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#Study Description
Brief Summary
Body dissatisfaction represents a prevalent condition in young women, and it is associated with low self-esteem, depression, and symptoms of Body Dysmorphic Disorder (BDD) and Eating Disorders (EDs). The aim of the trial is to test the effect of a mobile health application called 'GGBI: Positive Body Image' in reducing body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features in female university students considered at high-risk of developing Body Image Disorders (BIDs).
Hypothesis: Participants using 'GGBI: Positive Body Image' immediately following baseline assessment (Time 0; T0) (immediate-use App group: iApp) would exhibit greater reduction in body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features than participants who did not use 'GGBI: Positive Body Image' in this phase of the study (delayed-use App group: dApp). Following crossover (Time 1; T1), the investigators expect that participants gains in the iApp group would be maintained at follow-up (Time 2; T2).
#Intervention
- DEVICE : GGBI: Positive Body Image (Mobile App)
- Brief, game-like, training exercise for challenging body image disorder symptoms and associated psychological features
|
#Eligibility Criteria:
Inclusion Criteria:
* Presence of Body Image Disorder symptoms
Exclusion Criteria:
* Presence of a full-blown Body Image Disorder
* Presence of a psychotic/schizophrenic disorder
* Current treatment for a Body Image Disorder
Sex :
FEMALE
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
|
NCT04103606
|
{
"brief_title": "A Mobile-App Training to Reduce Body Image Disorder Symptoms and Associated Features in Female University Students",
"conditions": [
"Body Image Disorder",
"Body Dysmorphic Disorders",
"Eating Disorders"
],
"interventions": [
"Device: GGBI: Positive Body Image (Mobile App)"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT04103606",
"official_title": "A Mobile-App Training to Reduce Body Image Disorder Symptoms and Associated Psychological Features in Female University Students: a Randomized Controlled Pilot Study with Crossover Design",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-31",
"study_completion_date(actual)": "2021-12-31",
"study_start_date(actual)": "2019-01-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-19",
"last_updated_that_met_qc_criteria": "2019-09-24",
"last_verified": "2022-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-25",
"first_submitted": "2019-09-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients undergoing thoracic surgery after discharge from PACU or ICU.
Detailed Description
Dexmedetomidine has sedative and analgesic properties that may reduce the opioid requirement in post-operative patients, thereby decreasing the chance of post-operative respiratory depression that occurs with opioid administration. In addition, patients may be more alert with less opioid medication. Currently, dexmedetomidine is not approved for use longer than twenty-four hours and must only be administered in the Intensive Care Unit where patients can be continuously monitored.
This is a prospective, double-blinded, control group pilot study. One group (the control group) will receive a normal saline infusion and the second group (the treatment group) will receive low-dose Dexmedetomidine for up to 24 hours after they are admitted to an open nursing unit (not an Intensive Care Unit).
During the surgery, the anesthesiologist will administer dexmedetomidine during the surgical procedure after an optional loading dose. All patients will receive pain medication using a Patient Controlled Analgesia (PCA) pump as per standard practice. In addition, if the physician deems necessary, an On-Q Pain Pump will deliver local anesthetic surrounding the incision under direction of the surgeon.
Before discharge from the PACU or ICU, each subject will receive either low-dose dexmedetomidine or normal saline using a continuous infusion pump for up to 24 hours after the subject is discharged from either the PACU or the ICU to an open nursing unit. While on the open nursing unit patient vital signs, oxygen saturation, Ramsay score and pain score will recorded every two hours until the treatment drug is stopped.
#Intervention
- DRUG : Dexmedetomidine
- Dexmedetomidine titrated over 24 hours
- Other Names :
- Precedex, Dexdor Titrated 0.1 to 0.5 ug.kg.h-1
- OTHER : Placebo (Normal Saline)
|
#Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologists (ASA) class I, II or III
* Undergoing thoracic surgery on an inpatient basis
* Age 18 up to 85 years
Exclusion Criteria:
* Subject is pregnant and/or lactating
* Subject has a serious Central Nervous System (CNS)pathology/trauma that, per clinical judgment of the investigator, precludes responsiveness or survival.
* Subject for whom alpha-2 agonists are contraindicated
* Subject meets any of the following cardiovascular criteria:
* Acute unstable angina (defined during current hospital stay)
* Suspicion of acute myocardial infarction.
* Considered to have a left ventricular ejection fraction of less than 30%.Decision to exclude is predicated in the Investigator's opinion, and may be based on any combination of acute presentations, recently preformed diagnostic studies, or a history that suggests poor cardiac function. Pulmonary congestion of a non-cardiac origin or mild congestive failure primarily attributable to etiologies other than poor ventricular function are not exclusion criteria.
* Subject has participated in a trial with any experimental drug within 30 days prior to enrollment in the study, or has ever been enrolled in this study.
* Subject is unable to undergo any procedures required by the protocol.
* Subject has acute hepatitis, a history or presence of chronic hepatitis, and /or has had a positive result for Hepatitis B surface antigen test.
* Subject requires dialysis (e.g., hemodialysis, peritoneal dialysis, CVVHD).
* Subject has a known, uncontrolled seizure disorder.
* Subject has a known psychiatric illness that could confound a normal response to sedative treatment.
* Subject is terminally ill with a life duration expectancy of < 60 days.
* Subject has a history of Obstructive Sleep Apnea.
* Oxygen saturation is < 90% on room air.
* Subject is on beta blocker medication.
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
|
NCT00345384
|
{
"brief_title": "Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients",
"conditions": [
"Post-operative Pain",
"Respiratory Depression"
],
"interventions": [
"Drug: Dexmedetomidine",
"Other: Placebo (Normal Saline)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00345384",
"official_title": "Post-Operative Infusion of Low-Dose Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients: A Randomized, Double-Blind, Controlled Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-01",
"study_completion_date(actual)": "2010-01",
"study_start_date(actual)": "2008-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-08",
"last_updated_that_met_qc_criteria": "2006-06-27",
"last_verified": "2016-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-06-28",
"first_submitted": "2006-06-27",
"first_submitted_that_met_qc_criteria": "2015-07-27"
}
}
}
|
#Study Description
Brief Summary
This research study will test different doses of RG-HRV16 to find the minimum dose needed to give research subjects cold symptoms of at least moderate intensity. The study will also test the safety of RG-HRV16. This information will be used in future studies (for example, to test antiviral preparations, sprays that could protect from getting a cold or decrease cold symptoms or to understand more about how rhinovirus can lead to asthma worsening). RG-HRV16 is a common cold virus that has been made in a new way and has not been used in humans before.
Detailed Description
Rhinoviruses are the most frequently cause of the common cold. HRV16 (Family Picornaviridae Genus Rhinovirus type 16) has been used extensively to induce colds in studies of experimentally inoculated volunteers that are designed to study the pathogenesis of colds and effects of antiviral medications.
Experimental inoculation with human rhinovirus type 16 (HRV16) administered intranasally via aerosolization has been used at the University of Wisconsin for over 30 years, and has proven to be a safe tool to reproducibly induce symptomatic colds. HRV has been linked with exacerbations of asthma and COPD, and this model has been used to evaluate inflammatory mechanisms and to test the efficacy of treatments for the common cold. Recent refinements in the technology available to produce and safety test reagents that are intended to be administered to human volunteers as part of research protocols has prompted us to produce a new lot of HRV16 in accordance with standards of current Good Manufacturing Procedures (cGMP). For this inoculum, we have used a cDNA clone (reverse genetics) to generate source virus, thus this new virus inoculum will be referred to as RG-HRV16.
This approach has two main advantages over using viruses isolated from nasal secretions. First, several 'new' respiratory viruses (e.g. metapneumovirus, bocavirus, SARS, rhinovirus group C) have been discovered in the past 10 years, and there is little doubt that additional viruses will be discovered. Therefore, it is impossible to ensure that nasal secretions that are chosen for isolation of 'seed virus' contain only the pathogen of interest. This problem is minimized through the use of virus derived from a cDNA clone that was produced in E. coli. Second, RNA viruses, such as HRV, mutate as the virus grows because their RNA polymerases have no error-correcting function. The cDNA clone, reproduced by the much more accurate E. coli DNA polymerase, provides a stable source of virus sequence for production of future inocula.
This study represents a first-in-human, phase 1 study to assess the safety of RG-HRV16 in humans and identify the dose needed to produce moderate-to-severe colds in 75% of HRV16-seronegative human volunteers.
#Intervention
- BIOLOGICAL : RG-HRV16
- A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
- Other Names :
- Rhinovirus type 16
- DRUG : Placebo
- The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml.
|
#Eligibility Criteria:
Inclusion Criteria:
* Capable and willing to grant written informed consent (in English) and cooperate with study procedures and requirements including willingness to avoid cold symptom medications during the study.
* Age between 18 and 50 years (children and older adults will be excluded from the study due to the possibility of greater morbidity associated with upper respiratory infections in these age groups).
* Absence of HRV16 neutralizing antibody.
* Safety laboratory assessments within normal University of WI Hospital and Clinics (UWHC) ranges or grade 1 (mild) laboratory abnormalities which are deemed not clinically significant in the judgment of the PI. Labs to include CBC with differential and platelets, BUN, creatinine, AST, ALT and IgA and IgG serum immunoglobulins. Any lymphopenia outside of the normal range will be an absolute exclusion.
* Subjects must be willing to refrain from taking nasal decongestants, antihistamines or cough/cold preparations (this includes dietary supplements and homeopathic preparations used specifically for cold/flu e.g., vitamin C, zinc, echinacea) within the 7 days prior to Visit 1 and throughout the study until after the completion of Visit 5.
Exclusion Criteria:
* A chronic medical condition, which may increase risk or interfere with the conduct of the study, including, but not limited to heart disease, Type I of II diabetes mellitus, asthma, COPD, other chronic lung disease, perennial rhinitis and chronic rhinosinusitis.
* Subjects with household contacts who are pregnant or planning a pregnancy during the main subject's participation, who have chronic respiratory disease, who are children under the age of 2 years, or who are adults > 50 years.
* Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
* Subjects with seasonal allergies will be excluded only if allergy symptoms are present at baseline, or are anticipated to occur during the study period.
* Smoking within the past 6 months.
* Subjects who have received immunosuppressive treatment within the last 12 months.
* Upper respiratory infection (URI or sinusitis) in the past 4 weeks.
* Subjects with a history of a significant adverse reaction or intolerance to a previous live, attenuated vaccine.
* Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study.
* Unwillingness of study participants to use adequate birth control methods during the course of the study. Adequate birth control methods include oral contraceptives, injections such as Depo-Provera, an intrauterine device or double-barrier contraception (combination of condom and contraceptive sponge or cervical cap and spermicide or another combination approved in writing by the Principal Investigator).
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
|
NCT01769573
|
{
"brief_title": "A First-in-Human Safety and Dose-Finding Study of New Type-16 Human Rhinovirus (RG-HRV16) Inoculum in Healthy Volunteers",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Drug: Placebo",
"Biological: RG-HRV16"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01769573",
"official_title": "A First-in-Human Safety and Dose-Finding Study of New Type-16 Human Rhinovirus (RG-HRV16) Inoculum in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-11",
"study_completion_date(actual)": "2017-12",
"study_start_date(actual)": "2013-07"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-06-03",
"last_updated_that_met_qc_criteria": "2013-01-14",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-01-16",
"first_submitted": "2013-01-14",
"first_submitted_that_met_qc_criteria": "2019-02-19"
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to evaluate the suitability of 11C-ORM-13070 as a positron emission tomography tracer.
#Intervention
- DRUG : 11C-ORM-13070
- Single dose of i.v. solution
|
#Eligibility Criteria:
Inclusion Criteria:
* Good general health ascertained by detailed medical history and physical examination
* Males between 18 and 45 years
* Body mass index (BMI) between 18 <= age <= 30 kg/m2
* Weight 55 <= age <= 95 kg (inclusive)
Exclusion Criteria:
* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator
* Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant medication during the study.
* Regular consumption of more than 21 units of alcohol per week (1 unit = 4 cl spirits, about 13 g of alcohol)
* Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
* Inability to refrain from using nicotine-containing products during the stay in the study centre
* Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre e.g. propensity in getting headache when refraining from caffeine-containing beverages
* Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
* Abnormal 12-lead electrocardiogram (ECG) finding of clinical relevance
* Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part into the study
* Anatomical abnormality in MRI which may in the opinion of the investigator interfere with the interpretation of PET results
* Participation in a drug study within 3 months prior to the entry into this study
* Participation in a prior PET study
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00735774
|
{
"brief_title": "Suitability of 11C-ORM-13070 as a PET Tracer",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: 11C-ORM-13070"
],
"location_countries": [
"Finland"
],
"nct_id": "NCT00735774",
"official_title": "Suitability of 11C-ORM-13070 as a Positron Emission Tomography Tracer; an Open Study in Healthy Males",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-05",
"study_completion_date(actual)": "2009-05",
"study_start_date(actual)": "2008-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-11-25",
"last_updated_that_met_qc_criteria": "2008-08-13",
"last_verified": "2009-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-08-15",
"first_submitted": "2008-08-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Learning chronic pain self-management skills can help patients improve daily functioning and quality of life, while avoiding risks associated with opioids and other pharmacological treatments. Community health workers (CHWs) may help make chronic pain self-management interventions more accessible to older adults living in underserved communities. The goal of this study is to conduct a feasibility test of a chronic pain self-management intervention delivered by CHWs, in conjunction with mobile health tools, in a sample of 25 older adults recruited from community sites in Detroit, Michigan. This study will involve the use of mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and change in pain-related outcomes.
#Intervention
- BEHAVIORAL : STEPS (Seniors using Technology to Engage in Pain Self-management)
- Participants will meet with a community health worker (CHW) at a one-hour in-person study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and associated materials, and schedule six weekly telephone sessions with the CHW. Participants will be given a wearable physical activity tracker to use throughout the course of the program. They can choose to report daily step counts by automatically syncing to an app or via text message. Each week during the study period, participants will engage with content on the website, have a session with the community health worker, track their daily steps, and set and work toward pain-management goals.
|
#Eligibility Criteria:
Inclusion Criteria:
* English-proficient
* Age >= 60 years
* Ambulatory with or without assistive device
* Community-living
* Have a cell or landline phone
* Have Internet access (home or elsewhere)
* Self-reported chronic musculoskeletal pain (pain in muscles or joints for > 3 months); >4 (0 <= age <= 10 scale) average pain level over last week; >1 day/previous 30 when pain made it difficult to do usual activities
* Ability to attend a one-time study orientation session
Exclusion Criteria:
* Serious acute illness or hospitalization in last month
* Planned surgery in next three months
* Significant cognitive impairment as indicated by affirmative response to question: 'Do you have significant difficulties with your memory that get in the way of your usual daily activities?'
* Other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit.
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
|
NCT04095650
|
{
"brief_title": "A New Model to Reach Vulnerable Older Adults With Pain Self-management Support",
"conditions": [
"Chronic Pain"
],
"interventions": [
"Behavioral: STEPS (Seniors using Technology to Engage in Pain Self-management)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04095650",
"official_title": "A New Model to Reach Vulnerable Older Adults With Pain Self-management Support",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-05-14",
"study_completion_date(actual)": "2020-05-14",
"study_start_date(actual)": "2019-09-20"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-01-06",
"last_updated_that_met_qc_criteria": "2019-09-18",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-19",
"first_submitted": "2019-09-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
No studies have investigated the effects of a Sciatic nerve mobilization in subjects with neck pain. This study aims to determine the immediate effects of a lower limbs neural mobilization on cervical range of motion and on the perception of pain in the most common trigger points located in the cervical musculature.
Detailed Description
A convenience sample will be used to obtain subjects The subjects will be recruited through posted advertisements on social networks. The inclusion and exclusion criteria will be applied to the volunteers. The sample wil comprise university students and administrative workers with neck pain. The subjects will be screened by a screening questionnaire and all of them, they will be required to sign an inform consent before participating to the study. After signing it, they will be randomly divide into control group subject to a placebo technique and the intervention group subject to an active mobilization of the sciatic nerve.
To assess changes in cervical articular range, will be used, a cervical goniometer (CROM) and for changes in pressure pain threshold of the trigger points will be used a mechanical algometer. Furthermore, to asses changes in pain perception will be used a visual numerical scale. The statistical analysis will be performed using the statistical program SPSS 25.0, comparing the results between both groups.
#Intervention
- OTHER : Active neck mobilization
- The subjects, receive an active neck mobilization intervention.
- OTHER : Active Mobilization of the sciatic nerve
- The subjects, receive an active sciatic nerve mobilization intervention.
|
#Eligibility Criteria:
Inclusion Criteria:
* To spend more than 3 hours at the computer.
* To have or have had neck pain during the last 3 weeks.
Exclusion Criteria:
* To have had traumatisms, traffic accidents and surgeries in the last 2 months.
* To have taken any analgesic tablets before the treatment.
* To be in a physiotherapy treatment.
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
|
NCT03603054
|
{
"brief_title": "The Effect of Lower Limbs Neural Mobilization in Subjects With Cervical Pain.",
"conditions": [
"Neck Pain"
],
"interventions": [
"Other: Active Mobilization of the sciatic nerve",
"Other: Active neck mobilization"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT03603054",
"official_title": "Analysing the Immediate Effects of Sciatic Nerve Mobilization on the Range of Cervical Mobility and on the Myofascial Trigger Points of the Cervical Muscles. Pilot Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-01",
"study_completion_date(actual)": "2018-10-30",
"study_start_date(actual)": "2018-08-01"
},
"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)": "2018-12-03",
"last_updated_that_met_qc_criteria": "2018-07-25",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-27",
"first_submitted": "2018-07-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to look at the effects of a 10-week stress management in-person group program. The program will study emotions, stress, and stress management techniques (such as relaxation and coping techniques) on quality of life, distress, depression, and physical health in Spanish- speaking, Hispanic/Latino men diagnosed with Prostate Cancer (PC).
Detailed Description
This 5-year study evaluates the effects of a 10-week group-based linguistically translated and culturally adapted cognitive-behavioral stress and self-management (C-CBSM) intervention on symptom burden and health related quality of life (HRQoL) in Hispanic men treated for localized prostate cancer (PC). About 80% PC cases are diagnosed as early disease and have a 5- and 10-year survival rate of almost 100% and 99%, respectively.1 Most patients receive active treatment (\~70%) leading to prolonged treatment-related side effects and dysfunction persisting well beyond primary treatment. Survival is offset by chronic side effects such as sexual and urinary dysfunction, pain and fatigue that can lead to poor psychosocial functioning, impaired intimacy and social functioning, and masculinity concerns. Hispanic PC survivors report lower physical and social functioning, poorer emotional well-being and greater sexual and urinary dysfunction, even after accounting for SES and disease severity. These sequelae can lead to elevated glucocorticoid release and inflammatory cytokines that have a direct effect on these symptoms and can interfere with physiological pathways necessary for recovery of sexual and urinary functioning. We have shown that CBSM reduces symptom burden and improves HRQoL in bilingual Hispanic PC survivors. In a pilot we showed that a linguistic translation of CBSM with attention to sociocultural processes improved symptom burden and HRQoL in Spanish monolingual PC survivors. We have also shown that CBSM is associated with reduced glucocorticoid resistance and inflammatory gene expression pathways in circulating leukocytes among breast cancer survivors. We propose to (a) deliver a culturally adapted C-CBSM intervention in Spanish that places greater emphasis on salient sociocultural determinants of symptom burden and HRQoL in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo), (b) incorporate a neuroimmune model of symptom regulation and management, and (c) test the efficacy of C-CBSM, relative to standard non-culturally adapted CBSM, in two diverse Hispanic communities (Chicago \& Miami). We will test our aims in 200 Hispanic men post-treatment for localized PC with elevated symptom burden in a 2 x 4 randomized design with condition (C-CSBM vs. CBSM) as the between groups factors, and time (baseline, post-intervention \& 6- and 12-months post intervention) as the within groups factor.
Our Primary Aim is to determine whether randomization to C-CBSM, relative to standard CBSM, is associated with reduced symptom burden and improved HRQoL. Our Secondary Aims evaluate whether C-CBSM leads to greater improvements in the intervention targets (e.g., stress management, psychological distress \& interpersonal disruption), and physiologic adaptation (i.e., glucocorticoid receptor sensitivity \& inflammatory gene expression). We will also evaluate psychosocial and physiological mechanisms as mediators of C-CBSM's effects on our primary outcomes. We also explore several moderators (e.g., SES, acculturation, treatment, Hispanic origin) of C-CBSM's effect on primary outcomes and the effects of C-CBSM on cardiometabolic health (e.g., lipids, fasting glucose) via reduced inflammation.
Primary Aim 1: Determine whether participation in C-CBSM is associated with significantly greater reductions in symptom burden and improvements in HRQoL relative to participation in CBSM.
Secondary Aims:
Aim 2: Determine whether participation in C-CBSM is associated with significantly greater improvements in intervention targets (i.e., improved stress management, and reduced psychological distress and interpersonal disruption) relative to participation in the CBSM condition.
Aim 3: Determine whether participation in C-CBSM is associated with significantly greater activation of leukocyte glucocorticoid receptor and less inflammatory gene expression profiles relative to CBSM.
Aim 4: Determine whether C-CBSM related improvements in symptom burden and HRQoL are mediated by improvements in intervention targets and gene expression profiles.
#Intervention
- BEHAVIORAL : Cultural CBSM
- The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
- BEHAVIORAL : Standard CBSM
- The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
#Eligibility Criteria:
Inclusion Criteria:
* >= 18 years;
* Hispanic/Latino self-identification;
* Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention);
* Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
* Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within minimum of 4 months and maximum of 72-months;
* Some patients with prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) may be enrolled, per P.I. discretion, based on a case-by-case review;
* Willingness to be randomized and followed for approximately12 months.
Exclusion Criteria:
* History of non-skin cancer within the last 2 years.
* Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months, as these conditions can interfere with adequate participation in our experimental conditions may be exclusionary, per P.I. discretion, based on a case-by-case review;
* Active alcohol dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review;
* Active substance dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review; and
* Acute or chronic immune system medical conditions, medications or conditions that impact immune and endocrine function (e.g., Chronic Fatigue Syndrome (CFS), Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions), per PI discretion based on a case by case review.
* Individuals scoring >3 on the SPMSQ will be excluded or per PI discretion based on a case by case review.
.
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
|
NCT03344757
|
{
"brief_title": "Health Gatherings - For Your Health After Cancer",
"conditions": [
"Prostate Neoplasm",
"Genital Neoplasms, Male",
"Urogenital Neoplasms",
"Neoplasm, Prostate",
"Genital Diseases, Male",
"Prostatic Diseases"
],
"interventions": [
"Behavioral: Standard CBSM",
"Behavioral: Cultural CBSM"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03344757",
"official_title": "Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-01",
"study_completion_date(actual)": "2024-08-01",
"study_start_date(actual)": "2017-10-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2017-11-13",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-17",
"first_submitted": "2017-09-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a 24-week treatment period in participants with non-cystic fibrosis bronchiectasis.
Detailed Description
Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter, multi-national study to assess the efficacy, safety and tolerability, and pharmacokinetics (PK) of INS1007 administered once daily for 24 weeks in participants with non-cystic fibrosis bronchiectasis (NCFBE).
#Intervention
- DRUG : Brensocatib 10 mg
- Administered once per day for 24 weeks
- DRUG : Brensocatib 25 mg
- Administered once per day for 24 weeks
- DRUG : Placebo
- Administered once per day for 24 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical history consistent with NCFBE (cough, chronic sputum production and/or recurrent respiratory infections)
* Are current sputum producers with a history of chronic expectoration and able to provide a sputum sample during Screening
* Have at least 2 documented pulmonary exacerbations in the past 12 months before Screening
Exclusion Criteria:
* Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
* Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency
* Are current smokers
* Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
* Have any acute infections, (including respiratory infections)
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
|
NCT03218917
|
{
"brief_title": "Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis",
"conditions": [
"Non-Cystic Fibrosis Bronchiectasis"
],
"interventions": [
"Drug: Brensocatib 25 mg",
"Drug: Brensocatib 10 mg",
"Drug: Placebo"
],
"location_countries": [
"Netherlands",
"United States",
"Poland",
"Germany",
"Singapore",
"United Kingdom",
"New Zealand",
"Korea, Republic of",
"Spain",
"Australia",
"Bulgaria",
"Italy",
"Belgium",
"Denmark"
],
"nct_id": "NCT03218917",
"official_title": "Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety & Tolerability, and PK of INS1007 Administered Once Daily for 24 Weeks in Subjects With Non-CF Bronchiectasis - The Willow Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-12",
"study_completion_date(actual)": "2019-12-12",
"study_start_date(actual)": "2017-10-31"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-03-27",
"last_updated_that_met_qc_criteria": "2017-07-12",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-07-17",
"first_submitted": "2017-07-11",
"first_submitted_that_met_qc_criteria": "2023-01-16"
}
}
}
|
#Study Description
Brief Summary
This trial investigates the effects of FE 999049 compared to placebo.
#Intervention
- DRUG : Follitropin delta
- FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 12 µg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 µg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 µg, and the maximum daily dose was 24 µg.
Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early ovarian hyperstimulation syndrome (OHSS) with the exception of gonadotropin-releasing hormone (GnRH) agonist for triggering of final follicular maturation, was not allowed.
- Other Names :
- FE 999049, Rekovelle
- OTHER : Placebo
- Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049.
Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed.
|
#Eligibility Criteria:
Inclusion Criteria:
* Informed Consent Documents signed prior to any trial-related procedure.
* In good physical and mental health in the judgement of the investigator.
* Pre-menopausal females between the ages of 18 and 34 years. The participants must be at least 18 years (including the 18th birthday) when they sign the informed consent and no more than 34 years (up to the day before the 35th birthday) at the time of randomization.
* Body mass index (BMI) between 17.5 and 38.0 kg/m2 (both inclusive) at screening.
* Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor.
* Documented history of infertility for at least 12 months before randomization (not applicable in case of tubal or severe male factor infertility, or when the use of donor sperm is indicated).
* Regular menstrual cycles of 24 <= age <= 35 days (both inclusive).
* Hysterosalpingography, hysteroscopy or saline infusion sonography, documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous fibroids of any size or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) at screening or within 1 year prior to screening.
* Transvaginal ultrasound documenting presence and adequate visualization of both ovaries, without evidence of significant abnormality (e.g. enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) at screening. Both ovaries must be accessible for oocyte retrieval.
* Early follicular phase (cycle day 2 <= age <= 4) serum levels of FSH between 1 and 15 IU/L (results obtained within 3 months prior to randomization).
* Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests at screening or within 6 months prior to screening.
* Willing to accept single blastocyst transfer in the fresh cycle and in the cryopreserved cycles initiated within 12 months from the start of COS using blastocysts obtained in this trial.
Exclusion Criteria:
* More than one previous COS cycle for IVF/ICSI.
* Known endometriosis stage III-IV (defined by the revised ASRM classification, 2012 ).
* Known history of anovulation.
* One or more follicles greater than or equal to 10 mm (including cysts) observed on the transvaginal ultrasound prior to randomization on stimulation day 1.
* Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy [excluding ectopic pregnancy] and before week 24 of pregnancy).
* Known abnormal karyotype of participant or of her partner / sperm donor, as applicable, depending on source of sperm used for insemination in this trial. In case partner sperm will be used and the sperm production is severely impaired (concentration <1 million/mL), normal karyotype, including no Y-chromosome microdeletion, must be documented.
* Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
* Known inherited or acquired thrombophilia.
* Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
* Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of pharmacologically controlled sub-clinical hypothyroidism.
* Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
* Known moderate or severe impairment of renal or hepatic function.
* Any abnormal finding of clinical chemistry, hematology, thyroid-stimulating hormone (TSH) or prolactin, or vital signs at screening, which is judged clinically significant by the investigator.
* Known abnormal cervical cytology of clinical significance observed within three years prior to randomization (unless the clinical significance has been resolved).
* Findings at the gynecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g. congenital uterine abnormalities or retained intrauterine device.
* Pregnancy (negative urinary pregnancy tests must be documented at screening and prior to randomization) or contraindication to pregnancy.
* Known current active pelvic inflammatory disease.
* Use of fertility modifiers during the last menstrual cycle before randomization, including dehydroepiandrosterone (DHEA), metformin or cycle programming with oral contraceptives, progestogen or estrogen preparations.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 34 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03740737
|
{
"brief_title": "Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-1)",
"conditions": [
"Infertility"
],
"interventions": [
"Other: Placebo",
"Drug: Follitropin delta"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03740737",
"official_title": "A Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Trial Investigating the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Women Aged 18-34 Years Undergoing Assisted Reproductive Technology",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-11-11",
"study_completion_date(actual)": "2020-11-11",
"study_start_date(actual)": "2018-10-26"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-18",
"last_updated_that_met_qc_criteria": "2018-11-09",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-14",
"first_submitted": "2018-10-24",
"first_submitted_that_met_qc_criteria": "2023-12-21"
}
}
}
|
#Study Description
Brief Summary
To determine if yoga is beneficial in improving physical function quality of life and medical status in people with Parkinson's disease
Detailed Description
This pilot study is a randomized controlled study of 20-30 individuals with Parkinson's disease will have a control group with no training and a research group with yoga training. The control group will have the opportunity to attend yoga training of the same intensity after the study is completed. The effects of yoga will not be on the control group. Data on physical function will be derived from assessments including strength, balance, flexibility, ROM. gait, posture and functional analysis performed in the Georgia Holland Cardiopulmonary and Neuromuscular Research Lab. Questionnaires related to quality of life, depression and falls will determine psychological impact or yoga training. Vital signs, pulmonary function tests and blood draws will be done in the General Clinical research Center (GCRC) and protein analysis will be done in the diabetes research lab.
#Intervention
- BEHAVIORAL : Yoga Training
|
#Eligibility Criteria:
Inclusion Criteria:
* Parkinson's Disease
* Stage 1 <= age <= 3 Hoehn & Yahr
Exclusion Criteria:
* Decline in immune function
* 6 month joint surgery
* spinal fusions
* decline in mental status measured by Folstein Mini Mental Status Exam
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
|
NCT00312559
|
{
"brief_title": "The Therapeutics Effects of Yoga in Individuals With Parkinson's Disease",
"conditions": [
"Parkinson's Disease"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00312559",
"official_title": "The Therapeutic Effects of Yoga in Individuals With Parkinson's Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2007-03",
"study_start_date(actual)": "2006-02"
},
"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)": "2007-08-20",
"last_updated_that_met_qc_criteria": "2006-04-06",
"last_verified": "2007-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-04-10",
"first_submitted": "2006-04-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The SABR-ATAC trial (Stereotactic Ablative Radiotherapy and anti-TGFB Antibody Combination) is a phase I/II trial that studies the side effects and efficacy of fresolimumab, an anti-transforming growth factor beta (TGFB) antibody, when given with stereotactic ablative radiotherapy in patients with stage IA-IB non-small cell lung cancer. Fresolimumab may inhibit radiation side effects and block tumor growth through multiple mechanisms. Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiotherapy (SBRT), is a specialized form of radiation therapy that precisely delivers high dose radiation directly to tumors, thus killing tumor cells and minimizing damage to normal tissue. Giving fresolimumab with SABR may work better in treating patients with early stage non-small cell lung cancer than treating with SABR alone.
Detailed Description
PRIMARY OBJECTIVES:
Phase 1: Evaluate the safe dose of fresolimumab in combination with stereotactic ablative radiotherapy (SABR) in patients.
Phase 2. Evaluate the rate of radiation induced pulmonary fibrosis after SABR plus fresolimumab.
SECONDARY OBJECTIVES:
I. Evaluate potential adverse events in patients receiving fresolimumab plus SABR. (Phase I) II. Evaluate post treatment changes in pulmonary function. (Phase I) III. Evaluate recurrence rates and progression free survival. (Phase I) IV. Assess pharmacokinetics (PK) of fresolimumab in combination with SABR (optional for patient). (Phase I) V. Evaluate the rate and severity of radiation induced pulmonary fibrosis after SABR plus fresolimumab. (Phase I) VI. Evaluate the severity of radiation induced pulmonary fibrosis after SABR plus fresolimumab. (Phase II) VII. Evaluate potential adverse events in patients receiving fresolimumab plus SABR. (Phase II) VIII. Evaluate post treatment changes in pulmonary function. (Phase II) IX. Evaluate recurrence rates and progression free survival. (Phase II)
OUTLINE: This is a phase I, dose escalation study of fresolimumab followed by a phase II study.
* Phase 1: A cohort of 5 patients receive the pre-selected dose of 3mg/kg of fresolimumab. If one patient experiences a DLT, an additional 5 patients will be enrolled at 3 mg/kg. If no more patients experience a DLT, then 3 mg/kg will be the dose for the Phase 2 component. If 2 or more patients experience a DLT in the total expanded cohort (or 2 or more patients in the initial cohort experience DLT), then the investigational dose of fresolimumab will be changed to 1 mg/kg. If 2 or more patients in the initial cohort experience DLT before all 5 patients have been enrolled, the remaining patients will receive the lower dose of 1 mg/kg.
* Phase 2: Patients receive fresolimumab intravenously (IV) on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12.
After completion of study treatment, patients are followed up at 3, 6, and 12 months.
#Intervention
- BIOLOGICAL : Fresolimumab
- Given IV
- Other Names :
- Anti-TGF-Beta Monoclonal Antibody GC1008, GC1008, Human Anti-TGF-Beta Monoclonal Antibody GC1008, Immunoglobulin G4, anti-(transforming growth factor beta) (human monoclonal GC-1008 heavy chain), disulfide with human monoclonal GC-1008 light chain, Dimer
- RADIATION : Stereotactic Body Radiation Therapy
- Undergo SABR
- Other Names :
- SBRT
|
#Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed, histologically proven (or strongly suspected, see below) T1-T2aN0M0 (Stage IA-IB) non-small cell lung cancer (NSCLC), with maximum tumor diameter =< 5 cm under consideration for stereotactic ablative body radiotherapy (SABR) as definitive primary treatment
* Patient judged to be inoperable or at high surgical risk by a board qualified thoracic cancer surgeon who has evaluated the subject within the prior 12 weeks, or the patient's case has been discussed at a multidisciplinary tumor board with a thoracic cancer surgeon in attendance, or a patient who refuses surgery or declines to be evaluated for surgery.
* Able to give informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
* Men or women of child bearing potential must agree to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for at least 90 days after last study treatment (radiation or fresolimumab)
Exclusion Criteria:
* Significant anemia (hemoglobin below 9.0 g/dL) or neutropenia (absolute neutrophil count [ANC] < 1000/mm^3)
* Prior history of multifocal adenocarcinoma in situ (ie, classic or pure bronchioloalveolar carcinoma)
* Prior history of keratoacanthoma (well differentiated squamous cell skin cancer variant, often centrally ulcerated); history of basal cell cancer is allowed
* Pre malignant skin lesion(s) noted on prescreening skin exam, except for actinic (solar) keratosis
* Prior radiotherapy overlapping with high dose region of planned SABR course
* Prior history of head and neck; oral; or bladder cancer
* Prior receipt of systemic treatment (chemotherapy, targeted therapy, or immunotherapy) for the lesion under consideration of treatment
* Uncontrolled, inter current or recent illness that in the investigator's opinion precludes participation in the study, including those undergoing therapy for a separate invasive malignancy
* Contraindication to receiving radiotherapy
* Known allergy to components of fresolimumab
* Pregnant or breastfeeding. All women of child bearing potential (last menstrual period within the previous 12 months and not surgically sterile) will be tested for pregnancy at pre entry.
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
|
NCT02581787
|
{
"brief_title": "SABR-ATAC: A Trial of TGF-beta Inhibition and Stereotactic Ablative Radiotherapy for Early Stage Non-small Cell Lung Cancer",
"conditions": [
"Stage IA Non-Small Cell Lung Carcinoma",
"Stage IB Non-Small Cell Lung Carcinoma"
],
"interventions": [
"Biological: Fresolimumab",
"Radiation: Stereotactic Body Radiation Therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02581787",
"official_title": "Fresolimumab and Stereotactic Ablative Radiotherapy in Early Stage Non-small Cell Lung Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-02",
"study_completion_date(actual)": "2023-03-02",
"study_start_date(actual)": "2016-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"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)": "2024-03-27",
"last_updated_that_met_qc_criteria": "2015-10-19",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-21",
"first_submitted": "2015-10-16",
"first_submitted_that_met_qc_criteria": "2024-03-01"
}
}
}
|
#Study Description
Brief Summary
The overall goal of this study is to determine whether English-speaking adults who were discharged from an intensive care unit (ICU) at least one month ago and have some level of distress related to their ICU experience will be interested in, willing to use, and satisfied with a new mobile application (app) designed to help the user process a difficult memory. Participants must have internet access and a smartphone in order to use the app. The goal of the app is to help reduce the psychological distress associated with a memory by processing that memory at one's own pace with app guidance. Participants will be asked to use the app for 6 weeks at least 3 times a week for 30 or more minutes at a time. Participants will also be asked to complete questionnaires over a 12-week period.
The investigators aim to test how possible and realistic it is for people who were hospitalized with a critical illness to voluntarily use this app to process relevant distressing memories of their hospitalization. The investigators hope that these results will inform the design of a larger trial that will be able to test if this app can reduce distress in this patient population, as the app may offer affordable and accessible help for some patients experiencing illness-related distress.
Detailed Description
Critical illness can be an incredibly traumatic experience, often involving treatment in the intensive care unit (ICU), intubation or other invasive medical procedures, altered levels of consciousness, inability to communicate, sensory and sleep deprivation, physical pain, and delirium. The cumulative physical and psychological stress associated with critical illness can be severe enough to induce clinically-significant symptoms of posttraumatic stress disorder (PTSD). Patients with PTSD symptoms related to prior traumatic medical events are more likely to engage in unhealthy behaviors, such as tobacco use, sedentary lifestyle, poor diet, and medication nonadherence.
Exposure therapy (ET) is considered the gold standard treatment for PTSD and involves repeated exposure to trauma-related stimuli leading to habituation of maladaptive emotional responses and an increased sense of control and self-competence. ET is highly effective for improving PTSD triggered by more typical forms of trauma, such as military combat or sexual assault, but less is known about the role of ET for reducing PTSD symptoms after critical illness.
The goal of this pilot study is to conduct preliminary testing of a newly developed mobile application (Messy Memories) that uses remotely delivered ET to reduce psychological distress and improve health behaviors in survivors of critical illness. The user is asked to audio record a traumatic or distressing memory and process what it feels like to re-experience the memory. Users can return to their recorded memory as often as they like until it becomes easier to re-experience.
The investigators will assess the feasibility and acceptability of recruiting and engaging critical illness survivors in the Messy Memories intervention. They will also explore the efficacy of the intervention for engaging the mechanistic target (PTSD symptoms) to reduce psychological distress. Additional outcomes will include reduction in other psychological symptoms (e.g., depression, anxiety) and improvement in health behaviors (e.g., sleep patterns, physical activity). The results of this study will form the basis of a future adequately powered randomized controlled trial testing whether the Messy Memories intervention can significantly reduce psychological distress and, in turn, improve behavioral outcomes among critical illness survivors.
Aim 1: Assess the feasibility of recruiting and engaging critical illness survivors in a mobile application-based exposure therapy intervention (Messy Memories). Hypothesis: The intervention will be feasible based on recruitment, retention, and completion rates of ≥70%.
Aim 2: Assess the acceptability of recruiting and engaging critical illness survivors in a mobile application-based exposure therapy intervention (Messy Memories). Hypothesis: The intervention will be acceptable based on participant satisfaction ratings of ≥70% and qualitative analysis of exit survey responses.
Aim 3 (exploratory): Assess engagement of the mechanistic target (PTSD symptoms) by the mobile application-based exposure therapy intervention (Messy Memories). Hypothesis: Participants will report improvement in PTSD symptoms, based on pre-/post-intervention decrease in scores on the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5).
Participants will be asked to engage with the Messy Memories application at least 3 days a week for at least 30 minutes each day using their own mobile smartphone device. Participants may proceed through the modules of the application at their own pace and may return to any module as many times as they desire throughout the 6-week intervention period. Mechanistic target and clinical symptom assessments will occur at Week 0 (baseline), Week 3 (mid-intervention), Week 6 (end of intervention), and Week 12 (follow-up). All study procedures, including eligibility screening, consent process, outcome assessments, and exit surveys, will be conducted remotely via telephone or Zoom video conference.
#Intervention
- DEVICE : Messy Memories Intervention
- Messy Memories is a mobile application that allows users to self-administer exposure therapy techniques outside of the traditional psychotherapy context. Participants are asked to audio record a difficult ('messy') memory, including what they did, felt, thought, smelled, saw, etc. They are then asked questions about what it was like to re-experience the memory, such as what emotions were elicited (e.g., sadness, anger, fear). Next, participants are asked to process what the memory means to them. They are then instructed to listen to their recording as often as they like, until the memory becomes easier to re-experience. They respond to processing questions each time they listen to their prior difficult memory.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* Able to speak and write in English
* Previously admitted to an ICU
* Have internet access (e.g., Wi-Fi)
* Have access to an internet-equipped smartphone device (e.g., iPhone, Android)
* Meet a minimum threshold of psychological distress related to their prior critical illness as demonstrated by scoring >=10 points on the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5, see Measures section for a complete description).
Exclusion Criteria:
* ICU discharge occurred <30 days prior to the time of study enrollment
* Score <10 points on the PCL-5 during the initial eligibility screening
* Unable to comply with the protocol (either self-selected or indicating that s/he/they cannot complete all requested tasks) for reasons that include, but are not limited to, cognitive impairment (e.g., dementia), alcohol and/or substance abuse, or severe mental illness (e.g., schizophrenia).
* Unavailable for follow-up for reasons such as terminal illness and imminent plans to leave the United States (as this study may include migrant or mobile patients due to their citizenship and work issues).
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
|
NCT05849454
|
{
"brief_title": "Messy Memories: Mobile Application Therapy Following Critical Illness",
"conditions": [
"Critical Illness",
"Psychological Distress",
"Health Behavior"
],
"interventions": [
"Device: Messy Memories Intervention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05849454",
"official_title": "Messy Memories: A Mobile Application Exposure Therapy Intervention to Reduce Psychological Distress and Improve Health Behaviors Following Critical Illness",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-07-15",
"study_completion_date(actual)": "2024-09-04",
"study_start_date(actual)": "2023-10-31"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2023-04-28",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-05-08",
"first_submitted": "2023-04-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine. This results in back pain and stiffness, and causes difficulty with daily activities. Physical activity and exercise are key components of the management of ankylosing spondylitis, however many adults with ankylosing spondylitis do not meet physical activity recommendations. This study aims to investigate the effects of a twelve week intervention designed to increase physical activity and exercise in adults with ankylosing spondylitis.
Detailed Description
Participants will be randomly allocated to one of two groups. An intervention group will receive individual consultations with a physiotherapist. The aim of the meetings will be to motivate and support participants on an individual basis, with the goal of increasing weekly physical activity. The second group, the control group, will continue with their current management strategies. All participants will be assessed at baseline, post-intervention (after twelve weeks) and after a three month follow-up period. The primary outcome measure will be free-living physical activity over one week.
#Intervention
- BEHAVIORAL : Brief Intervention
- 'Brief Intervention' is the term used to mean verbal advice, discussion, negotiation or encouragement, with or without written or other support or follow-up. 'Brief Interventions' provide a structured way to deliver advice and involve the provision of formal help and follow-up. They aim to equip people with tools to change attitudes and handle underlying problems.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of ankylosing spondylitis (diagnosed by a rheumatologist).
* Able to read and understand the English language.
* On stable pharmacological management.
Exclusion Criteria:
* Under 18 years, or > 64 years
* Unable to read and understand the English language
* Concomitant cardiac, respiratory or neurological condition
* Co-morbidity restricting physical activity or inability to ambulate without a mobility aid
* Acute lower limb injury
* Uncontrolled epilepsy
* Cognitive difficulties limiting ability to follow safety and protocol instructions
* Pregnant
* Change in medication (type of dosage) within six weeks of testing
* On beta-blocker medication.
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
|
NCT02374502
|
{
"brief_title": "Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial",
"conditions": [
"Spondylitis, Ankylosing"
],
"interventions": [
"Behavioral: Brief Intervention"
],
"location_countries": [
"Ireland"
],
"nct_id": "NCT02374502",
"official_title": "Increasing Physical Activity in Ankylosing Spondylitis (INPACT-AS): a Randomised Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-10",
"study_completion_date(actual)": "2015-11",
"study_start_date(actual)": "2015-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-09",
"last_updated_that_met_qc_criteria": "2015-02-26",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-02-27",
"first_submitted": "2015-02-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study will be to evaluate in patients with type 2 diabetes the effects on liver fat of an intervention with a diet relatively rich in CHO/rich in fibre/low GI or a diet rich in MUFA, either combined or not with a structured program of physical exercise, with emphasis on mechanisms possibly underlining these effects, namely changes in postprandial triglyceride-rich lipoproteins, body fat distribution, insulin sensitivity, oxidative stress and inflammation, adipose tissue lipolytic activities, aerobic capacity and endothelial function.
#Intervention
- OTHER : Rich in MUFA diet -PA
- The patients will follow a rich in MUFA diet without a physical activity program.
- OTHER : high fiber/low glycemic index diet + pa
- patients will follow for two months a high fibre/ low glycemic index diet with a physical activity program.
- OTHER : Rich in MUFA diet+PA
- Patients will follow for two months a rich in MUFA diet with a physical activity program.
- OTHER : High fibre/low glycemic index diet-PA
- Patients will follow for two months a high fibre/low glycemic index diet without a physical activity program.
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and postmenopausal women
* Age 35 <= age <= 65 years
* BMI 27- 34 kg/m2
* HbA1c <8%
* Fasting plasma cholesterol <250 mg/dl
* Fasting plasma triglycerides <300 mg/dl
Exclusion Criteria:
* Hypolipidemic drugs
* Plasma creatinine >1.7 mg/dl transaminases > 2 norma values
* Ischemic heart disease or positive treadmill stress test
* High intensity regular physical activity
* Any disease or chronic or/and acute condition contraindicating physical activity(anaemia, and infectious, neoplastic, neurological and osteoarticular diseases).
Sex :
ALL
Ages :
- Minimum Age : 35 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01025856
|
{
"brief_title": "Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes",
"conditions": [
"Postprandial Lipids Metabolism",
"Type 2 Diabetes"
],
"interventions": [
"Other: High fibre/low glycemic index diet-PA",
"Other: high fiber/low glycemic index diet + pa",
"Other: Rich in MUFA diet -PA",
"Other: Rich in MUFA diet+PA"
],
"location_countries": null,
"nct_id": "NCT01025856",
"official_title": "Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-09",
"study_completion_date(actual)": "2011-09",
"study_start_date(actual)": "2009-09"
},
"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)": "2012-12-05",
"last_updated_that_met_qc_criteria": "2009-12-03",
"last_verified": "2012-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-12-04",
"first_submitted": "2009-12-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study explores the prevalence of chronic pain in individuals with COPD compared to healthy controls and examines the clinical implications of pain on symptoms associated with COPD, psychological effect and physical activity.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a major public health problem with considerable direct and indirect healthcare costs. COPD is a disease of the older age-group which results in significant disability, high health care costs and is a leading cause of morbidity. This rising disease burden is associated with the systemic effects of this condition, with the clinical presentation of dyspnoea, reduced exercise capacity, fatigue and anxiety all contributing to the reduced health-related quality of life (HRQoL) in people with COPD . In addition to these symptoms, the clinical profile may be further complicated by the presence of pain. Recent studies have found the prevalence of pain ranging from 37 to 72% in COPD, although the duration and frequency of pain experiences across the disease spectrum compared to healthy individuals have not been clearly defined. While chronic pain has been associated with hyperinflation in patients with asthma, the association between pain and lung disease severity, according to spirometry measures and hyperinflation has not been determined in COPD.
According to analysis of body charts, common regions of pain in COPD are the chest, thorax and neck, which are largely similar to healthy populations. However, it is not clear whether the origin of the pain source is musculoskeletal and/or related to postural changes or is due to other sources. Greater exploration of pain within specific spinal regions using well validated tools which focus on musculoskeletal pain will provide further insight into potential causes.
Patients with COPD frequently experience co-morbid conditions which include ischaemic heart disease, diabetes, cancer and musculoskeletal conditions . Although increased pain intensity in COPD appears to be associated with a higher number of co-morbidities, the relationship between co-morbidities and locations of pain, duration, frequency in COPD is not clear. Some concomitant conditions, such as musculoskeletal disorders may influence the prevalence and experience of pain, but this has not been explored in COPD.
In patients with moderate to severe COPD, increased pain severity has been linked to greater interference with activity and a poorer HRQOL. While this provides some insight into the clinical impact of pain, it is equally important to identify the link between pain and other commonly reported symptoms, including dyspnoea. Both pain and dyspnoea are recognised as multidimensional phenomenons, with physiological and psychological consequences and to gain a thorough understanding of each, evaluation of the sensory dimensions (intensity, quality, time course and location) and affective dimensions (unpleasantness and consequent emotional impact) is necessary. Patients with COPD have reported pain with coughing , but the link between the extent of breathlessness, including that experienced during activity and the experience of pain has not been determined. With the shared characteristics and common neural pathways which subserve distress and discomfort in pain and dyspnoea, understanding the relationship between these symptoms may provide further insight into the possible sources of pain in COPD.
To achieve a thorough profile of pain, assessment of the psychosocial impact of pain, including pain catastrophising is recommended. Pain catastrophising is associated with heightened pain experiences, increased levels of disability and depression in non-respiratory conditions and in cystic fibrosis. With anxiety and depression frequently reported in COPD, these clinical symptoms may interact with pain experiences, but the extent to this is unknown.
International guidelines for managing COPD advocate for the role of pulmonary rehabilitation, with compelling evidence of improvement in exercise capacity, reduction in breathlessness and improvement in HRQOL, irrespective of disease severity. As part of this, physical activity is a critical element to disease management. Recently, pain was associated with reduced level of physical activity in those with moderate to severe COPD. However, the relationship between pain locations and the influence upon physical activity is unknown.
Clinical relevance This study aims to impact directly on the important clinical outcomes of HRQOL and disease burden in COPD, markers that are strongly associated with hospitalisation and health care utilisation. Understanding the extent of this comorbidity of pain, its interaction with other symptoms and its broader clinical consequences is the first step in identifying whether modifications to the management of COPD, including the development or institution of therapeutic approaches to minimize pain are necessary. Understanding the psychological consequences of pain in COPD is essential in prioritizing those patients who may require further assessment and treatment of pain.
#Intervention
- OTHER : Prevalence study
- Prevalence study of chronic pain in COPD vs healthy controls
|
#Eligibility Criteria:
Inclusion Criteria:
* No diagnosis of COPD or other respiratory conditions
* No recent history (within last 4 weeks) of musculoskeletal injury
Exclusion Criteria:
* Diagnosis of other respiratory disease, including COPD
* Recent musculoskeletal injury
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05366946
|
{
"brief_title": "The Prevalence of Chronic Pain in COPD and Its Clinical Implications",
"conditions": [
"COPD"
],
"interventions": [
"Other: Prevalence study"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT05366946",
"official_title": "The Prevalence of Chronic Pain in COPD and Its Clinical Implications",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-10",
"study_completion_date(actual)": "2015-11",
"study_start_date(actual)": "2014-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-14",
"last_updated_that_met_qc_criteria": "2022-04-29",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-05-10",
"first_submitted": "2015-10-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
It was aimed to apply caffeine supplement to elite basketball players and to investigate the effects of this supplement on upper extremity performance, lactic acid level and fatigue. The investigators also aimed to investigate the effects of blood lactate level on performance and fatigue.
Detailed Description
The aim of this study is to examine the effects of caffeine supplementation on upper extremity performance, lactic acid and fatigue in elite basketball players and compare them with the placebo group. A total of 50 elite basketball players, 25 each in the caffeine and placebo groups, will participate in the study. Caffeine supplement will be given 1 hour before the measurements (5mg/kg). Muscular endurance before and after reinforcement, scapular muscular endurance test (SKET); arm movement speed, disc touch test (DDT); anaerobic power, medicine ball throwing (STF); lactic acid (LA) level will be evaluated by finger blood measurement and fatigue visual analog scale (VAS).
#Intervention
- DIETARY_SUPPLEMENT : Caffeine Supplement
- Caffeine tablet
|
#Eligibility Criteria:
Inclusion Criteria:
* Elite basketball players aged 19 <= age <= 44
* Individuals with caffeine consumption below 2 mg per kg per day
Exclusion Criteria:
* Individuals with systemic disease affecting the musculoskeletal system
* Individuals using supplements containing caffeine
* Individuals with any diagnosed neurological or orthopedic disease
Sex :
MALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 44 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05916352
|
{
"brief_title": "Effects of Caffeine on Upper Extremity Performance",
"conditions": [
"Sportive Performance",
"Caffeine"
],
"interventions": [
"Dietary Supplement: Caffeine Supplement"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05916352",
"official_title": "The Effect of Caffeine Supplementation on Blood Lactate Level, Performance and Post-Training Fatigue in Elite Basketball Players",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-14",
"study_completion_date(actual)": "2023-06-06",
"study_start_date(actual)": "2022-07-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-02",
"last_updated_that_met_qc_criteria": "2023-06-14",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-06-23",
"first_submitted": "2023-06-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby improve fixation, it might also cause complications. Migration as measured by RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use of a tourniquet influences fixation measured with RSA.
Detailed Description
The use of a tourniquet during total knee replacement (TKA) is a generally accepted routine at many departments. It is thought to facilitate dissection and reduce peroperative bleeding, but the main argument for its use is that bleeding bone surfaces might impair the fixation of cemented prostheses, because of less cement penetration.
We investigate in a RCT 50 patient with radiostereometric analysis, where 25 is randomized to a tourniquet during the hole operation and 25 are not.
Primary outcome is MTPM, a meassure of migration(loosening) of the kneeprosthesis.
Secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self assesed knee score (KOOS) Total follow up time 2 years
#Intervention
- PROCEDURE : No use of tourniquet
- Tourniquet is not applied i 25 pts
- Other Names :
- No Tourniquet
- PROCEDURE : Tourniquet
- Use of tourniquet
|
#Eligibility Criteria:
Inclusion Criteria:
* primary or secondary osteoarthritis without other severe disease (ASA 1 <= age <= 2).
Exclusion Criteria:
* were inability to give informed consent,
* rheumatic arthritis,
* malignancy,
* coagulation disorder or medical treatment influencing the coagulation,
* liver disease,
* severe heart disease or bilateral operation.
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
|
NCT01470482
|
{
"brief_title": "Does Tourniquet Use in Total Knee Replacement Improve Fixation",
"conditions": [
"Osteoarthritis, Knee"
],
"interventions": [
"Procedure: Tourniquet",
"Procedure: No use of tourniquet"
],
"location_countries": [
"Sweden"
],
"nct_id": "NCT01470482",
"official_title": "Does Tourniquet Use in Total Knee Replacement Improve Fixation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-05",
"study_completion_date(actual)": "2010-05",
"study_start_date(actual)": "2006-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-06-09",
"last_updated_that_met_qc_criteria": "2011-11-10",
"last_verified": "2015-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-11-11",
"first_submitted": "2011-11-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to investigate the changes in glycopeptides of serum immunoglobulin G in patients with acute myocardial infarction and the relationships between its change and prognosis.
Detailed Description
Immunoglobin G (IgG), a highly abundant glycoprotein in serum, is known to participate in blood immune responses.It has been an increasing interest in the analysis of the abnormal glycosylation of human lgG in healthy and disease states, such as autoimmune diseases and cancer.However, there is few relevant studies about the changes in glycopeptides of serum immunoglobulin G in patients with acute myocardial infarction. This study was performed for the frst timeto assess the quantitative changes of serum IgG glycosylation in patients with acute myocardial infarction and the relationships between its change and prognosis.
#Intervention
- DIAGNOSTIC_TEST : Quantitative measurements the changes of IgG glycosylation
- Serum (50 each group) is obtained into ethylenediaminetetraacetic acid（EDTA） tubes from all subjects via antecubital venepuncture.Blood is obtained into ethylenediaminetetraacetic acid（EDTA） tubes from all subjects via antecubital venepuncture to assess the quantitative changes of IgG glycosylation by HPLC-MRM at 0 , 3 and 7 days after admission.
|
#Eligibility Criteria:
Inclusion Criteria:
* diagnosed as STEMI.
* with left ventricular ejection fraction（LVEF）>=45%
* written informed consents are obtained
* admitted within 24 hours after chest pain attacked
Exclusion Criteria:
* complicated with rheumatic heart disease, coronary arteritis, hypertrophic cardiomyopathy or dilated cardiomyopathy
* complicated with malignant tumor,the immune system diseases, blood system diseases, recently (within 2 weeks) taking glucocorticoid drugs, the use of immunosuppressive agents and cerebral infarction
* with acute or chronic infection, surgery or trauma in the last month
* secondary hypertension, severe liver dysfunction,severe renal insufficiency
* with abnormal thyroid function or allergy to iodine agent refusal to sign the informed consent
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
|
NCT03394092
|
{
"brief_title": "Serum Concentration of lgG in Patient With Acute Coronary Syndrome",
"conditions": [
"Acute Coronary Syndrome"
],
"interventions": [
"Diagnostic Test: Quantitative measurements the changes of IgG glycosylation"
],
"location_countries": [
"China"
],
"nct_id": "NCT03394092",
"official_title": "Changes in Glycopeptides of Serum Immunoglobulin G in Patients With Acute Myocardial Infarction and the Relationships Between Its Change and Prognosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-01-15",
"study_completion_date(actual)": "2019-03-01",
"study_start_date(actual)": "2018-01-15"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-19",
"last_updated_that_met_qc_criteria": "2018-01-03",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-09",
"first_submitted": "2018-01-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to see if the Artificial Pancreas (AP) Platform can successfully control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a hospital setting. Investigators will also be studying to see if the heart rate informed Control To Range (hrCTR) can improve the performance of the system during and immediately after exercise.
Detailed Description
The artificial pancreas (AP), known as Closed-Loop Control of blood glucose in diabetes, is a system combining a continuous glucose monitor (glucose sensor), a control algorithm (complex mathematical formulas), and an insulin pump. The algorithms are intended to maintain your blood glucose level within a certain range. This is called Control-to-Range. The algorithms are intended to maintain your blood glucose level within a certain range. The algorithms run on a portable AP platform on an Android smart phone, called the Diabetes Assistant (DiAs) Medical Platform.
In this study, researchers hypothesize that the heart rate informed Control To Range (hrCTR) will limit the risk for hypo and hyperglycemia during and immediately after exercise in adolescents 12 - 17 years of age and assess if the hrCTR will improve additional measures of overall short term glycemic control in this population.
This trial will be performed at both Virginia Commonwealth University and the University of Virginia. IRB approvals have been obtained at both institutions.
#Intervention
- DEVICE : heart rate Control to Range System (hrCTR) using DiAs Platform
- Diabetes Assistant (DiAs) Medical Platform System
* A smart-phone medical platform (DiAs);
* Continuous Glucose Monitor;
* Insulin pump;
* Bluetooth connection;
* Remote Monitoring Server.
- OTHER : DiAs Control-to-Range System not informed for heart rate
- Not informing system of heart rate during exercise.
|
#Eligibility Criteria:
Inclusion Criteria:
* Criteria for documented hyperglycemia (at least 1 must be met):
* Fasting glucose >= 126 mg/dL - confirmed
* Two-hour Oral Glucose Tolerance Test (OGTT) glucose >= 200 mg/dL - confirmed
* Hemoglobin A1c (HbA1c) >= 6.5% documented - confirmed
* Random glucose >= 200 mg/dL with symptoms
* No data are available from the time of diagnosis but the participant has a convincing history of medical care and biochemical parameters consistent with T1DM
* Criteria for requiring insulin at diagnosis (1 must be met):
* Participant required insulin at diagnosis and continually thereafter
* Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did eventually require insulin that has been used continually
* Criteria for Type 1 Diabetes Mellitus (T1DM) (at least 1 must be met):
* Documented low or absent C-peptide level.
* Documented presence of islet cell autoantibodies (ICA) or glutamic acid decarboxylase (GAD65) autoantibodies.
* No data are available from the time of diagnosis but the participant has a convincing history of medical care and biochemical parameters consistent with T1DM
In addition, all subjects will meet the following additional criteria:
* Use an insulin pump (CSII) to treat his/her diabetes for at least 6 months
* Actively use a bolus calculator with the current insulin pump with pre-defined parameters for carbohydrate (CHO) ratio, insulin sensitivity factor (ISF), and target glucose
* Current HbA1c between 5.0% and 10.5% as measured with DCA2000 or equivalent device
* Not currently known to be pregnant, breast feeding, or intending to become pregnant (females)
* Demonstration of proper mental status and cognition for the study
* Willingness to avoid consumption of acetaminophen-containing products while wearing the continuous glucose monitor sensor.
Exclusion Criteria:
* Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM)
* Diabetic ketoacidosis within 6 months prior to enrollment
* Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
* Pregnancy, breast feeding, or intention to become pregnant
* Subjects weighing less than 40 kg
* Hematocrit <36% (females); <38% (males)
* Conditions which may increase the risk of hypoglycemia such as known history of cerebrovascular event, history of arrhythmias, seizure disorder, syncope, adrenal insufficiency, or neurologic disease
* Additional conditions which may inhibit the ability to perform exercise (e.g. injury to or immobility of limbs, neuromuscular disease, exercise-induced asthma requiring inhaler use within the last 12 months or clinically impaired pulmonary function)
* Use of a medication that significantly lowers heart rate (beta blockers, reserpine, guanethidine, methyldopa, clonidine, cimetidine, digitalis, calcium channel blockers, amiodarone, antiarrythmic drugs, or lithium)
* History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans
* Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the continuous glucose monitor (implantable cardioverter defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants)
* Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study admission.
* Psychiatric disorders that would interfere with study tasks (e.g. inpatient psychiatric treatment within 6 months prior to enrollment, uncontrolled anxiety or panic disorder)
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Medical conditions that would make operating a continuous glucose monitor, cell phone or insulin pump difficult (e.g. blindness, severe arthritis, immobility)
* Any skin condition that prevents sensor or pump placement on the abdomen or arm (e.g. bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis)
* Known micro vascular (diabetic) complications (other than diabetic non-proliferative retinopathy), such as history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy (other than microalbuminuria with normal creatinine) or neuropathy requiring treatment
* Active gastroparesis requiring current medical therapy
* If on antihypertensive, thyroid, or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
* Known bleeding diathesis or dyscrasia
* Allergy to medical adhesives, components of the insulin pump insertion set or continuous glucose monitor sensor
* Anticoagulant therapy other than aspirin
* Oral steroids
* Active enrollment in another clinical trial
* Unwillingness to avoid acetaminophen while wearing the continuous glucose monitor sensor.
* Unwillingness to withhold dietary supplements two weeks prior to and during admission
* Unwillingness to use an approved form of birth control during this study by a sexually active female participant.
* Subject develops a febrile illness within 24 hours of inpatient admission.
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
|
NCT01945060
|
{
"brief_title": "Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator",
"conditions": [
"Type 1 Diabetes Mellitus"
],
"interventions": [
"Other: DiAs Control-to-Range System not informed for heart rate",
"Device: heart rate Control to Range System (hrCTR) using DiAs Platform"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01945060",
"official_title": "Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator",
"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)": "2013-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-21",
"last_updated_that_met_qc_criteria": "2013-09-13",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-09-18",
"first_submitted": "2013-09-10",
"first_submitted_that_met_qc_criteria": "2023-08-18"
}
}
}
|
#Study Description
Brief Summary
This study will assess the efficacy and safety of initial treatment with sitagliptin and metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin alone and with metformin alone.
#Intervention
- DRUG : Sitagliptin 50 mg
- Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.
- Other Names :
- Januvia®, Tesavel®, Xelevia®, Ristaben®
- DRUG : Metformin 500 mg
- Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
- Other Names :
- Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
- DRUG : Sitagliptin 100 mg
- Sitagliptin 100 mg once daily for 24 weeks.
- Other Names :
- Januvia®, Tesavel®, Xelevia®, Ristaben®
- DRUG : Placebo
- Matching placebo tablets to sitagliptin or metformin for 24 weeks.
- DRUG : Metformin 850 mg
- Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
- Other Names :
- Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
|
#Eligibility Criteria:
Inclusion Criteria:
* has type 2 diabetes mellitus
* is male, a female who cannot have children, or a female who agrees to use birth control during the study
* is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5 <= age <= 11.0%) or on oral single AHA (A1C 7.0 <= age <= 10.5%) or low-dose AHA combination therapy (A1C 7.0 <= age <= 10.0%)
Exclusion Criteria:
* Patient has type 1 diabetes mellitus or ketoacidosis
* Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
* Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
* Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
* Patient is HIV positive
* Patient is pregnant
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 78 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01076088
|
{
"brief_title": "Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)",
"conditions": [
"Type 2 Diabetes Mellitus"
],
"interventions": [
"Drug: Metformin 500 mg",
"Drug: Sitagliptin 100 mg",
"Drug: Sitagliptin 50 mg",
"Drug: Metformin 850 mg",
"Drug: Placebo"
],
"location_countries": null,
"nct_id": "NCT01076088",
"official_title": "A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of Co-administration of Sitagliptin and Metformin in Patients With Type 2 Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12-24",
"study_completion_date(actual)": "2012-12-24",
"study_start_date(actual)": "2010-11-15"
},
"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)": "2017-05-23",
"last_updated_that_met_qc_criteria": "2010-02-24",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-02-25",
"first_submitted": "2010-02-24",
"first_submitted_that_met_qc_criteria": "2013-12-17"
}
}
}
|
#Study Description
Brief Summary
Fish oil is a rich source of omega-3 fatty acids, especially eicosapentanoic acid and docosahexaenoic acid, and it is not used widely in parenteral nutrition because fish oil emulsions have not been commercially available until very recently. The Objective of this study is to to evaluate the effect on blood lipid profiles of omega-3 enriched total parenteral nutrition in healthy Korean male subjects. This study is designed as a randomized, open-label, 2-treatment, 2-way crossover trial. Blood samples will be collected every 1 hour from 0 to 12 hours after starting an intravenous infusion for triglyceride, glucose, and insulin.
Detailed Description
Fish oil is a rich source of omega-3 fatty acids, especially eicosapentanoic acid and docosahexaenoic acid, and it is not used widely in parenteral nutrition because fish oil emulsions have not been commercially available until very recently. The Objective of this study is to to evaluate the effect on blood lipid profiles of omega-3 enriched total parenteral nutrition in healthy Korean male subjects.
This study is designed as a randomized, open-label, 2-treatment, 2-way crossover trial. The 16 subjects will be randomly assigned to 1 of 2 sequences of the two treatments: Combiflex® lipid peri or Winuf® peri will be infused via peripheral venous catheter for 6 hours at 3 ml/kg/h. Blood samples will be collected every 1 hour from 0 to 12 hours after starting an intravenous infusion for triglyceride, glucose, and insulin. Cholesterol, HDL-cholesterol, LDL-cholesterol, AST, ALT, and total bilirubin as liver function biomarkers, and hsCRP as inflammatory biomarker will be analysed at 0, 6 and 12 hour after starting an intravenous infusion.
#Intervention
- DRUG : Combiflex® lipid peri
- total parenteral nutrition solutions containing glucose, amino acids, electrolyte, soybean oil
- DRUG : Winuf® peri
- total parenteral nutrition solution containing glucose, amino acids, electrolyte, soybean oil, medium chain triglyceride, olive oil and fish oil
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects between the ages of 30 and 55 years
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg
* An informed consent document signed and dated by the subject
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Screening sitting blood pressure >150 mm Hg (systolic) or >90 mm Hg (diastolic)
* Use of tobacco in excess of the equivalent of 20 cigarettes per day
* Use of prescription or nonprescription drugs within 10 days
* Blood donation within 2 months prior to dosing, or plasma donation within 1 month prior to dosing
* Severe hyperlipidemic patients
* Severe liver failure patients
Sex :
MALE
Ages :
- Minimum Age : 30 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02468713
|
{
"brief_title": "Effect on Blood Chemistry and Inflammatory Marker of Omega-3 Enriched Total Parenteral Nutrition",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Combiflex® lipid peri",
"Drug: Winuf® peri"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT02468713",
"official_title": "An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Effect on Blood Lipid Profiles of Omega-3 Enriched Total Parenteral Nutrition in Healthy Korean Male Subjects",
"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)": "2015-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-06-11",
"last_updated_that_met_qc_criteria": "2015-06-08",
"last_verified": "2015-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-06-11",
"first_submitted": "2015-05-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a Phase 1, single-center, randomized, balanced, single-dose, two-treatment, two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the pharmacokinetics of PA-824. This study was designed to understand the possible effects of a high-calorie, high-fat meal on PA-824 absorption and pharmacokinetics. The hypothesis to be tested in this study is that the rate and extent of absorption of PA-824, as measured by Tmax, Cmax, AUC(0-t), and AUC(0 inf), are the same after a high-calorie, high-fat meal as compared with after a minimum 10-hour fast.
#Intervention
- DRUG : PA-824 1000 mg
- Two single administrations of 1000mg each administered by 5 tablets of 200mg, one administered in the fed state and one administered in the fasted state.
|
#Eligibility Criteria:
Inclusion Criteria:
* Have the ability to understand the requirements of the study, have provided written informed consent (as evidenced by signature on an informed consent document approved by an IRB), and agree to abide by the study restrictions.
* Be healthy non-tobacco/nicotine using (6-month minimum) adult subjects, 19 <= age <= 50 of age, inclusive.
* Be medically healthy subjects with clinically insignificant Screening results (among laboratory profiles, medical histories, ECGs, or physical exam), as deemed by the Principal Investigator.
* Have a body mass index of 18 to 29.
* Have negative urine test results for alcohol and drugs of abuse such as amphetamines, cannabinoids, and cocaine metabolites at both Screening and Check-in.
* Agree to follow the requirements set forth in the protocol regarding pregnancy controls and donation of sperm, blood, or blood components.
Exclusion Criteria:
* Any clinically significant (as deemed by the Principal Investigator) history, acute illness (resolved within 4 weeks of screening), or presence of cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal (including eating disorders), endocrine, metabolic, immunologic, dermatologic, neurologic, psychological, or psychiatric disease.
* Any serum creatinine or BUN measure beyond the upper limit of the normal range at Screening or Check-in. Individual values may be discussed with the Sponsor Medical Monitor.
* Positive Screening test for HCV, HBV, or HIV.
* History of peptic ulcer disease, gastritis, esophagitis, or gastroesophageal reflux disease.
* History of any cardiac abnormality (as deemed by the Principal Investigator).
* History of hypokalemia or hypomagnesemia.
* History of prolonged QT interval.
* Family history of Long-QT Syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease or CHF or terminal cancer)
* Resting pulse rate < 40 or > 100 bpm at Screening.
* At either Screening or the pre-dose read before the first dose, a QTcB (Bazett's correction) >430 msec, calculated from the average of triplicate reads collected at one sitting.
* At either Screening or the pre-dose read before the first dose, a QTcF (Fridericia's correction) >430 msec, calculated from the average of triplicate reads collected at one sitting.
* History or presence of alcoholism or drug abuse within the past 2 years (as deemed by the Principal Investigator).
* Use of alcohol within 72 hours prior to dosing.
* Significant history of drug and/or food allergies (as deemed by the Principal Investigator).
* For women, lactation.
* For women, positive test for serum HCG at Screening or Check-in.
* Use of any systemic or topical prescription medication within 14 days prior to dosing or during the study, except hormonal contraceptives in women.
* Use of any systemic or over-the-counter medication including vitamins, herbal preparations, antacids, cough and cold remedies, etc., within 7 days prior to dosing or during the study.
* Use of any drugs or substances within 30 days prior to dosing known to be strong inhibitors or inducers of cytochrome P450 enzymes (including xenobiotics, quinidine, tyramine, ketoconazole, testosterone, quinine, gestodene, metyrapone, phenelzine, doxorubicin, troleandomycin, cyclobenzaprine, erythromycin, cocaine, furafylline, cimetidine, dextromethorphan, etc.) or known to prolong the QT interval (including amiodarone, bepridil chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, procainamide, quinidine, sotalol, sparfloxacin, thioridazine, etc.).
* Use of any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine, etc.) within 30 days prior to dosing.
* Consumption of products containing grapefruit within 10 days prior to dosing.
* Any special dietary changes during the 30 days prior to dosing, as deemed by the Principal Investigator in consultation with the Sponsor Medical Monitor.
* Any strenuous exercise within 7 days of Check-in, as deemed by the Principal Investigator in consultation with the Sponsor Medical Monitor.
* Donation of whole blood or significant loss of blood within 56 days prior to dosing.
* Plasma donation within 7 days prior to dosing.
* Participation in another interventional clinical trial within 30 days prior to dosing.
* Hemoglobin < 12.0 g/dL.
* Previous use of PA-824.
* Any other factor which suggests to the Principal Investigator that the subject should not participate in the study.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01828827
|
{
"brief_title": "Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects",
"conditions": [
"Tuberculosis"
],
"interventions": [
"Drug: PA-824 1000 mg"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01828827",
"official_title": "A Phase 1, Randomized, Balanced, Single-Dose, Two-Treatment, Two-Period, Two-Sequence, Crossover, Open-Label Study of the Effect of Food on the Bioavailability and Pharmacokinetics of PA-824 Tablets in Healthy Adult Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-03",
"study_completion_date(actual)": "2007-03",
"study_start_date(actual)": "2007-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-01-14",
"last_updated_that_met_qc_criteria": "2013-04-08",
"last_verified": "2015-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-04-11",
"first_submitted": "2013-02-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for gastric cancer.
#Intervention
- BIOLOGICAL : Treatment group
|
#Eligibility Criteria:
Inclusion criteria:
* Clinical diagnosis with gastric or gastroesophageal cancer
* Karnofsky performance status score of at least 70
* Life expectancy of at least 3 months
Exclusion criteria:
* Prior treatment with chemotherapy or anticancer immunotherapy
* Bone marrow transplant within past year
* Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
* Central nervous system metastases
* Immunodeficiency
* Hypercalcemia
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
|
NCT00042510
|
{
"brief_title": "Safety and Efficacy of G17DT Immunogen in the Treatment of Gastric and Gastroesophageal Cancer",
"conditions": [
"Stomach Neoplasms",
"Esophageal Neoplasms"
],
"interventions": [
"Biological: Treatment group"
],
"location_countries": null,
"nct_id": "NCT00042510",
"official_title": "Open-Label,Multicenter Study of G17DT Immunogen in Combination w/ Cisplatin and 5-FU in Subjects w/ Metastatic or Locally Recurrent Gastric or Gastroesophageal Cancer Previously Untreated With Chemotherapy.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2003-02",
"study_completion_date(actual)": "2004-07",
"study_start_date(actual)": "2000-08"
},
"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)": "2014-08-28",
"last_updated_that_met_qc_criteria": "2002-07-31",
"last_verified": "2014-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2002-08-01",
"first_submitted": "2002-07-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this work is to assess the effectiveness and safety of Ulipristal Acetate in the management of 2nd trimester missed abortion along with misoprostol in pregnant women with previous caesarean section versus the use of misoprostol only with placebo as regards the time needed for abortion,Hypothesis: In pregnant women with 2nd trimester missed abortion with previous caesarean section , Ulipristal Acetate may decrease the time interval to achieve abortion when combined with Misoprostol in comparison to misoprostol alone.the included women divided to 2 groups Group A: will receive Ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal according to FIGO guidelines 2017.Group B: will receive placebo then 12 hours later start misoprostol 100µg every 6 hours buccal according to FIGO guidelines 2017. then we assess Induction-to-abortion interval time.
#Intervention
- DRUG : Ulipristal Acetate
- Group A: received Ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal. Then women in had rest for 24 hours after 5 doses of misoprostol and restarted misoprostol-only in both groups with the same above regimens, repeating the same sequence for two weeks unless there was excessive bleeding or infection or uterine contractions or cervical changes. If failed, patient proceeded to hysterotomy. If patient aborted, an obstetric US was done to assess the presence of remnants in the uterine cavity. Patient with remnants of conception proceeded suction evacuation.
- DRUG : Misoprostol
- Group A: received Ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal.Group B: received placebo tablet of same shape , texture of that of ulipristal then 12 hours later start misoprostol 100µg every 6 hours buccal. Then women in both groups had rest for 24 hours after 5 doses of misoprostol and restarted misoprostol-only in both groups with the same above regimens, repeating the same sequence for two weeks unless there was excessive bleeding or infection or uterine contractions or cervical changes. If failed, patient proceeded to hysterotomy. If patient aborted, an obstetric US was done to assess the presence of remnants in the uterine cavity. Patient with remnants of conception proceeded suction evacuation.
|
#Eligibility Criteria:
Inclusion Criteria:
* Women with 2nd trimester missed abortions
* Gestational age 13 <= age <= 26 weeks.
* Women with a previous caesarian section scar,(para 1cs till para 4 cs).
* Women counseled and chose medication abortion rather than surgical evacuation
Exclusion Criteria:
* Women with an accompanying medical disorder such as: Preeclampsia, Diabetes Mellitus or Heart disease.
* Primigravida women or non scarred uterus.
* Women with previous myomectomy or hysterotomy scar or upper segment caesarean section scar.
* Induction of abortion in women with congenital fetal malformations or positive fetal pulsations due to medical disorder.
* Women with placenta previa .
* Allergy or contraindications to either Ulipristal acetate or Misoprostol.
* Women with inevitable abortion in the form of vaginal bleeding or uterine contractions
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04989400
|
{
"brief_title": "Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion",
"conditions": [
"Induction of Second Trimester Abortion"
],
"interventions": [
"Drug: Ulipristal Acetate",
"Drug: Misoprostol"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04989400",
"official_title": "Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion in Women With Previous Caesarian Section: A Randomized Controlled Trial.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-01",
"study_completion_date(actual)": "2020-01-01",
"study_start_date(actual)": "2019-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-08-04",
"last_updated_that_met_qc_criteria": "2021-07-26",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-04",
"first_submitted": "2021-07-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators hypothesize that this modified ophthalmic draping will reduce the accumulation and rebreathing of carbon dioxide during eye surgery.
Detailed Description
Majority of eye surgery has been widely done under local anesthesia provided by the ophthalmologist with or without sedation.The surgical drapes used often covers the patients face and beyond in order to maintain sterility of the surgical field. This can lead to accumulation of carbon dioxide under ophthalmic drapes due to the exhaled carbon dioxide escapes incompletely through the drapes;hence results in an increase of carbon dioxide in the ambient air surrounding the patient's head.This causes an increase in arterial carbon dioxide partial pressure and thus hyperventilation and patient discomfort with restlessness and unable to stay still during the surgery.
In recent years,several types of ophthalmic drapes have been produced.This study is look for possible difference in accumulation of carbon dioxide under the standard ophthalmic drapes compared to the modified draping.
#Intervention
- DEVICE : forced air warmer (Bair Hugger)
- forced air warmer placed under the chin before draping, forced air warmer inflated after draping is completed.
- Other Names :
- Forced air warmer brand - Bair Hugger
- DEVICE : warming blanket
- warming blanket placed on torso of patient under the drape.
- Other Names :
- warming blanket brand - Thermamed warming system
|
#Eligibility Criteria:
Inclusion Criteria:
* ASA physical status I,II OR III,adult aged 40 <= age <= 80 old,scheduled to undergo elective eye surgery under local anaesthetic at UMMC will be enrolled in this study.
Exclusion Criteria:
* Pre-existing pulmonary disease,psychological disorders,neurological disorder and patient required sedation.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02036034
|
{
"brief_title": "Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia",
"conditions": [
"To Prevent Hypercarbia Under the Opthalmology Drape During Surgery.",
"To Prevent Hypothermia During Opthalmology Surgery."
],
"interventions": [
"Device: warming blanket",
"Device: forced air warmer (Bair Hugger)"
],
"location_countries": [
"Malaysia"
],
"nct_id": "NCT02036034",
"official_title": "Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-11",
"study_completion_date(actual)": "2012-01",
"study_start_date(actual)": "2010-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-01-14",
"last_updated_that_met_qc_criteria": "2014-01-11",
"last_verified": "2011-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-14",
"first_submitted": "2011-08-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is conducted to estimate population-based incidence rates of second primary malignancies among patients with CRPC similar to those treated with Xofigo. These rates will provide context for second primary malignancy incidence rates from the REASSURE study.
Furthermore this study aims to provide further information about the documentation of bone metastases in Medicare data and the extent of use of only oral androgen deprivation drugs among patients with Medicare Part D coverage, as well as to estimate overall survival of the study population.
Detailed Description
Xofigo (radium-223 dichloride) is an alpha-emitting pharmaceutical, which was approved for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The long-term safety profile of Xofigo is evaluated in the prospective REASSURE study, which estimates the incidence rates of second primary malignancies in patients with CRPC receiving Xofigo.
To provide context on that, this retrospective study is conducted to estimate background rates of second primary malignancies among patients with CRPC similar to those who are treated with Xofigo.
#Intervention
- OTHER : Not applicable for study
- Provide external perspective on background second primary cancer incidence rates for REASSURE study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Enrolled in both Medicare Parts A and B for at least 1 year before the cohort entry date (minimum lookback period for comorbidities and treatments)
* Primary site code of prostate cancer (International Classification of Diseases for Oncology, Third Edition [ICD-O-3] topography code C61.9) in SEER data
* Surgical castration or androgen deprivation therapy after prostate cancer diagnosis; androgen deprivation therapy will be indicated by the use of any of the following drugs: abarelix, bicalutamide, buserelin, cyproterone, degarelix, diethylstilbestrol, estramustine, flutamide, gonadorelin, goserelin, histrelin, leuprolide, medroxyprogesterone, megestrol, nafarelin, nilutamide, polyestradiol, triptorelin
* Evidence that prostate cancer was resistant to surgical castration or androgen deprivation therapy ('castration-resistant prostate cancer'), as indicated by starting one of the following second-line systemic therapies (cohort entry date): abiraterone, cabazitaxel, docetaxel, enzalutamide, mitoxantrone, or sipuleucel-T
* Cohort entry date 01 January 2006 or later
* Age >= 65 years in the US on the cohort entry date
Exclusion Criteria:
* Enrollment in an HMO (Health Maintenance Organization) in the year before the cohort entry date
* Diagnosis of any cancer other than prostate cancer or nonmelanoma skin cancer on or before the cohort entry date
* Any diagnostic code for metastases other than bone metastases or lymph node metastases on or before the cohort entry date
* Any claim for treatment with Xofigo on or before the cohort entry date.
Sex :
MALE
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02788409
|
{
"brief_title": "Incidence of Second Primary Malignancies in Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US",
"conditions": [
"Prostatic Neoplasms"
],
"interventions": [
"Other: Not applicable for study"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02788409",
"official_title": "Incidence of Second Primary Malignancies in Patients With Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-09",
"study_completion_date(actual)": "2018-05-09",
"study_start_date(actual)": "2016-05-15"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-08",
"last_updated_that_met_qc_criteria": "2016-05-27",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-02",
"first_submitted": "2016-05-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purposes of the study are 1) to know the concentrations of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD) and other cannabinoids in blood, urine, oral fluid and sweat after the experimental administration of a standardized cannabis preparation orally (decoction and oil) and vaporized 2) to evaluate the pharmacological acute effects and tolerability
Detailed Description
Medical cannabis' encompasses the use of cannabis and cannabinoids for therapeutic purposes. Includes drugs approved by regulatory agencies and pharmaceutical products. Recently, many countries have authorized the use of cannabis flower cups with a standardized amount of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD) and their acidic precursors (Δ-9-tetrahydrocannabinolic acid A \[THCA\] and cannabidiol acid \[ CBDA\]) for the treatment of different diseases. In Italy since January 2017 there has been for sale a standardized cannabis preparation produced by the Military Pharmaceutical Institute of Florence. This medicinal variety of cannabis sativa, known as FM2 has a variable THC and CBD percentage of between 5-8% and 7-12% respectively. To date, there are no studies on the pharmacokinetics of THC, CBD and other minor cannabinoids in conventional and unconventional biological matrices after oral administration of cannabis tea, cannabis oil and vaporized with the same medicinal preparation (FM2). The main objective is to know the concentrations of THC, CBD and metabolites, and other cannabinoids in blood, urine, oral fluid and sweat after the experimental administration of a standardized cannabis preparation orally (two formulations: cannabis tea and cannabis oil) and vaporized. In addition, the acute pharmacological effects and tolerability will be evaluated. Healthy recreational cannabis users with experience in oral use of cannabis will participate
#Intervention
- DRUG : Cannabis decoction
- A single 100 mL dose of cannabis decoction is administered containing 1.8 mg THC and 2.7 mg CBD.
- Other Names :
- Cannabis tea
- DRUG : Cannabis oil
- A single administration of 15 drops (045 mL) of cannabis oil containing 1.8 mg THC and 3.8 mg CBD.
- DRUG : Vaporized cannabis
- 100mg of vaporized cannabis is administered by Volcano vaporizer, wich containing 0.6-2 mg THC and 0.8-3 mg CBD
- Other Names :
- Inhaled cannabis
|
#Eligibility Criteria:
Inclusion Criteria:
* Understanding and accepting the study procedures and signing the informed consent.
* Male and females healthy volunteers (18 <= age <= 45 years.
* History and physical examination showing no organic or psychiatric disorders.
* The EKG and the blood chemistry and hematology at inclusion must be within the limits of normality. Minor or specific variations of the limits of normality are admitted if, in the opinion of the Principal Investigator, taking into account the state of science, they do not have clinical significance, do not pose a risk to the subjects and do not interfere with the evaluation of the product. These variations and their non-relevance will be specifically justified in writing.
* Body weight between 50 <= age <= 90 kilograms. Lower or higher weights are allowed, in the opinion of the Principal Investigator or the collaborators designated by him and that do not pose a risk to the subjects and do not interfere with the objectives of the study.
* BMI between 19 <= age <= 27 kg / m². Lower or higher BMIs are admitted, which in the opinion of the Principal Investigator or the collaborators designated by him that do not pose a risk to the subjects and do not interfere with the objectives of the study.
* Women with a menstrual cycle that lasts between 26 <= age <= 32 days and is regular.
* Subjects with social or recreational consumption of cannabis in the last 12 months and consumption of oral cannabis at least once in their life (eg cake, cookies, oils, infusion...).
Exclusion Criteria:
* Not meeting the inclusion criteria.
* History or clinical evidence of gastrointestinal, liver, kidney or other disorders that may involve an alteration in the absorption, distribution, metabolism or excretion of the drug, or that are suggestive of gastrointestinal irritation by drugs.
* Current or previous history of Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) substance use disorder (except nicotine and mild cannabis use disorder or DSM-IV for substance use disorder or abuse).
* Having donated blood in the previous 8 weeks, or having participated in clinical trials with drugs or nutraceuticals in the previous 12 weeks, except for having previously participated in this same study, in which a 3-week washout period is sufficient.
* Having suffered any organic disease or major surgery in the three months prior to the start of the study.
* Subjects who are intolerant or have had serious adverse reactions to cannabis.
* Having taken medication regularly in the month prior to the study sessions, with the exception of vitamins, herbal remedies or dietary supplements that, in the opinion of the Principal Investigator or the collaborators designated by him, do not pose a risk to the subjects and do not interfere with the objectives of the study. Treatment with single doses of symptomatic medication in the week prior to the study sessions will not be grounds for exclusion if it is assumed that it has been completely eliminated on the day of the experimental session.
* Smokers of more than 15 cigarettes a day.
* Subjects who are uncapable of understanding the nature of the trial and the procedures they are required to follow.
* Subjects with positive serology for hepatitis B, C or HIV.
* Women who are pregnant or breastfeeding, or who use hormonal contraceptives or do not use reliable contraceptive measures during the study (such as abstinence, intrauterine devices, barrier methods or with a vasectomized partner).
* Women with amenorrhea or severe premenstrual syndrome.
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
|
NCT04841993
|
{
"brief_title": "Pharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation",
"conditions": [
"Cannabis Use",
"Healthy Subjects"
],
"interventions": [
"Drug: Cannabis oil",
"Drug: Vaporized cannabis",
"Drug: Cannabis decoction"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT04841993",
"official_title": "Pharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation in Healthy Adult Recreational Cannabis Users",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-18",
"study_completion_date(actual)": "2021-02-28",
"study_start_date(actual)": "2018-12-10"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-04-12",
"last_updated_that_met_qc_criteria": "2021-04-09",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-12",
"first_submitted": "2021-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Abstract:
Introduction and Importance:
Recurrent diplopia poses a diagnostic challenge, necessitating a thorough evaluation to elucidate its underlying etiology and guide its management. We present the case of a 39-year-old farmer with recurrent 6th nerve palsy for over a decade, highlighting the complexity and persistence of this condition.
Case Presentation:
A 39-year-old farmer presented with recurrent diplopia attributed to 6th nerve palsy, with eight episodes over 14 years. Despite systemic steroid treatment, the symptoms recurred every 12-18 months. Clinical examination revealed right eye abduction impairment;-, no other abnormalities were detected. Magnetic resonance imaging (MRI) indicated rhinosinusitis, and the results of the autoimmune antibody test were negative.
Clinical Discussion:
This case challenges conventional diagnostic approaches, underscoring the need for a comprehensive evaluation and tailored management strategies. Despite extensive investigations, the etiology remains elusive, emphasizing the complexity of recurrent diplopia.
Conclusion:
Continued monitoring and further investigation are warranted to unravel the enigma of recurrent diplopia in this unique case, highlighting the importance of individualized approaches to guide optimal management.
Detailed Description
A Decade-Long Dance with Diplopia: Unraveling the Enigma of Recurrent 6th Nerve Palsy
ABSTRACT
Introduction and Importance:
Recurrent diplopia poses a diagnostic challenge, necessitating a thorough evaluation to elucidate its underlying etiology and guide its management. We present the case of a 39-year-old farmer with recurrent 6th nerve palsy for over a decade, highlighting the complexity and persistence of this condition.
Case Presentation:
A 39-year-old farmer presented with recurrent diplopia attributed to 6th nerve palsy, with eight episodes over 14 years. Despite systemic steroid treatment, the symptoms recurred every 12-18 months. Clinical examination revealed right eye abduction impairment;-, no other abnormalities were detected. Magnetic resonance imaging (MRI) indicated rhinosinusitis, and the results of the autoimmune antibody test were negative.
Clinical Discussion:
This case challenges conventional diagnostic approaches, underscoring the need for a comprehensive evaluation and tailored management strategies. Despite extensive investigations, the etiology remains elusive, emphasizing the complexity of recurrent diplopia.
Conclusion:
Continued monitoring and further investigation are warranted to unravel the enigma of recurrent diplopia in this unique case, highlighting the importance of individualized approaches to guide optimal management.
Keywords: Recurrent diplopia, 6th nerve palsy, autoimmune disease, systemic steroid, neuro-ophthalmology.
Highlights
* Recurrent diplopia is a diagnostic puzzle, especially in terms of etiology
* Despite treatment, the patient experienced recurrent diplopia attributed to 6th nerve palsy for 14 years, highlighting the chronic nature of the condition.
* Extensive evaluation failed to identify the underlying cause, which illustrates the diagnostic complexity of recurrent diplopia.
* Systemic steroid treatment provided temporary relief, but the recurrence persisted, necessitating long-term management.
* This case emphasizes the need for tailored approaches and ongoing monitoring to effectively address the challenges in managing recurrent diplopia.
INTRODUCTION Recurrent diplopia presents a diagnostic problem, especially when associated with 6th nerve palsy. The etiology of recurrent diplopia in older individuals has yet to be well described in the literature.1 We present a case of a 39-year-old male farmer with eight episodes of diplopia over 14 years, each responding to systemic steroid therapy but recurring every 12-18 months. Despite the patient's clinical response, the underlying etiology remains elusive, emphasizing the complexity of this rare condition. This case prompts a thorough exploration of the potential inflammatory or autoimmune origins of recurrent 6th nerve palsy, addressing the disorder's symptomatic relief and recurrent nature.1,2 This report contributes to the limited literature on such cases, shedding light on the challenges and considerations in managing this recurrent neuro-ophthalmological condition.
CASE REPORT
In this case, a 39-year-old male, a married farmer, was presented to the Neuromedicine OPD for a follow-up examination of recurrent diplopia attributed to 6th nerve palsy. The patient reported no recent instances of double vision or associated complaints during the follow-up visit. Notably, the last episode of diplopia occurred 13 months prior, and the patient had experienced eight such episodes over 14 years since 2008.
During the previous episode, the patient sought medical attention with the chief complaint of acute-onset double vision persisting for 10 days. No significant concurrent medical or surgical issues were reported, aside from a recurrent history of diplopia, and treatment during previous occurrences involving systemic steroid administration, resulting in the complete resolution of symptoms. Recurrence typically manifest within 12-18 months of treatment.
Clinical examination revealed that the patient could not abduct the right eye, whereas the remaining ocular and systemic examinations yielded normal results. Notably, there were no signs of myasthenia gravis, ptosis, and pain on the movement of the eyeballs, decreased visual acuity, trauma, red eyes, headache, focal neurological deficits, or meningeal or cerebellar abnormalities. Brain MRI revealed no abnormalities, except for the presence of rhinosinusitis.
A comprehensive antibody panel, including anti-acetylcholinesterase receptor antibodies and anti-MUSK antibody tests, was used to investigate the possibility of an autoimmune etiology. All results from these tests were negative, further complicating the determination of the underlying cause of recurrent diplopia. Continued monitoring and further investigations may be necessary to elucidate the nature of this unique case and to guide appropriate management.
DISCUSSION
The case of a 39-year-old male farmer with recurrent diplopia attributed to 6th nerve palsy highlights the diagnostic challenges and complexities of managing this rare condition. Despite the patient's clinical response to systemic steroid therapy, the underlying etiology remains elusive, emphasizing the need for thorough exploration of the potential inflammatory or autoimmune origins of recurrent 6th nerve palsy.
The literature suggests that benign recurrent 6th nerve palsy in children is rare, and recurrences are rarer.3, 4 This condition typically occurs following viral illnesses, infections, and immunization involving attenuated live vaccinations. In adults, the evaluation and management of recent-onset diplopia in adults with a history of long-standing strabismus can be perplexing and challenging.5 The causes of isolated recurrent ipsilateral sixth nerve palsies in older adults have not been well described in the literature, and the etiology of recurrent isolated sixth nerve palsies in older adults has not been well described.1 The clinical presentation of isolated recurrent diplopia from a sixth nerve palsy should prompt a neurologist or ophthalmologist to order a brain MRI with and without gadolinium as part of the initial workup to rule out a non-microvascular cause, such as a compressive lesion.1 The exact pathophysiologic mechanism of the relapsing and remitting course of the sixth nerve palsy has yet to be fully understood. This may be related to a structural lesion or an inflammatory process.1 The etiological diagnosis of diplopia is a clinical challenge.4 Binocular diplopia is referred to in the literature as the most common type, and there are several etiological mechanisms of binocular diplopia, including orbital disorders, extra-ocular muscle disorders, neuromuscular junction dysfunction, and primary or secondary visual cortex diseases.4 In conclusion, the case of a 39-year-old male farmer with recurrent diplopia attributed to 6th nerve palsy highlights the diagnostic challenges and complexities of managing this rare condition. The literature suggests that benign recurrent 6th nerve palsy in children is rare, and recurrences are rarer. By contributing to the existing literature on this rare condition, we aimed to enhance awareness among clinicians and foster a multidisciplinary approach to patient care, ultimately improving outcomes in individuals with similar presentations.
Consent:
Written informed consent was obtained from the patient for the publication of this case report. A copy of the written consent form is available for review by the editor-in-chief of the journal upon request.
Ethical Approval:
Ethical approval is not required for case report.
Source of Funding:
There is no source of Funding.
Research Registration:
Research registration is not required as this is only a case report.
Author contribution:
P.P.: Conceptualization, project administration, supervision, writing -review, and editing. K.R.B.: Conceptualization, project administration, supervision, writing-review, and editing. R.K.C: Formal analysis, writing -original draft, writing-review, and editing. N.R.: Writing- original draft, writing-review and editing. S.M.: Resources, supervision, writing-original draft, writing-review and editing. B.A.: Resources, writing-original draft, writing-review, and editing. K.S.: Resources, writing-original draft, writing-review, and editing.
Conflict of Interest:
The authors declare that they have no conflicts of interest. The work has been reported as being in line with SCARE criteria.
Guarantor:
Prabesh Panta.
Data availability statement:
The datasets are available from the corresponding author on reasonable request.
REFERENCES:
1. Chan JW, Albretson J. Causes of isolated recurrent ipsilateral sixth nerve palsies in older adults: a case series and review of the literature. Clin Ophthalmol Auckl NZ. 2015;9:373. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4348047/
2. Patel SV, Mutyala S, Leske DA, Hodge DO, Holmes JM. Incidence, associations, and evaluation of sixth nerve palsy using a population-based method. Ophthalmology. 2004 Feb ;111(2):369-75. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0161642003011849
3. Gonçalves R, Coelho P, Menezes C, Ribeiro I. Benign Recurrent Sixth Nerve Palsy in a Child. Case Rep Ophthalmol Med. 2017:8276256. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5763058/
4. Kushner BJ. Recently Acquired Diplopia in Adults With Long-standing Strabismus. Arch Ophthalmol. 2001 Dec 1;119(12):1795-801. Available from: https://doi.org/10.1001/archopht.119.12.1795
5. Alves M, Miranda A, Narciso MR, Mieiro L, Fonseca T. Diplopia: A Diagnostic Challenge with Common and Rare Etiologies. Am J Case Rep. 2015 Apr 13;16:220-3. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4410729/
|
#Eligibility Criteria:
Inclusion Criteria:
* This is only a case report of 39-years-old male.
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06512636
|
{
"brief_title": "A Decade-Long Dance With Diplopia: Unraveling the Enigma of Recurrent 6th Nerve Palsy",
"conditions": [
"Neurologic Manifestations"
],
"interventions": null,
"location_countries": [
"Nepal"
],
"nct_id": "NCT06512636",
"official_title": "A Decade-Long Dance With Diplopia: Unraveling the Enigma of Recurrent 6th Nerve Palsy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-03-15",
"study_completion_date(actual)": "2024-06-15",
"study_start_date(actual)": "2024-01-15"
},
"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)": "2024-07-22",
"last_updated_that_met_qc_criteria": "2024-07-16",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-07-22",
"first_submitted": "2024-07-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Abnormal uterine bleeding is characterized by excessive menstrual blood loss affecting over 50% of women of reproductive age. It can be debilitating and significantly affect a woman's quality of life. Tranexamic acid (TXA) prevents the breakdown of clots and fibrinolysis by binding to the lysine receptor on plasminogen while Calcium dobesilate improves microcirculation and vascular health by increasing nitric oxide synthesis leading to endothelium relaxation, so inhibits endothelial shedding. Calcium dobesilate and tranexamic acid have roles in managing bleeding disorders, but their use and efficacy can vary. Tranexamic acid is more established and widely used for abnormal bleeding, while calcium dobesilate role is less defined and more variable. Tranexamic acid reduces menstrual blood loss, but it has no affect on endothelium while calcium dobesilate reduces the oxidative stress , so improving endothelial health and provide the endothelial protection. Side effects include GI upset , hypersensitivity reactions and agranulocytosis. The side effects of both drugs are comparable.
Detailed Description
This Randomized control trial was conducted at Obstetrics \& Gynaecology unit Sahiwal Teaching Hospital from to for the period of two years after taking the approval from Institutional review board (IRB). Sample size of one hundred patients (Fifty in each group) was calculated. These patients were randomly allocated into two equal groups, fifty patients in each group. Written informed consent was obtained from each subject by explaining the risks and benefits associated with the drugs. Group A women were given 500mg tranexamic acid thrice a day for 5 days during menstrual cycle and in group B women were given 500 mg capsule Calcium dobesilate thrice a day for 5 days during menstruation for consecutive time period of three months. Women were also evaluated for adverse effects. The information was entered into specially designed proformas. The data was analyzed by SPSS version 21.0. Frequencies and percentages of categorical variables including marital status, parity and adverse effects were calculated and compared between two groups by applying chi square tests. t-Test was used for the calculation of mean and standard deviations of numerical variables like age, BMI, duration of symptoms, blood loss before and after intervention and reduction in blood loss and was compared between two groups. In all statistical analysis only p value less than 0.05 was considered significant.
#Intervention
- DRUG : Tranexamic Acid
- Group A received Trannexamic Acid 500mg three times a day for 5 days
- DRUG : Calcium dobesilate (Doxium)
- Group B recieved Cap.Calcium Dobesilate 500mg 3 times a day for 5 days
|
#Eligibility Criteria:
Inclusion Criteria:
* Women of 18 <= age <= 40 years
* Abnormal uterine bleeding
Exclusion Criteria:
* Patients with pregnancy
* Miscarriage
* Hypersensitivity to pharmacological agents to be used in trial
* Patients having moderate to severe anemia (Hb:<8gm/dl)
* Patients with thyroid abnormalities (TSH > 5mIU)
* Benign uterine conditions e.g. fibroid uterus, endometrial/cervical polyp
* Uterine malignancy
* Coagulation disorders (PT : >15sec).
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT06707051
|
{
"brief_title": "Effect of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin",
"conditions": [
"Heavy. Mentrual Bleeding",
"Abormal utèrine Bleeding",
"Bleeding",
"Uterine Bleeding",
"Hypersensitivity Response",
"GI Disturbance",
"Agranulocytosis",
"Bleeding Pattern",
"Endometrial",
"Endometrial Bleeding"
],
"interventions": [
"Drug: Tranexamic Acid",
"Drug: Calcium dobesilate (Doxium)"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT06707051",
"official_title": "Comparison of Efficacy of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-31",
"study_completion_date(actual)": "2024-06-30",
"study_start_date(actual)": "2022-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-27",
"last_updated_that_met_qc_criteria": "2024-11-26",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-11-27",
"first_submitted": "2024-10-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Intravitreal aflibercept has been approved for the treatment of visual impairments due to diabetic macular oedema (DMO) in Europe and the US in August 2014 and July 2014 respectively.
The main objectives of this observational cohort field study are to evaluate effectiveness of intravitreal aflibercept and to describe follow-up as well as treatment patterns in anti vascular endothelial growth factor (anti-VEGF) treatment naïve patients with DMO in routine clinical practice in the United Kingdom.
#Intervention
- DRUG : Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
- Anti-VEGF exposure is defined as treatment with intravitreal aflibercept for the treatment of DMO by the patient.according to the prescribing physician.
- DRUG : Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
- Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent \[Ophthalmologicals / Antineovascularisation agents (S01LA05)\] for the treatment of DMO by the patient.according to the prescribing physician.
- DRUG : Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
- Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent \[Ophthalmologicals / Antineovascularisation agents (S01LA05)\] for the treatment of DMO by the patient.according to the prescribing physician.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients aged >= 18 years.
* Patients diagnosed with type 1 or 2 diabetes mellitus.
* Patients diagnosed with DMO with central involvement (defined as the area of the centre subfield of OCT) treated with intravitreal aflibercept (in accordance with routine practice).
* Patients for whom the decision to initiate treatment with intravitreal aflibercept was made as per the investigator's routine treatment practice and prior to study inclusion.
* Patients must provide written informed consent.
Exclusion Criteria:
* Patients under the age of 18.
* Patients with contraindications as listed in the SmPC for intravitreal aflibercept.
* Patients with pre-planned cataract surgery during the observational period.
* Patients previously treated with intravitreal anti-VEGF within 28 days.
* Patients currently or previously treated with systemic anti-VEGF.
* Patients previously treated with intravitreal fluocinolone acetonide steroid.
* Patients participating in an investigational programme with interventions outside of routine clinical practice.
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
|
NCT02850263
|
{
"brief_title": "A Study to Assess the Effectiveness of Aflibercept in Routine Clinical Practice in Patients With Diabetic Macular Oedema",
"conditions": [
"Macular Edema"
],
"interventions": [
"Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)",
"Drug: Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02850263",
"official_title": "An Observational Study to Assess the Effectiveness of Intravitreal Aflibercept in Routine Clinical Practice tn Patients With Visual Impairment Due to Diabetic Macular Oedema (DMO)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-30",
"study_completion_date(actual)": "2020-11-23",
"study_start_date(actual)": "2016-07-05"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-02",
"last_updated_that_met_qc_criteria": "2016-07-27",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-29",
"first_submitted": "2016-05-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Diabetes mellitus is a disease of great frequency and is a major public health problem. In Lebanon, the incidence of diabetes is estimated at 12%, it is expected to double by the year 2025. Given the increasing prevalence of diabetes in Lebanon, the evolution of complications of this disease and the lack of studies at this level, it is appropriate to conduct a study that aims to evaluate the effects an education program for people with type 2 diabetes on their sense of self-efficacy and their ability to self-manage their disease to make them the most optimal therapeutic adherence possible. The design of this study is experimental type before / after randomization by diabetic patients. Education program delivered to the experimental group is the 'Accu-Chek Education Program' of Roche. Membership will be assessed using a biomarker HbA1c should be \<7%, and a questionnaire (Summary of Diabetes Self-Care Activities Measure), which measures self-care behaviors. Self-efficacy is measured using the Diabetes Management Self-Efficacy Scale. And this before the intervention and 3 months later. The sample will be 240 diabetic patients T2. Recruitment will be in outpatient diabetology a Hospital located in Beirut. Statistical analyzes used for descriptive variables are measures of central tendency, dispersion and frequency distribution. T-test and chi-square will be used to compare the socio-demographic characteristics of the 2 groups, experimental and control. To test hypotheses and determine the difference in the results of the dependent variables of the 2 groups, analysis of variance and covariance are used. The data will be processed using SPSS version 14.0.
Detailed Description
1. Following the implementation of a program of education, feeling of self-efficacy participants will be higher in the experimental group than in the control group.
2. Following the implementation of a program of education, self-management behaviors: monitoring the diet, the practice of physical exercise, self-monitoring blood sugar, taking medications and care feet, participants will be higher in the experimental group than in the control group.
3. Following the implementation of a program of education, the percentage of participants who have an HbA1c less than 7 will be higher in the experimental group than in the control group.
#Intervention
- BEHAVIORAL : education program
- education program in 6 hours and monitoring phone every 15 days
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years and over,
* Suffering from type 2 diabetes for at least one year,
* Lebanese speak, read and write Arabic,
* Have an HbA1c >= 7%
Exclusion Criteria:
* mental impairment
* a psychological problem uncontrolled and medicated
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
|
NCT01771887
|
{
"brief_title": "Effects of Education Program for Lebanese Diabetic T2 in Their Behavior of Auto Managing, of Self-efficacy and Adhesion",
"conditions": [
"Diabetes Mellitus"
],
"interventions": [
"Behavioral: education program"
],
"location_countries": [
"Lebanon"
],
"nct_id": "NCT01771887",
"official_title": "Assessing the Effects of Education Program for Lebanese Diabetic Type 2 in Their Behavior of Auto Managing Their Sense of Self-efficacy and on Their Adhesion Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2013-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-12-04",
"last_updated_that_met_qc_criteria": "2013-01-16",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-01-18",
"first_submitted": "2013-01-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research is to examine whether and to what extent training of different types of cognitive engagement will improve performance on fluid cognitive abilities that typically decline with age. The research covered by this protocol will use behavioral data that yield response latencies and accuracies of the untrained tasks, and brain activations in fMRI tasks, to test specific hypotheses about neural plasticity and cognitive plasticity from these engagement techniques. Hence, human subjects will be employed in an experiment lasting for 20 hours spanning over 2 months where they will either receive real-time strategy-based videogame training or crystallized intelligence training. In addition, long-term retention data will be obtained after 6 month post-training to investigate any long-term benefits.
Detailed Description
The purpose of this research is to examine whether and to what extent training of different types of cognitive engagement will improve performance on fluid cognitive abilities that typically decline with age (such as, speed of information processing, working memory capacity, episodic memory, and executive functions). The research covered by this protocol will use behavioral data that yield response latencies and accuracies of the untrained tasks, and brain activations in fMRI tasks, to test specific hypotheses about the extent of transfer, if any, and the underlying cognitive constructs that may be trained in the process. Hence, human subjects will be employed in an experiment lasting for 20 hours spanning over 2 months where they will either receive real-time strategy-based videogame training or crystallized intelligence training. In addition, long-term retention data will be obtained after 6 month post-training to investigate any long-term benefits.
#Intervention
- BEHAVIORAL : Real-time strategy-based videogame training
- Rise of Nation is a complex strategy-based video game, in which individualized-adaptive feedbacks are constantly given to players based on their performance.
- BEHAVIORAL : Semantic Knowledge training
- Packages of various cross-word puzzles include word search, word ladder, and word wheel.
|
#Eligibility Criteria:
Inclusion Criteria:
* Right-handed
* over 50 Years of Age
* native or fluent English speaker
* not Color-blind
* Magnetic Resonance Imaging eligible
* Mini Mental Status Examination Score >24
Exclusion Criteria:
* Left-handed or ambidextrous
* younger than 50
* cannot distinguish colors during color blindness test
* claustrophobia
* metal artifact in body
* over 300 lb
* pacemaker
* MMSE score lower than 24
* history of stroke
* history of substance or alcohol abuse
* currently taking anti-psychotic or anti-depression medication
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05924490
|
{
"brief_title": "Cognitive Engagement and Aging Mind",
"conditions": [
"Age-related Cognitive Decline"
],
"interventions": [
"Behavioral: Real-time strategy-based videogame training",
"Behavioral: Semantic Knowledge training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05924490",
"official_title": "Cognitive Engagement and Aging Mind: A Randomized Control Trial to Determine the Effects of Adaptive Real-time Strategy Game Training on Cognition and Brain Functions of Older Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-01",
"study_completion_date(actual)": "2018-10-01",
"study_start_date(actual)": "2013-01-31"
},
"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)": "2023-06-29",
"last_updated_that_met_qc_criteria": "2023-06-20",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-06-29",
"first_submitted": "2021-05-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Non-invasive mechanical ventilation (NIV) has not exhibited a reduction of reintubation after extubation failure compared to oxygen therapy. The reduction of reintubation with NIV versus oxygen therapy in patients with extubation failure was evaluated.
A clinical trial was conducted that included patients who underwent mechanical ventilation and developed acute respiratory failure after extubation. After extubation failure, thirty-three were assigned to NIV and thirty-two were assigned to oxygen therapy.
Detailed Description
Patients. Medical and surgical patients admitted to intensive care unit with 18 years of age or older in weaning from their first episode of mechanical ventilation for more than 24 hours were included. Patients with structural neurological disorder, acute toxic-metabolic neurological encephalopathy with neurological deficit \[estimated by a Glasgow Coma Score \<14 points\] at the time of weaning, neuromuscular disease, chronic obstructive pulmonary disease receiving non-invasive ventilation, limitation of life support therapy during their admission, tracheostomized patients, spinal cord injuries, scheduled surgical procedure during the 48 hours following extubation, intensive care unit readmission, transfer to another centre or a contraindication to non-invasive ventilation were excluded.
Weaning protocol. The beginning of weaning was considered when patients were conscious, without pain, connected to mechanical ventilation in pressure support ventilation mode, fraction of inspired oxygen ≤0.5, positive end-expiratory pressure +5cmH20, dopamine ≤5 mcgr/kg/min or noradrenaline ≤0.2 mcgr/kg/min, temperature \<38ºC and absence of metabolic acidosis. Weaning consisted of a spontaneous breathing trial, which is routinely performed in our unit with a T-tube connected to an oxygen source . The following conditions indicated a successful spontaneous breathing trial: oxygen partial pressure ≥60 mmHg or transcutaneous oxygen saturation\>90% with fraction of inspired oxygen \<0.5, carbon dioxide partial pressure \<50 mmHg (or an increase \<8 mmHg), pH \>7.32, respiratory rate \<35 bpm (or an increase \<50%), heart rate \<140 bpm (or an increase \<20%), systolic blood pressure \<180 mmHg, and absence of cardiac arrhythmias after a minimum period of 30-120 min. Once the test was completed, extubation and subsequent placement of a Venturi oxygen mask with 0.3-0.4 fraction of inspired oxygen was performed. The physician in charge was responsible for the process of removal of mechanical ventilation and subsequent extubation. In the case of T-tube test failure, the patient was reconnected to the ventilator. Patient who presented clinical deterioration within 48 hours after extubation (work of breathing, use of accessory muscles, paradoxical breathing) and/or respiratory-gasometric deterioration \[respiratory rate \>25 bpm or increase of \>50% with respect to the baseline respiratory rate, oxygen partial pressure \<65 mmHg, carbon dioxide partial pressure \>45 mmHg or pH \<7.33) \[19\] and who were candidates for non-invasive ventilation were included in the study. Extubation failure was classified as follows: 1) Acute respiratory failure secondary to airway problems: obstruction of the upper airway and aspiration or excess of secretions; 2) Acute respiratory failure not dependent of the airway: acute pulmonary oedema, congestive heart failure, hypoxemic and/or hypercapnic acute respiratory failure, encephalopathy and others (digestive bleeding, shock, etc.). Patients who required immediate reintubation after extubation failure were not included.
After confirming extubation failure and the possibility of eligibility to participate in the study, the patient was assigned to a group (non-invasive ventilation group or oxygen group) through the opening of a sealed envelope. Previously, a simple randomisation by a computerised system had been performed by a physician not involved in the study.
Non-invasive ventilation. BiPAP Vision and continuous positive airway pressure devices were used. For the BiPAP Vision, oronasal and facial masks and an active humidification system were used. Procedure: Once the patient was informed of the procedure, the type of mask was selected according to the clinical situation and anatomy of the patient, and the harness was placed. Ventilation was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. The rise time was 0.1-0.2 seconds. Continuous positive airway pressure. A continuous positive airway pressure device was used through the oronasal mask on the patient. The minimum initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O. The objective pressures of both devices were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. The fraction of inspired oxygen was increased in both devices until a transcutaneous oxygen saturation of 94-96% was achieved. Once the patient's cooperation and sufficient adaptability were achieved, the mask was adjusted to the harness with adjustable straps.
Oxygen therapy. The control group received oxygen therapy using a Venturi mask with an fraction of inspired oxygen up to 0.5 or using a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2 (estimated fraction of inspired oxygen of 1.0).
Both non-invasive ventilation/continuous positive airway pressure and oxygen therapy were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective. Withdrawal of non-invasive ventilation/continuous positive airway pressure was performed progressively with reduction of inspiratory airway pressure/expiratory positive airway pressure or positive end-expiratory pressure levels until complete disconnection of non-invasive ventilation. In both groups (study and control), after improvement, the fraction of inspired oxygen of the Venturi mask was set to 0.3-0.4. The criteria for failure of both non-invasive ventilation and oxygen therapy were: absence of clinical improvement (respiratory rate\>35 bpm, use of accessory muscles, thoracoabdominal asynchrony, encephalopathy) or deterioration of oxygenation (decrease in oxygen partial pressure or in oxygen partial pressure to fraction of inspired oxygen ratio), haemodynamic (noradrenaline \>0.5 mcgr/kg/min) or ventilation (increase in carbon dioxide partial pressure and decrease in pH) parameters. Modifications of fraction of inspired oxygen and inspiratory positive airway pressure/expiratory positive airway pressure or positive end-expiratory pressure levels, as well as the time of orotracheal intubation were performed according to the criteria of the physician. All patients received aspiration of secretions, postural changes, incentive spirometry and bronchodilators.
Parameters analysed. After inclusion in the study, demographic data, the reason of mechanical ventilation, severity according to the Simplified Acute Physiology Score 3, organ failure according to the Sequential Organ Failure Assessment scale (both of them at intensive care unit admission) and comorbidities were recorded. The duration both of mechanical ventilation until the first extubation and time of spontaneous breathing trial were measured. Neurological variables (Glasgow Coma Score), haemodynamic variables \[systolic blood pressure, diastolic blood pressure, mean blood pressure, heart rate\], respiratory variables (respiratory rate, transcutaneous oxygen saturation) and blood gases (oxygen partial pressure, fraction of inspired oxygen, oxygen partial pressure to fraction of inspired oxygen ratio, carbon dioxide partial pressure, pH, bicarbonate and lactic acid) were recorded during the T-test of patients eligible to participate in the study and later, when they presented acute respiratory failure due to extubation failure. Similarly, ventilatory parameters were recorded during the 1st,2nd, and 8th hours of randomisation. Time from extubation to acute respiratory failure extubation failure was recorded. After extubation failure, the following variables were recorded: reintubation, tracheostomy, organ failure (cardiovascular, coagulation, renal, liver, neurological) using the Sequential Organ Failure Assessment scale and infectious complications (pneumonia or tracheobronchitis associated to mechanical ventilation, urinary tract infection, bacteraemia) were determined. Also the duration both of non-invasive ventilation. and oxygen therapy and globally of mechanical ventilation, were calculated. The mortality rates in the intensive care unit, in the hospital, and at 90 days were determined.
Sample size. Based on previous results, it was considered that the need for intubation could be reduced by 35%. The estimated sample size was 30 patients in each group \[NIV group vs oxygen therapy\] with a confidence interval \[1-α\] of 95% and power \[1-β\] of 80%. Comparative analyses were conducted using Student's t test or the Mann-Whitney test for the comparisons of quantitative variables for parametric and non-parametric characteristics, respectively. For qualitative variables, chi-square statistic or Fisher's exact test were used. Differences were considered significant if P \<0.05. A per protocol analysis was performed. Multivariate analysis for repeated measures (with Bonferroni's correction) was performed with the aim of studying the influence either of NIV or oxygen therapy on respiratory parameters. The cumulative probability of survival was assessed using a Kaplan-Meier estimation of survival and a log-rank test to compare the two groups. The data were analysed using the statistical package SPSS 20.0.
#Intervention
- DEVICE : Non-invasive mechanical ventilation
- DEVICE : Continuous positive airway pressure
- DEVICE : Venturi mask
- DEVICE : Reservoir mask
|
#Eligibility Criteria:
Inclusion Criteria:
* Medical and surgical ICU patients with 18 years or older
* First episode of mechanical ventilation for more than 24 hours
Exclusion Criteria:
* Structural neurological disorder
* Acute toxic-metabolic neurological encephalopathy with neurological deficit [estimated by a Glasgow Coma Score (GCS) <14 points] at the time of weaning
* Neuromuscular disease
* Chronic obstructive pulmonary disease (COPD) receiving NIV
* Limitation of life support therapy during their admission
* Tracheostomized patients
* Spinal cord injuries
* Scheduled surgical procedure during the 48 hours following extubation
* Intensive care unit readmission
* Transfer to another centre
* Contraindication to non-invasive mechanical ventilation
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
|
NCT03832387
|
{
"brief_title": "Non-invasive Ventilation vs Oxygen Therapy After Extubation Failure",
"conditions": [
"Respiratory Failure"
],
"interventions": [
"Device: Non-invasive mechanical ventilation",
"Device: Reservoir mask",
"Device: Venturi mask",
"Device: Continuous positive airway pressure"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT03832387",
"official_title": "Non-Invasive Mechanical Ventilation Versus Oxygen Therapy in Patients With Acute Respiratory Failure After Extubation in a Intensive Care Unit",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-04",
"study_completion_date(actual)": "2016-09-04",
"study_start_date(actual)": "2009-03-29"
},
"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)": "2019-06-04",
"last_updated_that_met_qc_criteria": "2019-02-04",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-06",
"first_submitted": "2019-01-24",
"first_submitted_that_met_qc_criteria": "2019-02-26"
}
}
}
|
#Study Description
Brief Summary
Investigation of how the patients experience whole body MRA. After the WB-MRA the patients will fill in a questionnaire, that contains questions about the WB-MRA procedure and how the patient felt during the examination.
We expect that the patients will report a high degree of satisfaction with the WB-MRA procedure, with little discomfort.
Detailed Description
WB-MRA is performed in patients referred for conventional x-ray based angiography. The WB-MRA is performed first in all patients.
After both examinations are completed the patients will be asked to fill in a questionnaire containing questions about their experience of the 2 procedures.
We will then compare the results for the procedures.
#Intervention
- PROCEDURE : Whole body magnetic resonance angiography
|
#Eligibility Criteria:
Inclusion Criteria:
* Symptomatic lower extremity ischemia (claudication, ischemic wounds)
* Referred to digital subtraction angiography (DSA)
Exclusion Criteria:
* Renal insufficiency (GFR < 30 ml/min)
* Contra-indications for MRI-examination (claustrophobia, metal-implants, pacemaker)
* Dementia
* Pregnancy/lactation
* Allergy to gadolinium based MRI contrast agents
* Acute disease
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00556101
|
{
"brief_title": "Patient Acceptance of Whole Body Magnetic Resonance Angiography",
"conditions": [
"Atherosclerosis",
"Intermittent Claudication",
"MRI"
],
"interventions": null,
"location_countries": [
"Denmark"
],
"nct_id": "NCT00556101",
"official_title": "Whole Body Magnetic Resonance Angiography: Questionnaire Examination of Patient Acceptance.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2009-07",
"study_start_date(actual)": "2007-11"
},
"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)": "2009-08-19",
"last_updated_that_met_qc_criteria": "2007-11-08",
"last_verified": "2009-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-11-09",
"first_submitted": "2007-11-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to assess the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.
Detailed Description
Patients will be asked to evaluate the IPRA advices by connecting to IPRA© application by using their smartphone, 30 times a week for two weeks. At the end of this two week period, a satisfaction questionnaire will be completed.
#Intervention
- OTHER : A decision support software
- OTHER : Insulin Pump
- OTHER : Continuous glucose monitoring
|
#Eligibility Criteria:
Inclusion Criteria:
* men and women >= 18 years,
* patients with type 1 diabetes for more than 2 years,
* patients treated by insulin pump for more than 6 months,
* patients using of real-time continuous glucose monitoring for more than 3 months,
* patients able to evaluate the IPRA advices by connecting to IPRA© application 30 times a week,
* patient able to provide written informed consent,
* patient able to provide written non-disclosure agreement
Exclusion Criteria:
* pregnancy or breastfeeding,
* current infectious disease,
* patients with no smartphone® or Internet access,
* adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
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
|
NCT01883024
|
{
"brief_title": "Insulin Pump-RT Advisor (IPRA©): a Decision Support Software for Diabetic Patients Treated by Insulin Pump and Using Continuous Glucose Monitoring. Experimental Study. Evaluation by an Expert Patient Panel.",
"conditions": [
"Type 1 Diabetes"
],
"interventions": [
"Other: Insulin Pump",
"Other: A decision support software",
"Other: Continuous glucose monitoring"
],
"location_countries": [
"France"
],
"nct_id": "NCT01883024",
"official_title": "Prospective Study, Insulin Pump-RT Advisor (IPRA©): a Decision Support Software for Diabetic Patients Treated by Insulin Pump and Using Continuous Glucose Monitoring. Experimental Study. Evaluation by an Expert Patient Panel.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-07",
"study_completion_date(actual)": "2013-09",
"study_start_date(actual)": "2013-06"
},
"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)": "2023-05-24",
"last_updated_that_met_qc_criteria": "2013-06-20",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-21",
"first_submitted": "2013-06-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers
#Intervention
- DRUG : Atorvastatin/niacin extended-release
- 80 mg tablet atorvastatin once daily, 10 mg tablet placebo to atorvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
- Other Names :
- Lipitor, Niaspan
- DRUG : Atorvastatin
- 10 mg tablet atorvastatin once daily, 80 mg tablet placebo to atorvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
- Other Names :
- Lipitor
- DRUG : Simvastatin
- (Russia and Brazil) 80 mg tablet simvastatin once daily, 10 mg tablet placebo to simvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
- Other Names :
- Zocor
- DRUG : Simvastatin
- (Russia and Brazil) 10 mg tablet simvastatin once daily, 80 mg tablet placebo to simvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
- Other Names :
- Zocor
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient is diagnosed with carotid stenosis AND is scheduled to undergo carotid endarterectomy
* Female patients of reproductive potential must abstain from sex or use an acceptable method of birth control through out the study
Exclusion Criteria:
* Patient must undergo CEA less than 4 weeks after entering study
* Patient has recent history of acute coronary syndrome
* Patient has has coronary artery bypass graft surgery within 30 days of study start
* Patient has thyroid disease that has not been treated for more than 6 weeks
* Patient has donated blood within 8 weeks of study start
* Patient has poorly controlled diabetes mellitis
* Patient has human immunodeficiency virus (HIV) or Hepatitis B or C
* Patient is taking warfarin or other anticoagulants
* Patient is taking hormone replacement therapy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00804843
|
{
"brief_title": "Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)",
"conditions": [
"Carotid Atherosclerosis"
],
"interventions": [
"Drug: Atorvastatin/niacin extended-release",
"Drug: Simvastatin",
"Drug: Atorvastatin"
],
"location_countries": null,
"nct_id": "NCT00804843",
"official_title": "A Randomized Clinical Trial to Evaluate the Effects of High Dose Statin and Niacin Therapy on Excised Plaque Biomarkers in Patients Undergoing Carotid Endarterectomy (CEA)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-10",
"study_completion_date(actual)": "2010-10",
"study_start_date(actual)": "2009-04"
},
"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)": "2015-09-30",
"last_updated_that_met_qc_criteria": "2008-12-08",
"last_verified": "2015-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-12-09",
"first_submitted": "2008-12-08",
"first_submitted_that_met_qc_criteria": "2012-03-26"
}
}
}
|
#Study Description
Brief Summary
The study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid by dissection of the brain at autopsy. Amyloid in the brain is a key feature of Alzheimer's Disease (AD).
Detailed Description
There will be two primary analyses:
* The first primary analysis will evaluate the correlation between the blinded readers' rating of amyloid plaque density on the PET scan and the cortical amyloid plaque density at autopsy.
* The second primary analysis will evaluate the specificity of the blinded readers' rating of presence or absence of amyloid plaque density on the PET scan
For the autopsy population, subjects will be enrolled from various end-of-life (e.g. hospice / hospital / nursing home) and late-life (longitudinal studies of aging) populations. Enrollment will include subjects with various levels of cognitive status, ranging from cognitively normal through dementia. It is expected that amyloid plaque density in this elderly population will range from very low (normal aging) through moderate (e.g. cognitively normal subjects with asymptomatic amyloid deposits or mild cognitive impairment (MCI) subjects with intermediate levels of amyloid deposits) to very high (subjects with AD). The study will also enroll younger healthy subjects presumably devoid of amyloid in the specificity cohort.
Screening assessments may take place over several days and will include collection of demographic information, diagnostic interview, and safety assessments. At the time of screening, subjects or caregivers will be asked to provide consent for brain donation if they are not already enrolled in a brain donation program affiliated with this study, in addition to providing informed consent for the screening and imaging procedures in the study.
Subjects who qualify for the study will have a catheter placed for intravenous (i.v.) administration of florbetapir F 18. Subjects will receive a single i.v. bolus of 370 MBq (10 mCi) of florbetapir F 18 followed by brain PET imaging for 10 minutes duration, beginning approximately 50 minutes post-injection. Vital signs and safety labs will be obtained prior to the administration of florbetapir F 18 and at the completion of the imaging session. Adverse events will be continuously monitored during the imaging session. Subjects who experience an adverse event will not be discharged until the event has been resolved or stabilized.
#Intervention
- DRUG : florbetapir F 18
- Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration
- Other Names :
- 18F-AV-45, AV-45, Amyvid
|
#Eligibility Criteria:
Inclusion Criteria (autopsy cohort):
* Have a projected life expectancy of <= 6 months as determined by the principal investigator (e.g. terminal medical condition) or are already enrolled in a longitudinal study of aging with an autopsy component;
* Can tolerate a 10 minute PET scan; and
* Give informed consent for study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die.
Inclusion Criteria (specificity cohort):
* Cognitively and neurologically healthy males and females 18 <= age <= 40 of age;
* Who had no known risk factors for AD, including:
* Known genetic risk factors for AD, including an ApoE ε4 allele (note: ApoE genotype was determined after enrollment and was not disclosed to healthy control subjects). Scans from subjects carrying an ApoE ε4 allele were not included in the primary specificity analysis, but were included in an exploratory analysis;
* First degree relative with a known progressive dementing disorder;
* History of cognitive decline;
* History of neurologic, neurodegenerative, or psychiatric disease;
* History of head trauma; or
* Evidence of brain abnormality on a MRI scan;
* Who performed in an age-appropriate normal range on the Wechsler Logical Memory I & II, story A;
* Who could tolerate a 10-minute PET scan; and
* Who provided informed consent before any study procedures were performed.
Exclusion Criteria:
* Have primary brain tumor, known metastases to the brain, central nervous system (CNS) lymphoma;
* Have any major, focal structural loss of brain matter;
* Are aggressively being treated with life sustaining measures (e.g. currently on respirator; receiving high dose chemotherapy);
* Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive test for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);
* Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
* Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, secretase inhibitor);
* Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
* Are females of childbearing potential who are pregnant or not using adequate contraception.
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
|
NCT00857415
|
{
"brief_title": "Phase III Study of the Correlation Between Florbetapir F18 PET Imaging and Amyloid Pathology in the Brain",
"conditions": [
"Alzheimer's Disease"
],
"interventions": [
"Drug: florbetapir F 18"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00857415",
"official_title": "A Phase III Study of the Correlation Between Florbetapir F 18 (18F-AV-45) PET Imaging and Amyloid Pathology",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-03",
"study_completion_date(actual)": "2010-05",
"study_start_date(actual)": "2008-12"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"PHASE3"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-05-22",
"last_updated_that_met_qc_criteria": "2009-03-05",
"last_verified": "2012-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-03-06",
"first_submitted": "2009-03-05",
"first_submitted_that_met_qc_criteria": "2012-04-06"
}
}
}
|
#Study Description
Brief Summary
Chronic obstructive pulmonary disease (COPD) is a widespread disease that can have a major impact on the lives of individuals. An essential element in the treatment of COPD is rehabilitation of which supervised training is an important part. However, not all individuals with severe COPD can participate in the rehabilitation provided by hospitals and municipal training centres due to distance to the training venues and transportation difficulties. The aim of the feasibility study was to evaluate an individualised home based training and counselling programme via video conference to patients with severe COPD after hospitalization with regard to safety, clinical outcomes, patients' perception, organisational aspects and economic aspects.
#Intervention
- OTHER : Telemedicine training and counselling
- Training and counselling by the physiotherapist consisted of 3 weekly sessions, lasting 30-45 minutes, over a 3 week period, i.e. a total of 9 supervised sessions. Heart rate and oxygen saturation were monitored during the exercise training. This included thoracic mobilization exercises, cardio training, strength training and breathing exercises. The training intensity was progressed continuously.
There were 1-2 sessions with the occupational therapist, which consisted of training and counselling on energy conservation techniques. The first session was 60 minutes long and included assessment, counselling and training. This session was delivered in the second week of the intervention. The intervention concluded in the third week, with sessions of 30 minutes as required.
|
#Eligibility Criteria:
Inclusion Criteria:
* severe and very severe COPD (i.e. with an FEV1 (forced expiratory volume in 1 second) value under 50% of the predicted value, an FEV1/FVC (forced vital capacity) ratio < 70%, MRC (Medical Research Council Dyspnoea Scale) grade 3)
* >=40 years
* hospitalization with exacerbation of COPD
* declined participation in the hospital based rehabilitation
* participation in videoconference sessions with a nurse for one week immediately after discharge.
Exclusion Criteria:
* inability to communicate via telephone and computer
* systolic BP <100mm Hg
* X-rays of the thorax showing abnormalities suspicious of thoracic malignancy or lobar pneumonia
* a diagnosis of cancer or recurrence of cancer within the last 5 years
* hospitalization with septic shock, acute myocardial infarction (AMI) or other serious medical conditions (e.g. kidney disorder)
* heart failure (EF<30%)
* if the patient did not wish to participate.
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
|
NCT02085187
|
{
"brief_title": "Early Telemedicine Training in Patients With COPD",
"conditions": [
"Chronic Obstructive Pulmonary Disease (COPD)"
],
"interventions": [
"Other: Telemedicine training and counselling"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT02085187",
"official_title": "Early Telemedicine Training and Counselling After Hospitalization in Patients With Severe Chronic Obstructive Pulmonary Disease: A Feasibility Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2013-01",
"study_start_date(actual)": "2012-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-03-12",
"last_updated_that_met_qc_criteria": "2014-03-10",
"last_verified": "2014-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-03-12",
"first_submitted": "2014-03-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of a single administration of Metadoxine Extended Release (MDX) formulation for the treatment of adolescents diagnosed with ADHD that have predominantly inattentive symptoms. The study will also try to evaluate the efficacy of MDX and its level in the blood.
Detailed Description
This will be a randomized, double-blind, placebo-controlled multi-center, fixed dose, single dose study in adolescent subjects with PI-ADHD. Eligible subjects will be randomized in a 1:1 ratio to receive single administration of either MDX (approximately 14-22 mg/kg) or matching placebo.
Subjects taking a course of methylphenidate, amphetamine or atomoxetine at least two weeks prior to screening will require a 2-week wash-out (for methylphenidate, amphetamine) or a 4-week wash-out (for atomoxetine) and be requested to attend an interim screening visit.
The study will consist of three periods: a screening period of up to three weeks (and five in the case of atomoxetine washout), a 1 day treatment period, and a one-week safety follow-up period.
Overview of Study Visits Screening Period - Visit 1 (Screening/Baseline) Following signing of informed consent/assent, subjects will be screened for study eligibility. Each subject will undergo a battery of evaluations with various rating scales including Adolescent ADHD Clinical Diagnostic Scale1 (ACDS v1.2), Kiddie - Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL), Columbia-Suicide Severity rating scale (C-SSRS), State Trait Anxiety Inventory (STAI-A and STAI-T), Beck Depression Inventory (BDI), CGI-S (Clinical Global Impression - Severity), Time-Sensitive ADHD Symptom Scale (TASS), Wechsler Intelligence Scale for Children- fourth edition (WISC-IV) sub-tests2 and Test of Variables of Attention (TOVA)3. Eligible subjects who did not require a wash-out, will be eligible for the study. In addition, the following standard assessments will be performed: assessment of inclusion/exclusion, collection of demographic data, medical history, prior medications, neurological exam, neuropathy questionnaire, physical exam, height and weight, vital signs, ECG, laboratory evaluations including hematology (complete blood count, CBC), chemistry, plasma concentration of metadoxine, urinalysis, and serum pregnancy test for women of child bearing potential. The screening visit may be conducted over multiple days. Screening visit data will be considered baseline data for statistical analysis purposes for subject requiring no washout.
Visit 1a (Interim screening visit) This visit is applicable to subjects taking medications or supplements requiring washout such as methylphenidate, amphetamine or atomoxetine at any time during the 2 weeks preceding Visit 1 (screening); these subjects will undergo a 2-week washout (for cases such as methylphenidate or amphetamine treatment) or a 4-week washout (for cases such as atomoxetine treatment) period after which they will attend an interim screening visit. Baseline TOVA, WISC-IV sub-tests1, and TASS will be performed at Visit 1a. In addition, the C-SSRS, adverse events, and concomitant medications will be recorded at this visit.
Treatment Period - Visit 2 (Day 1, visit window + 3 days) At study visit 2 (Day 1), each eligible subject will be randomized in a 1:1 allocation to receive either MG01CI or matching placebo; dose will be determined by weight at screening visit 1. Investigational product will be administered at the clinic. The WISC-IV sub-tests of Digit Span, Coding, Letter Number Sequencing, and Symbol Search will be administered. Subjects will undergo evaluations with the TOVA test 3 to 5 hours post-dose to assess their response to treatment. In addition, subjects will complete the TASS prior to administration of study drug, and 3-5 hours post-dose. At this visit, the subjects will also undergo safety assessments including urine pregnancy test (pre-dose), vital signs , neurological exam, neuropathy questionnaire, the C-SSRS and recording of adverse events (AEs) and concomitant medications. Subjects will have blood drawn for plasma concentrations of metadoxine at 1-2 hours post-dose and 3-4 hours post-dose.
Follow-Up Period - Visit 3 (Day 8, visit window ± 3 days) One week after the end of treatment, subjects will complete the TASS and will undergo safety assessments including physical exam, neurological exam, neuropathy questionnaire, vital signs, ECG, laboratory evaluations (hematology, chemistry, and urinalysis including urine pregnancy test for women of child bearing potential), the C-SSRS, and documentation of concomitant medications and AEs, if any.
#Intervention
- DRUG : Metadoxine extended release
- MG01CI
- Other Names :
- MDX
- DRUG : Placebo
- Inactive drug
- Other Names :
- Sugar pill
|
#Eligibility Criteria:
Inclusion Criteria:
* Adolescent males and females, 13 <= age <= 17 years, inclusive, at screening visit, with visible axillary hair.
* Diagnosed with predominantly inattentive ADHD based on DSM V criteria for ADHD as assessed by the Adolescent ADHD Clinician Diagnostic Scale (Adol-CDS V1.2).
* Clinical severity of at least a moderate level (Clinical Global Impression-Severity score of 4 or above).
* STAI State score of <52, STAI Trait score of <52 and BDI score of <19.
* Sexually active subjects of childbearing potential must agree to use an effective contraceptive throughout the study (e.g., oral contraceptives or Norplant®; a reliable double barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam]; intrauterine devices; vasectomy; or abstinence) and for at least a month after the study, and must have a negative serum pregnancy test at the Screening Visit. Females of childbearing potential are defined as women who are between menarche and 2 years post-menopause and who are not surgically sterilized. Males and Female subjects who are not sexually active, and who agree to be abstinent throughout the study, will not be required to use birth control.
* Subject is able to attend the clinic regularly and reliably.
* Subject is able to swallow tablets and capsules.
* Able to understand, read, write and speak Hebrew fluently to complete study related materials.
* Parents or legal authorized guardians (LAR), and subject, able to understand and sign written informed consent/assent to participate in the study
* Subject and parents/LARs provide assent/consent to participate in the study. per applicable laws and regulations
* Subject weighs >=40 kg or <=100 kg
Exclusion Criteria:
* Subject has any psychiatric condition (e.g., schizophrenia or personality disorder as diagnosed by DSM-V) or clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by the investigator using medical history, physical examination, neurological examination, laboratory tests, and electrocardiograms. Common diseases such as mild hypertension, well-controlled type 2 diabetes mellitus (hemoglobin A1C <6.5%), etc, are allowed per the investigator's judgment as long as they are stable and controlled by medical therapy that is constant for at least 8 weeks before randomization and subsequently throughout the study. If there are any concerns about the suitability of the subject's medical or surgical condition, the investigator should review the subject's history with the medical monitor.
* Subject has a known or suspected human immune deficiency virus positive status or has diseases such as acquired immunodeficiency disorder, hepatitis C, hepatitis B, or tuberculosis.
* Subject has a history of an allergy or sensitivity to B-complex vitamins.
* Subject has a history of intellectual disability or a history or suspicion of autism spectrum disorder.
* Subject has a current clinically significant Axis I diagnosis (other than ADHD) according to the K-SADS-PL or has a lifetime history of bipolar disorder or psychosis.
* Subject has used mega-dose vitamin B6/pyridoxine during the 28 days before the Randomization Visit. Subjects will be allowed to have a 28-day washout of mega-dose vitamin B6/pyridoxine after the Screening visit. Routine multivitamin supplements will be allowed.
* Subject has used high-dose supplements of omega-3 fatty acids >= 500 mg on at least 1 day (such as softgels, capsules, or fish oils; regular daily dietary consumption of fish is allowed) or folic acid supplements (other than routine multivitamin supplements) during the 2 weeks before the Randomization Visit.
* Subject has used an investigational medication/treatment in the 30 days before the Screening Visit
* Subject has used any medication or food supplement that the investigator or the medical monitor considers unacceptable during the 14-day period before randomization. This includes, but is not limited to, sympathomimetic agents, clonidine, guanfacine, norepinephrine reuptake inhibitors, serotonin reuptake inhibitors, sedative-hypnotics, benzodiazepines, sedating antihistamines, herbal preparations that would confound safety or efficacy assessments, and narcotics. Questions regarding the acceptability of medications and food supplements (such as melatonin) will be discussed with the medical monitor before study entry.
* Subject has a current drug or alcohol dependence or substance abuse disorder according to DSM-V Text Revision criteria (excluding nicotine) or a history of such dependence within the last 6 months. Subject should also agree to keep their caffeine intake consistent and refrain from consuming >=300 mg per day of caffeine (no more than three 8-ounce servings of coffee) during the study.
* Subject has suicidality, defined as active ideation, an intent or plan, or any significant lifetime suicidal behavior (actual attempt, aborted attempt, interrupted attempt, or act or preparation towards imminently making a suicide attempt). Subjects exhibiting history (within previous 12 months) of non-suicidal self-injurious behavior will be excluded.
* Subject has taken any prescription or non-prescription ADHD medications during the 14 days before the randomization visit or 28 days in the case of atomoxetine..
* Subject is significantly visually impaired to an extent that is not able to be corrected by prescription glasses or contact lenses
* Subject is closely related to the sponsor, investigator, or study staff. Eligibility of subjects with any relationship to the sponsor, investigator, or study staff will be discussed with the medical monitor before study entry.
* Subject has any condition that, in the principal investigator's opinion, would place the subject at risk or influence the conduct of the study or interpretation of results, including (but not limited to) abnormally low intellectual capacity as judged by the investigator.
* Subject cannot fully comprehend the implications of the protocol, cannot comply with its requirements, or is incapable of following the study schedule for any reason.
* Subject is pregnant, lactating, or using an inadequate contraceptive method.
* Subject is not currently participating in other clinical trials.
Sex :
ALL
Ages :
- Minimum Age : 13 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02189772
|
{
"brief_title": "Safety and Tolerability Study of Metadoxine Extended Release (MDX) (Previously Known as MG01CI) in PI-ADHD Adolescent Subjects",
"conditions": [
"ADHD, Predominantly Inattentive Type"
],
"interventions": [
"Drug: Placebo",
"Drug: Metadoxine extended release"
],
"location_countries": [
"Israel"
],
"nct_id": "NCT02189772",
"official_title": "Randomized, Double-blind, Placebo-controlled, Multi-center, Fixed Dose Study Designed to Evaluate the Safety and Tolerability of a Single Administration of MG01CI (Metadoxine Extended Release, MDX) in Adolescents With Predominantly Inattentive Attention Deficit Hyperactivity Disorder",
"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)": "2014-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-04",
"last_updated_that_met_qc_criteria": "2014-07-14",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-07-15",
"first_submitted": "2014-07-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Currently, cancer is a disease of high incidence, already considered a public health problem. Among the most prevalent are head and neck neoplasms, and depending on the location and extent of the lesion, the treatments are surgery, chemotherapy and / or radiotherapy that have a great impact on the quality of life. Radiation therapy is a frequently chosen treatment, and depending on the dose of radiation, causes changes such as hyposalivation. There are techniques for salivary flow stimulation, however, most of the options involve the use of medications, which limits administration to part of the patients. Transcutaneous electric nerve stimulation (TENS) is an alternative that has been used to stimulate salivary flow, however there is a limited number of studies that have tested this technique after radiotherapy. The aim of this study was to verify the effect of TENS in increasing the salivary flow of individuals receiving radiotherapy to treat tumors of the head and neck. The sample will have 80 patients randomly divided into two groups: TENS group and Control group. In both groups, a quality of life questionnaire (UW-QOL) will be applied and a speech-language assessment will be performed. The hypothesis of this research is that TENS is effective in increasing the amount of saliva. Secondary outcomes involve the evaluation of the effect of this technique on the quality of life, mainly in the questions: speech, chewing, saliva and deglutition.
Detailed Description
The sample will have 80 patients randomly divided into two groups: 1) TENS group; 2) control group. A quality of life questionnaire (UW-QOL) will be applied and a speech-language assessment will be performed. The hypothesis of this research is that TENS increasing the amount of saliva. Secondary outcomes involve the evaluation of the effect of this technique on the quality of life, mainly in the questions: speech, chewing, saliva and deglutition.
#Intervention
- DEVICE : TENS
- TENS Group: Pre-test evaluations (Clinic Conditions; Live Quality; Salivary Flux); TENS treatments (50Hz / pulse duration of 250 ms / high intensities tolerated / continuously for 20 minutes / 2 sessions a week / 4 weeks / total of the 8 TENS sessions) and Post-test evaluations.
|
#Eligibility Criteria:
Inclusion Criteria:
Starts radiotherapy treatment without previous hipossalivation
The inclusion criteria according to information contained in electronic medical records and referred by the participants are:
* Patients undergoing oncological follow-up for the treatment of head and neck cancer at Santa Rita Hospital through radiotherapy;
* Have completed radiotherapy for at least 90 days;
* Do not present a history of carcinogenic lesion in the salivary glands (sublingual, submandibular and parotid);
* Do not present oral history of oral cancer;
* Have not undergone cervical emptying level I;
Exclusion Criteria:
Intolerance to the TENS
The exclusion criteria are:
* No xerostomia;
* Severe dysphagia;
* Stimulated salivary flow volume greater than 1.5 ml / minute;
* Use of glandular protective substances or salivary stimulants during the period of data collection;
* Use of a pacemaker or any other device that prevents electrical stimulation;
* Being pregnant;
* Unavailability of time to participate in the study (2x / week for one month);
* Excessive absences during treatment (> 30% of total sessions).
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
|
NCT03151889
|
{
"brief_title": "Eletric Stimulation for Hipossalivation Induced by Radiotherapy",
"conditions": [
"Hyposalivation",
"Electric Stimulation Therapy",
"Head and Neck Neoplasm",
"Radiotherapy"
],
"interventions": [
"Device: TENS"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT03151889",
"official_title": "Transcutaneous Electric Nerve Stimulation (TENS) Treatment for Hipossalivation Induced by Radiotherapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-30",
"study_completion_date(actual)": "2018-12-30",
"study_start_date(actual)": "2017-08-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-08-12",
"last_updated_that_met_qc_criteria": "2017-05-11",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-12",
"first_submitted": "2017-05-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia
#Intervention
- DRUG : Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg
- co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Crestor Tab. 20mg(Rosuvastatin 20mg) and placebo of Olmesartan 40mg
- DRUG : Olmesartan 40 mg, Rosuvastatin 20mg
- co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg).
- DRUG : Amlodipine/Olmesartan 10/40mg (Combination drug)
- co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 20 <= age <= 80
* patients with hypertension and hyperlipidemias
Exclusion Criteria:
* orthostatic hypotension
* History of ventricular tachycardia, atrial fibrillation
* uncontrolled diabetes mellitus
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03009487
|
{
"brief_title": "A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia",
"conditions": [
"Hypertension",
"Hyperlipidemias"
],
"interventions": [
"Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)",
"Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg",
"Drug: Olmesartan 40 mg, Rosuvastatin 20mg"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03009487",
"official_title": "A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04",
"study_completion_date(actual)": "2018-04",
"study_start_date(actual)": "2017-01"
},
"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)": "2022-01-11",
"last_updated_that_met_qc_criteria": "2017-01-01",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-01-04",
"first_submitted": "2016-12-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with upadacitinib.
Detailed Description
This is an open-label extension study to assess the long-term safety, tolerability, and efficacy of upadacitinib in adults with RA who have completed Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) Phase 2 randomized controlled trial (RCT) with upadacitinib.
All participants received treatment with 6 mg upadacitinib twice a day at the start of the study. Participants may have been up-titrated to 12 mg BID based on protocol-specified criteria. In Protocol Amendment 2 (January 2016) the study treatment was changed to a once daily (QD) formulation. Participants receiving 6 mg BID were transitioned to 15 mg QD and participants receiving 12 mg BID were transitioned to 30 mg QD dosing.
An optional 12-week vaccine sub-study was added in Protocol Amendment 3 (November 2017) to assess the impact of upadacitinib treatment (15 mg QD and 30 mg QD) with background methotrexate on immunological responses to pneumococcal 13-valent conjugate vaccine (PCV-13; Prevnar 13®) in RA patients. The vaccine substudy included 111 participants who were enrolled in the main study, the first participant was enrolled on 13 February 2018 and the the last participant completed the sub-study on 9 April 2020.
In Protocol Amendment 5 (December 2019), the protocol was revised to allow a decrease in upadacitinib dosing from 30 mg QD to 15 mg QD, as appropriate, based on investigator's medical decision or for safety/tolerability concerns.
#Intervention
- DRUG : Upadacitinib
- Tablet taken orally
- Other Names :
- ABT-494, RINVOQ®
- BIOLOGICAL : Pneumococcal 13-valent conjugate vaccine (PCV-13)
- Administered by intramuscular injection
- Other Names :
- Prevnar 13®
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who have completed Study M13 <= age <= 550 (NCT01960855) or Study M13 <= age <= 537 (NCT02066389) with upadacitinib (ABT-494) and did not develop any discontinuation criteria.
* If the subject has evidence of new latent tuberculosis (TB) infection, the subject must initiate and complete a minimum of 2 weeks (or per local guidelines, whichever is longer) of an ongoing TB prophylaxis before continuing to receive study drug.
* If female, subject must be postmenopausal, OR permanently surgically sterile, OR for women of childbearing potential practicing at least one protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug.
* Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.
Substudy:
* Must currently be enrolled in the main study.
* Must have been receiving a stable dose of upadacitinib (either 15 mg QD or 30 mg QD) for a minimum of 4 weeks prior to the Vaccination visit.
* Must have been on a stable dose of background methotrexate (no change in dose or frequency) for a minimum of 4 weeks prior to the Vaccination visit.
* If subject is on corticosteroids, must remain on a stable dose of <= 10 mg/day of prednisone or equivalent corticosteroid therapy for at least 4 weeks after the vaccination visit.
* Must meet the prescribing specifications as per local label requirements to receive Prevnar 13® vaccine.
* Willing to receive Prevnar13® vaccine.
Exclusion Criteria:
* Pregnant or breastfeeding female.
* Ongoing infections at Week 0 that have not been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled but not dosed until the infection has been successfully treated.
* Anticipated requirement or receipt of any live vaccine during study participation including up to 30 days after the last dose of study drug.
* Laboratory values from the visit immediately prior to Baseline Visit (local requirements may apply) meeting the following criteria:
* Serum aspartate transaminase (AST) or alanine transaminase (ALT) > 3.0 × upper limit of normal (ULN)
* Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73m^2
* Total white blood cell count (WBC) < 2,000/μL
* Absolute neutrophil count (ANC) < 1,000/μL
* Platelet count < 50,000/μL
* Absolute lymphocytes count < 500/μL
* Hemoglobin < 8 g/dL
* Enrollment in another interventional clinical study while participating in this study.
* Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study drug.
Substudy:
* Receiving any conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than methotrexate
* Receiving > 10 mg/day of prednisone or equivalent corticosteroid therapy.
* Receipt of any steroid injection within 4 weeks prior to Vaccination visit.
* History of severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13®.
* History of any documented pneumococcal infection within the last 6 months prior to the vaccination visit.
* Receipt of any vaccine 4 weeks prior to the vaccination visit and/or anticipation of any vaccination for 4 weeks after the vaccination visit.
* Receipt of any pneumococcal vaccine.
* Subject is not suitable for the sub-study as per the Investigator's judgment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02049138
|
{
"brief_title": "An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis",
"conditions": [
"Rheumatoid Arthritis"
],
"interventions": [
"Biological: Pneumococcal 13-valent conjugate vaccine (PCV-13)",
"Drug: Upadacitinib"
],
"location_countries": [
"Slovakia",
"Israel",
"Ukraine",
"Mexico",
"United States",
"Chile",
"Poland",
"United Kingdom",
"New Zealand",
"South Africa",
"Russian Federation",
"Spain",
"Bulgaria",
"Puerto Rico",
"Hungary",
"Belgium",
"Czechia",
"Latvia"
],
"nct_id": "NCT02049138",
"official_title": "Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) With Upadacitinib (ABT-494)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-07-29",
"study_completion_date(actual)": "2021-07-29",
"study_start_date(actual)": "2014-01-24"
},
"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)": "2022-07-12",
"last_updated_that_met_qc_criteria": "2014-01-28",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-30",
"first_submitted": "2014-01-28",
"first_submitted_that_met_qc_criteria": "2022-06-15"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate PET methodology to study in vivo synaptic dopamine release.
Detailed Description
The objective of this study is to evaluate PET methodology to study in vivo synaptic dopamine release.
#Intervention
- DRUG : Methylphenidate
|
#Eligibility Criteria:
Inclusion Criteria:
Healthy normals
Exclusion Criteria:
History of head trauma or loss of consciousness. Significant medical history. History of seizures.
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
|
NCT00015301
|
{
"brief_title": "Methylphenidate Raclopride Positron Emission Tomography (PET) Test - 11",
"conditions": [
"Cocaine-Related Disorders",
"Substance-Related Disorders"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00015301",
"official_title": "Methylphenidate Raclopride PET Test",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-06",
"study_completion_date(actual)": "2005-08",
"study_start_date(actual)": "2003-12"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-02-24",
"last_updated_that_met_qc_criteria": "2001-04-17",
"last_verified": "2002-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-04-18",
"first_submitted": "2001-04-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a research study about an experimental (investigational) oral ETEC vaccine (ACE527). ACE527 is a live attenuated vaccine that is being made to prevent disease from enterotoxigenic Escherichia coli (ETEC), which causes watery diarrhea, largely in children living in developing countries and in travelers to those countries. This research study is also testing an investigational adjuvant called dmLT. An adjuvant is something that is added to a vaccine to make it work better. The purpose of this study is two-fold. First, Part A aims to find out if the vaccine by itself or the vaccine combined with the adjuvant is safe, tolerable, and initiates an immune response. Second, Part B aims to find out if the vaccine by itself or the vaccine combined with the adjuvant prevents diarrheal disease when challenged with ETEC H10407. About 60 healthy adults, ages 18-50, will participate in Part A, and they will be required to stay in the research facility for several nights for the first dose, but will not be required to stay overnight for the second and third doses. Participants will be assigned to receive either the vaccine alone, the vaccine with adjuvant, or placebo by mouth. Study procedures include: stool samples, blood samples, and documentation of side effects. Participants will be involved in study related procedures for about 8 months.
Interested volunteers from Part A will along with volunteers who were never vaccinated in Part A will return to participate in Part B. These volunteers will be required to stay overnight in the research facility for several nights after challenge, after which they will be treated with antibiotics and sent home. Study procedures include stool samples, blood samples, and documentation of infection with ETEC H10407. If the vaccine with/without adjuvant is effective, the volunteers should not development diarrhea, but if the vaccine with/without adjuvant is not effective, the volunteers will have diarrhea for a few days.
Detailed Description
This study is a clinical trial in healthy adult volunteers to evaluate the safety, immunogenicity and efficacy of a live attenuated ETEC vaccine, ACE527, with and without a mucosal adjuvant, dmLT. This study was designed initially as a single site, Phase 1, double-blind, randomized, placebo-controlled, clinical trial in healthy adult volunteers to evaluate the safety and immunogenicity of a live attenuated ETEC vaccine, ACE527, with and without a mucosal adjuvant, dmLT (Part A). The addition of a challenge step provides a unique opportunity to evaluate the efficacy of the new lyophilized formulation of ACE527 vaccine, given in a two or three dose regimen, with and without dmLT, against wild type ETEC strain H10407 challenge (designated as Part B: Phase 2b Open Label Challenge Study). In addition, challenging the volunteers may allow for the identification of immune correlates of protection, taking advantage of newly available technologies (immune proteomics, transcriptomics, etc.)
ACE527 comprises three genetically attenuated and engineered strains of E. coli, with antigen profiles covering a wide range of ETEC surface colonization factor antigens (CFA/I, CFA/II \[CS1, CS2, CS3\] and CFA/IV \[CS5, CS6\]) and also expressing LT-B, the inactive subunit of LT (ETEC heat labile toxin). LT(R192G/L211A), or dmLT, is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine.
Volunteers were enrolled in Part A into each of two separate Cohorts. Cohort 1 and 2 volunteers received 10\^10 colony-forming units (cfu) total dose of ACE527, 10\^10 cfu total dose of ACE527 with 25 µg dmLT, or placebo at 0, 1, and 2 months. Enrollment and dosing of Cohort 2 was dependent on an acceptable safety profile of the first dose of Cohort 1, based on evaluation of data up until Day 3 by the Safety Review Committee (SRC). The first immunization of each Cohort was administered in the Center for Immunization Research (CIR) Inpatient Unit, followed by 72 hours of direct post-immunization observation. The SRC met after the first dose of cohort to determine continuation of volunteer dosing on an outpatient basis, and enrollment of Cohort 2. The SRC met again after the first dose of Cohort 2 after concluding that the first dose appeared safe and well tolerated, subsequent doses would be administered on an outpatient basis. Safety was assessed by solicited symptoms/subject memory aid and laboratory evaluations. Adverse events (AE)s were graded according to standardized criteria. The immunogenicity outcome measures of interest include serum immunoglobulin G (IgG) and immunoglobulin A (IgA) antibodies by enzyme-linked immunosorbent assay (ELISA) against all vaccine antigens, cytokine assays, B and T cell memory responses, shedding profile of ACE527, and vaccine specific mucosal IgA responses.
Part B challenge cohorts were recruited among those participating in Part A; plus additional unvaccinated control volunteers sufficient to enroll up to a total of 60 recruited, as needed. Volunteers in the Phase 2b study were enrolled and challenged in 2-4 cohorts due to the CIR Inpatient Unit capacity of 30 beds. A minimum of 8-10 controls were challenged with each cohort of vaccinees to ensure comparability of attack rates across challenge cohorts. Volunteers were admitted as inpatients and challenged, with approximately 2 x 10\^7 cfu of the fully virulent ETEC strain, H10407, followed by 5 days of direct observation. A Data Review Committee (DRC) will be convened to review the clinical data for all challenged volunteers and verify all outcomes per protocol definitions before any vaccine efficacy assessments were made.
#Intervention
- BIOLOGICAL : ACE527
- 3x10\^9 cfu ACE527 vaccine strain. Comprised of three genetically attenuated and engineered strains of E. coli, with antigen profiles covering a wide range of ETEC surface colonization factor antigens (CFA/I, CFA/II \[CS1, CS2, CS3\] and CFA/IV \[CS5, CS6\]) and also expressing LTB, the inactive subunit of LT (ETEC heat labile toxin). The constituent strains of ACE527 were:
* ACAM2025: a live, attenuated, CFA/I, LTB positive strain
* ACAM2022: a live, attenuated, CS5, CS6, LTB positive strain, and
* ACAM2027: a live, attenuated, CS1, CS2, CS3, LTB positive strain.
- BIOLOGICAL : dmLT
- A derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine (13). These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
- Other Names :
- LT(R192G/L211A)
- BIOLOGICAL : CeraVacx placebo
- CeraVacx® is used to neutralize gastric acidity upon ingestion of vaccine. It was also used as the placebo in this study. CeraVacx® was prepared from the commercial product (Cera Products, Inc.); 9.5 grams were added to sterile water for each dose and mixed. Each dose contained 7 grams of rice syrup, 2 grams of sodium bicarbonate, and 0.5 grams of trisodium citrate.
- BIOLOGICAL : H10407 challenge strain
- Approximately 2 x 10\^7 cfu of the fully virulent ETEC strain. Previously administered to 91 volunteers at this challenge dose by the CIR clinical team over the previous 4 years in conjunction with other Phase 1/2b trials.
- Other Names :
- ST+, LT+, CFA/I toxin
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female healthy adults between 18 and 50 years at the time of enrollment.
* General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of PI.
* Negative pregnancy test at screening and before the first (V0), second (V28), and third vaccinations (V56) for female volunteers of childbearing potential. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. Female volunteers unable to bear children must have this documented (e.g. tubal ligation or hysterectomy) or must have negative pregnancy tests.
* Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
* Completion of a training session and demonstrated comprehension of the protocol procedures and knowledge of ETEC associated illness by passing a written examination (70% pass score).
* Availability for the study duration, including all planned follow-up visits.
* Received at least 2 doses of ACE527 vaccine alone or in combination with 25 ug dmLT 4 <= age <= 6 months prior to challenge (Part B only)
Exclusion Criteria:
* Presence of a significant medical or psychiatric condition which in the opinion of the investigator precludes participation in the study. Some medical conditions which are adequately treated and stable would not preclude entry into the study. These conditions might include stable asthma controlled with inhalers or mild hypertension stably controlled with a single agent.
* Significant abnormalities in screening hematology, or serum chemistry as determined by PI or PI in consultation with the Medical Officer and sponsor.
* Presence in the serum of HIV antibody, HBsAg, or HCV antibody.
* Evidence of IgA deficiency (serum IgA < 7 mg/dl or limit of detection of assay).
* Evidence of current excessive alcohol consumption or drug dependence.
* Volunteers whose Body Mass Index (BMI) is less than 19.0 or greater than 34.0 (kg/m2)
* Recent vaccination or receipt of an investigational product (within 30 days before vaccination).
* Intention to donate blood or blood products within one month following the completion of study participation (note: The Red Cross will not allow blood donations for 1 year following participation in an investigational research study).
* Any other criteria which, in the investigator's opinion, would compromise the ability of the volunteer to participate in the study, the safety of the study, or the results of the study
* Working as a food handler, in child-care or as a healthcare worker with direct patient contact.
* Have household contacts who are <2 years or >80 years or infirm or immunocompromised (for reasons including corticosteroid therapy, HIV infection, cancer chemotherapy, or other chronic debilitating disease).
* Abnormal stool pattern (fewer than 3 per week or more than 3 per day).
* Regular (>= weekly) use of laxatives, antacids, or other agents to lower stomach acidity.
* Use of any medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding the first vaccination or planned use during the active study period.
* Symptoms consistent with Traveler's Diarrhea concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within two years prior to dosing, OR planned travel to endemic countries during the length of the study.
* Vaccination for or ingestion of ETEC, cholera, or LT toxin within 3 years prior to dosing.
* Use of antibiotics during the 7 days before dosing or proton pump inhibitors, H2 blockers or antacids within 48hours prior to dosing.
* History of diarrhea in the 7 days prior to vaccination (outpatient diarrhea is defined as >= 3 unformed (grade 3 or greater) loose stools in 24 hours).
* Known allergy to two of the three following antibiotics: Ciprofloxacin, amoxicillin, and/or trimethoprim/sulfamethoxazole
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
|
NCT01739231
|
{
"brief_title": "Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults",
"conditions": [
"Diarrhea"
],
"interventions": [
"Biological: dmLT",
"Biological: H10407 challenge strain",
"Biological: ACE527",
"Biological: CeraVacx placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01739231",
"official_title": "Safety, Reactogenicity, Tolerability, Immunogenicity and Efficacy of Live Attenuated ETEC ACE527 Vaccine Administered Alone or With a Double Mutant E. Coli Heat Labile Toxin (dmLT) in Healthy Adult Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-10",
"study_completion_date(actual)": "2014-01",
"study_start_date(actual)": "2012-09"
},
"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)": "2019-02-12",
"last_updated_that_met_qc_criteria": "2012-11-28",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-12-03",
"first_submitted": "2012-09-21",
"first_submitted_that_met_qc_criteria": "2018-11-27"
}
}
}
|
#Study Description
Brief Summary
This is a multicenter, randomized, controlled Phase IIa study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the antiviral activity and safety in subjects with with HBeAg-negative Chronic Hepatitis B treated with nucleos(t)ide reverse transcriptase inhibitors.
#Intervention
- DRUG : NrtIs
- Subjects will receive NrtIs therapy for 24 weeks.
- DRUG : HH-003
- Subjects will receive HH-003 20 mg/kg intravenously Q2W for 24 weeks.
- DRUG : HH-003+NrtIs
- Subjects will receive HH-003 20 mg/kg intravenously Q2W for 24 weeks. Subjects will receive NrtIs therapy for 24 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent form;
* Male or female aged from 18 to 65years (inclusively);
* 18 kg/m^2<=BMI<=32 kg/m^2, body weight>=45 kg for men and >=40 kg for women;
* At screening, etiological, clinical, or pathological evidence indicates chronic hepatitis B virus infection for at least 6 months; and negative HBeAg for more than 6 months; 10 IU/mL<=HBsAg<=3000 IU/mL; HBV DNA<=20 IU/mL; ALT<=1×ULN;
* Participants who have been on the treatment of nucleos(t)ide reverse transcriptase inhibitors (limited to entecavir [ETV], tenofovir disoproxil fumarate [TDF], or tenofovir alafenamide fumarate [TAF]) for at least 3 years (as judged by the investigator) at screening.
Exclusion Criteria:
* Females who are pregnant or lactating at screening;
* History of alcoholic liver disease, non-alcoholic steatohepatitis, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-HBV infection;
* History or presence of progressive liver fibrosis or cirrhosis, including but not limited to liver stiffness measurement [LSM] >= 9 kPa at screening, progressive liver fibrosis or cirrhosis (e.g., S >= 3 in GS score or METAVIR >= F3) by liver histopathology examination, according to the Consensus on the diagnosis and therapy of hepatic fibrosis [2019]; or the presence of ascites, hepatic encephalopathy, upper gastrointestinal bleeding, or esophageal and gastric varices.
* History or presence of hepatocellular carcinoma, or alpha-fetoprotein (AFP) >= 50 ng/mL at screening; or suspicion of hepatocellular carcinoma indicated by liver ultrasound, CT, or MRI.
* Use of antiviral therapy with interferon within 1 year prior to screening
* Any of the following lab test results at screening: total bilirubin >2xULN or direct bilirubin >1.5xULN, hemoglobin <120 g/L for males or <110 g/L ro females, platelets count<100,000/mm^3 (100×10^9/L), and absolute neutrophils count <1,500/mm^3 (1.5×10^9/L), Serum albumin < 35 g/L; international normalized ratio (INR) of prothrombin time > 1.3; or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.
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
|
NCT05839639
|
{
"brief_title": "A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors",
"conditions": [
"Chronic Hepatitis B"
],
"interventions": [
"Drug: HH-003",
"Drug: HH-003+NrtIs",
"Drug: NrtIs"
],
"location_countries": [
"China"
],
"nct_id": "NCT05839639",
"official_title": "A Multicenter, Randomized, Controlled Phase IIa Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-05",
"study_completion_date(actual)": "2023-05-17",
"study_start_date(actual)": "2021-10-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-09-28",
"last_updated_that_met_qc_criteria": "2023-04-20",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-05-03",
"first_submitted": "2023-04-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a multi-center, Prospective, observational study，to evaluate the safety and influencing factors of albumin-bound paclitaxel in the real-world chinese population，and evaluate of the efficacy of albumin-bound paclitaxel in patients with malignant tumors and its impact on quality of life.
#Intervention
- OTHER : Observational study
- Observational study of this study, no interventions involved
|
#Eligibility Criteria:
Inclusion Criteria:
* In patients with malignant tumor who have been treated with albumin-bound paclitaxel for the treatment.
Exclusion Criteria:
* No
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04060290
|
{
"brief_title": "Real-world Study for the Safety of Albumin-Bound Paclitaxel in Malignant Tumors",
"conditions": [
"Cancer"
],
"interventions": null,
"location_countries": [
"China"
],
"nct_id": "NCT04060290",
"official_title": "Real-world Study for the Safety of Albumin-Bound Paclitaxel in Malignant Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-02-01",
"study_completion_date(actual)": "2024-02-01",
"study_start_date(actual)": "2020-05-12"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-28",
"last_updated_that_met_qc_criteria": "2019-08-14",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-08-19",
"first_submitted": "2019-08-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The researchers recognized the possible clinical usefulness of a shielded device or jig to help increase the accuracy but decrease the time of loading the seeds into the biocompatible material used intra-operatively. Therefore, the researchers created a prototype of a device called the GammaTile (GT) loader (design patent pending). The reusable device will be made of surgical quality stainless steel of sufficient thickness (greater than 10 half-value layers (HVL) to provide significant staff and user shielding as well as allowing it to be sterilized. It is utilized intraoperatively but off of the operative field and has no direct patient contact. Currently two sizes are planned. The first will accommodate a 2 inch x 2 inch collagen square and the second will accommodate a 1 inch x 1 inch collagen square. These are the most commonly used sizes of lyophilized collagen used in the Barrow Neurosurgical Institute (BNI) operating rooms (OR).
Detailed Description
This is a 100 patient observational-design study for the purpose of testing the seed loader device as a method of arranging and securing the seeds in a carrier in a set pattern for the convenient use of the neurosurgeon against the backdrop of a hodgepodge of currently available techniques (seed in suture, seed in mesh, loose seeds), all of which currently need to be secondarily secured with some additional, not currently standardized material, in a cumbersome, time-consuming, and not assuredly accurate manner. An additional primary objective will be an assessment of the loader device as a radiation protection tool for the user and staff during seed placement in the carrier and prior to intracranial carrier placement. Secondary objectives will be conformality of pre- and post-implant dosimetry (expected vs achieved) and post implant stability (seed shift) over time as judged on a routine follow up MRI. An additional proposed endpoint is an economic (cost) comparison to other modalities.
Eligible patients are those deemed appropriate for and scheduled to undergo adjuvant brachytherapy of the central nervous system as determined by the radiation oncologist and neurosurgeon. Potential candidates will have a lesion(s) that may be newly diagnosed or recurrent, in need of gross total or near gross total resection, and such that in the opinion of the operating surgeon it would be both amenable to and in need of the proposed treatment. Informed consent will be obtained. Radiation oncologist and neurosurgeon will determine appropriateness of the proposed procedure and the radiation oncologist and neurosurgeon will determine the volume and configuration of the area to be implanted.
A carrier using currently available material (lyophilized bovine-derived collagen, Duraform or similar) stocked in the BNI OR. The isotope (seeds) are also already approved for use anywhere in the body, are in use and on the hospital's radioactive materials license (RML). Patients will have pre- and post-operative computerized tomography (CT) or magnetic resonance imaging (MRI) as routine care, and post-operative CT's as per routine implant case dosimetry. All applicable radiation safety procedures will continue to be followed. The sterilizable loader(s) will be provided as a non-charge-item, and are anticipated to be classified as a 'Class 1' device by the FDA as they are not implanted and have no direct patient contact.
#Intervention
- DEVICE : GammaTile seed loader
- Patients are chosen based on symptomatic tumor/radiographic finding of a surgically accessible mass. Surgery will be done in usual fashion. A cavity will be left where the tumor was. Size of operative bed will be measured using a surgical dissector and standard operating room ruler. A sheet of surgical fabric may be used to estimate size of cavity. If pathology is positive the study treatment will continue. If not, patient will not be on trial. If patient is eligible, radiation oncologist will form custom implants using a seed(s) of Cesium-131, with other biocompatible materials used to achieve maximum dosimetric conformality. Surgeon will place constructs into cavity until the operative bed is fully addressed. Implant is not expected to migrate. Surgicel, bioglue or similar material may be used to secure seeds. Wound will be closed in standard fashion. The last 10 patients will be asked to participate in an effort to gauge costs related to radiation portion of treatment.
|
#Eligibility Criteria:
Inclusion Criteria:
* Planned for resection of aggressive primary or metastatic brain tumor and appropriate for adjuvant radiotherapy.
* Zubrod Performance Score of 0 <= age <= 2.
* 18 years or older.
* Pre-operative stereotactic CT or MRI.
* Life expectancy >26 weeks.
* History and physical for all patients and detailed neurological exams.
* Signed study-specific informed consent form prior to study entry.
Exclusion Criteria:
* Negative biopsy if presumed diagnosis on imaging.
* External beam therapy is allowed if the implant is being used instead of a boost or cone down treatment.
* Life expectancy < 26 weeks.
* Inability to undergo post-operative CT for implant assessment, or postoperative follow-up imaging.
* Major medical or psychiatric illness, which, in the investigator's opinion, would prevent completion of treatment and/or interfere with follow-up.
* Inability or refusal to provide informed consent.
* Prior radiation therapy in excess of 100Gy to site of implant.
* Patients in which there is no cranium in place (for example, bone flap removed for infection).
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
|
NCT03088579
|
{
"brief_title": "Intraoperative Brachytherapy for Central Nervous System Lesions: A Validation Study of a Radioactive Seed Loading Device",
"conditions": [
"Central Nervous System Lesion"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT03088579",
"official_title": "Intraoperative Brachytherapy for Central Nervous System Lesions: A Validation Study of a Radioactive Seed Loading Device",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02-28",
"study_completion_date(actual)": "2020-08-11",
"study_start_date(actual)": "2013-04-02"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-04-12",
"last_updated_that_met_qc_criteria": "2017-03-16",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-03-23",
"first_submitted": "2017-03-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Transesophageal echocardiography (TEE) is becoming a more prevalent method of monitoring and diagnosis in the perioperative setting for critically ill patients and patients undergoing cardiac surgery. Many TEE measurements are extrapolated from transthoracic echocardiography (TTE) data and have not validated by transesophageal means. The aim of this study is to validate TEE assessment of right ventricular function by comparing them to simultaneously measured TTE measurements.
Likewise, there are currently no agreed upon values for RV free wall strain. Therefore, the investigators will attempt to define a range of normal values of RV free wall strain as compared to the other measures of RV function.
Detailed Description
Traditionally, all echocardiographic measurements have been studied utilizing TTE. Therefore the normal values and ranges for pathology findings have been defined by transthoracic means alone. TEE offers different images planes when compared to TTE, which may make the measurements obtained differ from those obtained by TTE. In the operating room environment the vast majority of echocardiography is completed by transesophageal means for many reasons; largely access to the patient and the continuous use of TEE as a hemodynamic monitor. However, given the fact that most echocardiographic measurements have only been validated by TTE, there remains a question as to the validity or precision of TEE-derived measurements.
#Intervention
- DIAGNOSTIC_TEST : Transesophageal Echocardiography
- TEE measures of right ventricular function
- Other Names :
- TEE
- DIAGNOSTIC_TEST : Transthoracic Echocardiography
- TTE measures of right ventricular function
- Other Names :
- TTE
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients undergoing elective cardiac surgery requiring TEE
Exclusion Criteria:
* Patient who do not wish to consent
* Patients with contraindications to TEE
* Urgent or emergent cardiac surgery
* Patients with preexisting open chest
* Patients with intrathoracic hardware (VAD, thoracostomy tube, etc)
* Non-English speaking subjects
* Cognitively impaired adults
* Pregnancy
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
|
NCT03264183
|
{
"brief_title": "Validating TEE Measurements of Right Ventricular Function",
"conditions": [
"Ventricular Function, Right",
"Echocardiography, Transesophageal"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT03264183",
"official_title": "Validating Transesophageal Echocardiographic Measurements of Right Ventricular Function",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-10",
"study_completion_date(actual)": "2018-10-10",
"study_start_date(actual)": "2017-09-18"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-06-24",
"last_updated_that_met_qc_criteria": "2017-08-24",
"last_verified": "2019-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-29",
"first_submitted": "2017-07-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this study we wish to investigate the analgesic effect of the administration of 0.2% ropivacaine for an adductor canal block as repeated boluses (20 ml every 8 hours) through a new suture-method catheter or a standard perineural catheter compared with a single bolus (20 ml), in patients following primary total knee arthroplasty.
Detailed Description
The aim of the study is to compare the clinical effects of three different administration forms for an ACB: repeated intermittent boluses through a Certa catheter (CC) versus repeated boluses through a standard catheter (through the needle) (SC) versus a single bolus (SB). Our dual hypothesis is that repeated boluses through a catheter (either Certa or standard catheter) reduces opioid consumption (primary outcome), as well as reduces pain scores, enhances ambulation and muscle strength compared with a single bolus, and that the Certa catheter is superior to a standard catheter.
#Intervention
- DRUG : Initial bolus (Certa and standard catheter groups)
- 10 ml of ropivacaine 0,75% will be used to ensure correct position of the needle and to expand the adductor canal, followed by injection of another 10 ml of ropivacaine 0.75% via the catheter during real time US imaging to ensure correct placement of the catheter.
- DRUG : Initial bolus (Single bolus group)
- 20 ml of ropivacaine 0.75%
- DRUG : Intermittent boluses (Certa and standard catheter groups)
- 20 ml of ropivacaine 0.2% every 8 hour in the catheter
- DRUG : Intermittent boluses (Single bolus group)
- 0.1ml of ropivacaine 0.2% every 8 hour in the sham catheter
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients scheduled for unilateral total knee arthroplasty in spinal anesthesia
* Patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions
* ASA 1 <= age <= 3
* Ability to perform a TUG test preoperatively
Exclusion Criteria:
* Patients who cannot cooperate
* Patients who cannot understand or speak Danish.
* Patients with allergy to the medicines used in the study
* Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
* Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
* Rheumatoid arthritis
* BMI > 40
* Neuromuscular pathology in the lower limbs
* Pregnancy
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
|
NCT03142789
|
{
"brief_title": "Adductor Canal Block After Total Knee Replacement - a Suture-method Catheter vs a Standard Catheter vs a Single Bolus",
"conditions": [
"Pain Management"
],
"interventions": [
"Drug: Initial bolus (Certa and standard catheter groups)",
"Drug: Intermittent boluses (Single bolus group)",
"Drug: Intermittent boluses (Certa and standard catheter groups)",
"Drug: Initial bolus (Single bolus group)"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT03142789",
"official_title": "Comparison of the Analgesic Effect of an ACB (Adductor Canal Block) Using a New Suture-method Catheter vs a Standard Perineural Catheter vs a Single Bolus: A Randomized, Blinded, Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-12",
"study_completion_date(actual)": "2018-04-12",
"study_start_date(actual)": "2017-05-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-05-01",
"last_updated_that_met_qc_criteria": "2017-05-04",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-05",
"first_submitted": "2017-05-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to assess speech therapy's effectiveness in understanding other people's thoughts (implied) using written stories. The main objective is to examine whether the therapy improves understanding of the stories worked on in the sessions. We also explore whether the observed progress is maintained one month after the end of treatment and whether it is generalized to neuropsychological tests, video material, and the participants' daily lives.
This therapy will be administered to four individuals with brain lesions, for six weeks, at the rate of two weekly sessions of one hour.
#Intervention
- BEHAVIORAL : Speech and language therapy
- The intervention focuses on understanding the thoughts of the characters. Twenty written stories will be used, which end with statements that can be interpreted literally, ironically, as a lie, a request or a faux-pas (maladroitness). At the end of each story, the participant should explain what the characters want to mean by their statement.
To help the participant in his understanding of the character's intention, he will be asked:
1) To mention as many intentions as possible that can be associated with the target statement presented out of context (eg: 'it's hot here' that can be interpreted literally, ironically, as a lie or a request) and to imagine contexts in connection with interpretation; 2. Analyze the relevant elements of the context (environment, the relationship between the characters, knowledge of the characters); 3. To judge the probability of the possible interpretations (pt 1) by justifying using the elements of the context analyzed previously (pt 2).
|
#Eligibility Criteria:
Inclusion Criteria:
* Have been the victim, in adulthood, of a moderate to severe traumatic brain injury (TBI) or a stroke, with at least right frontal lesions (objectified by imaging). The time between the TBI or stroke and participation in this study should be greater than six months.
* Be of French mother tongue or have an excellent mastery of French.
* Be between 20 and 65 years.
* Be right-handed
* Present problems in the understanding of non-literal language (irony, indirect requests), objectified by a neuropsychological examination.
Exclusion Criteria:
* Have a history of psychiatric disorder affecting social cognition (according to DSM-V criteria), and more specifically: autism, schizophrenia, bipolar disorders, major depressive disorders, borderline personality disorders, generalized anxiety disorders, obsessive-compulsive disorders, phobia social and eating disorders (anorexia, bulimia).
* Have chronic symptoms of an alcohol or drug dependence disorder (according to DSM-V criteria).
* Have significant uncorrected vision and/or hearing problems.
* Have aphasia and/or significant reading and comprehension problems.
* Present significant spatial neglect.
* Present an impaired capacity for judgment and discernment, objectified by a neuropsychological evaluation.
* Have been the victim of several TBI or stroke
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
|
NCT04708561
|
{
"brief_title": "Therapy of Pragmatic Disorders in Brain-damaged Individuals",
"conditions": [
"Brain Injuries, Traumatic",
"Right Hemispheric Stroke"
],
"interventions": [
"Behavioral: Speech and language therapy"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT04708561",
"official_title": "Therapy of Non-literal Language Comprehension Disorders in Brain-damaged Individuals: Case Studies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-10-31",
"study_completion_date(actual)": "2022-04-30",
"study_start_date(actual)": "2020-06-03"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-05-18",
"last_updated_that_met_qc_criteria": "2021-01-11",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-14",
"first_submitted": "2021-01-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AZD8848 in healthy subjects.
Detailed Description
A Phase 1, Single Centre, Double-blind, Randomised, Placebo-controlled, Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics after Administration of Multiple Ascending (MAD) Once Weekly Inhaled Doses of AZD8848 in Healthy Subjects
#Intervention
- DRUG : AZD8848
- Multiple doses inhaled IMP via a nebulizer
- DRUG : Placebo to match AZD8848
- Multiple doses inhaled matching placebo via a nebulizer
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male and/or female subjects aged 18 <= age <= 50 (inclusive) with suitable veins for cannulation or repeated venipuncture
* Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive for at least 3 months prior to Screening and be willing to continue on the chosen contraceptive with additonal use of condom until 3 months postdose
* Male subjects should be willing to use barrier contraception ie, condoms, from the first day of investigational product administration until 3 months after the last administration of investigational product
* Have a body mass index (BMI) between 18 and 32 kg/m2 and weigh at least 50 kg and no more than 110 kg
* Women must have a negative pregnancy test at screening and on admission to the study centre, must have a date of last menstruation, must not be lactating or must be of non-childbearing potential
Exclusion Criteria:
* Abnormal vital signs, after 10 minutes supine rest, defined as any of the following: SBP >140 mmHg, Diastolic blood pressure (DBP) >90 mmHg, Heart rate <40 or >85 beats per minute
* History of asthma or allergic rhinitis
* Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class as AZD8848 - Any clinically significant abnormalities in clinical chemistry.
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
|
NCT01818869
|
{
"brief_title": "To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses AZD8848 in Healthy Subjects",
"conditions": [
"Safety,",
"Tolerability,",
"Healthy Subjects"
],
"interventions": [
"Drug: Placebo to match AZD8848",
"Drug: AZD8848"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT01818869",
"official_title": "A Phase 1, Single Centre, Double-blind, Randomised, Placebo-controlled, Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Administration of Multiple Ascending (MAD) Once Weekly Inhaled Doses of AZD8848 in Healthy Subjects",
"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)": "2014-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-08-14",
"last_updated_that_met_qc_criteria": "2013-03-26",
"last_verified": "2015-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-03-27",
"first_submitted": "2013-03-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Remote patient monitoring is a potential component for the management of chronic conditions that may provide reliable and real-time physiological measurements for clinical decision support, alerting, and patient self-management. The purpose of this study is to evaluate an UHN-built remote monitoring system for patients with complex chronic conditions called Medly.
Detailed Description
Remote patient monitoring is a potential component for the management of chronic conditions that may provide reliable and real-time physiological measurements for clinical decision support, alerting, and patient self-management. The purpose of this study is to evaluate an UHN-built remote monitoring system for patients with complex chronic conditions called Medly. Patients with complex chronic conditions will be provided with a mobile phone and commercial home medical devices, such as a blood pressure monitor and weight scale. The measurements from the medical devices will be automatically sent to the mobile phone, and from there to a data server at the hospital for analysis and storage. Both clinicians and patients will be able to access these data and will be sent alerts by the system if the measurements are outside of the normal range. The system will be evaluated through interviews and comparing outcomes between the intervention and control groups.
#Intervention
- DEVICE : Medly
|
#Eligibility Criteria:
Inclusion Criteria:
All participants:
* Adults (age >= 18 years)
* Diagnosed with HF, COPD, CKD, and/or uncontrolled hypertension (individuals with diabetes who require blood glucose monitoring will be included as a co-morbidity only if patient's have at least one of the above four chronic illnesses, and will be in the form of self-care support only)
* Patient or their caregiver speaks and reads English adequately to provide informed consent and understand the text prompts in the application.
* Ability to comply with using the telemonitoring system (e.g, able to stand on the weight scale, able to answer symptom questions, etc.).
Primary chronic disease-specific criteria:
* Patients with HF as the primary chronic disease: with reduced ejection fraction (EF<0.40)
* Patients with COPD as the primary chronic disease: Spirometrically confirmed diagnosis of COPD of GOLD Stage II or higher (defined as post-bronchodilator FEV1 < 80% predicted and FEV1/FVC ratio < 70%); smoking history of >= 20 pack-years or homozygous alpha-1 antitrypsin deficiency; and prescribed an action plan for the early self-treatment of acute exacerbations
* Patients with CKD as the primary chronic disease: Grade 3 <= age <= 5 (eGFR < 60mL/1.73 m2)
* Patients with uncontrolled hypertension as the primary chronic disease: For non-diabetics: blood pressure >=140/90 mmHg auscultatory (manual measurement) or >=135/85 mmHg oscillometric (automated measurement). For diabetics: blood pressure >=130/80 mmHg
Exclusion Criteria:
* Patients on mechanical circulatory support
* Patients on the heart transplant list
* Terminal diagnosis with life expectancy < 1 year
* Dementia or uncontrolled psychiatric illness
* Resident of a long term care facility
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
|
NCT03127852
|
{
"brief_title": "Effects of Remote Patient Monitoring on Chronic Disease Management",
"conditions": [
"Heart Failure",
"Chronic Obstructive Pulmonary Disease",
"Chronic Kidney Disease",
"Uncontrolled Hypertension",
"Diabetes"
],
"interventions": [
"Device: Medly"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03127852",
"official_title": "Randomized Controlled Trial of a Mobile Phone-based Telemonitoring Application for Self-management and Clinical Decision Support for Patients With Complex Chronic Conditions",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-20",
"study_completion_date(actual)": "2020-12-15",
"study_start_date(actual)": "2016-08-23"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-21",
"last_updated_that_met_qc_criteria": "2017-04-20",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-25",
"first_submitted": "2016-08-09",
"first_submitted_that_met_qc_criteria": "2022-10-17"
}
}
}
|
#Study Description
Brief Summary
Ιt has been suggested that the accumulation of androgens in the micro milieu of the primate ovary, plays a critical role in early follicular development and granulosa cell proliferation. Increased intraovarian concentration of androgens seems to augment follicle stimulating hormone (FSH) receptor expression in granulosa cells and thus, potentially leading to enhanced responsiveness of ovaries to FSH. In addition, androgen excess has been shown to stimulate early stages of follicular growth and increase the number of pre-antral and antral follicles.
On the basis of these data, it has been hypothesized that increasing androgen concentration in the ovarian micro milieu in poorly responding patients might lead to an increase in the number and the maturity of oocytes after ovarian stimulation for IVF. Hence, recent efforts have been focused on the potential benefit of androgen administration in the probability of pregnancy in poor responders undergoing ovarian stimulation for IVF.
Pretreatment with transdermal testosterone has been suggested as a safe and effective way of increasing the intraovarian androgen concentration. Recently, published, randomized control trials (RCTs) have evaluated transdermal testosterone in poor responders undergoing ovarian stimulation for IVF, with inconclusive results.
In view of the conflicting or inconclusive data regarding the efficacy of the proposed intervention, this study will attempt to explore the role of transdermal testosterone pretreatment in poor responders undergoing IVF through a properly designed RCT. The lack of a universal definition of poor responders has been identified previously and recently, in an attempt to address this issue, universal criteria for the definition of poor ovarian response have been proposed following a consensus meeting in Bologna. In the present study, the Bologna criteria will be used on the contrary to previous studies.
Despite the advancement in assisted reproduction technologies, poor ovarian response (POR) is still considered to be one of the most challenging tasks in reproductive medicine. Poor ovarian response is considered to be an inadequate response to ovarian stimulation, defined usually by a low number of oocytes retrieved or a low number of developing follicles in a previous or in the running, respectively, in vitro fertilization (IVF) cycle. Given the severely diminished probability of pregnancy after IVF in these patients, the identification of an indisputably efficacious treatment, such as testosterone pretreatment, would be a promising alternative for poor responders undergoing IVF.
#Intervention
- DRUG : Testosterone
- 10 mg of testosterone gel applied on the external side of the thigh for 21 days starting from the first day of menstruation prior to initiation of ovarian stimulation with rFSH for IVF/ICSI
|
#Eligibility Criteria:
Inclusion Criteria:
* Advanced maternal age (>=40 years) or any other risk factor for POR
* A previous POR (<=3 oocytes with a conventional stimulation protocol)
* An abnormal ovarian reserve test (i.e. AFC < 5 <= age <= 7 follicles or AMH < 0.5- 1.1 ng/ml)
Exclusion Criteria:
* History of previous ovarian surgery
* Women with endocrine or metabolic disorders
* Women with active cancer disease
* Women with Stage III-IV Endometriosis
* Women with known hypersensitivity or allergy in any of the components of the drug
* Sperm only by ejaculation and not from FNA, TESE or refrigeration
Sex :
FEMALE
Ages :
- Minimum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01961336
|
{
"brief_title": "Transdermal Testosterone Pretreatment in Poor Responders Undergoing IVF",
"conditions": [
"Subfertility"
],
"interventions": [
"Drug: Testosterone"
],
"location_countries": [
"Greece"
],
"nct_id": "NCT01961336",
"official_title": "The Effect of Transdermal Testosterone Pretreatment in Poor Responders Undergoing Ovarian Stimulation for In-vitro Fertilization (IVF)",
"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)": "2013-10"
},
"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)": "2016-06-28",
"last_updated_that_met_qc_criteria": "2013-10-10",
"last_verified": "2016-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-10-11",
"first_submitted": "2013-10-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the effect of dexmedetomidine as an adjuvant of ropivacaine in the TAP block on cesarean section parturients under multimodal analgesia, optimize the multimodal analgesia program for cesarean section, and guide perioperative analgesia managemen。This is a single center, double-blind, randomized clinical trial.
#Intervention
- DRUG : Dexmedetomidine
- each side dexmedetomidine 0.5ug/kg TAP block
|
#Eligibility Criteria:
Inclusion Criteria:
* 1) 37 <= age <= 42 weeks of gestation
2) Plan cesarean section
3) Receiving patient controlled intravenous analgesia
4) Age>18 years
5) ASA（American Society of Anesthesiologists) grade I-III
6) Voluntary participation and informed consent
Exclusion Criteria:
* 1)The anesthesia method for cesarean section is general anesthesia or intraspinal anesthesia, and epidural administration is used
2) Combined with other opioids during operation
3) High risk pregnancy (multiple pregnancy, in vitro pregnancy, etc.) or pregnancy related complications (hypertension, preeclampsia, chorioamnionitis, etc.)
4) Times of previous cesarean section >= 3
5) BMI >= 50kg/m2 is not suitable for TAP block
6) Allergies or contraindications to the drugs involved in the study
7) Combined with operations other than tubal ligation and ovariectomy
8) Severe renal function impairment (SCR>176 µ mol/L and/or blood urea nitrogen>17.9 mmol/L), severe liver function impairment (ALT and/or aspartate aminotransferase exceed 3 times the upper limit of normal value)
9) Increased risk of coagulation dysfunction or bleeding (PLT<80 × 109/L or international normalized ratio> 1.5)
10) History of chronic pain or opiate abuse
11) Other clinical trials in the last three months
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
|
NCT05700045
|
{
"brief_title": "TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia",
"conditions": [
"Multimodal Analgesia",
"Cesarean Section"
],
"interventions": [
"Drug: Dexmedetomidine"
],
"location_countries": [
"China"
],
"nct_id": "NCT05700045",
"official_title": "Effect of Dexmedetomidine Combined With Ropivacaine Transverse Abdominal Plane Block (TAP) on Opioid Dosage After Cesarean Section Under Multimodal Analgesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-28",
"study_completion_date(actual)": "2023-09-30",
"study_start_date(actual)": "2023-05-31"
},
"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)": "2023-10-11",
"last_updated_that_met_qc_criteria": "2023-01-16",
"last_verified": "2022-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-01-26",
"first_submitted": "2022-12-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The overarching goal of the present study was to evaluate a MHSP-presented versus peer-presented mental health resilience skills-building online video outreach program against a wait-list comparison group.
Detailed Description
Participants were recruited using a study flyer distributed to students in-person on campus and online through email listservs, social media platforms, and from an existing database of university students who participated in previous studies and agreed to be followed-up with. Given the self-paced nature of the program, a staggered recruitment approach was used wherein new participants completed the online baseline questionnaires between January 2020 until early March 2020.
Participants were randomly assigned to one of the three groups (MHSP-presented, peer-presented, or a wait-list comparison group), while counterbalancing the three groups based on gender and preference for seeking help from MHSPs or peers (i.e., using results from the General Help-seeking Questionnaire). Two weeks after the baseline questionnaire was sent, participants in the intervention groups received either the MHSP-presented video or the peer-presented video (video 1) depending on which group they were randomly assigned to, as well as a link for access to the resource library. The following two videos were sent two weeks apart. Participants were encouraged to access the resource library over the duration of the program and were reminded with each video link sent. All participants then received post (T2) and follow-up measures (T3) 6 and 10 weeks following the baseline completion respectively. Participants in the wait-list comparison group were only asked to complete evaluation measures at the three time points (they only received the videos and resource library at the end of the study). Following completion of the study, students received an e-mail with a personalized profile indicating their individual scores on various measures and all participants received full access to the program resources (videos and resource library).
#Intervention
- BEHAVIORAL : Stress and Coping Online Outreach Program
- 3 videos and a resource library disseminated over the course of 9 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants were eligible for the study if they were between 18- 29 years, given the unique stressors associated with the developmental period of emerging adulthood (18 <= age <= 29 years).
* Participants were required to have access to the internet (at least weekly) as the study was completed entirely online.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 29 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05454592
|
{
"brief_title": "Peer-Presented Versus Mental Health Service Provider-Presented Mental Health Outreach Programs for University Students",
"conditions": [
"Stress",
"Self Efficacy",
"Social Support",
"Social Connectedness",
"Mindfulness",
"Quality of Life"
],
"interventions": [
"Behavioral: Stress and Coping Online Outreach Program"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT05454592",
"official_title": "Peer-Presented Versus Mental Health Service Provider-Presented Mental Health Outreach Programs for University Students: Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-05-08",
"study_completion_date(actual)": "2020-05-08",
"study_start_date(actual)": "2020-01-03"
},
"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)": "2022-07-12",
"last_updated_that_met_qc_criteria": "2022-07-07",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-12",
"first_submitted": "2022-07-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Fresh breast core biopsies suspicious for breast cancer that are usually taken during clinical breast assessments will be imaged via confocal microscopy.
The device so called HistologTM Scanner is based on confocal fluorescence and displays microscopic histology images superficial layers of fresh tissue.
After the imaging procedure the fresh breast tissue specimen will be followed according to the gold standard workflow (H\&E-stained images).
Subsequently, two pathologists will analyze the HistologTM Scanner obtained-images and H\&E-stained images for potential breast cancer structures.
A comparison of both analyses for cancer visualization will be performed to evaluate the feasibility of using confocal microscopy for breast cancer detection.
Detailed Description
During clinical breast assessments physicians may detect diagnostic findings suspicious for breast cancer. In such situations a biopsy has to be taken to confirm the diagnosis histologically. Once informed consent will be obtained, the physician will collect a biopsy sample using the standard procedure with US- or MG-guided Biospy. Immediately prior to gold standard pathology workflow (formalin fixation), HistologTM Scanner will be used to image the fresh biopsy specimens. The HistologTM Scanner (v1.0, SamanTree Medical SA, Lausanne, Switzerland, CE marking) is based on confocal fluorescence and displays microscopic histology images of superficial layers of fresh tissue after nuclear staining with Acridine Orange (30 seconds) and rinsing in saline solution.
Finally, the specimen will be processed following the gold standard workflow (H\&E-stained images).
Two independent pathologists will assess the HistologTM Scanner- and H\&E-stained images subsequently according to the B-classification (categories B1-B5; '0' was defined as 'no diagnosis possible') and determine the correspondence of the results.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult female patient >=18 years.
* Patient presenting with suspected breast carcinoma.
* Patient eligible for biopsy sampling.
* Patient must sign a written informed consent prior to research project entry.
Exclusion Criteria:
* Patient previously treated for breast carcinoma.
* Patient has undergone previous neo-adjuvant treatment.
* Patient is not willing to participate in the research project.
* Patient is not capable of consenting.
* Patient is younger than 18 years
* Patient is male
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03530722
|
{
"brief_title": "Ex-vivo Performance Evaluation of the Histolog™ Scanner for Human Breast Carcinoma Detection on Fresh Breast Core Biopsies",
"conditions": [
"Breast Cancer"
],
"interventions": null,
"location_countries": [
"Switzerland"
],
"nct_id": "NCT03530722",
"official_title": "Ex-vivo Performance Evaluation of the Histolog™ Scanner for Human Breast Carcinoma Detection on Fresh Breast Core Biopsies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-15",
"study_completion_date(actual)": "2017-12-11",
"study_start_date(actual)": "2017-07-04"
},
"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)": "2018-05-21",
"last_updated_that_met_qc_criteria": "2018-05-08",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-05-21",
"first_submitted": "2018-04-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an open, randomized (randomization ratio: 1:1), multiple dose, three way, three period cross over study to assess the potential for drug drug interactions between gemigliptin (a DPP-IV inhibitor mainly metabolized by CYP3A4) and metformin in a sample of healthy Mexican volunteers, aimed to determine whether the observed lack of drug-drug interactions between gemigliptin and metformin in the Korean population is reproducible in an ethnically different population characterized by a significant difference in the frequency of CYP3A4 polymorphisms associated with decreased enzymatic activity, such as CYP3A4\*1b, in comparison with Asian populations.
Detailed Description
Consenting, eligible healthy adult subjects sequentially received either gemigliptin 50 mg q.d., metformin 1000 mg twice a day or gemigliptin 50 mg q.d. plus metformin 1000 mg twice a day during 3 consecutive 7 day treatment periods separated by two 5-day washout intervals, in accordance with a randomly assigned treatment sequence. Starting on the sixth treatment period day, participating subjects underwent safety assessments and repeated (24 hour) blood and urine sampling for pharmacokinetic analysis. All subjects attended to a post-study visit for final safety assessments within 8 days of study completion or early withdrawal.
Urine and plasma samples where processed to determine gemigliptin and metformin concentrations using validated analytical methods and pharmacokinetic profiles of both gemigliptin and metformin were obtained using a non-compartmental method; both the rate and degree of gemigliptin and metformin absorption resulting from their concomitant administration relative to the administration of each drug alone were assessed in search of potential pharmacokinetic interactions, Finally, a post hoc assessment of the degree and rate of the absorption of gemigliptin in the study population relative to those of a group of Korean subjects participating in phase I, repeated dose gemigliptin studies was conducted.
#Intervention
- DRUG : Gemigliptin
- A 7-day treatment period with gemigliptin 50 mg q.d., followed by a 5-day washout period; a 7 day treatment period with metformin 1000 mg twice a day followed by a 5-day washout period and a final 7-day treatment period with gemigliptin 50 mg q.d. + metformin 1000 mg twice a day
- Other Names :
- Metformin, Gemigliptin 50 mg q.d. + metformin 1000 mg twice a day
- DRUG : Gemigliptin 50 mg q.d. + metformin 1000 mg twice a day
- A 7-day treatment period with gemigliptin 50 mg q.d. + metformin 1000 mg twice a day followed by a 5-day washout period; a 7-day treatment period with gemigliptin 50 mg q.d. followed by a 5-day washout period and a final 7-day treatment period with metformin 1000 mg twice a day
- Other Names :
- Gemigliptin, Metformin
- DRUG : Metformin
- A 7-day treatment period with 1000 mg metformin twice a day followed by a 5-day washout period; a 7-day treatment period with gemigliptin 50 mg q.d.+ metformin 1000 mg twice a day followed by a 5-day washout period and a final 7-day treatment period with gemigliptin 50 mg q.d.
- Other Names :
- Gemigliptin 50 mg q.d. + metformin 1000 mg twice a day, Gemigliptin
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects at age between 20 and 45 at the screening test
* Subjects with a body weight of 55kg or more but less than 90kg and a Body Mass Index (BMI) of between 18.0 or more but less than 27.0
* BMI (kg/m2) = Weight (kg) / {Height (m)}2
* Subjects who show the blood glucose level within the range of 70 <= age <= 125 mg/dL at the fasting plasma glucose (FPG) test conducted at screening
* Subjects who fully understand this clinical trial after hearing a detailed explanation about it, make a decision to participate in it by his/her own free will, and sign an informed consent form to comply with the precautions
Exclusion Criteria:
* Subjects who have a present condition or past history of any disease involving liver, kidney, nervous system, immune system, respiratory system, or endocrine system, hematologic and oncologic disease, cardiovascular disease, or psychiatric disorder (mood disorder, obsessive-compulsive disorder, etc.) (including subjects carrying hepatitis virus in case of liver disease)
* Subjects with a past history of a gastrointestinal system disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or a gastrointestinal system surgery (however, subjects with a history of appendectomy or hernioplasty are not excluded)
* Subjects with a medical history of allergic reaction to drugs (aspirin, antibiotics, etc.) or clinically significant hypersensitivity reaction
* Subjects who show one of the following results at screening test:
* Exceeds 1.5 times the upper limit of the normal range of blood AST (SGOT) and ALT (SGPT)
* The creatinine clearance calculated by Cockcroft-Gault equation is below 80 mL/min.
* QTc > 450 ms in ECG or clinically significant abnormal rhythm
* In the vital signs measured in sitting position after a rest for 3 minutes or longer, subjects who showed a systolic blood pressure of <= 100 mmHg or >= 150 mmHg, or a diastolic blood pressure of <= 60 mmHg or >= 95 mmHg)
* Subjects who have a past history of drug abuse or have shown a positive reaction to drugs that are used in abusive manner or cotinine at a urine drug screening
* Subjects who have taken any ethical drug or an herbal medication within 2 weeks before the date of first administration or have taken any over-the-counter (OTC) drug or vitamin preparation within 1 week (however, they can be included as subjects if considered appropriate at the investigator's discretion judgment)
* Subject who have already participated in other clinical trials within 2 months before the date of first drug administration
* Subject who have had whole blood donation within 2 months or component blood donation within 1 month before the date of first drug administration, or transfusion in 1 month before the date of first drug administration
* Subjects who have been drinking alcohol continuously (more than 21 units/week, 1 unit = 10 g of pure alcohol) or can't refrain from drinking alcohol during the clinical trial period
* Smokers (however, if the subject stopped smoking more than 3 months before the date of the first drug administration, he/she can be selected as a subject)
* 12) Subjects who have had grapefruit/ any food containing caffeine within 3 days before the date of the first drug administration
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03310749
|
{
"brief_title": "An Assessment of Pharmacokinetic Gemigliptin and Metformin Interactions in Healthy Mexican Volunteers",
"conditions": [
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: Metformin",
"Drug: Gemigliptin 50 mg q.d. + metformin 1000 mg twice a day",
"Drug: Gemigliptin"
],
"location_countries": [
"Mexico"
],
"nct_id": "NCT03310749",
"official_title": "A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Gemigliptin and Metformin After Oral Administration in Healthy Mexican Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-05-03",
"study_completion_date(actual)": "2016-05-03",
"study_start_date(actual)": "2016-01-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-10-16",
"last_updated_that_met_qc_criteria": "2017-10-13",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-16",
"first_submitted": "2017-09-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
Detailed Description
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA patients who currently use a nasal or nasal pillows mask will be recruited
This study will involve a baseline (Visit One) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask for use in-home (Visit Two). The participant then will come in to return the mask (Visit Three) and give feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two.
The mask and CPAP (if used from the loan research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of Obstructive Sleep Apnea.
Neither the investigators nor the participants will be blinded to the study.
#Intervention
- DEVICE : F&P Saturn
- Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
|
#Eligibility Criteria:
Inclusion Criteria:
* AHI >= 5 from diagnostic PSG night
* Aged 22 and over (FDA defined as adult)
* Either prescribed APAP, CPAP or Bi-Level PAP for OSA
* Existing nasal or nasal pillows mask users (preferable 70%:30% split)
* Fluent in spoken and written English
Exclusion Criteria:
* Inability to give informed consent
* Patient intolerant to CPAP therapy
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or CO2 retention
* Pregnant or think they may be 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
|
NCT03124069
|
{
"brief_title": "A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea",
"conditions": [
"Obstructive Sleep Apnea"
],
"interventions": [
"Device: F&P Saturn"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03124069",
"official_title": "A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-05-26",
"study_completion_date(actual)": "2017-09-30",
"study_start_date(actual)": "2017-04-24"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-14",
"last_updated_that_met_qc_criteria": "2017-04-18",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-21",
"first_submitted": "2017-04-11",
"first_submitted_that_met_qc_criteria": "2021-06-24"
}
}
}
|
#Study Description
Brief Summary
To evaluate the safety profiles of HTU-PA in patients with acute ischemic stroke.
Detailed Description
Cerebrovascular disease, the third leading cause of death after heart disease and cancer in developed countries, has an overall prevalence of 794 per 100,000. In the United States, it is estimated that more than 400,000 patients are discharged each year from hospitals after a stroke. The loss of these patients from the work force and the extended hospitalization they require during recovery make serious economic impact. In Taiwan, Cerebrovascular disease is the second cause of death.
#Intervention
- GENETIC : Recombinant Human Plasminogen Activator (HTUPA)
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects with cerebral ischemia at any location producing a serious measurable deficit by NIHSS scale and who received study medication within 5 hours after the onset of the symptom. A serious measurable deficit by NIHSS was defined as the NIHSS 9 and 20 (for brain stem stroke, patients with NIHSS > 20 were included).
* Subjects were 18 years, of either sex.
* Subjects or his/her legal guardians demonstrated their willingness to participate in the study and comply with its procedures by signing a written informed consent.
* Subjects with Modified Rankin Scale > 1.
Exclusion Criteria:
* Onset of symptoms on awaking from sleep.
* Intracranial bleeding detected on a pretreatment head computerized tomographic (CT) scan.
* Clinical presentation suggested a subarachnoid hemorrhage even if the head CT scan was normal.
* Head CT showed the evidence of early infarct sign > 1/3 of MCA territory.
* Subjects had generalized seizure at the onset of the stroke.
* Subjects with blood glucose < 50 mg/dl or > 400 mg/dl.
* Subjects had another stroke, head trauma, cerebral hemorrhage or ischemic infarction within 3 months prior to the study entry.
* Subjects with a significant surgery within 14 days prior to study entry.
* Subjects with a history of gastrointestinal or urinary tract hemorrhage within 21 days prior to the study entry.
* Subjects with lumbar puncture or arterial puncture of non-compressible site within 14 days prior to the study entry.
* Subjects had known bleeding diathesis.
* Subjects with other serious medical illness that interfered with the study.
* Subjects had a platelet count < 100,000/mm3; hematocrit < 30%.
* Subjects with other serious medical illness that interfered with the study.
* Subjects had aPTT or PT > upper normal limit.
* Subjects had uncontrolled hypertension (> 180 mmHg systolic or > 110 mmHg diastolic) without additional anti-hypertensive medication at screening visit.
* Subjects with recent transmural myocardial infarction and evidence of pericarditis within 3 weeks prior to the enrollment.
* Subjects had intracranial neoplasm, arteriovenous malformation, or aneurysm.
* Subjects had hemostasis defects including secondary to severe hepatic or renal disease.
* Subjects with history of drug or alcohol abuse within 1 year prior to the study entry.
* Subjects had significant hepatic dysfunction (SGOT/SGPT 3 x upper normal limit).
* Subjects had serum creatinine level 2 x upper normal limit or on renal dialysis.
* Subjects had administration of any other investigational drug within 30 days prior to study entry.
* Woman who was pregnant or nursing.
* Subjects had used other thrombolytics (streptokinase, tissue plasminogen activator, urokinase, anisoylated plasminogen streptokinase activator complex, anticoagulants).
* Subjects had severe cardiac disease (New York Heart Association Functional Classification III and IV).
* Subjects had history of cancer except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or any cancer in patient's disease free for more than 5 years.
* Subjects had any clinically significant deviation from normal in the physical examination that, in the investigator judgment, interfered with the study evaluation or affect subject safety.
* Subjects with history of lupus.
* Vasculitis was the cause of ischemic stroke.
* Subjects had been enrolled in this study previously.
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
|
NCT00418275
|
{
"brief_title": "Safety Study of a Recombinant Human Plasminogen Activator to Treat Acute Ischemic Stroke.",
"conditions": [
"Cerebrovascular Accident"
],
"interventions": null,
"location_countries": [
"Taiwan"
],
"nct_id": "NCT00418275",
"official_title": "A Dose Finding, Pharmacokinetic and Safety Study of a Recombinant Human Plasminogen Activator (HTU-PA) in Patients With Acute Ischemic Stroke",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2004-06",
"study_start_date(actual)": "2001-04"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"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)": "2007-01-04",
"last_updated_that_met_qc_criteria": "2007-01-03",
"last_verified": "2006-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-01-04",
"first_submitted": "2007-01-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this prospective, multi-centre, PMS cohort study was to monitor the safety of Cervarix, which is the first HPV vaccine licensed for use in China, to help prevent cervical cancer caused by HPV types 16 and 18. The vaccine was approved by National Drug Administration of China (CNDA), in July 2016.
As per the CNDA commitment, this study collected data regarding the safety of the vaccine, related information on potential immune-mediated diseases (pIMDs); which are diseases that could affect the immune system, and the effect on pregnancy outcomes (POs) including birth defects in the newborn.
Cervarix was approved for use in females between 9-25 years of age, for the prevention of cervical cancer, cervical intraepithelial neoplasia grade 1 (CIN1), cervical intraepithelial neoplasia grade 2, grade 3 (CIN 2/3) and adenocarcinoma in situ caused by high-risk human papillomavirus (HR-HPV) types 16 and 18.
In May 2018, Cervarix was also approved for use in women of age up to 45 years.
The exposed set (ES) comprised 3013 subjects, who were vaccinated with Cervarix, on a voluntary basis, as per standard practice. The study collected information on any adverse event following immunisation, pIMDs, POs and congenital anomalies.
#Intervention
- OTHER : Safety data collection (following routine vaccination)
- This study assessed the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine when administered routinely according to the Prescribing Information in female Chinese subjects aged between 9 and 45 years.
The intervention consisted in the active surveillance of adverse events following immunization and pregnancy outcomes if the vaccine was administered inadvertently during pregnancy. Information of potential adverse events and pregnancy outcomes were collected at immunisation visits, telephone contacts and through spontaneous reporting by the patient/LAR/physician.
|
#Eligibility Criteria:
Inclusion Criteria:
* Any Chinese female subject aged between 9 and 45 years, at the time of first vaccination dose, who received voluntary vaccination.
* Subjects for whom the investigator believed that they or their parent(s)/LAR(s) could and complied with the requirements mentioned in the protocol (e.g., return for the subsequent dose of vaccination and follow-up visits) were included in the study.
* Written informed consent was obtained from the subject. For subjects who were below the legal age of consent, written informed consent were obtained from the parent(s)/LAR(s) of the subject and informed assent were obtained from the subject according to EC requirement as well as local law.
Exclusion Criteria:
* Child in care
Sex :
FEMALE
Ages :
- Minimum Age : 9 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03438006
|
{
"brief_title": "A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects",
"conditions": [
"Cervical Intraepithelial Neoplasia"
],
"interventions": [
"Other: Safety data collection (following routine vaccination)"
],
"location_countries": [
"China"
],
"nct_id": "NCT03438006",
"official_title": "A Prospective, Multi-centre Post Marketing Surveillance (PMS) Cohort Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 L1 VLP AS04 Vaccine in Female Chinese Subjects Aged Between 9 and 45 Years, When Administered According to the Prescribing Information (PI) as Per Routine Practice.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-03",
"study_completion_date(actual)": "2020-12-03",
"study_start_date(actual)": "2018-05-31"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-09-08",
"last_updated_that_met_qc_criteria": "2018-02-13",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-19",
"first_submitted": "2018-02-13",
"first_submitted_that_met_qc_criteria": "2021-08-11"
}
}
}
|
#Study Description
Brief Summary
Allogenic differentiated adipocytes (ANT-adip-AL) is produced by well-established techniques including cell harvesting from lipoaspirates obtained from healthy donors, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label study. Subjects were received subcutaneous injection of ANT-adip-AL and followed for 8 weeks according to the clinical trial protocol.
#Intervention
- BIOLOGICAL : Repaircell
- allogenic differentiated adipocyte
|
#Eligibility Criteria:
Inclusion Criteria:
* male, 19 years or older
* volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening
* informed consent form signed
Exclusion Criteria:
* volunteers who have participated in other clinical studies related cell therapy within 30 days before this clinical trial
* volunteers who received any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
* volunteers who have tattoo or scar which disturb assessment of study at injection site
* volunteers who have Creutzfeldt Jacobs disease or related disease or family history
* volunteers who have allergy to bovine-derived materials
* volunteers who have infectious disease such as hepatitis B virus (HBV), hepatitis C virus (HCV)and HIV
* volunteers who have a symptom of septicemia or diagnosis of active Tuberculosis
* volunteers who have a clinically relevant history of abuse of alcohol or drugs
* volunteers who are considered not suitable for the study by investigator
* volunteers who have history of surgery for malignant cancer in the past 5 years
* volunteers who have congenital or acquired immunodeficiency syndrome
* volunteers who have horrible anemia or thrombopenia
* volunteers who have chronic disease such cardiovascular,renal and respirometer disease
* volunteers who were immunosuppressed by disease (ex: chronic heart failure)
* volunteers who were immunodepressed by treatment of medication
* volunteers who is being treated with blood derivatives/who is going to get a blood derivatives
* volunteers who have abnormal rage of CD4/CD8 ratio
Sex :
MALE
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01739530
|
{
"brief_title": "Safety of Repaircell in Healthy Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Biological: Repaircell"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01739530",
"official_title": "Phase I Study to Evaluate Safety of Repaircell in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-11",
"study_completion_date(actual)": "2009-12",
"study_start_date(actual)": "2009-03"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-12-04",
"last_updated_that_met_qc_criteria": "2012-11-29",
"last_verified": "2012-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-12-03",
"first_submitted": "2012-11-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
the trial assessed the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.
Detailed Description
The trial is a phase II, open label, non-randomized, prospective multicenter trial to assess the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.
#Intervention
- DRUG : Atazanavir
- 2pills/day
- DRUG : Ritonavir
- 1 pill/day
- DRUG : Tenofovir/emtricitabine
- 1 pill/day
|
#Eligibility Criteria:
Inclusion Criteria:
* Naïve of treatment HIV -1 infected patients
* CD4 above 100/mm3
Exclusion Criteria:
* pregnancy
* renal failure
* hepatitic disease
* ongoing opportunistic disease
* Hb under 8g/dl; platelets under 50 000/mm3; neutrophils under 750/mm3; Prothrombin index under 80%, Ca or Ph > 2.5 N
* drugs interacting with investigational drugs
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
|
NCT00528060
|
{
"brief_title": "Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada",
"conditions": [
"HIV Infections"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT00528060",
"official_title": "Pilot Study to Measure Exposure to Atazanavir, as a Component of Pharmacokinetic Parameters and Adherence Measured With MEMS in Naive HIV-infected Patients Treated Once Daily With Atazanavir Combined to Ritonavir and to Tenofovir/Emtricitabine. ANRS 134 Cophar 3",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-11",
"study_completion_date(actual)": "2008-11",
"study_start_date(actual)": "2008-01"
},
"study_design": {
"allocation": "NON_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)": "2011-12-22",
"last_updated_that_met_qc_criteria": "2007-09-10",
"last_verified": "2011-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-09-11",
"first_submitted": "2007-09-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to find an optimal dose to determine the safety and tolerability of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular injection in subjects with glabellar lines compared with the standard dose of BOTOX®
#Intervention
- BIOLOGICAL : MT10109
- Single dose intramuscular injection MT10109 vs Botox®
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults aged between 18 and 75 years with glabellar facial lines of at least moderate severity at maximum frown by investigator's assessment.
* Women of childbearing potential must have a negative serum pregnancy test at screening
Exclusion Criteria:
* Patients with an inability to substantially lessen glabellar lines by physically spreading them apart.
* Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
* Patients with an anaphylactic response history to botulinum toxin type A.
* Patients who have been administered botulinum toxin type A within the previous 6 months.
* Pregnant or lactating women.
* Participation in any research study involving drug administration within 90 days preceding enrollment.
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
|
NCT01485601
|
{
"brief_title": "Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines",
"conditions": [
"Glabellar Frown Lines"
],
"interventions": [
"Biological: MT10109"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT01485601",
"official_title": "A Randomised, Double-blind, Multi-centre, Phase II, Optimal Dose-finding Study to Determine the Safety and Efficacy of MT10109 (Clostridium Botulinum Toxin Type A) in Subjects With Moderate to Severe Glabellar Lines in Comparison to BOTOX®",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-03-30",
"study_completion_date(actual)": "2012-08-17",
"study_start_date(actual)": "2011-12-07"
},
"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)": "2024-02-22",
"last_updated_that_met_qc_criteria": "2011-12-02",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-12-05",
"first_submitted": "2011-12-01",
"first_submitted_that_met_qc_criteria": "2023-07-20"
}
}
}
|
#Study Description
Brief Summary
Study Objectives
1. To gather rich, evocative accounts of older patients aged 65 years and over -who may have felt disorientated in the Accident and Emergency department (A\&E) of a district hospital and who received an Intentional Compassionate Communication Intervention (ICCI)- about their personal experience of the A\&E
2. To gather rich and evocative accounts of a member of staff who delivers an Intentional Compassionate Communication Intervention (ICCI) to older people in the A\&E of a district hospital about their personal experience of doing so.
Detailed Description
1.1 Background The number of hospital emergency admissions has dramatically increased in England, by 42%, over the last 12 years (The Health Foundation 2018). Qualitative research published between 1990 and 2006 on the patient experience within the emergency department showed that most patients arrived at the A\&E with the perception that their injury or condition was serious or life threatening (Baraff et al. 1992; Olsson and Hansagi 2001; Nystrom et al. 2003) and this perception was often accompanied by physical pain (Britten and Shaw 1994). The situation is one in which patients feel vulnerable, anxious, stressed and fearful (Olsson and Hansagi 2001; Kihlgren et al. 2004).
In the UK, nearly a quarter of the people arriving at A\&E are over 65 years (Geddes 2013), older patients represent a demographic group whose emergency admissions have seen a particularly sharp rise over the last 12 years, especially patients aged 85 years or older (The Health Foundation 2018). This entails hospital staff having to deal in the emergency situation with patients presenting with much more complex needs associated with co-morbidities and often with less external support than younger people (Sorrel 2010).
Older patients are more prone to feel disorientated in A\&E. This can be due to a high percentage of them presenting with dementia, delirium, delirium superimposed on dementia or other CSD (Cognitive Spectrum Disorders), and they are also at higher risk of developing delirium while in the emergency department (Reynish et al. 2017). Delirium is a common medical problem that is characterised by changes in cognitive function. When delirium occurs, people are confused. Its onset is quite sudden, but it usually lasts only for a few days (NHS 2018). However, if not addressed delirium can become a serious complication which can lead to longer length of stay in hospital and higher mortality (Witlox et al. 2010). Stress is one of the common triggers for delirium and there is also some evidence that longer and particularly stressful A\&E experiences are associated with the risk of older patients developing delirium over the following hours (Bo et al. 2016).
There have been a few published studies exploring the experiences of A\&E from the specific point of view of older patients which report that most of them believe that their symptoms pose a serious threat to their life or to the control they exert over their lives (Olsson and Hansagi 2001; Kihlgrenet al. 2004) and that the attitudes of nurses in A\&E are often perceived as indifferent and inattentive, thus causing a feeling of exclusion and disappointment (Olofson et al. 2012). Empathy and compassion are perceived by patients to be the most significant elements of good care in A\&E (Kihlgren et al. 2005).
Compassionate Care is not a new concern for the NHS but following high profile failings (Francis 2013) government policies such as the Compassionate Care in the NHS (Department of Health 2015) have been introduced, further emphasising the importance of humanised care (Todres et al. 2009). Recent literature has explored different perspectives, from the poor experiences of care by older people living with frailty which, has been uncovered by the Francis Report (Singh et al. 2013), to the challenges experienced by nurses expected to deliver compassionate care, who often struggle to align the reality of practice to their ideals (Curtis et al. 2012).
Cornwell and Goodrich (2009 p.15), in a study exploring patients' experiences state: 'the presence or absence of compassion often marks the lasting and vivid memories patients and family members retain about the overall experience of care in hospital'. This is valid also for patients who are temporarily confused and/or live with dementia. Projects like the 'Dementia diaries' project, show that people can not only be aware of how they are treated and how they feel even in the middle of an extremely confused state, but they can also be able to recall this (Agnes' story 2018). Patient satisfaction should be considered a goal in itself; however, the literature also suggests that patients receiving clear and compassionate communication are more likely to disclose their symptoms enabling greater understanding of their situation and more accurate diagnoses (Epstein et al. 2005 and Cornwell and Goodrich 2009).
The evidence from the paragraphs above indicates that an investment in targeted compassionate communication for older people in A\&E could make their care more effective, with the potential to reduce complications and make healthcare delivery more economically sustainable for the NHS alongside giving patients and their families a better experience.
The awareness of the high incidence of stress in A\&E, and of the importance of compassionate care for older people has driven the development of a specific Intentional Compassionate Communication Intervention (ICCI) within the A\&E of a district hospital. The ICCI comprises proactive communication-focused support to older people. It involves a member of staff taking responsibility for the ICCI to meet older patients' psychological needs and relieve their anxieties through talking to them, sharing information with them and reassuring them when in A\&E.
The delivery of the intervention gives priority to support older people who are in A\&E alone and to those of them who appear to be cognitively impaired. The aim is to provide patients who may feel disorientated additional support in order to reduce the anxiety associated with being in A\&E. Using effective communication skills the member of staff demonstrates compassion and empathy to the older patients whilst they are in a busy A\&E department. Activities may include talking to them, gently re-orientating them if confused, by asking simple questions while using a friendly and reassuring tone of voice, offering a glass of water or a cup of tea, maybe a blanket. The member of staff can also try to reassure patients by enquiring with other staff about the outcome of an examination or about the next step into the patient's hospital stay when it happens to be too busy or staff is under too much pressure to be able to communicate with patients promptly and efficiently.
She also holds many hands, because of pain or because of fear. She purposefully uses a sense of humor to prompt a smile or a quick laugh. If words are not helpful (because the cognitive impairment is too severe, for example) she might play some music using an I-pad or bringing some soft toys for patients to cuddle. What lays at the basis of this intervention is the meeting between two human beings whereas one of them is in pain (psychological and often also physical) and the other one somehow 'feels' that pain and has a genuine wish to relieve it. The ICCI is totally person-centered and does not rely on any particular technique, rather it is exclusively based on a shared, deeply human drive.
A systematic review of literature Sonis et al. 2017) highlighted that most recent studies of patient experiences at A\&E are quantitative and use methods such as surveys or interviews, concentrating on judgments of patients after their A\&E visit. A few qualitative studies have been carried out. Baraff et al. (1992) showed that patients are very concerned about losing autonomy and independence, and Olthuis et al. (2014) showed that during the A\&E stay patients not only have to deal with their disorder, its consequences, and the situation they are in, but they are also continuously troubled by all kinds of matters. They found that it is a struggle for them to admit that something is wrong with them, to trust the health care professionals, to endure waiting periods, to have a blood sample taken, to undress, to deal with their relatives and reassure them, and even to get something to drink or eat.
Despite this, we still do not know very much about disorientated patients experiences in A\&E. Considering the above, and that there are few studies focusing on the lived experience of older patients in A\&E but currently no published studies that focus on the experience of Intentional Compassionate Care Interventions (ICCI) within A\&E, improved understanding of the lived experience of patients with regards to the provision of ICCI within A\&E would be of great value in nursing; particularly considering that the experience of older people in A\&E is often characterized by discomfort, fear, and pain, and can trigger disorientation and confusion. Moreover, people with Dementia or other cognitive impairments have a unique contribution to make in research. Hearing their voices can help people see the A\&E experience from their point of view, contributing to fight the assumptions and the stigma often associated with such a diagnosis (Alzheimer's Society 2018).
1.2 Clinical Data In the UK, nearly a quarter of the people arriving at A\&E are over 65 years (Geddes 2013) and older patients represent a demographic group whose emergency admissions have seen a particularly sharp rise over the last 12 years (The Health Foundation 2018). The experience of older people in the A\&E is often characterised by discomfort and anxiety (Baraff et al. 1992; Olsson and Hansagi 2001; Kihlgrenet al. 2004; Olofson et al. 2012). Stressful experiences may represent a possible trigger for delirium, a common and significant complication between older hospital patients which can affect the following course of recovery and the overall hospital length of stay (Cunningham and MacLullich 2013). There is some evidence that longer and particularly stressful A\&E experiences are associated with the risk of older patients developing delirium over the following hours (Bo et al. 2016).
Compassionate care seems to reduce patient anxiety (Gilbert and Procter 2006 and studies conducted in A\&E show that empathy and compassion are the most significant elements of good care for older patients in A\&E (Kihlgren et al. 2005).
1.3 Rationale
The results of the research will contribute to a deeper understanding of older potentially disoriented patients' lived experiences of being in A\&E and receiving an A\&E based ICCI. This study could impact upon NHS consideration of possible new roles in A\&E that are responsible for ICCI and how to make older patients' care more effective and sustainable, and give this patient group a better experience and outcome. Including people living with dementia or experiencing other cognitive disorders in the study is not only a way to improve their care, but also a way of valuing their contribution to society.
1.4 Risks/Benefits During the study patient participants will have the opportunity to reflect on their experience of being in A\&E, on their emotional needs and if and how these were met during their period in A\&E. Reflecting and acknowledging our need for human connection and meaningful interactions raises our awareness and this can translate into a benefit for these participants.
The recruitment of patient participants for interview may include those living with dementia or other cognitive impairments and it is recognised that they represent a vulnerable population. However, only those who have been identified as being able to give informed consent by a registered health care professional member of the Dementia Care Team, will be invited to participate to the study.
The researcher will remain sensitive to any sign of distress during the interview and suspend or stop their participation if indicated. Taking extra-care when interacting with vulnerable people is essential, however, excluding patients living with dementia from participation in research interviews could represent a form of discrimination, as their voice would seldom be heard in research and by the services they use. Lack of capacity can make people with dementia particularly vulnerable to discrimination (Alzheimer's Society 2018) and this is also valid for their participation to research. Under the Mental Capacity Act a person is presumed to be able to make their own decisions 'unless all practical steps to help them to make a decision have been taken without success' (Mental Capacity Act 2005).
When interacting with another person like during an interview, there is always a degree of risk of exposure to the Covid19 virus or other viruses for both the participant and the researcher. However, to minimise the risk for both parts, the researcher will only approach participants who have already been tested negative for Covid19 at their admission to the ward, and will do so in a Covid-Cold ward (where only patients tested negative to Covid19 are admitted, and where patients are regularly tested for Covid19.). She will approach them only after having carefully washed her hands and while wearing the appropriate PPE in place at the hospital. She will also maintain the appropriate safety distance suggested by the latest UK Government guidelines, and will not have any physical contact with the participant. The interview will last a maximum of 40 minutes to minimise the risk.
The researcher will not travel to the hospital if she develops symptoms of Covid19.
Also, the professional delivering the ICCI will be asked to participate in a series of online interviews about their experience (it is expected to run around 3 to 5 interviews which are expected to take place weekly) using a secure online platform, assessed and chosen following GDPR principles, and the same criteria of informed consent and freedom to withdrawn will apply too. The questions might touch on sensitive issues for the professional, and the researcher will remain sensitive to any sign of distress during the interview and suspend or stop their participation if indicated, also offering them emotional support. If further support is needed, she will signpost them to appropriate psychological support services.
The researcher will use good practices to ensure maximal security: the researcher will make sure to connect via a BU laptop which has all the required firewalls in place and that their internet connection is protected and will ask the professional to ensure her connection is similarly protected. the researcher will make sure that the online platform used for the online meeting is secure enough following GDPR principles and she will personally password protect and lock each meeting as soon as it starts. She will make sure that nobody else is in the room with her and will ask the ICCI professional to do the same to protect confidentiality. In addition, the researcher will make use of headphones so that there is no chance of participant being overheard, and will advise the participant to do the same.
2. Study Objectives and Design 2.1 Study Objectives
1. To gather rich, evocative accounts of older patients aged 65 years and over -who may have felt disorientated in the Accident and Emergency department (A\&E) of a district hospital and who received an Intentional Compassionate Communication Intervention (ICCI)- about their personal experience of the A\&E;
2. To gather rich and evocative accounts of a member of staff who delivers an Intentional Compassionate Communication Intervention (ICCI) to older people in the A\&E of a district hospital about their personal experience of doing so.
2.2 Study Endpoint The end point will be the completion of the qualitative analysis of transcripts from patients' interviews and the ICCI professional's interviews, when enough rich data to answer the research questions have been collected.
2.3 Study Design This is a qualitative study whose aim is to explore the lived experience of a sample of older patients (65 years and over) who may have felt disoriented in the A\&E of a district hospital and who received an ICCI.
Using Interpretative Phenomenological Analysis (IPA), in-depth interviews will be carried out with up to 15 patients and the professional delivering the ICCI at the site, and the data created from the transcripts will be analysed thematically.
2.4 Recruitment and consent: The researcher has spent more than one year collaborating with the Dementia Care Team both providing emotional support to patients at bedside and supporting staff and volunteers in relating to older patients in hospital. She also ran informal observations of the ICCI delivered in A\&E to orientate herself to the setting. As a result of this she developed a network of gatekeepers and has access to the wards and to different professionals, particularly in the context of the Dementia Care Team.
The Dementia Care Team will identify possible participants for the study across different wards in the hospital. An appropriately qualified professional member of the Dementia Care Team will assess participant's mental capacity specifically around the decision to consent to participate to the research at all three key points in the study: a) at introduction b) immediately before Informed Consent is given and c) immediately before the interview.
At introduction, after patients' permission for the researcher to visit them has been gained by a member of the care team, the researcher will approach them to give oral and written information (Participant Information Sheet V.6) and to ask for consent. This will happen in a so called Cold-Covid ward (where only patients tested negative for Covid19 are admitted) only when the care team has considered them physically and mentally fit for this and they have been tested negative for Covid19. In accordance with the Mental Capacity Act, the professional will verify if the patient is able to understand, retain, use and weight the information provided and to communicate his decision (Mental Capacity Act 2005).
Patients will be given as much time as they need to make their decision on whether to participate.
The professional delivering the ICCI will be initially approached by email -to their secure NHS trust email address- by the researcher's clinical supervisor to ask if they want to consider participate. If they agree, they will be given the researcher's contact details. When the professional will have contacted the researcher, they will be given all information needed about the study and their participation. If they still want to go ahead, they will receive a copy of a specific PIS (Participant Information Sheet for ICCI Professional V.1) and they will be allowed to ask any question via telephone or email and as much time as they need to make their decision. If they decide to participate, hey will then receive a copy of a specific ICF (ICF for ICCI professional V.1) and only after they will have signed it -in accordance with HRA and MHRA joint statement on seeking consent by electronic methods 2018 a typed electronic signature is sufficient for this study- and send it back to the researcher, an appointment for the first interview will be booked.
It is recognized that there is the potential for feelings of coercion in the workplace when asking a member of staff to take part to a study like this. With this in mind, it will be made very clear -both verbally and in the PIS- to the person involved, that there is no obligation for them to participate, and that if they refuses, that will not have any impact on them, on their job, or on their relationships with their manager and colleagues.
#Intervention
- OTHER : ICCI
- Intentional Compassionate Communication Intervention
|
#Eligibility Criteria:
Inclusion criteria For Patients:
* Patients aged 65 years and over;
* Admitted for any reason to the hospital via A&E;
* Patients presenting either alone or confused or with a diagnosis of dementia;
* Patients who received the ICCI while in A&E;
* Patients referred to the Dementia Care Team (which support patients admitted into the hospital who have a cognitive impairment either as a result of an underlying dementia -diagnosed or otherwise- or who are experiencing transitory cognitive symptoms such as confusion as a result of a delirium);
* Patients who are able to give informed consent to participate in the study as identified by a registered health care professional
* Patients who have been tested for Covid19 at admission to the ward and who are in a Cold-Covid ward
Inclusion criteria for the member of staff:
*The professional who has delivered the ICCI at the site over the last 3 years.
Exclusion criteria For Patients:
* Patients who cannot give informed consent;
* Patients with a physical condition that is immediately life-threatening or unstable;
* Patients involved in other clinical trials which present a significant burden to them.
* Patients who tested positive for Covid19
Exclusion criteria For the member of staff:
*If the member of staff is unable or unwilling to participate for any reason.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04085796
|
{
"brief_title": "ICCI for Older Patients in A&E",
"conditions": [
"Older Patients"
],
"interventions": [
"Other: ICCI"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04085796",
"official_title": "An Exploration of the Lived Experience of Receiving and Providing an Intentional Compassionate Communication Intervention (ICCI) for Older People While in Accident and Emergency Department",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-07-09",
"study_completion_date(actual)": "2021-07-09",
"study_start_date(actual)": "2019-09-09"
},
"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)": "2023-07-06",
"last_updated_that_met_qc_criteria": "2019-09-10",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-11",
"first_submitted": "2019-09-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Studies have shown the existence of a proprioceptive deficit in patients with Ehlers Danlos Syndrome (EDS) (genetic pathology of connective tissue with hypermobility, multifactor joint instability). A study dating from 2010 showed a qualitative improvement in disability when wearing compression garments (CG) in this pathology, particularly in the fields of proprioception and balance.
The purpose of this study is to quantify the effect of CG on standing static balance in patients with EDS.
Detailed Description
To evaluate the effect of CG on standing static balance in patients with EDS, this study is a pilot study, carried out according to a cross-over scheme of type AB/BA.
Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B). Patients will be randomly assigned to 2 groups: the AB or BA sequence will be randomized for each patient.
For each evaluation, a measurement with eyes open and eyes closed will be performed.
A clinical balance assessment by the Berg test will be performed for each of the conditions.
#Intervention
- OTHER : Evaluate the variation in the travel speed of the 'center of pressure' with and without compression garments.
- Each evaluation will be done according to the following protocol:
* Evaluation of the pain
* Berg test
* One test per condition starting with open eyes
* Standardized instructions:
* Break about 15 minutes (wash-out) between each test.
* Both conditions will be tested on the same day.
* Evaluation in an environment free from visual and audible interference.
|
#Eligibility Criteria:
Inclusion Criteria:
* EDS patients > 18 years walking around without technical assistance.
* Patients will need to be diagnosed both during the interview (presence of a family history, hypermobility and joint instability that has been evolving for years) and with a guide for analysis from EDS to AP-HP.
* Beighton's score must be 5/9 or higher.
* Free from any other pathology likely to have an impact on the balance.
* Patient with a CG as part of his or her management of the EDS
* Sufficient understanding to understand the objectives of the study and give consent.
* Patient affiliated or benefiting from a social security scheme
* Allergies to one of the components (Polyamide and Elastane) of the CG
* Recent compression garments less than 6 months old.
Exclusion Criteria:
* Patient under guardianship, curators, justice protection.
* Comorbidity likely to influence balance.
* Significant pain (assessed by the patient) induced by the use of CG.
* Any acute event requires the postponement of the assessment to ensure that the patient's progress is in the usual conditions.
* Any acute pathology having an impact on the musculoskeletal system and/or general condition.
* Pregnancy/breastfeeding
* Compression garments over 6 months old.
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
|
NCT03986229
|
{
"brief_title": "Evaluation of the Effect of Custom Compression Garments on Standing Static Balance in Ehlers Danlos Syndrome",
"conditions": [
"Ehlers-Danlos Syndrome"
],
"interventions": [
"Other: Evaluate the variation in the travel speed of the 'center of pressure' with and without compression garments."
],
"location_countries": [
"France"
],
"nct_id": "NCT03986229",
"official_title": "Evaluation of the Effect of Custom Compression Garments on Standing Static Balance in Ehlers Danlos Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-15",
"study_completion_date(actual)": "2022-03-15",
"study_start_date(actual)": "2019-04-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-12-15",
"last_updated_that_met_qc_criteria": "2019-06-11",
"last_verified": "2022-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-14",
"first_submitted": "2019-06-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this observational study is to study the non obstructive type of ischemic heart disease by identifying unique clinical features , frequency and age group .in patient admitted in coronary care unit , suffered from angina or heart attack. . The main question\[s\] it aims to answer are:
* how it different from classical type of ischemic heart disease ( obstructive coronary artery disease)
* what is frequency and age prevalence of these patient Participants evaluated by history , clinical examination, serum troponin and coronary angiography.
#Intervention
- PROCEDURE : CORONARY ANGIOGRAPHY
- coronary angiography by femoral or radial artery access
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with IHD ( MI, unstable angina ,chronic stable angina)
* >18 years
* patients undergoing CAG for emergency or elective situations.
Exclusion Criteria:
* Patients who were hemodynamically unstable.
* patients with incomplete data
* patients with clinical features of pericarditis or others of non cardiac origin chest pain .
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 81 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05738876
|
{
"brief_title": "Non Obstructive Versus Obstructive Coronary Artery Disease",
"conditions": [
"Non-Obstructive Coronary Artery Disease"
],
"interventions": null,
"location_countries": [
"Iraq"
],
"nct_id": "NCT05738876",
"official_title": "Non Obstructive Versus Obstructive Coronary Artery Disease Documented by Coronary Angiography; Prevalence & Diagnostic Features in a Single Center Experience : A Prospective Cross Sectional Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-01",
"study_completion_date(actual)": "2023-02-11",
"study_start_date(actual)": "2022-01-01"
},
"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)": "2023-02-22",
"last_updated_that_met_qc_criteria": "2023-02-13",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-02-22",
"first_submitted": "2023-02-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this clinical study is to evaluate the safety and clinical effectiveness of use of a physician-directed, patient self-management system, guided by left atrial pressure measurements, for use in patients with heart failure. The system allows patients to adjust their HF medications daily based on a physician-directed prescription plan and their current HF status, similar to the manner in which diabetes patients manage their insulin therapy. The goal of the LAPTOP-HF study is to demonstrate reductions in episodes of worsening heart failure (HF) and hospitalizations in patients who are managed with the left atrial pressure (LAP) management system (treatment group) versus those who receive only the current standard of care (control group).
Detailed Description
The Sponsor believes that direct measurements from your heart may provide an accurate, reliable and medically acceptable way of better managing your heart failure prior to your noticing symptoms or being hospitalized. This may enable you and your doctor to take preventative measures, by fine tuning your care including more frequently adjusting your medications with a goal of avoiding hospitalization.
#Intervention
- DEVICE : Left Atrial Pressure Monitoring System
- Left atrial lead is placed for ambulatory monitoring of left atrial pressure
- DEVICE : Patient Advisory Module
- Handheld device that provides medication reminders
|
#Eligibility Criteria:
Inclusion Criteria:
* Have ischemic or non-ischemic cardiomyopathy with either a history of reduced or preserved ejection fraction and heart failure for at least 6 months.
* NYHA Class III documented at screening visit.
* Be receiving appropriate medical therapy for heart failure as per ACC/AHA guidelines (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and beta-blocker) for at least 3 months prior to the randomization visit. Subject has been on stable medications maximized to the subject's tolerance of ACE or ARB and beta-blockers as determined by the study investigator for at least 30 days prior to randomization. Stable is defined as no more than a 100% increase or 50% decrease in dose. These criteria may be waved if a subject is intolerant of ACE, ARB or beta-blockers, or these agents are not indicated under the Guidelines. Such intolerance or lack of indications must be documented.
* Have a minimum of one (1) prior hospital admission within the last 12 months for acute exacerbation of HF of at least one (1) calendar date change duration requiring intravenous or invasive HF therapy. If CRT device previously implanted, the heart failure hospitalization must be >= 30 days after CRT implantation. Alternatively, if patients have not had a heart failure hospitalization within the prior 12 months, they must have an elevated Brain Natriuretic Peptide (BNP) level of at least 400pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at least 1,500pg/ml, according to local measurement at the time of screening (within 30 days of the screening visit/consent)
* Provide informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits.
* Are able to schedule Therapy Initiation within two weeks. Enrollment/Randomization may be delayed until this criterion is met.
Exclusion Criteria:
* Are under the age of 18 years.
* Are pregnant.
* Have intractable HF with resting symptoms despite maximal medical therapy (persistent NYHA Class IV and ACC/AHA HF Stage D). This includes patients receiving continuous or intermittent outpatient intravenous vasoactive medications (e.g., IV inotropes, IV vasodilators), patients treated with a ventricular assist device (VAD), and patients who have received a cardiac transplant or are listed for cardiac transplantation and likely to be transplanted within 12 months - even if their functional status has improved to NYHA Class III. Patients listed for cardiac transplantation who are not likely to be transplanted within 12 months and who have improved to NYHA Class III without outpatient IV vasoactive medications or a VAD are eligible for the study, if they meet the other inclusion/exclusion criteria.
* Have a resting systolic blood pressure < 80 or > 180 mmHg.
* Have an acute MI, Acute Coronary Syndrome, Percutaneous Coronary Intervention (PCI), new cardiac rhythm management device (Pacemaker, ICD, and CRT), CRM system revision, lead extraction or cardiac or other major surgery within 40 days.
* Have known coexisting, untreated, hemodynamically severe stenotic valve lesions, vegetations, hypertrophic cardiomyopathy with significant resting or provoked subaortic gradient, acute myocarditis, tamponade, or large pericardial effusion.
* Have an Atrial Septal Defect or Patent Foramen Ovale (with more than trace shunting on color Doppler or intravenous bubble study) or surgical correction of significant congenital heart disease involving atrial septum such as PFO or ASD closure device.
* Have a Stroke or Transient Ischemic Attack within 6 months.
* Have inadequate vascular access for device implantation.
* Have baseline 2-D echocardiographic evidence of, or history of, unresolved left atrial or ventricular thrombus.
* Have a recent (within 6 months) or persistent deep venous thrombosis, pulmonary or systemic thromboembolism.
* Have a life expectancy < 1 year due to another illness.
* Have coagulopathy or uninterruptible anticoagulation therapy or contraindication for all of the forms of antiplatelet/anticoagulant treatments anticipated in the protocol.
* Have an Estimated Glomerular Filtration Rate that remains < 30 ml/min/1.73 M2 by the MDRD method.
* Have a Liver Function Test > 3 times upper limit of normal.
* Have Severe Pulmonary Disease producing frequent hospitalizations for respiratory distress and requiring continuous home oxygen.
* Have pulmonary hypertension with a pulmonary artery systolic pressure of greater than or equal to 80 mm/Hg on screening echocardiogram.
* Have an active infection requiring systemic antibiotics.
* Have a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
* Are currently participating in a clinical investigation that includes an active treatment arm.
* Are unable to demonstrate understanding and capability of using the PAM patient advisory module appropriately.
* Patient does not have access to a telephone line usable for remote PAM follow-up or electrical outlet for recharging PAM.
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
|
NCT01121107
|
{
"brief_title": "Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy",
"conditions": [
"Heart Failure"
],
"interventions": [
"Device: Left Atrial Pressure Monitoring System",
"Device: Patient Advisory Module"
],
"location_countries": [
"New Zealand",
"United States"
],
"nct_id": "NCT01121107",
"official_title": "Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study",
"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)": "2010-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-21",
"last_updated_that_met_qc_criteria": "2010-05-09",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-12",
"first_submitted": "2010-05-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the long-term safety of IDEA-033 (an anti-inflammatory pain-relieving drug applied to the skin) in comparison to naproxen (an anti-inflammatory pain-relieving drug taken by mouth) for the treatment of osteoarthritis of both knees.
Detailed Description
This is a double-blind, active-controlled study of the safety of IDEA-033 in comparison to oral naproxen for the treatment of the signs and symptoms of osteoarthritis of the knee in patients who have completed Study 17-007 or who have discontinued Study 17-007 due to lack of efficacy. If a sufficient number of patients do not enroll from Study 17-007, patients with osteoarthritis of both knees who were not enrolled in Study 17-007 may be enrolled in this study. Patients treated with IDEA-033 in Study 17-007 will receive 100 mg per knee of ketoprofen gel twice daily and one placebo capsule twice daily for 52 weeks. Patients treated with oral naproxen or placebo in Study 17-007 will receive a 500 mg naproxen over-encapsulated tablet twice daily and placebo topical gel twice daily for 52 weeks. Patients who did not participate in Study 17-007 will be randomized to receive one of these two treatments. The primary outcomes of the study include the incidence and severity of adverse events, dermal-irritation scores, and changes in routine clinical laboratory tests and vital signs obtained at each visit.
Patients assigned to IDEA-033 in Study 17-007 will topically apply 100 mg per knee of ketoprofen gel twice daily and take one oral placebo capsule twice daily for 52 weeks. Patients assigned to oral naproxen or placebo in Study 17-007 will take one 500 mg naproxen over-encapsulated tablet orally twice daily and apply placebo topical gel twice daily for 52 weeks. Patients who did not participate in Study 17-007 will be randomized to receive one of these two treatments.
#Intervention
- DRUG : Ketoprofen
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who completed Study 17 <= age <= 007 or discontinued from Study 17 <= age <= 007 due to lack of efficacy
* Patients who did not complete or discontinue from Study 17 <= age <= 007 must have osteoarthritis of both knees for a minimum of six months
* Have moderate pain in the most involved knee when not taking non-steroidal anti-inflammatory drugs (NSAIDs)
* Must have used an oral NSAID on at least three days per week for the last three months, or 25 of the 30 days before screening
* Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last six months
Exclusion Criteria:
* Any patient currently receiving physical therapy to either knee or having a history of allergy, hypersensitivity or contraindication to ketoprofen, naproxen, or acetaminophen, an NSAID idiosyncrasy, or any other medical condition that would compromise the ability of the subject to complete the required assessments and visits
* For patients who did not participate in Study 17 <= age <= 007: having Grade 1 or Grade 4 severity of the most involved knee based on x-ray criteria
* Received intra-articular injections or arthroscopy of the most involved knee during three months before screening visit
* Have a large bulging effusion, or have inflammation of the most involved knee that could be related to gout, pseudogout-induced synovitis, or infection
* Have a history of partial or total knee replacement in either knee, or have a history of gout, pseudo-gout induced synovitis, or infection of the more severe knee
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
|
NCT00265304
|
{
"brief_title": "A Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for the Treatment of Osteoarthritis of the Knee",
"conditions": [
"Osteoarthritis, Knee"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00265304",
"official_title": "A Double-Blind, Long-Term Evaluation of the Safety of IDEA-033 in Comparison to Oral Naproxen for the Treatment of the Signs and Symptoms of Osteoarthritis of the Knee",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-07",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2005-07"
},
"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)": "2009-03-20",
"last_updated_that_met_qc_criteria": "2005-12-13",
"last_verified": "2009-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-12-14",
"first_submitted": "2005-12-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In total 20 subjects will be enrolled at one participating site -UMC Ljubljana. The 20 subjects will be treated with placebo and NBMI 300 mg in a cross-over design. In case of subject drop-outs, additional subjects may be enrolled as decided by the Sponsor, to allow for expected number of evaluable subjects in each group.
Detailed Description
· The study's primary objective is: To explore the efficacy of 28 days NBMI treatment on motor and non-motor symptoms and heath related quality of life in patients with Progressive Supranuclear Palsy or Multiple Systems Atrophy disease.
The study's secondary objectives are:
* to explore safety and tolerability of 28 day NBMI treatment in patients with Progressive Supranuclear Palsy or Multiple Systems Atrophy.
* to investigate the efficacy of NBMI daily oral administration for 28 days on fatigue in MSA and PSP patients,
* to investigate the efficacy of NBMI daily oral administration for 28 days on depression in MSA and PSP patients.
The study's exploratory aims are:
* to explore the effect of NBMI treatment on patient's brain iron levels as evaluated by MRI imaging,
* to explore the effect of NBMI on brain metabolism with FDG- PET- CT brain imaging,
* to explore the pharmacokinetics of NBMI in patients with PSP or MSA.
#Intervention
- DRUG : NBMI
- NBMI active treatment
- OTHER : Placebo
- Placebo for comparison
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient has clinically confirmed documented diagnosis of PSP or MSA, according to the current clinical criteria.
* Patient has a brain MRI finding consistent with the diagnosis of PSP or MSA at Screening.
* Patient is aged 40 years to 85 years inclusive at screening age.
* Patient is fluent in the local language and possesses sufficient auditory and visual capacities to allow neuropsychological testing.
* Patient and caregiver are able to read and understand informed consent.
* Patient is on a stable therapy for PSP, MSA for at least 1 month prior to screening visit.
* If the patient received i.v. amantadine treatment, the last infusion must have been administered at least 6 months prior to the screening (V01).
* Availability of a caregiver who sufficiently knows the patient and will be able to accompany the patient on the study visits and to participate in study assessments of the patient where required.
* Female patients are only eligible for the study if they are either surgically sterile or at least 2 years postmenopausal or have a negative result of serum hCG test at screening and apply to criteria no. 10.
* Female of childbearing potential can only participate in the study if willing to use acceptable, effective methods of contraception during the trial and for three month after the end of trial participation as defined in point 6.7. of this protocol.
* Male patients must either be surgically sterile or he and his female spouse/partner who is of childbearing potential must be willing to use highly effective methods of contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continuing throughout the study.
* Patient provides written informed consent.
Exclusion Criteria:
* Known history or presence of clinically significant other neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
* Known or suspected allergy hypersensitivity or idiosyncratic reaction to NBMI or any other drug substances with similar activity.
* Patient has known contraindication for MRI imaging such as MRI-incompatible metallic endoprosthesis or MRI-incompatible stent implantation or other as judged by the Investigator.
* Patient has claustrophobia that could prevent MRI imaging
* History of drug or alcohol addiction requiring treatment.
* Patient who had previous chronic exposure (within one year before recruitment) to iron from taking preparations/medications for rising iron
* History of malabsorption within the last year or presence of clinically significant gastrointestinal disease or surgery that may affect drug bioavailability, including but not limited to cholecystectomy.
* Patient is ridden to bed.
* Presence of hepatic or renal dysfunction. (SGOT and SGPT and bilirubin > X2 UNL. creatinine > 1.5mg/dl)
* Female patient who is pregnant (serum hCG level consistent with pregnancy diagnosis); or breastfeeding.
* Participation in a clinical trial that involved administration of an investigational medicinal product within 90 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
* Patient has a history with evidence of cerebrovascular disease (ischemic or haemorrhagic), or diagnosis of possible, probable or definite vascular Parkinsonism or dementia.
* Have clinically significant abnormal laboratory values (e.g. liver enzymes)
* Have clinically significant findings from a physical examination (e.g. fever)
* Patient has claustrophobia that could prevent him from attending MRI imaging
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04184063
|
{
"brief_title": "Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA)",
"conditions": [
"Progressive Supranuclear Palsy",
"Multiple System Atrophy"
],
"interventions": [
"Other: Placebo",
"Drug: NBMI"
],
"location_countries": [
"Slovenia"
],
"nct_id": "NCT04184063",
"official_title": "A Pilot Exploratory, Randomised, Placebo-controlled, Double Blinded, Cross-over , Phase 2a Study to Explore Efficacy and Safety of NBMI Treatment in Patients With Progressive Supranuclear Palsy (PSP) or Multiple System Atrophy (MSA)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-07-30",
"study_completion_date(actual)": "2021-06-30",
"study_start_date(actual)": "2019-09-16"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-09-23",
"last_updated_that_met_qc_criteria": "2019-12-02",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-12-03",
"first_submitted": "2019-07-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This phase Ib/II trial studies the side effects and best dose of bispecific antibody armed activated T-cells when given together with aldesleukin and sargramostim and to see how well they work in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Bispecific antibody armed activated T-cells are the patient's own T cells that are coated with a bispecific antibody comprising 2 antibodies chemically joined together. These antibodies have specific targets and binding properties that may give the T cells a greater ability to seek out, attach to, and kill more cancer cells.
Detailed Description
PRIMARY OBJECTIVES:
I. Confirm in a single dose phase I (3 to 6 patients \[pts\]) that 8 infusions of 10\^10 epidermal growth factor receptor (EGFR) bispecific antibody armed activated T cells (BATs) given twice per week in combination with interleukin (IL)-2 (aldesleukin) (300,000 IU/m\^2/day) and granulocyte-macrophage colony stimulating factor (GM-CSF) (sargramostim) (250 ug/m\^2/twice weekly) beginning 3 days before the 1st infusion and ending on the day of the last infusion is safe.
II. Perform a phase II clinical trial to estimate the clinical efficacy of 8 infusions of 10\^10 EGFR BATs in combination with IL-2 and GM-CSF in 39 evaluable pts (including the 3-6 pts in the single dose phase I).
SECONDARY OBJECTIVES:
I. Determine if infusions of EGFR BATs significantly increase cellular or humoral anti-pancreatic cancer (PC) responses by peripheral blood mononuclear cells (PBMC) at different time points after last EGFR BATs infusion and if those responses persist beyond 2 months (mos).
II. Obtain original tumor paraffin blocks prior to treatment and evaluate blocks for cluster of differentiation (CD)3, CD4, CD8, programmed cell death (PD)1/programmed cell death ligand (PDL)1, monocytes subpopulations, myeloid-derived suppressor cells (MDSC), and cytoplasmic interferon (IFN)-gamma and IL-10 by immunohistochemical staining to quantitate type and number of tumor infiltrating lymphocytes (TILs) in the tumor microenvironment to estimate whether the type and number correlate with clinical responses.
III. To determine the time to progression (TTP).
OUTLINE: This is a phase Ib, dose-escalation study of anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells followed by a phase II study.
Patients receive one of the following standard chemotherapy regimens at the discretion of the treating physician: gemcitabine hydrochloride intravenously (IV) over 30 minutes; gemcitabine hydrochloride IV over 30 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes; oxaliplatin IV over 2 hours, fluorouracil IV over 46 hours and leucovorin calcium IV over 2 hours; or fluorouracil IV over 46 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV, and oxaliplatin IV over 2 hours. Approximately 2 weeks after standard chemotherapy completion, patients receive anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV over 5-30 minutes twice weekly for 4 weeks. Patients also receive aldesleukin subcutaneously (SC) and sargramostim SC on day -3 before the first anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells infusion and continuing twice weekly until the final infusion.
After completion of study treatment, patients are followed up for 18 months.
#Intervention
- BIOLOGICAL : Aldesleukin
- Given SC
- Other Names :
- 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2, Recombinant Human Interleukin-2
- BIOLOGICAL : Antibody Therapy
- Given anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV
- Other Names :
- passive antibody therapy
- DRUG : Fluorouracil
- Given IV
- Other Names :
- 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU, AccuSite, Actino-Hermal, Adrucil, Arumel, Cytosafe, Efudex, Efurix, Fiverocil, Fluoro Uracil, Fluoroplex, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Flurox, Ribofluor, Ro 2-9757, Ro-2-9757, Timazin
- DRUG : Gemcitabine Hydrochloride
- Given IV
- Other Names :
- dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011
- DRUG : Irinotecan Hydrochloride
- Given IV
- Other Names :
- Campto, Camptosar, Camptothecin 11, Camptothecin-11, CPT 11, CPT-11, U-101440E
- OTHER : Laboratory Biomarker Analysis
- Correlative studies
- DRUG : Leucovorin Calcium
- Given IV
- Other Names :
- Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, Citrovorum Factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin
- DRUG : Oxaliplatin
- Given IV
- Other Names :
- 1-OHP, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669
- DRUG : Paclitaxel Albumin-Stabilized Nanoparticle Formulation
- Given IV
- Other Names :
- ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, nab-paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, protein-bound paclitaxel
- BIOLOGICAL : Sargramostim
- Given SC
- Other Names :
- 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin
|
#Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological proof of pancreatic adenocarcinoma; must have locally advanced or metastatic pancreatic cancer who have received at least first line chemotherapy and may have responding, stable or progressive disease
* Expected survival >= 3 months
* Karnofsky performance scale (KPS) >= 70% or Southwestern Oncology Group (SWOG) performance status 0 or 1
* Absolute neutrophil count (ANC) >= 1,000/mm^3
* Lymphocyte count >= 400/mm^3
* Platelet count >= 75,000/mm^3
* Hemoglobin >= 8 g/dL
* Serum creatinine < 2.0 mg/dl, creatinine clearance >= 50 ml/mm (can be calculated or measured)
* Total bilirubin =< 2 mg/dl (biliary stent is allowed)
* Serum glutamate pyruvate transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) < 5.0 times normal
* Left ventricular ejection fraction (LVEF) >= 45% at rest (multigated acquisition scan [MUGA] or echocardiogram [Echo])
* Females of childbearing potential, and males, must be willing to use an effective method of contraception
* Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy
Exclusion Criteria:
* Any chemotherapy related toxicities from prior treatment (> grade 2 per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0)
* Known hypersensitivity to cetuximab or other EGFR antibody
* Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
* Symptomatic brain metastasis
* Chronic treatment with systemic steroids or another immuno-suppressive agent
* Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to being registered for protocol therapy
* Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
* Known human immunodeficiency virus (HIV) infection
* Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
* Has an active infection requiring systemic therapy
* A serious uncontrolled medical disorder that in the opinion of the investigator may be jeopardized by the treatment with protocol therapy
* Females must not be breastfeeding
* Patient (Pt) may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the pt is not capable of being compliant
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
|
NCT02620865
|
{
"brief_title": "BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer",
"conditions": [
"Metastatic Pancreatic Adenocarcinoma",
"Recurrent Pancreatic Carcinoma",
"Stage III Pancreatic Cancer",
"Stage IV Pancreatic Cancer"
],
"interventions": [
"Drug: Oxaliplatin",
"Drug: Leucovorin Calcium",
"Drug: Irinotecan Hydrochloride",
"Biological: Aldesleukin",
"Biological: Sargramostim",
"Drug: Fluorouracil",
"Other: Laboratory Biomarker Analysis",
"Drug: Gemcitabine Hydrochloride",
"Biological: Antibody Therapy",
"Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02620865",
"official_title": "Phase Ib/II Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs) in Combination With Low Dose IL-2 and GM-CSF",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-21",
"study_completion_date(actual)": "2021-06-21",
"study_start_date(actual)": "2015-12"
},
"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)": "2023-05-15",
"last_updated_that_met_qc_criteria": "2015-12-01",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-03",
"first_submitted": "2015-12-01",
"first_submitted_that_met_qc_criteria": "2023-04-19"
}
}
}
|
#Study Description
Brief Summary
The aim of the study was to compare the analgesic efficacy of intranasal tapentadol nasal spray 44.5mg and intravenous paracetamol 1gm during the postoperative period by Visual analog scale(VAS)in patients undergoing lower limb(long bone fractures)orthopedic surgeries. Paracetamol is one of the most frequently used analgesic and antipyretic agents, interferes neither with platelet nor kidney functions nor does it present the unwanted side effects of NSAIDs. Tapentadol is a novel, centrally-acting analgesic with a dual mechanism of action, combining mu-opioid receptor agonism with norepinephrine reuptake inhibition. This dual mode of action is responsible for its opioid-sparing effect, which contributes to a reduction in some of the typical opioid-related adverse effects
Detailed Description
Inclusion criteria Age: From 18.00 Year(s) to 60.00 years Gender: Both American Society of Anesthesiologists (ASA) physical status: 1 \& 2, posted for elective lower limb orthopedic surgeries Exclusion criteria
1. Sepsis at the site of injection
2. Coagulopathy
3. Patients with history of renal, hepatic, cardiovascular disease
4. Patient on chronic opioid use Outcome Comparing postoperative analgesia between the groups every 12 hours after the intervention till about 72 hours post intervention. The secondary outcome is to compare the need for the rescue analgesia between the groups
#Intervention
- DRUG : Tapentadol Hydrochloride
- Intranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia
- Other Names :
- Paracetamol
|
#Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologists (ASA) physical status 1 & 2
* Posted for elective lower limb orthopaedic surgeries
Exclusion Criteria:
* Sepsis at the site of injection
* Coagulopathy
* Patients with history of renal, hepatic, cardiovascular disease
* Patient on chronic opioid use
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
|
NCT05999890
|
{
"brief_title": "Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol",
"conditions": [
"Lower Limb Fracture"
],
"interventions": [
"Drug: Tapentadol Hydrochloride"
],
"location_countries": [
"India"
],
"nct_id": "NCT05999890",
"official_title": "A Comparative Study Between Intranasal Tapentadol Versus Intravenous Paracetamol for Post-operative Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anaesthesia'",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-30",
"study_completion_date(actual)": "2021-12-30",
"study_start_date(actual)": "2021-07-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-21",
"last_updated_that_met_qc_criteria": "2023-08-11",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-21",
"first_submitted": "2023-08-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the effects of FID 114657 on tear film break-up time in dry eye patients.
#Intervention
- OTHER : FID114657
- artificial tears
- OTHER : SootheXP Emollient (Lubricant) Eye Drops
- artificial tears
|
#Eligibility Criteria:
Inclusion Criteria:
* The informed consent document and HIPAA privacy document must be read, signed and dated by the patient or legally authorized representative before conducting any procedures.
* Patients (minimum age 18) with dry eye. Criteria for the diagnosis must include the following characteristics at Visit 1 (Screening): Patients' self-assessment of dry eye status (answer of at least Some of the time to the question, 'How often have your eyes felt dry enough to want to use eye drops?');TFBUT <5 seconds in at least one eye; > Grade 1 for Meibomian Gland Expression in both eyes; Evidence of missing meibomian glands in both eyes.
* Able and willing to follow study instructions.
* Patients must have best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.
* Patients must not have used any topical ocular drops for approximately 24 hours prior to Visit 1.
Exclusion Criteria:
* History or evidence of ocular or intraocular surgery in either eye within the past six months.
* History or evidence of serious ocular trauma in either eye within the past six months.
* Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
* History of intolerance or hypersensitivity to any component of the study medications.
* History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
* Use of any concomitant topical ocular medications during the study period.
* Patients using systemic medications that may contribute to dry eye (e.g. cold and allergy medications, tricyclic antidepressants, hormone replacement therapies) may not be enrolled in the study unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1. In addition, the dosing regimen must remain stable throughout the study.
* Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude safe administration of the test article.
* Individuals unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
* Enrollment of investigator's office staff, relatives, or members of their respective households; or enrollment of more than one member of the same household.
* Participation in an investigational drug or device study within 30 days of entering this 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
|
NCT01023464
|
{
"brief_title": "Tear Film Break-Up Time Evaluation of FID 114657",
"conditions": [
"Dry Eye"
],
"interventions": [
"Other: SootheXP Emollient (Lubricant) Eye Drops",
"Other: FID114657"
],
"location_countries": null,
"nct_id": "NCT01023464",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-01",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2009-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-11-18",
"last_updated_that_met_qc_criteria": "2009-11-30",
"last_verified": "2012-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-12-02",
"first_submitted": "2009-11-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
An 8 week 'real-life' inhaled corticosteroid (ICS) dose reduction study in patients with severe asthma without evidence of bronchial hyperactivity.
Detailed Description
We aim to describe the proportion of patients with severe asthma, but without objective evidence of active disease, who can successfully be reduced in ICS dose for a period of 8 weeks. This is also intended as an exploration of the methodology and feasibility of step-down studies with this patient group, to act as a pilot for future projects.
This study enrolled patients from the SATS severe asthma study, in which they had undergone systematic investigation for comorbidities, triggers and barriers to good asthma control.
After baseline investigations, the patient's ICS dose is halved (or as close as possible to, but not below, 50%). Patients continued on the same inhaled steroid drug and device. Patients taking a combined ICS/LABA inhaler halve the dose of this, as per usual clinical practice. Other asthma medicaitons are continued unchanged.
#Intervention
- DRUG : Change to dose of patient's regular medication
- Dose reduction of the drug each patient was already taking
|
#Eligibility Criteria:
Inclusion Criteria:
* Physician-diagnosed asthma for at least 6 months
* Fulfill ERS/ATS giudelines for severe asthma
* Stable dose of ICS for at least 4 weeks
* Able to carry out study procedures
* Negative metacholine provocation test at screening
* Negative reversibility to beta agonist at screening
* FeNO under 50 ppb
Exclusion Criteria:
* Treatment with prednisolone, methotrexate, ciclosporin, omalizumab or nucala in the last 6 months
* FEV1 under 70% of predicted
* Acute upper or lower airway infection requiring antibiotics in the last 4 weeks
* Exacerbation of asthma requiring prednisolone in the last 6 months
* Current smoking
* Pregnancy or breastfeeding
* Other clinically significant lung disease
* Current participation in another interventional 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
|
NCT03321877
|
{
"brief_title": "Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity",
"conditions": [
"Asthma"
],
"interventions": [
"Drug: Change to dose of patient's regular medication"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT03321877",
"official_title": "Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity: Severe Asthma or Simply Over-treatment?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-05-31",
"study_completion_date(actual)": "2017-05-31",
"study_start_date(actual)": "2016-10-01"
},
"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)": "2017-10-26",
"last_updated_that_met_qc_criteria": "2017-10-23",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-26",
"first_submitted": "2017-10-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to investigate the effect of connective tissue manipulation on pain threshold in women with primary dysmenorrhoea. According to literature, there are studies that measure the pain threshold. But there is no randomized controlled trial which explore the short and long-term effects of connective tissue manipulation on primary dysmenorrhoea. Hypothesis of this study is that connective tissue manipulation increases pain threshold and decreases severity of pain in women suffer with primary dysmenorrhoea.
Detailed Description
Dysmenorrhoea has been defined painful menstruation. It is divided primary and secondary dysmenorrhoea according to the pathophysiology. Primary dysmenorrhoea is severe menstrual pain, occurs a short time after menarche and without pelvic pathology. Secondary dysmenorrhoea is severe menstrual pain that occurs related to pelvic pathology. In primary dysmenorrhoea, pain usually begins with menstruation and ends in 48-72 hours. Pain is usually felt in the lower abdomen and lumbosacral region. Fatigue, headache, vomiting, diarrhea and constipation may be accompanied by primary dysmenorrhoea.
It is difficult to determine the incidence and etiology of dysmenorrhoea because of the variety of the criteria used in the diagnosis of the dysmenorrhoea and subjective symptoms. But current studies show that primary dysmenorrhoea is common gynecological problem that affects majority of women. Tu et al. indicated that prevalence of primary dysmenorrhoea was between 20-90% percent and 15% of cases had severe symptoms.
Although the etiology of primary dysmenorrhoea is not fully understood, excessive prostaglandin production is believed to cause abnormal uterine activity. Hyperalgesia is present especially in the deep tissue during the menstrual cycle.
Various approaches have been proposed until now for the treatment of patients with dysmenorrhoea. These are medical treatments (for example paracetamol, NSAID, oral contraceptives), alternative treatments (for example herbal products and nutritional supplements, dietary changes), surgical treatments and physiotherapy and rehabilitation approaches. Connective tissue manipulation (CTM), physiotherapy and rehabilitation approach, has been found by German physiotherapist Elizabeth Dicke in 1929. CTM is a manual reflex therapy, which produces autonomic responses via cutaneous-visceral reflexes. This safe and effective technique consists short and long tractions, which performed on the patients' skin by the skilled and experienced physiotherapist. Although the effect mechanism of CTM has not been fully understood yet, it is known that the treatment method stimulates autonomic nervous system to rebalance the parasympathetic and sympathetic functions. CTM produces autonomic stimulus when the stroke is performed on the skin and blood vessels are stimulated by autonomic nerve endings located in the tissue interfaces. It has also found that stimulation of autonomic nerve endings may results in reduction of sympathetic vasoconstrictor tone leads to vasodilatation. Stimulation of skin with strokes affects segmental reflexes. It is known that stimulation of segmental reflexes can be used in treatment of organ dysfunctions. CTM applied to affected dermatome generates reflex effects in the associated organs, provides healing by increasing circulation and decreasing pain. Skin alterations and subcutaneous tissue tension are observed in the dermatomes and myotomes, which are innervated by same spinal cord level with malfunctioning organ. In addition to these effects, powerful stimulation of cutaneous mechanoreceptor induces gate control mechanism, increases pain threshold and decreases stress hormones and muscle tension.
The aim of this study is to investigate the effect of connective tissue manipulation on pain threshold in women with primary dysmenorrhoea. According to literature, there are studies that measure the pain threshold. But there is no randomized controlled trial which explore the short and long-term effects of connective tissue manipulation on primary dysmenorrhoea. Hypothesis of this study is that connective tissue manipulation increases pain threshold and decreases severity of pain in women suffer with primary dysmenorrhoea.
#Intervention
- OTHER : lifestyle advice
- Investigators will give lifestyle advice to patients such as exercising regularly, limiting caffeine, sugar and alcohol intake, reduction or cessation of smoking
- OTHER : connective tissue manipulation
- Investigators will apply connective tissue manipulation on lumbosacral, lower thoracic, and anterior pelvic regions starting from the estimated time of ovulation until the next period begins
|
#Eligibility Criteria:
Inclusion Criteria:
* Nulliparous women: aged > 18 years, diagnosis of primary dysmenorrhea according to Primary Dysmenorrhea Consensus Guideline, having regular menstrual cycles, a history of menstrual pain starting in the first few years after menarche and menstrual pain rated higher than 40 mm on a visual analog scale considering the last six months
Exclusion Criteria:
* Menstrual pain below 40 mm on the VAS
* Severe gastrointestinal, urogynecological or autoimmune disease
* other chronic pain syndromes
* psychiatric disorder
* childbirth
* positive pregnancy test
* intrauterine device
* urogynecologic surgery
* chronic medication including oral contraceptives or antidepressants for at least six months prior to study
* irregular menstrual cycles
* a history or ultrasonographic observation of pathologic conditions
Sex :
FEMALE
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
|
NCT02372123
|
{
"brief_title": "The Effect of Connective Tissue Massage in Women With Primary Dysmenorrhoea",
"conditions": [
"Dysmenorrhea",
"Pelvic Pain"
],
"interventions": [
"Other: lifestyle advice",
"Other: connective tissue manipulation"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT02372123",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-08",
"study_completion_date(actual)": "2015-08",
"study_start_date(actual)": "2015-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-12-11",
"last_updated_that_met_qc_criteria": "2015-02-20",
"last_verified": "2015-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-02-26",
"first_submitted": "2015-02-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Intraoperative Floppy Iris Syndrome (IFIS) is a potentially serious cataract surgery complication. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. There are a number of guidelines for operative technique modifications with the aim to prevent the development of IFIS. The study focuses on two options for prophylactic strategies: the application of atropine drops and the instillation of intracameral epinephrine.
Detailed Description
Intraoperative Floppy Iris Syndrome (IFIS) is a complication that may develop during cataract surgery. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. It is characterised by an unstable iris whose increased elasticity may lead to a number of complications during cataract extraction with a negative impact on vision outcomes. Basic features of IFIS are a 'floppy' iris that 'ripples' in irrigation, insufficiently inducible mydriasis with progressive intraoperative miosis (despite repeated application of mydriatics) and the tendency of the iris to prolapse into the phacoemulsification probe.
IFIS is a complication that makes surgery more difficult for the eye surgeon. There is a risk of intraoperative conditions such as rupture of the posterior capsule with lens masses luxation into the vitreous body, damage to the iris by surgical instruments, damage to the endothelium with washout of endothelial cells, hyphaema, or prolapse of the vitreous body into the anterior chamber.
There are several surgical approaches to prevent the development of IFIS and facilitate easier management of the entire cataract extraction in unstable iris. The investigators recommend patients apply 1% atropine drops twice a day for one week during the pre-operative period. A more elegant method is the administration of epinephrine into the anterior chamber at the beginning of the cataract surgery. The aim of this study is to evaluate the effectiveness of two mydriatic agents - the administration of atropine drops and the instillation of epinephrine into the anterior chamber and to compare their effectiveness in preventing IFIS.
#Intervention
- DRUG : 1% Atropine drops
- Patients administered 1% Atropine drops twice a day for a week before the cataract surgery.
- DRUG : Epinephrine
- Patients underwent the instillation of epinephrine into the anterior chamber at the beginning of the cataract surgery.
|
#Eligibility Criteria:
Inclusion Criteria:
* age-related cataract
* age > 18 years
* men with diagnosed benign prostatic hyperplasia
* history of having taken, or currently taking any systemic α1-adrenergic receptor antagonists for low urinary tract symptoms
* performing of pre-operative examination before cataract surgery
* signed informed consent
Exclusion Criteria:
* presence of any pupil deformity due to e.g. post-traumatic condition
* iris defect of any aetiology
* status post anterior uveitis
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
|
NCT06266962
|
{
"brief_title": "Comparing the Efficiency of Two Approaches in Patients at Risk of Developing Intraoperative Floppy Iris Syndrome",
"conditions": [
"Intraoperative Floppy Iris Syndrome",
"Cataract",
"Age-related Cataract",
"Adrenergic Receptor Antagonist Adverse Reaction"
],
"interventions": [
"Drug: 1% Atropine drops",
"Drug: Epinephrine"
],
"location_countries": [
"Czechia"
],
"nct_id": "NCT06266962",
"official_title": "Comparing the Efficiency of Two Prophylactic Approaches in Patients at Risk of Developing Intraoperative Floppy Iris Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-30",
"study_completion_date(actual)": "2022-09-30",
"study_start_date(actual)": "2020-07-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-20",
"last_updated_that_met_qc_criteria": "2024-02-19",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-02-20",
"first_submitted": "2024-02-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed to treat patients with Graves' disease with Rituximab in an attempt to prevent or reverse the physically deforming and debilitating consequences of this disease.
Detailed Description
Graves' Dysthyroid ophthalmopathy is an autoimmune disease characterized by inflammatory changes of the periocular and orbital region often in association with an underlying thyroid abnormality. These changes can be extremely debilitating and may lead to visual loss. Attempts at limiting or reversing the phenotypic expression of Graves' ophthalmopathy through aggressive orbital decompression surgery or targeting the inflammatory disease, using high dose systemic corticosteroids and/or orbital radiotherapy, have been limited to date by treatment ineffectiveness and co-morbidities. Selective B-cell depletion therapy offers a potential treatment alternative. This study is designed to treat patients with Graves' disease with Rituximab in an attempt to prevent or reverse the physically deforming and debilitating consequences of this disease.
#Intervention
- DRUG : Rituximab
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients eighteen years of age or older.Diagnosed with Graves' dysthyroid ophthalmopathy within one year of presentation.
* Manifest significant ophthalmic findings of active Graves' disease. (Clinical activity score 4 or greater)
* Evidence of thyroid abnormality (hyper or hypo thyroid) prior to thyroid treatment
* Elevated thyroid stimulating immunoglobulin, antithyroid peroxidase antibody or antithyroglobulin antibody.
Exclusion Criteria:
Long standing chronic disease. (greater than one year) History of ineffective prior orbital irradiation. Clinical activity score of less than 4.
* ANC < 1.5 x 103
* Hemoglobin: < 8.5 gm/dL
* Platelets: < 100,000/mm
* AST or ALT >2.5 x Upper Limit of Normal unless related to primary disease.
* IgG: < 5.6 mg/dl and IgM: < .55 mg/dl
* Positive Hepatitis B or C serology (Hep B Surface antigen and Hep C antibody)
* History of positive HIV (HIV conducted during screening if applicable)
* Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
* Receipt of a live vaccine within 4 weeks prior to randomization
* Previous Treatment with Rituximab (MabThera® / Rituxan®)
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* History of recurrent significant infection or history of recurrent bacterial infections
* Known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical, mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
* Lack of peripheral venous access
* History of drug, alcohol, or chemical abuse within 6 months prior to screening
* Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or lactation
* Concomitant malignancies or previous malignancies, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* History of psychiatric disorder that would interfere with normal participation in this protocol
* Significant cardiac, including significant or uncontrolled arrhythmia, or pulmonary disease (including obstructive pulmonary disease)
* History of systemic lupus erythematosis
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
Inability to comply with study and follow-up procedures
*
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
|
NCT00424151
|
{
"brief_title": "Rituximab Treatment of Graves' Dysthyroid Ophthalmopathy",
"conditions": [
"Graves' Dysthyroid Ophthalmopathy",
"Thyroid Related Orbitopathy"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00424151",
"official_title": "Rituximab Treatment of Graves' Dysthyroid Ophthalmopathy Phase I/II",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-03",
"study_completion_date(actual)": "2009-03",
"study_start_date(actual)": "2006-12"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"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)": "2010-10-06",
"last_updated_that_met_qc_criteria": "2007-01-17",
"last_verified": "2010-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-01-18",
"first_submitted": "2007-01-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This pilot study will provide data to aid in the planning of a follow-up multi-center randomized, controlled trial (RCT). As such, the sample size for this pilot is not driven by formal statistical hypothesis testing. Rather, the sample size of 100 patients (50 per arm) was derived in consultation with the study PI and Co-PI who are experts in vascular surgery, and in particular, the field of hemodialysis access interventions. The results of this pilot study will provide the data that is necessary for generation of specific hypotheses that can then be formally tested in the follow-up RCT
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient must be > 18 and < 85 years
* Patient or legally authorized representative must be willing to participate and able to understand, read, and sign the informed consent document before the planned procedure
* Eligible for de-clot procedure or evaluation of slow flow for a failing hemodialysis graft that previously provided access for at least 1 successful hemodialysis session
Exclusion Criteria:
* Patient or legally authorized representative cannot or will not provide written informed consent
* Known metal allergy precluding endovascular stent implantation
* Known reaction or sensitivity to iodinated contrast that cannot be pretreated
* Patients who are pregnant or lactating
* Patients with scheduled kidney transplant within the next 6 months
* Patients scheduled to switch to peritoneal dialysis within the next 6 months
* Patients with life expectancy of less than 6 months
* Participation in any other clinical research study that would interfere with the patient's participation in this study
* Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study
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
|
NCT01929369
|
{
"brief_title": "Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts",
"conditions": [
"THROMBOSED AV GRAFTS"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01929369",
"official_title": "Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-09",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2013-08"
},
"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)": "2015-02-20",
"last_updated_that_met_qc_criteria": "2013-08-22",
"last_verified": "2015-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-08-27",
"first_submitted": "2013-08-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
Detailed Description
For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30%-50%. Such rates of recurrence have serious economic consequences.
Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures.
The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilised on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration.
These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease. This observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.
|
#Eligibility Criteria:
Inclusion Criteria:
* Symptomatic coronary artery disease
* Subject has signed informed consent for data release
* Subject is geographically stable and willing to participate at all follow-up assessments
* Subject is >= 18 years
Exclusion Criteria:
* Subject did not sign informed consent for data release
* Pregnancy
* Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
* Currently participating in another study and primary endpoint is not reached yet.
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
|
NCT01667016
|
{
"brief_title": "BIOFLOW-III Austria Satellite Registry",
"conditions": [
"Coronary Artery Disease",
"Myocardial Ischemia"
],
"interventions": null,
"location_countries": [
"Austria"
],
"nct_id": "NCT01667016",
"official_title": "BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III Austria",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-06",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2012-08"
},
"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)": "2017-09-28",
"last_updated_that_met_qc_criteria": "2012-08-15",
"last_verified": "2017-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-08-17",
"first_submitted": "2012-08-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess the safety and reactogenicity of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.
#Intervention
- BIOLOGICAL : RSV vaccine GSK3003891A
- Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
- BIOLOGICAL : Boostrix
- Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject prior to performing any study specific procedure.
* Non-pregnant female between, and including, 18 and 45 years at the time of vaccination.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:
* has practiced adequate contraception for 30 days prior to vaccination, and
* has a negative pregnancy test on the day of vaccination and
* has agreed to continue adequate contraception during the entire study period.
Exclusion Criteria:
* Use of any investigational or non-registered product other than the study vaccine within 30 days prior to study vaccination, or planned use during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
* Chronic administration of immunosuppressants or other immune-modifying drugs, as well as administration of long-acting immune-modifying drugs during the period starting 6 months prior to study vaccination, or planned administration during the study period. Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/or any blood products during the period starting 3 months before study vaccination or planned administration during the study period.
* Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the study vaccination, with the exception of any licensed influenza vaccine which may be administered >= 15 days before or after study vaccination.
* Previous experimental vaccination against RSV.
* Family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of or current auto-immune disease.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by physical examination and/or Medical History.
* Lymphoproliferative disorder or malignancy within previous 5 years.
* History of hypersensitivity after a previous dose of any tetanus, diphtheria, or pertussis vaccine or to any component of Boostrix.
* History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with pertussis-containing vaccine.
* History of any neurological disorders or seizures.
* History of transient thrombocytopenia or neurological complications following a previous vaccination against diphtheria and/or tetanus.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
* Hypersensitivity to latex.
* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
* Current chronic alcohol consumption and/or drug abuse.
* Acute disease and/or fever at the time of enrolment.
* Body mass index (BMI) > 40 kg/m2.
* Pregnant or lactating female.
* Planned move to a location that will prohibit participating in the trial until study end.
* Any other condition that the investigator judges may interfere with study procedures.
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
|
NCT02753413
|
{
"brief_title": "Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women",
"conditions": [
"Respiratory Syncytial Virus Infections"
],
"interventions": [
"Biological: RSV vaccine GSK3003891A",
"Biological: Boostrix"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT02753413",
"official_title": "An Observer-blind Safety and Reactogenicity Study to Assess GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-28",
"study_completion_date(actual)": "2016-06-28",
"study_start_date(actual)": "2016-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-06-26",
"last_updated_that_met_qc_criteria": "2016-04-25",
"last_verified": "2018-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-27",
"first_submitted": "2016-04-21",
"first_submitted_that_met_qc_criteria": "2017-06-13"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the effects of oral estradiol and soy phytoestrogens on anxiety, stress responsivity and cognition in perimenopausal women.
Detailed Description
Anxiety is a common, but understudied complaint in midlife women, and increases during the menopausal transition. Changes in estrogen are dramatic during the menopausal transition, and indirect data suggest a potential role for estrogen, particularly estrogen receptor beta, in mediating anxiety. Two subtypes of the estrogen receptor, alpha and beta (ER-alpha and ER-beta), appear to be critically involved in the expression of anxiety in females. Compounds that preferentially target ER-beta, including plant-derived estrogens (phytoestrogens), lower both anxiety behaviors and responsivity to discrete stressors, including social stress, in laboratory animals. The primary aim of this proposal is to carry out the first study to translate these preclinical studies to humans by comparing and contrasting of the effects of phytoestrogens, estradiol, and placebo on daily anxiety and responses to moderate psychosocial stress in the laboratory. As second focus is emotional and non-emotional cognition. This focus stems from evidence that estrogen can protect against the negative impact of glucocorticoids on memory. These aims will be accomplished in a 12-week randomized placebo-controlled, clinical trial comparing three treatments: 1) a phytoestrogen supplement (Novasoy® 400, 55 mg tablet twice daily); 2) oral estradiol (1 mg/daily; plus 10 mg medroxyprogesterone acetate at study end 10 for 10 days); and 3) placebo (identical appearing tablets twice daily). The enrollment target is 120 healthy women in the menopausal transition (40 per group). To measure anxiety, women will complete the State-Trait Anxiety Inventory (STAI). To measure responsivity to psychosocial stress, parallel forms of the Trier Social Stress Test, a widely used laboratory induction that involves unanticipated public speaking and social evaluative fear, will be used to induce moderate psychosocial stress before and after treatment. At both laboratory sessions, measures of subjective stress (STAI), cortisol, and emotional memory performance will be obtained at multiple points during a control condition and during the psychosocial stress condition. Lastly, we will measure treatment effects on measures of verbal memory.
#Intervention
- DIETARY_SUPPLEMENT : Soy Phytoestrogen
- Novasoy® pill (55 mg)
- Other Names :
- NovaSoy 400
- DRUG : Estradiol
- Estradiol pill (1 mg)
- Other Names :
- estrogen, estradiol acetate
- DRUG : Medroxyprogesterone Acetate (MPA)
- medroxyprogesterone acetate (MPA) (10mg)
- Other Names :
- MPA
- DRUG : Soy Placebo
- oral placebo pill (0mg Soy Phytoestrogen)
- Other Names :
- sugar pill
- DRUG : MPA Placebo
- oral placebo pill (0mg MPA)
- Other Names :
- sugar pill
|
#Eligibility Criteria:
Inclusion Criteria:
* Female
* Perimenopausal as defined by the Stages of Reproductive Aging Workshop (STRAW) criteria, specifically in either of the two following stages: a) early transition defined as changes in cycle length of seven days or more in either direction in consecutive cycles or b) late transition defined as > 60 days amenorrhea and FSH > 40 IU/mL
* Intact uterus/ovaries (i.e. no surgical menopause)
* at least 1 self-reported hot flash per week
* Estrogen therapy not contraindicated
* Able to give informed consent
* Age between 40 and 65 years
* English as first and primary language
Exclusion Criteria:
* Positive pregnancy test or breastfeeding (pregnancy tests will be given to all women)
* Obesity > 35 BMI
* Previous history of endometrial hyperplasia/neoplasia
* Previous history of cancers of the breast or reproductive tract
* History of presence of myocardial infarction (MI) or stroke
* Current clinical diagnosis or a diagnosis within the past year of an anxiety disorder, severe recurrent depression, or severe psychiatric disturbance
* History of head injury with more than 60 minutes loss of consciousness
* History of neurological condition affecting cognitive function (e.g., brain tumor, multiple sclerosis)
* History of developmental disability affecting cognitive function (e.g., mental retardation, attention deficit)
* Current use of CNS-acting medication (e.g., antidepressants, anxiolytics, diphenhydramine)
* History or presence of cerebrovascular accident, sickle cell anemia
* History of alcohol or drug abuse as defined by DSM criteria
* Abnormal vaginal bleeding of undetermined cause
* Untreated or uncontrolled hypertension defined as systolic blood pressure greater than 165 mm hg or diastolic blood pressure greater than 95 mm hg
* Concurrent administration of medication containing estrogen, progestin, SERM within four months of enrollment
* Concurrent administration of medication containing St. John's wort, bisphosphonates, or dietary phytoestrogens within one month of enrollment
* History of migraine associated with hormone use
* History or presence of deep vein thrombosis, thrombophlebitis or thromboembolic disorder
* Current participation in any other clinical trial within 30 days of enrollment
* Smoker
* Diabetes
* Premature ovarian failure (defined as having last menstrual period before age 40)
* Abnormal PAP smear in previous year
* Abnormal mammogram in previous year
* Vegans (vegetarians who tend to consume greater than average doses of phytoestrogens)
* Allergy to soy (affects ~1% of people in the United States; reactions are typically mild)
* Symptomatic fibroids (significant size or significant menstrual changes)
* Menorrhagia
* Lactose intolerant
Sex :
FEMALE
Ages :
- Minimum Age : 40 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00997893
|
{
"brief_title": "Research Investigation of Soy and Estrogen",
"conditions": [
"Menopause",
"Hot Flashes"
],
"interventions": [
"Drug: MPA Placebo",
"Dietary Supplement: Soy Phytoestrogen",
"Drug: Estradiol",
"Drug: Soy Placebo",
"Drug: Medroxyprogesterone Acetate (MPA)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00997893",
"official_title": "Effects of Estradiol and Soy on Menopausal Symptoms",
"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)": "2009-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-12-07",
"last_updated_that_met_qc_criteria": "2009-10-18",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-10-19",
"first_submitted": "2009-10-18",
"first_submitted_that_met_qc_criteria": "2020-11-12"
}
}
}
|
#Study Description
Brief Summary
Patients with unilateral post-thrombotic obstruction of the iliac tract and or common femoral vein, eligible for stenting are included. Intravenous pressure is measured in both dorsal foot veins and both common femoral veins. Patients are asked to undergo a standardised treadmill test (3.2km/h, 0% slope that increases by 2%/2min, maximum walking time 26 min). Painfree and maximum action radius are noted.
Detailed Description
Rationale: PTA \& stenting in iliofemoral and iliocaval venous obstruction has been proven to be an effective method of treatment with good clinical results. However, no proper investigations have been made to objectify the reduction in (ambulatory) venous hypertension caused by this type of obstruction. Normal ambulatory venous pressure is below 20mmHg, though studies have already shown a linear relationship between the incidence of ulcers and an ambulatory intravenous pressure of more than 30mmHg. We believe that by measuring the (ambulatory) venous pressure before and after stenting, we will gain more knowledge on the hemodynamics of venous disease and its treatment and we will obtain information that might identify patients at risk of stent occlusion or the forming of an ulcer in an early stage. Identifying these patients will most certainly influence preventive treatment in the future.
Objective: To map the changes in intravenous pressure in post-thrombotic iliofemoral venous obstruction and evaluate the effect of PTA \& stenting with possible identification of a predictive parameter for success of treatment.
Study design: Prospective, observational study (healthy and diseased limb in one patient).
Study population: Patients with an iliofemoral venous obstruction, objectified on duplex ultrasonography and magnetic resonance venography, and the indication for stenting of the obstructed tract(s).
Intervention: All patients will undergo stenting of the obstructed venous tract. Patients receive the same therapy as they would have received not participating in this study; therefore this study has no influence on the treatment patients receive.
Main study parameters/endpoints: Primary outcome is the change in (ambulatory) venous pressure after stenting for deep venous obstructive disease. Other important endpoints are the absolute values for intravenous pressure, pain free walking distance and maximum walking distance. Additional outcome measurements are stent patency, CEAP score, Villalta score, venous clinical severity score, and generic and disease specific quality of life scores. Finally, transverse surface area, diameter and circumference of the common femoral vein will be measured.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients have to make three visits. Each visit will take approximately two hours. During each test day, patients will undergo intravenous pressure measurements in both dorsal foot veins, both common femoral veins and a vein in the left upper arm, which are measured via a venflon needle or microsheath (placed under ultrasound guidance) connected to a pressure transducer; a treadmill test lasting maximally 26 minutes; an air plethysmography, which they need to undergo anyway; and a duplex ultrasound to assess the common femoral vein. This is a very low risk study, since all diagnostic tools that are used or also used in usual clinical practice and given the low risk on mild complications. Patients can experience pain due to the insertion and removal of the venflons/microsheaths, due to compression of the groin after removal of the microsheaths and due to walking on a treadmill (because of venous claudication).
Amendment:
iv in the arm vein as a control is not performed anymore. An abdominbal wall collateral is cannulated instead, if present.
#Intervention
- PROCEDURE : PTA & stenting
- PTA \& stenting of the iliac veins and/or common femoral vein. Patients who need to undergo endophlebectomy of the common femoral vein with AV-fistula creation are also included.
|
#Eligibility Criteria:
Inclusion Criteria:
* Indication for stenting (possibly with endophlebectomy and AV-fistula), minimally 18 years, life expectancy of at least 6 months.
Exclusion Criteria:
* Younger than 18 years, life expectancy of less than 6 months, venous obstruction in the contralateral limb, peripheral arterial disease, pregnancy.
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
|
NCT01846780
|
{
"brief_title": "Treadmill Pilot Study (Invasive Pressure Measurements in PTS)",
"conditions": [
"Post-thrombotic Syndrome",
"May-Thurner Syndrome"
],
"interventions": [
"Procedure: PTA & stenting"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT01846780",
"official_title": "The Effect of PTA & Stenting on Intravenous Pressure in Deep Venous Obstructive Disease Before, After and During Ambulation on a Treadmill - Pilot Study.",
"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)": "2013-12"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-10-21",
"last_updated_that_met_qc_criteria": "2013-05-01",
"last_verified": "2015-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-05-03",
"first_submitted": "2013-05-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to measure specific chemokines, antibodies, and antibody-producing B cells in the blood of patients with hepatitis C virus (HCV) infection. Our hypothesis is that changes in chemokine levels affect the development of an effective immune response against HCV.
Detailed Description
The long-term goal of our research is to understand why immune complexes (ICs) are produced in patients infected with HCV, and whether these complexes affect virus interaction with target cells. We have found that many patients infected with HCV have an increased frequency of circulating B cells, but no evidence that the increased B cells are activated of proliferating. One possible mechanism for such an increase would be a change in levels of chemokines that influence B cell localization and trafficking. Our studies are aimed at testing the following hypotheses:
1. One hypothesis is that HCV infection results in increased levels of specific cytokines and chemokines that may affect the motility and localization of immature and mature B cells. An alternative model is that HCV infection leads to chronic antigenic stimulation of B lymphocytes, and that the abnormalities of B cell function associated with HCV infection reflect this chronic antigenic stimulation.
2. A second hypothesis is that autoantibodies and immune complexes present in HCV patient serum contribute to the persistence and spread of viral infection.
To test these hypotheses, we are measuring levels of chemokines, the frequency of circulating B cells (mature resting B cells, mature activated B cells, memory B cells, and immature B cells), and the levels and components of ICs in the blood of HCV-infected patients. Controls include healthy volunteers and patients with chronic liver disease unrelated to HCV infection. No interventions in patient care are planned. When patients elect to undergo standard antiviral therapies under the supervision of their hepatologists, we will study the outcomes of therapy (no virologic response, partial or transient virologic response, sustained virologic response) to determine whether any of the observed alterations in chemokine levels, B cell frequency or activation, or immune complex levels correlate with the patient's response to antiviral therapy.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers, no liver disease
* Chronic infection with hepatitis C virus
* Other chronic liver disease unrelated to hepatitis C virus
* Subjects in all groups must have sufficiently healthy veins to allow blood collection.
Exclusion Criteria:
* Any medical condition that, in the opinion of the investigators, precludes the patient's participation
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00219999
|
{
"brief_title": "Hepatitis C Virus and the Humoral Immune System",
"conditions": [
"Hepatitis C Virus"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00219999",
"official_title": "Hepatitis C Virus and the Humoral Immune System",
"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)": "2001-09"
},
"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)": "2013-08-09",
"last_updated_that_met_qc_criteria": "2005-09-19",
"last_verified": "2013-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-22",
"first_submitted": "2005-09-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This pilot study plan to investigate the sympathovagal balance in women affected by Irritable Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous vagal nerve electrical stimulation on digestive physiology (intestinal transit time, intestinal mucosal permeability, systemic and local inflammation), symptoms and quality of life.
The safety of the electrical stimulation of the left vagal nerve will also be evaluated.
Ten women, age between 18 and 60, will be included.
#Intervention
- DEVICE : Trans-cutaneous vagal nerve electrical stimulation
|
#Eligibility Criteria:
Inclusion Criteria:
* women aged 18 <= age <= 60,
* clinical Rome III criteria for IBS
Exclusion Criteria:
* pregnancy,
* low intensity symptoms (Francis score between 75 <= age <= 150)
* IBD, coeliac disease
* past history of abdominal surgery (appendectomy and cholecystectomy allowed)
* chronic use of analgesics, anti-depressants
Sex :
FEMALE
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
|
NCT02420158
|
{
"brief_title": "Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome",
"conditions": [
"Irritable Bowel Syndrome"
],
"interventions": [
"Device: Trans-cutaneous vagal nerve electrical stimulation"
],
"location_countries": [
"France"
],
"nct_id": "NCT02420158",
"official_title": "Sympatho-vagal Balance in Patients With Irritable Bowel Syndrome, and Evaluation of a Transcutaneous Vagal Nerve Electrical Stimulation on Symptoms and Quality of Life",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08",
"study_completion_date(actual)": "2018-08",
"study_start_date(actual)": "2015-05"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-01-04",
"last_updated_that_met_qc_criteria": "2015-04-16",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-04-17",
"first_submitted": "2015-04-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab.
#Intervention
- BIOLOGICAL : secukinumab 150 mg
- Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consiseds of one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also received two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
- Other Names :
- AIN457 150 mg
- BIOLOGICAL : secukinumab 300 mg
- Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consisted of two secukinumab 150 mg s.c. injections and took ke place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also receives two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
- Other Names :
- AIN457 300 mg
- BIOLOGICAL : Placebo
- Placebo were provided in 1 mL pre-filled syringes. Each dosing consisted of two s.c. injections and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then at Week 8 and at Week 12. At Week 16, ppIGA responders continued on placebo with dosing at Weeks 16, 17, 18, 19 and 20, then once every four weeks from Week 24 until Week 76 inclusive. At Week 80, ppIGA responders ended their participation in the study while ppIGA non-responders were re-randomized, to receive 150 mg or 300 mg secukinumab once every four weeks starting at Week 80 until Week 128 inclusive. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects with chronic, moderate to severe plaque type psoriasis for at least 6 months prior to randomization and significant involvement of the palms and soles at baseline, defined as palmoplantar Investigator's Global Assessment (ppIGA) score of >= 3 on a 5-point scale, as well as at least one skin plaque at baseline which is not in the palmoplantar area
* Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy
Exclusion Criteria:
* Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)
* Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium)
* Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply.
* Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL-17 or the IL-17 receptor
* Use of any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
* Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
* History of hypersensitivity to constituents of the study treatment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01806597
|
{
"brief_title": "Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis",
"conditions": [
"Moderate to Severe Palmoplantar Psoriasis"
],
"interventions": [
"Biological: secukinumab 150 mg",
"Biological: Placebo",
"Biological: secukinumab 300 mg"
],
"location_countries": [
"Slovakia",
"Israel",
"Netherlands",
"United States",
"Portugal",
"Canada",
"Russian Federation",
"Spain",
"Australia",
"Norway",
"Hungary",
"Finland",
"Turkey",
"Belgium",
"United Kingdom"
],
"nct_id": "NCT01806597",
"official_title": "A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Demonstrate the Efficacy at 16 Weeks of Secukinumab 150 and 300 mg s.c. and to Assess Safety, Tolerability and Long-term Efficacy up to 132 Weeks in Subjects With Moderate to Severe Palmoplantar Psoriasis",
"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)": "2013-06-19"
},
"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)": "2018-02-22",
"last_updated_that_met_qc_criteria": "2013-03-05",
"last_verified": "2018-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-03-07",
"first_submitted": "2013-01-23",
"first_submitted_that_met_qc_criteria": "2018-01-22"
}
}
}
|
#Study Description
Brief Summary
In the absence of 2019-ncov specific therapeutic drugs, arbidol is effective against a variety of coronaviruses in vitro pharmacodynamics. In order to observe the efficacy and safety of arbidol in the treatment of 2019-ncov infected pneumonia, this study is planned.
Detailed Description
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. The number of cases of infection with 2019-nCoV identified in Wuhan increased markedly over the later part of January 2020, with cases identified in multiple other Provinces of China and internationally. Mathematical models of the expansion phase of the epidemic suggested that sustained person-to-person transmission is occurring, and the R-zero is substantially above 1, the level required for a self-sustaining epidemic in human populations.
There is currently no specific treatment for 2019-ncov-infected pneumonia. Arbidol tablet is a non-nucleoside broad-spectrum antiviral drug with immune-enhancing effect. Abidor is pharmacodynamic in vitro against a variety of coronaviruses.This is a randomized, open, multicenter clinical study of pneumonic subjects diagnosed with 2019-ncov infection. The main objective was to compare the viral negative conversion rate in the first week after the subjects were randomized to arbidol plus basic treatment.
In this study, 380 eligible patients with pneumonia diagnosed with 2019-ncov infection were randomly assigned to one of two treatment groups at a 1:1 ratio.
patients will receive one of two treatment regimens: A .Abidor tablets + basic treatment B. basic treatment Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days Basic treatment :The basic treatment used by the investigator was based on the condition of the patient.
#Intervention
- DRUG : Arbidol
- Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days
- Other Names :
- The basic treatment used by the investigator was based on the condition of the patient
- OTHER : basic treatment
- basic treatment
|
#Eligibility Criteria:
Inclusion Criteria:
* aged 18 <= age <= 65 old (including 18 and 65 years);
* male and non-pregnant female;
* respiratory tract specimens or hematology samples detected positive results of SARS-CoV-2 by real-time transcriptase polymerase chain reaction (RT-PCR).
* mild clinical status, defined as having mild clinical symptoms but no signs of pneumonia on imaging or moderate clinical status, defined as having fever, respiratory symptoms and pneumonia on imaging or severe clinical status, defined as having an oxygen saturation (SaO2) of 93% or less at ambient air or a ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at or below 400 mgHg, which can be rectified by oxygen inhalation through nasal catheter or face mask.
Exclusion Criteria:
included a physician decision that involvement in the trial was not in the patient's best interest, known allergic reaction and / or severe allergic to arbidol, blood system dysfunction (platelet count <100×109/L, hemoglobin level <90g/L), severe liver dysfunction (total bilirubin level >2 times the normal upper limit, aspartic aminotransferase and alanine aminotransferase levels >3 times normal upper limit),severe renal dysfunction (serum creatinine >1.5 times the upper limit of normal value, calculated creatinine clearance rate <50 ml/min), treated with arbidol before admission, history of severe heart disease or clinically significant arrhythmia considered unsafe for the trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04260594
|
{
"brief_title": "Clinical Study of Arbidol Hydrochloride Tablets in the Treatment of Pneumonia Caused by Novel Coronavirus",
"conditions": [
"2019-nCoV"
],
"interventions": [
"Other: basic treatment",
"Drug: Arbidol"
],
"location_countries": [
"China"
],
"nct_id": "NCT04260594",
"official_title": "Randomized, Open, Multicenter Study on the Efficacy and Safety of Arbidol Hydrochloride Tablets in Treating Pneumonia in Patients Infected With Novel Coronavirus (2019-ncov).",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-12",
"study_completion_date(actual)": "2020-12-30",
"study_start_date(actual)": "2020-02-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-09-08",
"last_updated_that_met_qc_criteria": "2020-02-06",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-07",
"first_submitted": "2020-02-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice
#Intervention
- DRUG : Triclosan/Copolymer/fluoride toothpaste
- Twice daily usage
- Other Names :
- Total toothpaste
- DRUG : sodium monofluorophosphate toothpaste
- Twice daily usage
- Other Names :
- Colgate cavity protection toothpaste
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects must be adult males or females 18 <= age <= 60 old
* Subjects must be able and willing to follow study procedures and instructions
* Subjects must have generalized, moderate plaque-associated gingivitis as determined by the Investigator or designee during the screening examination
* Subjects must present with at least 20 teeth in the functional dentition, excluding third molars
* Each subject must have at least four teeth with probing depths of 4 <= age <= 5 millimeters and at least 30% of sites bleeding to gentle probing
Exclusion Criteria:
* Subjects who have chronically used (two weeks or more) Total (Triclosan/Copolymer) dentifrice within 6 months prior to enrollment
* Subjects with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity
* Subjects with periodontitis as indicated by periodontal pocketing 6 millimeters at screening
* Subjects with a history of early onset periodontitis or acute necrotizing ulcerative gingivitis
* Subjects with concomitant endodontic or periodontal therapy other than prophylaxis within 6 months prior to enrollment
* Subjects with orthodontic appliances or removable partial dentures
* Subjects chronically treated (two weeks or more) with any medication known to affect inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs, steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within one month of the screening examination. All other medications for chronic medical conditions should be initiated at least three months prior to enrollment
* Subjects who currently smoke or who report using tobacco products within one year of screening.
* Subjects who have been treated with antibiotics for medical or dental reasons within 3 months prior to enrollment
* Subjects having clinically significant or unstable organic disease; subjects having compromised healing potential such as those with diabetes mellitus or connective tissue disorders; subjects having heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis
* Female subjects who report being pregnant
* Subjects who use hormonal contraceptives must have started the method 30 days prior to the screening examination.
* Subjects with active infectious diseases such as hepatitis, human immunodeficiency virus or Tuberculosis
* Subjects diagnosed with human immunodeficiency virus (HIV) or subjects that are immunocompromised as determined by the Investigator
* Medical condition which precludes not eating/drinking for approximately 8 hours.
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
|
NCT00941668
|
{
"brief_title": "Evaluate Inflammation Caused by Gingivitis in Adults",
"conditions": [
"Gingivitis"
],
"interventions": [
"Drug: sodium monofluorophosphate toothpaste",
"Drug: Triclosan/Copolymer/fluoride toothpaste"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00941668",
"official_title": "Evaluate Inflammation Caused by Gingivitis in Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-08",
"study_completion_date(actual)": "2008-08",
"study_start_date(actual)": "2007-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-08-27",
"last_updated_that_met_qc_criteria": "2009-06-03",
"last_verified": "2015-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-07-17",
"first_submitted": "2008-09-26",
"first_submitted_that_met_qc_criteria": "2009-06-03"
}
}
}
|
#Study Description
Brief Summary
Both extra corporeal shock wave and dexamethasone iontophoresisare effective in treatment of knee osteoarthritis but which one is more effective is not clear yet . so the purpose of this study was to investigate and compare between the effect of shock wave and iontophoresis in treatment of knee osteoarthritis . it was hypothesized that there will be no difference between the effect of shock wave and iontophoresis on treatment of knee osteoarthritis.
Detailed Description
60 subjects with grade II knee osteoarthritis will be recruited from outpatient clinic of faculty of physical therapy and then they will be assigned randomly by sealed envelope into three groups ;group A (shock wave group) will received radial extracorporeal shock wave ,group B (Iontophoresis group ) will receive deaxamthasone iontophoresis and group c (control group) will receive traditional tratment ( stregnthening exerciseces) all treatment will be once session per week for four weeks .pain intensity ,knee ROM and knee injury and osteoarthritis outcome score physical function short (KOOS-PS).
#Intervention
- DEVICE : radial extracorporeal shock wave
- Radial shock wave device, Swiss DolorClast (EMS Electro Medical Systems, Nyon, Switzerland)
- DEVICE : iontophoresis
- Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED):
- OTHER : Exercise
- strengthening exercise
|
#Eligibility Criteria:
Inclusion Criteria:
* Symptomatic knee OA for at least 3 months according to clinical criteria of American College of Rheumatology
* Radiologic findings had to be compatible with knee OA, with kelgren and Lawrence (K-L) grade 2 in a simple X ray .
* Tenderness on medial tibial plateau
* Intensity of pain: visual analogue scale equal to 5 or greater
* Failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others)
Exclusion Criteria:
* Neuorological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months
* Any contraindication to magnetic resonance imaging or radiography, or trauma history on knee
* history of previous knee surgery -
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04731350
|
{
"brief_title": "Shock Wave Versus Iontophoresis in Treatment of Subjects With Knee Osteoarthritis",
"conditions": [
"Knee Osteoarthritis"
],
"interventions": [
"Other: Exercise",
"Device: radial extracorporeal shock wave",
"Device: iontophoresis"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04731350",
"official_title": "Effect of Extra Corporeal Shock Wave Versus Dexamethasone Iontophoresis in Treatment of Knee Osteoarthritis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-01",
"study_completion_date(actual)": "2023-01-15",
"study_start_date(actual)": "2021-01-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-03-07",
"last_updated_that_met_qc_criteria": "2021-01-28",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-29",
"first_submitted": "2021-01-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Chronic rhinitis is affecting more than 200 million people worldwide. Its prevalence is estimated to be as high as 30% of the Western population. Rhinitis is defined as symptomatic inflammation of the inner lining of the nose and is characterized by the following symptoms: rhinorrhea, nasal blockage, nasal itching and/or sneezing. The cut-off point for defining rhinitis as chronic rhinitis is considered to be persisting symptoms for over more than twelve weeks Chronic rhinitis can be divided into three major subgroups; based on the knowledge of the major etiological factor: infectious rhinitis, allergic rhinitis and non-allergic, non-infectious rhinitis, in literature also referred to as nonallergic rhinitis. Non-inferiority in efficacy of the two novel treatment regimes i.e. capsaicin nasal spray 0,01mM (2puffs/nostril/day) during 4 weeks and capsaicin nasal spray 0,001mM (2puffs/nostril/day) during 4 weeks compared to the current treatment of capsaicin nasal spray 0,1mM (5/day administered on a single day) with regard to the change from baseline in VAS for major nasal symptom on week 4.
(Estimated placebo effect is 25%.)
#Intervention
- DRUG : Capsaicin
- via nasal spray
- DRUG : placebo
- via nasal spray
|
#Eligibility Criteria:
Inclusion Criteria:
* idiopathic rhinitis patients with at least 2 persistent (> 12w) rhinological symptoms (nasal discharge, sneezing, nasal congestion) for an average of at least 1 h per day,
* idiopathic rhinitis patients with a total nasal symptoms score (TNS) of 5 or more on a visual analogue scale (VAS).
* Age > 18 and < 65 years.
* Written informed consent.
* Willingness to adhere to visit schedules.
* Adequate contraceptive precautions in female patients with childbearing potential.
Exclusion Criteria:
* Patients with concomitant allergic rhinitis, demonstrated by positive skin prick test (Hal reagents) and/or immunoglobins E in blood. *
* Patients with structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall), septal perforation, hypertrophy of the inferior turbinates.
* Patients with local allergic rhinitis (LAR) or entopy.
* Systemic steroid treatment less than 4 weeks before the inclusion in the study, nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion.
* Inability of the patient to stop taking medication affecting nasal function like ß-blockers.
* History of prolonged use or abuse of decongestant nasal spray like xylometazoline spray and/or use or abuse of decongestive oral medication.
* Evidence of infectious rhinitis/rhinosinusitis or common cold within 4 weeks prior to inclusion.
* Pregnancy or lactation. **
* Any disorder of which might compromise the ability of a patient to give truly informed consent for participation in this study.
* Enrollment in other investigational drug trial(s) or receiving other investigational agent(s) for any other medical condition.
* Contra-indications for the use of local anesthesia (cocaine 5%).
* Smoking or occupational exposure to irritants (like hypochlorite, persulfates, isocyanates).
* Nasal malignancies or severe comorbidity like granulomatosis or vasculitis.
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
|
NCT02288156
|
{
"brief_title": "Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis",
"conditions": [
"Non-allergic Rhinitis"
],
"interventions": [
"Drug: Capsaicin",
"Drug: placebo"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT02288156",
"official_title": "Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12",
"study_completion_date(actual)": "2018-12",
"study_start_date(actual)": "2015-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-06-22",
"last_updated_that_met_qc_criteria": "2014-11-10",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-11-11",
"first_submitted": "2014-11-06",
"first_submitted_that_met_qc_criteria": "2020-12-16"
}
}
}
|
#Study Description
Brief Summary
The purpose of the research is to prove the analgesic efficacy of a novel technique in regional anaesthesia, i.e. the catheter under the erector spinae muscle (ESC). Investigators will evaluate the use of the ESC for analgesia after video-assisted thoracoscopic lung surgeries in comparison to the standard method of post-operative analgesia, which is the multiple level intercostal block given at the end of surgery by the surgeon. Investigators will compare the amount of opioid analgesics required by the patient using the patient controlled pump, the pain status in 48-hours after surgery and compare the differences between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.
#Intervention
- PROCEDURE : Erector Spinae Catheter
- Patients in the experimental group will receive the Erector Spinae Catheter with an initial bolus ob 20ml 0,5% levobupivacaine prior the surgery and will be administered local anesthetics for 48 hours post-operatively.
- Other Names :
- continuous regional analgesia
- PROCEDURE : Intercostal block
- Patients in the comparative group will receive standard treatment, i.e. the multi-level intercostal block with 20ml 0,5% levobupivacaine administered at the end of the surgery by the surgeon.
- Other Names :
- Single shot regional analgesia
- DRUG : Ropivacaine 0.2% Injectable Solution
- Patients in the experimental group will receive Ropivacaine 0,2% continous infusion of 5ml/h with boluses 15ml/4h by the Erector Spinae Catheter for 48 hours post-operatively.
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent
* ASA (American Society of Anesthesiologists status) I-III
* Elective video-assisted thoracic surgery - lobectomy with 3 ports technique
* No contraindications for regional anesthesia
Exclusion Criteria:
* Allergy to local anesthetic
* Pregnancy, breastfeeding
* BMI>35
* Inflammation in the area of ES catheter insertion
* Inability to use the PCA pump
* Inability to execute the main inspiratory and expiratory pressure measurements
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
|
NCT04665531
|
{
"brief_title": "Postoperative Analgesia With a Catheter Under the Erector Spinae Muscle for Videothoracoscopic Lung Surgery",
"conditions": [
"Neoplasm of Lung",
"Thoracic Surgery, Video-Assisted"
],
"interventions": [
"Procedure: Intercostal block",
"Drug: Ropivacaine 0.2% Injectable Solution",
"Procedure: Erector Spinae Catheter"
],
"location_countries": [
"Slovenia"
],
"nct_id": "NCT04665531",
"official_title": "Postoperative Analgesia With a Catheter Under the Erector Spinae Muscle for Videothoracoscopic Lung Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-14",
"study_completion_date(actual)": "2022-06-14",
"study_start_date(actual)": "2020-02-19"
},
"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)": "2022-07-19",
"last_updated_that_met_qc_criteria": "2020-12-06",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-11",
"first_submitted": "2020-11-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the amount of polyethylene wear associated with knee replacement designs that incorporate either a fixed or mobile bearing. Tibial polyethylene inserts retrieved from modular total knee replacements during revision operations will be analyzed by obtaining micro-CT images of the retrieved inserts. The components of total volumetric polyethylene loss, including wear associated with the medial articular, lateral articular and backside regions of the insert be quantified by comparing the worn insert with an unworn control. The investigators hypothesize that the fixed bearing inserts where the polyethylene is locked to the metal baseplate will demonstrate more volumetric wear than the mobile bearing inserts that are designed to slide or rotate on the metal baseplate.
Detailed Description
Polyethylene wear is a major factor limiting the longevity of total knee arthroplasty. Evaluation of the volumetric wear of explanted polyethylene tibial inserts can provide valuable insight into the performance of different designs. Current technologies available to measure the volumetric wear of tibial inserts include gravimetric techniques, coordinate measuring machines (CMM), laser-scanning, and micro-CT.
In this study, we will employ micro-CT to determine volumetric wear because it allows us to obtain high-resolution three-dimensional images of the entire insert volume, including the surfaces as well as the interior of the insert. The micro-CT images will be used to reconstruct the entire three-dimensional geometry of the insert (including subsurface voids) and we will use image analysis software to partition the reconstructed insert into discrete regions (i.e. medial/lateral articulating surfaces, backside, and post), allowing us to determine how various regions contribute to total implant wear. By subdividing the insert into discrete regions, our analysis techniques will also enable us to account for material removed from the insert during explantation when evaluating implant wear. By comparing retrieved inserts with unworn controls using three-dimensional image analysis software, we will also quantify plastic deformation by measuring the volume of material that has deformed outside the confines of the control insert. Additionally, inspection of shape differences between the worn and unworn specimens will enable us to distinguish between implant wear, plastic deformation and volume differences associated with manufacturing tolerances. Although partial voluming effects can make edge detection challenging, high resolution micro-CT images tend to minimize these effects and we will use gravimetric measurements to determine an insert-specific Hounsfield threshold that will be used to define the image volume for each specimen. We will subsequently validate the accuracy of the reconstructed insert volume derived from the micro-CT image by comparing it with linear measurements from the actual specimen at several discrete locations.
The use of micro-CT scans to evaluate the in vivo volumetric wear associated with different designs will enable accurate measurement of volumetric polyethylene loss from different regions of the insert. This information will provide a better understanding of the clinical outcome associated with different design strategies and provide data to guide future development efforts. We hypothesize that fixed bearing inserts, where the polyethylene is locked to the metal baseplate, will demonstrate more volumetric wear than the mobile bearing inserts that are designed to slide or rotate on the metal baseplate.
Articular side wear will be measured by registering micro-CT images from retrieved and control inserts on unworn portions of the articular surface using the Analyze image analysis software (Mayo Biomedical Imaging Resource, Rochester, MN). Differences in volume among the retrieved and unworn control inserts will be evaluated accounting for plastic deformation that may occur in vivo. Volumetric wear for the entire insert and subregions will be calculated by subtracting the volume of plastic deformation (corresponding to regions of the retrieved insert outside the boundaries of the control insert) from the volume of material lost within the confines of the original insert geometry. We will compare wear among the mobile and fixed bearings using an Independent Sample t-test or Mann-Whitney U, depending on the distribution of the data. We will also use multiple linear regression analysis to examine the relationship between insert wear and other variables, including time in vivo, terminal sterilization technique for the insert and patient-related factors such as gender, age, and body mass index (BMI).
|
#Eligibility Criteria:
Inclusion Criteria:
* DePuy mobile and fixed bearing polyethylene tibial inserts retrieved after at least 12 months in vivo.
* Inserts terminally sterilized by gas plasma or with gamma radiation in oxygen-free barrier packaging.
Exclusion Criteria:
* Inserts that were sterilized by gamma radiation and exposed to oxygen in packaging.
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
|
NCT01165957
|
{
"brief_title": "A Comparison of Wear Among Mobile and Fixed Bearing Knee Replacements",
"conditions": [
"Osteoarthritis"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01165957",
"official_title": "A Comparison of Volumetric Wear Among DePuy Mobile and Fixed Bearing Knee Tibial Inserts",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-05",
"study_completion_date(actual)": "2012-05",
"study_start_date(actual)": "2010-06"
},
"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)": "2012-08-01",
"last_updated_that_met_qc_criteria": "2010-07-19",
"last_verified": "2012-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-07-20",
"first_submitted": "2010-07-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the effect of a prognosis-guided vs standard medical therapy in the: 1) duration of hospital stay; 2) cost-effectiveness; 3) satisfaction and quality of life; 4) in-hospital and 30-day all-cause mortality; and 5) 30-day readmissions in normotensive patients with acute symptomatic pulmonary embolism (PE).
Design: Prospective, randomized, controlled, single blind trial. Normotensive patients with acute symptomatic PE will be randomly assigned to follow a prognosis-guided treatment, or to receive usual care.
Setting: Respiratory, Medicine and Emergency Departments in 15 Spanish hospitals.
Analyses: Data for the primary and secondary end points will be analyzed according to the intention-to -treat principle. The intention-to-treat analysis will include all randomly assigned patients. For the efficacy end points, investigators will use the Mann-Whitney U test. We will also use competing risk regression models according to Fine and Gray. For the safety end points, comparisons will be made with the use of the chi-square test. Separate analyses will be done in key prespecified subgroups of patients, according to age and hospital size.
#Intervention
- OTHER : Prognosis-guided therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Confirmed PE by objective testing
* Signed and dated informed consent of the subject available before the start of any specific trial procedures
Exclusion Criteria:
* Pregnancy
* Haemodynamic instability
* Contraindication to anticoagulant therapy
* Life expectancy less than 3 months
* Participation in other clinical trials during the present clinical trial
* Use of a fibrinolytic agent, surgical thrombectomy, interventional (transcatheter) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE
* Inability to the follow-up visits
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
|
NCT02733198
|
{
"brief_title": "Prognostication in Acute Pulmonary Embolism",
"conditions": [
"Pulmonary Embolism"
],
"interventions": [
"Other: Prognosis-guided therapy"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT02733198",
"official_title": "Effect of a Prognostic Algorithm to Reduce Length of Stay in Acute Pulmonary Embolism: a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11",
"study_completion_date(actual)": "2019-11",
"study_start_date(actual)": "2017-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-11-18",
"last_updated_that_met_qc_criteria": "2016-04-05",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-11",
"first_submitted": "2016-04-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A high fructose diet increases fasting and post-prandial triglyceride (TG) concentrations in sedentary healthy human subjects.These effects may be secondary to fructose-induced hepatic de novo lipogenesis. Recent evidence indicate that exercise can prevent fructose induced dyslipidemia.This study will evaluate
1. how exercise effects the metabolic fate of oral fructose 1a) when exercise is performed before fructose ingestion 1b) when exercise is performed after fructose ingestion Metabolic effects of exercise will be assessed in healthy male subjects by measuring fructose oxidation (13CO2 production), fructose conversion into glucose (13C glucose concentrations in blood) and hepatic fructose conversion into lipid (13C palmitate-very low density lipoprotein (VLDL) concentrations in blood) after ingestion of 13C-labelled fructose meals
2. how fructose and protein modulate muscle glycogen and intramyocellular lipid repletion after exercise Healthy male subjects will be fed various fructose, glucose, lipid and whey protein meals after a glycogen/intramyocellular lipid depleting exercise. The effects of meals' composition will be assessed after 24 hours by measuring intramyocellular lipids and glycogen using proton-magnetic resonance spectroscopy (MRS).
#Intervention
- OTHER : exercise
- cycling at 100W during 60 min
- DIETARY_SUPPLEMENT : fructose
- isocaloric nutrition with fructose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise
- DIETARY_SUPPLEMENT : glucose
- isocaloric nutrition with glucose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise
|
#Eligibility Criteria:
Inclusion Criteria:
* males
* 18 <= age <= 40 years
* 19 kg/m2>BMI>25kg/m2
* moderate to high usual physical activity
* non-smokers
Exclusion Criteria:
* family history of diabetes mellitus
* ECG anomaly
* any medication
* participation to blood spending or other clinical study in the 3 months before the beginning of this study
* consumption of drugs
* consumption of more than 50g alcool/week
* family history of food intolerance
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01866215
|
{
"brief_title": "Effects of Exercise on Fructose Metabolism",
"conditions": [
"Healthy Subjects"
],
"interventions": [
"Dietary Supplement: glucose",
"Dietary Supplement: fructose",
"Other: exercise"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT01866215",
"official_title": "Effects of Exercise on Fructose Metabolism",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-01",
"study_completion_date(actual)": "2014-01",
"study_start_date(actual)": "2013-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-06-04",
"last_updated_that_met_qc_criteria": "2013-05-30",
"last_verified": "2014-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-05-31",
"first_submitted": "2013-05-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study will investigate the test-retest variability of thermal thresholds in patients with persistent pain after open inguinal herniotomy. Sensory mapping with a cool metal roller delineated an area with cool sensory dysfunction on the painful site. In this area and in a contralateral area as a control, 5 sites were outlined, including the point of maximum pain. In these total 10 sites warmth detection threshold (WDT), cool detection threshold (CDT) and heat pain threshold (HPT) were assessed using quantitative sensory testing. Tests were repeated after a 4-6 weeks interval.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with persistent pain after open inguinal herniotomy
* Age > 18 years
Exclusion Criteria:
* Cognitive impairment
* Drug or alcohol abuse
* Bilateral inguinal hernia operation
* Nerve injury from other causes
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01768130
|
{
"brief_title": "Variability in Thermal Thresholds in Patients With Persistent Pain After Open Inguinal Herniotomy",
"conditions": [
"Persistent Pain After Open Inguinal Herniotomy"
],
"interventions": null,
"location_countries": [
"Denmark"
],
"nct_id": "NCT01768130",
"official_title": "Variability in Thermal Thresholds in Patients With Persistent Pain After Open Inguinal Herniotomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-10",
"study_completion_date(actual)": "2013-10",
"study_start_date(actual)": "2011-04"
},
"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)": "2014-02-28",
"last_updated_that_met_qc_criteria": "2013-01-11",
"last_verified": "2014-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-01-15",
"first_submitted": "2013-01-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
IgA nephropathy (IgAN) is the most prevalent form of primary glomerulonephritis in the Western world. Although most IgAN patients take a benign longterm course, about 20-30% progress to end-stage renal disease (ESRD) over 20 years. The majority of current treatment recommendations is based on weak evidence.
In the randomized, controlled Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgAN (STOP-IgAN) trial, the investigators analyzed whether additional immunosuppression on top of standardized supportive care provides renal benefits in patients with progressive IgAN. Patients with persisting proteinuria \>0.75 g/d (n=162) despite optimized supportive treatment including control of blood pressure and proteinuria, were randomized to either continue on supportive care or to receive additional immunosuppression during the 3-year trial phase. It was observed that immunosuppressive therapy in addition to optimized supportive care led to more full clinical remissions, but eventually did not better preserve renal function, did not better save patients from ESRD development and evoked more adverse effects such as infections, weight gain and diabetes.
Aim of this planned study is to analyze renal outcome measures and adverse effects in the longterm observation of all randomized STOP-IgAN participants to ascertain quality and strength of the original trial results. By its observational nature, this quality control study includes the 162 IgAN patients (with the exception of drop-out patients) that had been previously randomized into the original STOP-IgAN trial.
Information on serum creatinine, proteinuria, ESRD, death, relevant adverse events such as major cardiovascular events, osteoporosis, osteonecrosis, bone fractures, diabetes, malignancies and interim treatment will be collected as available from existing routine records until March 31, 2018.
Primary endpoint is the time to the first occurring event of the binary composite of all-cause death, ESRD or decline in estimated glomerular filtration rate (eGFR) by at least 40% as compared to enrollment into the original trial. Secondary outcome measures comprise the individual components of the primary endpoint, absolute eGFR at the end of observation, proteinuria and adverse events. Information on specific treatments with renin-angiotensin-system (RAS)-blocking agents and/or interim immunosuppression will also be collected. All data will be recorded in a pseudonymous fashion in a central electronic data base located at the PI's site.
Detailed Description
Aim: Observational quality control study to analyze renal outcome measures and adverse events in the longterm observation of all randomized STOP-IgAN participants to ascertain quality and strength of the original trial results.
Eligible subjects/sample size: By its observational nature, this study includes the 162 IgAN patients (with the exception of drop-out patients) that had been previously randomized into the original STOP-IgAN trial. Since this study is performed as quality control study of previously randomized patients, a new written informed consent is not necessary.
Endpoints: Primary endpoint is the time to the first occurring event of the binary composite of all-cause death, ESRD or decline in estimated glomerular filtration rate (eGFR) by at least 40% as compared to enrollment into the original trial (time-to-event analysis). Secondary outcome measures comprise the individual components of the primary endpoint, absolute eGFR at the end of observation, proteinuria and adverse events. Information on specific treatments with renin-angiotensin-system (RAS)-blocking agents and/or interim immunosuppression will also be collected.
Data collection: Available information on serum creatinine, proteinuria, ESRD, death, relevant adverse events such as major cardiovascular events, osteoporosis, osteonecrosis, bone fractures, diabetes, malignancies and interim treatment will be collected retrospectively as available from existing nephrology routine records until March 31, 2018. The involved nephrology departments (all in Germany) will be contacted by phone and asked to provide these informations from the randomized STOP-IgAN patients. All data will be recorded in a pseudonymous fashion in a central electronic data base located at the PI's site. To assure high-standard data quality, source data entry will be performed in a double-entry mode, i.e. each data point will be entered independently by two individuals.
#Intervention
- OTHER : observation
- Observation of renal outcome parameters and adverse events in the follow-up beyond the 3-year trial phase of the original STOP-IgAN trial.
|
#Eligibility Criteria:
Inclusion Criteria:
All randomized STOP-IgAN participants.
Exclusion Criteria:
Drop-outs of the main STOP-IgAN trial.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03488368
|
{
"brief_title": "Longterm Renal Oucomes of STOP-IgAN Trial Participants",
"conditions": [
"IgA Nephropathy"
],
"interventions": [
"Other: observation"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT03488368",
"official_title": "Quality Control of STOP-IgAN Trial Results in Longterm Observation With Existing Routine Data of Randomized Trial Participants (STOP-IgAN - Longterm) - Observational Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-07-31",
"study_completion_date(actual)": "2018-12-31",
"study_start_date(actual)": "2018-02-01"
},
"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)": "2019-03-26",
"last_updated_that_met_qc_criteria": "2018-03-28",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-04-05",
"first_submitted": "2018-03-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objectives of this study are to characterize the clinical performance and wear mechanisms of all-ceramic posterior crowns. The wear rate of all-ceramic crowns and opposing enamel in selected patients will be quantified. The relationship of each subject's maximum clenching force and wear rate will also be analyzed.
Detailed Description
High strength ceramics have been used in dentistry for constructing fixed partial denture. Their advantages are their acceptable fracture resistance, excellent biocompatibility, moderate opacity, etc. Because the increase in demand for more esthetic restoration, various ceramic materials have been used as a core material for several all-ceramic systems. Their properties have been investigated extensively in many in vitro studies. Currently, there are not much results regarding clinical performance and wear mechanism of ceramic-based prosthesis and more information are required for future research.
#Intervention
- OTHER : lithia-disilicate-based crown
- all-ceramic crown
- Other Names :
- ceramic crown
|
#Eligibility Criteria:
Inclusion Criteria:
* Occlusion: At least 20 remaining teeth for each patient, and at least one posterior endodontically treated tooth with natural opposing teeth
* Bruxism: No evidence based on an intraoral examination
* Dental history: No evidence of either moderate or severe periodontal disease
* Medical history: Good to excellent general health
Exclusion Criteria:
* Periodontal status: Pocket depth greater than 4 mm
* Occlusion:
* Evidence of bruxism or excessive biting or clenching force
* Abutment tooth that opposes a removable partial denture
* Abutment tooth for fixed partial dentures
* Gingival recession of an abutment tooth more than 1 mm from the cementoenamel junction
* Tooth with first or second degree of tooth mobility
* Tooth with extensive carious lesions
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
|
NCT00889239
|
{
"brief_title": "Clinical Performance and Wear Mechanism of Hot-Pressed Ceramic Crowns",
"conditions": [
"Ceramic and Dental Enamel Wear"
],
"interventions": [
"Other: lithia-disilicate-based crown"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT00889239",
"official_title": "Clinical Performance and Wear Mechanism of Hot-Pressed Ceramic Crowns",
"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)": "2004-05"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-05-15",
"last_updated_that_met_qc_criteria": "2009-04-27",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-04-28",
"first_submitted": "2009-04-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Improving the management of perioperative anxiety is important. Anxiety can have an impact on the intervention and can increase postoperative complications as well as emotional and behavioral incidents that then have an impact on adherence to care. These findings are also true in interventional cardiology. That is why, for several months, the Grenoble University hospital paramedical team, in collaboration with the medical profession, improved by using several techniques (educational sheet, therapeutic communication). Following a survey of the patients of Grenoble university hospital, a gray area persists in their care. The room where the patient attends his examination. The investigators would then use the new technology that makes virtual reality in the transfer room to evaluate its benefit in a random study on preoperative anxiety in interventional cardiology.
#Intervention
- OTHER : VIRTUAL REALITY
- Patient equipped with virtual reality in transfer room
|
#Eligibility Criteria:
Inclusion Criteria:
* Major male or female patient
* Coronarography procedure programmed for exploration of coronary artery disease following a positive ischemia test, realized in ambulatory
* Patient who has given written consent to participate in the study
Exclusion Criteria:
* Arrhythmia patient and / or patient with a pacemaker
* Hemodynamic instability
* Patient who has already had coronarography
* Prior revascularization by coronary bypass
* End-stage renal disease (Creatinine clearance <30 ml / min),
* Allergy to iodine contrast agent
* Blind or visually impaired patient (high degree)
* Deaf or hard of hearing patient
* Patient with claustrophobia or unable to wear a mask over the eyes
* Patient whose physical or psychological state could compromise obtaining informed consent and compliance with protocol requirements
* Patient under administrative or judicial supervision
* Foreign patient who does not understand French
* Major patient protected by law (article L1121 <= age <= 8 and L1121 <= age <= 5)
* Pregnant or lactating patient
* Patient not affiliated with social security
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
|
NCT04242563
|
{
"brief_title": "Virtual Reality for Preoperative Anxiety in Interventional Cardiology",
"conditions": [
"Anxiety"
],
"interventions": [
"Other: VIRTUAL REALITY"
],
"location_countries": [
"France"
],
"nct_id": "NCT04242563",
"official_title": "Virtual Reality for Preoperative Anxiety in Interventional Cardiology",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-07-12",
"study_completion_date(actual)": "2021-07-12",
"study_start_date(actual)": "2020-02-02"
},
"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)": "2022-05-19",
"last_updated_that_met_qc_criteria": "2020-01-22",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-27",
"first_submitted": "2019-12-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Video-assisted thoracoscopic (VATs) lobectomy is mild to moderately pain procedure. For conventional thoracotomy, there are many invasive pain control such as epidural analgesia, paravertebral block. However, for VATs, the invasive pain control somehow are too invasive. Nefopam is non-opioid painkilling medication, Serotonin, norepinephrine, dopamine reuptake inhibitor. Many study were demonstrated positive outcome of nefopam usage in many operation such as abdominal surgery, laparocopic surgery, orthopedic surgery. Nevertheless, nefopam for VATs is not well studied yet.
#Intervention
- DRUG : Nefopam 20 MG/ML
- Nefopam group nefopam 20 mg during surgery and follow by 80 mg in 24 hours postoperative
- DRUG : Placebo
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Schedule to video-assisted thoracoscopic surgery : VATs lobectomy
* Can operate a patient-controlled analgesia (PCA) device
* No contraindication for nefopam
Exclusion Criteria:
* Epilepsy, on monoamine oxidase (MAO) inhibitors, glaucoma
* Creatinine clearance < 60 ml/min
* Liver disease: child-pugh score B or C
* Allergy to nefopam
* Chronic opioid use
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04241640
|
{
"brief_title": "Nefopam for Post Video-Assisted Thoracoscopic Lobectomy",
"conditions": [
"Pain, Postoperative"
],
"interventions": [
"Drug: Nefopam 20 MG/ML",
"Drug: Placebo"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT04241640",
"official_title": "Nefopam for Post Video-Assisted Thoracoscopic Lobectomy Pain Management and the Improvement of Enhanced Recovery After Surgery (ERAS): a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-08-01",
"study_completion_date(actual)": "2023-03-01",
"study_start_date(actual)": "2020-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-20",
"last_updated_that_met_qc_criteria": "2020-01-24",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-27",
"first_submitted": "2020-01-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of the study is to conduct a randomized controlled trial to determine the impact of a multi-level culturally-sensitive decision support intervention on colorectal cancer screening adherence among 400 Chinese and Korean American primary care patients.
Detailed Description
This study culturally adapts existing evidence-based decision support navigation intervention and tests its efficacy among 200 Chinese and Korean American men and 200 Chinese and Korean American women aged 50 to 75 eligible for colorectal cancer screening. Participants are recruited from primary care physician clinics. The study is designed to compare colorectal cancer screening outcomes between the decision support navigation intervention and the advanced control. Those randomized to the advanced control group only receives an informational booklet, a stool blood test kit and a reminder by mail. Those randomized to the decision support navigation intervention group receives everything the advanced control group receives as well as decision support and navigation contacts. Investigators in the study develop an individualized screening plan using a theory-based online Decision Counseling Program, share the plan with the participants' primary care physicians, and have primary care physicians to encourage the colorectal cancer screening to participants. Using outcomes data collected by survey and medical record review, this study: (1) determines overall colorectal cancer screening adherence in the culturally adapted decision support navigation intervention vs. the advanced control; (2) measures change in colorectal cancer screening decision stage in the culturally adapted decision support navigation intervention vs. the advanced control; and (3) assesses colorectal cancer screening test-specific (stool blood test vs. colonoscopy) adherence in the culturally adapted decision support navigation intervention vs. the advanced control. Additionally, investigators in the study evaluate intervention reach, effectiveness, adoption, implementation, and maintenance using interview data.
#Intervention
- BEHAVIORAL : Advanced Control
- Participants receive linguistically and culturally tailored information booklet on colorectal cancer and colorectal cancer screening, colonoscopy instructions, stool blood test kits and reminder by mail. Participants' height, weight, and waist/hip circumference, blood pressure, blood glucose, and cholesterol levels will be measured by trained research staff. Participants will also receive the result of body measurements right away as a free service.
- BEHAVIORAL : Culturally-Adapted Decision Support Navigation Intervention
- Participants in this group receive everything that advanced control group receives. In addition to a set of standard materials, they receive culturally and linguistically adapted decision counseling from the patient navigator. The patient navigator develops an individualized colorectal cancer screening plan using a theory-based online Decision Counseling Program. After the Program is completed, the patient navigator develops individualized colorectal cancer screening plan and shares the information with participants and participants' primary care physicians. Then, primary care physicians encourage the colorectal cancer screening to participants.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female Chinese and Korean American patients aged 50 to 75, who are not up to date for colorectal cancer screening
Exclusion Criteria:
* Those with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancer screening.
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:
Yes
|
NCT03481296
|
{
"brief_title": "Screening TO Prevent ColoRectal Cancer (STOP CRC) Among At-Risk Chinese and Korean American Primary Care Patients",
"conditions": [
"Colorectal Cancer"
],
"interventions": [
"Behavioral: Advanced Control",
"Behavioral: Culturally-Adapted Decision Support Navigation Intervention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03481296",
"official_title": "Culturally Adapted Multilevel Decision Support Navigation Trial To Reduce Colorectal Cancer Disparity Among At-Risk Asian American Primary Care Patients",
"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)": "2018-08-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-03",
"last_updated_that_met_qc_criteria": "2018-03-26",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-03-29",
"first_submitted": "2018-03-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The frequency of severe forms of COVID-19 is higher in people with neuromuscular disease and in severe cases and long hospital stays, the disability of some neuromuscular patients may worsen due to prolonged bed rest . Finally, the symptoms of certain diseases such as myasthenia gravis can worsen after an infection such as COVID-19.
Thanks to an unprecedented research effort, vaccines are now available and others still in development. The first studies published in medical journals are reassuring about the efficacy and safety of these vaccines. However, they have been studied in the general population and we do not yet have specific information in neuromuscular patients.
This is the reason why the Va-C-NEMUS observatory was launched.
Detailed Description
Prevention of COVID-19 in neuromuscular patients is therefore fundamental and vaccination is eagerly awaited by patients and their healthcare teams. An unprecedented research effort has made it possible to create vaccines in a very short time when no vaccine directed against a coronavirus has existed until now. Some of these vaccines are based on proven technologies while others such as RNA vaccines are very innovative. The results of the phase III studies of 3 of them have just been published (Pfizer/BioNTech, Moderna and Astra-Zeneca). Among them, the Pfizer-BioNTech and Moderna vaccines have received authorization for use from the European Medicines Agency. The data on the individuals enrolled in these trials are still not very detailed. However, we already know that in the Pfizer/BioNTech trial, patients on immunosuppressants were excluded. For the Astra-Zeneca vaccine, the publication combines data from 4 different trials. In two of them the patients had to be in 'good health'. In any case, we do not know the pathologies presented by patients outside the usual risk factors for the severe form of COVID-19 (age, obesity, cardiovascular diseases, respiratory diseases). No data on neuromuscular patients are currently known. The vaccination campaign began in France in January 2021. The first neuromuscular patients should be vaccinated soon depending on their comorbidities, but many questions arise in these patients both in terms of safety and efficacy.
#Intervention
- OTHER : Survey
- 1 initial questionnaire and 1 monthly follow-up questionnaire for 11 months
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient with one of the following neuromuscular diseases:
* Autoimmune myasthenia gravis, Lambert-Eaton syndrome
* Congenital myasthenic syndromes
* Myositis
* Inflammatory neuropathies
* Hereditary neuropathies (Charcot-Marie-Tooth disease, etc.)
* Amyloid neuropathies
* Spinal atrophies
* Myotonic dystrophies type 1 (Steinert disease) and 2 (PROMM)
* Duchenne and Becker muscular dystrophies
* Muscular dystrophies of the girdles
* Pump disease
* Congenital myopathies
* Congenital muscular dystrophies
* Metabolic myopathies
* Other myopathies with confirmed genetic diagnosis
* Patient > 18 years
* Patient having understood that the follow-up of a possible side effect of the vaccination or of a COVID-19 must be carried out by his usual doctor (s) and not by the observatory team Va-C-NEMUS
* Patients having been informed of the study and having expressed their agreement
Exclusion Criteria:
* Patient under legal protection, curatorship or tutorship
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05311904
|
{
"brief_title": "Efficacy and Safety of Vaccination Against COVID-19 in Neuromuscular Patients",
"conditions": [
"Neuromuscular Diseases"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT05311904",
"official_title": "Observatory of the Efficacy and Safety of Vaccination Against SARS-CoV-2 in Neuromuscular Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-03",
"study_completion_date(actual)": "2023-02-03",
"study_start_date(actual)": "2021-03-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-06",
"last_updated_that_met_qc_criteria": "2022-04-01",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-05",
"first_submitted": "2021-03-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Clinical Trial comparing the 1,550-nanometer fractionated photothermolysis system laser to the 755 nanometer picosecond laser using a split-face (Right-Left) comparison. Patients will receive laser treatments at week 0, week 4, and week 8. Photographs will be taken prior to laser treatment at each visit, and at the week 24 follow-up visit. Photographs will be reviewed by blinded assessors to rate each side of the face and change from baseline photos.
Detailed Description
This is a Clinical Trial comparing the 1,550-nanometer fractionated photothermolysis system laser to the 755 nanometer picosecond laser using a split-face (Right-Left) comparison. Both of these lasers are currently FDA approved for acne scarring.
Approximately 18 subjects, men and women with Fitzpatrick skin types I through V and facial acne scarring of grades III-IV (moderate to severe) will be enrolled. Both sides of the participants' face should have similar amount and severity of acne scarring. Participants will be over 18 years old. Patients have to be otherwise healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity.
Patients have to be overall healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity. Per PI discretion, any serious medical condition that may interfere with the study. In addition, patients who have been taking isotretinoin for a period of 6 months before treatment will be excluded.
Patients will have photographs taken at every visit prior to the laser treatments at week 0, week 4, and week 8. Photographs will also be taken at the week 24 follow-up visit. Photos will then be assessed by qualified blinded reviewers for comparison.
#Intervention
- DEVICE : 1,550 fracionated photothermolysis laser
- All subjects will have one side of their face treated with one laser, and the other side with the other laser.
- DEVICE : 755 picosecond laser
- All subjects will have one side of their face treated with one laser, and the other side with the other laser.
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women with Fitzpatrick skin types I through V and facial acne scarring of grades III-IV (moderate to severe) will be enrolled. Both sides of the participants' face should have similar amount and severity of acne scarring. Participants will be > 18 years. Patients have to be otherwise healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity.
Exclusion Criteria:
* Patients have to be overall healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity. Per PI discretion, any serious medical condition that may interfere with the study. In addition, patients who have been taking isotretinoin for a period of 6 months before treatment will be excluded.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03988049
|
{
"brief_title": "Comparison of 1,550 and 755 Laser in a Split-face Trial",
"conditions": [
"Acne Scars - Mixed Atrophic and Hypertrophic"
],
"interventions": [
"Device: 755 picosecond laser",
"Device: 1,550 fracionated photothermolysis laser"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03988049",
"official_title": "Comparison of a 1,550 Nanometer Erbium: Glass Fractional Laser and 755-nanometer Alexandrite Picosecond Pulse Duration Laser With Diffractive Lens Array in the Treatment of Acne Scars: a Randomized, Split-face Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-01",
"study_completion_date(actual)": "2019-10-30",
"study_start_date(actual)": "2017-03-08"
},
"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)": "2021-06-29",
"last_updated_that_met_qc_criteria": "2019-06-14",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-17",
"first_submitted": "2017-12-06",
"first_submitted_that_met_qc_criteria": "2021-06-08"
}
}
}
|
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