo thermal therapy"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT04183673",
"official_title": "Efficacy of Laser + Cryo-thermal Therapy in Rehabilitation Following Total Knee Replacement Surgery: a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-01-31",
"study_completion_date(actual)": "2019-02-28",
"study_start_date(actual)": "2018-05-29"
},
"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)": "2022-04-01",
"last_updated_that_met_qc_criteria": "2019-11-28",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-12-03",
"first_submitted": "2019-11-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this prospective randomized study is to assess whether empirical Left Atrial Appendage (LAA) isolation along with the standard approach of pulmonary vein isolation (PVI) and ablation of extra-pulmonary triggers is superior to the standard approach alone in enhancing the long-term success rate of catheter ablation in persistent or long-standing persistent atrial fibrillation (AF) patients.
Detailed Description
Persistent (PeAF) and long-standing persistent (LSP) AF are defined as sustained AFs extending beyond seven days and one year respectively (1). Hypertensive, ischemic, valvular and other structural heart diseases most commonly underlie these arrhythmias (2) and the resulting abnormal atrial substrate is believed to be the major contributor toward perpetuation of AF in these non-paroxysmal categories. Several studies have demonstrated that pulmonary vein isolation (PVI) by radiofrequency catheter ablation (RFCA) though successfully restores sinus rhythm in most patients with paroxysmal AF; it has limited success in these sustained arrhythmias (3). Presence of potential trigger-generating areas in the left and right atrium besides pulmonary veins, with reported incidence from 3.2% to 47% (4), can be held responsible for this limited success. These areas include superior vena cava, ligament of Marshall, crista terminalis, coronary sinus, left atrial (LA) posterior wall and LA appendage (3). Therefore, in order to enhance the procedural-success rate, various hybrid measures have emerged to target the PV as well as extra-PV areas that have the ability to initiate or maintain AF. Several previous studies have demonstrated the prevalence of LAA firing in patients with recurrence of AF/AT (atrial tachycardia) after catheter ablation of AF (4). Embryologically, LAA is the remnant of primitive LA, which is formed by the adsorption of primordial PV and their branches during 4th week of embryonic development. Therefore, it is logical to suggest that LAA may initiate AF like pulmonary veins. In an earlier study conducted by our group on 987 AF patients, LAA firing was revealed to be the source of AF in 27% of patients and 93% of those patients were arrhythmia free 6 months after LAA isolation (4).
Our study aims to compare the procedure outcome for two different ablation strategies; 1) standard approach of pulmonary vein isolation extended to the posterior wall down to the coronary sinus and to the left side of the interatrial septum along with isolation of superior vena cava and ablation of complex fractionated atrial electrograms (CFAE) in the atria and coronary sinus, 2) standard approach plus LAA isolation.
Hypothesis: LAA isolation combined with standard ablation procedure enhances the procedural success rate in non-paroxysmal AF patients undergoing catheter ablation.
#Intervention
- PROCEDURE : RFCA of PV and extra-PV triggers
- PVAI and isolation of extra PV triggers
- PROCEDURE : LAA isolation along with the conventional ablation strategy
- PVAI + isolation of extra PV triggers + LAA isolation
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 75 years
* History of PeAF or LSP AF refractory to antiarrhythmic drugs
* Willing and ability to understand and sign an informed consent
Exclusion Criteria:
* Reversible causes of AF (hyperthyroidism)
* Left atrial thrombus
* Moderate to severe valvular heart disease
* Contraindication for anticoagulation
* Life expectancy < 12 months
* Pregnancy
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
|
NCT01362738
|
{
"brief_title": "Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients With Persistent or Long-standing Persistent Atrial Fibrillation Undergoing Catheter Ablation",
"conditions": [
"Persistent Atrial Fibrillation"
],
"interventions": [
"Procedure: LAA isolation along with the conventional ablation strategy",
"Procedure: RFCA of PV and extra-PV triggers"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01362738",
"official_title": "Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients With Persistent or Long-standing Persistent Atrial Fibrillation Undergoing Catheter Ablation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-06",
"study_completion_date(actual)": "2016-11",
"study_start_date(actual)": "2010-11"
},
"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)": "2017-04-26",
"last_updated_that_met_qc_criteria": "2011-05-27",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-30",
"first_submitted": "2011-05-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HLX04-O administered every 4 weeks in participants with wet age-related macular degeneration (wAMD)
Detailed Description
This is a Phase I/II, Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of HLX04-O Administered by Intravitreal Injection in Subjects with wet Age related Macular Degeneration (wAMD).The study will be conducted in approximately 6 sites in China.
#Intervention
- DRUG : recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection
- 0.05mL (12.5mg/0.5mL/vial) HLX-04-O solution at a 4-week interval for intravitreal injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Capable to fully understand and sign the informed consent form (ICF).
* Women or men aged >=50 years when signing the ICF.
* Newly diagnosed or recurrently, active subfoveal or juxtafoveal CNV lesions secondary to AMD in the study eye. (Active CNV was defined as leakage on FA and subretinal or intraretinal fluid on OCT).
* The total lesion area (including bleeding, scar and neovascularization) of the study eye <=12 disc area (DA).
* The BCVA letters between 15 and 78, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
* Clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm the diagnosis.
Exclusion Criteria:
* Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis or atrophy involving the fovea, or CNV due to other causes in the study eye (e.g., ocular histoplasmosis, trauma, or pathological myopia, etc.).
* The fellow (non-study) eye needs anti-VEGF IVT injection (e.g. CNV due to wAMD, trauma, pathological myopia, retina vein occlusion, diabetic macular edema, etc) in the next 3 months, in the investigator's judgment.
* Active or recent (within 1 month prior to dose 1) intraocular, extraocular or periocular infection (including but not limited to conjunctivitis, keratitis, scleritis or endophthalmitis), or history of idiopathic or autoimmune-associated uveitis in either eye.
* Vitreous hemorrhage in study eye within 3 months prior to dose 1.
* Aphakia (except intraocular lens) or posterior capsular rupture of the lens (except yttrium aluminium-garnet (YAG) laser posterior capsulotomy after intraocular lens implantation >=1 month prior to first dose) in the study eye.
* Corneal dystrophy or history of corneal transplantation, scleral softening or history of scleral softening, history of rhegmatogenous retinal detachment or macular hole (Stage II, III or IV) in the study eye.
* Uncontrolled glaucoma (defined as intraocular pressure [IOP] >=25 mmHg despite treatment with antiglaucoma medication), and/or glaucoma filtering surgery (e.g., trabeculectomy, scleral nipping, non-penetrating trabeculectomy, etc.).
* Equivalent spherical diopter of the study eye >=-8D. For participants who had undergone refractive correction or cataract surgery, the equivalent spherical diopter of the study eye before surgery >=-8D.
* Estimated by the Investigator, any concurrent intraocular condition except wAMD (e.g., diabetic retinopathy, dry AMD, retina vein occlusion, uveitis, angioid streaks, retinal detachment, macular epiretinal membrane, amblyopia, central serous chorioretinopathy, etc.) in the study eye that limited the potential to gain visual acuity upon treatment with the investigational product, or could have required medical or surgical intervention during the study to prevent or treat visual loss.
* Underwent intraocular surgery including verteporfin photodynamic therapy (PDT), transpupillary thermotherapy, macular translocation, vitrectomy, laser photocoagulation in macular area, other surgery in macular area or surgery to treat AMD.
* Previous intraocular or periocular surgery within 1 month prior to dose 1(including laser photocoagulation in juxtafoveal, cataract surgery, etc.), or current unhealed wound, moderate or severe ulcer or history of fracture in the study eye.
* Subconjunctival or intraocular or systemic use of corticosteroids within 3 months (including subconjunctival or intraocular long-acting implant within 6 months).
* Previous systemic anti-VEGF therapy or IVT injection of any anti-VEGF drug into either eye or other ocular use of anti-VEGF drug (ranibizumab, aflibercept or conbercept) within 3 months prior to dose 1.
* Participated in any drug (other than vitamins and minerals) or device clinical trials within 3 months or the duration of 5 half-lives of the study drug (which is longer) prior to dose 1 and have used the test drug or received device treatment.
* Pregnancy or lactation.
* Men or women fail to meet both of the following ones: 1) women must have a negative serum pregnancy test result within 14 days prior to initiation of the study intervention; 2) agreement to remain abstinent (refrain from heterosexual intercourse) or use effective contraceptive methods from signed ICF to at least 6 months following the last dose of the study intervention. Effective contraceptive methods include bilateral tubal ligation, male sterilization, established physical contraception and copper intrauterine devices (IUDs).
* Stroke or myocardial infarction within 6 months prior to dose 1, uncontrolled hypertension (systolic blood pressure>=160 mmHg, or diastolic blood pressure >=100 mmHg), etc.
* Uncontrolled diabetes (defined as HbA1c>10.0%).
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) is more than twice the upper limit of normal (ULN), and/or serum creatinine is 1.2 times more than the ULN, and is clinically significant in the opinion of the Investigator.
* Abnormal coagulation function（prothrombin time >= 3 seconds over ULN, activated partial thromboplastin time >= 10 seconds over ULN）
* Active disseminated intravascular coagulation and obvious bleeding tendency within 3 months prior to dose 1.
* Evidence of significant uncontrolled concomitant diseases such as cardiovascular diseases, nervous system diseases, respiratory system diseases, urinary system diseases, digestive system diseases and endocrine diseases.
* Current treatment for active systemic infection, or history of recurrent serious infections.
* Known active or suspected autoimmune diseases, requiring systemic immunosuppressive therapy.
* Positive for syphilis screening test or positive for human immunodeficiency virus (HIV) screening test.
* Known allergy to any component of the study intervention or history of allergy to fluorescein(only for patients who cannot undergo OCT-A examination but have to undergo ICGA examination) or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.
* Participant who has been diagnosed to be COVID-19 within 1 month prior to dose 1 or who has received COVID-19 vaccine within 1week prior to dose 1.
* In the Investigator's judgment, there is evidence of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the participant at high risk for treatment complications, or other conditions considered not amenable to this study.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04993352
|
{
"brief_title": "Evaluate the Safety and Efficacy of HLX04-O in Subjects With wAMD",
"conditions": [
"Age Related Macular Degeneration"
],
"interventions": [
"Drug: recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection"
],
"location_countries": [
"China"
],
"nct_id": "NCT04993352",
"official_title": "A Phase I/II, Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of HLX04-O Administered by Intravitreal Injection in Subjects With Wet Age Related Macular Degeneration (wAMD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-07",
"study_completion_date(actual)": "2023-03-13",
"study_start_date(actual)": "2021-07-15"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-23",
"last_updated_that_met_qc_criteria": "2021-07-28",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-06",
"first_submitted": "2021-07-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will develop an integrated treatment for adolescents who are depressed and suicidal and their parents who are depressed and have a history of suicidality.
Detailed Description
Depression, like many psychiatric disorders, has a genetic component that makes it more likely that members of the same family will have the disorder. Depression in parents, particularly mothers, may put the children at greater risk for depression. When an adolescent whose parent is depressed develops depression himself or herself, treating both the parent and the adolescent may be more effective than treating only the adolescent. This study will test a depression treatment that targets depressed suicidal adolescents with a parent or primary caretaker who is also depressed and has a history of suicidality.
Participation in this study will last 6 months. Participants will be randomly assigned to receive either concurrent parent and adolescent treatment or adolescent only treatment. For those assigned to concurrent treatment, both the adolescent participants and one of their parents will receive individual cognitive behavioral therapy (CBT) counseling sessions and joint family counseling sessions. In the adolescent only treatment condition, adolescent participants will receive individual CBT sessions, but parents will not, and both will receive joint family sessions. Counseling sessions will last 1 hour and occur weekly for 3 months, and then every other week for 3 months. CBT identifies and attempts to change problematic thought patterns. All participants will receive medication consultation if necessary.
Participants will complete assessments at baseline, post-treatment, and 6 months after completing treatment. These assessments will include questionnaires and interviews about depression, suicidal thoughts, mood regulation, behavioral problems, and family. At post-treatment and the 6-month follow-up, participants will also be asked to give feedback about the counseling, medication consultation, and their satisfaction.
#Intervention
- BEHAVIORAL : Concurrent treatment
- Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment.
- Other Names :
- CBT for adolescents and parents
- BEHAVIORAL : Adolescent treatment only
- Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase
|
#Eligibility Criteria:
Inclusion Criteria for Adolescents:
* Lives at home with at least one parent or guardian
* Speaks English
* Must have made a suicide attempt and be diagnosed with major depressive disorder (MDD)
Inclusion Criteria for Primary Caretakers:
* Speaks English
* Current diagnosis of MDD and a history of suicidality
Exclusion Criteria for Adolescents:
* Judged to have developmental or cognitive delays or psychotic disorders on the basis of a standard psychiatric exam
* Diagnosis of bipolar disorder or a substance dependence (people with a diagnosis of substance abuse are eligible)
* Only one adolescent per family is eligible
Exclusion Criteria for Primary Caretakers:
* Diagnosis of bipolar disorder or substance dependence
* If taking antidepressants, not on a stable dose for 3 months
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00951821
|
{
"brief_title": "Concurrent Treatment for Depressed Parents and DepressedAdolescents",
"conditions": [
"Depression",
"Suicide"
],
"interventions": [
"Behavioral: Concurrent treatment",
"Behavioral: Adolescent treatment only"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00951821",
"official_title": "Concurrent Treatment for Parents and Adolescents Who Attempt Suicide",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-12",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "2009-07"
},
"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)": "2015-08-31",
"last_updated_that_met_qc_criteria": "2009-08-03",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-08-04",
"first_submitted": "2009-08-03",
"first_submitted_that_met_qc_criteria": "2015-08-04"
}
}
}
|
#Study Description
Brief Summary
After surgery for gastrointestinal cancer (stomach cancer, pancreaticobiliary cancer, colorectal cancer), many patients experiences various symptoms such as weight loss, diarrhea, constipation and excessive gas due to structural and functional changes in the gastrointestinal tract. These changes are thought to be influenced by alterations in gut microbiota following surgery, but prospective studies are still lacking. It is anticipated that the prebiotic effects of red ginseng may lead to positive changes in total gut bactera after gastrointestinal caner surgery.
Through this study, Investigators aim to investigate the impact of red ginseng consumption on gut microbiota composition, gastrointestinal symptoms, and nutritional status improvement following surgery for gastrointestinal cancer.
#Intervention
- PROCEDURE : Arm I (Red ginseng)
- Step 1. Confrim the inclusion and exclusion criteria to select participants and abtain informed consent before surgery.
Step 2. Before surgery, research nurses randomly assign patients to either the Red ginseng or Control group (single-blind study).
Step 3. Blood tests and stool samples following rectal enema are collected from all patients before surgery.
Step 4. Depending on the type of gastrointestinal cancer (stomach cancer, pancreatobiliary cancer, colorectal cancer), radical resection surgery is performed.
Step 5. From 1 to 4 months after surgery, a three months period is designated for the Red ginseng group to take red ginseng tablets as instructed, with compliance assessements included.
Step 6. Four months after surgery, blood tests and stool samples are collected from all patients.
Step 7. After obtaining samples from the final registered patients, we will commission a contracted institution to conduct microbiome analysis test.
|
#Eligibility Criteria:
Inclusion Criteria:
* Pathologically diagnosed with gastrointestinal cancers (stomach cancer, pancreatobiliary cancer, colorectal cancer) prior to surgery.
* Clinically staged and anticipated to not receive adjuvant chemotherapy after surgery.
* Eligible for complete surgical resection (R0 resection).
* ASA (American Society of Anesthesiologists) score of 3 or below.
* Intereseted in health functional foods.
* Not consumed probiotics or prebiotics for at least three months prior to study enrollment.
* Willing to refrain from consuming additional probiotics or prebiotics during the study period, apart from the provided red ginseng tablets.
Exclusion Criteria:
* Patients aged >= 80 years.
* Patients who received neoadjuvant therapy before surgery.
* Patients with underlying gastrointestinal disorders (e.g., inflammatory bowel disease, ulcerative colitis, Crohn's disease, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, short bowel syndrome, other hereditary gastrointestinal diseases, and autoimmune diseases).
* Patients unable to orally consume red ginseng tablets.
* Patients with a history of previous abdominal organ surgery, radiation therapy, or chemotherapy.
* Patients with intestinal obstruction before surgery.
* Patients regularly taking probiotic or prebiotic supplements.
* Patients requiring formation of an ileostomy after surgery.
* Patients with uncontrolled diabetes that may affect gastrointestinal function.
* Patients with underlying conditions such as liver failure or renal failure.
* Patients allergic to red ginseng.
* Patients who received more than two weeks of antibiotic treatment during hospitalization.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06561516
|
{
"brief_title": "Effects of Red Ginseng on Gastrointestinal Symptoms and Microbiota After Surgery for Gastrointestinal Cancer",
"conditions": [
"Stomach Cancer",
"Pancreatobiliary Cancer",
"Colorectal Cancer"
],
"interventions": [
"Procedure: Arm I (Red ginseng)"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT06561516",
"official_title": "Effects of Red Ginseng on Gastrointestinal Symptoms and Microbiota After Surgery for Gastrointestinal Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-07-14",
"study_completion_date(actual)": "2023-07-14",
"study_start_date(actual)": "2022-06-14"
},
"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)": "2024-08-20",
"last_updated_that_met_qc_criteria": "2024-08-19",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-08-20",
"first_submitted": "2024-08-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients with chronic obstructive pulmonary disease (COPD) have elevated risk of mortality and cardiopulmonary events, particularly following exacerbations. While single inhaler triple therapies (SITTs), such as budesonide/glycopyrrolate/formoterol fumarate (BGF), reduce mortality and cardiopulmonary event risk versus dual bronchodilator therapy, there is limited evidence comparing outcomes associated with SITTs versus multiple inhaler triple therapies (MITTs). SKOPOS-MAZI was a retrospective comparative effectiveness study in patients with COPD aged ≥40 years using US administrative claims data from Optum's de-identified Clinformatics® Data Mart Database. The primary and secondary endpoints were time to all-cause mortality (ACM) and time to first severe cardiopulmonary event following initiation of BGF or MITT (identification period: October 1, 2020-June 30, 2023; index date: first prescription fill). Relative hazards of outcomes were assessed until a censoring event using Cox proportional hazards models, with inverse propensity treatment weighting accounting for between-group imbalances (standardized mean difference \>0.1) in baseline characteristics.
#Intervention
- DRUG : BGF
- Budesonide/glycopyrrolate/formoterol fumarate
- Other Names :
- Breztri
- DRUG : MITT
- Multiple-inhaler triple therapy
- Other Names :
- Open triple therapy combination
|
#Eligibility Criteria:
Inclusion Criteria:
* 1 initial prescription for BGF or MITT starting October 1, 2020 through to the latest available data update, AND
* Age >=40 years on date of first prescription for BGF or MITT episode, AND
* Continuous medical and pharmacy health plan eligibility for >=12-months (365 days) prior to first prescription for BGF or MITT AND
* 2 medical claims with diagnoses for COPD at least 30 days apart occurring on or anytime in the patient's available 24-month history before the first BGF prescription or MITT episode, with one diagnosis occurring in the immediate 12-month period prior to or on initiation of BGF or MITT
Exclusion Criteria:
* Age <40 at time of treatment initiation
* Invalid or unknown gender
* If death date occurs prior to or on study index date
* <12 months (365 days) of medical and pharmacy health plan eligibility/coverage prior treatment initiation
* Presence of >=1 prescription claim for any triple therapy during the patient's entire available baseline history (BGF, FF/UMEC/VI or MITT)
* 'potential MITT use' in baseline, MITT for baseline purposes will be defined as >=1 days continuous days where all three MITT components (ICS, LABA, LAMA) are observed in combination (dual + monotherapy) or as three separate monotherapy components
* History of any of the following conditions, procedures or events during the immediate baseline 12-month period: (a) >=1 medical claim (i.e., office, ED or hospital) in any position with a diagnosis for alpha-1-antitrypsin deficiency, interstitial fibrosis, lung cancer, pulmonary embolism, sarcoidosis; (b) >=1 medical claim for hospice services; (c) Any medical Bill Type Code (BILL_TYPE_CODE ) starting with 81 or 82; or Revenue codes (RVNU_CD): 0651 <= age <= 0659; (d) >=1 medical claim with a diagnosis code of encounter related to clinical trial participation (Z00.6) at any point during the study period (including both baseline and follow-up periods)
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06744374
|
{
"brief_title": "A Comparative Effectiveness Study of Mortality Outcomes and Related Cardiopulmonary Events Among a Cohort of Chronic Obstructive Pulmonary Disease (COPD) Patients Who Initiate Breztri and Multiple Inhaler Triple Therapy (MITT) in the United States (US)",
"conditions": [
"Pulmonary Disease, Chronic Obstructive"
],
"interventions": [
"Drug: BGF",
"Drug: MITT"
],
"location_countries": [
"United States"
],
"nct_id": "NCT06744374",
"official_title": "An Observational, Non-Interventional Comparative Effectiveness Study of Mortality Outcomes and Related Cardiopulmonary Events Among a Cohort of Commercially Insured Chronic Obstructive Pulmonary Disease (COPD) Patients Who Initiate Breztri and Multiple Inhaler Triple Therapy (MITT) in the United States (US)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-03-30",
"study_completion_date(actual)": "2024-03-30",
"study_start_date(actual)": "2024-02-29"
},
"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)": "2024-12-20",
"last_updated_that_met_qc_criteria": "2024-12-17",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-12-20",
"first_submitted": "2024-12-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Abstract
Background:
Local external cooling of the postoperative field is a treatment paradigm aiming for enhanced recovery after joint surgery. It is supposed to reduce pain and improve mobilization, enabling same day surgery.
Hypothesis:
Systematic postoperative cooling and compression after knee arthroscopy will reduce pain and also be reflected by changes in local levels of metabolic and inflammatory variables in the synovial membrane.
Study design:
Prospective randomised study; Level of evidence 1.
Methods:
Forty-four otherwise healthy patients were included in the study and randomised to systematic cooling and compression or NO cooling and compression after knee arthroscopy. Microdialysis of the synovial membrane was performed postoperatively with measurements of PGE2, glucose, lactate, glycerol, glutamate and blood flow (ethanol exchange ratio). Local temperature was monitored as well as postoperative pain (VAS and NRS).
Results:
The application of a cooling and compression device after knee arthroscopy resulted in significantly lower temperature in the operated knee (skin, joint capsule and intraarticularly).
The cooling and compression diminished energy requirements in synovial tissue and a 3 temperature sensitive influence on inflammation (PGE2) were shown. No effect on postoperative pain was detected.
Conclusion:
Local cryotherapy and compression after knee arthroscopy significantly lowered local knee temperature postoperatively. A correlation with synovial PGE 2 and temperature was shown.
Since PGE2 is a pain and inflammatory marker this implicates a positive anti-inflammatory effect induced by postoperative local cooling and compression. Hypothermia is proposed to have a protective effect in ischemic tissue. This is probably due to a decreased metabolic rate and therefore decreased energy requirements as shown by stable levels of lactate despite lower blood flow indicated by increasing ethanol ratio.
#Intervention
- DEVICE : Cooling and compression
- Cooling and compression of the knee postoperatively with an Aircast device.
|
#Eligibility Criteria:
Inclusion Criteria:
* indication for knee arthroscopy due to suspected meniscus injury
Exclusion Criteria:
* osteoarthritis or known systemic inflammatory disease, eg RA
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:
No
|
NCT01247376
|
{
"brief_title": "Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy",
"conditions": [
"Knee Arthroscopy",
"Meniscus",
"Inflammation",
"Hydrops",
"Cooling"
],
"interventions": [
"Device: Cooling and compression"
],
"location_countries": [
"Sweden"
],
"nct_id": "NCT01247376",
"official_title": "Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": "2010-06",
"study_start_date(actual)": "2008-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-11-24",
"last_updated_that_met_qc_criteria": "2010-11-23",
"last_verified": "2010-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-11-24",
"first_submitted": "2010-11-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
evaluatation the efficacy of Aleovera in prevention and treatment of chemotherapy-induced oral mucositis in children suffering from acute leukemia in terms of appearance and severity
#Intervention
- OTHER : Second arm: Using aleovera for Prevention and Treatment of Chemotherapy-Induced Oral Mucositis
- Second arm : aleovera 3 times daily after brushing teeth
|
#Eligibility Criteria:
Inclusion criteria
* Patients suffering from Acute leukemia( Acute Lymphocytic Leukemia ).
* Patients scheduled for chemotherapy treatment.
* Patients who range from 3 <= age <= 13 old.
* Patients with no history of any chemotherapy or radiotherapy. 5 -Both sexes Exclusion Criteria
1-Patients scheduled for radiotherapy treatment . 2-Existence of any signs or symptoms of oral mucositis. 3-Unwilling to participation in the study 4- Patients with any other systemic diseases or other neoplasms.
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 13 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT06757270
|
{
"brief_title": "Efficacy of Aleo Vera Use in Prevention and Treatment of Chemotherapy-Induced Oral Mucositis in a Group of Egyptian Children with Acute Leukemia",
"conditions": [
"Oral Mucositis"
],
"interventions": [
"Other: Second arm: Using aleovera for Prevention and Treatment of Chemotherapy-Induced Oral Mucositis"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT06757270",
"official_title": "Efficacy of Aleo Vera Use in Prevention and Treatment of Chemotherapy-Induced Oral Mucositis in a Group of Egyptian Children with Acute Leukemia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-03-07",
"study_completion_date(actual)": "2024-03-07",
"study_start_date(actual)": "2023-03-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2025-01-03",
"last_updated_that_met_qc_criteria": "2024-12-26",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2025-01-03",
"first_submitted": "2024-12-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to evaluate the effects of martial therapy, comparing different formulations, sucrosomal ferric pyrophosphate, SunActive®Fe micronized and ferric gluconate and different ways of administration, orally and intravenous, in subjects affected by sideropenic microcytic hypochromic anemia identified by the simultaneous presence of anemia, microcytosis and hypoferremia.
Detailed Description
Background: Iron deficiency anemia (IDA) still remains universally a worldwide problematics. Anemia is defined as a hemoglobin value \<12.0 g/dL (7.45 mmol/L). Management of IDA is based on martial iron supplementation. The purpose of the study is to evaluate the effects of martial therapy, comparing different formulations, sucrosomal ferric pyrophosphate, SunActive®Fe micronized and ferric gluconate and different ways of administration, orally and intravenous, in subjects affected by sideropenic microcytic hypochromic anemia identified by the simultaneous presence of anemia, microcytosis and hypoferremia.
Trial Design, Methods and Findings: Clinical data from 106 outpatients (82.8% female and 17.2% male, mean age 50.4 years) were collected at Department of Internal Medicine, National Relevance and High Specialization Hospital Trust, ARNAS Civico-Di Cristina-Benfratelli, Palermo, Italy. The study envisaged five arms (2 + 3). At the first two arms were assigned patients with non-severe anemia Hb\> 10 g/dl (Hb \<12 g/dl for women and Hb \<13 g/dl for men), treated with SunActive®Fe micronized or Lipofer®. At the other three arms were assigned patients with severe anemia (Hb \<10 g/dl) treated respectively with SunActive®Fe micronized, Lipofer® or with intravenous ferric gluconate infusions according to departmental protocols. The followed methodology is defined in the PROBE project (acronym of Prospective Randomized Open Blinded End-point). The end points will be blinded with respect to the three treatments, as it will be the statistical analysis.
#Intervention
- DIETARY_SUPPLEMENT : SunActive®Fe
- SunActive® Fe is a colorless, odorless, tasteless iron fortifier in a powder form. This product is most commonly used to increase the amount of iron in food, beverage, and dietary supplement applications.
- DIETARY_SUPPLEMENT : Lipofer®
- Lipofer® is a micronized and microencapsulated source of iron, enhances the bioavailability of iron and does not taste metallic or oxidize unsaturated fats.
- DIETARY_SUPPLEMENT : Intravenous ferric gluconate
- Sodium ferric gluconate complex is an iron replacement product for treatment of iron deficiency anemia. The stable macromolecular complex is negatively charged at alkaline pH with an apparent molecular weight of 289,000 - 440,000 daltons on gel chromatography. It is composed of iron (III) oxide hydrate directly bonded to sucrose with a chelating gluconate function in a molar ratio of two iron molecules to one gluconate.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of iron deficiency anemia, microcytic and hypochromic
* Age >18
Exclusion Criteria:
* Diagnosis of Celiac Disease
* Patients who refuse to sign the informed consent
* Clinically relevant cognitive Turbe
* Hemodynamic instability defined by the presence of low blood pressure SBP <100 FC> 100
* Dyspnea after modest effort worsening over the past 10 days
* Oxygen peripheral saturation values <94%
* Ischemic heart Recent and / or lower limbs
* Acute conditions with subacute or at recruitment
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
|
NCT03771092
|
{
"brief_title": "Comparing the Efficacy of Different Iron Formulations: Sucrosomal Ferric Pyrophosphate, SunActive®Fe and Intravenous Ferric Gluconate",
"conditions": [
"Iron Deficiency Anemia"
],
"interventions": [
"Dietary Supplement: Intravenous ferric gluconate",
"Dietary Supplement: SunActive®Fe",
"Dietary Supplement: Lipofer®"
],
"location_countries": null,
"nct_id": "NCT03771092",
"official_title": "CONTROLLED RANDOMIZED PILOT STUDY TO COMPARE THE EFFICACY OF DIFFERENT IRON FORMULATIONS: SUCROSOMAL FERRIC PYROPHOSPHATE, SUNACTIVE Fe AND INTRAVENOUS FERRIC GLUCONATE",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-05-30",
"study_completion_date(actual)": "2018-10-30",
"study_start_date(actual)": "2015-11-02"
},
"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)": "2018-12-10",
"last_updated_that_met_qc_criteria": "2018-12-07",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-12-10",
"first_submitted": "2018-11-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the normal distribution of nasal tissue cathelicidin antimicrobial peptides (cAMP) levels in subjects with normal smell and subjects with smell dysfunction. The investigators will also look at the effect of nasal saline irrigation on olfaction and cAMP levels and if nasal irrigation is capable of harvesting olfactory cilia. The investigators hypothesize that nasal saline will have no effect on olfaction and will be inadequate to harvest olfactory cilia.
Detailed Description
The investigators will recruit 40 subjects: 10 with olfactory dysfunction and 30 with normal olfaction. The normal olfaction group will be randomized (15-15)to either daily saline nasal irrigation for one week or no irrigation. Normal olfaction subjects will be seen for two visits, olfactory dysfunction for one. All subjects will complete an UPSIT (smell identification test)and a co-morbidity form. All subjects will have a brief nasal exam and then have nasal cells collected by means of a curette on one side and a cytobrush on the other. All subjects will receive Afrin and lidocaine, to improve visualization and for comfort during cell collection. Subjects will then complete a Comfort Scale related to the methods of cell collection. Normal olfaction subjects randomized to nasal irrigation will receive instructions on how to do it and the irrigation results will be collected for analysis along with the nasal cells. At their return visit, normal olfaction subjects will repeat the UPSIT and the comfort scale--all normal olfaction subjects will have a repeat cell collection. Subjects randomized to nasal irrigation will also complete a transition scale which asks if they feel the irrigation made a difference in their sense of smell. Subjects are compensated for time with a gift card.
#Intervention
- OTHER : saline nasal irrigation
- subjects irrigate with nasal saline daily for one week
|
#Eligibility Criteria:
Inclusion Criteria:
Normal olfactory function cohort:
* self-reported normal smell function
* age greater than 18 years
Olfactory dysfunction cohort:
* ICD9 diagnostic code for olfactory dysfunction
* idiopathic olfactory dysfunction
* age greater than 18 years
Exclusion Criteria:
* allergy to lidocaine
* active upper respiratory infection
* previous nasal or sinus surgery
* current tobacco use
* unable to give consent due to language barrier, cognitive or medical issues
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
|
NCT01332825
|
{
"brief_title": "cAMP (Cyclic Adenosine Monophosphate) Levels in the Nose",
"conditions": [
"Olfactory Disorder"
],
"interventions": [
"Other: saline nasal irrigation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01332825",
"official_title": "cAMP Levels in the Nose",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-10",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2011-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-12-12",
"last_updated_that_met_qc_criteria": "2011-04-08",
"last_verified": "2013-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-04-11",
"first_submitted": "2011-04-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of PC-1005 gel when used as a rectal microbicide in HIV-uninfected men and women (cis or transgender) with a history of consensual receptive anal intercourse.
Detailed Description
PC-1005 is a multipurpose prevention technology (MPT) microbicide in development that is active against HIV, HPV, and HSV-2. This study will evaluate the safety and pharmacokinetics of PC-1005 gel when administered rectally.
The study will enroll HIV-uninfected men and women (cis or transgender) with a history of consensual receptive anal intercourse. All participants will receive 3 single escalating doses of rectally administered PC-1005: 4 mL, 16 mL and 32 mL.
The study includes a total of 9 clinic visits and 1 follow-up contact by phone or in person. Participants will receive doses of PC-1005 at Visits 3, 5, and 7. A 2-to-6 week washout period will follow each dosing visit. If no adverse events that preclude continuation to the next dose are identified during this period, participants will receive the next scheduled dose of PC-1005. Participation in this study will last approximately 3 to 5 months.
Study visits will include physical examinations, throat swabs, behavioral assessments and interviews, and collection of blood, urine, rectal tissue, and cervical, vaginal, and rectal fluid.
#Intervention
- DRUG : PC-1005 gel
- PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL, 16 mL, and 32 mL doses administered rectally.
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women (cis or transgender) who are >= 18 years at Screening, verified per site standard operating procedure (SOP)
* Able and willing to provide written informed consent
* HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in the protocol and willing to receive HIV test results
* Able and willing to provide adequate locator information, as defined in site SOP
* Available to return for all study visits and willing to comply with study participation requirements
* In general good health at Screening and Enrollment, as determined by the site Investigator of Record (IoR) or designee
* At Screening, history of consensual receptive anal intercourse (RAI) at least once in their lifetime per participant report
* Willing to not take part in other research studies involving drugs, medical devices, genital or rectal products, or vaccines for the duration of study participation (including the time between Screening and Enrollment)
* Willing to follow abstinence requirements for the duration of study participation (See the protocol for additional information)
* For participants of childbearing potential: a negative pregnancy test at Screening and Enrollment
* For participants of childbearing potential: Per participant report at Enrollment, using an effective method of contraception and intending to use an effective method for the duration of study participation; these include:
* Hormonal methods, excluding vaginal rings
* Intrauterine device (IUD) inserted at least 42 days prior to Enrollment (but not past the maximum length of recommended usage according to package instructions)
* Sterilization of participant or partner at least 42 days prior to Enrollment
* Self-identifies as having sex with women exclusively
Exclusion Criteria:
* At Screening:
* Hemoglobin Grade 1 or higher*
* Platelet count Grade 1 or higher*
* White blood count Grade 2 or higher*
* Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher*
* Serum creatinine greater than 1.3x the site laboratory upper limit of normal (ULN)
* International normalized ratio (INR) greater than 1.5x the site laboratory ULN
* History of inflammatory bowel disease by participant report
* * As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1, July 2017
* Note: Otherwise eligible participants with an exclusionary test result can be re-tested during the screening process. If a participant is re-tested and a non-exclusionary result is documented within 45 days of providing informed consent for screening, the participant may be enrolled.
* Known adverse reaction to latex or polyurethane (ever)
* Anticipated use of and/or unwillingness to abstain from the following medications during study participation:
* Anticoagulant medications
* Rectally-administered medications
* Known adverse reaction to any of the components of the study product
* Use of pre-exposure prophylaxis (PrEP) for HIV prevention within 1 month prior to Enrollment, and/or anticipated use and/or unwillingness to abstain from PrEP during trial participation
* Use of post-exposure prophylaxis (PEP) for potential HIV exposure within the 3 months prior to Enrollment
* Condomless RAI and/or penile-vaginal intercourse with a partner who is known to be HIV-positive or whose status is unknown in the 6 months prior to Enrollment
* Non-therapeutic injection drug use in the 12 months prior to Enrollment
* Participation in research studies involving drugs, medical devices, genital or rectal products, or vaccines within 30 days of the Enrollment Visit
* Gynecologic, genital, or rectal procedure (e.g., tubal ligation, dilation and curettage, piercing, hemorrhoidal resection, polyp removal) 60 days or less prior to Enrollment, or rectal biopsy, 7 days or less prior to Enrollment. Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap test as well as IUD insertion/removal are not exclusionary. Anoscopy and endoscopy without rectal biopsies are not exclusionary
* Per participant report, medical records, clinical diagnosis and/or diagnostic testing at either Screening or Enrollment:
* Diagnosis or treatment of any anogenital sexually transmitted infection (STI) in the past 3 months (including window between Screening and Enrollment)
* Symptoms, clinical or laboratory diagnosis of active pharyngeal, anorectal infection or reproductive tract infection (RTI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines (http://www.cdc.gov/std/treatment)
* Current symptomatic urinary tract infection (UTI)
* Infections requiring treatment include Neisseria gonorrhea (GC), Chlamydia trachomatis (CT) infection, syphilis, active herpes simplex virus (HSV) lesions, anogenital sores or ulcers, or symptomatic genital warts, chancroid, pelvic inflammatory disease (PID), symptomatic bacterial vaginosis (BV), symptomatic vaginal candidiasis, other vaginitis, and trichomoniasis.
* Note: Otherwise eligible participants with an exclusionary UTI, BV and/or candida finding may be re-tested during the screening process.
* Note: HSV-1 or HSV-2 seropositive diagnosis with no active lesions is permitted since treatment is not required.
* Participants who meet any of the following additional criteria will be excluded from the study:
* Pregnant or breastfeeding at either Screening or Enrollment or planning to become pregnant or begin breastfeeding during study participation. Note: A documented negative pregnancy test performed by study staff is required for inclusion; however, a self-reported pregnancy is adequate for exclusion from screening/enrollment into the study.
* Last pregnancy outcome 90 days or less prior to Screening
* Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
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
|
NCT03408899
|
{
"brief_title": "Evaluating the Safety and Pharmacokinetics of PC-1005 Administered Rectally to HIV-1 Seronegative Adults",
"conditions": [
"HIV Infections"
],
"interventions": [
"Drug: PC-1005 gel"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03408899",
"official_title": "A Phase 1 Safety and Pharmacokinetic Study of PC-1005 (MIV-150/Zinc Acetate/Carrageenan Gel) Administered Rectally to HIV-1 Seronegative Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-19",
"study_completion_date(actual)": "2019-04-19",
"study_start_date(actual)": "2018-06-19"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-04-14",
"last_updated_that_met_qc_criteria": "2018-01-18",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-24",
"first_submitted": "2018-01-18",
"first_submitted_that_met_qc_criteria": "2023-04-13"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the potential effects of repetitive transcranial magnetic stimulation in the improvement of neuropsychological deficits and symptomatology in borderline personality disorder patients. Specially in cognitive flexibility, inhibition control and social cognition.
Detailed Description
This is a randomized, parallel group clinical trial to evaluate the efficacy of two protocols of repetitive Transcranial Magnetic Stimulation (rTMS), the application will be over dorsolateral prefrontal cortex (DLPFC) right and left, in patients with borderline personality disorder. 40 ambulatory patients with a borderline personality disorder diagnosis from the National Institute of Psychiatry in México will be included. All Patients will be randomly assigned and will complete a total of 23 sessions rTMS, in any of two groups:
5 Hz Group.- This group will receive rTMS sessions, 5 per week during three weeks (acute treatment phase), and after that, one session a week for the next eight weeks (follow up). The rTMS will be applied over the left DLPFC at 5 Hz, 1500 pulses per session in 100% of Motor threshold
1 Hz Group.- This group will receive rTMS sessions, 5 per week during three weeks (acute treatment phase), and after that, one session a week for the next eight weeks (follow up).
The rTMS will be applied over the right DLPFC at 1 Hz, 900 pulses per session in 100% of Motor threshold All sessions will be applied with a 'Dantec' transcranial magnetic stimulator. The affective, borderline and anxiety symptoms will be evaluated at baseline, and every 5 TMS sessions during the acute treatment phase, and once at the end of the 8-weeks follow up. In same form for neuropsychological evaluations .
Categorical variables will be described by percentages and frequencies. Continuous variables will be described by means and standard deviations. Treatment groups will be compared using Student's T test. Cognitive, anxiety, borderline and affective symptom scale scores between treatment groups will be compared using repeated measures ANOVA
#Intervention
- DEVICE : Left rTMS 5 Hz
- The subjects will receive transcranial magnetic stimulation (5 Hz of frequency over left dorsolateral prefrontal cortex . Once a day on monday to friday. Until receive 15 sessions. After this the subjects, will be received 8 more sessions of TMS, one session at week for next eight weeks
- DEVICE : Right r TMS 1 Hz
- The subjects will receive transcranial magnetic stimulation (1 Hz of frequency over right dorsolateral prefrontal cortex . Once a day on monday to friday. Until receive 15 sessions. After this the subjects, will be received 8 more sessions of TMS, one session at week for next eight weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of borderline personality disorder according to diagnostic and statistical manual of mental disorders IV text revision
* Treatment with selective inhibitors of serotonin reuptake
* Mass corporal index more than 19
Exclusion Criteria:
* Suicide risk or suicide attempt recent or actual
* History of epilepsy or seizures
* History of cranial trauma with loss awareness
* Intracranial or intraocular ferromagnetic devices, including skull prosthesis.
* Pregnant womens.
* Neurosurgery, cardiac pacemaker, lefthander
* Patients with psychotic symptoms, bipolar disorder or substance addiction.
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
|
NCT02273674
|
{
"brief_title": "TMS in Borderline Personality Disorder Patients",
"conditions": [
"Borderline Personality Disorder"
],
"interventions": [
"Device: Right r TMS 1 Hz",
"Device: Left rTMS 5 Hz"
],
"location_countries": [
"Mexico"
],
"nct_id": "NCT02273674",
"official_title": "Repetitive Transcranial Magnetic Stimulation in Borderline Personality Disorder Patients. Effects in Clinical Measurements, Inhibition, Cognitive Flexibility, and Social Cognition Process",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-01",
"study_completion_date(actual)": "2016-02",
"study_start_date(actual)": "2014-01"
},
"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)": "2016-02-23",
"last_updated_that_met_qc_criteria": "2014-10-21",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-10-24",
"first_submitted": "2014-10-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Compare plasma metabolites following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young and older participants.
#Intervention
- DIETARY_SUPPLEMENT : No MCT intake with breakfast, no lunch
- Water given with a regular standardize breakfast and water given at noon without lunch.
- Other Names :
- CTL
- DIETARY_SUPPLEMENT : No MCT intake with lunch, no breakfast
- Water given in the beginning of the metabolic study day without breakfast and water given at noon with a regular standardize lunch.
- Other Names :
- CTL inverted
- DIETARY_SUPPLEMENT : 10g of Betaquik
- BQ10 given with a regular standardize breakfast and BQ10 given at noon without lunch.
- Other Names :
- BQ10
- DIETARY_SUPPLEMENT : 10g of Betaquik with low-carbs breakfast
- BQ10 given with a low-carbs standardize breakfast and BQ10 given at noon without lunch.
- Other Names :
- BQ10LC
- DIETARY_SUPPLEMENT : 20g of Betaquik
- BQ20 given with a regular standardize breakfast and BQ20 given at noon without lunch.
- Other Names :
- BQ20
- DIETARY_SUPPLEMENT : 10g of Betaquik with lunch, no breakfast
- BQ10 given in the beginning of the metabolic study day without breakfast and BQ10 given at noon with a regular standardize lunch.
- Other Names :
- BQ10 inverted
|
#Eligibility Criteria:
Inclusion Criteria:
* 10 health young (20 <= age <= 40 y old) and 10 health older (> 60 y old) participants
* Men and women
Exclusion Criteria:
* smoking
* diabetes (fasting glucose >7.0 mmol/l and glycated hemoglobin >6.9%)
* strenuous aerobic exercise more than three times a week
* untreated hypertension, dyslipidemia, and abnormal renal, liver, heart or thyroid function
* under medication known to affect triglycerides and carbohydrates metabolism (i.e. diuretics, beta-blockers, steroids, insulin sensitizing)
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03830268
|
{
"brief_title": "Acute Medium Chain Triglycerides (MCT) Intake in Young and Older Participants",
"conditions": [
"Ketonemia"
],
"interventions": [
"Dietary Supplement: 10g of Betaquik with lunch, no breakfast",
"Dietary Supplement: No MCT intake with lunch, no breakfast",
"Dietary Supplement: 10g of Betaquik with low-carbs breakfast",
"Dietary Supplement: No MCT intake with breakfast, no lunch",
"Dietary Supplement: 10g of Betaquik",
"Dietary Supplement: 20g of Betaquik"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03830268",
"official_title": "Optimisation of Acute Medium Chain Triglycerides Intake Characteristics on Different Plasma Metabolites in Young and Older Participants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-25",
"study_completion_date(actual)": "2019-06-25",
"study_start_date(actual)": "2017-06-02"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-25",
"last_updated_that_met_qc_criteria": "2019-02-04",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-05",
"first_submitted": "2019-02-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Invasive Aspergillosis (IA) has increasingly been recognized as an emerging disease of non-neutropenic patients and in patients admitted to the ICU, even in the absence of an apparent predisposing immune-deficiency, with incidence ranges from 0.3% to 5.8% with an overall mortality rate exceeding 80%.
#Intervention
- OTHER : silver nanoparticle
- fungicidal effect of silver nanoparticles on aspergillus isolates
|
#Eligibility Criteria:
Inclusion Criteria:
* intensive care patients
Exclusion Criteria:
* none
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04431804
|
{
"brief_title": "THYME AND CARVACROLL Nanoparticle Effect on Fungi",
"conditions": [
"Aspergillosis"
],
"interventions": null,
"location_countries": [
"Egypt"
],
"nct_id": "NCT04431804",
"official_title": "Effect of Thyme and Carvacroll Nanoparticles on Aspergillus Fumigatus Isolate From Intensive Care Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09-20",
"study_completion_date(actual)": "2020-09-30",
"study_start_date(actual)": "2020-06-11"
},
"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)": "2020-11-05",
"last_updated_that_met_qc_criteria": "2020-06-11",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-16",
"first_submitted": "2020-06-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The specific purpose of this study is to determine the effect of movement training on the onset of motor skills in babies born prematurely. We hypothesize that infants who participate in movement training will show advances in motor skills, visual attention, and toy-oriented behavior.
Detailed Description
The long term goal of this research program is to develop detailed intervention options for physical therapy treatment of very young preterm infants at risk for disability. The ability of infants to start reaching marks the beginning of an infants' ability to independently explore objects, and impacts development across multiple domains, including cognitive, language, and social. The aim of this study is to determine if bi-daily movement training will advance the reaching abilities of infants born preterm as compared to non-movement trained controls.
Movement Training Group:
Parents/Caregivers will be instructed to improve their infants' awareness and ability to reach for toys with their arms and legs by performing two sets of 10 minutes of daily exercises with them. The first 10 minutes will focus on improving awareness of their arms and toys (such as bells on their wrists). The second 10 minutes of activity that focuses on introducing infants to a task-space they rarely experience at this age, the task-space required for midline reaching (such as moving the infant's arm to a midline toy). An experimenter will visit each family in their homes every other week (the week that is not a testing week) to assure correctness of training, encourage full participation and answer any questions.
Social Training Group:
To control for increased social interaction that accompanies the enhanced training, parents of infants in this group will serve as a control group. Parent/Caregivers will be asked to perform 2x a day of 10 minutes face-to-face social interaction with their infants. Parents and infants will receive a 10 minute audio tape of popular kids' songs. They will be instructed to place infants supine or in a bouncy seat and interact with the infant visually and verbally during this time period along with the music.
After the study is completed, each group will be offered the training booklet that the opposite group received.
#Intervention
- BEHAVIORAL : Movement Training
- This group of infants underwent specific movement training activities two times per day with their parents.
- BEHAVIORAL : Social Training
- This group underwent special social interactions with their parents two times each day.
|
#Eligibility Criteria:
Inclusion Criteria:
* Infants born less than 33 weeks gestation (up to and including 32 6/7 weeks)
* Infants born weighing less than 2500 grams
Exclusion Criteria:
* Orthopedic, visual or hearing impairments
* Fetal drug exposure
Sex :
ALL
Ages :
- Minimum Age : 6 Weeks
- Maximum Age : 11 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00268931
|
{
"brief_title": "Development Training in Babies Born Preterm",
"conditions": [
"Premature Birth"
],
"interventions": [
"Behavioral: Movement Training",
"Behavioral: Social Training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00268931",
"official_title": "Enhanced Developmental Training Experiences in Babies Born Preterm",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-04",
"study_completion_date(actual)": "2008-04",
"study_start_date(actual)": "2004-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-04-16",
"last_updated_that_met_qc_criteria": "2005-12-21",
"last_verified": "2013-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-12-23",
"first_submitted": "2005-12-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study evaluates the long-term safety of repeated administrations of Meditoxin® in the treatment of moderate to severe glabellar lines.
#Intervention
- DRUG : MEDITOXIN®
- 20U of Meditoxin® is injected to two places on the corrugators muscle for each eye and one place on the procerus muscle, total of 5 sites.
- Other Names :
- Neuronox®
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women aged between 20 and 65
* Patients attaining >=grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
* Patients who can comply with the study procedures and visit schedule
* Patients who voluntarily sign the informed consent
Exclusion Criteria:
* Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
* Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
* Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
* Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
* Patients who were injected with botulinum toxin within the past 3 months
* Patients with allergy or hypersensitivity to the investigational drugs or their components
* Patients who have bleeding tendency or taking anti-coagulant
* Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
* Patients with skin disorders or infection at the injection site
* Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
* Patients who are unable to communicate or follow the instructions
* Patients who are not eligible for this study based on the judgment of an investigator
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
|
NCT03289169
|
{
"brief_title": "Long-term Safety and Efficacy of MEDITOXIN® in Treatment Glabellar Lines",
"conditions": [
"Glabellar Frown Lines"
],
"interventions": [
"Drug: MEDITOXIN®"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03289169",
"official_title": "A Single-Arm Trial, Open-label, Repeated, Long-term, Multi-center, A Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment With MEDITOXIN® in Treatment of Glabella Line",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-29",
"study_completion_date(actual)": "2019-05-29",
"study_start_date(actual)": "2016-12-30"
},
"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)": "2020-08-27",
"last_updated_that_met_qc_criteria": "2017-09-19",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-09-20",
"first_submitted": "2017-09-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
GSK2981278 is a highly potent and selective inverse agonist of retinoic acid receptor-related orphan receptor gamma (ROR gamma) that is under development for topical treatment of plaque type psoriasis suitable for topical therapy.
This is the first study to administer GSK2981278 to subjects with psoriasis. This proof-of-concept study will evaluate the safety, tolerability and initial efficacy of a range of concentrations of GSK2981278 ointment with repeated topical applications in adult subjects with psoriasis. Results of this study will provide first clinical information on the drug's safety and efficacy in psoriasis and inform the selection of concentration of GSK2981278 ointment to be evaluated in subsequent clinical studies.
This is a Phase 1, single center, test field-randomized, vehicle- and positive- controlled, subject- and evaluator-blind study. All subjects will receive all 6 treatments on 6 test fields, for intra-individual treatment comparison. For every subject, the manner of assignment of each treatment to a particular test field will be according to a randomization scheme. Thus, the test fields within each subject, and not the subjects themselves, will be randomized.
The study will consist of screening, followed by a treatment period of 19 days, and a follow-up visit at Day 27 (+/-2) for subjects who will consent for biopsy. During the treatment period, subjects will receive all of these treatments: GSK2981278 ointment 0.03% weight by weight \[w/w\], 0.1% w/w, 0.8% w/w, 4% w/w, GSK2981278 vehicle, and betamethasone valerate 0.1% cream. The test fields on which these treatments will be applied will be identified on stable plaque(s) on the upper extremities, thighs and/or trunk. A blinded evaluator (an investigator or designee) will perform the measurements and assessments whereas an unblinded study staff member (not an evaluator) will perform biopsy collection.
#Intervention
- DRUG : GSK2981278 0.03%
- GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.03%. Approximately 200 microliters of the GSK2981278 0.03% ointment will be applied topically to the assigned test field once daily.
- DRUG : GSK2981278 0.1%
- GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.1%. Approximately 200 microliters of the GSK2981278 0.1% ointment will be applied topically to the assigned test field once daily.
- DRUG : GSK2981278 0.8%
- GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.8%. Approximately 200 microliters of the GSK2981278 0.8% ointment will be applied topically to the assigned test field once daily.
- DRUG : GSK2981278 4%
- GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 4%. Approximately 200 microliters of the 4% ointment will be applied topically to the assigned test field once daily.
- DRUG : Vehicle
- GSK2981278 vehicle will be supplied as a white to off-white ointment containing no drug substance. Approximately 200 microliters of the vehicle will be applied topically to the assigned test field once daily.
- DRUG : Betamethasone valerate 0.1%
- Betamethasone valerate will be supplied as a cream. Approximately 200 microliters of the 0.1% betamethasone valerate cream will be applied topically to the assigned test field once daily.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years and above, at the time of signing the informed consent.
* Subjects with stable plaque psoriasis for >= 6 months, as confirmed by the subject.
* Up to three plaque area(s) sufficient for six test fields. The target lesion(s) should be on the trunk, upper extremities or thighs (excluding hands and skin folds); psoriatic lesion(s) on the knees or elbows are not to be used as a target lesion. It is recommended, but not required, that all selected plaques are symmetrical in location, size and clinical characteristics.
* Plaques to be treated should have a comparable thickness of the Echo Lucent Band (ELB) (as a surrogate for the psoriatic infiltrate thickness) of at least 200 micrometers on Day 1.
* Male:
Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until after the last dose of study medication.
* Vasectomy with documentation of azoospermia.
* Male condom. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
* Female of non-reproductive potential (FNRP):
A FNRP is eligible to participate in this study if she meets at least one of the following conditions:
* Females with one of the following procedures documented and no plans to utilize assisted reproductive techniques (e.g., in vitro fertilization or donor embryo transfer): Bilateral tubal ligation or salpingectomy; Hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Bilateral Oophorectomy (surgical menopause)
* Post-menopausal women (including all women > 60 years, see below), Post-Menopause criteria: Females 60 years or older; A practical definition accepts menopause after 1 year without menses with an appropriate clinical profile, e.g., age appropriate, >45 years, in the absence of hormone replacement therapy (HRT) or medical suppression of the menstrual cycle (e.g., leuprolide treatment) [In questionable cases for women < 60 years, a blood sample with simultaneous follicle stimulating hormone and estradiol falling into the central laboratory's post-menopausal reference range is confirmatory (these levels need to be adjusted for specific laboratories/assays)]; Females under 60 years, who are on HRT and wish to continue, and whose menopausal status is in doubt, are required to use a highly effective method to avoid pregnancy, as outlined in the protocol. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a highly effective method to avoid pregnancy
* Capable of giving signed informed consent, which includes compliance with the pre-specified requirements and restrictions.
Exclusion Criteria:
* Alanine aminotransferase (ALT) >2xUpper Limit of Normal (ULN) and bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* Corrected QT (QTc) interval > 450 milliseconds (msec) or QTc > 480 msec in subjects with Bundle Branch Block. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), and/or machine-read. The QTc should be based on single QTc values of ECG obtained over a brief recording period.
* Any condition that, in the judgement of the investigator, would put the subject at unacceptable risk for the participation in the trial.
* Current evidence of another ongoing or any acute cutaneous infection, history of repeated or chronic significant skin infections (unless irrelevant in the opinion of the investigator, i.e. onychomycosis, labial herpes or other minor diagnosis).
* Clinically-relevant skin disease, other skin pathologies, or a history of skin cancer, that may, in the opinion of the investigator, contraindicate participation or interfere with test field evaluations.
* History of malignancy within 5 years prior to dosing, except adequately treated noninvasive cancer of the skin (basal or squamous cell).
* Psoriasis other than plaque variants.
* Use of prohibited concomitant medications or products within the defined washout periods before the Day 1 visit and during the trial.
* 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 investigator or Medical Monitor, contraindicates their participation.
* Contraindications according to summary of product characteristics of the active positive control.
* Symptoms of a clinically significant illness that may, in the opinion of the investigator, influence the outcome of the trial in the 4 weeks before baseline visit and during the trial.
* Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
* A positive pre-study drug/alcohol screen.
* A positive test for human immunodeficiency virus (HIV) antibody.
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
* Prolonged exposure to natural or artificial sources of ultraviolet (UV) radiation within 2 weeks prior to the Day 1 visit or intention to have such exposure during the study, thought by the investigator likely to modify the subject's psoriasis.
* In the opinion of the investigator or physician performing the initial examination the subject should not participate in the clinical trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent.
* Close affiliation with the investigator (e.g. a close relative) or persons working at Bioskin GmbH or subject is an employee of sponsor.
* Subject is institutionalized because of legal or regulatory order.
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
|
NCT02548052
|
{
"brief_title": "Study of Safety and Efficacy of Topical GSK2981278 Ointment in Plaque Psoriasis",
"conditions": [
"Psoriasis"
],
"interventions": [
"Drug: GSK2981278 0.8%",
"Drug: GSK2981278 4%",
"Drug: GSK2981278 0.03%",
"Drug: GSK2981278 0.1%",
"Drug: Vehicle",
"Drug: Betamethasone valerate 0.1%"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT02548052",
"official_title": "A Phase I Trial to Evaluate Safety and Efficacy of Topically Applied GSK2981278 Ointment in a Psoriasis Plaque Test",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02-19",
"study_completion_date(actual)": "2016-02-19",
"study_start_date(actual)": "2015-10-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-15",
"last_updated_that_met_qc_criteria": "2015-09-10",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-14",
"first_submitted": "2015-09-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Background: Low back pain (LBP) is still a frequent health problem. Recurrance of symptoms leads to high absence at work. It was proved in previous studies that low back manual massage has a significant impact on pain reduction. Trabert current (TC) is common physical modality used in rehabilitation of patients with LBP. The aim of study was to assess the effectiveness of manual massage in comparison to TC in patients with LBP.
Methods: Sixty patients with LBP were enrolled in to the study. In all patients discopathy and spondyloarthrosis were diagnosed. The subjects were randomly assigned to two groups: massage (I=30) and TC (II=30) therapy. The procedures were performed for ten days. Pain intensity was assessed by Numerical Rating Scale. Quality of life and the degree of disability were evaluated by Oswestry Disability Index and Roland-Morris Disability Questionnaire.
Results: In both groups pain reduction and functional improvement were observed after therapy. However, better results were noticed in group I.
#Intervention
- DEVICE : Trabert current
- Trabert current is an interrupted direct current of low frequency (143 Hz) applied via medium sized electrodes supported on a thick moist viscose sponge. These electrodes are placed near the spinal column along the thoracolumbar region. The electrodes are separated from each other by a distance of 3-4 cms.The current is passed through electrodes placed on the body. The intensity of the current is gradually increased short of pain. The feeling should be a pronounced but a comfortable 'tingling' sensation ('comfortably strong'). By doing this, the optimum current strength specific to the patient is found. The intensity of the current is slowly increased in the first few minutes as patients get used to the sensation. It is thought that this current provides pain relief, reduces muscle spasm and increases blood flow.
- Other Names :
- Ultra-Reiz current
- OTHER : Manual massage
- Therapeutic massage is the manipulation of the soft tissue of whole body areas to bring about generalised improvements in health.Massage is thought to work through a mechanical action and a reflex action. A mechanical action is created by moving the muscles and soft tissues of the body using pressure and stretching movement. This mechanical action is based on breaking up fibrous tissue and loosen stiff joints.It may help heal damaged muscle, stimulate circulation, clear waste products via the lymphatic system, boost the activity of the immune system, reduce pain and tension and induce a calming effect.
|
#Eligibility Criteria:
Inclusion Criteria:
* confirmed in X-ray spondyloarthrotic changes in lumbar area of spine
* pain of lumbar area lasting than 1 year
Exclusion Criteria:
* cardiac rythm disturbances
* cardiac pacemaker
* heart failure
* pulmonary embolism
* atherosclerosis
* neoplasmatic diseases
* skin lesions or purulent changes in the area of procedure
* pregnancy
* advanced osteoporosis
* spine fractures
* fever
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03772093
|
{
"brief_title": "The Effectiveness of Short-term Massage Versus Trabert Current Therapy in Patients With Low Back Pain",
"conditions": [
"Low Back Pain"
],
"interventions": [
"Other: Manual massage",
"Device: Trabert current"
],
"location_countries": null,
"nct_id": "NCT03772093",
"official_title": "The Effectiveness of Short-term Massage Versus Trabert Current Therapy in Patients With Low Back Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09-30",
"study_completion_date(actual)": "2018-10-30",
"study_start_date(actual)": "2016-01-01"
},
"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)": "2018-12-11",
"last_updated_that_met_qc_criteria": "2018-12-10",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-12-11",
"first_submitted": "2018-12-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This project has been completed and consisted of a randomised trial of six tailored decision aids giving patients evidence-based information about faecal occult blood test screening for bowel cancer. 314 Australians aged between 50-74 years were recruited from five general practices and randomised to received either the tailored decision aid with age-gender and family history specific information and values clarification exercise or a standard government information sheet.
The decision aid significantly increased the proportion of people who were informed participants in the screening program.
#Intervention
- BEHAVIORAL : Decision Aid
|
#Eligibility Criteria:
Inclusion Criteria:
* People aged 50 <= age <= 74 years who were eligible for FOBT screening under current Australian guidelines and had not had screening for colorectal cancer in the preceding two years
Exclusion Criteria:
* Poor English, impaired cognition, significant comorbidity
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00148226
|
{
"brief_title": "ICIBS Trial - Improving Patient Information About Bowel Cancer Screening - a Decision Aid Trial",
"conditions": [
"Colorectal Cancer Screening"
],
"interventions": null,
"location_countries": [
"Australia"
],
"nct_id": "NCT00148226",
"official_title": "Randomized Controlled Trial of Patient Decision Aids for Faecal Occult Blood Test Screening",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2005-09",
"study_start_date(actual)": "2003-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "ECT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2006-01-04",
"last_updated_that_met_qc_criteria": "2005-09-05",
"last_verified": "2005-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-07",
"first_submitted": "2005-09-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study of a randomized controlled trial aims to evaluate the feasibility of a 12-week sleep program and the randomized controlled trial research procedure. In total 20 participants will be recruited and randomized to the intervention or control group.
Detailed Description
This feasibility study of a randomized controlled trial, aims to evaluate the feasibility of a 12-week sleep program consisting on aerobic exercise and cognitive-behavioral therapy. In this study the investigators wish to evaluate the program as well as the randomized controlled trial research procedure.
In total 20 participants will be recruited and randomized to either the intervention group (n=10) or control group (n=10).The intervention group will participate in two exercise sessions each week and four sessions based on cognitive-behavioral therapy for insomnia.
#Intervention
- BEHAVIORAL : 12-week aerobic exercise and cognitive-behavioral therapy
- 12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Prostate cancer
* Receiving treatment with androgen deprivation therapy or in combination with chemotherapy
* Insomnia
* Over 18-yers old
* Understand oral and written Danish
* Written informed consent
Exclusion Criteria:
* Medical assessment that does not allow aerobic exercise
* Severe cognitive problems
* Night work during the interventions period
* Exercise training more than three times a week
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03444532
|
{
"brief_title": "Feasibility Study Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia",
"conditions": [
"Cancer of Prostate",
"Insomnia"
],
"interventions": [
"Behavioral: 12-week aerobic exercise and cognitive-behavioral therapy"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT03444532",
"official_title": "Feasibility Study of a Randomized Controlled Trial Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-31",
"study_completion_date(actual)": "2019-05-31",
"study_start_date(actual)": "2018-03-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-05-05",
"last_updated_that_met_qc_criteria": "2018-02-22",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-23",
"first_submitted": "2018-02-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study has 2 primary research questions, 4 secondary research questions, and 2 auxiliary research questions targeting elderly with hearing impairment. The research questions are:
Primary study questions:
1. Can the use of the smart hearing aids reduce loneliness at the end of intervention?
2. Can the use of the smart hearing aids improve quality of life at the end of intervention?
Secondary study questions:
3. Can the use of the smart hearing aids improve the communication quality between caregivers and participants at the end of intervention?
4. How is the satisfaction of the participants with the smart hearing aids?
5. What are the factors leading to the use and non-use of the smart hearing aids?
6. What is the usage time of the smart hearing aids?
Auxiliary study questions:
7. How is the caregiver burden when facilitating the participants to use the smart hearing aids?
8. What are the perceived benefits and acceptability of the smart hearing aids?
Detailed Description
Study design
This is a randomised waitlist controlled trial of comparing the outcome indicators between elders using the smart hearing aids for 6 weeks and elders not using the aids. Elders with hearing impairment from District Elderly Community Service, Haven of Hope Christian Service (HOH DECS) and Day Care Centre for the Elderly, Haven of Hope Christian Service (HOH DE) per the verbal or written medical recommendation by doctor, nurse, physiotherapist, occupational therapist or speech therapist, or currently using hearing aids other than the smart hearing aids in the current study. We will also explore the perceived benefits and acceptability of the smart hearing aids of the participants and caregivers.
This protocol complies with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Guideline for Good Clinical Practice (ICH-GCP) and Declaration of Helsinki.
Subjects
Elders with hearing impairment per the verbal or written medical recommendation by doctor, nurse, physiotherapist, occupational therapist or speech therapist, or currently using hearing aids other than the smart hearing aids in the current study from HOH DECS and HOH DE will be recruited for the main analysis.
Procedures
Caregiver training
Identical training sessions will be delivered to caregivers on calibrating and facilitating the participants to use the smart hearing aids.
Participants' recruitment and consent
In the study sites, the staff will invite eligible residents and members to join the trial. Residents scoring above the cutoff for dementia in Montreal Cognitive Assessment (MoCA) and not receiving a medical diagnosis of dementia or other mentally incapacitating disease will be classified as competent in giving consent. For elders scoring below the cutoff in MoCA or receiving a diagnosis of mentally incapacitating disease, we will follow the criteria stated in the Alzheimer Europe Report (2011) to ensure that they are provided chances to give consent. In particular, four criteria will be evaluated, including 1) the person must have sufficient capacity to understand the information, 2) the person is able to retain, use and weight up such information for making a decision, 3) the person will understand the benefit, risk, and convenience, 4) the person must have the ability to communicate the decision. The University of Hong Kong (HKU) research staff and the care staff will first commit them in a causal chat to assess their ability to communicate and understand the dialogues.
If residents / members are competent in giving consent, both residents / members and their family members will be approached for consent. In cases residents are not competent in giving consents, only their family members will be approached for consent. They will then be referred to join a 1-to-1 study introduction session. In this session, HKU research staff and service unit staff will introduce the study to the participant, and invite them to sign a consent form. As a voluntary participation, the participants have the right to withdraw from the study and intervention any time without consequences.
For caregivers, written informed consent will be obtained before doing qualitative interview.
Baseline assessment
After the consent is obtained, the HKU research staff will assist the participants to complete UCLA Loneliness Scale 3-item (UCLA 3-item), World Health Organization Quality of Life Brief Version (WHOQOL-BREF), and Satisfaction with Amplification in Daily Life (SADL) (if they currently use other brands of hearing aids).
Randomization
Participants will be individually randomized to experimental group to use the smart hearing aids from week 1 to week 6, or wait-list control group to follow existing practice (i.e. using no hearing aids or using hearing aids other than the smart hearing aids) from week 1 to week 6 and use the smart hearing aids from week 8 to week 14. A list of random numbers will be generated to create a list of random group allocation (either experimental or wait-list control; allocation ratio 1:1), using the rand function of Excel. The research staff will perform the randomization procedure, by assigning consenting participants who meet all eligibility criteria to the two groups using the list.
Calibration
The caregivers will calibrate the smart hearing aids for the participants in the experimental group at the first day of week 1 and the wait-list control group at week 8 through the designated mobile application. Caregivers will help the participants to choose the amplification level which best suits their needs.
Implementation
Participants in the experimental group can use the smart hearing aids whenever they want during the trial period (i.e. from week 1 to week 6). For participants living in residential setting, caregivers will facilitate them to use the smart hearing aids upon request from the participants or when the caregivers deem the aids beneficial. For participants living in community setting, they will use the smart hearing aids when needed. Their caregivers shall provide assistance in facilitating the participants to use the smart hearing aids. The smart hearing aids do not require any payment from the study participants. They have to return the hearing aids after the study.
Participants in the wait-list control group will continue the current practice (i.e. using conventional hearing aids or no hearing aids) from week 1 to week 8, and will use the smart hearing aids from week 8 to week 14. Caregivers will facilitate the participants to use the smart hearing aids.
Data collection
HKU research staff who is blinded to the group allocation will administer all the questionnaire in assessing the primary outcomes. For the experimental group, the questionnaire assessing the primary outcomes and the secondary outcomes of communication quality and satisfaction with the hearing aids will be administered at baseline and week 6. HKU research staff will conduct questionnaire exploring the secondary outcomes of factors leading to the use and non-use of the smart hearing aids, usage time with caregivers and participants and the auxiliary outcome of caregiver burden at week 1, week 3, and week 6. For wait-list control group, the questionnaire assessing the primary outcomes will be administered at baseline, week 6 and week 14. The questionnaire exploring the secondary and auxiliary outcomes will be conducted by HKU research staff with caregivers and participants at week 8, week 10, and week 14.
In case of events (e.g. COVID-19) that prohibit HKU research staff from conducting assessment on site, assessment will be conducted via online communication apps (e.g. Zoom).
Qualitative interview
To collect feedback towards the smart hearing aids, we will use purposive sampling to select 10 - 15 participants and 4 - 8 caregivers to conduct semi-structured qualitative interviews to collect opinion on their perceived acceptance and benefits on the features of the smart hearing aids. An interview guide with open-ended and iterative questions will be used to probe for more experiences from the interviewees. Each interview will be conducted by a trained research assistant and will last about 30 minutes.
Blinding
Participants and caregivers cannot and will not be blinded to the intervention. Assessor(s) of the follow-up outcomes and the research analysts will not be involved in the recruitment and intervention delivery and will be blinded to the group allocation (single blindness).
Sample size determination
The sample size is estimated by the current number of elders with hearing impairment and / or currently using hearing aids other than the smart hearing aids used in this study in the test sites. In the HOH DECS, 10 elders have been diagnosed hearing impairment and / or are using hearing aids other than the smart hearing aids used in the study. In the HOH DE, 20 have been diagnosed or are using other hearing aids. Therefore, the study will include 30 elders in total.
With reference to Nieman et al. (2022), the between group change difference on UCLA loneliness scale (20-item version) is 2.26 with a pooled variance of 61.9. Using the sample size calculation formula in Noordzij et al. (2010), Type 1 error rate of 5% and power 80%, the number of participant required for each group, 18 participants are required in each group for analysis. Assuming attrition rate of 5%, at least 20 participants need to be recruited.
Data analyses
Main analysis
Linear mixed model analysis will be used to test the interaction between group and time. A partial-eta square will be used to estimate the effect size of the outcome indicators in comparing the intervention group with the wait-list control group. Dependent sample t-test will be used to investigate the within group effects based on the data from both experimental and wait-list control group.
Process evaluations
For the quantitative secondary outcomes, descriptive statistics will be used to show the opinions. For the qualitative secondary outcomes, the content will be analyzed using framework analysis to construct a coherent and logical structure from the classification of many opinions.
Qualitative interview
The interview content will be transcribed verbatim in Chinese for further analysis. We will analyze the qualitative interview transcripts using framework analysis to construct a coherent and logical structure from the classification of many opinions and perceptions on the use of the smart hearing aids. The results will then be discussed and consolidated in the panel meetings with the co-authors.
#Intervention
- DEVICE : Experimental group intervention
- The caregivers will calibrate the smart hearing aids for the participants in the experimental group at the first day of week 1 through the designated mobile application. Caregivers will help the participants to choose the amplification level which best suits their needs.
Participants in the experimental group can use the smart hearing aids whenever they want during the trial period (i.e. from week 1 to week 6). For participants living in residential setting, caregivers will facilitate them to use the smart hearing aids upon request from the participants or when the caregivers deem the aids beneficial. For participants living in community setting, they will use the smart hearing aids when needed. Their caregivers shall provide assistance in facilitating the participants to use the smart hearing aids. The smart hearing aids do not require any payment from the study participants. They have to return the hearing aids after the study.
- DEVICE : Wait-list control group intervention
- The caregivers will calibrate the smart hearing aids for the participants in the wait-list control group at week 8 through the designated mobile application. Caregivers will help the participants to choose the amplification level which best suits their needs.
Participants in the wait-list control group will continue the current practice (i.e. using conventional hearing aids or no hearing aids) from week 1 to week 8, and will use the smart hearing aids from week 8 to week 14. Caregivers will facilitate the participants to use the smart hearing aids.
|
#Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for participants:
* With hearing impairment per the verbal or written medical recommendation by doctor, nurse, physiotherapist, occupational therapist or speech therapist, or currently using hearing aids other than the smart hearing aids in the current study, and
* Able to understand Chinese
Inclusion criteria for caregivers:
* Responsible for helping the participants to use the smart hearing aids, and
* Able to understand Chinese
Exclusion Criteria:
Exclusion criteria for participants:
* Unable to use the hearing aids independently, and
* Unable to use the hearing aids with caregivers' assistance, or
* Ménière's disease, or
* Deafness (i.e. cannot hear speech, even when the speaker is talking loudly next to the better hearing ear)
Exclusion criteria for caregivers:
* Nil
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT05772949
|
{
"brief_title": "Effectiveness of a Smart Hearing Aid on Improving Psychosocial Well-being in Elderly",
"conditions": [
"Technology"
],
"interventions": [
"Device: Wait-list control group intervention",
"Device: Experimental group intervention"
],
"location_countries": [
"Hong Kong"
],
"nct_id": "NCT05772949",
"official_title": "Effectiveness of a Smart Hearing Aid on Improving Psychosocial Well-being in Elderly: A Randomized-controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-12",
"study_completion_date(actual)": "2023-09-12",
"study_start_date(actual)": "2023-03-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-29",
"last_updated_that_met_qc_criteria": "2023-03-02",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-03-17",
"first_submitted": "2023-03-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A study to assess, in a two-arm open-label cluster randomized clinical trial, the efficacy of a 5-day course of LPV/r treatment in preventing COVID-19 in asymptomatic individuals exposed to a SARS-CoV-2 documented index patient, compared to surveillance alone.
#Intervention
- DRUG : Lopinavir/ritonavir
- 2x 200mg/50mg, twice daily for 5 days (bid, PO)
|
#Eligibility Criteria:
Inclusion criteria:
* Documented close contact with a person with either a PCR-confirmed SARS-CoV-2 or a positive rapid SARS-CoV-2 antigen test (as per standard of care).
* Enrolment of the participant no more than 7 days since last contact with index case;
* >= 16 years;
* Informed consent as documented by signature (including parent's or legal guardian's signature if the participant is between 16 and 18 y.o.).
Exclusion criteria*:
* Fever (temperature >38.0°C) and/or respiratory symptoms (cough, dyspnea) and/or new anosmia/ageusia;
* Individuals with previous confirmed SARS-CoV-2 infection, dating within the last six months ;
* Known impairment of liver function;
* Known hypersensitivity to the study medications;
* Use of any medications that are contraindicated with lopinavir/ritonavir using the website www.hiv-druginteractions.org/checker
* Individuals on boosted protease inhibitor (other than LPV) or boosted elvitegravir as part of an antiretroviral therapy
* Inability to be followed-up for the trial period
* Documented vaccination against SARS-CoV-2
* Where necessary, additional biological and clinical assessment will be performed, based on clinical judgement.
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04364022
|
{
"brief_title": "Efficacy of Pragmatic Same-day COVID-19 Ring Prophylaxis for Adult Individuals Exposed to SARS-CoV-2 in Switzerland",
"conditions": [
"Prevention of COVID-19"
],
"interventions": [
"Drug: Lopinavir/ritonavir"
],
"location_countries": [
"Brazil",
"Switzerland"
],
"nct_id": "NCT04364022",
"official_title": "Efficacy of Pragmatic Same-day Ring COVID-19 Prophylaxis for Adult Individuals Exposed to SARS-CoV-2 in Switzerland: an Open-label Cluster Randomized Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-03-24",
"study_completion_date(actual)": "2021-03-24",
"study_start_date(actual)": "2020-04-23"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-04-12",
"last_updated_that_met_qc_criteria": "2020-04-24",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-27",
"first_submitted": "2020-04-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study tests the effects of cannabinoid levels in blood on pain relief, inflammation, and cognitive dysfunction in chronic pain patients who choose to use edible cannabis. Over a two-week period, participants use an edible product of their choice. Blood levels of 9-delta-tetrahydrocannabinol (THC) and cannabidiol (CBD) will be measured before, during, and after the two-week exposure period to determine whether there are associations with pain, inflammation, sleep, physical activity, anxiety/depression, and cognitive dysfunction. After the two-week self-administration period, participants will be followed for six months to collect self-report data on cannabis use, pain levels, sleep quality, and mental health symptoms.
Detailed Description
The National Center for Health Statistics reports that approximately 76 million Americans suffer from chronic pain, affecting the lives of more Americans than cancer, diabetes, and heart disease combined. Perhaps because of its ubiquity and the challenge to its treatment, relief from chronic pain is by far the most commonly cited condition by patients for use of marijuana, with 87%-94% of medical marijuana users reporting using for relief of a pain condition.
Although the mechanisms are still unclear, marijuana and its constituent cannabinoids, including 9-delta-tetrahydrocannabinol (THC), are thought to be involved in reducing pain and associated inflammation. However, THC is also associated with harm in the form of cognitive dysfunction. Synergistic interactions of multiple cannabinoids are believed to produce different effects on both pain relief and cognitive function as compared to THC alone. For example, cannabidiol (CBD) is another primary cannabinoid that may work synergistically with THC in a multi-target analgesic approach.
This study examines the effects of cannabinoids in edible form on pain relief, inflammation, and cognitive dysfunction in chronic pain patients who choose to use marijuana in the context of a short-term (2 weeks), patient-oriented, observational design and a mobile pharmacology and phlebotomy lab.
#Intervention
- DRUG : Cannabis Edible
- Self-Directed Use (ad-libitum)
|
#Eligibility Criteria:
Inclusion Criteria:
* Intent to initiate use of marijuana to treat chronic pain
* At least one episode of lifetime marijuana use, but infrequent marijuana use for prior six months
* Self-reported non-specific chronic low back pain for at least three months
* Health eligibility approved by study physician
* At least mild to moderate pain intensity OR pain interferes with important life functions
Exclusion Criteria:
* Other drug use (cocaine, methamphetamine, etc.) in the past 3 days and/or actively seeking or in treatment for any substance use disorder
* Use of marijuana to treat pain at any time in lives
* Current use of psychotropic medications (other than SSRIs and ADHD meds), or use of antivirals, steroids, or regular use of maximal doses of NSAIDS
* A daily tobacco user
* Are currently pregnant or trying to become pregnant
* Acute illness (other than chronic pain) or any immune-related disease (e.g., HIV)
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03522324
|
{
"brief_title": "Pain Research: Innovative Strategies With Marijuana",
"conditions": [
"Chronic Pain",
"Chronic Low Back Pain",
"Cannabis Use"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT03522324",
"official_title": "An Observational Study of the Effects of Edible Cannabis and Its Constituent Cannabinoids on Pain, Inflammation, and Cognition",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-04-10",
"study_completion_date(actual)": "2023-10-12",
"study_start_date(actual)": "2018-06-01"
},
"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)": "2023-10-16",
"last_updated_that_met_qc_criteria": "2018-05-09",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-05-11",
"first_submitted": "2018-04-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary Objectives:
* Dose Escalation Part A: To determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B
* Dose Expansion Part B: To assess the antitumor activity of single agent of SAR442085 at the RP2D in patients with RRMM
Secondary Objectives:
* To characterize the safety profile of SAR442085
* To characterize the pharmacokinetics (PK) profile of SAR442085 when administered as a single agent
* To evaluate the potential immunogenicity of SAR442085
* To assess preliminary evidence of antitumor activity in the Dose Escalation Part A
Detailed Description
Patient will continue to receive study medication until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason why investigator considers it appropriate to discontinue study medication. Once permanently discontinued, study medication cannot be restarted at later timepoint.
#Intervention
- DRUG : SAR442085
- Pharmaceutical form:Sterile lyophilized powder for reconstitution for infusion Route of administration: intravenous
|
#Eligibility Criteria:
Inclusion criteria :
* Participant must be at least 18 years or of the country's legal age of majority if the legal age is >18 years, at the time of signing the informed consent.
* Participant has given voluntary written informed consent.
* Participant has been previousy diagnosed with multiple myeloma based on standard criteria.
* Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior lines of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide), at least 1 anti-CD38 monoclonal antibody and at least 1 steroid. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards. (3) Participant had at least a minimal response (MR) to the anti-CD38 antibody containing regimen and had last dose of anti-CD38 monoclonal antibody at least 9 months prior to study entry. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards.
* Part B and the last cohort(s) of Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior line of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide) and at least 1 steroid. (3) Prior therapy has not included an anti-CD38 monoclonal antibody.
* Participant has myeloma disease progression on or after last therapy.
* Participant must have measurable disease as defined as at least one of the following:
* Serum M protein >=0.5 g/dL (>=5 g/L)
* Urine M protein >=200 mg/24 hours
* Serum FLC assay: Involved FLC assay >=10 mg/dL (>=100 mg/L) and an abnormal serum
* FLC ratio (<0.26 or >1.65).
* A male participant must agree to use contraception during the intervention period and for at least 150 days after the last dose of study drug and refrain from donating sperm during this period.
* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
* Not a woman of childbearing potential (WOCBP)
* A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 150 days after the last dose of study intervention.
Exclusion criteria:
* Participant is diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, superficial bladder carcinoma or low risk prostate cancer.
* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score >2.
* Participant has a history of Chronic obstructive pulmonary disease (COPD) or asthma.
* Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade <=1 or baseline (exception: alopecia).
* Participant has congestive heart failure (New York Heart Association) Grade >=II; cardiac myopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension, QT interval corrected by the Fridericia method >480 msec (Grade >=2).
* Participant has had acute myocardial infarction within 6 months before first dose of study medication.
* Participant has ongoing sensory or motor neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >=3.
* Participant has active autoimmune disease including autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, inflammatory bowel syndrome, pneumonitis or any chronic condition requiring a higher corticosteroid systemic equivalent than prednisone 10 mg daily.
* Known acquired immunodeficiency syndrome (AIDS) or related illnesses or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or to have active hepatitis A, B (defined as a known positive hepatitis B surface antigen (HBsAg) result or positive HepB DNA), or C (defined as a known quantitative hepatitis C [HCV] ribonucleic acid RNA results greater than the lower limits of detection of the assay or positive HCV antigen) infection.
* Participant has positive Coombs test at baseline.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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
|
NCT04000282
|
{
"brief_title": "First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma",
"conditions": [
"Plasma Cell Myeloma"
],
"interventions": [
"Drug: SAR442085"
],
"location_countries": [
"France",
"United States",
"Taiwan",
"Spain",
"Czechia",
"Greece"
],
"nct_id": "NCT04000282",
"official_title": "An Open-label, First-in-human, Single Agent, Dose-escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442085 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-08-29",
"study_completion_date(actual)": "2023-09-04",
"study_start_date(actual)": "2019-08-19"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-03",
"last_updated_that_met_qc_criteria": "2019-06-25",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-27",
"first_submitted": "2019-06-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The overall objective of this project is to compare three home-managed treatment regimens for subacute low back pain: Progressive Exercise Plan (PEP), NMES (neuromuscular electrical stimulation) core strength training and standard primary care management (PCM). Each of the two treatment arms will be supplemented by Primary Care Management. The specific aim of the study is to determine whether the two treatment regimes are significantly more efficacious than standard PCM alone in improving lower back muscle strength, daily physical activity, physical function, quality of life, and symptoms associated with subacute LBP.
Detailed Description
The overall objective of this project is to compare three home-managed treatment regimens for subacute low back pain: Progressive Exercise Plan (PEP), NMES (neuromuscular electrical stimulation) core strength training and standard primary care management (PCM). The central hypothesis is that the NMES with PCM core strength training and PEP with PCM will show significantly greater improvements in muscle strength, pain, mobility/function, daily activity and quality of life (QOL) than PCM alone in military members with low back pain lasting three to eighteen weeks. The rationale for this study is that increasing torso muscle strength and decreasing pain through strength training exercises will significantly improve mobility, physical activity, QOL and reduce disability. Such outcomes could ultimately result in improved deployability, retention of military personnel and decreased economic costs in this population. The specific aims will be to determine whether the two treatment régimes are significantly more efficacious than standard PCM alone in improving lower back muscle strength, daily physical activity, physical function, quality of life, and symptoms associated with subacute LBP. After consent and baseline testing, active duty male and female subjects, ages 18 to \<45, (n=135) with LBP will be randomly assigned to one of the three groups. Each of the two treatment arms will be supplemented by PCM and compared to a group receiving standard PCM alone. All groups will receive nine weeks of home therapy. Using longitudinal mixed regression models, differences in time trends for the outcome variables among controls and those in the treatment groups will be examined. In these regression analyses, the important primary measures will be expressed as a function of time, treatment group, and group-by-time interactions, while controlling for important covariates. Positive results could translate into accelerated rehabilitation, decreased symptoms and lower medical costs with better patient outcomes.
#Intervention
- BEHAVIORAL : Progressive Exercise Plan
- The goal of PEP is to reduce back pain, disability, and improve trunk flexibility, strength and endurance through controlled, gradual, progressive back exercises. PEP teaches muscle strengthening exercises and self-management strategies to promote back fitness. PEP sessions provide a standardized self-management framework for performing the exercises at home. PEP is performed every other day/week for about \~1 hour over a period of 9 weeks. PEP consists of 3 sequential phases with each phase lasting 3 weeks. Exercises become progressively more difficult and intense, focusing on back stretching and strengthening that progressively load and unload the lumbar spine by means of flexion/extension exercises. The PEP group will perform 31 exercise sessions for 60 minutes on alternating days.
- DEVICE : NeuromuscularElectricalStimulation(NMES)
- The NMES treatment group will receive a portable battery-operated device, Recovery Back (Neurotech®, Minnetonka, MN) with a 2-garment site-specific system: back \& abdomen. NMES muscle contractions will be elicited by an electrical impulse generated by the Recovery Back system. The device delivers a pre-set program of NMES using a symmetrical biphasic square pulse waveform. (Moore SR, Shurman J, 1997) The garments are light-weight, breathable fabric that wraps around the waist with precise placements for the reusable electrodes. The controller uses a rechargeable battery with charger supplied. The NMES protocol consists of 30-minutes of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back training, next day Abdominal training).
- BEHAVIORAL : Primary Care Management (PCM)
- All participants will receive standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase their activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants will receive an information sheet on LBP advising them to remain active and use self-care options such as heat application. To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.
|
#Eligibility Criteria:
Inclusion Criteria: Diagnosed with low back pain, categorized as lumbago or unspecified backache;
* greater than 3 weeks and less than 18 weeks since the onset of the episode of LBP;
* active duty military service member at the time of diagnosis;
* age >=18 and <45 years;
* ability to provide freely given informed consent.
Exclusion Criteria:
Those who might be at risk of adverse outcomes from the study interventions will be excluded. This includes individuals with
* recurrence of LBP that is less than 3 months from prior episode;
* a significant co-morbid medical condition (such as severe hypertension, neurological disorder or pacemaker/defibrillator) in which NMES strength training or unsupervised exercise is contraindicated and would pose a safety threat or impair ability to participate;
* previous back surgeries;
* inability or unwillingness to participate in an exercise or strengthening program;
* clinical evidence of a lumbar radiculopathy;
* inability to speak and/or read English;
* pregnancy;
* vision impairment, where participant is classified as legally blind;
* unwillingness to accept random assignment; or
* a score >=23 on Center for Epidemiological Studies-Depression scale.
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:
Yes
|
NCT03502187
|
{
"brief_title": "Subacute Low Back Pain in Active Duty",
"conditions": [
"Subacute Low Back Pain"
],
"interventions": [
"Behavioral: Progressive Exercise Plan",
"Device: NeuromuscularElectricalStimulation(NMES)",
"Behavioral: Primary Care Management (PCM)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03502187",
"official_title": "Home-based Approaches for Subacute Low Back Pain in Active Duty: Randomized, Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-05-28",
"study_completion_date(actual)": "2020-05-28",
"study_start_date(actual)": "2018-04-17"
},
"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)": "2022-01-25",
"last_updated_that_met_qc_criteria": "2018-04-10",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-04-18",
"first_submitted": "2018-03-29",
"first_submitted_that_met_qc_criteria": "2021-12-27"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics of SCTA01(anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.
Detailed Description
This is a Phase 1, First-in-Human, Randomized, Double-blinded, Placebo-Controlled, Single Ascending Dose Study of SCTA01(Anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.
Dose escalation will be guided by a safety review of clinical signs and symptoms, adverse events (AEs), and laboratory results of the prior dose cohort.
An Interim analysis will be performed after Day 28 post-dose for the last dose cohort for review.
#Intervention
- BIOLOGICAL : SCTA01
- recombinant humanized anti-SARS-CoV-2 monoclonal antibody
- OTHER : Placebo
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Able to provide written informed consent
* Males or females. Aged >= 18 years
* Body mass index (BMI) between 18.0 and 26.0 kg/m2
* Normal or abnormal but non-clinical significant physical examination, vital signs, 12-ECG and chest CT, etc
* No plan of pregnancy and being willing to use effective contraceptive measures (including partner) from informed consent to 6 months after administration of SCTA01/placebo (abstinence，sterilization operation，contraceptive barrier，acyeterion , etc.)
Exclusion Criteria:
* Having a history of severe allergy, such as severe allergic reactions, urticaria, angioedema;
* Having one of the following evidence on SARS-CoV-2 infection(previous tests were accepted)：
* SARS-CoV-2 positive: reverse transcription-polymerase chain reaction (RT-PCR) and/or next generation sequencing (NGS)
* Previous viral gene sequencing showed high homology with the known SARS-CoV-2
* Positive specific antibody IgM or IgG against serum SARS-CoV-2
* Having a history of severe allergies, such as severe allergic reactions, urticaria, angioedema;
* Having active infection or fever before to enrollment(>= 37.3℃)
* Having primary disease in main organs, such as heart, lung, kidney, liver, nervous system, gastrointestinal system dysfunction, history of thrombocytopenia or abnormal bleeding
* Suffering from autoimmune diseases or a history of autoimmune diseases (such as systemic lupus erythematosus, thyroid Inflammation, vasculitis, etc.)
* Within 7 days prior to the first dose of SCTA01/placebo, subject has received any prescription drugs, non-prescription drugs, Chinese herbal medicines and health products
* Within 3 months prior to the first dose of SCTA01/placebo, subjects who participated in other clinical study, or remaining in the elimination period of the drug (within 5 half-lives) before treatment
* Within 30 days prior to the first dose of SCTA01/placebo, subjects who have received vaccine
* Within 3 months prior to the first dose of SCTA01/placebo, subjects who have received blood product treatment or blood donation and hemorrhage >=400mL, or subjects who has a blood donation plan within 3 months after treatment
* Within 6 months prior to the first dose of SCTA01/placebo, subjects who have received major surgery, or has surgery plan during clinical trail
* Pregnant or lactating women or positive β-HCG, has plan of pregnancy from informed consent signed to 6 months after administration of SCTA01/placebo
* Positive of anti-HIV, TP-Ab, anti-HCV, anti-HBV
* Having a history of epilepsy
* Having a history of malignancies
* Within 3 months prior to screening, sujects who have drunk more than 14 standard units (1 standard unit contains 14g alcohol, such as 360mL beer, 45mL spirits with 40% alcohol or 150mL wine), or positive of alcohol breath test
* Within 3 months prior to screening, subjects who smoked more than 5 cigarettes per day, do not accept smoking cessation during the study
* Having a history of drug addiction and drug abuse; or who have a positive urine test result for drug abuse; or cannot guarantee that they will not abuse drugs during the study
* Subjects who are not able to follow the plan to complete the study
* Subjects who are not considered suitable for the study by investigators
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
|
NCT04483375
|
{
"brief_title": "Safety, Tolerability and Pharmacokinetics of SCTA01, an Anti-SARS-CoV-2 Monoclonal Antibody, in Healthy Chinese Subjects",
"conditions": [
"Coronavirus Disease 2019(COVID-19)"
],
"interventions": [
"Other: Placebo",
"Biological: SCTA01"
],
"location_countries": [
"China"
],
"nct_id": "NCT04483375",
"official_title": "A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics of SCTA01 in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-11-17",
"study_completion_date(actual)": "2020-11-17",
"study_start_date(actual)": "2020-07-24"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-23",
"last_updated_that_met_qc_criteria": "2020-07-22",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-23",
"first_submitted": "2020-07-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed to determine whether molecular detection of breast cancer cells in the peripheral blood of Stage IV breast cancer patients is a clinically relevant predictor of progression-free and overall survival. Stage IV breast cancer patients who have measurable breast cancer metastases and are initiating a regimen of systemic therapy are eligible for enrollment. Multi-marker real-time RT-PCR analysis will be performed on peripheral blood specimens from 92 breast cancer patients and 120 healthy volunteers. Peripheral blood specimens from breast cancer patients will be obtained at the time of study entry (prior to initiation of systemic therapy) and at serial time points during follow-up. Subjects will be followed longitudinally until death, although the study has been powered so that the primary objective can be addressed after 12 months of follow-up. Healthy volunteers will be asked to provide a blood sample at time of enrollment but will not be followed.
#Intervention
- OTHER : Blood draw
|
#Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria - Stage IV breast cancer patients
* Patient age must be > 21 years.
* Patient must have a tissue diagnosis of invasive breast cancer.
* Patient must have documented evidence of metastatic disease.
* Patient must have measurable lesions.
* Patients must be initiating systemic therapy. Patients receiving hormonal therapy, and/or chemotherapy alone or in combination with other therapies are eligible.
* Patient must have an ECOG performance status of 0, 1, or 2.
* Patient must be available for follow-up.
* Patient or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
* The patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided the following criteria are met: (1) patient has undergone potentially curative therapy for all prior malignancies, (2) patients have been considered disease free for at least 5 years (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).
Inclusion Criteria - Healthy volunteers
A volunteer will be eligible for inclusion in this study only if ALL of the following criteria apply:
* Volunteer age must be > 21 years.
* Volunteer or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
* Patients with benign breast disease are eligible for enrollment.
* The volunteer with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided both of the following criteria are met: (1) patient has undergone potentially curative therapy for all prior malignancies, (2) patient has been considered disease free for at least 5 years (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).
Exclusion Criteria:
Exclusion Criteria - Stage IV breast cancer patients
A patient will be ineligible for inclusion in this study if ANY of the following criteria apply:
* No documented metastatic disease.
* No measurable lesions.
* Bone only and/or brain metastasis.
* Patient is not initiating a new regimen of systemic therapy.
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
|
NCT00355316
|
{
"brief_title": "A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients",
"conditions": [
"Breast Neoplasms"
],
"interventions": [
"Other: Blood draw"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00355316",
"official_title": "Peripheral Blood Molecular Staging of Breast Cancer: A Prospective Cohort Study Designed to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Peripheral Blood of Stage IV Breast Cancer Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-11",
"study_completion_date(actual)": "2013-02",
"study_start_date(actual)": "2005-11"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-06-21",
"last_updated_that_met_qc_criteria": "2006-07-19",
"last_verified": "2013-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-07-21",
"first_submitted": "2006-07-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
* Background : The general experience with the Virtual Reality application approach suggests that this treatment concept is promising in stroke rehabilitation
* Purpose : In shopping activity in a real supermarket and in simulated with the investigators virtual shopping simulation (VAP-S = virtual action planning supermarket), the investigators will compare people who had undergone a stroke who receive conventional rehabilitation or virtual training in VAP-S.
Detailed Description
The objective of this study is firstly to examine the effectiveness of using virtual reality-based training VAP-S on the ability to run errands in a real supermarket in individuals with stroke. Virtual environment provide useful way to explore planning and secondly to examine the effectiveness of using VR in the assessment of cognitive planning for patients. A virtual supermarket was designed in which participants carried out a task close to daily activities: a test of shopping list. Of the 70 subjects (7 centres), 35 randomly allocated to the control group, and the other 35 subjects randomly allocated to the experimental group. Subjects will be evaluated by a therapist who will not be involved in the training program and did not know about the subject's group assignment.
Statistical analysis : We will calculate descriptive statistics for the clinical characteristics of each group. We will use to compare the baseline demographic characteristics, the pretraining and posttraining variables between groups, independent-samples t-tests for means and Chi-square tests for frequencies. A significance level of 0.05 is set for all analyses.
#Intervention
- OTHER : Rehabilitation
- The experimental group patients receive rehabilitation by training 'Virtual Action Planning - Supermarket' on a computer 45 minutes 5 times a week during a 2-week period. The control group will receive similar duration cognitive rehabilitation (no extra computer training) during this period (problem solving and occupational therapy).
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults
* 1 to 18 months after stroke
* Without dementia or previous clinical stroke
* With executive impairment (Grefex battery)
* Barthel score equal or more than 40
* With cognitive disability leading to specific rehabilitation
* Given and informed consent
Exclusion Criteria:
* dementia or severe psychiatric disease
* epilepsy
* disorder of consciousness
* visual agnosia
* severe visual impairment
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
|
NCT01365858
|
{
"brief_title": "Virtual Action Planning in Stroke: a Control Rehabilitation Study",
"conditions": [
"Stroke"
],
"interventions": [
"Other: Rehabilitation"
],
"location_countries": [
"France"
],
"nct_id": "NCT01365858",
"official_title": "Effectiveness of Virtual Reality-based Cognitive Training in Daily Living in Stroke Patients Using Virtual Action Planning Supermarket (VAP-S)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-02",
"study_completion_date(actual)": "2014-02",
"study_start_date(actual)": "2011-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-11-13",
"last_updated_that_met_qc_criteria": "2011-06-01",
"last_verified": "2014-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-06-03",
"first_submitted": "2011-05-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary Objectives:
To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in patients with solid tumors.
To assess the anti-tumor activities of SAR405838 / pimasertib in patients with solid tumors.
Secondary Objectives:
To characterize the pharmacokinetic profile of SAR405838 and pimasertib.
To evaluate the pharmacodynamic effect of the SAR405838 and pimasertib.
To characterize genetic status in tumor tissue and circulating tumor DNA.
Detailed Description
The duration of the study for an individual patient will include a period to assess eligibility of up to 4 weeks, a treatment period of at least 6 weeks of study treatment, and an end-of-study visit at least 30 days (or until the patient receives another anti-cancer therapy, whichever is shorter) following the last administration of study drug.
#Intervention
- DRUG : SAR405838
- Pharmaceutical form:capsule
Route of administration: oral
- DRUG : Pimasertib
- Pharmaceutical form: capsule
Route of administration: oral
|
#Eligibility Criteria:
Inclusion criteria:
* Histologically or cytologically confirmed diagnosis of a solid tumor.
* Presence of locally advanced or metastatic disease with at least one measurable lesion.
* Ability to provide written informed consent. Evidence of a personally signed informed consent.
Exclusion criteria:
* Age <18 years.
* Eastern Cooperative Oncology Group performance status of >1.
* Inadequate functions of bone marrow, liver, and kidney.
* Positive pregnancy test in women of child-bearing potential.
* Pregnancy or breast-feeding.
* Extensive prior radiotherapy.
* The patient has retinal degenerative disease, history of uveitis, or history of retinal vein occlusion, or history of retinal detachment, or has medically relevant abnormalities identified on screening ophthalmologic examination.
* Prior history of myositis or rhabdomyolysis.
* Recent major surgery or trauma, unhealing/open wounds.
* The patient has had congestive heart failure, unstable angina, a myocardial infarction, cardiac conduction abnormality or pacemaker or a stroke within 3 months of entering the study.
* The patient has a baseline corrected QT interval (QTc) >480 ms or left ventricular ejection fraction (LVEF) <50% or less than the lower limit of normal.
* The patient has a previously-identified allergy or hypersensitivity to components of the study treatment formulations.
* Unwillingness or inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
* Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods.
* Recent history of acute pancreatitis.
* Clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that could affect the safety of the patient; alter the absorption of the study drugs; or impair the assessment of study results.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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
|
NCT01985191
|
{
"brief_title": "A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients",
"conditions": [
"Neoplasm Malignant"
],
"interventions": [
"Drug: SAR405838",
"Drug: Pimasertib"
],
"location_countries": [
"France",
"Netherlands"
],
"nct_id": "NCT01985191",
"official_title": "A Phase 1 Study of Combination Therapy With SAR405838 and Pimasertib in Patients With Advanced Cancer",
"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)": "2013-11"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-25",
"last_updated_that_met_qc_criteria": "2013-11-08",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-11-15",
"first_submitted": "2013-10-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Background Balance impairment is a key factor contributing to falls in older adults. Conceptually, clinicians may be able to prescribe targeted exercises if specific impairments can be identified. Objective Our objective was to use a model of balance subsystems to identify balance impairments and demonstrate the effectiveness of targeted (matched) exercises to improve balance and reduce fall risk in community-dwelling older adults. The investigators used the Balance Evaluation System Test (BESTest) as the model because it categorizes balance into 6 subsystems. Design Randomized, partially blinded, pretest-post-test clinical trial consisting of 2 Phases: 1. A comparison between impairment-matched exercises and a control, and 2. A comparison between impairment-matched and mismatched exercises. Setting Senior independent living community. Participants Adult volunteers (n = 40; aged 74-94) recruited as sample of convenience who met the criteria. Participants (n = 20) identified with impairment in the biomechanical (BC) constraints subsystem and participants (n = 20) with impairment in anticipatory postural adjustment (APA) subsystem were enrolled and randomized into 2 subgroups (matched and control/delayed mismatched; n = 10 each subgroup). Intervention Phase 1: Participants in the matched subgroup received a 6-week exercise program matched to their impaired subsystem while the mismatched subgroup served as control. Phase 2: Following the delay, participants in the mismatched group received a 6-week exercise program mismatched to their impairment. Measurements Primary outcome variables were scores on the targeted subsystem (BC, APA), BESTest total, Berg Balance Scale, and fear of falling measure. Quality of life was a secondary outcome. Outcome data were collected by the tester blind to pretest scores and group allocation. Results The matched exercise subgroups demonstrated both statistical and clinical improvement in all outcome variables compared to the control; and showed greater improvement in balance impairments compared to the mismatched subgroup, but not in fall risk reduction. Limitations The therapist who administered the pretest knew the subgroup assignment and implemented the exercises. Conclusions Results provide preliminary evidence that using a balance assessment model to identify impairments in the BC and APA subsystems and prescribing targeted exercises reduces these balance impairments for older adults and may warrant future studies.
#Intervention
- OTHER : Matched: Targeted (specific) balance exercise interventions
- OTHER : Mismatched: Untargeted (non-specific) balance exercise interventions
|
#Eligibility Criteria:
Inclusion Criteria:
* individuals who met the criteria for a concurrent psychometric study (older adults aged 65 years and older, cognitively able to understand and follow simple instructions,and able to walk independently with or without an assistive device for more than 100 ft); and demonstrated
* elevated fracture risk
* elevated fall risk
* impaired balance in either the BC or APA subsystem of balance as identified with BESTest.
Exclusion Criteria:
* individuals who had:
* a progressive diseases or unstable medical conditions
* major surgery in the past 3 months
* physician's orders not to participate in an exercise program for any reason
* impairment in both BC and APA subsystems
* impairments in more than a total of 3 subsystems
* who were currently receiving treatment for balance or fall prevention.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02615899
|
{
"brief_title": "Effectiveness of Impairment Specific Exercises for Balance and Fall Risk in Community-Living Older Adults at Risk: A Randomized Controlled Trial",
"conditions": [
"Balance, Postural",
"Exercise Therapy"
],
"interventions": [
"Other: Matched: Targeted (specific) balance exercise interventions",
"Other: Mismatched: Untargeted (non-specific) balance exercise interventions"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02615899",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-02",
"study_completion_date(actual)": "2015-02",
"study_start_date(actual)": "2013-11"
},
"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)": "2015-11-26",
"last_updated_that_met_qc_criteria": "2015-11-25",
"last_verified": "2015-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-11-26",
"first_submitted": "2015-11-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Red blood cell transfusion (RBC) is the main symptomatic treatment for severe anemia. RBC transfusion has proven its efficacy regarding mortality and morbidity, but it is not without side effects. The infectious side effects of transfusion are largely considered under control, non-infectious side effects are taking center stage. Seeking explanations for the beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and optimal use of this precious resource.
The investigators aim to study the impact of donor and RBC characteristics on patient survival.
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 18 and over
* Erythrocyte Transfusion between 2007 and 2011
* Performed at the University Hospital of Besançon or Dijon
Exclusion Criteria:
* Transfusion of any blood product prior to January 1st, 2007
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
|
NCT02852993
|
{
"brief_title": "Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté",
"conditions": [
"Erythrocyte Transfusion for All Conditions"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT02852993",
"official_title": "Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-06",
"study_completion_date(actual)": "2015-06",
"study_start_date(actual)": "2013-09"
},
"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)": "2016-08-02",
"last_updated_that_met_qc_criteria": "2016-08-01",
"last_verified": "2016-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-08-02",
"first_submitted": "2016-07-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The SAFE study examines the effects of brief mindfulness-based cognitive-behavioral intervention aimed at improving risk-related attention skills (risk detection, problem solving, assertiveness, and help seeking) in order to reduce substance use and victimization among young people (ages 18-21) experiencing homelessness.
Detailed Description
Youth (ages 18-21) living at a local youth shelter will be recruited and randomly assigned to receive the SAFE intervention (plus usual case management) or to receive usual case management only. Those assigned to SAFE will receive 12 mindfulness-based, cognitive-behavioral modules through a 3-day intensive group intervention provided by an agency intern and a hired project staff member. The intervention uses mindfulness-based cognitive-behavioral approaches to augment youth attention to risk-related processes, including risk detection, problem solving, assertiveness, and help seeking skills. It is hypothesized the intervention will result in reduced substance use and victimization and that these effects will be explained, at least in part, by improved risk-related attention skills (risk detection, problem solving, assertiveness, and help seeking skills). Post baseline interview, participants will be randomly assigned and will participate in a posttest interview (1 week post baseline) and follow up interviews at 6-weeks, 3-months, and 6-months post baseline interview.
#Intervention
- BEHAVIORAL : Safety Awareness For Empowerment (SAFE)
- SAFE is a mindfulness-based cognitive-behavioral intervention that aims to build risk-related attention skills.
|
#Eligibility Criteria:
Inclusion Criteria:
* Reside at the partnering community based youth shelter
Exclusion Criteria:
As measured by the KSADS (a semi-structured diagnostic interview administered by trained interviewers at baseline):
* presence of psychotic symptoms;
* presence of a life-threatening medical/chronic neurological illness that would prevent participation in a 4-day intervention and/or assessments;
* suicide attempt in last 6 months without current enrollment in therapy or related services to address;
* chronic self-injurious behavior/cutting without current enrollment in therapy or related services to address
* hospitalization or residential treatment for psychiatric reasons in last 6 months without current enrollment in therapy or related services to address.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04183400
|
{
"brief_title": "Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness",
"conditions": [
"Substance Use",
"Victimization"
],
"interventions": [
"Behavioral: Safety Awareness For Empowerment (SAFE)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04183400",
"official_title": "Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06",
"study_completion_date(actual)": "2020-09",
"study_start_date(actual)": "2015-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-28",
"last_updated_that_met_qc_criteria": "2019-11-27",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-12-03",
"first_submitted": "2019-11-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to establish FET-PET as an additional therapy assessment parameter in patients diagnosed with a glioblastoma multiforme receiving radiochemotherapy and adjuvant chemotherapy after previous resection or biopsy.
|
#Eligibility Criteria:
Inclusion Criteria:
* neuroradiologically suspected Glioblastoma multiforme
* histological verification will be obtained either by microsurgery or by stereotactic biopsy. The neuropathological diagnosis will be verified by a reference neuropathologist
* patients will undergo radiochemotherapy subsequent to surgical procedure
* patients older than 18 years
* Karnofsky Performance Score >=70
* pregnant or nursing female patients will not be included in this study
* safe contraceptive methods during the radiochemotherapy and chemotherapy
Exclusion Criteria:
* patients in whom informed consent cannot be obtained due to organic brain syndrome or insufficient language skills
* patients who cannot lie quiet for a time period of app. two hours during the FET-PEt scan
* medical history of a metastatic brain disease
* patients in whom an MRI scan cannot be performed due to claustrophobia metallic protheses or pacemakers 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:
No
|
NCT01089868
|
{
"brief_title": "Usefulness of Therapy Monitoring by Means of [(18)F]Fluoroethyltyrosine-Positron Emission Tomography (FET-PET) in Glioblastoma Multiforme Patients",
"conditions": [
"Glioblastoma Multiforme"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT01089868",
"official_title": "Quantification of Therapy Effects After Microsurgery, Percutaneous Irradiation and Chemotherapy by FET-PET Analysis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06",
"study_completion_date(actual)": "2012-07",
"study_start_date(actual)": "2007-01"
},
"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)": "2012-08-07",
"last_updated_that_met_qc_criteria": "2010-03-18",
"last_verified": "2012-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-19",
"first_submitted": "2010-03-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to develop a questionnaire to measure patient expectations of breast-conserving therapy (breast-conserving surgery and radiation). This questionnaire will assist both surgeons and patients by helping provide valuable information to patients about what to expect during and after surgery.
#Intervention
- BEHAVIORAL : qualitative interviews with patients
- BEHAVIORAL : questionnaires
|
#Eligibility Criteria:
Inclusion Criteria:
* Female
* Age 18 <= age <= 75
* Patients who are scheduled to undergo lumpectomy at MSKCC as part of breast conserving therapy for invasive breast cancer OR who have completed BCT (lumpectomy and radiation) at least 6 months prior to recruitment
Exclusion Criteria:
* Inability to speak or understand English
* Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability
* Patients undergoing lumpectomy without radiation
Sex :
FEMALE
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
|
NCT02753673
|
{
"brief_title": "Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Behavioral: questionnaires",
"Behavioral: qualitative interviews with patients"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02753673",
"official_title": "Patient Expectations of Breast Conserving Therapy: Broadening a Patient Reported Outcomes Instrument",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-13",
"study_completion_date(actual)": "2020-04-13",
"study_start_date(actual)": "2016-04-20"
},
"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)": "2020-04-14",
"last_updated_that_met_qc_criteria": "2016-04-25",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-28",
"first_submitted": "2016-04-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Participants will be randomly allocated to either Yakult ingestion or a control group. For the first 20 days, subjects will consume their normal diet (keeping a detailed food diary throughout). On days 21-28 they will switch to a high-fat/high-calorie diet.
The investigators hypothesise that consuming a high-fat, high-energy diet for 7 days will alter the composition of the gut microbiota and induce metabolic endotoxaemia / systemic inflammation as well as decreasing whole body insulin sensitivity (as we have shown previously). In contrast, the investigators hypothesise that consuming Yakult for 21 days before and 7 days throughout the high-fat diet will maintain a favourable gut microbiota and prevent metabolic endotoxaemia / systemic inflammation and thus maintain insulin action / insulin sensitivity.
#Intervention
- DIETARY_SUPPLEMENT : Yakult light
- A fermented milk drink containing the probiotic Lactobacillus casei Shirota
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and females
* Aged 18 <= age <= 30
* Physically active (exercising at least 3 times per week for more than 30 min at a time)
* Non-smoker
* Free from cardiovascular or metabolic disease
* Weight stable for at least 6 months
* Normal body mass index (BMI: 18.5 <= age <= 24.9 kg/m2)*
* Compliant (i.e. understands and is willing, able and likely to comply with all study requirements)
* Note: If BMI is >24.9, but body fat % (as measured by bioelectrical impedance analysis) is below 21% in males and 31% in females, then the subject may still be recruited at the PI's discretion.
Exclusion Criteria:
* Using probiotic or prebiotic supplements within the previous 3 months
* Vegetarians and vegans
* Diagnosis of insulin resistance, pre-diabetes or full diabetes
* Underweight (determined as BMI less than 18.5 kg/m2)
* Overweight or obese (determined as BMI greater than 24.9 kg/m2)
* Those on a calorie controlled diet or other dietary restrictions that would prevent them from consuming the probiotic treatment and high fat/high calorie diet.
* Those who are unwilling to restrict their intake of fermented dairy products.
* Those with known or suspected food intolerances, allergies or hypersensitivity
* Women who are known to be pregnant or who are intending to become pregnant over the course of the study.
* Participation in another clinical trial
* Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 ml of blood in the previous 12 months.
* Participants who take any form of regular medication that is known to affect either the gut microbiota and/or insulin sensitivity or who have taken any antibiotics in the previous 3 months.
* Participants who know they would not be available for all the lab visits during the 4-week study period.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03037918
|
{
"brief_title": "Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans",
"conditions": [
"Insulin Sensitivity",
"Insulin Resistance",
"Type 2 Diabetes Mellitus"
],
"interventions": [
"Dietary Supplement: Yakult light"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03037918",
"official_title": "Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans. A Large-cohort, Mechanistic Follow-up Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08-31",
"study_completion_date(actual)": "2018-08-31",
"study_start_date(actual)": "2017-02-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-10-31",
"last_updated_that_met_qc_criteria": "2017-01-27",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-01-31",
"first_submitted": "2017-01-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial. Around 260 eligible subjects are planned to be enrolled and randomized in a 1:1 ratio to either the HSK3486 arm or propofol arm. The main objective is to evaluate the efficacy of HSK3486 vs. propofol for the induction of sedation/anesthesia in subjects undergoing fiberoptic bronchoscopy.
#Intervention
- DRUG : HSK3486
- Subjects \< 65 years old:Initial dose of 0.4 mg/kg followed by 0.15 mg/kg if needed;Subjects ≥ 65 years old:75% of the dose for subjects \< 65 years old.
- DRUG : Propofol
- Subjects \< 65 years old:Initial dose of 2 mg/kg followed by 0.75 mg/kg if needed;Subjects ≥ 65 years old:75% of the dose for subjects \< 65 years old.
|
#Eligibility Criteria:
Inclusion Criteria:
*Subjects receiving laryngeal mask airway-assisted diagnostic and/or therapeutic fiberoptic bronchoscopy; 2.Male or female, ASA I-III, >= 18 and < 80 years; 3.Body mass index (BMI) >= 18 and <= 30 kg/m2; 4.Respiratory rate >= 10 and <= 24 bpm; SpO2 >= 93%; SBP >= 90 mmHg; DBP >= 55 mmHg; HR >= 50 and <= 100 bpm during screening and baseline periods; 5.Capable of understanding the procedure and method of this study, willing to sign an informed consent form and to complete this study in strict accordance with the study protocol.
*
Exclusion Criteria:
* Patients with contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
* Patient known to be allergic to eggs, soy products, opioids and their antidotes, and propofol; patient having contraindications to propofol, opioids and their antidotes;
* Patients who have undergone endotracheal intubation and/or mechanical ventilation prior to diagnostic or therapeutic bronchoscopy;
* Medical history or evidence of any of the following prior to screening/at baseline, which may increase sedation/anesthesia risk:
1. History of cardiovascular diseases: uncontrolled hypertension [systolic blood pressure (SBP) >=170 mmHg and/or diastolic blood pressure (DBP) >=105 mmHg without treatment, or SBP > 160 mmHg and/or DBP >100 mmHg after antihypertensive treatment], aneurysm, severe arrhythmia, heart failure, Adams-stokes syndrome, New York Heart Association (NYHA) Class >= III, severe superior vena cava syndrome, pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medical treatment, II-III degree atrioventricular block (excluding patients with pacemakers) or QTcF interval >= 450 ms [during screening only (corrected using Fredericia's formula1)];
2. History of respiratory diseases: severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, history of tracheoesophageal fistula or airway tear, severe respiratory infection within 2 weeks prior to screening;
3. History of neurological and psychiatric disorders: craniocerebral injury, possible convulsions, intracranial hypertension, cerebral aneurysms, history of cerebrovascular accidents; schizophrenia, mania, insanity, long-term use of psychotropic drugs, and history of cognitive dysfunction;
4. History of gastrointestinal diseases: gastrointestinal retention, active hemorrhage, or history of gastroesophageal reflux or obstruction that may lead to aspiration;
5. History of uncontrolled clinically significant liver, kidney, blood system, nervous system or metabolic system diseases judged by the investigator to be probably unsuitable for involvement in the study;
6. History of alcohol abuse within 3 months prior to screening, abuse defined as average of > 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine);
7. History of drug abuse within 3 months prior to screening;
8. History of blood transfusion within 14 days prior to screening;
* Patients with the following respiratory risks during screening/at baseline:
1. Acute asthma attack;
2. Sleep apnea syndrome;
3. History of malignant hyperthermia or family history;
4. History of failed tracheal intubation;
5. Difficult airway (modified Mallampati score >= III) as determined by the investigator;
* Patient who received any of the following medications or treatments during screening/at baseline:
1. Received any investigational drug within 1 month prior to screening;
2. Received propofol, other sedatives/anesthetics, and/or opioid analgesics or compounds containing analgesics within 72 h prior to baseline;
* Laboratory results meeting any of the following criteria during screening/at baseline, confirmed by re-examination:
1. WBC <= 3.0 × 10^9/L;
2. Platelets <= 80 × 10^9/L;
3. Hemoglobin <= 80 g/L;
4. Prothrombin time >= 1.5 × ULN;
5. Activated partial thromboplastin time (aPTT) >= 1.5 × ULN;
6. ALT and/or AST >= 3 × ULN;
7. Total bilirubin >= 1.5 × ULN;
8. Serum creatinine >= 1.5 × ULN.
* Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; or subjects who are planning pregnancy within 3 month after the completion of the trial (including male subjects);
* Subject judged by the investigator to have any other factors unsuitable for involvement in the 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
|
NCT04111159
|
{
"brief_title": "A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Subjects Undergoing Fiberoptic Bronchoscopy",
"conditions": [
"Sedation or Anesthesia"
],
"interventions": [
"Drug: HSK3486",
"Drug: Propofol"
],
"location_countries": [
"China"
],
"nct_id": "NCT04111159",
"official_title": "A Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of Sedation/Anesthesia in Subjects Undergoing Fiberoptic Bronchoscopy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-19",
"study_completion_date(actual)": "2020-07-27",
"study_start_date(actual)": "2019-12-06"
},
"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)": "2020-12-17",
"last_updated_that_met_qc_criteria": "2019-09-28",
"last_verified": "2020-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-01",
"first_submitted": "2019-09-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research study is to evaluate the feasibility and acceptability of an intervention (viewing of video recordings) designed to reduce psychological distress among African Americans during treatment for cancer. This knowledge will inform a larger test of an intervention.
Detailed Description
This study addresses a need to integrate spirituality with cancer care as requested among African Americans. In the PI's research with African Americans, a dominant mental health promoting strategy used in response to a cancer diagnosis is the use of religious stories and songs. African Americans have a strong cultural history of relying on religious stories and songs to overcome oppression and mental suffering encountered in their lived experience. If successful, the findings from this preliminary study will contribute to the evidence that spirituality is important to cancer care and to achieving optimal patient outcomes among this medically underserved population. More importantly, the infusion of spirituality in cancer care has to potential to reduce the high levels of psychological distress experienced among African Americans and FCG's; to enable them to become more engaged in their cancer care and in supportive family relationships; and, ultimately to improve the overall quality of life for African American cancer patients and FCGs. The actual administration of the intervention (viewing of video recordings) will take approximately 30 minutes with all sessions to occur over a 3 week period. The intervention will consist of participants viewing a selection of video recorded vignettes during 3 weekly sessions. The vignettes are of actual African American cancer survivors narrating stories of ways in which hymns can be used to overcome their anxieties and depressed moods through the use of a hymn.
#Intervention
- BEHAVIORAL : Faith-Based African American Cancer Survivorship Storytelling Intervention
- The intervention will consist of participants viewing a selection of video recorded vignettes during 3 weekly sessions. There will be 5 vignettes included in each session with each vignette edited to a real time of 3-4 minutes (each session is 30 minutes). Since the intervention is designed to be self-administered, there will be a video recorded introduction and instructions for use narrated by the PI. The vignettes are of actual African American cancer survivors narrating stories of ways in which hymns can be used to overcome their anxieties and depressed moods through the use of a hymn. The hymns included represent exemplars from the 5 themes prevalent in the PI's previous research
- Other Names :
- Hymns Intervention
|
#Eligibility Criteria:
Inclusion Criteria for Patients:
* Age 30 <= age <= 89 years
* Newly diagnosed with any stage cancer
* Treatment plans to include weekly outpatient chemotherapy
* Previously screened and with greater than 0 level of psychological distress
* Willingness to participate in all study activities including data collection
* Willing to identify a family caregiver (FCG) (immediate or extended family member) to also participate
Exclusion Criteria for Patients:
* Have completed surgery with no plans for chemotherapy
* Find conversations around religion or spirituality emotionally upsetting
* Have completed more than half of prescribed chemotherapy treatments
* In hospice care
* Not able to provide informed consent
Inclusion Criteria for Family Caregiver:
* Immediate or extended family member of the patient
* 18 years or older
* Able to provide informed consent
* Willing to participate in study activities, including data collection
Exclusion Criteria for Family Caregiver:
* Find conversations around religion or spirituality emotionally upsetting
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 89 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03082612
|
{
"brief_title": "Faith-Based African American Cancer Survivorship Storytelling",
"conditions": [
"Cancer"
],
"interventions": [
"Behavioral: Faith-Based African American Cancer Survivorship Storytelling Intervention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03082612",
"official_title": "Faith-Based African American Cancer Survivorship Storytelling: A Culturally Relevant Intervention to Alleviate Psychological Stress",
"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)": "2018-06-28"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-05",
"last_updated_that_met_qc_criteria": "2017-03-16",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-03-17",
"first_submitted": "2017-03-14",
"first_submitted_that_met_qc_criteria": "2023-09-11"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to investigate which anti-inflammatory treatment is best at preventing postoperative inflammation following cataract surgery. We want to compare topical prophylaxis with NSAID eye drops to topical prophylaxis with a combination of NSAID and prednisolone. We also want to compare topical prophylaxis with eye drops to drop-less surgery where the anti-inflammatory drug is administered to the subtenonal space at the conclusion of the surgical procedure. In addition, we want to investigate if topical anti-inflammatory prophylaxis should be initiated preoperatively or postoperatively. The primary outcome is change in central macular thickness, measured by optical coherence tomography, 3 months after surgery.
#Intervention
- DRUG : NSAID + prednisolone, preoperative
- Ketorolactrometamol 5 mg/ml and prednisolone acetate 1% w/v eye drops are administered 3 times pr. day, starting 3 days prior to surgery and until 3 weeks after surgery.
- Other Names :
- Group a1
- DRUG : NSAID + prednisolone, postoperative
- Ketorolactrometamol 5 mg/ml and prednisolone acetate 1% w/v eye drops are administered 3 times pr. day, starting on the day of surgery and until 3 weeks after surgery.
- Other Names :
- Group a2
- DRUG : NSAID, preoperative
- Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting 3 days prior to surgery and until 3 weeks after surgery.
- Other Names :
- Group b1
- DRUG : NSAID, postoperative
- Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting on the day of surgery and until 3 weeks after surgery.
- Other Names :
- Group b2
- DRUG : Drop-less surgery
- A depot of 0.5 ml Dexamethason Krka 4 mg/ml solution for injection/infusion is administered during cataract surgery.
- Other Names :
- Group c
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with age-related cataracts
* >= 18 years years
* Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months.
* Capacity to consent
* Scheduled to undergo cataract surgery at the ophthalmic department at Rigshospitalet-Glostrup, Denmark
* The surgeon must be experienced, defined by a minimum of 1000 cataract extractions completed
* Only 1 eye can be included for each participant, but there are no restrictions as to whether it is the eye that undergoes surgery first or last. If both eyes of a participant are eligible, it will be decided by randomization which eye to be included in the study
* Informed consent to participation
Exclusion Criteria:
* Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study
* Medical history of epiretinal membrane, retinal vein occlusion, retinal detachment, uveitis, glaucoma, diabetes mellitus, exudative age-related macular degeneration (AMD) or AMD with geographical atrophy
* Significant complications to surgery such as posterior capsule rupture/vitreous loss, choroidal hemorrhage, and dislocated lens material
* Pregnancy
* Fertile women, i.e. women who are not menopausal.
* Women who breastfeed
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
|
NCT03383328
|
{
"brief_title": "Study for Optimizing Anti-inflammatory Prophylaxis",
"conditions": [
"Postoperative Cystoid Macular Edema",
"Irvine-Gass Syndrome"
],
"interventions": [
"Drug: Drop-less surgery",
"Drug: NSAID + prednisolone, preoperative",
"Drug: NSAID + prednisolone, postoperative",
"Drug: NSAID, postoperative",
"Drug: NSAID, preoperative"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT03383328",
"official_title": "Effect of Drop-less Surgery Compared to Topical NSAID Alone and Combination of Steroid and NSAID on Central Macular Thickness After Cataract Surgery, a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-18",
"study_completion_date(actual)": "2019-12-18",
"study_start_date(actual)": "2018-02-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-12-20",
"last_updated_that_met_qc_criteria": "2017-12-19",
"last_verified": "2019-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-12-26",
"first_submitted": "2017-12-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
GOELAMS LLC98 is a prospective randomized trial comparing in previously untreated B and C Binet stages B-CLL and on an intent to treat basis two strategies. Conventional chemotherapy consisted of six monthly courses of CHOP, followed by 6 CHOP courses every other 3 months in case of response. Experimental arm consisted of high dose therapy with autologous CD34+ purified progenitor cell support, used as consolidation of Complete Remission or Very Good Partial Response obtained after 3 monthly courses of CHOP, followed by 3 to 6 monthly-courses of fludarabine in case of insufficient response.
Detailed Description
The aim of the prospective randomized GOELAMS LLC 98 trial reported here was to compare two therapeutic strategies in previously untreated B and C Binet stages B-CLL patients less than 60 years old. Conventional chemotherapy (Arm A) consisted of six monthly courses of CHOP, i.e. vincristin IV 1 mg/m2 on day 1, doxorubicin IV 25 mg/m2 on day 1, cyclophosphamide (Cy) 300 mg/m2 and prednisone 40 mg/m2 both given orally from day 1 to day 5, followed by 6 CHOP courses every other 3 months in case of response. Fludarabine (25 mg/m2 /d IV for 5 consecutive days) was used in case of non response (stable disease or progression) after 3 CHOP courses. This conventional therapy was compared to high dose therapy with autologous CD34+ purified progenitor cell support (Arm B), used as consolidation of Complete Remission (CR) or Very Good Partial Response (VGPR, defined by \>50 % tumoral response and bone marrow lymphocyte infiltration \<30%) obtained after 3 monthly courses of CHOP. In the absence of CR or VGPR, 3 to 6 monthly-courses of fludarabine were performed before mobilization with Cy 4 g/m2 + G-CSF administration. The conditioning regimen included TBI 12 Gy and Cy 60 mg /kg /d for 2 days.
#Intervention
- PROCEDURE : Stem cells autograft
- Treatment by Intensive Chemotherapy and autograft
|
#Eligibility Criteria:
Inclusion Criteria:
* CLL with Lymphocitis > 15.10 9/L
* B-CLL stage B or C
* Patients > 18 years and < 60 years
* No previous treatment of CLL
* ECOG performance status < 2
* Good cardiac function
* Patient's written informed consent
Exclusion Criteria:
* B-CLL stage A
* Age > 60 years
* previous treatment of CLL
* ECOG performance status > 2
* Cardiac or pneumo Insufficency
* hepatic or renal Insufficency
* Seropositivity HIV
* Previous other malignancy
* Fertile male and female patients who cannot or do not wish to use an effective method of contraception
* Any coexisting medical or psychological condition that would preclude participation to the required study procedures
* NOt signed Patient's informed consent
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:
No
|
NCT00535912
|
{
"brief_title": "Phase III Study Treatment of CLL B and C",
"conditions": [
"Leukemia, Lymphocytic, Chronic"
],
"interventions": [
"Procedure: Stem cells autograft"
],
"location_countries": null,
"nct_id": "NCT00535912",
"official_title": "A Multicentric Phase III Study in Patients With CLL B and C < 60 Years Not Treated: 6 Montly CHOP + 6 CHOP Every 3 Months Versus 3 Montly CHOP + Intensification and Autograft",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-03",
"study_start_date(actual)": "1999-01"
},
"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)": "2007-11-01",
"last_updated_that_met_qc_criteria": "2007-09-26",
"last_verified": "2007-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-09-27",
"first_submitted": "2007-09-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
#Intervention
- DRUG : Charcoal and Budesonide/formoterol Easyhaler 320/9 microg
- 2 inhalations as a single dose
- DRUG : Charcoal and Symbicort Turbuhaler
- 2 inhalations as a single dose
- DRUG : Budesonide/formoterol Easyhaler 320/9 microg
- 2 inhalations as a single dose
- DRUG : Symbicort Turbuhaler forte
- 2 inhalations as a single dose
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy males and females aged 18 <= age <= 60 years.
* Normal weight, at least 50 kg.
Exclusion Criteria:
* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
* Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
* Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
* Known hypersensitivity to the active substance(s) or the excipient of the drug.
* Pregnant or lactating females.
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
|
NCT01593826
|
{
"brief_title": "Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler",
"conditions": [
"Asthma"
],
"interventions": [
"Drug: Symbicort Turbuhaler forte",
"Drug: Charcoal and Symbicort Turbuhaler",
"Drug: Budesonide/formoterol Easyhaler 320/9 microg",
"Drug: Charcoal and Budesonide/formoterol Easyhaler 320/9 microg"
],
"location_countries": [
"Finland"
],
"nct_id": "NCT01593826",
"official_title": "Pharmacokinetic Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 320/9 Microg/Inhalation and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-10",
"study_completion_date(actual)": "2012-10",
"study_start_date(actual)": "2012-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-11-22",
"last_updated_that_met_qc_criteria": "2012-05-04",
"last_verified": "2012-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-08",
"first_submitted": "2012-05-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether nasal irrigation with Xylitol or saline are effective in the treatment of chronic rhinosinusitis and fatigue symptoms associated with Gulf War Illness.
Detailed Description
Background: Gulf War Illness (GWI) results in tremendous impact to quality of life. Symptoms of chronic rhinosinusitis (CRS) and fatigue are the first (47%) and third (41%) most common symptoms of patients with GWI, respectively. These symptoms are biologically characterized by a milieu of elevated levels of proinflammatory cytokines; to date, the profile of these cytokines in serum and nasal secretions is incompletely understood and has not been assessed in response to therapy. Nasal irrigation (NI) is a therapy which bathes the nasal cavity with a solution (liquid). There are two promising forms of NI; saline NI (S-NI) is hypothesized to improve sinus symptoms by thinning and clearing mucus and inflammatory mediators, decreasing mucosal edema and improving ciliary function. Xylitol NI (X-NI) has been shown to change the salinity of the mucosal surface resulting in enhanced antimicrobial properties. Although NI is an evidence-based adjunctive therapy for CRS and has been reported to be effective for CRS and fatigue, it has not been assessed in a GWI population.
Specific Aims, Hypotheses and Study Design: The specific aims of this proposal are to determine whether routine care plus S-NI, or X-NI, compared to routine care alone, result in improved health-related quality of life (HRQoL), are cost-effective and decrease proinflammatory bias in subjects with GWI who suffer from CRS and fatigue.
Consistent with our specific aims, we will test the following hypotheses: In an RCT setting, at 26 weeks post-enrollment, adults with GWI and symptoms of CRI and fatigue, treated with routine care plus S-NI or X-NI, compared to those treated with routine care alone, will demonstrate:
H1: improved HRQoL: a) sinus-disease specific HRQoL as evaluated by the validated Sinonasal Outcomes Test (SNOT-20) questionnaire (primary outcome measure); b) fatigue-specific HRQoL as assessed by the validated questionnaire, the Multidimensional Fatigue Inventory (MFI); and c) overall HRQoL as assessed by the validated questionnaire the Medical Outcomes Survey Short Form-36 (SF-36; mental and physical health domains) augmented with 18 sleep- and breathing related questions.
H.2: greater cost-effectiveness as measured by the average cost of the intervention divided by the average effectiveness (as assessed by a improvement in SNOT-20 scores), and reported as the 'dollars spent per subject restored to health.'
H.3: improved treatment satisfaction as assessed by a single-item treatment satisfaction score and a qualitative exit interview.
H.4: improved proinflammatory bias: a) reduced activation and dysregulation of proinflammatory pathways as determined by a reduction in URI-specific inflammatory cytokines in serum and nasal secretions; and b) improved serum-based complete blood count, sedimentation rate or C-reactive protein, or nasal swab-based neutrophil or eosinophil counts.
Study Design: 26 week duration of follow-up, 3-arm RCT (N=75). All groups will utilize routine care for their GWI and symptoms of CRS and fatigue. Groups 1 and 2 will in addition add S-NI or X-NI twice daily to their routine care, respectively. Group 3 will continue to use routine care with no other additions (control group); control group participants will be offered NI training and related materials (xylitol or saline per subject preference) after they complete their 26-week follow-up period.
Impact: Positive findings would suggest a number of important effects:
* Statistically positive results on HRQoL outcome measures would suggest that NI can provide effective adjunctive therapy for CRS and fatigue in adults with GWI, improving health of affected patients and potentially providing gains to society through reduced health care utilization and absenteeism related costs.
* Positive biomarker findings would contribute to our better understanding of the etiology of CRS and fatigue in the GWI population and of possible biological pathways underlying the NI efficacy.
* The finding that either form of NI is cost effective would provide economic justification for its clinical use.
#Intervention
- OTHER : Nasal Irrigation - Saline
- Liquid-based nasal irrigation (NI) is performed using a nasal irrigation cup ('neti pot'), a simple hand-held vessel that uses the force of gravity to gently irrigate the user's nasal cavity. Subjects will be requested to perform NI twice daily. The subjects will prepare the saline solution by themselves using the study-provided kit which will include packets of salt powder and the neti pot; subjects will dissolve the powder in lukewarm tap water to achieve a 2% buffered saline solution. The solution is then delivered to the nasal cavity using neti pot.
- Other Names :
- 2% buffered saline
- DRUG : Nasal Irrigation - Xylitol
- Liquid-based nasal irrigation (NI) is performed using a nasal irrigation cup ('neti pot'), a simple hand-held vessel that uses the force of gravity to gently irrigate the user's nasal cavity. Subjects will be requested to perform NI twice daily. The subjects will prepare the Xylitol solution by themselves using the study-provided kit which will include packets of Xylitol powder and the neti pot; subjects will dissolve the powder in lukewarm tap water to achieve a 5% Xylitol solution. The solution is then delivered to the nasal cavity using neti pot.
- Other Names :
- 5% Xylitol solution
|
#Eligibility Criteria:
Inclusion Criteria:
* English fluency and basic reading and writing literacy.
* Deployment to the Persian Gulf (e.g., Iraq, Kuwait, Saudi Arabia) for the purpose of Operation Desert Shield or Operation Desert Storm during the first Gulf War (1990 <= age <= 1991).
* Meeting criteria for a diagnosis of GWI as based on the 'Kansas' GWI case definition; only the Kansas case definition (from among the several currently used case definitions) can differentiate between Gulf War-deployed and non-deployed Gulf era veterans.
* Meeting criteria for a diagnosis of chronic rhinosinusitis (CRS) using self-reported symptoms and based on clinical guidelines; eligible subjects will report:
* sinonasal symptoms for at least 12 weeks;
* a constellation of sinonasal symptoms including either two or more major factors, or 1 major and 2 minor factors (see Table 1 below), or chronic nasal purulence for 12 or more weeks; and
* a moderate to severe HRQoL impact (>= 3 points on a 0 <= age <= 10 Likert severity scale) as assessed by a single item question:11 'What has been the average level of your sinus symptoms daily over the past month on a 0 <= age <= 10 scale?' This item is consistent with eligibility criteria used in prior NI studies.
* Chronic fatigue of moderate-to-severe severity defined as scoring at least 3 points on a single question (0 <= age <= 10 Likert scale): 'What has been the average level of your daily fatigue over the past month on a 0 <= age <= 10 scale?'
Exclusion Criteria:
* Self-reported pregnancy.
* Current use of liquid NI or xylitol nasal spray; regular use is defined as 1 or more irrigations weekly for 3 consecutive weeks.
* Self-reported neurological or musculoskeletal conditions that could facilitate aspiration, or patients who otherwise cannot physically perform the NI procedure.
* Self-reported borderline personality disorder.
* Inability or stated reluctance to reliably participate in study activities.
* Severe or unstable mental health problems that would preclude safe or reliable study participation as based on an in-person evaluation by a psychiatry team; active delusional disorder, depressive disorder or alcohol/drug abuse or dependence will be a primary target of this interview using both a structured clinical interview (MINI ref) and psychiatry team evaluation.
Sex :
ALL
Ages :
- Minimum Age : 35 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01700725
|
{
"brief_title": "Gulf War Illness Nasal Irrigation Study",
"conditions": [
"Persian Gulf Syndrome",
"Chronic Sinusitis",
"Fatigue",
"Acute Sinusitis"
],
"interventions": [
"Other: Nasal Irrigation - Saline",
"Drug: Nasal Irrigation - Xylitol"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01700725",
"official_title": "Nasal Irrigation for Chronic Rhinosinusitis and Fatigue in Patients With Gulf War Illness",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06",
"study_completion_date(actual)": "2017-05",
"study_start_date(actual)": "2012-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-21",
"last_updated_that_met_qc_criteria": "2012-10-01",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-10-04",
"first_submitted": "2012-08-14",
"first_submitted_that_met_qc_criteria": "2019-05-03"
}
}
}
|
#Study Description
Brief Summary
The aim of the trial is to study the possible mechanism of the pain reducing effect of CT at peripheral venipuncture
#Intervention
- PROCEDURE : Venipuncture with 'cough-trick'
|
#Eligibility Criteria:
Inclusion Criteria:
* Male volunteers aged 20 <= age <= 40 years, height 165 <= age <= 190 cm.
* Physical status I according to American Society of Anesthesiologists (ASA) classification.
* Straight run of the vein on the dorsum of the non-dominant hand at least 4 cm long and 3 mm thick
* No analgesics, anticoagulants and/or antiplatelet agents, sedatives or alcohol
Exclusion Criteria:
* History of peripheral neuropathy
* Abnormal skin conditions (infection, scars, psoriasis, eczema)
* Unsuccessful venipuncture
* Inflamed site of VP within 1 week after VP
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00233844
|
{
"brief_title": "Studying the Analgesic Mechanism of the 'Cough-Trick'",
"conditions": [
"Pain",
"Acute Pain",
"Venipuncture"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00233844",
"official_title": "Studying the Analgesic Mechanism of the 'Cough-Trick' - Randomized Crossover Volunteer Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": null,
"study_start_date(actual)": "2004-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2005-10-06",
"last_updated_that_met_qc_criteria": "2005-10-05",
"last_verified": "2005-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-10-06",
"first_submitted": "2005-10-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The strategy of neonatal screening for Cystic Fibrosis in France relies on Immuno Reactive Trypsinogen (IRT) at day 3/DNA analysis with a CF Elucigen 30 mutations kit/ IRT safety-net at day 21. This strategy has significantly improved the performance of CF neonatal screening (NNS) in terms of positive predictive value and sensitivity but revealed new difficulties. Up to 85-90% of CF patients detected through the NNS program has a classical CF form with a positive sweat test and 2, 1 or no CF causing mutations but the remainder has either 2 CFTR mutations with at least one non-CF causing mutation and a sweat test \<60mmol/L or 1, 0 CFTR mutation and an intermediate sweat test value ≥ 30 et \< 60mmol/L raising a diagnosis and prognosis dilemma. Meanwhile the vast majority of these cohorts will remain asymptomatic over time, some will develop symptoms prompting clinicians to maintain a rigorous surveillance for the entire atypical cohort, whose modalities vary a lot among centers and countries.
This prospective multicenter study with a standardized assessment of a matched cohort with 'atypical' CF versus 'classical' CF from 6 years of age (60-65 cases in each cohort) is aimed at evaluating pulmonary and nutritional status to, better define the best monitoring follow-up, therapeutic management and familial genetic counseling.
Detailed Description
The strategy of neonatal screening for Cystic Fibrosis in France relies on Immuno Reactive Trypsinogen (IRT) at day 3/DNA analysis with a CF Elucigen 30 mutations kit/ IRT safety-net at day 21. This strategy has significantly improved the performance of CF neonatal screening (NNS) in terms of positive predictive value and sensitivity but revealed new difficulties. Up to 85-90% of CF patients detected through the NNS program has a classical CF form with a positive sweat test and 2, 1 or no CF causing mutations but the remainder has either 2 CFTR mutations with at least one non-CF causing mutation and a sweat test \<60mmol/L or 1, 0 CFTR mutation and an intermediate sweat test value ≥ 30 et \< 60mmol/L raising a diagnosis and prognosis dilemma. Meanwhile the vast majority of these cohorts will remain asymptomatic over time, some will develop symptoms prompting clinicians to maintain a rigorous surveillance for the entire atypical cohort, whose modalities vary a lot among centers and countries.
This prospective multicenter study with a standardized assessment of a matched cohort with 'atypical' CF versus 'classical' CF from 6 years of age (60-65 cases in each cohort) is aimed at evaluating pulmonary and nutritional status to, better define the best monitoring follow-up, therapeutic management and familial genetic counseling.
#Intervention
- RADIATION : Lung CT scan
- Lung CT scan without injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Atypical CF cohort: children identified trough newborn screening on a hypertrypsinemia, who are older than 6 years at the time of inclusion and who carry a) 2 CFTR gene mutations of the CF30 kit with at least one R117H whatever the value of the sweat test or b) 2 CFTR gene mutations of the CF30 kit with a sweat test chloride < 60mmol/L or c) 1 or 0 mutation in the CF30 kit with a sweat test >= 30 and <60mmol/L and identification of additional mutations by comprehensive screening of the gene
* Classical CF cohort: children identified by newborn screening on a hypertrypsinemia, who are matched with an Atypical CF by age and sex if possible and who were diagnosed with a classical CF based on a sweat test > 60 mmol/ L with 0, 1 or 2 CF causing gene mutations.
Exclusion Criteria:
*
* Drugs such as CFTR modulators interfering with the phenotypic expression of the disease.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 10 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02869932
|
{
"brief_title": "Prospective Study of the Phenotypic Expression of Cystic Fibrosis (CF) Screened Positive Newborns With an Atypical Form of CF (DPAM)",
"conditions": [
"Cystic Fibrosis"
],
"interventions": [
"Radiation: Lung CT scan"
],
"location_countries": [
"France"
],
"nct_id": "NCT02869932",
"official_title": "Prospective Study of the Phenotypic Expression of Cystic Fibrosis (CF) Screened Positive Newborns With an Atypical Form of CF (DPAM)",
"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)": "2012-03"
},
"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)": "2023-02-06",
"last_updated_that_met_qc_criteria": "2016-08-12",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-08-17",
"first_submitted": "2015-01-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Radiotherapy is a common treatment for lung cancer. One Challenge of delivering radiation treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. In some situations, tumors move enough during breathing so that some or all of the tumor may be missed by a radiation treatment. One way to decrease the amount a lung tumor moves during radiotherapy treatments is for patients to held their breath briefly during a radiation treatment. By doing this, a patient's lung tumor may not move as much as it would during regular breathing. In this study, the investigators aim to study patients with lung cancers which move during breathing. Patients will be asked to hold their breath after inspiration while a CT scan of their lung tumor is obtained. The purpose of this study is to study how much less patients' lung tumors move when they hold their breath
#Intervention
- OTHER : CT scan of the chest under deep inspiration breath hold
- computed tomography scan of the chest under dep inspiration breath hold conditions
|
#Eligibility Criteria:
Inclusion Criteria:
* biopsy confirmed primary lung cancer
* undergoing radiotherapy or chemoradiotherapy
* able to perform adequate deep inspiration breath hold
* patients of childbearing potential must practice adequate contraception
* signed study-specific informed consent form
Exclusion Criteria:
* unable to perform adequate deep inspiration breath hold
* prior tumor resection
* prior chest or neck RT
* pregnant
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
|
NCT00643370
|
{
"brief_title": "Quantifying Lung Tumor Movement Under Deep Inspiration Breath Holds",
"conditions": [
"Lung Cancer"
],
"interventions": [
"Other: CT scan of the chest under deep inspiration breath hold"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00643370",
"official_title": "Quantifying Lung Tumor Movement Under Dep Inspiration Breath Holds",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-01",
"study_completion_date(actual)": null,
"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)": "2016-02-17",
"last_updated_that_met_qc_criteria": "2008-03-25",
"last_verified": "2011-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-03-26",
"first_submitted": "2008-03-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Women's awareness about the danger of certain medicines taken during pregnancy presents a real public health issue. To enhance awareness and information for women and healthcare professionals, new pictograms ' pregnant women ' appeared on medication boxes, on October 16, 2017. These new pictograms can change women's perception of self-medication during pregnancy and of the danger of taking certain medicines for the unborn development. Furthermore, the investigators can wonder if the meaning of these pictograms is well understood. Therefore, the study's primary aim is to assess the knowledge of pregnant or childbearing age women about the pictograms associated with the danger of certain medicines taken during pregnancy.
#Intervention
- BEHAVIORAL : questionary
- A quantitative questionnaire has been created under primary and secondary assumptions. Questionnaires are going to be distributed to women who are agree to participate to this study. The questionnaires are going to be delivered by the investigators.
Women can answer the questionnaire in the waiting room of consultation's services. The questionnaire will be anonymous and the return of questionnaires will be made personally.
|
#Eligibility Criteria:
Inclusion Criteria:
* women who agree to participate to the study
* women who understand french language (oral and written)
* pregnant women and women of childbearing age from 18 <= age <= 45 old.
Exclusion Criteria:
* Women who have already answered the questionnaire
* women who don't want to answer the questionnaire
* women who don't understand french language
* women who are under the age of 18 or over the age of 45
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
|
NCT04020432
|
{
"brief_title": "Knowledge Assessment of Women About Pictograms Associated With the Danger of Medicines Taken During Pregnancy",
"conditions": [
"Knowledge, Attitudes, Practice",
"Pregnancy Related"
],
"interventions": [
"Behavioral: questionary"
],
"location_countries": [
"France"
],
"nct_id": "NCT04020432",
"official_title": "Knowledge Assessment of Pregnant or Childbearing Age Women About Pictograms Associated With the Danger of Certain Medicines Taken During Pregnancy.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-11",
"study_completion_date(actual)": "2021-12-11",
"study_start_date(actual)": "2019-07-11"
},
"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)": "2023-03-22",
"last_updated_that_met_qc_criteria": "2019-07-12",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-16",
"first_submitted": "2019-07-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Cancers that have spread to the liver from the primary cancer location (liver metastases) that cannot be removed surgically (unresectable) can be treated with chemotherapy and/or radiation therapy. Previous research has shown that tumours often have abnormal blood vessels that may reduce the effect of radiation therapy. New drugs, known as 'anti-angiogenic' drugs have been shown in animal and human studies to damage or change tumour blood vessels in ways that may make tumors more sensitive to radiation treatment. 32- 44 Patients diagnosed with unresectable liver metastasis will be invited to take part in this study. The purpose of this study is to investigate the use of a new anti-angiogenic drug called Sorafenib, in combination radiation therapy and chemotherapy. The study will test how effective the new treatment is, the side effects associated with the new treatment, and to help establish safe dosages of the study medication.
Detailed Description
In this study, Stereotactic Body Radiation Therapy(SBRT) and Whole Liver Radiotherapy (WLRT) will be used concurrently with sorafenib at 3 different dosages to determine the tolerability and efficacy of this combined treatment. Sorafenib doses will be 200mg twice daily orally for 28 days in level I, 400 mg in the morning and 200mg in the evening in level II, and 400mg twice daily orally for 28 days in level III . Radiotherapy will be started at day 8, patients will receive a total of 6 fractions over 2 weeks. Patients will be assessed weekly during treatment, 1 month post-tx, then at 3-month intervals for up to a year after tx, and then followed-up at 6-month intervals up to 3 years. Once the Maximum Tolerated Dose (MTD) is established, an expanded cohort for each stratum will accrue such that a total of 10 patients per strata. This will allow us to gain further experience with this regimen and consolidate the safety and efficacy data. Quality of Life (QOL) assessment will be carried out at baseline and 1/3/6/9 mos post-tx. Patients will also be offered correlative studies looking at biomarkers through tissue, blood, and urine samples, and an imaging study looking at tissue perfusion.
#Intervention
- DRUG : Sorafenib
- Sorafenib doses will be 200mg twice daily orally for 28 days in level I, 400 mg in the morning and 200mg in the evening in level II, and 400mg twice daily orally for 28 days in level III . Radiotherapy will be started at day 8, patients will receive a total of 6 fractions over 2 weeks. Patients will be assessed weekly during treatment, 1 month post-tx, then at 3-month intervals for up to a year after tx, and then followed-up at 6-month intervals up to 3 years.
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed liver metastases
* Largest burden of disease should be hepatic if there's extrahepatic disease exists
* Tumour should be medically inoperable
* Patient have a life expectancy of at least 3 months and a KPS performance status of at least 60%.
* Patient should be 18 years or older
* Patient should have adequate organ function
* Patient have Creatinine <= 2 times upper limit of normal range
* Patient recovered from the effects of prior therapy
* Patient (or person representing the patient) should be able to give informed consent
* Patient have Child's A score (5 or 6) score
* For women of childbearing age, birth control is being used and the pregnancy test is negative
Exclusion Criteria:
* No major surgery in the past 4 weeks.
* No previous use of sorafenib previously.
* Patient should not have or is receiving systemic therapy or investigational agents within 2 weeks of radiotherapy
* No previous upper abdominal radiation therapy to the liver.
* No serious medical conditions that may be aggravated by treatment, including but not limited to: myocardial infarction within 6 months, congestive cardiac failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders,serious infections, active peptic ulcer disease, active liver disease or previous stroke.
* Patients who are infected with human immunodeficiency virus (HIV), should not be receiving combination anti-retroviral therapy
* No clinically significant liver failure (i.e. encephalopathy or ascites found clinically).
* No thrombolytic therapy within 4 weeks or are they receiving other anticoagulant therapy.
* No underlying cirrhosis with Child's B or C score.
* No history of uncontrolled, life threatening malignancy within the past 6 months.
* Patient should not have a variceal bleed or other gastrointestinal bleed in the past 2 months.
* No brain metastases
* Patient should not be pregnant.
* Patients on Rifampin, St. John's Wort, Phenytoin, Carbamazepine, Phenobarbital, or Chronic use (more than 4 weeks) of dexamethasone
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
|
NCT00892424
|
{
"brief_title": "Sorafenib-RT Treatment for Liver Metastasis (SLIM)",
"conditions": [
"Liver Metastasis",
"Cancer"
],
"interventions": [
"Drug: Sorafenib"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00892424",
"official_title": "Phase I/II Trial of Radiation Therapy and Sorafenib for Treatment of Unresectable Liver Metastases",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09-08",
"study_completion_date(actual)": "2020-09-08",
"study_start_date(actual)": "2008-11"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-10",
"last_updated_that_met_qc_criteria": "2009-05-01",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-05-04",
"first_submitted": "2009-05-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The Norwegian health authorities has initiated a three-year trial of telehealth solutions as part of the treatment of patients with chronic illness in the period 2018-2021. Within the trial, telehealth indicates that patients are followed-up outside health-care facilities using information and communication technologies (ICTs). Patients who are followed up using telehealth solutions can answer questions about their own health and/or perform measurements related to their health (e.g. blood pressure, blood glucose, oxygen measurement, weight) via a tablet according to a personalized schedule. The measurement values are transferred from the measuring devices to a tablet so that the users can easily see them and track their results over time. The results are also transmitted digitally to a follow-up service, a healthcare center with nurses, who contacts the patient when needed. The follow-up service provides medical support and guidance based on the patient's needs and planned follow-up, and will, in consultation with the user, evaluate whether the user should contact the general practitioner (GP) or emergency room.
The study population of the trial includes users with comprehensive medical needs, with medium to high risk of worsening of their condition, hospitalization or increased need for health and care services.
The evaluation includes three main parts: 1) An effect evaluation which is designed as a randomized control trial, 2) a cost-benefit analysis, and 3) a process evaluation which aims to provide recommendations for how to organize and implement telemedicine in clinical practice. The primary outcomes include physical and mental health state, patient experience and use of health services.
The effect evaluation is designed as a pragmatic open label multi-center randomized control trial, with two parallel arms with 300 patients in each arm. Patients are recruited between February 2019 and June 2020.
#Intervention
- DEVICE : Telemedicine: tablet and possibly tools to perform measurements
- Users of telemedicine can answer simple questions about their health condition and/or perform measurements related to their health (e.g., blood pressure, blood sugar, oxygen saturation, weight) via a tablet or a similar device. The results are transferred from the measuring devices to the tablet so that users can easily see them and track their own results over time. The results are transmitted digitally to a follow-up service. The follow-up service contacts the patient in case of signs of deterioration or when measurements lie outside what is normal values for the individual. The follow-up service provides medical support and guidance based on the patient's needs and plan for follow-up, and will, in consultation with the patient, assess whether this should contact their GP/emergency room.
|
#Eligibility Criteria:
Inclusion Criteria:
* The patient has a considerable disease burden and comprehensive medical needs
* The patient has a chronic disease
* The patient has medium to high risk of worsening of their condition, hospitalization or increased need for health and care services
* The patient has a high consumption of healthcare services
* The patient has a reduced level of function
* The patient is motivated to use telehealth solutions
* The patient is likely to benefit from the use of telehealth solutions
Exclusion Criteria:
* The patient is not competent to consent
* The patient is unable to handle the tablet and the measuring equipment to be used
* The patient has a substance abuse
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
|
NCT04142710
|
{
"brief_title": "Pragmatic Randomized Control Trial of Telehealth vs Standard Care in Follow-up of Patients With Chronic Conditions",
"conditions": [
"Chronic Disease",
"Diabetes",
"Vascular Diseases",
"Chronic Lung Disease",
"Cancer",
"Psychiatric Disorder"
],
"interventions": [
"Device: Telemedicine: tablet and possibly tools to perform measurements"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT04142710",
"official_title": "A Pragmatic Randomized Control Trial Comparing Telehealth With Standard Clinical Care in the Follow-up of Patients With Chronic Conditions Within the Primary Care Setting",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-30",
"study_completion_date(actual)": "2021-06-30",
"study_start_date(actual)": "2019-02-09"
},
"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)": "2021-10-07",
"last_updated_that_met_qc_criteria": "2019-10-25",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-29",
"first_submitted": "2019-07-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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