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#Study Description
Brief Summary
The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be used.
#Intervention
- DEVICE : Veriset™ Hemostatic Patch
- Topical Hemostat
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject or authorized representative has provided informed consent.
* Subject is >= 18 years.
* Subject is scheduled for nonemergent surgery where a topical hemostatic agent would be used to control bleeding emanating from a tissue bed following organ dissection or removal or a bleeding tumor tissue bed following resection or dissection, via an open approach.
* Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
* Subject has an appropriate Target Bleeding Site (TBS) during the surgical procedure.
* TBS bleeding assessment is Type 2 or 3 (refer to table in protocol).
Exclusion Criteria:
* Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
* Subject has an estimated life expectancy of less than 6 months.
* Subject is scheduled for another planned surgery and the subsequent surgery would jeopardize the previous application of study treatment.
* Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death.
* Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with the study.
* Subject has an active local infection at the TBS.
* The investigator determines that participation in the study may jeopardize teh safety or welfare of the subject.
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
|
NCT01719172
|
{
"brief_title": "A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue",
"conditions": [
"Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach"
],
"interventions": [
"Device: Veriset™ Hemostatic Patch"
],
"location_countries": [
"Austria",
"Germany"
],
"nct_id": "NCT01719172",
"official_title": "A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-05",
"study_completion_date(actual)": "2013-06",
"study_start_date(actual)": "2012-09"
},
"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)": "2014-02-27",
"last_updated_that_met_qc_criteria": "2012-10-30",
"last_verified": "2014-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-11-01",
"first_submitted": "2012-10-30",
"first_submitted_that_met_qc_criteria": "2014-01-17"
}
}
}
|
#Study Description
Brief Summary
Waterpipe smoking is a tobacco use method in which smoke passes through a partially-filled water jar. Burning charcoal heats the waterpipe tobacco which produces the smoke that the user inhales. Waterpipe smoking was associated with increased risk for coronary heart and pulmonary diseases. This Waterpipe Study will inform the FDA on regulating waterpipe tobacco products and reduce the harm of it use. This study will be conducted at homes of hookah smokers, in natural settings, aimed to determine the effects of waterpipe smoking practices on physiological injury markers and biomarkers of toxicity of waterpipe tobacco smoking. The investigators will employ a repeated measures design. The investigators will recruit a sample of 50 adult male and female exclusive waterpipe smokers and a control sample of 25 male and female non-smokers via intercept interviews from San Diego County, California communities. Waterpipe smokers will smoke one waterpipe tobacco head (10g) of Starbuzz during 3 separate sessions with a 7-day washout period before each session, as follows: Session 1, Smoking waterpipe tobacco using 1 quick-light charcoal and room temperature water in the waterpipe jar, Session 2, Smoking waterpipe tobacco using 1 quick-light charcoal and adding ice cubes to the water in the waterpipe jar, and Session 3, Smoking waterpipe tobacco without charcoal using a charcoal-free electrically heated waterpipe head to heat the tobacco, and room temperature water in the waterpipe jar. The following data will be collected: a) Tobacco Use History, b) 4-week Tobacco Exposure Diary, c) Waterpipe Use Session Form, d) Carbon monoxide (CO) exposure: Micro+ Smokerlyzer® CO monitor will be used for exhaled CO pre and 2 minutes post each smoking session, e) Pulmonary function testing and measuring blood pressure, heart rate and respiratory rate, and f) 6 first morning urine samples: pre and post the 3 sessions to measure urinary cotinine, a metabolite of nicotine, 4-(methylnitrosamino)-1- (3-pyridyl)-1-butanol (NNAL) and NNAL-glucuronides (total NNAL), metabolites of the lung carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), 1-hydroxypyrene (1-HOP), a metabolite of the genotoxic carcinogen pyrene, and S-phenylmercapturic acid (SPMA), a metabolite of the human hematotoxicant and leukemogen benzene. The investigators will explore exposure levels to furan, a liver toxicant and carcinogen, among waterpipe smokers via measuring its urinary metabolite Furan-BDA-NAL.
Detailed Description
Globally, 1 in 3 adults or 1.2 billion people smoke. The World Health Organization (WHO) estimated that tobacco is responsible for the death of 1 in 10 adults worldwide, about 6 million premature deaths each year. In the United States (U.S.), cigarette smoking is responsible for more than 480,000 deaths per year, including nearly 42,000 deaths resulting from secondhand smoke exposure. Tobacco use is the single leading most preventable cause of disease, disability, and mortality in the U.S. Tobacco research tends to focus on cigarettes; however, the rise in waterpipe (WP) tobacco use globally warrants studying all aspects of its toxicity. In 2005, the WHO called for a better understanding of WP tobacco smoking. In 2007, the American Lung Association labeled WP smoking as an emerging deadly trend. WP tobacco use was associated with increased risk for Chronic obstructive pulmonary disease (COPD), heart diseases, lung cancers, oral and esophageal cancers.
COPD is a major public health problem leading to airflow obstruction. In the U.S., tobacco smoke is a key factor in the development of COPD, which was the third leading cause of death in the U.S. in 2014. WP smoking decreases respiratory quality of life in adults. Studies found that pulmonary function following WP smoking was impaired as measured by forced expiratory volume (FEV1), forced vital capacity (FVC), FEV1/FVC, and Forced Expiratory Flow (FEF25-75%). Studies investigating acute cardiovascular injury markers due to WP smoking showed significant increases in heart rate, and in systolic and diastolic blood pressure.
In 2014, the U.S. Food and Drug Administration (FDA) initiated regulation WP tobacco. The FDA proposed that the manufacturers of WP tobacco disclose to the FDA their products' ingredients and report harmful and potentially harmful constituents (HPHCs). A review study showed that exposures to HPHCs are 10-100 times higher in WP tobacco smoke than in cigarette smoke. To inform the FDA on the regulation of WP tobacco products, and reduce the harm of it use, the investigators propose a Waterpipe Project in a natural setting to determine the differential effects of WP smoking practices on physiological injury markers, and biomarkers of toxicants and carcinogens.
Worldwide, the WP is used in Africa, Asia, China, India, and the Middle East. Adolescents and young adults in the U.S. are experimenting with WP smoking. The 2014 U.S. National College Health Assessment II found that nearly one third of U.S. undergraduate college students (38.2% of men and 31.4% of women), reported ever using WP tobacco, and 11.6% of men and 8.3% of women reported current use (past 30 days). Among high school students, the 2013 U.S. National Youth Tobacco Survey showed that 15.1% of boys and 13.5% of girls reported ever WP use.
The WP (hookah) consists of a head, a body, a hose, and a water jar. The tobacco is placed in the head and covered with a perforated aluminum foil to allow air-flow. Burning charcoal is placed on top of the aluminum foil. Upon deep inhalation via the WP hose, suction forces hot air through the head, heating and combusting the tobacco to produce the smoke that is forced down the WP body, into and out of the water in the airtight jar, and through the hose into the smoker's mouth and respiratory system. Smokers inhale charcoal toxicant emissions in addition to those from the WP tobacco. Charcoal combustion contributes greatly to benzene, carbon monoxide (CO) and carcinogenic yields. CO is a smoke toxicant that reduces the blood's ability to transport oxygen to various organs, including the brain, and can cause dizziness, headache, syncope and nausea.
A charcoal-free electrically heated WP head is commercially available. Users were satisfied with this device because they did not have to deal with charcoal fire hazardous ambers and ashes, in addition to enjoying the feeling of reduced harm. WP smokers normally use room temperature water in the WP jar. However, other liquid media are gaining in popularity. According to anecdotal evidence, 'adding ice cubes in the WP jar has an enjoyable cooling effect to the inhaled smoke'. Smokers practice adding ice cubes at home, and for an extra charge hookah lounges provide this option for customers. Toxic chemicals in WP tobacco smoke include cotinine, a metabolite of the addictive drug nicotine; 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) and NNAL-glucuronides (total NNAL); metabolites of the lung carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK); 1-hydroxypyrene (1-HOP), a metabolite of the genotoxic carcinogen pyrene; and S-phenylmercapturic acid (SPMA), a metabolite of the human hematotoxicant and leukemogen benzene; and Furan-BDA-NAL, a metabolite of the carcinogen furan.
METHODS. will compare exhaled CO, pulmonary functions, blood pressure, heart rate and respiratory rate, and urinary levels of cotinine, NNAL, SPMA, and 1-HOP in first void WP smoker urine samples the morning of, and the morning after a WP smoking session across 3 smoking practices. The investigators will recruit a sample of 50 adult male and female exclusive WP smokers and a control sample of 25 male and female non-smokers. Participants will be recruited and qualified via random intercept screen interviews from San Diego County, California communities. Over a 3-week study period, WP smokers will smoke one WP tobacco head (10g) of Starbuzz during 3 separate sessions with a 7-day washout period before each session in their home in a natural setting: Week 1-Session 1, WP smokers will smoke using 1 quick-light charcoal and room temperature water in the WP jar, Week 2-Session 2, WP smokers will smoke using 1 quick-light charcoal but adding ice cubes to the water in the WP jar, Week 3-Session 3, WP smokers will smoke WP tobacco without charcoal using the electric WP head and room temperature water. The investigators will collect the following forms: a) Tobacco Use History; b) 3-week Tobacco Use and Exposure Diaries; c) WP Smoking Session Day and Exposure Form; and will measure d) CO exposure: Micro+ Smokerlyzer® CO monitor will be used for exhaled CO two minutes pre and post each smoking session; e) Pulmonary function testing and measuring blood pressure, heart rate and respiratory rate pre and post each smoking session; and f) 6 first morning urine samples: pre and post the 3 sessions to measure urinary cotinine, NNAL, 1-HOP, SPMA, and Furan-BDA-NAL. Efforts will be made to recruit equal samples of males and females. Flexible scheduling for study activities where applicable. Proration of incentives will apply for completed activities.
The 3-Week Study period: comprised of 3 WP smoking sessions with 7-day wash-out periods
WP Smoking Session 1. Day 1 - Office Visit: The Office Visit is expected to take between 60 and 90 minutes where potential participants will be trained on the study activities. Consent will be obtained, study forms will be completed, and study related materials such as forms and urine cups will be provided. Scheduling will be arranged for the 3 WP smoking sessions and corresponding home visits. Saliva Test: Trained by the PI, the RAs will use NicAlert, an accurate and valid commercial semi-quantitative instant saliva cotinine test, to validate non-smoking status, which the investigators used successfully in their previous studies. The following physiological baseline data will be collected: pulmonary functions, blood pressure, heart rate and respiratory rate. Days 2 - 6: The RAs will contact participants by phone on the 4th day to confirm adherence to the 7-wash-out period and diaries, and on the 6th day to remind participants to collect the first morning urine sample on day 7, and to arrange for a home visit for the first WP smoking session. Day 7: WP smoking session 1. WP smokers will provide one first morning urine sample and store it in their refrigerator (freezer section). WP smokers will smoke WP tobacco (10 grams) as they normally do using charcoal and room temperature water in the water jar. The RAs will collect expired CO levels 2 minutes before and 2 minutes after concluding smoking, and will measure pulmonary functions, blood pressure, heart rate and respiratory rate thereafter. Day 8: Participants will provide a first morning urine sample. The RAs will pick up the 2 urine samples (frozen in a cooler to transfer them to the research center laboratory), and arrange for the 2nd WP smoking session home visit, provide forms, urine cups package for week 2 of the study. WP Smoking Session 2. Days 1 through 7 are similar to session 1 with the exception that the RAs will add one tray of ice cubes and water in the WP jar. The RAs will arrange for a training session to use the charcoal-free electrically heated WP head. WP Smoking Session 3. Days 1 through 7 are similar to session 1 using room temperature water in the WP jar, however using the charcoal-free electrically heated WP head instead of using charcoal. During the last visit, the day after the 3rd smoking session, the RAs will interview participants to complete the Illnesses and Health Care History Form, pick up the final urine samples, and thank the participants.
#Intervention
- DEVICE : Waterpipe smoking
- In a repeated measures design, 50 adult male and female exclusive WP tobacco smokers will smoke WP tobacco weekly over a 3-week study period with 3 WP smoking practices as follows: 1) using room temperature water in the WP jar, 2) adding ice cubes to the water in the WP jar, and 3) using a charcoal-free electronic WP head to heat the tobacco. Six Spot first morning urine samples will be provided by participants. Two urine samples per each of the 3 smoking sessions. Urine samples will be provided on the day of the WP tobacco smoking session and the following day. Physiological measures will be taken at Baseline during the office visit and before and after each of the 3 WP tobacco smoking sessions.
|
#Eligibility Criteria:
Inclusion Criteria for a Waterpipe Tobacco Smoker
* Adult male or female exclusive waterpipe tobacco smoker
* Smokes at least 1 waterpipe tobacco head per month
* Smokes waterpipe tobacco at home
* Age >= 21 years
Inclusion Criteria for a Non-Smoker
* Adult male or female non-smoker
* Lived in a 'non-smoker home' at least in the last month
* Age >= 21 years
Inclusion Criteria for a Non-Smoker Home
* No smokers have lived in in the past month
* No visitors had smoked indoors/outdoors in the past month
Exclusion Criteria
* Major physical/psychiatric illnesses
* Daily waterpipe smokers
* Pregnant women
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03253653
|
{
"brief_title": "Assessing Toxicity of Waterpipe Tobacco Smoking",
"conditions": [
"Waterpipe Smoking"
],
"interventions": [
"Device: Waterpipe smoking"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03253653",
"official_title": "Assessing Toxicity of Waterpipe Tobacco Smoking in Laboratory and Naturalistic Settings",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09-25",
"study_completion_date(actual)": "2018-09-25",
"study_start_date(actual)": "2017-10-20"
},
"study_design": {
"allocation": null,
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-29",
"last_updated_that_met_qc_criteria": "2017-08-15",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-18",
"first_submitted": "2017-08-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main hypothesis of this study is that Kangaroo Father Care (KFC) will positively impact acute physiologic and long-term behavioral outcomes in infants, fathers, and families.
Detailed Description
Screening:
Participants will be recruited from the NICU at Prentice Women's Hospital. A member of the study team will screen all NICU patients for inclusion and exclusion criteria by reviewing electronic medical records. A screening and enrollment log will be kept to track families who have been approached and agreed or declined to participate in the study. The screening and enrollment log will be kept on a secure REDCap server housed by Northwestern University. Only the study team will have access to this log.
Kangaroo Care (KC) Intervention:
After enrollment, families will be scheduled to participate in two sessions of KC over two sequential days. The goal will be to schedule the KC sessions for the same time of day (i.e. morning, afternoon, or evening). However, if this is not possible given the parents', the sessions will be scheduled for any time of day that participating parents are able to visit their infant in the NICU. Each session will include two hours of continuous KC, with one day focused on Kangaroo Mother Care (KMC) and the other on Kangaroo Father Care (KFC), in a randomized order. These sessions will include continuous skin-to-skin holding of the infant by the parent, per standard of care protocol.
Physiologic Recording:
1) Infant: Prior to the first scheduled KC session, two wearable, wireless biosensors will be placed on the infant to continuously capture physiology measures including electrocardiogram (ECG), heart rate (HR), oxygen saturation (SpO2), body temperature, respiratory rate, movement, systolic blood pressure (BP-S), and others for the duration of the study. One device will be placed on the infant's chest or back. A second device will be placed peripherally, on the infant's leg, foot, arm, or hand. The devices are encapsulated in a medical-grade silicone and will be adhered to the infant's skin using a medical-grade adhesive, similar to the adhesives standardly used in the NICU. The biosensors will be left in place for up to 48 hours, but will be checked by study staff at least once every 24 hours to ensure skin integrity and signal quality. The adhesives will be changed between uses. 2) Parent: The same type of wearable, wireless biosensor will also be used to record 4 hours of continuous physiology including ECG, HR, temperature, movement, SpO2, and others in the infant's parents. The biosensor will be placed on the parent's chest 1 hour before the start of a scheduled KC session and worn for 1 hour preceding the scheduled KC session, during the 2-hour KC session, and for 1 hour after the completion of the KC session. The biosensor will be worn by the parents for approximately 4 hours in total.
Skin Monitoring:
Before and after the wearable biosensors are placed on the infant, the infant's skin integrity will be evaluated using the age-appropriate, NICU standard of care protocol for monitoring skin integrity. Study staff will take photographs of the skin at the site of biosensor placement before the biosensors are placed and after the biosensors are removed. Skin changes occurring while the biosensor is adhered to the infant's skin will be documented photographically. No faces will be photographed. The study team will consult the bedside care team within 1 hour for any ≥2 changes in skin integrity (based on the age-appropriate skin integrity scale score).
Video Monitoring:
In some patients, video monitoring of patient position and movement will be utilized during the study. This is an optional, additional part of the study in which families can choose to participate or not participate. For participating patients/families, a video camera will be mounted in the patient room for the duration of the KC sessions.
Saliva Sample Collection:
Saliva will be collected from enrolled infants and parents non-invasively to evaluate the effects of KFC on established biomarkers of stress (cortisol and testosterone) and father-infant bonding (oxytocin). Before, during, and after each KC session, saliva will be collected from the participating parent, and their infant. A trained member of the study team will collect saliva from infants using oral swabs made from an inert polymer and appropriately sized for an infant mouth (approximately 5 mm). Oral swabs will be taken from the infant immediately prior to beginning a KC session (T1), 30 minutes into the KC session (T2), and 30minutespost-session (T3). Parents will self-collect saliva samples at the time points outlined above, using an adult-sized oral swab. At T2, the trained study team member will be able to help the parent collect the saliva sample, if necessary, while the parent continues to hold their infant. This approach to salivary sample collection and biomarker analysis is similar to that established by previous studies of kangaroo care and takes into consideration the30-minute delay before cortisol reactivity in saliva.
Saliva Questionnaires:
When saliva is collected from parents at time points T1, T2, and T3, parents will also be asked to complete a brief saliva questionnaire. These questionnaires will take approximately five minutes each to complete and will be completed on paper or directly in REDCap, depending upon the participant's preferences. At T2, a study team member will be able to help the parent complete the survey, if necessary, while the parent continues to hold their infant. Data provided on surveys completed on paper will be transferred to secure REDCap forms by study staff and destroyed within 24 hours. All questionnaire data will be stored long term on the secure REDCap server housed by Northwestern University.
Psychosocial Questionnaires:
This study will employ psychosocial measures to capture the short- and long-term impacts of KFC. Specifically, validated measures of parenting confidence, relationship quality, infant bonding, and father involvement will be assessed via a set of paper or REDCap surveys administered in the NICU (short term) at baseline and the day before discharge (T-1) , and at home (long term) at 2 weeks (T+14) and 4 weeks (T+30) after discharge. Each of these sets of surveys will take approximately 30 minutes to complete. At baseline, each parent will complete the Revised Dyadic Adjustment Scale (RDAS) and the Postpartum Bonding Questionnaire (PBQ). At T-1, each parent will complete the RDAS , the PBQ, and the Parenting Sense of Competence Scale (PSOC). These questionnaires will be completed on paper or directly in REDCap, depending upon the participant's preferences. Data provided on surveys completed on paper will be transferred to secure REDCap forms by study staff and destroyed within 24 hours. At T+14 and T+30, each parent will complete the RDAS, the PBQ, the PSOC, and a Father Involvement Questionnaire. These questionnaires will be completed directly in REDCap only. Each parent will receive an email containing a link to their set of questionnaires at both post-discharge time points. All questionnaire data will be stored long term on the secure REDCap server housed by Northwestern University.
Wearable Sensor Data Collection:
The wearable sensor that will be used in this study can stream data continuously using near field communication (NFC) or Bluetooth technology. An encrypted laptop, iPad, or similar device will be left in the patient room and used to capture the continuous data stream from the wearable sensor. Additionally, wearable biosensors can include onboard memory, and physiologic streams may be recorded to this onboard memory until transfer to an encrypted laptop for analysis.
Standard of Care Data Collection:
In all patients in rooms where data from standard of care monitoring is recorded on the BedMaster system, this data will be used for comparison to data captured using the wearable sensors. In participants in rooms where this system is not available, the MediCollector system will be used to capture background data during the approximately 48-hour study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Infants: Infants who are born at Prentice Women's Hospital between 30 0/7 and 36 6/7 weeks gestation, are <=20 days old at the time of enrollment, and do not meet any of the study's exclusion criteria will be eligible for participation in this study. Additionally, infants will only be included in this study if both of their biological parents are eligible and agree to participate.
* Parents: Parents who are >=18 years, English speaking, expect mother and father to raise the infant together in the same household regardless of their marital status, and do not meet any of the study's exclusion criteria will be eligible for participation in this study. Additionally, family units will only be included in this study if both biological parents of the infant are eligible and agree to participate. Only English speaking parents will be included in this trial because the study questionnaires are only available in English.
Exclusion Criteria:
* Infants: Infants who are intubated or sedated, are receiving vasopressors or analgesics, have any congenital anomalies or skin abnormalities deemed likely to impact KC by clinical team, have received or are planned to receive surgical intervention, or are experiencing other symptoms or receiving other intervention that will impact the utilization of KC, wearable sensors, and/or oral swabs will be excluded from this study.
* Parents: Parents who are showing any signs of illness or taking corticosteroids or testosterone supplementation will be excluded from this study. Non-English speaking parents will also be excluded from this study because the questionnaires associated with this study are only available in English.
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 20 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04727125
|
{
"brief_title": "Evaluating the Effects of Kangaroo Care in the NICU",
"conditions": [
"Kangaroo Care",
"Premature Birth",
"Fathers"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT04727125",
"official_title": "Evaluating the Effects of Kangaroo Care in the NICU",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-04-12",
"study_completion_date(actual)": "2022-01-01",
"study_start_date(actual)": "2019-05-17"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-03-10",
"last_updated_that_met_qc_criteria": "2021-01-25",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-27",
"first_submitted": "2021-01-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to:
* Create a database including a description of the patient population that undergoes total hip replacement with special emphasis on orthopedic and cardiovascular complications and the quality of life 1 year postoperatively.
* Characterise the patient at risk for the above mentioned events
* Create methods for predicting patients at risk for short-term (90 days) and long term (1 year) complications in relation to hip replacement surgery.
Detailed Description
Introduction:
Total hip replacement surgery is a standard procedure, which has been shown to be both cost-effective and to give the patient a pain free daily living. Since Sir Charnley made total hip replacement a standard procedure millions of hips have been implanted.
In Denmark about 100 out of 100.000 did get a hip replacement operation in 2001(DHAR).
When a patient with a painful hip due to arthrosis, arthritis, fracture sequelae and other reasons, is offered a total hip replacement, several issues are taken into consideration: concurrent diseases, bone quality, age, life expectancy, prosthesis type, operation methods etc.
In the elderly patient a thorough medical evaluation is performed in order to minimise the intraoperative risc for cardiopulmonary morbidity. Nearly all patients in Denmark (over 99%) are getting thromboprophylaxis during the hospital stay to minimise cardiovascular complications.
After surgery the patients visits the outpatient clinic for routine control after 3 and 12 months. After that time the patient is usually out of orthopedic control.
Evaluations of the procedures in Scandinavian countries are collected in databases. These databases are constructed by national collection of data sheets from each hospital performing the procedures. The collected data most often only include data as far as the arthroplasty is concerned. Normally there is no monitoring of the quality of the collected data - a considerable margin of errors in the results produced from these databases must there for be expected.
The amount of publications concerning total joint replacement is enormous, but most publications in this field come from clinical trials dealing with new pharmacological products or new implants.
Very few authors have considered the overall patient morbidity and quality of life after the hip replacement operation.
Therefore this Ph.D. project is planned to get more and newer data of the population that is offered a total hip replacement. Furthermore, it will be attempted to find prognostic factors as far as the overall risk for cardiopulmonary complications in the first 1 - 3 years after the operation.
Purpose:
The purpose of this study is to:
Create a database including a description of the patient population that undergo total hip replacement with special emphasis on orthopedic and cardiovascular complications and the quality of life 1 year postoperatively.
Characterise the patient at risk for the above mentioned events
Create methods for predicting patients at risk for short-term (90 days) and long term (1 years) complications in relation to hip replacement surgery.
Hypothesis:
It is a well defined small group of high risk patients that gets the serious cardiovascular complications.
The risk for cardiovascular complications is increased for a longer period than the postoperative hospital stay.
A not neglectable group of the patients do not get the expected benefit from the operation.
Methods:
A prospective monocentre, longitudinal cohort study of 500 patients operated in the County of Frederiksborg from 01.01 2004.
The data will be collected by interview before the operation, on day 5 and after 3 month and a year.
And additional data will be collected from patient files, local hip- and anaesthesia databases, laboratory system, the Danish Hospital Discharge Register (LPR), autopsy reports and death register.
Statistical methods:
In the PhD study is included various courses, including a course on statistical methods. External statistical aid might be necessary.
Patients:
Inclusion criteria:
All patients to be operated with total hip replacement in Frederiksborg amt from 01.01.2004 until 500 pt. have been included.
Exclusion criteria:
Refuse of consent and age under 18years.
Ethical Considerations:
Local Scientific Ethical Committee and theDanish Dataprotection Agency has to approve the project.
The project follows the Guidelines for Good Clinical Practise.
The investigation will not imply any discomfort and no risk for the patient.
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients operated with Hip Arthroplasty Replacement in Hillerød and Hørsholm Hospitals from 1.1 2004.
Exclusion Criteria:
* Written informed consent denied
* Patients under 18 years.
* Patients not habitants of Denmark at the time of the operation.
* Patients without a CPR-number (civil registration number).
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
|
NCT00159185
|
{
"brief_title": "Epidemiology Study in Major Orthopaedic Surgery",
"conditions": [
"Thrombosis",
"Postoperative Complications",
"Quality of Life"
],
"interventions": null,
"location_countries": [
"Denmark"
],
"nct_id": "NCT00159185",
"official_title": "Epidemiology Study in Major Orthopaedic Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-05",
"study_start_date(actual)": "2004-01"
},
"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)": "2006-07-21",
"last_updated_that_met_qc_criteria": "2005-09-09",
"last_verified": "2005-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-12",
"first_submitted": "2005-09-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Diarrhea is a common problem in the pediatric population. Children with cancer are especially at increased risk for gastrointestinal infection-related morbidity and mortality due to their ongoing immunosuppression. However, the epidemiology of diarrheal illnesses in immunocompromised children is poorly understood. In the past, many or most cases of gastroenteritis have gone undiagnosed, largely due to a lack of sensitive diagnostic tests and a presumption that a large proportion of cases are due to treatment, rather than infections. The availability of new diagnostic tests that detect many gastrointestinal pathogens simultaneously offers the first opportunity to gain a comprehensive picture of the causes of infectious diarrhea in children with cancer.
Researchers at St. Jude Children's Research Hospital want to learn about the epidemiology of diarrheal diseases in pediatric oncology patients utilizing broadly multiplexed, automated PCR.
Detailed Description
This study plans to enroll participants in two groups:
* GROUP 1: Participants with hematologic malignancies or solid tumors.
* Participants who agree to take part in this research study will have stool samples collected at diagnosis (baseline sample) and each month thereafter for 12 months from the time of enrollment. Stool samples will be screened for different types of microbes that may be present. For participants who develop diarrhea during these 12 months, three additional stool samples will be collected on Day 0, Day 7 and Day 14; two blood samples and mid-turbinate nasal swab will be collected as well on Day 0 and Day 7 of the first observed diarrheal episode to screen for additional microbes that may be the cause of the diarrhea.
* GROUP 2: Participants who are hematopoietic stem cell transplant (HSCT) patients.
* Participants who agree to take part in this research study will have stool samples collected within one week prior to conditional chemotherapy (baseline sample) and weekly thereafter for a total of 16 weeks (pre- and early post-engraftment periods), followed by monthly for 8 months. Stool samples will be screened for different types of microbes that may be present. For participants who develop diarrhea, three additional stool samples will be collected on Day 0, Day 7 and Day 14; two blood samples and mid-turbinate nasal swab will be collected as well on Day 0 and Day 7 of the first observed diarrheal episode to screen for additional microbes that may be the cause of the diarrhea. For GROUP 2 participants, two diarrheal episodes will be studied per patient: the first diarrheal episode during the pre-engraftment period, and the first diarrheal episode during the post-engraftment period.
Participants with a change in cancer treatment plan enrolled on study: Group 1 participants who experience a change in their cancer treatment plan necessitating an allogeneic stem cell transplant will be taken off study for group 1 and offered the opportunity to consent to group 2 Participants who chooses to then enroll on group 2 will complete the 12-month study requirements as defined in the protocol for group 2 participants.
General health information from participant medical records and other health-related information about symptoms will also be obtained at the time of collection of the samples.
PRIMARY OBJECTIVE:
* To assess the prevalence of microbial pathogens in the stool of pediatric oncology patients with diarrheal illness.
SECONDARY OBJECTIVES:
* To describe the clinical course, symptomatology, morbidity and mortality associated with diarrheal diseases in pediatric oncology patients at St. Jude Children's Research Hospital.
* Evaluate the performance of the multiplex polymerase chain reaction (PCR) assay for the diagnosis of infectious diarrhea in comparison to the standard of care methods.
|
#Eligibility Criteria:
Inclusion Criteria:
* Equal to or less than 18 years.
* GROUP 1: Patients diagnosed in the preceding 14 days with confirmed diagnosis at St. Jude of a new hematological malignancy or solid tumor in the preceding 14 days, OR patients diagnosed with a new hematological malignancy or solid tumor and has initiated chemotherapy within the previous 72 hours from enrollment.
* GROUP 2: Patients scheduled to receive conditioning for hematopoietic stem cell transplant (HSCT) in the subsequent 7 days.
* Parent or legal guardian willing and able to give informed consent and comply with study requirements.
* Anticipated to be available for all study visits.
Exclusion Criteria:
* Patients from GROUP 1 (diagnosed in the preceding 14 days with a new hematological malignancy or solid tumor) who underwent HSCT in the previous 12 months.
* Has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Sex :
ALL
Ages :
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02464098
|
{
"brief_title": "Epidemiology of Diarrheal Diseases in Pediatric Oncology Patients",
"conditions": [
"Diarrhea"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT02464098",
"official_title": "Epidemiology of Diarrheal Diseases in Pediatric Oncology Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-06",
"study_completion_date(actual)": "2021-12-31",
"study_start_date(actual)": "2015-11-19"
},
"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)": "2022-02-08",
"last_updated_that_met_qc_criteria": "2015-06-03",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-06-08",
"first_submitted": "2015-06-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Investigators are seeking to learn how well different cooling temperatures along with different blood flow pathways to the brain reduce the risk of injury to the brain in participants planning to undergo elective aortic arch and hemiarch surgery. Participants will be randomized to receive a cerebral protection strategy of either: deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) or moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP). Evidence of neurologic injury will be assessed with neurologic exams, neurocognitive tests, MRI imaging of the brain and measurement of plasma S-100 levels during post operative follow ups.
Detailed Description
The purpose of this study is to investigate the impact of the two most commonly employed methods of cerebral protection upon mitigating neurologic injury in participants planning to undergo elective aortic arch and hemiarch surgery. Participants will be recruited from patients undergoing ascending aortic and hemiarch replacement using hypothermic circulatory arrest at Emory University Hospital and Emory Saint Joseph's Hospital. Participants will be randomized to receive a cerebral protection strategy of either: deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) or moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP). Evidence of neurologic injury will be assessed with neurologic exams, neurocognitive tests, MRI imaging of the brain and measurement of plasma S-100 levels during post operative follow up. Follow up visits will be conducted at Days 1, 3, 7, and 180 post operation.
#Intervention
- PROCEDURE : DHCA+RCP
- During deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) the participant is placed on cardiopulmonary bypass (heart-lung machine) and their body temperature is lowered to a range of 14-18 °C. Once the goal temperature has been achieved, the circulation is stopped and aortic arch replacement is performed in a bloodless surgical field. Blood will be pushed to the brain through arterial vessels, much like the natural blood flow pattern. Once the aortic arch repair is complete, cardiopulmonary bypass is reinstituted, the participant is rewarmed, and separated from cardiopulmonary bypass.
- PROCEDURE : MHCA + SACP
- During moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA + SACP) the participant is placed on cardiopulmonary bypass (heart-lung machine0 and the native blood flow to the brain is temporarily suspended. The body is cooled to temperatures of ≤28°C and blood is administered to the brain via an artery in the neck during the period of arch reconstruction. Once the aortic arch repair is complete, cardiopulmonary bypass is reinstituted, the participant is rewarmed, and separated from cardiopulmonary bypass.
|
#Eligibility Criteria:
Inclusion Criteria:
Patients at Emory University Hospital and Emory Saint Joseph's Hospital planning to undergo:
* Elective surgical replacement of the ascending aorta and proximal ('hemiarch') using hypothermic circulatory arrest
* Concomitant cardiac procedures (e.g valve replacement, coronary artery bypass, etc.) in addition to ascending aortic and hemiarch replacement
* Any of the following cannulation and cerebral protection strategies:
1. Right axillary artery cannulation, deep hypothermic circulatory arrest, retrograde cerebral perfusion
2. Right axillary artery cannulation, moderate hypothermic circulatory arrest, unilateral selective antegrade cerebral perfusion
Exclusion Criteria:
* Undergoing total arch replacement
* Undergoing hemiarch replacement without the use of hypothermic circulatory arrest
* Undergoing hemiarch replacement using hypothermic circulatory arrest with a method of cerebral protection not listed in the Eligibility Criteria.
* Pregnant women or women who are nursing.
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
|
NCT02750423
|
{
"brief_title": "Neurologic Injury Following Aortic Arch Replacement",
"conditions": [
"Aortic Arch Replacement",
"Hemi Arch Replacement"
],
"interventions": [
"Procedure: DHCA+RCP",
"Procedure: MHCA + SACP"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02750423",
"official_title": "Neurologic Injury AAR: Neurologic Injury Following Aortic Arch Replacement: A Comparison of Two Different Cerebral Protection Strategies (A Pilot Study)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12",
"study_completion_date(actual)": "2017-12",
"study_start_date(actual)": "2016-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-03-30",
"last_updated_that_met_qc_criteria": "2016-04-21",
"last_verified": "2018-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-25",
"first_submitted": "2016-04-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is a pilot RCT to examine the feasibility, acceptability and preliminary effectiveness of a 6-week acceptance-based diabetes education programme (ACT-DE) on diabetes distress, self-care efficacy and behaviours of adults with type 2 diabetes in Hong Kong.
It is hypothesise that the ACT-DE programme will:
* Be acceptable, feasible and beneficial for adults with type 2 diabetes to improve their psychological distress and self-care.
* Significantly reduce participants' diabetes distress (primary outcomes), when compared with the usual care (control) group immediately post-intervention;
* Significantly improve self-care efficacy, self-care behaviour and psychological flexibility (secondary outcomes) than the control group immediately post-intervention.
Detailed Description
Diabetes distress is an aversive feeling and emotional disturbance specific to diabetes, including the burden of daily self-care, worry and guilty feelings, and low satisfaction level with health care professionals. Around 36% of people with type 2 diabetes worldwide suffered from diabetes distress, which is associated with poor self-care performance, low self-efficacy in diabetes management and higher blood glucose levels. Acceptance and Commitment Therapy, one of the mindfulness and acceptance-based interventions, integrated with diabetes education are found to be potentially effective interventions for reducing diabetes distress.
Participants who agreed to participate in the study were randomly allocated into the intervention (N=24) and the control group (N=24). Participants in the intervention group received a 6-week group-based acceptance and commitment therapy integrated with diabetes education (ACT-DE). There were five sessions in 6 weeks with 120 minutes per session. The group size were 6. While participants in the control group received one session of diabetes education without any information on acceptance and commitment therapy.
#Intervention
- BEHAVIORAL : ACT-DE
- The acceptance and commitment therapy is a psychological component to cultivate participants' acceptance attitude to diabetes and motivate them for a value-driven persistent diabetes self-management, directed by six psychological processes in the hexagonal model of ACT, including acceptance, cognitive defusion, the present moment, self-as-context, value clarification and committed action.
- BEHAVIORAL : DE
- DE
|
#Eligibility Criteria:
Inclusion Criteria:
* community-dwelling adults Hong Kong Chinese residents,
* aged 18 <= age <= 64,
* diagnosed with type 2 diabetes for over one year;
* at least moderate level of diabetes distress as measured with the Chinese Diabetes Distress Scale (CDDS-15; mean score >2 per item);
* having suboptimal blood glucose control as shown by HbA1c level of >= 7% in the laboratory results within the past six months;
* able to communicate in Cantonese and give written content.
Exclusion Criteria:
* history of a clinically diagnosed mental illness such as depression and anxiety disorder, and/or an acute/severe medical disease;
* noticeable cognitive impairment(s) as indicated by the total score (<6 of 10) of the Abbreviated Mental Test;
* recently received/receiving any psychological therapy such as mindfulness or acceptance-based therapy.
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
|
NCT05563987
|
{
"brief_title": "ACT-DE for Diabetes Distress in Adults With Type 2 Diabetes: A Pilot RCT",
"conditions": [
"Acceptance and Commitment Therapy",
"Type 2 Diabetes",
"Diabetes Distress"
],
"interventions": [
"Behavioral: DE",
"Behavioral: ACT-DE"
],
"location_countries": [
"Hong Kong"
],
"nct_id": "NCT05563987",
"official_title": "The Effects of an Acceptance-based Diabetes Education (ACT-DE) Programme for Adults With Type 2 Diabetes on Diabetes Distress: a Pilot RCT",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-02-28",
"study_completion_date(actual)": "2022-03-30",
"study_start_date(actual)": "2021-10-01"
},
"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)": "2022-10-04",
"last_updated_that_met_qc_criteria": "2022-09-30",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-03",
"first_submitted": "2022-09-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is a prospective study looking at healthy adults who will have urine collected at 4 set times throughout the course of the day. On Day 2, 3, and 4 subjects will drink a bottle of water containing True lemon and on days 2 and 3 double the amount of fluid intake from Day 1. On day 4 the subject will collect urine samples at 4 set times throughout the day. The pH of all of the urine samples will be checked with a urine dipstick and the samples will be sent to Litholink Lab for electrolyte composition analysis.
Detailed Description
20 subjects will be recruited and consented in the Urology Clinic office. Subjects will complete a questionnaire asking about weight, height, history of kidney stones, whether they are on any diuretics, medications that alter urine chemistries, or special diets. BMI will be calculated. Day 1 will begin at 5p.m. on the day before first morning void is collected. The subjects will collect a spot urine sample on the first void at home, then at 9-10AM, 1-2 PM and 4-5PM. They will be provided 4 sterile urine cups labeled for the different timed collection marked at the 20-30 ml line to indicate how much urine should be collected. Subjects will be instructed to refrigerate their first voids.The 2nd, 3rd and 4th void samples will be collected in the office during the designated times, and given to study personnel. The subjects will record the time of each void, the time given to the study representative, the times they eat, and their approximate fluid intake on the provided diaries. Subjects will be asked not to void outside of the timed collections. If they do void outside of these times, they will be asked to record the extra times that they void.
On Day 2, 3, and 4 the subject will drink a bottle of water with True Lemon after 5pm. On days 3 and 4 the subjects will double their fluid intake using Day 1 as a guide. On Day 4 the subjects will collect 4 urine samples as previously described for Day1. They will be instructed to mix 1 packet of True lemon in one 16.9oz (500 mL) bottle of Poland Spring. All True Lemon packets (True Citrus, 11501 Pocomoke Court Suite D, Baltimore, MD 21220). and Poland Spring (Nestle Waters North America) bottles will be provided to subjects by the research study team.
UA dipsticks will be used in office to evaluate for pH and specific gravity. Samples will also be sent to lab for evaluation of chemical composition of creatinine, citrate, and calcium. Electrolytes will be indexed against creatinine to evaluate their concentrations without having a 24-hour void volume amount A sample of citrate-Poland Spring will be sent to Litholink for analysis of Calcium and Citrate for reference.
#Intervention
- DIETARY_SUPPLEMENT : Normal fluid intake without true lemon
- 16.9oz water with True Lemon
- DIETARY_SUPPLEMENT : Double fluid intake plus 3 bottles of water with True Lemon
- No intervention
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adult subjects
Exclusion Criteria:
* Subjects taking diuretics
* Subjects who have known kidney disease
* Subjects with history of known nephrolithiasis
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
|
NCT03645785
|
{
"brief_title": "Variation in Urine Electrolytes, pH and Specific Gravity Throughout the Day",
"conditions": [
"Healthy"
],
"interventions": [
"Dietary Supplement: Normal fluid intake without true lemon",
"Dietary Supplement: Double fluid intake plus 3 bottles of water with True Lemon"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03645785",
"official_title": "Variation in Urine Electrolytes, pH and Specific Gravity Throughout the Day and the Effect of Increased Fluid Intake on Intra-Day Urine Composition",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-20",
"study_completion_date(actual)": "2019-05-20",
"study_start_date(actual)": "2018-08-28"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-02-21",
"last_updated_that_met_qc_criteria": "2018-08-22",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-08-24",
"first_submitted": "2018-05-30",
"first_submitted_that_met_qc_criteria": "2021-02-02"
}
}
}
|
#Study Description
Brief Summary
Ingested or skin produced vitamin D is either hydroxylated in the liver to 25-hydroxyvitamin D (25(OH)D), metabolized and excreted in the urine, or stored in adipose and other tissues. The capacity for vitamin D storage in adipose tissue is not known, nor the importance of such storage which may potentially be of vital importance when intake or solar exposure is limited. In the present study we will include 76 subjects who have participated in an intervention study with vitamin D (20.000 IU per week) versus placebo for the prevention of type 2 diabetes, and who have completed the study after 5 years or who have been excluded because of diagnosed type 2 diabetes or for other reasons. If vitamin D is stored to any extent in the body the subjects given 20.000 IU vitamin D per week for 2-5 years will have a considerable amount of stored vitamin D and accordingly, a slow decline in serum 25(OH)D during the following year without vitamin D substitution, which will be measured in the present study. If our hypothesis is correct, that vitamin D can be stored in significant amounts when the supply is abundant; current advice on vitamin D supplementation mainly during winter should be changed to 'year around' in order to build up sufficient stores for the months without sufficient sun light.
|
#Eligibility Criteria:
Inclusion Criteria:
* previously participated in a vitamin D study
Exclusion Criteria:
* pregnancy
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01729013
|
{
"brief_title": "Duration of Vitamin D Stores After Prolonged Vitamin D Substitution",
"conditions": [
"Obesity"
],
"interventions": null,
"location_countries": [
"Norway"
],
"nct_id": "NCT01729013",
"official_title": "Duration of Vitamin D Stores After Prolonged Vitamin D Substitution",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-05",
"study_completion_date(actual)": "2015-08",
"study_start_date(actual)": "2012-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-09-22",
"last_updated_that_met_qc_criteria": "2012-11-19",
"last_verified": "2015-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-11-20",
"first_submitted": "2012-11-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Hyperuricemia is seen in about 20% of adults in the general population, Chronic hyperuricemia, frequently manifesting as the gout, is a well-known risk factor of joint damage but has been also linked to a variety of other pathologies mostly affecting the cardiovascular system. The close relation between high uric acid concentration and increased risk of cardiovascular disease has been reported for more than a century. Furthermore, many studies reported a strong association between hyperuricemia, arterial hypertension, obesity and cardiovascular diseases even in an absence of typical clinical manifestations of gout.
Several studies showed that the prevalence of hyperuricemia in patients with hypertension is much higher than in the general population and may worsen after the onset of antihypertensive treatment. That may indicate that hyperuricemia may be also caused by antihypertensive drugs. In contrast to diuretics and nonselective beta blockers the agents that block the renin-angiotensin-aldosterone system have had a neutral effect on serum uric acid. Several clinical studies showed that losartan in contrast to other AT1-receptor agonists, may have specific uricosuric properties and thereby can lower uric acid concentration. It has been speculated that uricosuric effect could make losartan particularly useful for the treatment of arterial hypertension associated with hyperuricemia and metabolic syndrome.
The uricosuric effect of losartan is most likely due to overlapping two different mechanisms regulating the excretion of uric acid. Losartan may increase uric acid tubular secretion in the same way as other inhibitors of the renin-angiotensin-aldosterone system, but in addition it may specifically inhibit post-secretory resorption of uric acid in the proximal tubule. The effect may be due to a specific structure of the losartan molecule. The urateanion transporter is a monoammonium selective transporter, and the losartan molecule is mainly a monoanion at normal pH range (as opposed to dianion e.g. eprosartan) and therefore is a good substrate for the exchanger. However, this concept remains speculative since, e.g. irbesartan which is also a monoanion has no consistent uricosuric effect.
Fructose, in contrast to other carbohydrates causes an increase of serum uric acid concentration, which may facilitate the development of the metabolic syndrome.
Detailed Description
The study group included 16 patients (15F, 1M, mean age 64.5 ± 9.8 years). The patients selected for the study fulfilled the AHA/NHLBI 2005 criteria of the meta-bolic syndrome \[30\] and ESC/ESH criteria of arterial hypertension. The exclusion cri-teria included an antihypertensive therapy with the renin-angiotensin-aldosterone axis blocking agent used anytime during last 3 months, current or past therapy with SGLT2 inhibitor, GLP-1 agonist or DPP4-inhibitor, suspected or confirmed secondary form of hypertension, estimated glomerular filtration rate \<60 ml/min/1.73 m2, chron-ic liver disease, acute infection, psychiatric disorders, mean serum potassium con-centration at last three measurements \<4.0 mmol/l, or aspartate aminotransferase or alanine aminotransferase or creatinine kinase \> x1.5 upper range limit were excluded. Seven patients had diabetes mellitus of which 4 were treated with insulin. Twelve pa-tients were receiving metformin. Waist circumference was measured on the initial visit. Plasma lipids and blood glucose were measured in a fasting state during the study.
The study was designed as a randomized, crossover, head-to-head comparative study. Randomization was carried out using MS Excel random number generator. After qualification each patient was randomly assigned to receive either losartan (Lorista, KRKA, Slovenia) or eprosartan (Teveten, Solvay Pharmaceuticals, Austral-ia). The patients were taking all other previously prescribed drugs in unmodified dos-es during the whole course of the study. Each study drug was given in a random or-der as a single morning dose (50 mg of losartan or 600 mg of eprosartan) for two periods each lasting 3 months separated by 2-week wash-out time.
Oral fructose tolerance with the administration of 75 g of fructose was con-ducted 3 times during the study in each patient, i.e. at baseline and after each of the treatment periods. Before the commencement of OFTT, the patients collected the urine for 2 hours for assessment of the urinary excretion of uric acid and creatinine. Other baseline measurements included blood pressure, serum concentration of glu-cose, uric acid, creatinine and plasma lipids (total, HDL- and, LDL-cholesterol and triglycerides). Subsequent blood samples were taken three times during each OFTT, i.e. after 30, 60 and 120 minutes from its start to determine serum uric acid concen-tration. In addition, peripheral blood pressure was measured before the collection of each blood sample. After 120 minutes blood was also taken to assess plasma lipids. The second timed 2-hour urine collection was obtained during OFTT. The same pro-cedures were repeated after each treatment period. The patients took all their pre-scribed medication including the study drug in the morning 120 minutes before the beginning of OFTT Routine automated laboratory tests were used to assess blood and urine pa-rameters. Blood pressure was taken in a sitting position with the aneroid sphygmo-manometer. Blood pressure was measured both at baseline and after 3-month ther-apy with each study drug. The mean from four measurements obtained between 0 and 120 minutes OFTT was taken for the analysis. Blood pressure was measured by a designated single member of the staff. Mean blood pressure (MAP) was calculated for all measurements as diastolic BP + 1/3 of pulse pressure (systolic BP - diastolic BP).
The results are expressed as mean ± SD or median with interquartile range depending on each variable distribution. 95% confidence intervals were calculated for the changes of the parameters caused by the treatment. Statistical significance was defined at p\<0.05. The within-group comparisons were analyzed using one-way ANOVA and t-test for normally distributed variables or alternatively with non-parametric Wilcoxon test. The normality of the variable distribution was checked with Shapiro-Wilk test. The Pearson or Spearman correlation coefficient was used to as-sess the relations between variables depending on their distribution. Area under the curve (AUC) of serum uric acid during oral fructose tolerance test was calculated using the trapezoidal rule.
#Intervention
- DRUG : losartan and eprosartan
- . Each study drug was given in a random order as a single morning dose (50 mg of losartan or 600 mg of eprosartan) for two periods each lasting 3 months separated by 2-week wash-out time.
- Other Names :
- Lorista, Teveten
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 years
* Fulfillment of three or more of the AHA / NHLBI 2005 assessment criteria for the metabolic syndrome:
* abdominal obesity (i.e. handling in women >=88 cm) male >= 102 cm
* concentration of triglycerides in the form >=150 mg / dl
* concentration of HDL fraction (men <40 mg / dL, women <50 mg / dL)
* blood pressure >= 130/85 mmHg
* Correction of fasting glucose >=100 mg / dL)
* Written and informed consent to participate in the case of
Exclusion Criteria:
* Congenital defects in fructose metabolism (hereditary fructose intolerance and idiopathic fructosuria)
* Mental illness, dementia
* Insufficient cooperation with the patient, non-compliance with doctor's recommendations
* Pregnancy
* Bilateral renal artery stenosis or stenosis to a solitary kidney and other contraindications for angiotensin receptor antagonists
* Chronic use of uricosuric drugs, xanthine oxidase inhibitors and AT1 receptor inhibitors
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
|
NCT04954560
|
{
"brief_title": "Effect of Losartan or Eprosartan on Fructose Hyperuricemia",
"conditions": [
"Uric Acid Concentration, Serum, Quantitative Trait Locus 7"
],
"interventions": [
"Drug: losartan and eprosartan"
],
"location_countries": null,
"nct_id": "NCT04954560",
"official_title": "Losartan and Eprosartan Induce a Similar Effect on Oral Fructose-induced Rise in Serum Uric Acid Concentration in Patients With Metabolic Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-01-01",
"study_completion_date(actual)": "2010-01-01",
"study_start_date(actual)": "2008-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-08",
"last_updated_that_met_qc_criteria": "2021-06-29",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-07-08",
"first_submitted": "2021-06-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
evaluation and comparison of the accuracy of conventional and digital impression for full arch screw retained prosthesis for edentulous maxilla.
Detailed Description
Each patient received 6 implants in the maxillary ridge (widely distributed across the arch) in the following positions: central incisors, canines/first premolar teeth and first molar teeth aided by surgical stent. then each patient received 2 types of impression techniques Technique 1 :conventional impression conventional open tray impression technique with splinted transfers using vinylpolysiloxane and Technique2 : Digital impression taken using original scan bodies torqued to the implants .three dimensional accuracy of impression techniques was evaluated using linear measurements and 3D deviation between the two techniques was measured.
#Intervention
- OTHER : impression techniques for implant used for maxillary screw retained hybrid prosthesis
- conventional splinted open tray impression technique was done for maxillary implants to fabricate screw retained hybrid prosthesis and digital intra oral impression was done for the same patients after screwing scan bodies to the implants intra orally.
evaluation of accuracy and 3D deviation between the two techniques was done
- Other Names :
- digital and conventional impression techniques
|
#Eligibility Criteria:
Inclusion Criteria:
* The patients were selected according to the following inclusion criteria:
1. Completely edentulous maxillary and mandibular ridges
2. Healthy ridge covered by normal oral mucosa and free from any ridge flabbiness.
3. All of the patients were dissatisfied with the retention and stability of their maxillary conventional dentures and expressed a strong desire for a more stable prosthesis.
4. Sufficient bone quantity and quality in the front and posterior maxillary regions, as determined by preoperative CBCT, to accommodate six implants with a diameter of at least 3.5 mm and a length of at least 10 mm.
5. Enough restorative space (from the mucosa covering the crest of the maxillary residual ridge to the occlusal plane) to allow the fixed prosthesis to be constructed ,preliminary jaw relationship revealed this.
6. It's been at least a year since the last extraction.
Exclusion Criteria:
<!-- -->
1. Systemic diseases that may alter tissue response to implantation and affects osseointegration (radiation, diabetes, osteoporosis, bleeding disorders or hepatic patients)
2. Long term immunosuppressive and corticosteroid drug therapy.
3. Patient with abnormal habits as clenching and bruxism.
4. Smoking patients.
5. Patients with problems in TMJ.
6. Neuromuscular diseases.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05321589
|
{
"brief_title": "Accuracy of Conventional and Digital Impression Techniques Used for Maxillary Hybrid Prosthesis",
"conditions": [
"Prosthesis Durability"
],
"interventions": [
"Other: impression techniques for implant used for maxillary screw retained hybrid prosthesis"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05321589",
"official_title": "Accuracy of Digital and Conventional Impression Techniques for Maxillary Full Arch Screw Retained Hybrid Prosthesis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-02-20",
"study_completion_date(actual)": "2022-03-20",
"study_start_date(actual)": "2021-03-01"
},
"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)": "2022-04-11",
"last_updated_that_met_qc_criteria": "2022-04-04",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-11",
"first_submitted": "2022-03-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is conducted Asia, Europe and North America. The aim of this study is to describe insulin therapy adherence and the burden of non-adherence on patient functioning, well-being and diabetes management.
#Intervention
- BEHAVIORAL : No treatment given
- Completion of 90-item online questionnaire.
- BEHAVIORAL : survey
- Completion of 58-item online questionnarie.
|
#Eligibility Criteria:
Inclusion Criteria:
* PATIENTS WITH T2DM:
* Diagnosed with type 2 diabetes by a healthcare professional
* Currently being treated with insulin medication, excluding premix insulin treatment
* Age at least 40 years
* Diagnosed as having type 2 diabetes over the age of 40
* HCPs:
* Primary care physician, diabetes specialist (diabetologist/endocrinologist) or diabetes specialist nurse/diabetes nurse educator
* Have a minimum of 2 years experience within current speciality
* See a minimum of 20 type 2 diabetes patients per month (40 for diabetes specialists), of which at least 10 per month must be on modern (analogue) inulins
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01950637
|
{
"brief_title": "GAPP 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus",
"conditions": [
"Diabetes",
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Behavioral: survey",
"Behavioral: No treatment given"
],
"location_countries": [
"Japan",
"United States",
"Germany",
"United Kingdom",
"Canada",
"Denmark"
],
"nct_id": "NCT01950637",
"official_title": "GAPP 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-01",
"study_completion_date(actual)": "2013-01",
"study_start_date(actual)": "2012-01"
},
"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)": "2017-01-13",
"last_updated_that_met_qc_criteria": "2013-09-23",
"last_verified": "2017-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-09-25",
"first_submitted": "2013-09-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the safety and immunological effects of polyethylene glycolated-interleukin-2 (PEG-IL-2) on asymptomatic (without symptoms) HIV-seropositive patients who are taking zidovudine (AZT). To enhance measures of immune function with well-tolerated doses of PEG-IL-2, an immunomodulator, in a regimen designed to allow its use in outpatients with normal daily activity (i.e., full-time employment, etc.). Recombinant IL-2 (without PEG modification) was administered to HIV-infected patients by daily intradermal injection. At the low doses used, this was non-toxic, well-tolerated, and gave a systemic response as measured by natural killer cell and lymphokine-activated killer cell activity, but required daily administration. In the current study, the PEG modification of IL-2 is used since it has a much longer prolonged half-life compared with the non-PEG compound, without loss of functional activity.
Detailed Description
Recombinant IL-2 (without PEG modification) was administered to HIV-infected patients by daily intradermal injection. At the low doses used, this was non-toxic, well-tolerated, and gave a systemic response as measured by natural killer cell and lymphokine-activated killer cell activity, but required daily administration. In the current study, the PEG modification of IL-2 is used since it has a much longer prolonged half-life compared with the non-PEG compound, without loss of functional activity.
In the first, dose-escalation phase of the study, PEG-IL-2 is injected into the skin of the back by either the intradermal (ID) or subcutaneous (SC) route, to establish an optimal dose (which when given ID results in local induration = or \> 25 mm without significant toxicity). The ID and SC routes are compared for systemic effect and toxicity. In the second phase of the study, the PEG-IL-2 is administered for 6-8 weeks using the optimal dosage, frequency, and route determined in the initial phase (probably 2-3 times per week) while local and systemic effects are monitored. These include measures of viral titer, peripheral blood mononuclear cell phenotype, CBC and CD4 counts, and in vitro cytotoxicity assays.
#Intervention
- DRUG : Interleukin-2, Polyethylene Glycolated
|
#Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Zidovudine (AZT).
* Necessary topical agents such as nystatin, clotrimazole, and acyclovir.
* Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
* Oral antibiotics for PCP prophylaxis if hematologically stable for = or > 30 days prior to study entry.
* Necessary systemic agents for the treatment of other chronic disorders, such as diabetes or asthma.
Patients must have:
* HIV-1 seropositivity.
* Asymptomatic.
* No opportunistic infection for 8 weeks prior to study entry.
* Been on azidothymidine (AZT) (= or > 500 mg/day) for at least 8 weeks prior to beginning interleukin-2 (IL-2), with stable CD4 cell counts.
Prior Medication:
Allowed:
* Zidovudine (AZT).
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Active, life-threatening opportunistic infection (OI) with bacterial, viral, fungal, or protozoan pathogens.
* Fever = or > 101 F. within 10 days prior to study entry.
* Significant central nervous system (CNS) disease including AIDS dementia, psychiatric disability, or seizure disorder.
* Significant cardiac disease (New York Heart Association Stage III or IV).
* Significant pulmonary disease (Forced Expiratory Volume < 75 percent.
* Weight loss = or > 10 percent within last 3 months.
Concurrent Medication:
Excluded:
* Systemic therapy for opportunistic infection (OI).
Patients with the following are excluded:
* Presence of antibody to interleukin-2 (IL-2).
* Diseases or symptoms listed in Exclusion Co-Existing Conditions.
Prior Medication:
Excluded within 12 weeks prior to study entry:
* Other immunomodulators.
* Corticosteroids.
* Other experimental therapy.
* Anti-neoplastic chemotherapy.
Active drug or alcohol abuse.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00002017
|
{
"brief_title": "Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2",
"conditions": [
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00002017",
"official_title": "Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2",
"recruitment_information": null,
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2005-06-24",
"last_updated_that_met_qc_criteria": "2001-08-30",
"last_verified": "1991-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-08-31",
"first_submitted": "1999-11-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of an experimental HIV vaccine. The vaccine will be given with or without IL-12 DNA adjuvant (at three escalating doses of 100, 500, and 1,500 mcg respectively), a substance that helps the body respond to a vaccine. This study will also determine the safety and tolerability of an experimental HIV vaccine boosted with two adjuvants.
Detailed Description
The HIV epidemic is a major global health challenge, causing tremendous human suffering and economic loss throughout the world. The need for a safe, effective, and affordable HIV preventive vaccine is critical. This study will determine the safety and immunogenicity of an experimental HIV vaccine, HIV-1 gag DNA, given with or without an IL-12 adjuvant and boosted HIV-1 gag DNA with or without IL-12 DNA adjuvant.
This study will comprise two parts (Parts A and B). Part A will last 9 months and Part B, 15 months. Part A will consist of 48 participants enrolled in 4 groups. Group 1 participants will be randomly assigned to receive the gag DNA vaccine or placebo. Participants in Groups 2, 3, and 4 will be randomly assigned to receive the gag DNA vaccine and either 100 mcg, 500 mcg, or 1,500 mcg IL-12 DNA or placebo. Vaccinations for Groups 1 through 4 will be given intramuscularly and will occur at study entry and at Months 1 and 3.
Part B will consist of 96 participants, enrolled in 3 groups. Participants in Part B will receive their first vaccination 2 weeks after Part A participants receive their second vaccination. Group 5 participants will receive either the HIV-1 gag DNA vaccine or placebo. Group 6 participants will receive either the HIV-1 gag DNA vaccine plus IL-12 DNA or placebo. Vaccinations for Groups 5 and 6 will occur at study entry and at Months 1, 3, 6, and 9. Group 7 participants will receive either the gag DNA vaccine plus IL-12 DNA or placebo at study entry and at Months 1 and 3. Throughout the study, blood and urine collections will occur, physical exams will be conducted, HIV testing and counseling will be offered, and interviews and questionnaires will be completed.
#Intervention
- BIOLOGICAL : HIV-1 gag DNA
- A 0.75 mL intramuscular injection of HIV gag DNA vaccine into the deltoid
- BIOLOGICAL : HIV-1 gag DNA plus IL-12 DNA adjuvant
- Injection IL-12 DNA adjuvant intramuscularly into the deltoid
- BIOLOGICAL : CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine)
- A 1 mL intramuscular injection in the deltoid
- BIOLOGICAL : Sodium chloride injection (0.9%)
- All placebo groups will receive an intramuscular injection of sodium chloride (0.9%) in the deltoid.
Group 1 will receive a 0.75 mL injection on Days 0, 28, and 84. Group 2 will receive a 0.8 mL injection on Days 0, 28, and 84. Group 3 will receive a 1.0 mL injection on Days 0, 28, and 84. Group 4 will receive a 1.5 mL injection on Days 0, 28, and 84. Group 5 will receive a 0.75 mL injection on Days 0, 28, 84, 168, and 273. Group 6 will receive a 1.5 mL injection on Days 0, 28, 84, 168, and 273. Group 7 will receive a 1.5 mL injection on Days 0, 28, and 84 and a 1 mL injection into the deltoid on Days 168 and 273.
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV uninfected
* Access to a participating HIV Vaccine Trials Unit (HVTU)
* Willing to receive HIV test results
* Willing and able to comply with all study requirements
* In good general health
* Willing to use acceptable methods of contraception for at least 21 days prior to study entry and until the last study visit. More information about this criterion can be found in the protocol.
* Hepatitis B surface antigen negative
* Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive
* Weighs of or greater than 110 pounds (50 kg)
Exclusion Criteria:
* HIV infection
* HIV vaccines or placebos in prior HIV trial
* Immunosuppressive medications within 168 days prior to first study vaccination
* Blood products within 120 days prior to first study vaccination
* Live attenuated vaccines within 30 days prior to first study vaccination
* Medically indicated subunit or killed vaccines within 14 days prior to first study vaccination
* Pneumococcal vaccine within 14 days prior to first study vaccination
* Allergy treatment with antigen injections within 30 days prior to first study vaccination
* Current anti-tuberculosis (TB) preventive therapy or treatment
* Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
* Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
* Any job-related responsibility that would interfere with the study
* Allergies to local amide-type anesthetics
* Serious adverse reactions to vaccines, including hypersensitivity and related symptoms. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
* Autoimmune disease or immunodeficiency
* Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded.
* Moderate to severe asthma. More information on this criterion can be found in the protocol.
* Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded.
* Thyroid disease or surgical removal of the thyroid requiring medication during the 12 months prior to study entry
* Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study entry, with episodes requiring medication in the 2 years prior to study entry
* Hypertension that is not well controlled by medication OR blood pressure of 150/100 or higher at study entry
* Body mass index (BMI) of 40 or greater OR BMI of 35 or greater, if certain criteria are met. More information about these criteria can be found in the protocol.
* Bleeding disorder
* Cancer. Participants with surgically removed cancer that, in the opinion of the investigator, is unlikely to recur are not excluded.
* Absence of the spleen
* Plans to become pregnant during the study
* Pregnancy or breastfeeding
Exclusion Criterion for Participants in Part B:
* Allergies to yeast-derived products
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
|
NCT00111605
|
{
"brief_title": "Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults",
"conditions": [
"HIV Infections"
],
"interventions": [
"Biological: Sodium chloride injection (0.9%)",
"Biological: HIV-1 gag DNA",
"Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant",
"Biological: CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine)"
],
"location_countries": [
"Thailand",
"United States"
],
"nct_id": "NCT00111605",
"official_title": "A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Gag DNA Vaccine With or Without IL-12 DNA Adjuvant, Boosted With Homologous Plasmids in Healthy, HIV-1 Uninfected Adult Participants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2008-05",
"study_start_date(actual)": null
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-10-14",
"last_updated_that_met_qc_criteria": "2005-05-23",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-05-24",
"first_submitted": "2005-05-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The Psoriasis and a chronic dermatosis characterized by abnormal proliferation of cells epithelial, vessel dilation and inflammation locally, which presents erythematous-scaly lesions in various areas of the body, preferably in the scalp, region and religious joints as elbows and knees. It occurs equally in both sexes and can appear at any age, and the mean age for the onset of the disease and around 27.3 years.
The halobetasol propionate and an ultra-potent corticoid. Its chemical structure and similar to the Clobetasol corticoid this, until then classified as the most potent corticoid used worldwide in clinical practice. However, the molecular structure of Halobetasol gives it increased its activity antiinflammatory and anti-proliferative.
The objective of this study is evaluating the efficacy and tolerability of the drug Halobetasol propionate cream formulation as a treatment in patients with plaque psoriasis mild to moderate, compared to the substance of similar power, Clobetasol propionate - Psorex - Cream.
Detailed Description
The patients eligible will be informed about the procedures of the study and that agree to participate and sign the TCLE will be initially evaluated clinically for the clinical diagnosis of psoriasis plate with mild and moderate involvement of up to 20% of body surface. After the procedures for selection (initial clinical evaluation and verification of the criteria for inclusion and exclusion) the patients will be photographed, receive treatment and will be targeted and to manage it in proper way and standardized, when they do so at home. In each return (after 7, 14 days) will be held photographs of injuries, clinical examination, evaluation of adverse events and dispensing of medicine to patients.
The drugs dispensed will be sufficient for daily use until the next return. The product will be applied once a day, during night, preferably after the bath. The follow-up visits will occur in times of 07 and 14 days after the start of treatment. If there is complete improves the disease, treatment is interrupted before this date. On each visit will be examined by clinical parameters validated scales of assessment internationally (PASI), which provide the exact data of changes in the framework of each patient in each parameter measured. As parameters of the tolerability will be evaluated frequency and intensity of adverse events and the potential of irritative formulations, will be held photo of patients and questionnaires of cosmeticidade the formulation. Patients will be geared not to expose to the sun during the treatment period. At the end of the study, patients who present evolution will be full of injuries released the study and those who are still with obvious symptoms have treatment interrupted because of the risk of prolonged use of the drug under study. These patients will be referred to the Health Service for maintenance treatment with a new therapy. The patients who are released and make recurrence of the disease due to the rebound effect will be
#Intervention
- DRUG : halobetasol
- The patients will be treated with halobetasol once a day for 15 days.
- DRUG : clobetasol
- The patients will be treated with clobetasol once a day for 15 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients of both sexes, adults > 18 years, holders of psoriasis plating of mild to moderate,
* Patients with area of involvement of up to 20% of body surface,
* Patients with good physical and mental health
* Patients who agree with the purposes of the study and sign the Informed Consent
Exclusion Criteria:
* Patients with skin diseases other than psoriasis or which alter the clinical evaluation and development of disease,
* Patients with psoriasis in more than 20% of the body,
* Patients with other types of psoriasis that are not 'plating',
* patient with a scalp psoriasis who have difficulty in application of the product,
* Patients who have made topical treatment for psoriasis in the 2 months preceding the study,
* Patients who have made systemic treatment for psoriasis in the 4 months preceding the study,
* Patients who do not agree with the conditions described in the Statement of Informed Consent
* Patients who are pregnant and breastfeeding,
* Patients in use of oral anticoagulants,
* Patients who have psoriatics addition to plaques of skin disorders caused by fungi or bacteria.
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
|
NCT00715975
|
{
"brief_title": "Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis",
"conditions": [
"Psoriasis"
],
"interventions": [
"Drug: clobetasol",
"Drug: halobetasol"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT00715975",
"official_title": "Clinical Trial of Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis Plate, and as Comparator the Product Psorex (Clobetasol Propionate).",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-05",
"study_completion_date(actual)": "2010-08",
"study_start_date(actual)": "2008-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-09-02",
"last_updated_that_met_qc_criteria": "2008-07-14",
"last_verified": "2010-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-07-15",
"first_submitted": "2008-07-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A randomized clinical trial comparing drug abuse and HIV risk reduction counseling (DC-HIV) alone, DC-HIV combined with naltrexone maintenance, and DC-HIV combined with buprenorphine maintenance for the treatment of heroin addicts in Malaysia.
Detailed Description
Combining drug abuse and HIV risk reduction counseling with opioid agonist maintenance treatment (OMT) or antagonist maintenance treatment with naltrexone (NMT) is effective for reducing illicit drug use and preventing HIV transmission associated with heroin dependence, but support for NMT and OMT remains tenuous in many Western Pacific countries (e.g., Malaysia, Indonesia and Singapore) where heroin addiction and HIV infection are epidemic and closely linked due to injection drug use (IDU) and high-risk sexual behaviors among addicts. Promising results of NMT in Malaysia have created interest in evaluating OMT using buprenorphine (BMT) and comparing the efficacy of counseling alone and counseling combined with BMT or NMT. This 24-week, randomized double blind clinical trial compares the efficacy for preventing heroin use and relapse and reducing HIV risk behaviors of manual-guided, HIV risk reduction and drug counseling (DC-HIV) alone or when combined with buprenorphine maintenance treatment (BMT) or naltrexone maintenance treatment (NMT) for recently detoxified and currently abstinent heroin dependent patients (N=180) in Malaysia (Specific Aim 1). The study will allow evaluation of 3 hypotheses: DC-HIV plus naltrexone is superior to DC-HIV alone; DC-HIV plus buprenorphine is superior to DC-HIV alone; and DC-HIV plus naltrexone is superior to DC-HIV plus buprenorphine. Primary outcome measures, assessed by 3x/wk urine toxicology testing and self-report, include resumption of heroin use, 1 or 3 weeks continuous relapse and reductions in HIV risk behaviors. The project will also evaluate the characteristics of treatment-seeking heroin addicts in Malaysia (including specific risk behaviors and patterns of HIV risk behaviors; prevalence of psychiatric and other medical comorbidity; and patterns of social, family, vocational, and criminal activity and service needs-Specific Aim 2). This data will be used to revise the DC-HIV manual to address the specific circumstances and risk behaviors of Malaysian heroin addicts. Finally, the project provides clinical training for health professionals and training and mentoring in drug abuse treatment and HIV prevention research to clinical researchers who will continue development, implementation, evaluation and dissemination of HIV prevention and drug abuse treatment approaches in Malaysia after the project ends (Specific Aim 3). The results of the study will inform government policy and support for HIV prevention and drug abuse treatment efforts in Malaysia and possibly also in other Western Pacific countries.
#Intervention
- DRUG : Buprenorphine/Subutex
- DRUG : Naltrexone
- PROCEDURE : Drug counseling
|
#Eligibility Criteria:
Inclusion Criteria:
* Opioid dependence
Exclusion Criteria:
* Dependence on alcohol, benzodiazepines or sedatives
* Suicide or homicide risk
* Psychotic disorder or major depression
* Inability to read or understand the protocol or assessment questions
* Life-threatening or unstable medical problems
* Greater than 3 times normal liver enzymes (AST, GGT)
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00383045
|
{
"brief_title": "HIV Risk Reduction and Drug Abuse Treatment in Malaysia",
"conditions": [
"Opiate Dependence"
],
"interventions": null,
"location_countries": [
"Malaysia",
"United States"
],
"nct_id": "NCT00383045",
"official_title": "HIV Risk Reduction and Drug Abuse Treatment in Malaysia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2007-08",
"study_start_date(actual)": "2003-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-31",
"last_updated_that_met_qc_criteria": "2006-09-28",
"last_verified": "2009-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-10-02",
"first_submitted": "2006-09-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research study is to determine whether the investigational drug GM602, is effective and safe in the treatment of ischemic stroke (strokes caused by a blood clot blocking the flow of blood through one, or more of the blood vessels supplying the brain) when administered up to 18 hours after symptoms begin.
Detailed Description
Stroke is a serious and life threatening disease. About 85% of all strokes are ischemic, caused by a blood clot or plaque that blocks a blood vessel in the brain. The thrombolytic drug tissue plasminogen activator (tPA) is the only early treatment for acute ischemic stroke approved by the FDA. Treatment with tPA must be administered within three hours of the stroke onset. Furthermore, tPA treatment carries a recognized risk of bleeding in the brain. GM602 is an investigational drug that may act as a neuroprotectant in patients who have had a stroke. It is thought to stop cell death and reduce inflammation in the injured area of the brain. This study is designed to evaluate the safety and efficacy of GM602 administered intravenously to patients in three consecutive daily doses of 320 mg/dose or 480 mg/dose, the initial dose administered within 18 hours after onset of acute ischemic stroke in the Middle Cerebral artery region.
#Intervention
- DRUG : GM602
- First 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 320 mg/dose of GM602 or placebo in a 2:1 ratio, then the next 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 480 mg/dose of GM602 or placebo in a 2:1 ratio. Concurrently, 18 severe patients will be randomized in the same manner. Total 12 moderate and 12 severe patients will receive GM602.
- Other Names :
- GM6, GM604, GM608, MNTF
- DRUG : Placebo Comparator
- First 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 320 mg/dose of GM602 or Matching Placebo (Bacteriostatic Saline) for GM602 in a 2:1 ratio, then the next 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 480 mg/dose of GM602 or placebo in a 2:1 ratio. Concurrently, 18 severe patients will be randomized in the same manner. Total 6 moderate and 6 severe patients will receive placebo.
- Other Names :
- Bacteriostatic saline
|
#Eligibility Criteria:
Inclusion Criteria:
* > 18 years
* Be eligible for MRI or CT scan
* Have suffered acute ischemic stroke in the middle cerebral artery (MCA) distribution, as verified by the Screening diffusion-weighted imaging (DWI) abnormality and Screening perfusion-weighted imaging pressure-work index (PWI ) abnormality
* Have NIH Stroke Scale (NIHSS) score total score of 9 <= age <= 20 inclusive at screening
* Have suffered acute ischemic stroke within 18 hours
* Have been functionally independent with a Modified Rankin Score (mRS) of 0 or 1 prior to suffering stroke
* Patients who received tPA or FDA approved mechanical device can also enroll
* completed informed consent form
Exclusion Criteria:
* Have history of stroke in the past 3 months
* Cannot be evaluated using MRI/CT
* Have stroke of the brainstem or cerebellum
* Have clinical presentation consistent with acute MI by EKG criteria (STEMI) at screening
* Have hemorrhage revealed by CT or MRI scan
* Have > 1/3 MCA territory HYPER intensity as seen on MRI OR >1/3 MCA territory HYPO intensity as seen on CT
* Have blood sugar level >400 mg/DL or<50 mg/dL
* Have kidney disease, creatinine > 2.0
* Have had recent (within 90 days) serious head trauma or head trauma with loss of consciousness
* Have any prior history of seizure
* Have clinically relevant pre-existing neurological deficit (Historical Rankin score >= 2)
* Have any other known clinically significant medical disorder (cardiovascular, hepatic, renal, endocrine, respiratory, immunological, cancer, AIDS)
* Life expectancy of less than 6 months due to comorbid conditions
* Women of child bearing potential who are pregnant or breast-feeding or unable to practice birth control during the study period
* Have participated in any other trial of an investigational agent within 90 days prior to screening
* Informed consent cannot be obtained
* Unable to participate in study visits
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
|
NCT01221246
|
{
"brief_title": "Efficacy and Safety Study of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within 18 Hours",
"conditions": [
"Stroke"
],
"interventions": [
"Drug: Placebo Comparator",
"Drug: GM602"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01221246",
"official_title": "A Phase 2 Double Blinded, Randomized, Placebo Controlled Dose Escalation Study to Evaluate the Efficacy and the Safety of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within an 18-hour Treatment Window",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-07-07",
"study_completion_date(actual)": "2016-07-07",
"study_start_date(actual)": "2011-03-08"
},
"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)": "2019-08-12",
"last_updated_that_met_qc_criteria": "2010-10-13",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-10-14",
"first_submitted": "2010-10-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the effects of daily consumption for 4 weeks of a fermented milk drink containing a live probiotic microorganism, Lactobacillus casei strain Shirota (LcS) compared to a placebo without LcS, among adults with functional constipation.
#Intervention
- DIETARY_SUPPLEMENT : Probiotics fermented milk
- 80ml fermented milk containing min. 30 billion live L. casei Shirota strain, administered orally once a day for 4 weeks
- DIETARY_SUPPLEMENT : Nutrient drink
- 80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with functional constipation based on ROME II criteria
* Has a constipation severity score (Chinese Constipation Questionnaire or CCQ score) of at least 5, which is the cut-off point for constipated subjects (Chan et al, 2005)
* Free of any cardiovascular related diseases, diabetes, cancer, neurological diseases or any other serious illness, not physically or mentally handicapped
* Living in Klang Valley, with no pre-determined plans to be out of town for one week or longer during scheduled intervention period
Exclusion Criteria:
* Body Mass Index of less than 16, or 30 and above
* Pregnant
* Regular ingestion of probiotic products within the preceding four weeks
* Regular use of laxatives (average once a week or more)
* Intake of anticholinergics medications or medications against diarrhea or antibiotics in the preceding 1 month
* Persons with milk protein allergy
* Persons with constipation of organic or neurological origin based on health screening
* Persons with alarm features as assessed by physician during health screening
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
|
NCT01161784
|
{
"brief_title": "The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults",
"conditions": [
"Constipation"
],
"interventions": [
"Dietary Supplement: Nutrient drink",
"Dietary Supplement: Probiotics fermented milk"
],
"location_countries": [
"Malaysia"
],
"nct_id": "NCT01161784",
"official_title": "The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": "2010-06",
"study_start_date(actual)": "2010-01"
},
"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)": "2010-07-14",
"last_updated_that_met_qc_criteria": "2010-07-13",
"last_verified": "2010-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-07-14",
"first_submitted": "2010-07-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed chemotherapy-induced nausea and vomiting (CINV) induced by non- anthracyclines plus cyclophosphamide (AC) based moderately emetogenic chemotherapy (MEC).
#Intervention
- DRUG : metoclopramide
- DRUG : dexamethason
- DRUG : palonosetron
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient has been diagnosed with histologically or cytologically confirmed solid cancer
* Starting with first cycle of chemotherapy of moderate emetogenic risk, which does not include a combination of anthracycline plus cyclophosphamide
* Age >= 18
* WHO <= 1
* Patient is able to understand and speak Dutch
Exclusion Criteria:
* Patient with nausea and/or vomiting in 48 hours before start of chemotherapy treatment
* Patient submitted to concomitant radiotherapy or submitted to radiotherapy 15 days before start of chemotherapy or planned to receive radiotherapy during 8 days after administration of chemotherapy
* Patient with concomitant severe comorbidy, such as: o Intestinal obstruction o Active peptic ulcer o Hypercalcemia o Uncontrolled diabetes mellitus o Pheochromocytoma o Tardive dyskinesia o Epilepsia o Active infective diseases o Brain - or leptomeningeal metastases o Psychiatrical disorders o Parkinsonism
* Current use of corticosteroids (similar to prednisone >= 10 milligrams per day)
* Current alcohol abuse
* 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
|
NCT02135510
|
{
"brief_title": "MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy",
"conditions": [
"Solid Tumors"
],
"interventions": [
"Drug: dexamethason",
"Drug: metoclopramide",
"Drug: palonosetron"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT02135510",
"official_title": "MEtoclopramide, DExamethasone or Axoli (Palonoseton) for the Prevention of Delayed Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy: the MEDEA-trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-01",
"study_completion_date(actual)": "2019-03-01",
"study_start_date(actual)": "2013-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-31",
"last_updated_that_met_qc_criteria": "2014-05-06",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-05-12",
"first_submitted": "2014-05-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to conduct an open trial examining the feasibility and acceptability of an adapted heart rate variability biofeedback and smoking cessation treatment that was using a primarily virtual remote intervention.
Detailed Description
The present investigation is an open trial investigating the feasibility and acceptability of heart rate variability biofeedback smoking cessation treatment (HRVB-SCT) for individuals who smoke cigarettes. Significant findings will also support the expansion of HRVB as a transdiagnostic treatment adjunct that alters cardiac vagal functioning to promote emotional and behavioral regulation, changing the status quo of cognitive-behavioral intervention approaches and decreasing the health and economic burden of smokers who suffer from emotional distress.
The goals are to: (a) assess the feasibility and acceptability of the HRVB-SCT intervention (b) assess the efficacy of the intervention in modifying smoking behavior and emotional distress; and (c) collect additional information to inform a subsequent randomized clinical trial.
#Intervention
- BEHAVIORAL : Cognitive-Behavioral Smoking Cessation
- Participants will be provided with six individualized smoking cessation counseling sessions designed to help them prepare to quit, set a quit date, behaviorally manage early abstinence, and to resume cessation upon lapse.
- Other Names :
- Cognitive-behavioral therapy, Smoking cessation counseling
- BIOLOGICAL : Heart Rate Variability Biofeedback
- Participants will be provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation.
- Other Names :
- Biofeedback, Respiratory biofeedback
- DRUG : Nicotine patch
- All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
- Other Names :
- Transdermal nicotine patch, Nicotine replacement therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 21 <= age <= 50
* Smoking >= 5 cigarettes, daily, for at least two years
* Expired carbon monoxide analysis of breath sample >=8 ppm
* A score of > 5 on the Readiness to Quit Ladder (i.e., desire to quit smoking within the next 6 months)
* Ability to read and speak English fluently
* Computer and Smartphone proficient
Exclusion Criteria:
* Use of other tobacco or nicotine products for recreation or to aid in cessation or use of medication to aid in smoking cessation or currently receiving counseling for smoking cessation
* Endorsement of current or past psychotic or manic symptoms indicative of bipolar spectrum or schizophrenia spectrum disorders and/or current suicidal or homicidal ideation
* Self-reported pending legal issue with potential to result in incarceration
* Plan to move from the New Brunswick, New Jersey area within the next 6 months
* Inability to provide written informed consent
* Current evidence of another substance use disorder
* Severe visual or hearing impairments
* Self-reported medical condition or medication use that may be contraindicated for participation in heart rate variability biofeedback training or confound autonomic parameters: Being overweight or obese (i.e., body mass index > 35); Severe asthma or breathing problems (e.g., chronic obstructive pulmonary disease, emphysema, bronchitis); currently pregnant or lactating or plans to become pregnant in the next 4 months; Autoimmune disorder (e.g., multiple sclerosis; under or overactive thyroid); Neurodegenerative disorder (e.g., Alzheimer's disease, Parkinson's disease); Current use of a psychotropic medication or use of other medication that may affect the cardiovascular system (e.g., mood stabilizers, anti-psychotics, monoamine oxidase inhibitors, tricyclics, beta blockers, benzodiazepines; patients taking selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors will be enrolled if on a stable regimen for at least 6 weeks); History of heart murmur or arrhythmia; Pacemaker or other implanted cardiac devices; Heart disease; or Abnormal heart or respiratory parameters including respiration rate > 20 breaths per minute, extra systoles, or hypertension (e.g., blood pressure reading >= 140/90; this may be determined following baseline assessment. Importantly, the presence of any of these exclusion factors, if unknown to the participant would not put them at any risk if they participated in the study, it would simply make the cardiovascular data more difficult (if not impossible) to process and interpret, and
* Self-reported medical issues of potential concern to nicotine patch users (i.e., unstable angina pectoris, myocardial infarction, or significant cardiac arrhythmia (including atrial fibrillation) in the past 90 days
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05224050
|
{
"brief_title": "Heart Rate Variability Biofeedback for Smoking Cessation Treatment",
"conditions": [
"Tobacco Smoking"
],
"interventions": [
"Biological: Heart Rate Variability Biofeedback",
"Behavioral: Cognitive-Behavioral Smoking Cessation",
"Drug: Nicotine patch"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05224050",
"official_title": "Open Trial of Heart Rate Variability Biofeedback for Smoking Cessation Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-15",
"study_completion_date(actual)": "2023-06-15",
"study_start_date(actual)": "2021-11-29"
},
"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)": "2024-05-01",
"last_updated_that_met_qc_criteria": "2022-01-31",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-02-04",
"first_submitted": "2021-12-13",
"first_submitted_that_met_qc_criteria": "2024-04-29"
}
}
}
|
#Study Description
Brief Summary
The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product.
Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.
LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful.
In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg.
The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg.
Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procedures.
Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem cell transplant will be performed for six months post cell transplant.
#Intervention
- BIOLOGICAL : MESENDO
- 40 subcutaneous injections of biological product
- BIOLOGICAL : Placebo
- 40 subcutaneous injections of placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Males or females older than 18 years.
* Limb ischemia with ABI of < 0.7 in the index lower extremity in two consecutive examinations done at least 1 week apart.
* Limb ischemia with resting ischemic pain and/or claudication at 100 meters and/or non-healing ulcers.
* Claudication
* Patients not considered candidates for surgical or percutaneous revascularization, due to poor target vessels, inability to cross total occlusions, or a morbidity which precludes general anesthesia.
Exclusion Criteria:
* Inability to provide informed consent.
* Previous angiogenic therapy.
* Known sensitivity to gentamycin and/or amphotericin B.
* Use or expected use of antineoplastic drugs.
* Any illness, which might affect the patient's survival after enrollment in the protocol.
* Any illness or significant laboratory abnormality, which in the investigator's judgment will interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study results.
* No evidence of acute infection
* WBC > 15000.
* WBC < 4000.
* Serum Creatinine > 3.0 mg/dL in patients who are not in hemodialysis.
* Pregnant women or women planning to become pregnant or unwilling to use appropriate birth control methods before and 2 months after cell infusion.
* Recent myocardial infarction within 3 months prior to screening.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00721006
|
{
"brief_title": "Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia",
"conditions": [
"Critical Limb Ischemia",
"Severe Leg Ischemia",
"Peripheral Artery Disease",
"Peripheral Vascular Disease"
],
"interventions": [
"Biological: Placebo",
"Biological: MESENDO"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00721006",
"official_title": "Phase II Safety/Efficacy Study of A Combination Stem Cell Therapy That Develops Mature Stable Vessel Formation in Ischemic Limbs",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-08",
"study_completion_date(actual)": "2010-09",
"study_start_date(actual)": "2008-06"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-05-09",
"last_updated_that_met_qc_criteria": "2008-07-22",
"last_verified": "2010-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-07-23",
"first_submitted": "2008-07-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary Objective:
- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)
Secondary Objective:
* To assess the effect of the 2 lixisenatide regimens on:
* The percentage of participants who reached the target of HbA1c \< 7% or ≤ 6.5% at Week 24
* Fasting Plasma Glucose (FPG)
* 7-point Self-Monitored Plasma Glucose (SMPG) profiles
* Body weight
* To assess the safety and tolerability of the 2 lixisenatide regimens
Detailed Description
The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.
#Intervention
- DRUG : Lixisenatide (AVE0010)
- Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
- DEVICE : Self-injector pen device (OptiClik®)
- DRUG : Metformin
- To be kept at stable dose (≥1.5 g/day) throughout the study.
- Other Names :
- Route of administration: Oral
|
#Eligibility Criteria:
Inclusion criteria:
* Participants with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit
* Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.
Exclusion criteria:
* Screening HbA1c < 7.0% and > 10.0%
* Fasting plasma glucose at screening > 250 mg/dL (> 13.9 mmol/L)
* Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin
* Participants who usually did not eat breakfast
* Type 1 diabetes mellitus
* Body Mass Index (BMI) <= 20 kg/m^2 and > 40 kg/m^2
* Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
* Amylase and/or lipase > 3 times the upper limit of the normal laboratory range ( ULN) at screening
* Alanine aminotransferase (ALT) > 3 ULN at screening
* Calcitonin ≧ 20 pg/ml (5.9 pmol/L) at screening
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)
* Any contra-indication related to metformin
* Any previous treatment with lixisenatide
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01517412
|
{
"brief_title": "Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin",
"conditions": [
"Type 2 Diabetes Mellitus"
],
"interventions": [
"Drug: Lixisenatide (AVE0010)",
"Device: Self-injector pen device (OptiClik®)",
"Drug: Metformin"
],
"location_countries": [
"France",
"Ukraine",
"United States",
"Poland",
"Germany",
"Romania",
"Canada",
"Russian Federation",
"Spain",
"Czech Republic"
],
"nct_id": "NCT01517412",
"official_title": "A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-05",
"study_completion_date(actual)": "2013-05",
"study_start_date(actual)": "2012-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-14",
"last_updated_that_met_qc_criteria": "2012-01-20",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-01-25",
"first_submitted": "2012-01-16",
"first_submitted_that_met_qc_criteria": "2016-08-22"
}
}
}
|
#Study Description
Brief Summary
Patients that are on total knee/hip replacement initiate prophylaxis treatment on the hospital ground. Once they leave the hospital, as outpatients they continue with the treatment at least during two consecutive weeks. Patients will be instructed to follow treatment recommendations (either LMWH or oral treatment, at physician discretion) and to come back to the surgeon after that period. At that visit, the Treatment Satisfaction Questionaire with Medication (TSQM) test as well as the Moriski-Green Questionaire (measures compliance with medication) will be answer by the patient. TSQM is an self administered validated scale (validated also in spanish) that measures in a generic way the treatment satisfaction to a treatment. Morinski-Green test will be used to measure the compliance degree on medication.
#Intervention
- BEHAVIORAL : No Drug
- Patients in daily life clinical treatment receiving pharmacological agents to prevent VTE.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients in antithrombotic prophylaxis treatment after total knee/hip replacement. This is an epidemiological study where the patients to be included will be those that are treated with antithrombotics as out-patients in real life conditions.
Exclusion Criteria:
* Patients who has been previously treated with injectable antithrombotic treatments.
* Diabetic patients treated with insulin.
* Patients who do not sign Informed Consent Form.
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
|
NCT00911001
|
{
"brief_title": "SALTO - Epidemiological Study on Compliance and Treatment Satisfaction",
"conditions": [
"Thromboembolism"
],
"interventions": [
"Behavioral: No Drug"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT00911001",
"official_title": "Compliance and Treatment Satisfaction in Prophylaxis of Postsurgical Thromboembolism",
"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)": "2008-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-09-19",
"last_updated_that_met_qc_criteria": "2009-05-29",
"last_verified": "2013-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-06-01",
"first_submitted": "2009-05-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this clinical research study is to learn if the results of a positron emission tomography/computed tomography (PET/CT) scan done 10-14 days after beginning chemotherapy and radiation (chemoradiation) can predict how a patient with cancer of the esophagus will respond to chemoradiation. Researchers also want to learn if biomarkers (substances in the body associated with cancer) found in tumor tissue can predict response to chemoradiation.
Detailed Description
You have cancer of the esophagus and you and your doctor have agreed that you will have treatment with chemoradiation to try to shrink the cancer. You will then have surgery to remove any remaining tumor.
How well cancer of the esophagus responds to chemoradiation varies from person to person. Currently, doctors cannot tell before surgery in which patients the chemoradiation will kill all of the cancer, some of the cancer, or not much of the cancer. Studying patients' PET/CT scans and tumor tissue for biomarkers may help researchers predict how an individual patient will respond to chemoradiation. This could spare future patients from having unnecessary surgery or chemoradiation treatment that is not effective.
PET and CT scans are both standard imaging tests that doctors use to find cancer in the body. The PET scan detects the signal of actively growing cancer cells in the body and the CT scan shows the location, size, and shape of the cancer. Combining these scans provides more complete information on cancer location, growth, and changes in the cancer over time.
Currently, routine testing for esophageal cancer at MD Anderson includes a PET/CT scan at the time of diagnosis and 5 or 6 weeks after chemoradiation is completed. Researchers hope that analyzing changes seen in an 'early' PET/CT scan (performed between 10-14 days after starting chemoradiation) compared to the PET/CT scan taken at the time of diagnosis may predict how well the chemoradiation will work against the patient's cancer.
PET/CT Scan:
If you are found to be eligible to take part in this study, 10-14 days after you start your chemoradiation treatment you will have a PET/CT scan performed.
You will need to fast (not have anything to eat or drink except water) for 4-6 hours before the PET/CT scan. Blood (about 1 teaspoon) will be drawn to check your blood sugar level.
You will receive a small amount of fluorodeoxyglucose (FDG) solution by vein. Cancer cells use sugar at a higher rate than normal cells do. FDG is a radioactive form of glucose (sugar) commonly used during a PET scan. The FDG helps show areas in the body where there is cancer cell growth. After receiving the FDG solution, you will rest in a quiet, darkened room for 45-60 minutes before the PET/CT scan. The entire procedure should take about 3 hours.
This PET/CT scan will be compared to your routine PET/CT scan. Your doctor will tell you of the results of this PET/CT scan. However, the results will not change the planned treatment you receive, unless the scan shows that the disease has gotten worse.
Biomarkers Testing:
Researchers will collect samples of tumor tissue previously collected at MD Anderson. This tissue will be used for biomarker testing.
Length of Study:
You will be off active study once you complete the PET/CT scan.
Medical Record Information Collection and Long-Term Follow-Up:
The study staff will collect information from your medical record on tests, evaluations, and treatments you receive as part of your routine care. The study staff will continue to collect this information from your medical record as long as you are a patient at MD Anderson.
If you stop coming to MD Anderson, you will be called by the study staff every 3 months after surgery for the first year and then every 6 months after that. During this call, you will be asked about your health status. The call should take about 5 minutes.
This is an investigational study. PET/CT scans are routine tests for patients with cancer of the esophagus. The early PET/CT scan for the purpose of this study is investigational.
Up to 95 patients will take part in this study. All will be enrolled at MD Anderson.
#Intervention
- PROCEDURE : PET/CT (FDG PET/CT)
- PET/CT scan with fluorodeoxyglucose (FDG) solution by vein, scan done 10-14 days after beginning chemotherapy and radiation (chemoradiation).
- Other Names :
- Positron emission tomography/computed tomography
- OTHER : Biomarker Testings
- Tissue obtained at MDACC during previous biopsy and at time of post chemoradiation surgery will be used for biomarker analysis.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient must have histologic documentation of adenocarcinoma or squamous carcinoma of the esophagus at M. D. Anderson Cancer Center (MDACC).
* Patients with localized carcinoma of the esophagus who have undergone standard testing and been evaluated by the multidisciplinary team at MDACC and are considered appropriate candidates for and are willing to undergo chemoradiation therapy followed by surgery at MDACC. Radiation may be delivered as proton or photon. These patients have clinical stage II or III cancers and they are considered medically fit to undergo surgery.
* Patient must have undergone a baseline esophagealgastroduodenoscopy (EGD) with biopsy and endoscopic ultrasonography at MDACC, with tissue available for biomarker analysis.
* Patient must have undergone a baseline FDG-PET/CT at MDACC or an outside institution.
* Patient must be willing to undergo a research 'early' FDG-PET/CT (12 +/- 2 days from the start of chemoradiation).
* Patient must provide written informed consent.
* Patient must be >= 18 years.
Exclusion Criteria:
* Patient is unable or unwilling to comply with the requirements of the protocol.
* Patient had baseline FDG-PET/CT scan maximum SUV of < 4.0.
* Patient is not a candidate for chemoradiation followed by surgery.
* Patients who received induction chemotherapy prior to chemoradiation therapy are excluded.
* Patients with T1N0 or T4anyN are 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
|
NCT00833625
|
{
"brief_title": "FDG-PET-CT and Biomarkers in Esophageal Cancer",
"conditions": [
"Gastrointestinal Disease",
"Esophageal Cancer"
],
"interventions": [
"Procedure: PET/CT (FDG PET/CT)",
"Other: Biomarker Testings"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00833625",
"official_title": "FDG-PET-CT and Biomarkers to Assess Pathologic Response in Surgical Specimens of Patients With Localized Esophageal Cancer After Chemoradiation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2009-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-28",
"last_updated_that_met_qc_criteria": "2009-01-29",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-02-02",
"first_submitted": "2009-01-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a single-arm, phase II trial (monocentric) study designed to determine To evaluate activity of Cabozantinib in terms of ORR according to the RECIST 1.1 criteria in Metastatic Collecting Duct Renal Cell Carcinoma
Detailed Description
This is a single-arm, phase II trial (monocentric)
#Intervention
- DRUG : cabozantinib
- cabozantinib 60 mg orally once daily
|
#Eligibility Criteria:
Inclusion Criteria:
* Written Informed Consent Form
* Unresectable, advanced or metastatic collecting ducts carcinoma untreated with any systemic agent for advanced disease
* Measurable disease as defined by RECIST v1.1 criteria
* Age >=18 years
* ECOG Performance Status 0 <= age <= 1
* Any of the following laboratory test findings:
* Hemoglobin > 9 g/dL (5.6 mmol/L)
* WBC > 2,000/mm3
* Neutrophils > 1,500/mm3
* Platelets > 100,000/mm3
* AST or ALT < 3 x ULN (< 5 x ULN if liver metastases are present)
* Total Bilirubin < 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
* Serum creatinine < 1.5 x upper limit of normal (ULN) or creatinine clearance >= 40 mL/min (measured or calculated by Cockroft-Gault formula)
* Lipase < 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis
* PT-INR/PTT <= 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care
* Availability of a representative FFPE tumor specimen collected within 24 months of starting first-line cabozantinib that enables the definitive diagnosis of CDC (the archival specimen must contain adequate viable tumor tissue to enable candidate biomarkers status; the specimen may consist of a tissue block or at least 15 unstained serial sections; for core needle biopsy specimens, at least two cores should be available for evaluation)
* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and for 4 months after the last dose of study treatment
* Female subjects of childbearing potential must not be pregnant at screening
Exclusion Criteria:
* Previous therapy for advanced disease; any medical adjuvant treatment must have been stopped at least six months before entry into the study
* History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
* Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >=140 mmHg or diastolic blood pressure (DBP) of >= 90mmHg].
* History of cerebrovascular accidents, including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
* Major surgery or trauma within 28 days before to study entry; the such as catheter placement not considered to be major surgery).
* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before randomization.
* Evidence of active bleeding or bleeding diathesis and/or clinically-significant GI bleeding within 6 months before the first dose of study treatment; 3 months for pulmonary hemorrhage and patients with tumor invading or encasing any major blood vessels.
* Patients with GI disorders associated with a high risk of perforation or fistula formation.
* Subjects with clinically relevant ongoing complications from prior radiation therapy.
* Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
* Previous or ongoing treatment (except for adjuvant therapies) with any of the following anti-cancer therapies: chemotherapy, immunotherapy, target therapies, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of Cabozantinib
* Inability to swallow tablets or capsules.
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
|
NCT03354884
|
{
"brief_title": "caBozantinib in cOllectiNg ductS Renal Cell cArcInoma",
"conditions": [
"Collecting Duct Carcinoma (Kidney)"
],
"interventions": [
"Drug: cabozantinib"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT03354884",
"official_title": "caBozantinib in cOllectiNg ductS Renal Cell cArcInoma (BONSAI)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-11-19",
"study_completion_date(actual)": "2020-11-19",
"study_start_date(actual)": "2018-01-12"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-05-10",
"last_updated_that_met_qc_criteria": "2017-11-27",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-28",
"first_submitted": "2017-11-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response (MMR) or better after stopping TKI therapy.
Secondary goals include:
* Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of Complete molecular remission (CMR), risk score, duration of TKI treatment, type of TKI pretreatment)
* Evaluation of quality of life (QoL) in patients stopping TKI
* Evaluation of medico-economic impact of stopping TKI
* Estimating the number of patients in CMR who are eligible for stopping TKI therapy by setting up a screening log
* Time to recovery of CMR There will be no randomised comparison. Based on the experience of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month molecular-relapse-free survival probability of at least 40%. An interim analysis will be performed after a pilot phase where 200 patients have been observed for at least six months. Formally, it is planned to test the null hypothesis H0: Six-month molecular relapse-free survival probability P ≤ 40% against the alternative hypothesis H1: Six-month molecular-relapse-free survival probability P \> 40%. Eligible are adult CML patients in chronic phase on TKI treatment in CMR for at least one year (\> 4 log reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by a PCR within a standardized CMR laboratory). Clinical and biological monitoring will be performed during 3 years: Associated scientific projects are performed. Recruitment period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500
#Intervention
- OTHER : Stopping treatment with TKI
- stopping until loss of MMR
|
#Eligibility Criteria:
Inclusion Criteria:
* CML in CP under treatment with TKI in first line or in second line because of toxicity to first line TKI or with TKI in combination
* Duration of TKI treatment before enrolment at least 3 years
* At least complete molecular remission MR4
* Before inclusion confirmation of CMR4 through a EUTOS-CMR laboratory
* Baseline data and documentation on treatment before study entry available
* Both sexes but fertile women only if using effective contraceptive
* Health insurance coverage
* >= 18 years
Exclusion Criteria:
* Under 18 years
* Hospitalized patients without ability to give informed consent
* Adults under law protection or without ability to consent
* Previous or planned allogeneic stem cell transplantation
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
|
NCT01596114
|
{
"brief_title": "European Stop Tyrosine Kinase Inhibitor Study",
"conditions": [
"Chronic Myeloid Leukemia"
],
"interventions": [
"Other: Stopping treatment with TKI"
],
"location_countries": [
"France",
"Netherlands",
"Sweden",
"Portugal",
"Germany",
"Greece",
"Norway",
"Finland",
"Czechia",
"Denmark"
],
"nct_id": "NCT01596114",
"official_title": "Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukemia After Stopping TKI",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-12-03",
"study_completion_date(actual)": "2019-12-31",
"study_start_date(actual)": "2012-05-30"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-05",
"last_updated_that_met_qc_criteria": "2012-05-09",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-10",
"first_submitted": "2012-05-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Several studies have investigated the mechanical behavior of the thoracolumbar spine. However, an accurate reference for normal functional local alignment and segmental motion at the thoracolumbar junction is still illusive. Therefore, we conducted a cross-sectional cohort study with a balanced distribution of age and sex of healthy subjects to examine the normal alignment and segmental motion at the thoracolumbar junction using dynamic plain radiography. This study aimed to provide data that can be used when planning surgery or performing rehabilitation in pathological situations.
#Intervention
- RADIATION : plain radiography (x-ray)
- Radiographic imaging of the subjects was performed, and anteroposterior, lateral, flexion-extension, and right-left lateral bending radiograph views were obtained
|
#Eligibility Criteria:
Inclusion Criteria:
* A total of 120 asymptomatic healthy volunteer subjects aged 20 to 79 without back pain complaints were included if they successfully met the study's exclusion criteria
Exclusion Criteria:
* (1) coronal deformity (Cobb angle > 10°); (2) a history of prior spine surgery; (3) a history of hip or knee arthroplasty or any other realignment surgery of the lower extremities (osteotomy, trauma, etc.); (4) complaints of back or neck pain that resulted in missed work, affected daily living activities, participation in recreational activities or required narcotic pain medication; (5) degenerative or pathologic conditions of the spine that necessitated physician intervention (i.e., physician appointment or epidural steroid injections); (6) non-ambulatory patients; (7) a history of neuromuscular disorders, inflammatory arthritis, or congenital anomalies; and (8) pregnancy
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 78 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06138912
|
{
"brief_title": "Thoracolumbar Junction",
"conditions": [
"Spinal Curvatures"
],
"interventions": [
"Radiation: plain radiography (x-ray)"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT06138912",
"official_title": "Normal Functional Local Alignment and Segmental Motion at the Thoracolumbar Junction: A Cross-Sectional Study of Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-31",
"study_completion_date(actual)": "2021-12-31",
"study_start_date(actual)": "2020-01-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-18",
"last_updated_that_met_qc_criteria": "2023-11-14",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-11-18",
"first_submitted": "2023-11-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Donor T cells that are treated in the laboratory may be effective treatment for malignant glioma. Aldesleukin may stimulate the white blood cells to kill tumor cells. Combining different types of biological therapies may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best way to give therapeutic donor lymphocytes together with aldesleukin in treating patients with stage III or stage IV malignant glioma.
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the safety of GRm13Z40-2 CTL CNS loco-regional cellular immunotherapy in research participants with recurrent or refractory/ progressive malignant glioma (WHO Grades 3 or 4).
II. To assess the safety of convection enhanced delivery (CED) of recombinant human Interleukin-2 (rhuIL-2) used in conjunction with GRm13Z40-2 CTL adoptive transfer.
SECONDARY OBJECTIVES:
I. To investigate the ability of 9-(4-fluoro-3-hydroxy-methyl-butyl) guanine (18FHBG) positron emission tomography PET to image GRm13Z40-2 CTL's in research participants.
II. To study the impact of concurrent dexamethasone administration on the tempo and magnitude of T cell allograft rejection responses in treated research participants by tracking the frequency of anti-GRm13Z40-2 immune responses in serially acquired peripheral blood samples.
III. To evaluate ganciclovir administration for ablating transferred GRm13Z40-2 in vivo should significant graft-mediated toxicities be encountered.
OUTLINE: Patients receive GRm13Z40-2 therapeutic allogeneic lymphocytes intratumorally (IT) over 10 minutes on days 1 and 3 and aldesleukin IT over 3 hours on days 2-5 (days 1-5 in week 2). Treatment repeats every week for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed annually for at least 15 years.
#Intervention
- BIOLOGICAL : therapeutic allogeneic lymphocytes
- Given intratumorally
- Other Names :
- ALLOLYMPH
- BIOLOGICAL : aldesleukin
- Given intratumorally
- Other Names :
- IL-2, interleukin II, Proleukin, recombinant human interleukin-2, recombinant interleukin-2, TCGF, interleukin
- OTHER : laboratory biomarker analysis
- Optional correlative studies
- PROCEDURE : positron emission tomography
- Optional correlative studies
- Other Names :
- FDG-PET, PET, PET scan, tomography, emission computed
|
#Eligibility Criteria:
Inclusion Criteria:
* Histological verification of grade III or IV MG at original diagnosis
* Radiographic evidence of progression/recurrence of the measurable disease more than 12 weeks after the end of radiation therapy
* Expression of IL13Ralpha2 by immunohistochemistry
* Karnofsky performance status (KPS) >= 60
* Disease recurrence/progression in the cerebral hemisphere, which is in at least one area of enhancement amenable to biopsy after protocol enrollment in the following locations:
* Adjacent or near previous resection cavity
* Distant from primary location; this includes tumor spread to contralateral hemisphere, corpus callosum, thalamus, basal ganglion, or subependymal locations
* Research participant has recovered from toxicity of prior therapies; an interval of at least 12 weeks must have elapsed since the completion of radiation therapy; at least 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen; and at least 4 weeks since the completion of a non-nitrosourea-containing cytotoxic chemotherapy regimen; if a patient's most recent treatment was with a targeted agent only, and s/he has recovered from any toxicity of this targeted agent, then a waiting period of only 2 weeks is needed from the last dose and the start of study treatment, with the exception of bevacizumab where a wash out period of at least 4 weeks is required before starting study treatment
* History of prior treatment with Temodar if no evidence of intolerance; documentation of intolerance to Temodar is not required
* Creatinine < 1.6
* White blood cell (WBC) >= 2,000/dl (or absolute neutrophil count [ANC] > 1,000) Platelets >= 100,000/dl unsupported by transfusion or growth factor, international normalized ratio (INR) < 1.3
* Bilirubin < 1.5
* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) < 2 X upper limits of normal
* Female research participants of childbearing potential must not be pregnant as evidenced by a serum beta-HCG pregnancy test obtained within 7 days of enrollment
* Research participants having reproductive potential must agree to use effective contraception during participation on this protocol
* In the opinion of the neurosurgeon, research participant requires on-going dexamethasone therapy
Exclusion Criteria:
* Survival expectation less than 4 weeks
* Pulmonary- Requirement for supplemental oxygen use that is not expected to resolve within 2 weeks, Cardiac- Uncontrolled cardiac arrhythmia, hypotension requiring pressor support, Renal- Dialysis dependent, Neurologic- refractory seizure disorder, clinically evident progressive encephalopathy
* Tumors with the following characteristics:
* Large tumor recurrence causing significant symptoms from brain shift or mass effect, and thus not requiring 'decompressive' craniotomy
* Tumors located primarily in the basal ganglion or thalamus
* Tumors with significant involvement of midbrain, cerebellum, pons and medulla will be excluded due to neurological risks associated with edema exacerbation from therapy
* Research participants with any non-malignant intercurrent illness which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it unwise to enter the research participant on protocol shall be ineligible
* Positive human immunodeficiency virus (HIV) serology based on testing within 4 weeks of enrollment
* Research participants being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator
* Failure to understand the basic elements of the protocol and/or the risks/benefits of participating in this pilot study
* History of ganciclovir and/or magnetic resonance imaging (MRI) contrast allergy or intolerance History of intolerance to IL-2
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01082926
|
{
"brief_title": "Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2",
"conditions": [
"Anaplastic Astrocytoma",
"Anaplastic Ependymoma",
"Anaplastic Meningioma",
"Anaplastic Oligodendroglioma",
"Brain Stem Glioma",
"Ependymoblastoma",
"Giant Cell Glioblastoma",
"Glioblastoma",
"Gliosarcoma",
"Grade III Meningioma",
"Meningeal Hemangiopericytoma",
"Mixed Glioma",
"Pineal Gland Astrocytoma",
"Brain Tumor"
],
"interventions": [
"Other: laboratory biomarker analysis",
"Procedure: positron emission tomography",
"Biological: therapeutic allogeneic lymphocytes",
"Biological: aldesleukin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01082926",
"official_title": "Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09",
"study_completion_date(actual)": "2013-09",
"study_start_date(actual)": "2010-05"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-06-08",
"last_updated_that_met_qc_criteria": "2010-03-08",
"last_verified": "2015-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-09",
"first_submitted": "2010-03-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Serrated Polyposis Syndrome (SPS) is a high-risk condition for colorectal cancer (CRC). SPS patients have a cumulative CRC risk of 1.9% in 5 years despite a strict endoscopic surveillance in specialized centers. Proximal serrated lesions are endoscopically challenging to detect due to their unremarkable morphology. Endocuff is a novel device comprised of a cap with a row of finger-like projections with a unique dynamic shape that help to flatten mucosal folds during withdrawal of the instrument in order to improve detection of lesions. Recent studies have reported an increase of detection rate and mean per patient of adenomas with Endocuff-assisted Colonoscopy compared with Standard Colonoscopy. The purpose of this study is to assess the usefulness of Endocuff-assisted Colonoscopy to detect serrated lesions in SPS patients undergoing surveillance compared to Standard Colonoscopy in a randomized fashion
Detailed Description
According to own data and similarly to previous published studies, patients diagnosed of Serrated Polyposis Syndrome undergoing annual surveillance after clearance of all serrated lesions ≥ 5mm, have a mean of 5 serrated lesions per patient at follow-up colonoscopies. The study was powered to establish a 25% significant increase in the mean of serrated lesions per patient in the Endocuff-assisted colonoscopy group. Accepting an alpha risk of 0.05, a beta risk of 0.2 and a loss rate of 10% in a bilateral contrast, a sample size of 124 patients (62 in each arm) are required to achieve statistic significance.
#Intervention
- DEVICE : Endocuff-assisted Colonoscopy
- Colonic examination with Endocuff-assisted Colonoscopy
- Other Names :
- ECC
|
#Eligibility Criteria:
Inclusion Criteria:
*Adults with diagnosis of Serrated Polyposis Syndrome undergoing surveillance colonoscopies after clearance of all lesions >=5mm
Exclusion Criteria:
* Patients with known strictures
* Partial or total colonic resection
* Acute diverticulitis
* Concomitant inflammatory bowel disease
* Suspected or proven lower gastrointestinal bleeding
* Non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure
* Inability to sign informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02592603
|
{
"brief_title": "Endocuff for Surveillance of Serrated Polyposis Syndrome",
"conditions": [
"Polyposis"
],
"interventions": [
"Device: Endocuff-assisted Colonoscopy"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT02592603",
"official_title": "Endocuff-assisted vs. Standard Colonoscopy for Surveillance of Serrated Polyposis Syndrome: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07",
"study_completion_date(actual)": "2017-07",
"study_start_date(actual)": "2015-10"
},
"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)": "2017-08-04",
"last_updated_that_met_qc_criteria": "2015-10-29",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-30",
"first_submitted": "2015-10-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In the clinical setting, it is difficult to obtain effective rehabilitation during the acute phase, the reasons may include insufficient awareness of early rehabilitation due mainly to a limitation in number and variety of rehabilitation professionals in Low- and middle-income countries. It is necessary to shift tasks to other healthcare providers who are trained to provide rehabilitation like nurses. The purpose of this study is to examine the feasibility and effectiveness of a modified Barthel Index based rehabilitation nursing program on acute stroke inpatients.
Detailed Description
Ischemic stroke is the main cause of disability in the world. More than 70% of stroke patients show various degrees of neural function impairment. Early rehabilitation in acute phase is beneficial for improving patient's activity of daily livings and motor function. However, it is difficult to obtain effective rehabilitation during the acute phase of stroke because of the insufficiency of professional rehabilitation therapists in stroke wards in China. The investigators assume that implementing program based on modified Barthel Index can realize nursing-directed motor rehabilitation during acute phase of ischemic stroke. The present study is to conduct quasi-experimental research to confirm the feasibility and effectiveness of nursing-directed precision rehabilitation in acute stroke patients.
#Intervention
- BEHAVIORAL : The modified Barthel Index-based rehabilitation nursing program
- The intervention with the program based on the MBI classified function of patients into five levels, with every 20 points as a level, Each level corresponds to different training items. Training items included self-care training and training in transfer activities, sitting balance, walking, and sit-to-stand, etc. Each training session lasting at least 30 minutes, two sessions per day, for seven continuous days. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.
- BEHAVIORAL : Usual care
- Patients in the control group received clinical usual care including the activities of daily living assessment, early mobilization guide and health education. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.
|
#Eligibility Criteria:
Inclusion Criteria:
* diagnosed with ischemic stroke and met the diagnostic criteria of the World Health Organization;
* initial stroke within seven days, with limb dysfunction;
* NIHSS scale consciousness scores of 0 or 1;
* provided informed consent form.
Exclusion Criteria:
* incomplete clinical data;
* having a physical disability or other diseases that affect the limb function;
* having cognitive impairment or other diseases that interfere with participation;
* having serious cardiopulmonary dysfunction or another disease that requires absolute bed rest;
* having progressive stroke or having severe complications that patients drop the study before completion.
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
|
NCT04402736
|
{
"brief_title": "Feasibility and Effectiveness of Rehabilitation Nursing for Acute Stroke",
"conditions": [
"Acute Ischemic Stroke",
"Nursing"
],
"interventions": [
"Behavioral: Usual care",
"Behavioral: The modified Barthel Index-based rehabilitation nursing program"
],
"location_countries": [
"China"
],
"nct_id": "NCT04402736",
"official_title": "Feasibility and Effectiveness of a Modified Barthel Index-based Rehabilitation Nursing Program for Acute Ischemic Stroke",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-29",
"study_completion_date(actual)": "2018-11-20",
"study_start_date(actual)": "2018-01-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-12",
"last_updated_that_met_qc_criteria": "2020-05-24",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-05-27",
"first_submitted": "2020-05-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Improving upper extremity movement and function in patients with stroke has been one of the primary goals for patients and rehabilitation professionals. Thermal stimulation (TS) had been first found by a domestic research group to be effective to facilitate sensory and motor recovery in patients with stroke within a month. However, the immediate and long-term effects of TS and the mechanism of brain plasticity in patients with stroke for more than three months (golden recovery stage) remain unknown. Thus, we will design a single-blind randomized controlled trial to investigate the immediate and long-term effects of TS in patients with stroke at subacute and chronic stages.
Detailed Description
The study was an assessor-blinded randomized controlled clinical trial. Participants with UE impairment for more than 3 months poststroke were randomly assigned to either the experimental (EXP) group or the control group. All participants received regular conventional rehabilitation programs. The EXP group received an additional UE-TS protocol for 30 minutes a day (3 days/week for 8 weeks); the control group received the same TS protocol over the lower extremity (LE). The Brunnstrom's recovery stage, the Modified Ashworth Scale (MAS), the Stroke Rehabilitation Assessment of Movement (STREAM), the Action Research Arm Test (ARAT), and the Barthel Index (BI) were outcome measures and were administered at baseline, 4 weeks and 8 weeks post inception, and at one-month follow-up.
#Intervention
- DEVICE : A custom-made constant temperature thermal stimulation system (FIRSTEK, Model-B401L, B-300, local company, Taiwan).
- The subjects meeting our criteria will be randomly assigned to either the experimental group or the control group. First stage (3 months after onset), the subjects in the experimental group will receive an upper extremity Thermal Stimulation (TS) protocol for 30 minutes (3 times a week for 8 weeks). The subjects in the control group will receive a lower extremity TS protocol.
|
#Eligibility Criteria:
Inclusion Criteria:
* first-ever stroke survivors with unilateral hemispheric lesions from a hemorrhagic or nonhemorrhagic stroke;
* stroke onset more than 3 months and less than 3 years prior to study enrollment;
* no severe cognitive impairments and able to follow instructions;
* the ability to sit on a chair for more than 30 minutes independently.
Exclusion Criteria:
* musculoskeletal or cardiac disorders that could potentially interfere with experimental tests;
* diabetic history or sensory impairment attributable to peripheral vascular disease or neuropathy;
* speech disorder or global aphasia;
* participating in any experimental rehabilitation or drug studies;
* skin injuries, burns, or fresh scars at the sites of stimulation;
* contraindication of heat or ice application.
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
|
NCT01078727
|
{
"brief_title": "Safety Study of Thermal Stimulation on Upper Extremity Motor Recovery to Stroke",
"conditions": [
"Stroke"
],
"interventions": null,
"location_countries": [
"Taiwan"
],
"nct_id": "NCT01078727",
"official_title": "Thermal Stimulation on Upper Extremity Movement and Function in Patients With Stroke",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-07",
"study_completion_date(actual)": "2010-01",
"study_start_date(actual)": "2007-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-03-02",
"last_updated_that_met_qc_criteria": "2010-03-01",
"last_verified": "2008-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-02",
"first_submitted": "2010-02-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About Pregnant Women's Service Quality and Satisfaction
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult over the age of 20 pregnant women.
* Clear consciousness, those without severe cognitive impairment, such as dementia, mental retardation or mental illness.
* Literacy and the use of Chinese or Taiwanese.
* Willingness to participate in the research.
Exclusion Criteria:
Refused to participate in the research
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01208610
|
{
"brief_title": "The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About Pregnant Women's Service Quality and Satisfaction",
"conditions": [
"Pregnant Women"
],
"interventions": null,
"location_countries": [
"Taiwan"
],
"nct_id": "NCT01208610",
"official_title": "The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About Pregnant Women's Service Quality and Satisfaction",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2010-06",
"study_start_date(actual)": "2010-02"
},
"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)": "2010-09-24",
"last_updated_that_met_qc_criteria": "2010-09-23",
"last_verified": "2010-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-09-24",
"first_submitted": "2010-09-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate whether the use of the Oncotype DX DCIS score can guide delivery of radiation in women with low to moderate risk DCIS who have had breast conserving surgery
Detailed Description
A prospective cohort study, conducted in Canada, to evaluate whether the use of the DCIS score changes the treatment recommended and the treatment received in women with low to moderate risk DCIS following breast conserving surgery who are candidates for radiation therapy. We plan to study 280 eligible, consenting women who will have their tumour tissue specimen sent to Genomic Health to assess their DCIS score.
At each centre, all patients with DCIS referred to radiation oncology will be documented. When a physician identifies an eligible patient, the patient will be approached by the referring physician or delegate to voluntarily provide informed consent to participate in this study. Consenting patients will be registered through the Ontario Clinical Oncology Group's (OCOG) web-based registration system. Data related to the patient demographics, surgery details, and tumour characteristics will be collected. The preliminary treatment recommendation and patient preference for treatment will be documented. Patient Decisional Conflict will be documented by the patient using the Decisional Conflict Scale (DCS). The patient's tumour specimen will be sent for analysis to Genomic Health. DCIS score results will be sent to the referring physician. OCOG will also receive the DCIS score results. The final treatment recommendation, patient preference, and treatment received by the patient will be documented. Patient decisional conflict will be documented by the patient using the DCS. The study data will be verified by source documentation.
|
#Eligibility Criteria:
Inclusion Criteria:
(1) Women with newly diagnosed breast cancer treated by definitive surgery with histological evidence limited to DCIS.
Exclusion Criteria:
* Age < or = 45;
* Treated by mastectomy;
* Surgical margins of <1mm;(re-excisions may be performed where results are regarded as clear margins, these cases will not exclude patients);
* Tumour size >2.5cm;
* Any invasive breast cancer including micro invasion;
* Histological evidence of multifocality (defined as having more than one distinct focus of DCIS with >5mm of intervening benign breast tissue in one quadrant of the breast);
* Any associated lobular carcinoma in situ;
* Previous diagnosis of ipsilateral invasive carcinoma or DCIS of the breast;
* Any contraindication for whole breast irradiation such as chronic heart or lung disease or previous ipsilateral chest wall radiotherapy;
* Physician/patient unwilling to comply with study protocol; and
* Inability to provide informed consent (e.g. dementia or severe cognitive impairment).
Sex :
FEMALE
Ages :
- Minimum Age : 46 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02766881
|
{
"brief_title": "Evaluation of the DCIS Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS",
"conditions": [
"DCIS"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT02766881",
"official_title": "Evaluation of the Ductal Carcinoma In Situ Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-13",
"study_completion_date(actual)": "2019-09-30",
"study_start_date(actual)": "2016-08"
},
"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)": "2020-02-19",
"last_updated_that_met_qc_criteria": "2016-05-06",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-05-10",
"first_submitted": "2016-05-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial in China will evaluate the efficacy and safety of pertuzumab + trastuzumab + docetaxel compared with placebo + trastuzumab + docetaxel in participants with previously untreated HER2-positive metastatic breast cancer.
#Intervention
- DRUG : Docetaxel
- Docetaxel (75-mg/m\^2) was administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
- DRUG : Pertuzumab
- Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles) was administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
- Other Names :
- Perjeta
- DRUG : Placebo
- Placebo matched to pertuzumab was administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
- DRUG : Trastuzumab
- Trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles) was administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
- Other Names :
- Herceptin
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease that is suitable for chemotherapy
* HER2-positive metastatic breast cancer (MBC)
* Left ventricular ejection fraction (LVEF) greater than or equal to (>=) 55 percent (%) at baseline (within 42 days of randomization)
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Women of childbearing potential and men should agree to use an effective form of contraception and to continue its use for the duration of study treatment and for at least 7 months after the last dose of study treatment (trastuzumab and/or pertuzumab)
Exclusion Criteria:
* History of anti-cancer therapy for MBC (with the exception of one prior hormonal regimen for MBC)
* History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting
* History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of less than (<) 12 months
* History of persistent Grade >= 2 hematologic toxicity resulting from previous adjuvant therapy
* Grade >= 3 peripheral neuropathy at randomization
* History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin carcinoma that has been previously treated with curative intent
* Current clinical or radiographic evidence of central nervous system (CNS) metastases
* History of exposure to cumulative doses of anthracyclines
* Current uncontrolled hypertension or unstable angina
* History of congestive heart failure (CHF) of any New York Heart Association (NYHA) classification, or serious cardiac arrhythmia requiring treatment
* History of myocardial infarction within 6 months of randomization
* History of LVEF decrease to < 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy
* Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy
* Inadequate organ function within 28 days prior to randomization
* Current severe, uncontrolled systemic disease
* Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment
* Pregnant or lactating women
* History of receiving any investigational treatment within 28 days of randomization
* Current known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or active hepatitis B virus (HBV)
* Receipt of intravenous (IV) antibiotics for infection within 14 days of randomization
* Current chronic daily treatment with corticosteroids (excluding inhaled steroids)
* Known hypersensitivity to any of the protocol-specified study treatments
* Concurrent participation in an interventional or noninterventional 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
|
NCT02896855
|
{
"brief_title": "A Study to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel Versus Placebo + Trastuzumab + Docetaxel in Previously Untreated Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Drug: Docetaxel",
"Drug: Placebo",
"Drug: Pertuzumab",
"Drug: Trastuzumab"
],
"location_countries": [
"China"
],
"nct_id": "NCT02896855",
"official_title": "A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab+Herceptin+Docetaxel Versus Placebo+Herceptin+Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-06-27",
"study_completion_date(actual)": "2021-01-22",
"study_start_date(actual)": "2016-09-13"
},
"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)": "2021-12-16",
"last_updated_that_met_qc_criteria": "2016-09-07",
"last_verified": "2021-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-12",
"first_submitted": "2016-09-07",
"first_submitted_that_met_qc_criteria": "2019-06-18"
}
}
}
|
#Study Description
Brief Summary
To evaluate a star-shaped incision technique to thick-gingiva and thingingiva patients treated with implant-supported fixed prosthesis. The star-shaped incision would be an effective and simple method to reconstruct gingival papillae and avoid the gingival recession in thick-gingiva patients treated with implant-supported fixed prosthesis, and it is worthy of clinical extend.
Detailed Description
Objective: To evaluate a star-shaped incision technique to thick-gingiva and thin-gingiva patients treated with implant-supported fixed prosthesis. Methods and Materials: 24 patients received cross-shaped incision were assigned into thick-gingiva group (16 cases) and thin-gingiva group (8 cases). Follow-up examination was carried out 3 and 12 months after final restoration. Clinical and radiographic evaluation including gingival papilla height, modified plaque index, modified sulcus bleeding index, periodontal depth, and crestal marginal bone level were utilized.
#Intervention
- DIAGNOSTIC_TEST : The biotype of gingiva
- The biotype of gingival was determined by periodontal probe.
|
#Eligibility Criteria:
Inclusion criteria
* Good general health, no chronic systemic diseases.
* All subjects included in this study needed to have one missing premolar or molar teeth with adjacent natural teeth.
* All subjects included in this study had been treated with one bone-level implant insertion in the premolar or molar region. The patients had insufficient gingival papilla height (referred to contralateral natural tooth which also had insufficient gingival papilla height) and at least 2 mm of keratinized tissue width around the implant.
Exclusion criteria
* Active periodontal infections.
* Heavy smoking (> 10 cigarettes per day).
Sex :
ALL
Ages :
- Minimum Age : 22 Years
- Maximum Age : 58 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05190614
|
{
"brief_title": "Radiographic Evaluation of a Star-shaped Incision Technique",
"conditions": [
"Clinical and Radiographic Effect",
"Thick-gingiva",
"Thin-gingiva",
"Implant"
],
"interventions": [
"Diagnostic Test: The biotype of gingiva"
],
"location_countries": [
"China"
],
"nct_id": "NCT05190614",
"official_title": "Radiographic Evaluation of a Star-shaped Incision Technique for Thick-gingiva and Thin-gingiva Patients Treated With Implant-supported Fixed Prosthesis: a Randomized Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-01",
"study_completion_date(actual)": "2021-06-01",
"study_start_date(actual)": "2019-06-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-01-13",
"last_updated_that_met_qc_criteria": "2021-12-30",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-01-13",
"first_submitted": "2021-12-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this randomized study is to investigate the effect of introducing contextual variation on transfer when learning a technical skill in a group of medical students. The main questions it aims to answer is: If context variation of specific affordance conditions enhance the learner's ability to transfer out? Participants will practice performing an invasive ultrasound guided procedure either on a fantom with maximum affordances or with contextual variation. Researchers will compare the maximum affordances group and the contextual variation group to see if its effects compared to the control group with minimal affordances.
Detailed Description
Participants:
Participants are medical student from the University of Copenhagen. They are recruited by announcements on student fora on Facebook.
Randomization:
The participants are randomized to the intervention group contextual variation, the intervention group maximum affordances or control group minimum affordances in an 1:1:1 allocation ratio. In addition, the order of the four transfer tests (a, b, c and d) is randomly selected for each participant. The randomization was conducted by an independent research assistant at CAMES. Random permuted blocks are generated online for both the intervention and the transfer test.
Equiptment:
The training session is conducted on a ballistic gel cube. Three cavities are excavated corresponding to the points of a triangle at the bottom of the cube. Each cavity include a 5' latex balloon filled with 10ml water. The ballistic gel is coloured with graphite thus, the cavities can only be visualized by ultrasound. The participants are instructed to perform ultrasound guided needle puncture of the cavities using a 20 ml syringe and a 15 cm, 18 Gauge biopsy needle. When all the three cavities are emptied the participant receive a new cube with refilled balloons. The new cube is equivalent to the old apart from being rotated 180 degrees. The participant are given one hour to empty as many cavities as possible. They are encouraged to track the needle with ultrasound while in the cube. The transfer test is performed on a CVS mannikin. The GE HealthCare LOGIQTM e Ultrasound is used with a C1-5 RS probe with or without the GE HealthCare C1-5 non-sterile ultrasound needle guide for both the training session and the transfer tests.
Intervention:
In the first learning session the participants are provided with an ultrasound probe and a needle and instructed to detect and aim at a fixed target in a cube made of ballistic gel. The contextual variation group alternate between six affordance conditions where the surface of the model i either half covered combined with no guide, a partial guide or a complete guide. The maximum affordances group has half the surface model covered and a complete guide throughout the session. The control group has the whole surface uncovered and no guide throughout the session. The participants will have 60 minutes to complete the training.
Transfer test:
The groups are re-invited seven days after completed training for a transfer test. The transfer test include four cases (a, b, c, d) where the overall aim is to perform a CVS procedure on a CVS mannikin. In case a and b, the participant has the affordances of a guide on the ultrasound probe and the screen. In case c and d, there is a lack of affordances by not using a guide on the probe or screen. The placental position is anterior in case a and c, and posterior in case b and d. The transfer test measures both the transfer out, i.e. applying a skill learned in one context to a new context, and transfer in, how the learner learns with the acquired skills in the new context. The order of the transfer tests is randomized at inclusion. The participants receive a brief introduction to the chorionic villus sampling (CVS) procedure ahead of the transfer test by watching a video where the procedure is performed in a clinical setting.
#Intervention
- OTHER : Contextual variation
- The participants are instructed to perform ultrasound guided needle puncture of the cavities using a 20 ml syringe and a 15 cm, 18 Gauge biopsy needle. When all the three cavities are emptied the participant receive a new cube with refilled balloons. The new cube is equivalent to the old apart from being rotated 180 degrees. The participant are given one hour to empty as many cavities as possible. They are encouraged to track the needle with ultrasound while in the cube. The transfer test is performed on a CVS mannikin. The GE HealthCare LOGIQTM e Ultrasound is used with a C1-5 RS probe with or without the GE HealthCare C1-5 non-sterile ultrasound needle guide for both the training session and the transfer tests.
- Other Names :
- Maximum affordances
- OTHER : Maximum affordances
- The participants are instructed to perform ultrasound guided needle puncture of the cavities using a 20 ml syringe and a 15 cm, 18 Gauge biopsy needle. When all the three cavities are emptied the participant receive a new cube with refilled balloons. The new cube is equivalent to the old apart from being rotated 180 degrees. The participant are given one hour to empty as many cavities as possible. They are encouraged to track the needle with ultrasound while in the cube. The transfer test is performed on a CVS mannikin. The GE HealthCare LOGIQTM e Ultrasound is used with a C1-5 RS probe with or without the GE HealthCare C1-5 non-sterile ultrasound needle guide for both the training session and the transfer tests.
|
#Eligibility Criteria:
Inclusion Criteria:
* Passed a general anatomy exam
* Proficiency in Danish
Exclusion Criteria:
* Previous ultrasound experience except mandatory training as part of the medical curriculum
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05834374
|
{
"brief_title": "Training for Transfer by Contextual Variation",
"conditions": [
"Medical Education"
],
"interventions": [
"Other: Maximum affordances",
"Other: Contextual variation"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT05834374",
"official_title": "Training for Transfer by Contextual Variation: A Randomized Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-10-07",
"study_completion_date(actual)": "2021-10-07",
"study_start_date(actual)": "2021-03-17"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-04-28",
"last_updated_that_met_qc_criteria": "2023-04-17",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-04-28",
"first_submitted": "2023-04-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective, random controlled trial(RCT) study. 430 patients undergoing coronary artery bypass grafting were enrolled. Our new way of cardiac denervation, defined as excision of Marshall ligament and Waterstone fat pad, was performed in 215 patients, and the other 215 patients were used as control subjects. All the patients need to equip with electronic monitor to record heart rhythms within 6 days after CABG. The investigators will compare the incidence of postoperative atrial fibrillation between two groups, and follow up 30 days after discharged.
#Intervention
- PROCEDURE : cardiac denervation
- Excision of Marshall ligament and Waterstone fat pad during CABG.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing simple CABG (on-pump/off-pump) for the first time.
* Patients who signed the informed consent form and willing to undergo cardiac denervation.
Exclusion Criteria:
* Age < 18；
* Emergent CABG;
* Cardiac surgery history；
* Receiving other cardiac surgery except of CABG at the same time, such as Morrow、valvular surgery、ventricular aneurysm surgery、congenital heart diseases surgery；
* Requiring mechanical or pharmacological therapy for hemodynamic support before CABG, such as ECMO or IABP;
* History of AF ;
* Taking antiarrhythmic agents except of beta-blockers last 2 weeks.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05009914
|
{
"brief_title": "A New Way of Cardiac Denervation to Reduce the Incidence of AF After CABG.",
"conditions": [
"Cardiac Denervation",
"Postoperative Atrial Fibrillation"
],
"interventions": [
"Procedure: cardiac denervation"
],
"location_countries": [
"China"
],
"nct_id": "NCT05009914",
"official_title": "Assessing a New Way of Cardiac Denervation to Reduce the Incidence of Atrial Fibrillation After Coronary Artery Bypass Grafting.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-13",
"study_completion_date(actual)": "2024-01-30",
"study_start_date(actual)": "2022-08-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-13",
"last_updated_that_met_qc_criteria": "2021-08-10",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-18",
"first_submitted": "2021-06-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This project will utilize the first web-based program to provide tailored injury prevention education. The existing Safety in Seconds program was adapted into a smartphone platform. Parents are recruited from and engage in the program in the clinical setting (PED or PTS). Parents download the app onto their smartphone which is used to ask the questions, collect a parent's responses, assess the parents' safety needs and give tailored directions for proper car sear use. The control group parents will also engage with the smartphone app and receive immediate feedback. However, they will receive tailored educational messages about smoke alarms. Parents will also have access to the online SIS v 2.0 Parent Portal which will have educational features (e.g., tips for keeping children content in their CSSs, links to helpful websites). The investigators will use emerging technology such as push notification and email to remind parents to visit the portal and have their child's car seat reassessed.
The investigators plan to conduct a cost benefit analysis of the program's expected financial benefit from the perspective of a third party payer of medical claims and an in-depth examination of program adoption and implementation using qualitative data collected from key informant interviews, direct observations of the clinic environments, and document review.
#Intervention
- OTHER : Parent Action Report
- Parent Action Report will be displayed after the baseline assessment and contain educational safety messages.
- OTHER : Parent Portal
- Parents will have access to the Parent Portal, and they will be encouraged to visit it at any time.
|
#Eligibility Criteria:
Inclusion Criteria:
* Visiting the Pediatric Emergency Department (PED) at Johns Hopkins Hospital or Arkansas Children's Hospital
* Parent or guardian of child 4 <= age <= 7 years
* English speaking
* Have and Android or iPhone smartphone
* Drive with the child in a car at least once per week in a car that the parent owns, borrows or gets a ride round-trip
* Resident of Baltimore City, MD or Little Rock, AR and surrounding area.
Exclusion Criteria:
* PED has flagged case as suspected abuse
* Another household member is enrolled in the study
* In Arkansas, less than 18 years without parent present at the PED
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02345941
|
{
"brief_title": "Safety in Seconds 2.0: An App to Increase Car Seat Use",
"conditions": [
"Injuries"
],
"interventions": [
"Other: Parent Portal",
"Other: Parent Action Report"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02345941",
"official_title": "Evaluating a Web-based Child Passenger Safety Program: Safety in Seconds 2.0",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-04",
"study_completion_date(actual)": "2016-12",
"study_start_date(actual)": "2014-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-12-26",
"last_updated_that_met_qc_criteria": "2015-01-19",
"last_verified": "2016-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-01-26",
"first_submitted": "2015-01-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with multiple myeloma
#Intervention
- DRUG : imexon
|
#Eligibility Criteria:
Inclusion Criteria:
* Advanced myeloma, with measurable disease as defined in the protocol.
* Prior treatment, at least 2 prior regimens are required. This may include prior treatment with investigational products.
* Able to perform the activities of daily living.
* Off prior therapy for at least 2 <= age <= 4 weeks depending on the drug.
* Blood counts and blood chemistries in or near normal range.
* If female, neither pregnant nor nursing.
* Willing to use contraceptives to prevent pregnancy.
* No other serious illnesses.
* No other active malignancy.
* No serious infections.
* No current other drug therapy for the myeloma except for steroid therapy under certain circumstances. Biphosphonate therapy is permitted.
* Prior radiation is permitted.
Exclusion Criteria:
* Use of corticosteroids for amyloid disorders, or high dose chronic steroids.
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
|
NCT00327249
|
{
"brief_title": "Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients",
"conditions": [
"Multiple Myeloma"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00327249",
"official_title": "A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) for Patients With Previously Treated Multiple Myeloma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-07",
"study_completion_date(actual)": "2008-01",
"study_start_date(actual)": "2005-10"
},
"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)": "2009-08-11",
"last_updated_that_met_qc_criteria": "2006-05-17",
"last_verified": "2009-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-05-18",
"first_submitted": "2006-05-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purposes of this study is to investigate the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy.
Detailed Description
Mechanical ventilation results in the disruption of the alveolar-capillary barrier and increased permeability, a hallmark of experimental ventilator-induced lung injury. These mechanical forces also induce an increase in the concentrations of inflammatory cytokines.
The benefits of deep neuromuscular blocks for laparoscopic procedures are controversial and most of the studies undertaken have only sought to improve surgical conditions. Theoretically, deep neuromuscular block permits a lower abdominal insufflation pressure, which leads to better respiratory mechanics and gas exchange. The investigators examined the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy. The investigators hypothesized that deep neuromuscular block (PTC 1 or 2) and low pressure pneumoperitoneum (8 mmHg) would improve respiratory mechanics and reduce inflammatory processes associated with biotrama during mechanical ventilation compared with moderate neuromuscular block (TOF count 1 or 2 ) and standard pressure pneumoperitoneum (12-15 mmHg).
#Intervention
- DRUG : Deep neuromuscular block
- Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum
- Other Names :
- Deep neuromuscular block with rocumeron
- DRUG : Moderate neuromuscular block
- Moderate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum
- Other Names :
- Moderate neuromuscular block with rocumeron
|
#Eligibility Criteria:
Inclusion Criteria:
* ASA physical status I or II, aged 25 <= age <= 80, scheduled for laparoscopic surgery with trendelenburg position
Exclusion Criteria:
* cerebrovascular disease
* uncontrolled hypertension, asthma, COPD
* neuromuscular disorder
* patients who have had abdominal surgery
* morbid obesity (body mass index > 35 kg/m2)
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03576118
|
{
"brief_title": "Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy",
"conditions": [
"Pneumoperitoneum"
],
"interventions": [
"Drug: Deep neuromuscular block",
"Drug: Moderate neuromuscular block"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03576118",
"official_title": "The Effects of Moderate Versus Deep Neuromuscular Block on Respiratory Mechanics and Biotrauma in Patients With Intraoperative Protective Lung Ventilation for Laparoscopy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-12",
"study_completion_date(actual)": "2019-09-19",
"study_start_date(actual)": "2018-11-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-06-11",
"last_updated_that_met_qc_criteria": "2018-06-22",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-03",
"first_submitted": "2018-06-14",
"first_submitted_that_met_qc_criteria": "2020-05-31"
}
}
}
|
#Study Description
Brief Summary
The data available for the efficacy of AScVS and prazosin is generated through different trials done in different clinical setting. Hence it was felt worthwhile to confirm the documented efficacy of AScVS and prazosin in terms of time taken for clinical recovery in a clinical trial. Along with this, effects of both the therapies on various biochemical parameters will be recorded and compared with. It was also felt necessary to study the effect of combination on the clinical outcome.
Detailed Description
Red Scorpion (Mesobuthus Tamulus Concanesis Pocock) sting is a common medical emergency in the coastal regions of India and is a cause for considerable morbidity and mortality.
Signs and symptoms show either cholinergic or adrenergic predominance. Cholinergic symptoms are profuse sweating, priapism, bradycardia, increased salivary and bronchial secretions and vomiting. Adrenergic symptoms are transient hypertension followed by hypotension, tachycardia, tachypnoea, pulmonary edema and circulatory failure in later stages. Scorpion venom blocks voltage dependent inactivation of sodium channels, resulting in intense persistent voltage depolarization of autonomic nerves with massive release of catecholamines from adrenal medulla and parasympathetic and sympathetic nerve endings.
Prazosin a selective alpha-1 blocker is used as the treatment for scorpion sting, which can only counteract the manifestations of sympathetic over-activity. Experimentally and clinically it is seen that scorpion venom stays in the body for 24-36 hours, as Prazosin does not neutralize the venom, 3 hourly round the clock doses of prazosin and continuous I.C.U. monitoring is necessary with alpha blocker therapy. However, ideal treatment modality remains neutralization of venom in the systemic circulation.
Since 1997 enzyme refined AScVS ( Monovalent Anti-scorpion venom serum against Mesobuthus tamulus concanesis Pocock.) has been made available by Haffkine Biopharmaceuticals, Mumbai for field use. Throughout the konkan(western coastal Maharashtra, India) area the same species of scorpions responsible for fatal envenomation is found.
From 1997-2002, 48 patients of serious scorpion envenomation were treated with AScVS(1). Based on this experience a clinical scoring system for dose requirement was evolved based on sweating, pulse rate, respiratory rate, blood pressure, CNS effects and presence of priapism. In our experience computed doses given as intravenous bolus are more effective and successfully ameliorated signs and symptoms in all patients. Subsequently 16 patients were given treatment with either AScVS (n=8), Prazosin (n=5) and a combination of both (n=3) so as to compare the effects of these available treatment modalities. It was found that the patients receiving either AScVs or a combination showed a complete recovery approximately within 4 hours of onset of therapy as against patients receiving Prazosin, who required 16 hours for recovery. There was no mortality in any of the group. There was not a single incidence of anaphylaxis after administration of AScVS. Release of adrenaline in the systemic circulation by scorpion sting itself appears to be protective against the danger of anaphylaxis. The label on the AScVS vials states that the maximum dose is 3 vials, which can be given either intramuscular or by intravenous route. However we used AScVS as slow bolus intravenously and dose was decided clinically depending upon the severity of the patient condition. (maximum 10-15vials.) Based on this experience, an open labeled, randomized controlled parallel group clinical trial has been initiated. Eighty-three patients have been recruited so far, 28 patients each, in AScVS and AScVS + prazosin group and 27 patients in Prazosin group, two patients out of 27 in Prazosin group were withdrawn as both the pediatric patients (around 12 years old) developed pulmonary edema after few hours, so AScVS had to be given. The onset of relief (based on composite score) with AScVS or combination of AScVS with prazosin was early and complete recovery occurred at 4.14+/- 1.6 hrs. and 3.46+/- 1.10hours. However, in patients receiving only prazosin, the clinical score was found to worsen initially, followed by a gradual improvement and subsequent complete recovery, at 19.28 +/- 5.03 hrs. (p\<0.001 vs AScVS). Recovery time with AScVS is much shorter because after complete neutralization of venom, fresh secretion of catecholamines stop and adrenaline and nor-adrenaline which are already in circulation have action as short as 1 to 2 minutes. These findings appear consistent with our clinical experience and indicate that in the near future AScVS would evolve as a safe, efficacious and life saving treatment modality for patients with severe scorpion envenomation. Use of clinical scoring system can enable the clinician to select the optimum dose of AScVS to be administered.
Neutralization of venom is thus proved to be better than therapy for complications, akin to the dictum 'prevention is better than cure'.
References:
1. Natu VS, Murthy RKK, Deodhar KP. Efficacy of species specific Antiscorpion venom serum (AScVS) against severe, serious scorpion stings (mesobuthus tamulus concanesis pocock.)-An experience from rural hospital in western Maharashtra. JAPI, 2006; 54: 283-7.
#Intervention
- DRUG : Antiscorpion venom serum(AScVS).
- AScVS therapy group
If the score is 5 and if the patient belongs to pediatric group(\>12-14): 1 vial AScVS as i.v. slow bolus after test dose If the score is 5 and if the patient is adult: 2 vials of AScVS as i.v. slow bolus after test dose. For injection, 1 vial will be dissolved in 10 ml distilled water and given over a period of 4 to 5 minutes.
According to the scores 1 vial for pediatric and 2 vials for adult patient will be increased as shown below:
Vials of AScVS Composite score Child Adult 5-10 2 4 \> 10-15 3 6 \>15- 21 4 8
- Other Names :
- AScVS(Haffkine)
- DRUG : T.Prazosin
- Prazosin therapy Prazosin (30 micrograms/Kg/dose): 500 micrograms for pediatric patient, and 1mg for adult patients) will be given every 3 hourly orally till complete recovery.
- Other Names :
- T.Prazosin (sun pharma)
- DRUG : AScVS + Prazosin
- Combination AScVS and Prazosin therapy In this group, AScVS therapy will be given as mentioned in AScVS therapy group and in addition, prazosin(500 micrograms for pediatric patient and 1mg for adult patients,30 micrograms/Kg/dose) every 3 hourly will be given.
- Other Names :
- AScVS (Haffkine), T. Prazosin (sun pharma)
|
#Eligibility Criteria:
Inclusion Criteria: (All of the following)
* Patients of both sexes, in the age range of 12 <= age <= 65 years
* reporting to the PHC/ hospital within 48 hours of scorpion sting and
* associated with s/s of scorpion envenomation having composite score between 5 and 21 (as computed based on the criteria below:)
Criteria Grade Symptoms
Sweating 0 Limited to the extremity of the sting site.
* Minimal sweating all over the body, slight nasal secretions
* Generalized sweating with rigors and cold extremities.
* Gen.profuse sweating,wetting of clothes and cold clammy skin.
Pulse rate 0 70- 90
* 91 - 100
* 101 - 120 or < 70
* 121 - 140 or < 60 or irreg pulse
* 141 - 160
* > 160
Respiratory rate 0 < 20
* 20 - 30
* 31 - 40 without crepitations
* 31 - 40 with crepitations
* > 40 with crepitations
* > 40 with crepitations and cyanosis
Blood pressure 0 120/80
* Systolic: 121 -140 and diastolic: 81 -90
* Systolic: 141 -160 and diastolic: 91 <= age <= 100
* Syst: 161 -180 and diast: 101 <= age <= 110 Or syst <100
* Syst: 181 -200 and diast: 111 <= age <= 120 Or syst <100
* Syst: > 200 and diast: >120 Or syst < 60
CNS effects 0 No sensory involvement
* Minimal tingling numbness around mouth
* Tingling, numbness around mouth and giddiness
* Altered sensorium, patient roudy
* Patient semiconscious
* Patient unconscious
Priapism 2 Slight erection 3 Strong erection
To obtain a composite score, grades for individual criterion will be added. Maximum score: 25 and minimum score: 0
Exclusion Criteria: (Any of the following)
* Composite score less than 5 and greater than 21.
* Grade of 5 in any of the criterion
* Severe Pulmonary edema with oxygen saturation below 80%.
* Severe scorpion envenomation with reporting time more than 2 days
* Any other serious medical disease which/treatment of which may confound the results e.g. cardiac diseases, diabetes, renal diseases etc.
* Severe anaphylactic reaction to any of the study drugs
* Patient (or relative in case of child) not willing to participate
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00753064
|
{
"brief_title": "AScVS and/ or Prazosin for Scorpion Envenomation",
"conditions": [
"Scorpion Envenomation"
],
"interventions": [
"Drug: AScVS + Prazosin",
"Drug: Antiscorpion venom serum(AScVS).",
"Drug: T.Prazosin"
],
"location_countries": [
"India"
],
"nct_id": "NCT00753064",
"official_title": "Comparative Study of Efficacy of Antiscorpion Venom Serum(AScVS)vs Prazosin in the Management of Severe Scorpion(Mesobuthus Tamulus Concanesis Pocock)Envenomation and Evaluation of Effects of the Combination of AScVS + Prazosin Therapy.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-12",
"study_completion_date(actual)": "2007-12",
"study_start_date(actual)": "2006-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-09-16",
"last_updated_that_met_qc_criteria": "2008-09-15",
"last_verified": "2008-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-16",
"first_submitted": "2008-09-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.
Detailed Description
Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure.
Erythropoiesis stimulating agents have been established as a treatment for anemia in chronic renal failure subjects, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia in patients with chronic kidney disease. Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents.
Study participants received doses of peginesatide administered once every 4 weeks or darbepoetin alfa administered once every 2 weeks. Total commitment time for this study was a 4 week screening period followed by a minimum of 52 weeks of study treatment. Eligible participants were randomized in equal proportions to two peginesatide treatment regimens and one control, darbepoetin alfa, treatment regimen.
To evaluate the cardiovascular safety of peginesatide, a cardiovascular composite safety endpoint (CSE) was defined for use in prospectively planned analyses which combined cardiovascular safety data from the four Phase 3 peginesatide studies (NCT00598273, NCT00597753, NCT00598442, and NCT00597584). The CSE consisted of six events: death, stroke, myocardial infarction, and serious adverse events of congestive heart failure, unstable angina, and arrhythmia. An independent Event Review Committee (ERC) was used to provide blinded adjudication of potential CSE events.
#Intervention
- DRUG : peginesatide
- Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
- Other Names :
- Omontys, Hematide, AF37702 Injection
- DRUG : peginesatide
- Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
- Other Names :
- Omontys, Hematide, AF37702 Injection
- DRUG : Darbepoetin alfa
- As prescribed, starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
- Other Names :
- Aranesp
|
#Eligibility Criteria:
Inclusion Criteria:
* Chronic renal failure with an estimated glomerular filtration rate < 60 milliliter per minute per 1.73m^2 and not expected to begin dialysis for at least 12 weeks.
* Two consecutive hemoglobin values >= 8.0 g/dL and < 11.0 g/dL within 4 weeks prior to randomization.
Exclusion Criteria:
* Females who are pregnant or breast-feeding.
* Treatment with an ESA in the 12 weeks prior to randomization.
* Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
* Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
* Known bleeding or coagulation disorder.
* Known hematologic disease or cause of anemia other than renal disease
* Poorly controlled hypertension
* Evidence of active malignancy within one year prior to randomization.
* A scheduled kidney transplant
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
|
NCT00598273
|
{
"brief_title": "Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis",
"conditions": [
"Chronic Renal Failure",
"Chronic Kidney Disease",
"Anemia"
],
"interventions": [
"Drug: Darbepoetin alfa",
"Drug: peginesatide"
],
"location_countries": [
"Puerto Rico",
"United States"
],
"nct_id": "NCT00598273",
"official_title": "AFX01-11: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-03",
"study_completion_date(actual)": "2010-02",
"study_start_date(actual)": "2007-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-02-12",
"last_updated_that_met_qc_criteria": "2008-01-18",
"last_verified": "2013-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-21",
"first_submitted": "2008-01-10",
"first_submitted_that_met_qc_criteria": "2012-06-22"
}
}
}
|
#Study Description
Brief Summary
This is an open label, phase II study to evaluate the capacity of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) to induce objective responses in patients with Mucosa Associated Lymphoid Tissue (MALT) lymphoma presenting with measurable disease.
#Intervention
- DRUG : Rituximab and Lenalidomide
- Rituximab 375 mg/m² i.v. day 1 Lenalidomide 20 mg p.o. daily for 21 days Cycles should be repeated every 28 days. Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses will stop therapy/study, while patients with PR or SD will be given another two cycles for a maximum of 8 cycles.
|
#Eligibility Criteria:
Inclusion Criteria selected:
* Histologically verified diagnosis if MALT lymphoma of any localization
* Measurable disease upon diagnosis or first or greater relapse after local therapy, prior chemotherapy orHP-eradication. In addition, also in patients with gastric MALT-lymphoma judged refractory to HP-eradication by a minimum follow-up of 12 months after successfulHP-eradication will be included in the study. Patients with gastric MALT lymphoma and no evidence of HP-infection may be enrolled immediately
* Ann Arbor Stage I-IV
* In case of prior treatment with Rituximab, the presence of CD20 on lymphoma cells must have been demonstrated before inclusion in the trial.
* ECOG performance status of 0,1 or 2
* Patient must be able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin
Exclusion Criteria selected:
* Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma ('high grade lymphoma') - component
* Use of any investigational agent within 28 days prior to initiation of treatment with lenalidomide
* History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
* Major surgery, other than diagnostic surgery, within the last 4 weeks
* Evidence of CNS involvement
* A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
* Severe peripheral polyneuropathy
* Clinically significant cardiac disease or myocardial infarction within the last 6 months
* Known hypersensitivity to thalidomide or lenalidomide or rituximab
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
|
NCT01611259
|
{
"brief_title": "Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue",
"conditions": [
"Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)"
],
"interventions": [
"Drug: Rituximab and Lenalidomide"
],
"location_countries": [
"Austria"
],
"nct_id": "NCT01611259",
"official_title": "Phase II Trial of Rituximab Plus Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-05",
"study_completion_date(actual)": "2015-02",
"study_start_date(actual)": "2012-05"
},
"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)": "2017-11-06",
"last_updated_that_met_qc_criteria": "2012-05-31",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-06-04",
"first_submitted": "2012-05-18",
"first_submitted_that_met_qc_criteria": "2017-06-19"
}
}
}
|
#Study Description
Brief Summary
The Emergency Department (ED) is a unique environment in medicine, and many safety mechanisms used in other hospital settings cannot be applied in the ED. For example, clinical pharmacists have traditionally provided extra layers of protection to hospital inpatients by cross-checking provider orders for appropriate dosing, contraindications, and interactions. Because medications in the ED must be accessed immediately and are often one-time doses, the use of central pharmacy services would introduce an unacceptable delay to the administration of medication. Although some hospitals have programs in place in which a pharmacist responds to the ED for cardiac arrests or trauma team activations, few have reported programs which involve a clinical pharmacist assigned exclusively to the emergency department. Nonetheless, published reports have asserted that ED-based pharmacists can increase patient safety. Although this concept appears logical, no study has attempted to show that these programs reduce potential adverse drug events in the ED. We propose to implement and optimize an ED Pharmacist (EDP) program as a safe practice intervention in a large ED. The hospital has provided funding for two permanent full time positions starting at the beginning of the award period. In the initial phase interviews of physicians, nurses, pharmacists, and patients will be conducted and the results will be used to optimize the EDP role. A large-scale chart review study will then be conducted to evaluate whether there is a reduction in frequency of potential and adverse drug events during times that the EDP is on duty. Staff perceptions of the effectiveness of this program will also be evaluated. The overall goal of this initiative is to create an effective EDP program that will decrease the rate of adverse drug events in ED patients, and to create a 'toolkit' to facilitate the introduction of similar programs into other EDs. This toolkit will include a description of the formal, optimized role of the EDP, challenges and solutions in implementation, and evidence to support the efficacy of such a program.
#Intervention
- PROCEDURE : presence of an emergency pharmacist in the ED
|
#Eligibility Criteria:
Inclusion Criteria:
* pediatric (less than 19), geriatric (>64), or critically ill (all ages)
Exclusion Criteria:
* investigator involved or incomplete chart
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00382434
|
{
"brief_title": "Emergency Pharmacist Safety Study",
"conditions": [
"Adverse Drug Event, Potential Adverse Drug Event, and Quality Measures"
],
"interventions": [
"Procedure: presence of an emergency pharmacist in the ED"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00382434",
"official_title": "The ED Pharmacist as a Safety Measure in Emergency Medicine",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-12",
"study_start_date(actual)": "2005-08"
},
"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)": "2010-01-14",
"last_updated_that_met_qc_criteria": "2006-09-27",
"last_verified": "2010-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-09-29",
"first_submitted": "2006-09-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will determine the effectiveness of an intervention consisting of combined strategies in reducing the symptoms of both depression and chronic back pain.
Detailed Description
The relationship between depression and back pain is complex. Depression is the most common mental condition associated with chronic back pain. Despite this relationship, many patients with depression and back pain seek treatment only for one of the two conditions, which can worsen the untreated condition. An intervention that reduces the symptoms of both depression and back pain is needed. This study will determine the effectiveness of an integrated intervention in reducing both back pain and depression symptoms.
Participants will be randomly assigned to receive either an integrated intervention or standard of care for 6 months. Participants in the integrated intervention group will receive cognitive behavioral therapy for back pain and antidepressants and/or problem solving therapy for depression. Study visits will initially occur once a week and then taper to once every 2 weeks for the 6-month duration; the time of tapering will depend on participant response to treatment and will be at the investigator's discretion. Depression and back pain symptoms will be assessed in all participants at study entry, at the end of treatment, and 6 months after the end of treatment. The study entry and study completion assessments will occur during study visits. The last assessment will be a telephone interview.
#Intervention
- BEHAVIORAL : Cognitive behavioral therapy
- Cognitive behavioral therapy focuses on identifying and eliminating maladaptive beliefs and thoughts.
- DRUG : Antidepressants
- Antidepressant drugs try to eliminate symptoms of depression such as persistent sadness and disinterest in normal or pleasurable activities.
- BEHAVIORAL : Problem solving therapy
- Problem solving therapy identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment.
|
#Eligibility Criteria:
Inclusion Criteria:
* Roland back pain score of 7 or greater
* Diagnosis of major depression
* Plan to stay enrolled in Group Health Cooperative for the duration of the study and 1 year after the study
Exclusion Criteria:
* Prior surgery
* Cauda equina syndrome (compression and paralysis of nerve roots)
* Schizophrenia or bipolar disorder treatment within 2 years prior to study entry
* Current or prior psychiatric or psychological care for back pain or depression
* At high risk for suicide
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00158275
|
{
"brief_title": "Combined Interventions for Treating Depression and Chronic Back Pain",
"conditions": [
"Back Pain",
"Depression"
],
"interventions": [
"Drug: Antidepressants",
"Behavioral: Cognitive behavioral therapy",
"Behavioral: Problem solving therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00158275",
"official_title": "Integrated Care for Depression and Chronic Back Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-08",
"study_completion_date(actual)": "2006-08",
"study_start_date(actual)": "2004-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-10-13",
"last_updated_that_met_qc_criteria": "2005-09-07",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-12",
"first_submitted": "2005-09-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Phase I study of Megace F will be conducted to investigate pharmacokinetics and safety compared to Megace OS.
Phase I study divided into 3 parts written as belows.
Part 1 Megace F in fasting volunteers vs Megace F in fed volunteers Part 2 Megace F vs Megace OS in fed volunteers Part 3 Megace F vs Megace OS in fasting volunteers
#Intervention
- DRUG : Megace F
- Megace F oral suspension
- DRUG : Megace OS
- Megace oral suspension
|
#Eligibility Criteria:
Inclusion Criteria:
age: 20 <= age <= 55 years body weight: greater than 50kg written informed consent
Exclusion Criteria:
known allergy to Megesterol acute or chronic diseases which could affect drug absorption or metabolism positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 3 months prior to the start of the study
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01397214
|
{
"brief_title": "Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers",
"conditions": [
"Cachexia",
"Anorexia"
],
"interventions": [
"Drug: Megace F",
"Drug: Megace OS"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01397214",
"official_title": "A Randomized, Open-label, Single-dose, Cross-over Study to Investigate Safety and Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-09",
"study_completion_date(actual)": "2012-01",
"study_start_date(actual)": "2011-07"
},
"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)": "2012-07-02",
"last_updated_that_met_qc_criteria": "2011-07-18",
"last_verified": "2012-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-07-19",
"first_submitted": "2011-07-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Demographic changes in the industrialized world are expected to prompt a need for better organized and more efficient health care services. In order to curb costs, health care providers in many countries are searching for viable alternatives to hospitalizations. Norwegian white papers and reform documents presume that the municipalities will play a central role in meeting the growth in demand for health services. Central public policy documents and national research strategies highlight that we need pathways characterized by good quality and safe care, and which are responsive to needs, based on user involvement, continuity of care and successful collaboration within and between service levels. The 2012 Coordination Reform placed new responsibilities on municipalities in the delivery of primary health care services and on hospitals as deliverers of specialist services, as well as on the integration and collaboration between the two organizational levels. This reform mandates that all 428 Norwegian municipalities are obliged to establish or co-operate on establishing Municipal Acute Wards (MAW) (In Norwegian: Kommunale akutte døgnplasser), so as to alleviate pressure on hospitals. However, the research basis for these units is relatively weak. Hence, there is little information on the outcomes regarding the quality, cost-effectiveness, patient-reported as well as personnel-reported outcomes of this new level of care.
This study aims at assessing the outcome of admissions to MAWs compared to a general hospital for patients in need of acute care, that can be treated at a lower and decentralized level of health care, with potentially less resources than traditional hospitalizations. The study will use a Randomized Controlled Trial (RCT) design. It builds on previous research and systematic reviews, and aims to assess several outcomes, patient experiences (NORPEQ), health-related quality of life, short-term mortality and morbidity, and draws on linkages to national registers. The primary hypothesis is that there is no difference in patient experiences between admissions to a MAW versus a hospital. The secondary hypothesis was that there is no difference in outcomes such as readmission, length of stay, self-assessed health-related quality of life (HRQoL) measured by the EuroQol 5 items 5 level (EQ-5D-5L) index, and health status measured by the RAND-12, between patients admitted to a MAW versus a hospital
Detailed Description
No other randomized, controlled studies have been conducted to compare healthcare services as offered in MAWs to those offered in hospital. The study will use an RCT design, which is a strong study design. The study includes measures of patient experiences and HRQoL. The project is interdisciplinary and cross-sectoral, and it represents research in, about and with support from the municipalities, which is a prioritized area of research, together with health services research, for the owners of the Østfold Hospital Trust, Helse Sør-Øst (HSØ). The project incorporates users in the planning of the project, which may contribute better acceptance of and a successful completion of the project. This proposal addresses key aspects of the CR and other national strategic documents. The CR has mandated the establishment of MAWs all over Norway as of 2016, without any strong scientific documentation of cost-effectiveness. The study builds on data from previous research, stating that there is a need for more solid documentation about new levels of acute hospital care. The proposed study will assess several aspects of quality of care and will contribute useful information for evaluation and future planning of MAWs, as an alternative to hospitalization. Therefore the researchers think this project is timely. The MAWs in Østfold County are small to medium-sized and are expected to be representative for the majority of MAWs in Norway, and therefore of broad national interest. These outputs will be important for authorities, politicians, healthcare leaders, and professionals as well as researchers involved in developing, implementing and refining decentralized acute health care services as an alternative to hospitalization- to the best of the patients. Moreover, the project outputs will be of international interest, in particular in countries with national health insurance with broad coverage, as in the Nordic countries, the UK, Canada and Australia.
#Intervention
- OTHER : Level of healthcare services
- Patiens judged to be eligible for admittance to a municipal acute care wrad will be admitted to hospital as an intervnetion, to be able to compare same patient groups.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >=18 years
* Ability to provide written, informed consent
* Eligible for admission at a MAW according to established admission criteria
* Assessed and referred by a GP, by a physician at the local Casualty (Legevaktslege), or a physician in a nursing home on the same day
Exclusion Criteria:
* Psychiatric or cognitive impairment
* No Norwegian national identification number
* Acute disability in elderly, requiring extensive diagnostic procedures
* Patients admitted to the MAW via the diagnostic loop*
* Previous admission to a MAW during the project period (to prevent patients being included more than once in the project)
* Insufficient Norwegian language skills to respond to the questionnaires
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
|
NCT03885206
|
{
"brief_title": "Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital",
"conditions": [
"Patient Experience",
"Medical Emergencies",
"Mortality",
"Morbidity",
"Co-morbidity",
"Quality of Life"
],
"interventions": [
"Other: Level of healthcare services"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT03885206",
"official_title": "Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital: a Multicenter, Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-31",
"study_completion_date(actual)": "2021-01-31",
"study_start_date(actual)": "2019-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-04",
"last_updated_that_met_qc_criteria": "2019-03-19",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-21",
"first_submitted": "2018-12-05",
"first_submitted_that_met_qc_criteria": "2024-08-23"
}
}
}
|
#Study Description
Brief Summary
This study assesses the impact of mind-wandering on reading and math.
Detailed Description
This study assesses the impact of mind-wandering on reading and math. Specifically 120 middle school student participants will receive descriptive measures (of achievement, attention and related factors including mind-wandering), and will receive a brief (\~30 min) lesson in reading and math (order counterbalanced). Participants will receive a brief pre-test, the lesson, and then a post-test on the reading and math outcomes. 75% of the participants will receive a brief manipulation that sets up the influence of mind-wandering, as well as redirects when probe-caught mind-wandering occurs. The remaining participants will receive only redirects, and only randomly. Among participants to receive the mind-wandering manipulation, an equal number will receive this only for reading, only for math, and for both reading and math.
#Intervention
- BEHAVIORAL : mind-wandering intervention
- Participants in this condition receive a brief introduction to the potential impact of mind-wandering (before learning, proactive), and are redirected to lesson if 'probe-caught' mind-wandering are endorsed (during learning, reactive)
- BEHAVIORAL : mind-wandering comparison
- Participants in this condition receive no introduction, and only redirection, and the redirection is random, not in reaction to mind-wandering
|
#Eligibility Criteria:
Inclusion Criteria:
* enrollment in schools where we have permission to conduct the study
Exclusion Criteria:
* students known to be enrolled in separate curricula (e.g., life-skills classes)
Sex :
ALL
Ages :
- Minimum Age : 11 Years
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05296252
|
{
"brief_title": "Attention and Achievement: A Mind Wandering Investigation",
"conditions": [
"Attention Disturbances"
],
"interventions": [
"Behavioral: mind-wandering comparison",
"Behavioral: mind-wandering intervention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05296252",
"official_title": "Attention and Achievement (A Subproject Affiliated With the Texas Center for Learning Disabilities or TCLD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-15",
"study_completion_date(actual)": "2022-06-15",
"study_start_date(actual)": "2022-05-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-19",
"last_updated_that_met_qc_criteria": "2022-03-23",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-25",
"first_submitted": "2022-01-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Dreams are a remarkable experiment in psychology and neuroscience, conducted every night in every sleeping person. 74% of awakenings from REM sleep resulted in recall of a dream, as compared with only 9% of awakenings from NREM sleep. The association between dreaming and REM sleep was subsequently replicated by many other investigators; typically, around 80% of REM awakenings yield dreams. It became clear over time that there is a good deal of mental activity that occurs during NREM sleep. Typically, it is more thought like, fragmentary, and related to daily concerns than the vivid, hallucinatory, predominantly visual narratives that are most commonly reported from REM sleep. But even this distinction appears not to be absolute. There is now wide acceptance of the view that some dreaming that is indistinguishable from REM sleep dreaming occurs in NREM sleep, most frequently in the sleep-onset period. General anesthesia causes a drug-induced state of unconsciousness and is a non-physiological process that is similar to natural sleep. Patients receiving propofol for maintenance of general anesthesia often report higher incidences of dreaming than patients maintained with volatile anesthetics. One explanation is that propofol and volatile anesthetic have different pharmacological effects in the central nervous system. An alternative explanation is that propofol is associated with more rapid emergence from anesthesia than the older volatile anesthetics, allowing patients to report their dreams before they are forgotten. In order to further verify the hypothesis, the investigators choose gynecological general anesthesia to observe whether the generation of dreams is related to the dose of general anesthesia maintenance .
#Intervention
- DRUG : Propofol
- The low maintenance dose propofol group was maintained at 4-6 mg/kg/h ；and The high maintenance dose propofol group was maintained at 8-12 mg/kg/h
|
#Eligibility Criteria:
Inclusion Criteria:
* between 18 and 70 years
* with an ASA physical status of I or II
Exclusion Criteria:
* presence of sleep disorders
* pain syndrome
* cardiovascular disease
* sleep apnea syndrome
* psychosis
* history of opioid usage
* history of abnormal operation or anesthesia recovery
* unwillingness to provide informed consent
* a patient with a language communication disorder
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05173688
|
{
"brief_title": "The Relationship Between Different Doses of Propofol and the Occurrence of Dreams in Short Surgery Under General Anesthesia",
"conditions": [
"Dreaming",
"General Anesthesia"
],
"interventions": [
"Drug: Propofol"
],
"location_countries": [
"China"
],
"nct_id": "NCT05173688",
"official_title": "The Relationship Between Different Doses of Propofol and the Occurrence of Dreams in Short Surgery Under General Anesthesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-10",
"study_completion_date(actual)": "2022-05-10",
"study_start_date(actual)": "2021-11-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-06-02",
"last_updated_that_met_qc_criteria": "2021-12-29",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-12-30",
"first_submitted": "2021-11-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary aim of the study is to determine if the CF Quantum Sweat Test provides sweat chloride results that are equivalent to the results from traditional sweat testing. The secondary aim of the study is to assess the quantity not sufficient rate of the CF Quantum Sweat Test compared to traditional sweat testing.
Detailed Description
All 50 states and the District of Columbia are performing newborn screening for cystic fibrosis (CF). Infants who have a positive newborn screen require follow-up with a sweat test. Gibson-Cooke Quantitative Pilocarpine Iontophoresis (GCQPIT) requires collecting sweat in microbore tubing or on gauze/filter paper and analyzing sweat using a chloridometer. This test has many difficulties including specimens that are quantity not sufficient (QNS), many steps of pipetting solutions in the laboratory, and the need for a chloridometer to analyze sweat chloride concentration. The only manufacturer of a chloridometer has ceased production of this instrument. The CF Quantum® Sweat Test System (CFQT) overcomes all of the difficulties of GCQPIT. This pilot study will determine if the CFQT provides results that are equivalent to GCQPIT.
|
#Eligibility Criteria:
Inclusion Criteria:
* clinical diagnosis of cystic fibrosis
* patients who require a sweat test
Exclusion Criteria:
* Infants less than 48 hours of age
* Patient is receiving oxygen by open delivery
* collection site has diffuse inflammation or rash
Sex :
ALL
Ages :
- Minimum Age : 2 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01345617
|
{
"brief_title": "A Study of Sweat Testing Using a Quantitative Patch",
"conditions": [
"Cystic Fibrosis"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01345617",
"official_title": "A Study of Sweat Testing Using a Quantitative Patch",
"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)": "2012-01"
},
"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)": "2018-08-29",
"last_updated_that_met_qc_criteria": "2011-04-29",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-02",
"first_submitted": "2011-04-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research study is to evaluate the effects of the chemotherapeutic drug, Trastuzumab (Herceptin) on the heart. Trastuzumab (Herceptin) is used to treat specific types of breast cancer and is known to cause weakening of the heart. Unfortunately, little is know as to why this this happens. The investigators want to identify any factors that may lead to the early detection, treatment and prevention of the cardiotoxicity (heart problem) associated with this drug.
Detailed Description
As a subject participating in this study the following information will be collected: complete past medical history including age, height, and weight will be done with each echocardiogram; blood pressure at clinic visits during treatment with trastuzumab, type of cancer will be noted, type of chemotherapy, doses of chemotherapy, type and dose of chemotherapy in the past, type and dose of radiation therapy received, names and doses of cardiac medications, results of cardiac tests, results of lab tests, family history of heart disease, and social history which will include risk factors for developing heart disease including tobacco and alcohol use. This information will be entered into a database for the investigators to try and detect any factors that may lead to the cardiotoxicity (heart problem) that may be caused by Trastuzumab (Herceptin).
Any transthoracic echocardiogram (heart ultrasound) ordered will be further evaluated for special parameters that may help to detect weakening of the heart earlier than a normal ultrasound. An echocardiogram (heart ultrasound) is when a probe is placed on the chest and pictures are taken using sound waves and a special camera.
#Intervention
- PROCEDURE : Transthoracic echocardiogram (ultrasound)
- Any transthoracic echocardiogram (ultrasound) of the heart, performed as part of standard clinical care, will be further evaluated for special parameters that may help to detect weakening.
- Other Names :
- Transthoracic echocardiogram
|
#Eligibility Criteria:
Inclusion Criteria:
* Age greater than 18 years
* Her 2 positive breast cancer.
* Patients who are currently receiving Trastuzumab (Herceptin).
* Patients who received Trastuzumab (Herceptin) after the formation of the UFHealth Medical Plaza pharmacy database was initiated.
Exclusion Criteria:
* Age less than 18 years
* Patients who have not received Trastuzumab (Herceptin).
* Patients who received Trastuzumab prior to the formation of the UFHealth Medical Plaza pharmacy database.
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
|
NCT02080390
|
{
"brief_title": "Strain Imaging in Breast Cancer Patients Receiving Trastuzumab",
"conditions": [
"Her 2 Positive Breast Cancer"
],
"interventions": [
"Procedure: Transthoracic echocardiogram (ultrasound)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02080390",
"official_title": "Strain Imaging in Breast Cancer Patients Receiving Trastuzumab",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-10-28",
"study_completion_date(actual)": "2019-02-14",
"study_start_date(actual)": "2014-09"
},
"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)": "2019-03-01",
"last_updated_that_met_qc_criteria": "2014-03-04",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-03-06",
"first_submitted": "2014-02-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial is conducted in Asia, Europe, South America, and the United States of America (USA).
The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes.
#Intervention
- DRUG : Faster-acting insulin aspart
- Administrated subcutaneously (s.c., under the skin) at each main meal.
- Other Names :
- NN1218
- DRUG : basal insulin
- Administrated subcutaneously (s.c., under the skin) once daily.
|
#Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (Visit 1)
* Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH for at least 3 months prior to the screening visit (Visit 1)
* Current treatment with a) metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b) metformin in combination with sulfonylurea (SU) or glinide or Dipeptidyl peptidase-IV inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
* HbA1c by central laboratory a) 7.5 <= age <= 9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1) or b) 7.5 <= age <= 9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (OAD) (sulphonylurea (SU), glinide, dipeptidyl peptidase-IV (DDP-IV) inhibitors, alpha-glucosidase inhibitors (AGI) combination group at the screening visit (Visit 1)
* Body mass index (BMI) equal or less than 40.0 kg/m^2
Exclusion Criteria:
* Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days of consecutive treatment) and not within 3 months prior to the screening visit (Visit 1)
* Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) within the last 3 months prior to screening (visit 1)
* Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1)
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
|
NCT01850615
|
{
"brief_title": "Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes",
"conditions": [
"Diabetes",
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: basal insulin",
"Drug: Faster-acting insulin aspart"
],
"location_countries": [
"India",
"Mexico",
"United States",
"Romania",
"Argentina",
"Slovenia"
],
"nct_id": "NCT01850615",
"official_title": "Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-11-17",
"study_completion_date(actual)": "2014-11-17",
"study_start_date(actual)": "2013-09-23"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-06-12",
"last_updated_that_met_qc_criteria": "2013-05-06",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-05-09",
"first_submitted": "2013-04-17",
"first_submitted_that_met_qc_criteria": "2017-12-18"
}
}
}
|
#Study Description
Brief Summary
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of LTM1201L, LTM1201LN, LTM1201LB, LTM1201LD administered before sleep on OSA phenotype traits and OSA severity during sleep.
#Intervention
- DRUG : Placebo oral capsule
- Placebo capsule before sleep
- DRUG : LTM1201L
- LTM1201L capsule before sleep
- DRUG : LTM1201LN
- LTM1201LN capsule before sleep
- DRUG : LTM1201LB
- LTM1201LB capsule before sleep
- DRUG : LTM1201LD
- LTM1201LD capsule before sleep
|
#Eligibility Criteria:
Inclusion Criteria:
* AHI > 10 events/h during NREM supine sleep
Exclusion Criteria:
* Any medical condition other than well controlled hypertension and mild diabetes.
* Any medication known to influence breathing, sleep/arousal, or muscle physiology.
* Claustrophobia.
* Inability to sleep supine.
* Allergy to any of the medications tested in the protocol.
* History of kidney stones, hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D.
* Individuals with underlying cardiac disease, such as arrhythmias.
* Individuals taking psychiatric medications, such as an MAO-I, SSRI or SNRI, or any of the studied medications for medical care.
* For women: Pregnancy.
* Pulmonary hypertension
* Severe OSA with a mean SaO2 lower than 88%
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03640052
|
{
"brief_title": "Pharmacological Activation of HMN for OSA",
"conditions": [
"Obstructive Sleep Apnea"
],
"interventions": [
"Drug: LTM1201L",
"Drug: LTM1201LB",
"Drug: LTM1201LN",
"Drug: Placebo oral capsule",
"Drug: LTM1201LD"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03640052",
"official_title": "Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-30",
"study_completion_date(actual)": "2019-12-31",
"study_start_date(actual)": "2018-10-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-02-24",
"last_updated_that_met_qc_criteria": "2018-08-17",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-08-21",
"first_submitted": "2018-08-17",
"first_submitted_that_met_qc_criteria": "2020-02-11"
}
}
}
|
#Study Description
Brief Summary
Objectives
1. To determine the uptake of universal HIV testing among Thai men who have sex with men (MSM) and transgender women (TG)
2. To determine the uptake of antiretroviral treatment (ART) regardless of CD4 count among Thai MSM/TG who test positive for HIV
Subject population:. Men or transgender women who have sex with men,Thai nationals, age ≥18 years old, Have engaged in anal intercourse with a man without using a condom at least one time in the last 6 months or have had at least 3 male sex partners in the last 6 months,Not known to be HIV-positive (either have never been tested for HIV or have had a previous negative HIV test)
Number of participants:2000 Thai MSM and TG with approximately 76%-90% in Bangkok, 5%-12% in Lampang and 5-12% in Ubonratchathani.
Detailed Description
All participants will receive HIV testing at baseline. The frequency of study visits to determine HIV status in HIV-negative participants will be every 6 months for a total follow up time of 24 months. Once HIV-positive status is confirmed, participants will be offered ART immediately regardless of CD4 count. Those who accept ART will be seen more frequently following ART initiation, at 2 weeks, 4 weeks, 2 months, 3 months and every 3 months thereafter until completion of 24 months of follow-up. Those who deny immediate ART will have clinic visits every 6 months to monitor HIV disease. HIV-negative participants will be asked to come for HIV re-testing every 6 months or sooner if they feel exposed to risk
|
#Eligibility Criteria:
Inclusion Criteria:
* Thai nationals
* Age >18 years
* Men or transgender women who have sex with men
* Have engaged in anal intercourse with a man without using a condom at least one time in the last 6 months or have had at least 3 male sex partners in the last 6 months
* Not known to be HIV-positive (either have never been tested for HIV or have had a previous negative HIV test)
* Have signed the consent form
Exclusion Criteria:
* Known HIV-positive serostatus
Sex :
MALE
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:
Yes
|
NCT01869595
|
{
"brief_title": "Thai MSM/TG Test and Treat Study",
"conditions": [
"HIV Testing Rate",
"Acceptance of Immediate ART"
],
"interventions": null,
"location_countries": [
"Thailand"
],
"nct_id": "NCT01869595",
"official_title": "Prospective Study of Study to Evaluate the Feasibility of Universal HIV Testing and Antiretroviral Treatment Regardless of CD4 Count Using the Test and Treat Strategy Among Men Who Have Sex With Men and Transgender Women in Thailand",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12",
"study_completion_date(actual)": "2020-11",
"study_start_date(actual)": "2012-11"
},
"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)": "2024-11-25",
"last_updated_that_met_qc_criteria": "2013-06-01",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-05",
"first_submitted": "2013-06-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study investigates the effect of a computerized approach/avoidance retraining (aka cognitive bias modification) over and above treatment as usual for patients in treatment for substance use disorders. The computerized training entails viewing pictures of drug and non-drug related stimuli, and then using the computer to make the drug pictures smaller and the non-drug pictures larger. Participants will also take part in an EEG/event-related brain potential assessment at the beginning and end of treatment to identify brain measures that are associated with treatment response.
Detailed Description
Methodology Participants must be receiving treatment for substance use disorders in the adolescent program of the University of Michigan Addiction Treatment Services (UMATS) clinic. Participants must be between the ages of 14-65.
The study entails five components
1. Neurophysiological assessment. (Baseline)
2. Assessment of substance use and psychiatric disorders. (Baseline)
3. Bias retraining treatment protocol. (after baseline, 6 training sessions over a two week period)
4. Second neurophysiological assessment at the end of treatment. (6 weeks after baseline)
5. Six-month follow-up to assess substance use and psychiatric disorders. (6 months after baseline)
Each component is described in more detail below:
1. Assessment of substance use and psychiatric disorders will be completed using well-validated structured interviews and questionnaires. This assessment will take place as soon as participants can be scheduled following their entry into treatment at the UMATS clinic.
2. Neurophysiological assessment will entail several procedures that reliably elicit brain responses that are associated with substance use disorders and antisocial behavior. The first neurophysiological assessment will take place as soon as participants can be scheduled following their entry into treatment at the UMATS clinic.
The different tasks are described below. Participants will be asked to perform tasks that involve responding to letters and pictures on a computer monitor while physiological responses will be recorded continuously during the experiment. This will be achieved by the use of sensors positioned on the head, forearms, palms, and face. These sensors are filled with a nonirritating paste and attached to the skin using medical tape.
The tasks are as follows:
1. Picture Viewing and Emotion Regulation Task-Duration: approximately 40 minutes The subject will be presented with a number of different pictures from the International Affective Picture System (IAPS) including traditional unpleasant, neutral, and pleasant images as well as images of drugs and drug-related paraphernalia. Pictures are presented following an instruction cue asking the person to enhance (upregulate) or diminish (downregulate) their affective responses.
2. Go/No go task - Duration: 10 minutes During this procedure, participants will respond to two different letters by selecting one of two buttons that are associated with each letter. They will be asked to inhibit their response if the letter they are viewing is the same as the letter just viewed. It is intended to measure cognitive control. Drug-related pictures will also be included as distractors to examine their effects on performance and EEG/event-related potential (ERP) measures.
3. Gambling/feedback task-Duration: 10 minutes During this procedure, participants will see 2 squares, side-by-side on the monitor in front of them. Each square will have a money amount displayed inside of it. Sometimes the squares show 5 cents, and sometimes they show 25 cents. The task is simply to choose one of the squares on each trial, either the one on the left or the one on the right. After a delay of about one second, the participant will be told if he or she won or lost the amount of money inside the square he or she chose. If the selected square turns GREEN that means the participant won the amount of money shown inside the square. If the chosen square turns RED that means the participant lost the amount of money shown inside the square. At the same time, the unselected will also turn either green or red, to inform the participant how much he or she would have won or lost if the other square had been selected.
3) Bias retraining treatment protocol. In addition to treatment as usual at the UMATS clinic, participants will be randomized into either bias retraining or sham training conditions. At a pre-test session, participants will complete an approach-avoidance task (AAT) to measure initial bias to drug-related stimuli. The AAT are each completed on a laptop computer.
The AAT includes 20 pictures of drug-related stimuli and 20 pictures of non-drug related stimuli. Pictures are presented equally in landscape and portrait format. After the pictures appear on a monitor, participants will be instructed to use a joystick to either enlarge (pull the joystick closer) or shrink (push the joystick away) the pictures. In this task, the required response is unrelated to the content of the pictures. Specifically, participants are instructed to pull the joystick to approach pictures in portrait format or push pictures in landscape format. The difference between the median response time for drug versus non-drug related pictures is used as a measure of bias. The AAT takes 5 minutes to complete.
The bias retraining protocol will then utilize the AAT. Participants will again be instructed to push or pull the joystick dependent upon whether the picture is in portrait or landscape formant. For participants in the experimental condition, all drug-related pictures will be in landscape format, that is, all participants in the experimental condition will push the joystick to shrink the drug-related pictures. For participants in the control condition, drug-related pictures will be presented equally in portrait and landscape format. During training, participants have to correct all errors. Training sessions will entail 200 trials with a short break at the halfway point. Each session takes about 15 minutes to complete.
The pre-test assessment of bias (AAT) will take place as soon as participants can be scheduled following their entry into treatment at the UMATS clinic. The bias retraining protocol will begin the day following the pre-test assessment of bias. Participants will then take part in 6 training sessions (each requires approximately 15 minutes to complete) over a two week period.
Prior to and following each administration of the AAT, participants will complete a rating of their current feelings of craving to use drugs on a 6-point scale ranging from I don't want to use drugs at all to I would love to use drugs right now. If the participant endorses a 4 or higher on the scale following presentation of the AAT, they will be queried by research staff who will be trained in basic cognitive behavioral techniques to assist the participant in reducing any feelings of craving. As participants are actively engaged in treatment for substance use problems (i.e., consistently thinking and talking about drug use), it is unlikely that words or pictures of drug-related stimuli will elicit sufficient craving to trigger a relapse. Also, all participants will either be in the presence of or near a parent and/or regular treatment provider, further minimizing the risk that any procedures would elicit a relapse.
Participants will also complete a brief symptom inventory at their bias retraining sessions so that we can track their progress over the course of treatment. The participant's primary therapist will also be asked to make brief ratings regarding the participant's engagement and progress at the end of active treatment. Finally, to provide an objective measure of treatment adherence, participants will be drug tested. Drug testing is conducted randomly as part of UMATS treatment, and we will request access to the results of those tests.
4) A second neurophysiological assessment will take place 6 weeks following the baseline assessment, at which point participants will have transitioned out of active treatment (e.g., intensive outpatient). Participants will repeat the same protocol as the first neurophysiological assessment in order to detect any changes in brain responses as a consequence of treatment condition. Participants will also complete the AAT and a brief inventory of symptoms.
5) Six months after entry into treatment at UMATS, participants will be asked to complete questionnaires regarding their substance use and psychiatric symptoms as well as the AAT.
Statistical Design We predict that symptom measures and EEG/ERP measures assessed at baseline will be associated with treatment response as measured by scores on the brief symptom inventory administered at training sessions, results of drug testing, and therapist ratings. Multilevel models will be used to estimate the associations between baseline measures (modeled as fixed effects) and the repeated measures of the outcome variables (repeated measures nested within individuals). To examine the effects of treatment condition (bias retraining versus sham training), a group-based multilevel model (similar to repeated measures ANOVA) will be used to test for any group differences on the EEG/ERP measures assessed at baseline and the follow-up neurophysiological assessment. Similar group-based multilevel models (similar to repeated measures ANOVA) will also be used to test for group differences on the substance use and psychiatric symptom measures assessed at baseline and the 6-month follow-up, as well as the measures of treatment progress (drug tests, symptom measures, therapist ratings) assessed between the baseline assessment and the second neurophysiological assessment at the end of treatment.
Power analysis and target N for recruitment. For the regression and multilevel modeling analysis of dimensional outcomes, an n = 85 will provide 80% to detect the anticipated effect (r = .30, α = .05). For the group-based multilevel models, groups of 41 will provide 80% to detect the anticipated effect. Therefore, our goal is to recruit enough participants such that each group (experimental and control) will include at least 40 participants with a baseline and follow-up neurophysiological assessment. We anticipate a 15% attrition rate. Therefore, we plan to recruit 94 participants.
#Intervention
- BEHAVIORAL : Bias retraining
- Participants will view pictures of drug (e.g., alcohol) and non-drug stimuli (e.g., soft drinks) on a computer. Participants will then use the computer to make the drug pictures smaller and the non-drug pictures larger.
- BEHAVIORAL : Sham retraining
- Participants will view pictures of drug and non-drug related stimuli on a computer. Participants will then use the computer to make the pictures larger or smaller based on the tilt of the picture (slightly to the left or right), but without regard to the content of the picture.
|
#Eligibility Criteria:
Inclusion Criteria:
Patient in treatment for substance use disorders. Alcohol use problems. -
Exclusion Criteria:
Detoxification treatment. Severe mental illness (e.g., psychotic symptoms)
*
Sex :
ALL
Ages :
- Minimum Age : 14 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02016378
|
{
"brief_title": "EEG/Event-related Brain Potential Risk Markers as Predictors and Outcomes of SUD Treatment in Adolescents",
"conditions": [
"Alcohol Use Disorder"
],
"interventions": [
"Behavioral: Bias retraining",
"Behavioral: Sham retraining"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02016378",
"official_title": "EEG/Event-related Brain Potential Risk Markers as Predictors and Outcomes of SUD Treatment in Adolescents",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12",
"study_completion_date(actual)": "2022-12",
"study_start_date(actual)": "2014-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "SINGLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-12-13",
"last_updated_that_met_qc_criteria": "2013-12-13",
"last_verified": "2022-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-20",
"first_submitted": "2013-11-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to learn about a drug-drug interaction. When two medications are taken together at the same time, one medication may change the activity of the other medication in the body - this is called a drug-drug interaction. This study is looking at the effect the Bayer study drug, copanlisib, has on metformin, a commonly used medication to treat diabetes. During the study, blood and urine samples will be collected and analyzed to learn about pharmacokinetics (how copanlisib changes metformin levels in the body) and pharmacodynamics (the effect metformin has on the body when taken together with copanlisib) when someone takes both copanlisib and metformin together.
#Intervention
- DRUG : Copanlisib (Aliqopa, BAY80-6946)
- The copanlisib dose for this study is the standard dose recently approved and also used in Phase 1, 2 and 3 studies across the copanlisib development program: 60 mg i.v. infusion administered intermittently on Days 1, 8 and 15 of a 28-day cycle.
In this study subjects will receive a single i.v. dose of 60 mg copanlisib on day 8.
- DRUG : Metformin
- Single dose of 1000 mg is administered orally.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female subjects - as determined by the investigator or medically qualified designee based on medical evaluations, including medical history, physical examination, laboratory tests and cardiac monitoring
* Aged 18 <= age <= 45 at the first screening visit
* Body Mass Index (BMI) of 18.0 - 34 kg / m*2 , with body weight >= 50 kg
* Creatinine clearance >= 90 mL/min using the Modification of Diet in Renal Disease
* Adequate end organ and bone marrow function
Exclusion Criteria:
* Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus)
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Relevant respiratory insufficiency / disorder
* Administration of strong CYP3A4 inhibitors or inducers within 2 weeks prior to dosing
* Known history of hypersensitivity (or known allergic reaction) to copanlisib, metformin, related compounds, or any components of the formulation
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
|
NCT03655301
|
{
"brief_title": "Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Drug: Copanlisib (Aliqopa, BAY80-6946)",
"Drug: Metformin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03655301",
"official_title": "An Open-label, Non-randomized, Phase I Study to Evaluate the Effect of Copanlisib (a Single Intravenous Dose of 60 mg) on the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Metformin (MATE2-K Substrate) in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-12",
"study_completion_date(actual)": "2019-02-12",
"study_start_date(actual)": "2018-09-11"
},
"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)": "2020-01-28",
"last_updated_that_met_qc_criteria": "2018-08-30",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-08-31",
"first_submitted": "2018-08-30",
"first_submitted_that_met_qc_criteria": "2019-12-05"
}
}
}
|
#Study Description
Brief Summary
It is important to determine how high femoral anteversion, which is one of the lower extremity malalignments, affects physical performance and to what extent it affects the daily life of the individual. As far as we know, there is no study on this subject except for a study conducted by Staheli et al. in 1977. Therefore, the investigators planned to determine whether and to what extent high femoral anteversion has an effect on physical performance in healthy young adults.
Detailed Description
One of the factors associated with problems in the lower extremity is changes in the angle of femoral anteversion. High femoral anteversion causes pathological changes in the sagittal and coronal planes, especially in the transverse plane, and changes the gait biomechanics. Femoral anteversion angle; It is the angle formed by the plane of the femoral condyle and the plane passing through the femoral neck and the femoral head. The femoral anteversion angle, which is 55°-60° in the intrauterine period, is approximately 30° at birth. In the postnatal period, with normal growth, it decreases by 1.5° per year until the age of 15, decreasing to 26° at the age of 5, 21° at the age of 9 and 15° at the age of 16.
Toe-in gait pattern may be due to foot deformity (metatarsus adductus) and/or transverse alignment disorder of the long bones (tibial torsion and/or femoral anteversion height). When the angle of anterversion is high, walking with the feet turned in is 30.9% at the age of 4, 15% at the age of 4, and around 4% in adults. High femoral anteversion, which is the most common cause of inward walking in early childhood, is mostly seen symmetrically, with a higher incidence in girls and hypermobile children. Most cases are idiopathic and some patients have a familial predisposition.
Alignment disorders in the lower extremities can cause problems affecting other segments of the body, postural disorders and problems in the musculoskeletal system, as well as affect physical performance. The study, which will examine the physical performance status of young adults with high femoral anteversion, will be carried out as a cross-sectional study. The universe of the study will consist of students aged 17-26 who continue their education at the Faculty of Health Sciences of Bezmialem Vakıf University in the 2022-2023 academic year. Within the scope of our cross-sectional study, an application will be made for the approval of the Ethics Committee before the data are collected. The study, which will start after the permission is obtained, will be carried out in accordance with the Declaration of Helsinki. Evaluation and testing of all cases will be done at Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. 22 subjects with high femoral anteversion angle and 22 subjects with normal femoral anteversion angle will be included in the study. Within the scope of the study, demographic information of all participants will be obtained with the evaluation form and clinical evaluations will be made. Flexibility with sit-reach test, hand grip strength with hydraulic hand dynamometer, general muscle strength with analog back-leg-chest dynamometer, functional performance with single-leg and double-leg horizontal jump tests, and functional capacities with 6-minute walking test will be evaluated. 'Statistical Package for the Social Sciences (SPSS) 20.0 for Windows' package program will be used in the statistical analysis of the data obtained from the study which the investigators planned to evaluate physical performance in young adults with high femoral anteversion. All data will be analyzed with the Kolmogorov-Smirnov test to determine the distribution characteristics. In the study, descriptive statistics (mean±standard deviation, minimum-maximum, number and percentile) will be given for discrete and continuous variables. When the differences between two independent groups are evaluated, 't-Test in Independent Groups' in case the parametric test prerequisites are met; If not, the 'Mann Whitney -U Test' will be used. 'Chi-Square Test' will be used to determine the relationships between two discrete variables. When the variables meet the parametric test prerequisites, the correlation coefficients and statistical significance will be calculated with the 'Pearson Test', when they do not, the correlation coefficients and statistical significance for the relations between the variables will be calculated with the 'Spearman Test'.
#Intervention
- OTHER : Sit and reach test
- It will be used to measure the flexibility of the participants.
- OTHER : Hand grip strength measurement
- Grip strength will be evaluated with a hand dynamometer in the position recommended by the American Association of Hand Therapists.
- OTHER : Back-leg-chest muscle strength measurement
- An analog Back Leg-Chest dynamometer will be used to evaluate general muscle strength.
- OTHER : Functional performance
- Single-leg and double-leg horizontal jump test will be used to evaluate lower extremity functional performance. The tests will be carried out according to the Eurofit test battery (Council of Europe, 1988).
- OTHER : Functional capacity
- Functional capacity will be evaluated with six minute walk test according to the ATS criteria.
|
#Eligibility Criteria:
Inclusion Criteria:
* Bilateral increased femoral anteversion
* Hip internal rotation >60 degrees, external rotation <45
* According to the Craig test, the anteversion angle is between 20 <= age <= 40 degrees
* Absence of a history of neurological or psychiatric disease
* Absence of intellectual disability to prevent participation in assessment and treatment
* Not participating in any exercise/physiotherapy program in the last six months
* Body mass index within normal limits (18.5 <= age <= 24.9 kg/m2)
Exclusion Criteria:
* Having a history of BoNT-A or surgery in the last 6 months
* Leg length inequality
* Beighton score of 4 and above
* Presence of 3rd degree pes planus
Sex :
ALL
Ages :
- Minimum Age : 17 Years
- Maximum Age : 26 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05882981
|
{
"brief_title": "Increased Femoral Anteversion and Physical Performance",
"conditions": [
"High Femoral Anteversion",
"Muscle Strength",
"Flexibility",
"Functional Performance",
"Functional Capacity"
],
"interventions": [
"Other: Functional performance",
"Other: Hand grip strength measurement",
"Other: Functional capacity",
"Other: Sit and reach test",
"Other: Back-leg-chest muscle strength measurement"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05882981",
"official_title": "Evaluation of Physical Performance of Young Adults With Increased Femoral Anteversion",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-20",
"study_completion_date(actual)": "2024-01-14",
"study_start_date(actual)": "2023-10-20"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-17",
"last_updated_that_met_qc_criteria": "2023-05-27",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-05-31",
"first_submitted": "2023-05-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Metabolic disorders that can occur during pregnancy, in particular disorders of lipid metabolism and insulin resistance, can have a detrimental effect on pregnancy and the fetus.
The triglyceride level and other lipids increase slightly during pregnancy. This increase has a positive effect on the development of the fetus. However, an excessive increase in lipid levels can cause some metabolic disorders such as gestational diabetes and increase feto-maternal morbidity/mortality.
While some existing studies have shown that elevated triglyceride levels can cause fetal macrosomia, others have found no correlation between these two variables. The ratio of triglycerides to HDL is a widely used marker for lipid disorders. In addition, the triglyceride-glucose index is also an index used to detect insulin resistance.
Detailed Description
In this study, the investigators aimed to investigate whether the ratio of triglycerides to high-density lipoprotein cholesterol and the triglyceride glucose index are associated with fetal macrosomia in low-risk nulliparous pregnant women.
#Intervention
- OTHER : TyG index
- association between TyG index and triglyceride to high-density lipoprotein cholesterol ratio with fetal macrosomia
- Other Names :
- Triglyceride to high-density lipoprotein cholesterol ratio
|
#Eligibility Criteria:
Inclusion Criteria:
* Screening for fetal macrosomia was based on the term defined according to the standards of the American College of Obstetricians and Gynecologists (ACOG).
* Low-risk nulliparous singleton pregnant women.
* Age between 18 and 40 years
Exclusion Criteria:
* Post-term pregnancies
* Hospitalized for preterm labor or preterm premature rupture of membranes.
* Gestational diabetes mellitus, diabetes mellitus type I - type II.
* Pregnant women with fetal growth restriction, hypertensive pregnancy disorders, familial hypercholesterolemia and hyperlipidemia.
* Multiparous pregnant women
* Multiple pregnancies
* Pregnant women with chronic diseases.
* Pregnant women with impaired liver function;
* Pregnant women with body mass index <25 and >40 kg/m2.
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:
Yes
|
NCT06463990
|
{
"brief_title": "Influence of TyG Index and TG/HDL-C Ratio on Fetal Macrosomia",
"conditions": [
"Fetal Macrosomatia",
"Lipid Metabolism Disorders",
"Hyperlipidemias"
],
"interventions": [
"Other: TyG index"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06463990",
"official_title": "Association Between the Triglyceride-glucose Index and the Ratio of Triglyceride to High-density Lipoprotein Cholesterol With Fetal Macrosomia in Low-risk Nulliparous Pregnant Women",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-07-30",
"study_completion_date(actual)": "2024-08-25",
"study_start_date(actual)": "2023-01-01"
},
"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)": "2024-09-03",
"last_updated_that_met_qc_criteria": "2024-06-17",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-06-18",
"first_submitted": "2024-06-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to investigate the effect of laser ablation (LA) in minimally invasive management of pilonidal disease (PD).
Data of the patients with PD who were eligible for simple debridement have been prospectively collected since March 2018, when laser ablation treatment came into use in our institution. Laser ablation treatment was offered to all eligible patients. All the patients underwent debridement (removal of hair and/or necrotic tissues through pits using a clamp/curette/brush) of PD; LA was added to the procedure in patients who were willing to have LA. The surgical outcome of two procedures was compared. The primary outcome measure was recurrence at 36 months.
#Intervention
- DEVICE : Laser ablation
- A diode-laser that has been reported to be safe and effective in several treatments including pilonidal disease, anal fistula, hemorrhoids, and vascular ablation was used to obtain shrinkage of pilonidal cyst
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with Class III, IV, and V pilonidal disease according to Tezel Navicular Area Classification
* Patients who underwent debridement for pilonidal disease
Exclusion Criteria:
* Patients with acute abscess (Tezel Class II)
* Antibiotic use within 4 weeks before surgery
* Patients lost to follow-up at 3,7 and 30 days; 6, 12 and 36 months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05569135
|
{
"brief_title": "Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease",
"conditions": [
"Pilonidal Disease"
],
"interventions": [
"Device: Laser ablation"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05569135",
"official_title": "Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease: Retrospective Analysis of Mid-term Outcome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-03",
"study_completion_date(actual)": "2022-10-03",
"study_start_date(actual)": "2018-03-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-06",
"last_updated_that_met_qc_criteria": "2022-10-05",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-06",
"first_submitted": "2022-10-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study evaluated the impact of Opioid-Free Anesthesia (OFA) and Fentanyl Anesthesia (FNT) on the hemodynamics of the circulatory system (HR, esCCO, esCCI, esSVI, BP: SYS, DIA, MEAN) in obese patients with a BMI \> 40 undregoing laparoscopic bariatric surgery. Patients in the OFA group were anesthetized as follows: before induction: ketamine 0.15 mg/kg (corrected body weight), lidocaine 1-1.5 mg/kg (corrected body weight) slow infusion, magnesium sulfate 30-50 mg/kg (corrected body weight), dexamethasone 8 mg, paracetamol 2.0g. Maintenance: continuous infusion of ketamine 0.125-0.25 mg/kg/h (corrected body weight), lidocaine 1.5-3 mg/kg/h (corrected body weight), magnesium sulfate 10 mg/kg/min (corrected body weight), and rocuronium bromide 1.25 µg/kg/min (corrected body weight) were used. Patients in the FNT group were anesthetized as follows: before induction: fentanyl 1.5-3 µg/kg (corrected body weight) iv, preoxygenation with 100% oxygen for 3 minutes, propofol 2.5 mg/kg (actual body weight) and following confirmation of mask ventilation, rocuronium bromide 0.6 mg/kg (actual body weight) bolus. After achieving full neuromuscular blockade, the patient was intubated and connected to the anesthesia machine and ventilated with 1-1.5 MAC desflurane.
Detailed Description
Adult patients (over 18 years old) with a BMI ≥ 40, ASA ≤ II, qualified for elective bariatric surgery under general anesthesia with endotracheal intubation, who provided informed, voluntary consent to participate in the study, were included. Patients with BMI \< 40, ASA III and above, heart failure, arrhythmias (especially bradyarrhythmia), hypovolemia, shock, unstable coronary artery disease, autonomic neuropathy with orthostatic hypotension, with a history of allergic reactions, pregnancy, indications for urgent surgical intervention, or those who did not consent to participate in the study, were excluded. Patients' weight, height, and BMI were measured. All obtained data were anonymized.
After transporting the patient to the operating room, the envelope was opened, and the patient was assigned to either the OFA or FNT anesthesia group.
Patients in the OFA group were anesthetized as follows: before induction: ketamine 0.15 mg/kg (corrected body weight), lidocaine 1-1.5 mg/kg (corrected body weight) slow infusion, magnesium sulfate 30-50 mg/kg (corrected body weight), dexamethasone 8 mg, paracetamol 2.0g. Induction: after three minutes of preoxygenation with 100% oxygen, propofol 2.5 mg/kg (actual body weight) was administered. Following confirmation of mask ventilation, rocuronium bromide 0.6 mg/kg (actual body weight) was given. Bag-mask ventilation with 100% oxygen continued for 3 minutes. After achieving full neuromuscular blockade, confirmed by the loss of all four responses using a peripheral nerve stimulator, the patient was intubated and connected to the anesthesia machine and ventilated with 1-1.5 MAC sevoflurane. Maintenance: ketamine 0.125-0.25 mg/kg/h (corrected body weight), lidocaine 1.5-3 mg/kg/h (corrected body weight), magnesium sulfate 10 mg/kg/min (corrected body weight), and rocuronium bromide 1.25 µg/kg/min (corrected body weight) were used. After surgery, neuromuscular blockade was reversed with sugammadex at 2-4 mg/kg (corrected body weight). The patients were also administered ephedrine in case of hypotension, atropine for bradycardia, and beta-blockers for tachycardia and hypertension.
Patients in the FNT group were anesthetized as follows: before induction: fentanyl 1.5-3 µg/kg (corrected body weight) iv, preoxygenation with 100% oxygen for 3 minutes, propofol 2.5 mg/kg (actual body weight) and following confirmation of mask ventilation, rocuronium bromide 0.6 mg/kg (actual body weight) bolus. Bag-mask ventilation with 100% oxygen and 2% inhaled sevoflurane continued for 3 minutes. After achieving full neuromuscular blockade, the patient was intubated and connected to the anesthesia machine and ventilated with 1-1.5 MAC desflurane. Maintenance dose for fentanyl was 0.003-0.006 µg/kg/min (corrected body weight) and rocuronium bromide 1.25 µg/kg/min (corrected body weight) were used. After surgery, neuromuscular blockade was reversed with sugammadex at 2-4 mg/kg (corrected body weight).
During induction, patients were positioned supine with the head and torso elevated at a 25-degree angle on a positioning pad. Anesthetic monitoring included HR, NIPC-SYS, NIPC-MEAN, NIPC-DIA, SpO2, esCCO, esCCI, and esSVI using the Vismo monitor and EtCO2.
Hemodynamic parameters (esCCO, esCCI, esSVI, NIPC-SYS, NIPC-MEAN, NIPC-DIA, HR) were measured before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10).
The objective of the study is to compare the impact of OFA on hemodynamic parameters measured by non-invasive technique: esCCO, esCCI, esSVI, NIPC-SYS, NIPC-MEAN, NIPC-DIA, HR, in obese patients with BMI \> 40, with those obtained during the commonly used FNT anesthesia.
#Intervention
- DRUG : Opioid Free Anaesthesia
- patients received opioid free anesthesia
- DRUG : Opioid based Anesthesia
- patients received opioid based anesthesia
|
#Eligibility Criteria:
Inclusion Criteria:
* obese patients with a BMI > 40 kg/m2 undergoing elective laparoscopic bariatric surgery
Exclusion Criteria:
* lack of consent
* emergency operation
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
|
NCT06714981
|
{
"brief_title": "Hemodynamics Stability During Opioid Free Anesthesia for Patients with Obesity",
"conditions": [
"Obesity",
"General Anesthesia",
"Opioid Free Anaesthesia"
],
"interventions": [
"Drug: Opioid based Anesthesia",
"Drug: Opioid Free Anaesthesia"
],
"location_countries": [
"Poland"
],
"nct_id": "NCT06714981",
"official_title": "A Comparison of Opioid-Free Anesthesia (OFA) and Standard Fentanyl-based General Anesthesia in Patients with Morbid Obesity Undergoing Laparoscopic Bariatric Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-02",
"study_completion_date(actual)": "2023-06-02",
"study_start_date(actual)": "2022-01-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-04",
"last_updated_that_met_qc_criteria": "2024-12-03",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-12-04",
"first_submitted": "2024-11-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this study, a more specific and systematic Home-Based Cognitive Rehabilitation Program Driven by a Tablet Application is developed and the purpose of the program is to check whether cognitive function is improved when the program is applied to patients with MCI.
Detailed Description
The subjects of recruitment were the elderly with mild cognitive impairment living in the local community. Assessments were conducted 7 days before and after the intervention. Subjects received Korean-Montreal Cognitive Assessment(MoCA), semantic verbal emory test (SVLT), number memorization test; Digit Span Test (DST), category word fluency test (CWFT), phonemic word fluency test (PWFT), Korean-mini mental state test (K-MMSE), and geriatric depression scale (GDS) before and 8 weeks after the intervention.
#Intervention
- OTHER : Home based cognitive rehabilitation program
- The home based cognitive rehabilitation program intervention was conducted for 30 minutes each time, 3 times a week for 8 weeks, a total of 24 times.
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women over the age of 55
* Those who have visual and auditory abilities without difficulties in conducting this research
* Those with K-MMSE (Korean-Mini Mental State Examination) score of 24 or higher and 16<=K-MoCA score<23
* In the case of patients taking dementia treatment, those who have the same treatment regimen and dose for 3 months or more from the screening date
* A person who can understand and respond to the questionnaire questions.
* A person who voluntarily decided to participate in this study and gave written consent to the informed consent form
Exclusion Criteria:
* Those with a history of alcohol or drug abuse,
* Those with a past history of uniaxial psychiatric disorders, including intellectual disability, schizophrenia, alcoholism, and bipolar disorder
* A person who is unable to communicate
* Those who show all neurological symptoms that cause cognitive decline, such as Parkinson's disease, cerebral hemorrhage, brain tumor, and hydrocephalus
* Those with a record of being unconscious for more than 1 hour due to head trauma or mild repetitive head trauma
* Those with symptoms of depression that may affect cognitive function
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05275153
|
{
"brief_title": "Effectiveness of a Home-Based Cognitive Rehabilitation Program in Patients With MCI",
"conditions": [
"Cognitive Impairment",
"Mild Cognitive Impairment"
],
"interventions": [
"Other: Home based cognitive rehabilitation program"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT05275153",
"official_title": "Effectiveness of a Home-Based Cognitive Rehabilitation Program Driven by a Tablet Application in Patients With Mild Cognitive Impairment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-30",
"study_completion_date(actual)": "2021-08-02",
"study_start_date(actual)": "2020-04-22"
},
"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)": "2022-03-11",
"last_updated_that_met_qc_criteria": "2022-03-10",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-11",
"first_submitted": "2022-03-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery.
Detailed Description
This registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery. Our goal is to test if primary surgery improves overall survival in bone only metastasis.
#Intervention
- PROCEDURE : Surgery
- Surgery to primary tumor
- Other Names :
- mastectomy, lumpectomy
- DRUG : Systemic therapy
- Systemic therapy based on tumor phenotype
- Other Names :
- Chemotherapy, hormone therapy, biphosphanetes
|
#Eligibility Criteria:
Inclusion Criteria:
* Primary breast tumor amenable for complete surgical resection
* Patients in good physical condition for receiving protocol driven locoregional and systemic treatment
* Patients eligible for sentinel lymph node (SLN) biopsy and receiving radiotherapy.
Exclusion Criteria:
* Primary tumor not amenable for complete resection (such as tumor extending to neighboring tissues; T4a,c or inflammatory breast cancer; T4d)
* Primary tumor with extended infection, bleeding, or necrosis
* Patients with poor physical condition which prevents the patient from receiving protocol driven locoregional and systemic treatment
* Synchronous primary cancer at the contralateral breast
* Previous diagnosis of other cancers (excluding basal cell skin cancer
* Squamous cell skin cancer
* Cervical intraepithelial neoplasia)
* Clinically involved contralateral axillary nodes
* Patients not suitable for adequate follow-up
* Failure to give informed consent
Sex :
FEMALE
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
|
NCT02125630
|
{
"brief_title": "Bone Metastasis and Surgery in Breast Cancer",
"conditions": [
"Breast Cancer",
"Surgery"
],
"interventions": [
"Procedure: Surgery",
"Drug: Systemic therapy"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT02125630",
"official_title": "The Effect of Primary Surgery in Patients With Stage IV Breast Cancer With Bone Metastasis Only",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06",
"study_completion_date(actual)": "2019-06",
"study_start_date(actual)": "2014-01"
},
"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)": "2019-07-31",
"last_updated_that_met_qc_criteria": "2014-04-28",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-29",
"first_submitted": "2014-04-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the safety and efficacy of oral valacyclovir hydrochloride (256U87) vs. acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients (CD4 greater than or equal to 100).
Detailed Description
Efficacy variables include the length of the episode, the time to lesion healing, the duration and severity of pain/discomfort, the duration of viral shedding, the proportion of patients with aborted episodes, the proportion of patients requiring extended therapy.
#Intervention
- DRUG : Valacyclovir hydrochloride
- DRUG : Acyclovir
|
#Eligibility Criteria:
Inclusion Criteria
Patients must have the following:
* HIV-infected individual (CD4 = or > 100) with a history of recurrent anogenital herpes.
* Signed the consent form or present a signed parental consent form if below 18 years.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Hepatic impairments as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine. History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigators opinion, potentially limit the retention and absorption of oral therapy.
Patients with the following are excluded:
* Hepatic impairment as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine.
* History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigator's opinion, potentially limit the retention and absorption of oral therapy.
Prior Medication:
Excluded:
* Systemic antiherpes or immunomodulatory therapy within 30 days prior to entry.
Sex :
ALL
Ages :
- Minimum Age : 13 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00002000
|
{
"brief_title": "A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients",
"conditions": [
"Herpes Simplex",
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00002000",
"official_title": "A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients",
"recruitment_information": null,
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2005-06-24",
"last_updated_that_met_qc_criteria": "2001-08-30",
"last_verified": "1996-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-08-31",
"first_submitted": "1999-11-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a randomized controlled trial to assess ways to address post-operative ileus (POI) in adult patients on the liver transplant service undergoing either liver transplant or resection surgery. Patient who speak and understand English will be randomized into one of three groups including a.)control group receiving standard therapy for post-operative ileus, b.)group receiving standard therapy and acupressure bracelets, and c.)group receiving standard therapy and sugar free gum four times daily.
Detailed Description
Any patient undergoing liver transplant or resection surgery will be asked to participate in the study and assigned to a control or investigational group. Pertinent information will be collected from the medical record including gender, age in years, diagnosis, type of surgery, length of stay, medications used for pain or nausea, and first bowel movement. The subjects will also be asked to keep a journal of their bowel habits, signs and symptoms of gastrointestinal distress/post-operative ileus, use of medications, first bowel movement, satisfaction with bowel management and any additional comments.
Aims of the study are to determine the effectiveness of the three arms of this trial for the resolution of POI as noted by first post-operative bowel movement; to determine if there is a difference in the length of stay based on the interventions; and to determine if there is a difference in patient satisfaction based on the intervention.
#Intervention
- DRUG : stool softener
- ducosate sodium, Milk of Magnesia, dulcolax
- Other Names :
- Milk of Magnesia, Dulcolax
- DEVICE : Arm B: Acupressure bracelet
- Bioband
- Other Names :
- Bioband
- DIETARY_SUPPLEMENT : sugar free gum
- Orbit
- Other Names :
- generic
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients >= 19 years who speak and read English and have had a liver transplant or liver resection surgery
Exclusion Criteria:
* Patients less than 19 years having liver transplant or liver resection surgery
* Non-English speaking
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01156129
|
{
"brief_title": "Interventions to Decrease the Impact of Post-OPerative Ileus After Liver Transplant or Resection Surgery",
"conditions": [
"Ileus"
],
"interventions": [
"Device: Arm B: Acupressure bracelet",
"Dietary Supplement: sugar free gum",
"Drug: stool softener"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01156129",
"official_title": "Interventions to Decrease the Impact of Post-Operative Ileus After Liver Transplant or Resection Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-07-01",
"study_completion_date(actual)": "2012-12-01",
"study_start_date(actual)": "2010-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-09-07",
"last_updated_that_met_qc_criteria": "2010-07-01",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-07-02",
"first_submitted": "2010-06-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Despite carrying the vast majority of the global mental disorder burden, 75% of adults with mental disorders in Low and Middle Income Countries have no access to services. This study will test strategies for integrating first and second line evidence-based depression and trauma-related disorder treatments with primary care services at a large public sector hospital and conduct robust cost and cost-benefit analyses of each treatment to produce a 'menu' of cost-benefit options for personalized, integrated mental health care with corresponding effectiveness and implementation values.
Detailed Description
Mental disorders are a leading cause of global disability, driven by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Despite nearly 15 years of efficacy research showing that local non-specialists can provide evidence-based care for depression and anxiety in LMICs, few studies have advanced to the critical next step: identifying strategies for sustainable 'real world' non-specialist treatment including integration with existing healthcare platforms and response to common clinical dilemmas, such as what treatment to start with and how to modify it.
Given the need to personalize treatment to achieve remission (absence of disease) and the scarcity of mental health specialists in LMICs, successful reduction of population-level disability caused by depression and anxiety requires (1) evidence-based strategies for first-line and second-line (non-remitter) treatment delivered by non-specialists, with (2) confirmation of presumed mechanism of action and (3) patient-level moderators of treatment outcome to inform personalized, non-specialist treatment algorithms.
The research team has worked in western Kenya for 6 years with a UCSF-Kenya collaboration that supports integrated HIV services at over 70 primary healthcare facilities in Kisumu County (Family AIDS Care and Education Services \[FACES\]). Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) (26%) and Posttraumatic Stress Disorder (PTSD) (35%). Kenyan leaders lack an evidence base for two essential treatments - psychotherapy and second generation antidepressants- without which scale-up will fall short of its potential. We conducted a randomized, controlled trial in Kisumu County of Interpersonal Psychotherapy (IPT) delivered by non-specialists for HIV-positive patients with MDD and PTSD. In our study, IPT achieved full remission of MDD and PTSD in the majority of participants.
Given the high prevalence of MDD-PTSD co-morbidity, we will collaborate with the FACES team providing services to Kisumu County Hospital (KCH) primary care outpatient clinic (\~10,000 patients/month) to conduct a randomized trial of IPT versus fluoxetine for MDD and/or PTSD. Local non-specialists will be trained in mental health care for the SMART and hired through the Kenyan Ministry of Health to work at KCH. SMART participants will be randomized to: (1) first line treatment with IPT or fluoxetine; (2) second line treatment for non-remitters- treatment 'switch' (e.g., IPT to fluoxetine) or treatment 'combination' (e.g., addition of IPT to fluoxetine). Research with mental health specialists in high income countries suggests that antidepressants and psychotherapy have equivalent short-term efficacy and that psychotherapy yields superior long-term relapse prevention. We will test the role of previously identified mechanisms in mediating remission and key moderators of treatment effect. Results of moderator and Q learning analyses will produce first and second-line non-specialist treatment algorithms.
#Intervention
- DRUG : Fluoxetine
- Fluoxetine is a selective serotonin reuptake inhibitor that is FDA approved for the treatment of depression. Compared to placebo, fluoxetine is more likely to produce symptom response for MDD. Despite the interim development of many other antidepressants since the development of fluoxetine, it remains a first line treatment for depression.
- BEHAVIORAL : Interpersonal Psychotherapy
- IPT was developed in the 1980s by Gerald Klerman and Myrna Weissman to address interpersonal issues in depression. IPT is now considered evidence-based, first-line treatment for depression. IPT improves symptoms by addressing problems in social relationships. IPT is traditionally delivered as weekly one-hour sessions over 12 weeks, focused on one interpersonal problem area.
- Other Names :
- IPT
|
#Eligibility Criteria:
Inclusion Criteria:
* Kisumu County Hospital (KCH) adult primary care outpatient clinic attendees who screen positive for depression and/or PTSD
* Ability to attend weekly IPT sessions/fluoxetine monitoring; (3) >= 18 years
Exclusion Criteria:
* Cognitive dysfunction compromising ability to participate in IPT or accurately take fluoxetine (lack of orientation to person, place, time and situation)
* acute suicidality requiring higher level of care
* drug/alcohol use disorders requiring substance use treatment (AUDIT score of 8 or higher, DAST score of 3 or higher)
* history of mania or requiring treatment for hypomania
* Outside mental health treatment during the study treatment phases (any mental health treatment is allowed during follow-up phases and is recorded by study team).
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
|
NCT03466346
|
{
"brief_title": "SMART-DAPPER: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research Project",
"conditions": [
"Depression, Unipolar",
"Posttraumatic Stress Disorder",
"Trauma"
],
"interventions": [
"Behavioral: Interpersonal Psychotherapy",
"Drug: Fluoxetine"
],
"location_countries": [
"Kenya"
],
"nct_id": "NCT03466346",
"official_title": "A Sequential, Multiple Assignment Randomized Trial (SMART) for Non-specialist Treatment of Common Mental Disorders in Kenya: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research (DAPPER) Project",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-05-06",
"study_completion_date(actual)": "2024-05-06",
"study_start_date(actual)": "2020-08-31"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-10",
"last_updated_that_met_qc_criteria": "2018-03-08",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-03-15",
"first_submitted": "2018-03-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the feasibility and toxicity of the combination of paclitaxel, carboplatin, and topotecan in patients with previously untreated, stage III or IV epithelial ovarian carcinoma or primary peritoneal carcinoma. We will also make a preliminary evaluation of the efficacy of this three drug regimen in the initial treatment of these patients.
Detailed Description
Upon determination of eligibility, all patients will be receive:
Paclitaxel + Carboplatin + Topotecan
a maximum of six courses of chemotherapy will be given at 21 day intervals
#Intervention
- DRUG : Topotecan
- DRUG : Paclitaxel
- DRUG : Carboplatin
|
#Eligibility Criteria:
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
* Epithelial ovarian carcinoma or primary peritoneal carcinoma
* Willing to consider second-look surgery to evaluate response if necessary
* No previous treatment with chemotherapy or radiation therapy
* Ability to perform activities of daily living with minimal assistance
* Adequate bone marrow, liver and kidney function
* Written informed consent
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
* Age < 18 years
* Brain metastases
* Recent history of significant heart disease within 6 months
* Other significant medical conditions
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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
|
NCT00193297
|
{
"brief_title": "Topotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma",
"conditions": [
"Ovary Cancer"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00193297",
"official_title": "A Phase II Study of a Three-Day Schedule of Topotecan Plus Paclitaxel and Carboplatin on Day Three in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-06",
"study_completion_date(actual)": "2006-06",
"study_start_date(actual)": "2002-02"
},
"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)": "2011-05-03",
"last_updated_that_met_qc_criteria": "2005-09-12",
"last_verified": "2011-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-19",
"first_submitted": "2005-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators will develop a novel diabetes prescriber superuser educational program focused on inpatient diabetes management for physicians, based on their input. The investigators will then examine the impact of the diabetes prescriber superuser program and an analogous diabetes nurse superuser program that is already developed on glycemic control and other outcomes in hospitalized patients with diabetes.
Detailed Description
Both hyperglycemia and hypoglycemia in the hospital are associated with various adverse outcomes, including increased complications, length of stay, cost, and mortality. To address this issue, Johns Hopkins Hospital (JHH) established an Inpatient Glucose Management Program in 2006 to address hypoglycemia and hyperglycemia and to ensure safe, standardized care delivery for hospitalized patients with diabetes. To support nursing education and compliance with JHH glucose management policies, the diabetes nursing 'superuser' program was initiated in January 2007 and was critical to implementing the hypoglycemia policy nursing interventions. Following the establishment of hospital-wide glucose management policies and order sets for hypoglycemia and hyperglycemia, the nursing diabetes 'superuser' education program, and clinical decision support tools for prescribers, there was a significant and sustained reduction in the incidence of hypoglycemia (\~20%) over a 3-year time period. However, the incidence of severe hyperglycemia was not significantly reduced by these interventions, indicating a differential impact of the program on hyperglycemia compared to hypoglycemia. The investigators believe this disparity is due to the hypoglycemia policy being implemented by the nursing staff, whereas the hyperglycemia policy and order set are implemented by prescribers (e.g., housestaff and hospitalists). Given the success of the investigators nursing program's in contributing to sustained reduction in hypoglycemia, the investigators hypothesize that an analogous diabetes prescriber superuser program, targeting physicians, will be an effective educational approach to addressing persistent hyperglycemia. The investigators proposal (1) it seeks to improve diabetes treatment in the hospital, a routine and relevant healthcare setting and (2) it utilizes existing healthcare infrastructure integrated into all hospitals-nursing staff and physicians-making it practical, scalable, and sustainable in other health systems. The investigators have the following specific aims: (1) to develop the diabetes prescriber superuser educational curriculum through Johns Hopkins Health System (JHHS) stakeholder community engagement; (2) to refine and package the JHH diabetes nursing and prescriber superuser educational curricula into an electronic tool kit and disseminate it locally to the 3 JHHS hospitals, based on stakeholder feedback; and (3) to evaluate the impact of implementing the JHH diabetes nursing and prescriber superuser programs at 3 JHHS hospitals on glycemic clinical outcome measures (primary). The investigators will secondarily assess the program's impact on glycemic process and economic measures.
#Intervention
- OTHER : Education intervention
- The investigators will develop and deliver a diabetes physician and nursing inpatient diabetes superuser educational curriculum focused on delivering safe, evidence-based diabetes care in the hospital setting. The physician educational curriculum will consist of 10 case-based modules taught to internal medicine residents at two academic hospitals and taught to hospitalists at two academic hospitals and one community hospital. The nursing educational curriculum will consistent of 12 case-based modules taught to unit-based nurses at two academic hospitals and one community hospital. These educational interventions will be delivered over a 6-month time frame from August 2016-April 2017.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult (>18 years)
* non-obstetrical patients admitted to the medical services where housestaff and hospitalist superusers have been trained with Type 1 diabetes or Type 2 diabetes
* individuals with hospital-related hyperglycemia who do not carry a prior diabetes diagnosis
Exclusion Criteria:
* Adults (>18 years) with diabetic ketoacidosis
* hyperosmolar coma
* diabetes with other coma.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02847390
|
{
"brief_title": "Implementation and Evaluation of an Inpatient Diabetes Superuser Education Program",
"conditions": [
"Diabetes Mellitus"
],
"interventions": [
"Other: Education intervention"
],
"location_countries": null,
"nct_id": "NCT02847390",
"official_title": "Implementation and Evaluation of an Inpatient Diabetes Superuser Education Program",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-30",
"study_completion_date(actual)": "2019-06-30",
"study_start_date(actual)": "2015-08"
},
"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)": "2019-08-21",
"last_updated_that_met_qc_criteria": "2016-07-25",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-28",
"first_submitted": "2016-07-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main purpose of this study is to examine the safety of the study drug in patients with locally advanced unresectable pancreatic adenocarcinoma. The study team would like to know about any side effects a patient may have when given the study drug. Another goal of the study is to determine if combining dendritic cells and the study drug can be possibly used as a vaccine for this disease. Dendritic cells are cells that are present in the body's immune system that help your body fight disease.
#Intervention
- BIOLOGICAL : Poly-ICLC
- BIOLOGICAL : dendritic cell
|
#Eligibility Criteria:
Inclusion Criteria:
Each of the following criteria must be met in order for a patient to be considered eligible for enrollment.
* Patients must have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma that is locally advanced and unresectable. Patients with endocrine or neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible.
* Patients must have measurable disease per RECIST 1.1. One or more tumors measurable on CT scan per RECIST 1.1. (Eisenhauer)
* Patients may have had prior cancer therapy. Patients do not need to demonstrate progression to be considered for this trial.
* Eastern Cooperative Oncology Group (ECOG) performance status <=2.
* Age >= 18 years.
* Patient must have an expected life expectancy greater than 3 months.
* Signed, written IRB-approved informed consent.
* Bilirubin <= 3 times upper limit of normal (CTCAE Grade 2 baseline)
* AST (SGOT), ALT (SGPT) <= 3 x ULN (CTCAE Grade 1 baseline)
* Serum creatinine <=1.5 XULN (CTCAE Grade 1 baseline)
* Acceptable hematologic status, defined as:
* Absolute neutrophil count >= 1000 cells/mm3
* Platelet count >= 75,000 (plt/mm3), (CTCAE Grade 1 baseline)
* Hemoglobin >= 9 g/dL.
* Urinalysis with no clinically significant abnormalities.
* PT and PTT <= 1.5 X ULN after correction of nutritional deficiencies that may contribute to prolonged PT/PTT
Exclusion Criteria:
Each of the following criteria should not be present in order for the patient to be considered eligible for enrollment.
* Patients must not have metastatic disease. Patients with evidence of metastatic disease at the time of screening or prior to the administration of DC vaccination will be considered a screen failure and excluded from study.
* Prior surgery is allowed provided at least 14 days has elapsed between surgery and registration. Prior radiation/chemo is allowed provided that at least 28 days have elapsed since the last treatment.
* Patients must not have any serious uncontrolled acute or chronic medical condition that would interfere with this treatment. Examples would include active acute or chronic infection requiring antibiotics, uncontrolled cardiovascular, endocrine, or infectious disease.
* Patient must not have clinically significant ascites.
* Patients must not have significant ongoing cardiac problems, myocardial infarction within the last six months, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia or congestive heart failure.
* Patients with known brain metastases are not eligible. However, brain-imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms. If brainimaging studies are performed, they must be negative for disease. Patients must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol treatment.
* Due to the undetermined effect of this treatment regimen in patients with HIV-1 infection and the potential for serious interaction with anti-HIV medications, patients known to be infected with HIV are not eligible for this study.
* Due to the possibility of harm to a fetus or nursing infant from this treatment regimen, patients must not be pregnant or nursing. Women of child bearing potential must have a negative pregnancy test completed during study screening. Women and men of reproductive potential must have agreed to use an effective contraceptive method.
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.
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
|
NCT01677962
|
{
"brief_title": "A Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Pancreatic Adenocarcinoma",
"conditions": [
"Pancreatic Adenocarcinoma Non-resectable"
],
"interventions": [
"Biological: dendritic cell",
"Biological: Poly-ICLC"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01677962",
"official_title": "A Feasibility and Safety Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-09",
"study_completion_date(actual)": "2016-05",
"study_start_date(actual)": "2012-08"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-12-15",
"last_updated_that_met_qc_criteria": "2012-08-29",
"last_verified": "2016-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-09-03",
"first_submitted": "2012-08-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.
Detailed Description
This study will evaluate a three drug regimen in the form of two pills which will be taken for 28 days for the prevention of HIV infection. Two drugs are combined in an FDA-approved pill called TRUVADA, containing the HIV medications, tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, taken as one pill once a day. The third drug is a new formulation, raltegravir 400mg pill taken twice a day.
#Intervention
- DRUG : TRUVADA + Raltegravir
- TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg
- Other Names :
- tenofovir DF, emtricitabine
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a negative HIV-1 RNA assay
* Possible non-occupational exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure.
* Able to understand the study procedures and willing to sign informed consent
Exclusion Criteria:
* Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
* Pregnancy.
* Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive serum HBV DNA; or prior lamivudine therapy for hepatitis B.
* Creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula.
* Unwillingness to participate in study procedures, including Mental Health referral and intervention.
* Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir.
* Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir.
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
|
NCT00594646
|
{
"brief_title": "HIV Non Occupational Post-Exposure Prophylaxis (PEP)",
"conditions": [
"HIV Infections"
],
"interventions": [
"Drug: TRUVADA + Raltegravir"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00594646",
"official_title": "A Phase IV Open-Label Evaluation of Safety, Tolerability and Patient Acceptance of Raltegravir (MK-0518) Combined With a Fixed-Dose Formulation of Tenofovir Following Potential Exposure to HIV-1",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-03",
"study_completion_date(actual)": "2010-08",
"study_start_date(actual)": "2008-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-25",
"last_updated_that_met_qc_criteria": "2008-01-07",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-16",
"first_submitted": "2008-01-07",
"first_submitted_that_met_qc_criteria": "2015-08-10"
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to test the effect of a new shared care model for type 2 diabetes care and compare it with a standardized care management program in a specialized hospital-based out-patient clinic.
The hypothesis is that participants with type 2 diabetes followed in a shared care program will have a comparable outcome in HbA1c to participants receiving standard care.
Detailed Description
The prevalence of patients with type 2 diabetes is in growth globally. In order to secure high quality in diabetes care it is necessary to rethink the way in which the care is organized. The investigators want to test a new model of shared care across the interface of primary and secondary care sector for patients with type 2 diabetes who are at risk stratification level 2. Based on a national and regional risk stratification model patients can be stratified to three levels according to risk and complexity of treatment: level 1 (uncomplicated), level 2 (intermediate risk) and level 3 (high risk).
The objective of the study is to show equal outcomes among the participants being treated in either a shared care program or an established program in a specialized outpatient clinic.
The study is a non-inferiority randomized controlled trial. The shared care model will be tested during a period of three years. All participants are offered four medical visits a year. The shared care intervention consists of one annual comprehensive check-up at the outpatient clinic and three quarterly visits at a general practice. The control group is followed with four quarterly visits at the outpatient clinic including an annual comprehensive check-up. The recruitment period spans over approximately 12 months, and participants are randomized to intervention or control group in a 1:1 ratio.
#Intervention
- OTHER : Shared care
|
#Eligibility Criteria:
Inclusion Criteria:
* Must be over the age of 18 years
* The diagnosis of type 2 diabetes
* Risk stratification level 2
* Capable of speaking and writing in Danish
* Give oral and written consent before entering the study
Exclusion Criteria:
* Diagnosed with other types of diabetes than type 2 diabetes
* Risk stratification level 1 or 3
* Being pregnant or breastfeeding
* Having severe co-morbidity with life expectancy less than five years
* Being under such conditions, that the patient will not be able to show up or go through with the appointments (e.g. moderate to severe dementia and severe psychiatric conditions)
* Participating in long-lasting interventions (>2 weeks) that potentially affects the primary outcome in our study or patients participating in studies which include blood sampling amounting to >5 % of the blood volume two months prior to the randomisation and/or 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
|
NCT02586545
|
{
"brief_title": "Shared Care for Patients With Type 2 Diabetes Across the Primary and Secondary Health Care Sector",
"conditions": [
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Other: Shared care"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT02586545",
"official_title": "Shared Care for Patients With Type 2 Diabetes Across the Primary and Secondary Health Care Sector",
"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)": "2015-08"
},
"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)": "2019-01-03",
"last_updated_that_met_qc_criteria": "2015-10-22",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-26",
"first_submitted": "2015-10-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary Objective:
* To assess efficacy of Nasacort® (triamcinolone) nasal spray, 55 µg per dose, in comparison with Flixonase® (fluticasone) nasal spray, 50 µg per dose, by reflective total nasal symptom score (rTNSS) (24 h) after 28 days of treatment compared with baseline (0 day of treatment) in adult patients suffering from PAR (perennial allergic rhinitis).
Secondary Objectives:
* To evaluate safety of Nasacort® (triamcinolone) nasal spray, in comparison with Flixonase® (fluticasone) administered for 28 days by assessment of adverse events reports.
* To evaluate patient and physician satisfaction after 28 days of treatment by 5-point scale.
* To estimate improvement of quality of life during the study by mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ).
Detailed Description
The total study duration per patient will be up to approximately 33 days.
#Intervention
- DRUG : triamcinolone XRG5029
- Pharmaceutical form: spray solution
Route of administration: nasal
- Other Names :
- Nasacort®
- DRUG : fluticasone
- Pharmaceutical form: spray solution
Route of administration: nasal
- Other Names :
- Flixonase®
|
#Eligibility Criteria:
Inclusion criteria:
* Females and males >=18 and <=50 years.
* Patients with previously diagnosed PAR with a positive skin prick test response to an appropriate allergen performed not earlier than 12 months prior to the Screening visit.
* Patients must be clinically symptomatic (rTNSS reflecting symptoms for the previous 24 h >=8 with two or more symptoms rated as moderate or severe).
* Negative urine pregnancy test during screening before first dose of study medication is administered in women with child-bearing potential.
* Women must use an effective contraceptive method during the study period.
* Patients should be able to understand the study, including risks and adverse events; collaborating with Investigator and proceed according with protocol.
* Signed informed consent form.
Exclusion criteria:
* Compromised ability to provide informed consent.
* Participation in any other clinical study.
* History of severe local reaction(s) or anaphylaxis to skin testing.
* Upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or viral upper respiratory infection within 2 weeks prior to the Screening Visit.
* Subjects who have used any drug (Flixonase or Nasacort) in an investigational protocol 4 weeks prior to the Screening Visit.
* Female subjects who are breast-feeding, pregnant, or intend to become pregnant.
* Patients with nasal abnormalities, including nasal polyps, and marked septum deviation that interferes with nasal airflow.
* Recent (in the last 3 months) or unhealed nasal septum ulcers, nasal surgery, or nasal trauma.
* Specific immunotherapy finished later than 6 months prior to Visit 1.
* Use of following medications:
* Intranasal corticosteroids within 4 weeks prior to Visit 1;
* Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid within 8 weeks prior to Visit 1;
* Cromones within 2 weeks prior to Visit 1;
* Short-acting antihistamines, including antihistamines contained in insomnia formulations within 3 days prior to Visit 1;
* Long-acting antihistamines within 10 days prior to Visit 1: loratadine, desloratadine, fexofenadine, cetirizine;
* Intranasal antihistamines within 2 weeks prior to Visit 1;
* Intranasal, oral, or inhaled anticholinergics within 3 days prior to Visit 1;
* Oral antileukotrienes within 3 days prior to Visit 1;
* Use of immunosuppressive medications 8 weeks prior to screening.
* Patients allergic to or have sensitivity to the study drug (triamcinolone acetonide, fluticasone propionate) or its excipients.
* Patients suffering from SAR (seasonal allergic rhinitis).
* Patients suffering from non-allergic rhinitis.
* Patients suffering from rhinitis medicamentosa.
* Patients suffering from non-allergic rhinitis caused by viral, bacterial etc infection.
* Patients suffering from bronchial asthma.
* Patients suffering from chronic sinusitis.
* In case of non-allergic rhinitis, nasal trauma or other condition that during the study can interfere with symptoms evaluation, subject would be excluded from the study.
* Patients with physical impairment that would affect subject's ability to participate safely and fully in the study.
* Clinical evidence of a Candida infection of the nose.
* History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would affect the proper daily diary filling.
* Previous history and/or current diagnosis of glaucoma and cataract.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03317015
|
{
"brief_title": "A Study to Assess Efficacy and Safety of Nasacort® Nasal Spray in Comparison With Flixonase® Nasal Spray in Adults Suffering From Perennial Allergic Rhinitis (PAR)",
"conditions": [
"Rhinitis Allergic"
],
"interventions": [
"Drug: fluticasone",
"Drug: triamcinolone XRG5029"
],
"location_countries": null,
"nct_id": "NCT03317015",
"official_title": "A Randomized, Double-blind, Parallel-group, Multicenter, Phase III Prospective Non-inferiority Clinical Trial to Assess Efficacy and Safety of Nasacort® Nasal Spray (Triamcinolone, 55µg) in Comparison With Flixonase® Nasal Spray (Fluticasone, 50 µg) in Adults Suffering From PAR (Perennial Allergic Rhinitis) Administered Once a Day for 28 Days",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07-10",
"study_completion_date(actual)": "2017-07-10",
"study_start_date(actual)": "2016-11-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-04-25",
"last_updated_that_met_qc_criteria": "2017-10-18",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-23",
"first_submitted": "2017-10-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Background:
Patients who undergo laparoscopic surgical resection of colorectal cancer may experience various post-operative symptoms (e.g., pain, nausea and vomiting, and anxiety) and limitation of daily activities (e.g., walking capacity). There is also a risk of post-operative complications and a prolonged hospital stay due to complications. Patients who underwent surgical resection may have experienced chronic pain, anxiety/depression, or diminished quality of life. The physical, psychological, and functional aspects of patients' disorders imply the necessity of multidisciplinary care, including complementary or traditional medicines such as acupuncture. This study aims to assess whether acupuncture treatment, combined with an enhanced recovery program after surgery in an inpatient care setting is effective than only an enhanced recovery program after surgery.
Objective:
To assess the effectiveness and safety of acupuncture combined with an enhanced recovery program after surgery to reduce postoperative symptoms and improve functional recovery and the patients' quality of life.
#Intervention
- DEVICE : acupuncture
- Points of Stomach 36 (ST36), Stomach 37 (ST37), Liver 3 (LR3), Large Intestine 11 (LI11), Large Intestine 4 (LI4), Spleen 6 (SP6), Spleen 4 (SP4) and Pericardium 6 (PC6) will be used. Electrical stimulation with alternating frequency of 2 to 100 Hz will be applied to the selected points (LI4 to LI11, ST36 to ST37, and bilateral SP6).
Rationale of acupuncture treatments will include both traditional theory of harmonizing gastrointestinal function and strengthening vital energy as well as modern experimental and clinical evidence of regulating gastrointestinal motility and other symptom managements. Treatments will be provided by qualified hospital staff (Korean medical doctors) with more than 10 years of clinical experience.
- OTHER : early recovery program after surgery
- An enhanced recovery program after surgery that was designed and is currently implemented by surgeons, anesthetists, dietitians, and nurses will be provided. The program includes preoperative education, early water/food intake, early mobilization, early removal of Foley catheter and drains, structured nursing care, and nutritional support.
- Other Names :
- fast-track recovery program
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing elective laparoscopic surgery of colorectal cancer resection (right hemicolectomy, left hemicolectomy, anterior resection with primary anastomosis, and low anterior resection with loop ileostomy for fecal diversion)
* Patients aged 18 to 75
* American Society of Anesthesiologists Grade 1 to 2
* Eastern Cooperative Oncology Group Grade 0 to 2
* Written informed consents
Exclusion Criteria:
* Pregnancy
* Inflammatory bowel disease
* Comorbidities that may affect outcomes of surgery (e.g., chronic kidney disease, chronic liver disease, cardiopulmonary failure, and diabetes with complications)
* Resection of other organs for radical removal of colorectal cancer
* Patients requiring enterolysis due to previous history of abdominal surgery
* Obstructive colorectal cancer
* Metastatic colorectal cancer
* Cognitive impairment that may affect the patient's ability to complete the outcome assessments
* Previous history of stroke
* Previous history of sensitive reaction to acupuncture
* Patients unable to cooperate with acupuncture treatments
* Pacemaker implantation
* Previous history of epilepsy
* Patients who have received Korean medicine treatments (acupuncture, moxibustion, cupping, or herbal medicine) within 2 weeks
* Patients who have participated in other trials within 3 months
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
|
NCT02388256
|
{
"brief_title": "Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection",
"conditions": [
"Colorectal Cancer"
],
"interventions": [
"Device: acupuncture",
"Other: early recovery program after surgery"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT02388256",
"official_title": "Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02",
"study_completion_date(actual)": "2016-04",
"study_start_date(actual)": "2015-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-06-28",
"last_updated_that_met_qc_criteria": "2015-03-09",
"last_verified": "2016-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-13",
"first_submitted": "2015-03-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices. It will also validate the device survival information given in Boston Scientific's Product Performance Report by comparing the pulse generator (PG) survival probability in the study to that presented in the Product Performance Reports (PPR)
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject has been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device according to current guidelines and/or center's current practice
* Subject is willing and capable (or appropriate legal representative is willing and capable) of authorizing access to and use of health information as required by an Institution's Institutional Review Board (IRB), Research Ethics Board (REB) or Ethics Committee (EC)
* Is willing and capable (or appropriate legal representative is willing and capable) of providing authorization/consent for participation in the study.
Exclusion Criteria:
* Subject is unable or unwilling to comply with the study protocol requirements
* Subject is under the legal age for signing study consent in accordance with state or national law
* Subject has a life expectancy of less than twelve months
* Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician's discretion)
* Subject on active heart transplant list
* Subject with any prior pulse generator infection or lead infection which is either systemic or localized
* Subject received a commercially available Boston Scientific ICD or CRT-D device with a battery capacity of 1.5 amp/hour or less
* Subject implanted with Boston Scientific's subcutaneous implantable defibrillator system (s-ICD) or has a lead that is under recall/advisory at the time of enrollment
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02091011
|
{
"brief_title": "LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices",
"conditions": [
"Implantable Cardioverter Defibrillators",
"CRT-D Cardiac Resynchronization Therapy Defibrillator"
],
"interventions": null,
"location_countries": [
"Japan",
"United States",
"Germany",
"United Kingdom",
"Canada",
"Spain",
"Switzerland",
"Korea, Republic of"
],
"nct_id": "NCT02091011",
"official_title": "LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-08",
"study_completion_date(actual)": "2021-08",
"study_start_date(actual)": "2014-01-27"
},
"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)": "2022-08-02",
"last_updated_that_met_qc_criteria": "2014-03-18",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-03-19",
"first_submitted": "2014-03-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
IMPAACT 2032 was a Phase IV prospective, open label, non-randomized opportunistic study. The objectives of this study were to describe the pharmacokinetic (PK) properties and safety of remdesivir (RDV) administered intravenously as part of clinical care among hospitalized pregnant and non-pregnant women of childbearing potential with coronavirus disease of 2019 (COVID-19). RDV was provided and managed by the participant's treating physician and was not provided as part of this study.
Detailed Description
IMPAACT 2032 was a Phase IV prospective, open label, non-randomized opportunistic study to evaluate the PK and safety of RDV when administered to pregnant and non-pregnant women of childbearing potential for treatment of COVID-19. Participants were pregnant and non-pregnant women hospitalized for COVID-19 who received daily RDV infusions, typically for 5 days but in some cases for up to 10 days, as part of their clinical care. RDV was provided and managed by the participants' treating physician and was not provided as a part of this study.
This study was comprised of two population-based arms: Arm 1 included pregnant women of any gestational age (GA) and Arm 2 included non-pregnant women of childbearing potential, who were between 18 and 45 years of age. The target sample size was 20 PK-evaluable participants per arm. Study sites were located in the United States.
Study procedures for this study were limited to data collection and blood specimens for PK. Except for PK sampling, study procedures were largely done via medical chart abstraction or remote contact/telemedicine visit. Collection of clinical and laboratory data started at 48 hours before the first infusion and continued through 4 weeks after the last infusion. In addition, data were collected at the time of delivery for participants in Arm 1, and limited data were also collected from the birth and newborn exam records of their infants. All participants were followed for safety through 4 weeks after the last infusion; Arm 1 participants who were still pregnant at that time had an additional follow-up at the time of delivery. If there was a gap in time between 4 weeks after the last infusion and delivery, no data were collected during that interval.
No formal statistical comparisons were made between Arm 1 and Arm 2 for primary and secondary objectives. Therefore, all analyses for primary and secondary outcome measures represent single arm evaluations.
#Intervention
- DRUG : Remdesivir
- RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
|
#Eligibility Criteria:
Inclusion Criteria: Arm 1 (Pregnant Women)
* Of legal age or otherwise able to provide independent informed consent or is unable to provide informed consent (e.g., impaired capacity) and a Legally Authorized Representative (LAR) is willing and able to provide written informed consent on behalf of the participant
* At study entry, viable intra-uterine pregnancy of any gestational age, based on medical records.
* At study entry, hospitalized AND has confirmed or suspected COVID-19, based on medical records.
* At study entry, receiving or expected to receive RDV for COVID-19 clinical care, as prescribed by the clinical care provider and documented in medical records.
Inclusion Criteria - Arm 2 (Non-Pregnant Women)
* Of legal age or otherwise able to provide independent informed consent or is unable to provide informed consent (e.g., impaired capacity) and a Legally Authorized Representative (LAR) is willing and able to provide written informed consent on behalf of the participant
* At study entry, between 18 and 45 years, based on medical records and participant report.
* Assigned female at birth and at study entry not taking cross-sex hormone therapy.
* At study entry, not suspected to be pregnant, based on participant report and/or investigator or designee determination.
* At study entry, hospitalized AND has confirmed or suspected COVID-19, based on medical records.
* At study entry, receiving or expected to receive RDV for COVID-19 clinical care, as prescribed by the clinical care provider and documented in medical records.
Exclusion Criteria:
* At study entry, has started or received the 4th RDV infusion.
* At study entry, evidence of post-menopausal status (medical or surgical), based on medical records and/or participant report.
* At study entry, any contraindications to RDV treatment for COVID-19, based on investigator or designee determination.
* Received or administered any disallowed medications within 48 hours prior to study entry.
* At study entry, has any other condition, that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04582266
|
{
"brief_title": "PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US",
"conditions": [
"COVID-19"
],
"interventions": [
"Drug: Remdesivir"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04582266",
"official_title": "Pharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the United States",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-13",
"study_completion_date(actual)": "2022-04-13",
"study_start_date(actual)": "2021-03-31"
},
"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)": "2023-06-09",
"last_updated_that_met_qc_criteria": "2020-10-08",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-10-09",
"first_submitted": "2020-10-08",
"first_submitted_that_met_qc_criteria": "2023-05-16"
}
}
}
|
#Study Description
Brief Summary
Hypoglycaemia unawareness is a common complication in patients with type 1 diabetes and with insulin-treated type 2 diabetes of long duration. The loss of autonomic symptoms to hypoglycemia does not solely depend on loss of adrenaline responses.Differences in sensitivity to catecholamines may also be involved.
Reconciling the data on β2-adrenergic receptor polymorphism to those on loss of β-adrenergic sensitivity in diabetic patients with hypoglycemia unawareness, we hypothesize that hypoglycemia unawareness is at least partly the result of desensitization of the β2-adrenergic receptor and that patients who are homozygous for arginine at codon 16 are particularly susceptible for this desensitization process, whereas patients who are homozygous for glycine at codon 16 are resistant for desensitization.
Objectives
1. To determine whether, and if so to what extent, antecedent hypoglycemia reduces β2-adrenergic sensitivity in healthy subjects with Arg16 homozygosity.
2. To investigate whether or not healthy subjects with Gly16 homozygosity are resistant to desensitization
3. To confirm that antecedent hypoglycemia reduces the heart rate response to isoproterenol and to assess to what extent this reduced response is mediated by impairments in baroreflex sensitivity.
#Intervention
- PROCEDURE : Hypoglycemia
|
#Eligibility Criteria:
Inclusion Criteria:
* Informed consent
* Homozygous for Arginine at codon 16 or homozygous Gly at codon 16
* No regular usage of medication other than oral contraceptives
Exclusion Criteria:
* History of cerebrovascular, cardiovascular, or peripheral vascular disease
* Smoking
* Alcohol usage of more than 10 units per week
* Inability to abstain from xanthine-derivatives (coffee, tea, cola, chocolate, cacao) or alcohol for 2 days
* BMI above 30 kg/m2
* Participation to any other trial in the preceding 3 months
* Ongoing disease of any kind
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00160056
|
{
"brief_title": "The Effect of Antecedent Hypoglycaemia on β2-adrenergic Sensitivity",
"conditions": [
"Diabetes",
"Hypoglycemia Unawareness"
],
"interventions": [
"Procedure: Hypoglycemia"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT00160056",
"official_title": "The Effect of Antecedent Hypoglycaemia on β2-adrenergic Sensitivity in Subjects With Homozygous Arg16 and gly16 Polymorphism of the β2-adrenergic Receptor",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-04",
"study_completion_date(actual)": "2009-04",
"study_start_date(actual)": "2005-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-05-12",
"last_updated_that_met_qc_criteria": "2005-09-09",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-12",
"first_submitted": "2005-09-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess the acceptability and feasibility of screening common mental health difficulties in fathers and partners of women accessing perinatal mental health services.
Detailed Description
Where women have mental health disorders, this can put significant strain on their partners. As well as supporting the mother and dealing with worries and uncertainty about her wellbeing, partners may take on additional childcare and household duties alongside maintaining work commitments. As a result, mental health professionals are considering ways to involve and support partners and other family members where women are accessing specialist services.
This feasibility study will involve the screening of fathers/partners of women accessing perinatal mental health services, for mental health disorders including depression, anxiety disorders and post-traumatic stress disorder (PTSD). Previous empirical evidence has largely focussed on fathers but we will include partners i.e., whoever the mother identifies as her partner, therefore including individuals in same sex relationships or when the main partner is a stepparent. The screening questionnaires will help us to understand the mental health needs of fathers/partners of women who are being cared for by perinatal mental health services. This will also help us see if partners find it acceptable to complete questionnaires on their mental health and family functioning online.
Three groups of participants will be approached across a 6-month period. The first; fathers/partners of women being treated in a Mother and Baby Unit. The second; fathers/partners of women being treated in community services (i.e. community Perinatal Mental Health Services). The third; fathers/partners of women who have not experienced mental health difficulties in the perinatal period.
Fathers/partners in the clinical groups will initially be approached by clinicians in the relevant service (Mother and Baby Unit or Community Perinatal Mental Health Teams). They will be asked for verbal consent to be contacted by the research team. The research team will then contact the participant and provide further information about the study and obtain informed consent. Participants in the control group will be recruited online via social media and through local charities and community groups.
Fathers/partners will be invited to complete screening questionnaires on their mental wellbeing -(the Edinburgh Post-natal Depression Scale (EPDS), the Gotland Male Depression Scale, the Generalised Anxiety Disorder-7 scale (GAD-7), the City Birth Trauma Scale), a demographic questionnaire and the Couple's Satisfaction Index. Participants will be able to complete these questionnaires online or via hard copies.
The study will help to inform our understanding of whether fathers/partners find it acceptable to complete mental health screening questionnaires. It will also help to identify if fathers/partners are more at risk of developing mental health difficulties if the mother is also experiencing a mental health difficulty.
|
#Eligibility Criteria:
Inclusion Criteria:
Fathers and partners of women:
* Admitted to the SLaM Mother and Baby Unit or
* Seen by SLaM Community Perinatal Mental Health services or
* Not accessing a mental health service currently or during the perinatal period (pregnancy to 12-months postpartum).
* Biological father, step-father, same sex partner or any other adult that identifies as the woman's 'primary' partner.
* Women who are pregnant or up to 12-months post-partum
* Adult fathers/partner aged 18 years and above
* Father/partner has proficient level of English to complete screening questionnaires.
* Father/partner has the ability to complete questionnaires electronically on a phone/table/computer or to complete paper questionnaires
* Father/partner is able to give informed consent and comply with study procedures
Exclusion Criteria:
Fathers and partners
* Unable to provide consent to complete questionnaires Women
* In the 'healthy' group - if the mother is accessing mental health services or has done during the perinatal period (pregnancy to 12-months postpartum) Infant offspring
* Aged over 12 months
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04971460
|
{
"brief_title": "The Mental Well-being of Fathers and Partners",
"conditions": [
"Mental Health Disorder",
"Fathers"
],
"interventions": null,
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04971460",
"official_title": "The Mental Well-being of Fathers and Partners of Women Accessing Perinatal Mental Health Services",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-31",
"study_completion_date(actual)": "2022-05-31",
"study_start_date(actual)": "2021-07-24"
},
"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)": "2022-09-23",
"last_updated_that_met_qc_criteria": "2021-07-16",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-07-21",
"first_submitted": "2021-05-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. To find correlations with other perioperative factors and clinical/pathological disease characteristics.
#Intervention
- DRUG : Morphine
- Morphine intravenous
- DRUG : Piritramid
- Piritramid intravenous
|
#Eligibility Criteria:
Inclusion Criteria:
* patients undergoing open radical surgery for colorectal cancer
* age > 18 years
* signed informed consent
Exclusion Criteria:
* intolerance of the study drugs
* history of CRC surgery
* neoadjuvant therapy
* other malignancy not in permanent remission
* chronic opioid medication or opioid administration within 7 days preoperatively
* immunosuppressive or corticosteroid therapy
* surgery within 30 days preoperatively (except minor)
* chronic or acute 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
|
NCT03700541
|
{
"brief_title": "Influence of Opioid Analgesia on Circulating Tumor Cells in Laparoscopic Colorectal Cancer Surgery",
"conditions": [
"Colorectal Cancer",
"Circulating Tumor Cell"
],
"interventions": [
"Drug: Piritramid",
"Drug: Morphine"
],
"location_countries": [
"Czechia"
],
"nct_id": "NCT03700541",
"official_title": "Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Laparoscopic Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-01",
"study_completion_date(actual)": "2023-12-06",
"study_start_date(actual)": "2019-01-07"
},
"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)": "2023-12-07",
"last_updated_that_met_qc_criteria": "2018-10-07",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-10-09",
"first_submitted": "2018-10-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
For patients with cerebral oligometastases who are in adequate clinical condition stereotactic radiosurgery (SRS) is the treatment of choice, being recommended by international guidelines for the treatment of one to four lesions. Newer findings have shown that for patients with more than four lesions SRS can be considered as a favorable alternative to whole-brain radiotherapy (WBRT), the currently established standard-of-care treatment. With modern techniques highly conformal SRS of multiple lesions has become feasible with comparable clinical effort and minimal toxicity as compared to WBRT. Developments in magnetic resonance imaging (MRI- imaging) have produced highly sensitive contrast-enhanced three-dimensional fast spin echo sequences such as SPACE that facilitate the detection of very small and early-stage lesions in a fashion superior to the established Magnetization Prepared Rapid Gradient Echo (MPRAGE) series.
Since it has been established that the response of brain metastases to SRS is better for smaller lesions and that WBRT can come at the price of significant neurotoxicity, the investigators hypothesize that 1) earlier detection of small brain metastases and 2) early and aggressive treatment of those by SRS will result in an overall clinical benefit by delaying the failure of repeated localized therapy and thus preserving quality of life and potentially prolonging overall survival. On the other hand however, overtreatment might be a valid concern with this approach since it has yet to be proved that a clinical benefit can be achieved.
The current study aims to stretch the boundaries of the term 'cerebral oligometastases' by performing SRS for up to ten cerebral metastases, compared to the established clinical standard of four, given that existing data supports the non-inferiority of this approach and given that modern Cyberknife SRS facilitates the treatment of multiple lesions with minimal treatment-associated toxicity.
Detailed Description
Scientific Background: Brain metastases are the most common intracranial cancer manifestations, affecting up to one third of adult cancer patients with systemic spread. Prognosis is generally poor with overall survival ranging below 6 months on average. However, a more detailed inspection reveals a prognostic subgroup, for which improved overall survival and clinical symptom control can be achieved and that is most descriptively characterized by favorable clinical performance (KPI ≥ 70%) and extracranially controlled disease. Whereas for most patients with brain metastases whole-brain radiotherapy, steroids or best supportive care represent the palliation treatment of choice, the abovementioned subgroup is eligible to profit from a locally radical therapy concept and in those cases neurosurgical resection and stereotactic radiosurgery have both produced favorable results. In patients unsuitable for neurosurgical resection, single- or multifraction, SRS has several distinct advantages over WBRT, the most significant being short treatment time, less posttherapeutic neurocognitive impairment, better local tumor control and little to no hair loss. Furthermore, SRS can be repeated multiple times or performed before or after WBRT. Current clinical guidelines recommend SRS in cases of cerebral oligometastases, defined as one to four intracranial lesions with an extracranially controlled systemic disease status. However, recent data suggests that it may be a suitable treatment for patients with five to ten or even more than ten lesions, being non-inferior to the SRS of four or less lesions. There are several factors supporting this rationale: On the one hand technical improvements in the field of SRS have significantly facilitated the treatment of a higher number of target lesions with little to no increase in toxicity and comparable clinical effort. On the other hand, the ever improving sensitivity of medical imaging has caused an increase in the detection of oligometastatic constellations, enabling their treatment in an earlier stage. For a long time the contrast-based high-resolution cranial computer tomography (cCT) had been the gold standard of detecting cerebral metastases. This was significantly improved by the introduction of magnetic resonance imaging (MRI) with contrast-enhanced T1-weighted sequences. Sensitivity was further improved with the introduction of 3T MRI into clinical routine and the development of high-resolution three-dimensional gradient-echo sequences such as the contrast-based T1-weighted MPRAGE, featuring a slice thickness of 0.9 mm and multiplanar reconstruction, thus enabling the detection of very small sized lesions in the range of one to a few millimeters. However, the use of gradient-echo (GE) techniques to obtain three-dimensional high-spatial-resolution images comes at the cost of inferior contrast enhancement and higher susceptibility to artifacts than is the case with two-dimensional spin-echo (SE) techniques. Recent developments in MRI research have produced another sequence that might prove even superior to MPRAGE in the specific detection of very small and early brain metastases: Sampling perfection with application-optimized contrasts by using different flip angle evolutions (SPACE) is a three-dimensional fast SE sequence that combines high contrast enhancement superior to MPRAGE with a high spatial resolution and multiplanar reconstruction. Kato et al. have found this sequence to be significantly superior to MPRAGE in the detection of contrast enhanced parenchymal lesions, especially if those are \< 5mm in size as is characteristic of small very-early-stage cerebral metastases.
Trial Objectives: It is the purpose of this study to evaluate treatment response and toxicity after SRS of up to ten simultaneous cerebral metastases, treating either all lesions visible in the highly sensitive SPACE MRI sequence or only those visible in the conventional contrast-based MPRAGE sequence. Treatment response is evaluated with respect to the ineligibility for further cerebral SRS at 12 months after initial SRS, defined by simultaneous new occurrence or progression of \> 10 brain metastases (as a surrogate parameter for overall local control), furthermore overall survival and cognitive function and quality of life.
Patients´Selection: A total of n=200 patients will be enrolled into the trial (n=100 per treatment group). All patients fulfilling the inclusion and exclusion criteria will be informed about the study and included into the study if they declare informed consent. Registration for the study must be performed before the start of RT.
Trial Design: The trial will be performed as a single-center two-armed prospective randomized Phase II study. Patients will be randomized into an experimental arm and a control arm. All patients will receive pre-therapeutic MRI imaging as described in (Chapter 6) and imaging will be assessed by a radiologist. For patients in the experimental arm, all available MRI series, including SPACE will be taken into consideration for the definition of treatment target lesions. For patients in the control arm the assessing radiologist will be blinded with respect to the SPACE sequence and for the definition of treatment target lesions primarily contrast-based three-dimensional MPRAGE, complemented by all non-SPACE MRI sequences will be taken into consideration.
#Intervention
- RADIATION : stereotactic radiosurgery (SRS)
- All patients will receive a pre-treatment cranial MRI for diagnostic and treatment planning purposes.
In Arm A, the contrast-based T1-weighted SPACE sequence is utilized for GTV definition. In Arm B, the contrast-based T1-weighted three-dimensional MPRAGE sequence is utilized for GTV definition. In both cases the GTV consists of all contrasted tissue associated with the target lesion and all additional tissue judged by an experienced physician to be part of the suspect target lesion. To the GTV a PTV margin of 1 mm is added by isotropic expansion that can be slightly modified if deemed necessary by the treating physician (e.g. intersection with adjoining OAR).
Dose prescription to the PTV for target lesions will be as follows:
* 20 Gy to the 70%-isodose (lesions \< 2 cm max. diameter)
* 18 Gy to the 70%-isodose (lesions 2 - 3 cm max. diameter)
* 6 x 5 Gy to the conformally surrounding isodose (lesions \> 3 cm max. diameter)
|
#Eligibility Criteria:
Inclusion Criteria:
* radiologically confirmed metastases of the brain with an underlying history of a malignant illness
* between one and ten suspect intracranial lesions, taking into consideration all available series of the pre-therapeutic MRI (performed at Heidelberg University Hospital and including SPACE sequence)
* age >= 18 years
* Karnofsky Performance Score (KPS) >= 70
* for women with childbearing potential, (and men) adequate contraception.
* ability to understand character and individual consequences of the clinical trial
* written informed consent (must be available before enrolment in the trial)
Exclusion Criteria:
* refusal of the patient to take part in the study
* Small-cell lung cancer (SCLC) as primary malignant illness
* More than 10 suspect intracranial lesions in the initial pre-therapeutic MRI imaging (performed at Heidelberg University Hospital and including SPACE sequence)
* metastasis so close to OAR that initial single-session SRS would be impossible due to lacking radiotolerance
* known contraindications against the performing of cranial MRI
* previous radiotherapy of the brain
* Patients who have not yet recovered from acute toxicities of prior therapies
* Pregnant or lactating women
* Participation in another clinical study or observation period of competing trials, respectively
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
|
NCT03303365
|
{
"brief_title": "Cyberknife Radiosurgery for Patients With Brain Metastases Diagnosed With Either SPACE or MPRAGE Sequence",
"conditions": [
"Brain Metastases",
"Adult Solid Tumor"
],
"interventions": [
"Radiation: stereotactic radiosurgery (SRS)"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT03303365",
"official_title": "Cyberknife Radiosurgery for Patients With Brain Metastases Diagnosed With Either SPACE or MPRAGE Sequence - A Prospective Randomized Evaluation of Response and Toxicity",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-01",
"study_completion_date(actual)": "2021-06-01",
"study_start_date(actual)": "2018-02-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-11-03",
"last_updated_that_met_qc_criteria": "2017-10-02",
"last_verified": "2022-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-06",
"first_submitted": "2017-10-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This research study is studying Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells) for treating people with relapsed or refractory CD37+ hematologic malignancies and to understand the side effects when treated with CAR-37 T Cells.
- Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells) is an investigational treatment
Detailed Description
This is a two-part, non randomized, open label, single site Phase 1 study. Participants who fulfill eligibility criteria will be entered into the trial Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells).
This study consists of 2 parts:
* Part A (Dose Escalation): The investigators are looking the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects in participants that have relapsed or refractory CD37+ hematologic malignancies, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated
* Part B (Expansion Cohort): Part B: Expansion Cohort: Participants will be treated at the respective dose (at or below the Maximum Tolerated Dose), as determined during Part A (Dose Escalation).
* A total of 18 participants will be enrolled to this trial
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies.
Investigational' means that the intervention is being studied The U.S. Food and Drug Administration (FDA) has not approved CAR-37 T Cells as a treatment for any disease.
This is the first time that CAR-37 T Cells will be given to humans
#Intervention
- BIOLOGICAL : CAR-37 T cells
- CAR-37 is an investigational treatment that uses the participant own immune cells, called T cells, to try to kill the cancerous cells
|
#Eligibility Criteria:
Inclusion Criteria:
Voluntarily sign informed consent form.
Age >=18 years of at the time of signing informed consent
Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2 Karnofsky >=60%, see Appendix A)
* Diagnosis of relapsed/refractory (R/R) CD37+ hematologic malignancy as defined as one of the following:
* Mature B cell neoplasms
* Follicular Lymphoma (FL) grade 1, grade 2, or grade 3a
* RR disease after 2 or more prior lines of therapy AND
* 1 of the prior lines of therapy must include an anti-CD20 antibody monotherapy.
* Marginal Zone Lymphoma (MZL) nodal or extranodal:
* R/R disease after 2 or more prior lines of therapy AND
* 1 of the prior lines of therapy must include an anti-CD20 antibody monotherapy
* Diffuse large B-cell lymphoma (DLBCL), including transformed follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and grade 3b Follicular Lymphoma (FL).
* R/R disease after 2 or more prior lines of therapy OR
* Relapsed following autologous SCT,OR
* Ineligible for autologous SCT.
* Mantle cell lymphoma
* R/R disease as defined by disease progression after last regimen (including autologous SCT), OR Refractory disease as defined as failure to achieve a CR to last regimen.
* Prior therapy must include:
* Anthracycline or bendamustine-containing chemotherapy AND
* Anti-CD20 monoclonal antibody therapy AND
* BTKi therapy
* Chronic lymphocytic leukemia (CLL)
* CLL with an indication for treatment based on iwCLL guidelines and clinical measurable disease (lymphocytosis > 5×109/L and/or measurable lymph nodes and/or hepatic or splenomegaly)
* Subjects must have received previous treatment as follows:
* Subjects with high-risk features, defined as having complex cytogenetic abnormalities (3 or more chromosomal abnormalities), 17p deletion, TP53 mutation, or unmutated IGHV, must have failed at least 1 line of prior therapy, including a BTKi OR
* Subjects with standard-risk features must have failed at least 2 lines of prior therapy, including a BTKi OR
* Subjects who are BTKi intolerant and have received < 6 months of BTKi therapy, must have failed at least 1 high-risk line of non-BTKi therapy or 2 standard-risk lines of non-BTKi therapy OR
* Subjects who are ineligible for BTKi, must have failed at least 1 (high-risk) line of non-BTKi therapy or 2 (standard-risk) lines of non-BTKi therapy.
* Small lymphocytic lymphoma (SLL)
* SLL (lymphadenopathy) or SLL (splenomegaly and < 5x 109 CD19+ CD5+ clonal B lymphocytes/L [<5000/μL] in the peripheral blood at diagnosis with measurable disease defined as at least one lesion > 1/5 cm in the greatest transverse diameter that is biopsy-proven SLL)
* Subjects must have received previous treatments as follows:
* Subjects with high-risk features, defined as having complex cytogenetic abnormalities (3 or more chromosomal abnormalities), or 17p deletion, or TP53 mutation, or unmutated IGHV, must have failed at least 1 line of prior therapy, including a BTKi OR
* Subjects with standard-risk features must have failed at least 2 lines of prior therapy, including a BTKi OR
* Subjects who are BTKi intolerant and have received < 6 months of BTKi therapy must have failed at least 1 high-risk or 2 standard-risk other lines of non-BTKi therapy OR
* Subjects who are ineligible for BTKi, must have failed at least 1 high-risk or 2 standard-risk other lines of non-BTKi therapy.
* Mature T cell neoplasms:
* Peripheral T-Cell lymphoma (PTCL)/Cutaneous T-Cell Lymphoma (CTCL)
* R/R after 2 or more prior lines of therapy OR
* Relapse following autologous stem cell transplant OR
* T-cell prolymphocytic leukemia (TPLL) --- Diagnosis of TPLL with plan for subsequent therapy.
* Evidence of CD37 expression on tumor cells as demonstrated by flow cytometry and/or IHC on fresh biopsy or historic samples.
* Subjects must have measurable disease according to appropriate disease specific criteria.
* Adequate absolute lymphocyte count (ALC > 100 cells/ul) within one week of apheresis.
* Adequate bone marrow function defined by absolute neutrophil count (ANC) >1000 cells/mm3 without growth factor support (filgrastim within 7 days of pegfilgrastim within 14 days) and untransfused platelet count >50,000 mm3.
* Left ventricular ejection fraction > 40%
* Adequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) < 2.5 × upper limit of normal (ULN) and direct bilirubin < 1.5 × ULN.
* Adequate renal function defined by creatinine clearance >30 ml/min using the Cockcroft-Gault formula.
* The effects of CAR-37 T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to leukapheresis and until 6 months post CAR-37 infusion. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men with partners of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 4 months after last CAR-37 T cells administration.
* Ability and willingness to adhere to the study visit schedule and all protocol requirements
Inclusion criteria for lymphodepletion:
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2 (Karnofsky >=60%, see Appendix A).
* No Active, uncontrolled, systemic bacterial, viral, or fungal infection. If febrile, the patient must be afebrile for 24 hours and blood cultures negative for 48 hours on appropriate antibiotic therapy.
* Oxygen saturation >92% on room air while awake.
* No additional anti-cancer therapy since leukapheresis excluding steroids at or below physiologic dosing.
Exclusion Criteria:
* Prior CD37 targeted therapies.
* Treatment with an any investigational cellular therapy within 8 weeks prior to apheresis.
* Any systemic anti-cancer therapy within 1 weeks of leukapheresis excluding steroids at or below physiologic dosing.
* Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed.
* Ongoing systemic immunosuppression for acute and/or chronic GVH as a result of previous allogeneic bone marrow transplant and at least 12 weeks out from prior allogeneic SCT.
* Significant co-morbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, and/or recent significant traumatic injury.
* Active, uncontrolled, systemic bacterial, viral, or fungal infection.
* Subjects with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.
* Subjects with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months.
* Subjects with arterial vascular disease such as history of cerebrovascular accident or peripheral vascular disease requiring therapeutic anti-coagulation.
* Subjects with history of a new pulmonary embolism within 6 months of beginning lymphodepletion.
* Subjects with second malignancies if the second malignancy has required therapy in the last 3 years or is not in complete remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy other than hormonal therapy.
* Pregnant or lactating women
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04136275
|
{
"brief_title": "CAR-37 T Cells in Hematologic Malignancies",
"conditions": [
"Hematologic Malignancy",
"Leukemia",
"Lymphoma",
"Lymphoma, B-Cell",
"Lymphoma, T-Cell",
"Lymphoma, Non-Hodgkin"
],
"interventions": [
"Biological: CAR-37 T cells"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04136275",
"official_title": "A Phase I Clinical Trial with CAR-37 T Cells for the Treatment of Patients with Relapsed or Refractory CD37+ Hematologic Malignancies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-30",
"study_completion_date(actual)": "2024-03-01",
"study_start_date(actual)": "2020-06-19"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-12",
"last_updated_that_met_qc_criteria": "2019-10-21",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-23",
"first_submitted": "2019-10-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the seroprevalence of Hepatitis A Virus (HAV), Varicella-Zoster virus (VZV), Cytomegalovirus (CMV), Herpes Simplex (HSV) and Bordetella pertussis (BP)infections in Mexico.
Detailed Description
In order to document the epidemiological changes in the sero-prevalence of Hepatitis A, Human simplex virus (1 and 2), Varicella-Zoster virus and Cytomegalovirus infections, we propose to conduct a population based, seroprevalence, cross-sectional study, in Mexico. This will allow the identification of susceptible populations, which in turn, will serve as evidence for the elaboration of recommendations for the prevention of Hepatitis A, Human simplex virus, Varicella-Zoster virus and Cytomegalovirus infection in the region.
This study was conducted using data and serum samples from a random sample of subjects that participated in the 2006 National Health and Nutrition Survey.
#Intervention
- OTHER : Serum sample
- Serum samples collected
|
#Eligibility Criteria:
Inclusion Criteria:
* Previously enrolled subjects aged >= 1 <= age <= 70 for National Health and Nutrition Survey 2006 in Mexico, with previously obtained informed consent
Exclusion Criteria:
* Information required for the study is not available or incomplete.
* Inadequate or insufficient serum sample to detect viral agents required for the study.
* Serum sample wrongly identified.
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01160081
|
{
"brief_title": "Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis",
"conditions": [
"Viral Hepatitis Vaccines",
"Hepatitis A",
"Cytomegalovirus",
"Varicella-Zoster Virus",
"Bordetella Pertussis Infection",
"Herpes Simplex (1 and 2)"
],
"interventions": [
"Other: Serum sample"
],
"location_countries": [
"Mexico"
],
"nct_id": "NCT01160081",
"official_title": "Sero-prevalence of Hepatitis A Varicella-Zoster Virus, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis in Mexico",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-09",
"study_completion_date(actual)": "2010-09",
"study_start_date(actual)": "2010-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-01-25",
"last_updated_that_met_qc_criteria": "2010-07-08",
"last_verified": "2010-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-07-12",
"first_submitted": "2010-07-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study evaluates the omission of incentive spirometry use following bariatric surgery. Half of participants will receive an incentive spirometer while the other half will not. Oxygen saturation and pulmonary complications after surgery will be measured to examine the effectiveness of incentive spirometry.
Detailed Description
Incentive spirometry is speculated to improve pulmonary function in the postoperative period, though data to support this is lacking. Patients undergoing bariatric surgery are at increased risk for pulmonary compromise as they are obese and undergoing foregut surgery.
This study aims to examine the effect of incentive spirometry after bariatric surgery by performing a prospective randomized trial. Subjects will be randomized to either receive an incentive spirometer or not. The primary outcome measure of oxygen saturation off of supplemental oxygen will be taken preoperatively and at 6,12, and 24 hours postoperatively. Secondary outcome measures include rate of pulmonary complications, and time to wean off of supplemental oxygen.
#Intervention
- DEVICE : Incentive spirometer
- Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm.
- Other Names :
- Control
- DEVICE : No incentive spirometer
- No incentive spirometer is provided to the patient, this is the study arm.
- Other Names :
- Study
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients medically cleared to undergo bariatric surgery per the usual screening process
Exclusion Criteria:
* None
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02431455
|
{
"brief_title": "The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery",
"conditions": [
"Obesity, Morbid",
"Complications of Bariatric Procedures",
"Pulmonary Atelectasis",
"Pneumonia"
],
"interventions": [
"Device: No incentive spirometer",
"Device: Incentive spirometer"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02431455",
"official_title": "The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-05",
"study_completion_date(actual)": "2016-05",
"study_start_date(actual)": "2015-06"
},
"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)": "2016-08-25",
"last_updated_that_met_qc_criteria": "2015-04-30",
"last_verified": "2016-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-05-01",
"first_submitted": "2015-04-01",
"first_submitted_that_met_qc_criteria": "2016-07-15"
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing non-cardiac surgery during dual antiplatelet therapy.
|
#Eligibility Criteria:
Inclusion Criteria:
* intake of Clopidogrel, Prasugrel, or Ticagrelor within the last 7 days
* spontaneous bleeding or impeding surgery (major vascular surgery, intraperitoneal or intrathoracic surgery, ENT-surgery, orthopedic or trauma surgery, prostatic surgery)
Exclusion Criteria:
* concomitant medication with warfarin
* renal insufficiency needing dialysis
* concomitant therapy with GPIIB/IIIA Antagonists
* expected duration of operation >30min
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01606865
|
{
"brief_title": "Platelet Inhibition and Bleeding in Patients Undergoing Non-Cardiac Surgery",
"conditions": [
"Postoperative Bleeding"
],
"interventions": null,
"location_countries": [
"Austria"
],
"nct_id": "NCT01606865",
"official_title": "Does Platelet Inhibition Predict Surgery Related Bleeding in Patients Undergoing Non-Cardiac Surgery During Dual Antiplatelet Therapy",
"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)": "2010-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-10-23",
"last_updated_that_met_qc_criteria": "2012-05-25",
"last_verified": "2014-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-28",
"first_submitted": "2012-05-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A first in human experimental treatment in which an experimental medicine,Nuc-1031, is used in combination with a standard cancer medicine, carboplatin, to treat ovarian cancer which reappear after standard cancer treatment. The aim of the trial is to determine safety, effectiveness, and clinical activity of this combination treatment.
Detailed Description
Nuc-1031 and carboplatin combination is a new experimental treatment for ovarian cancer which reappear after standard chemotherapy. Chemotherapy is the name for drug treatments to kill or control the growth of cancer cells. Although there is some evidence from laboratory and clinical studies that Nuc-1031 is effective in the treatment of ovarian cancer, it has not yet been tested in combination with another chemotherapy drug. So this combination treatment is classed as a first in human study(Phase1B). The aim of the study is to investigate whether adding Nuc-1031 to carboplatin can improve the benefits of chemotherapy.
Other purposes are to find out whether Nuc-1031 is safe to give with carboplatin, to identify the correct dose of Nuc-1031 when given with carboplatin and establish how effective the combination is at treating ovarian cancer. This study is also designed to enable us to find out whether Nuc-1031 adds further benefit, over and above that achieved by carboplatin alone, when treating ovarian cancer. and carboplatin combination will be given in six cycles. Each cycle is 3 weeks long. On first day of first week of each cycle (day1), selected study participants will receive one dose of both Nuc-1031 and Carboplatin chemotherapy. Following this, the study participant will receive a second dose of Nuc-1031 alone on first day of second week (day 8). This schedule will be repeated every 3 weeks for 6 cycles.
#Intervention
- DRUG : Nuc-1031 and Carboplatin
- Nuc-1031 IV injection on day 1 and day 8 repeated every 21 days Carboplatin IV infusion on day 1 repeated every 21 days (Total 6 cycles)
|
#Eligibility Criteria:
Inclusion Criteria:
* Provision of signed written informed consent.
* Original diagnosis and/or histological confirmation of relapsed epithelial ovarian, fallopian tube or primary peritoneal cancer.
* Relapse <=24 months from completion of platinum (carboplatin or cisplatin) or platinum-containing regimen.
* Age >= 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
* Measurable disease as defined by Response Evaluation Criteria In Solid Tumours (RECIST) criteria version 1.1; January 2009 and/or evaluable disease (evaluable: cytologically or radiologically detectable disease such as ascites, peritoneal deposits, or lesions which do not fulfill RECIST criteria version 1.1 for measurable disease) [1,2]. Participants for whom disease and response to therapy can be monitored by serum Cancer Antigen 125 (CA125) levels will also be eligible.
* Adequate bone marrow function as defined by: White Blood Cells of >= 3 x109/L, Absolute Neutrophil Count (ANC) of >= 2.0 x 109/L, platelet count of >= 100.0 x 109/L, and haemoglobin of >= 9 g/dL.
* Adequate liver function, as determined by: Serum total bilirubin <=1.5 x Upper Limit of Normal [(ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <= 2.5 x ULN, albumin >= 30g/L.
* Adequate renal function assessed as glomerular filtration rate(GFR) >= 60 mL/min using Cr51-ethylenediaminetetraacetic acid (EDTA) method.
* Ability to comply with protocol requirements.
* Participants must be postmenopausal (12 months of amenorrhea), surgically sterile or they must agree to use a physical method of contraception. Oral or injectable contraceptive agents cannot be the sole method of contraception. Participants of child-bearing potential must have a negative serum pregnancy test within seven days prior to the first study drug administration.
Exclusion Criteria:
* History of allergic reactions attributed to previous gemcitabine treatment.
* Previous treatment with Nuc-1031.
* History of allergic reactions attributed to previous carboplatin treatment.
* Symptomatic Central Nervous System (CNS) or leptomeningeal metastases.
* Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy for bone pain), or immunotherapy within 28 days of first receipt of study drug (within 6 weeks for nitrosoureas and mitomycin C). Hormone therapy within 14 days of first receipt of study drug.
* Prior toxicities from chemotherapy or radiotherapy which have not regressed to Grade <= 1 severity [National Cancer Institute -Common Terminology Criteria for Adverse Events, (NCI-CTCAE) version 4.03] except for neuropathy and alopecia.
* Another active cancer (excluding basal cell carcinoma) within the last 3 years.
* Participants with uncontrolled concomitant illness or active infection requiring IV antibiotics.
* Participants with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with a their participation in the study, or with the interpretation of the results.
* Known Human Immunodeficiency Virus (HIV) or known active Hepatitis B or C.
* Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc.) that, in the judgment of the investigator, may affect the participant's ability to sign the informed consent and undergo study procedures.
* Currently pregnant, lactating or breastfeeding
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
|
NCT02303912
|
{
"brief_title": "Safety and Efficacy Study of Nuc-1031 and Carboplatin Combination to Treat Recurrent Ovarian Cancer",
"conditions": [
"Recurrent Ovarian Cancer"
],
"interventions": [
"Drug: Nuc-1031 and Carboplatin"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02303912",
"official_title": "Phase 1B Open Label Study to Assess the Safety, Pharmacokinetics and Clinical Activity of Nuc-1031 Given on Days 1 & 8 With Carboplatin on Day 1, q3-weekly for 6 Cycles in Participants With Recurrent Ovarian Cancer.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-01-23",
"study_completion_date(actual)": "2017-01-23",
"study_start_date(actual)": "2014-11"
},
"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)": "2021-05-18",
"last_updated_that_met_qc_criteria": "2014-11-25",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-01",
"first_submitted": "2014-10-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this observational cross-sectional study is to develop a clinical diagnostic system for intrinsic acute kidney disease (AKD) to help clincians make non-invasive diagnosis when a kidney biopsy is not available. The main questions it aims to answer are:
1. Can a clinical model comprised of common clinical indexes help diagnose AKD ?
2. Can a combinition of several urinary biomarkers help diagnose AKD ? The study will be conducted in retrospective cohorts of patients with AKD undergoing kidney biopsy. The gold standard of the study is histological diagnosis of AKD. The model will be developed in a derivation cohort from one center, and will be further externally validated in a multicent cohort. The urinary biomarkers will only be tested in the derivation cohort.
Detailed Description
Acute kidney disease is a frequent syndrome characterized by a sudden loss of kidney function. AKD caused by intrinsic kidney diseases are usually more severe than other causes. The treatment of intrinsic AKD mostly depends on a definite pathological diagnosis, requiring invasive kidney biopsy which is not available in all AKD cases. The goal of this study is to develop a clinical diagnostic system comprised of clinical model and urinary biomarkers for intrinsic AKD to help clincians make non-invasive diagnosis.
#Intervention
- DIAGNOSTIC_TEST : Clinical model
- Clinical model: a clinical model based on basic demorgraphic information and commonly executed laboratory tests to differentiate different pathological types of intrinsic AKD.
- DIAGNOSTIC_TEST : Urinary biomarkers
- Urinary biomarkers: biomarkers help differentiate different pathological types of intrinsic AKD.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients with AKD undergoing kidney biopsy between Jan. 1, 2020 and Dec. 31, 2024.
Exclusion Criteria:
* Patients were excluede if they
1. underwent a biopsy to evaluate renal allograft rejection;
2. had a history of hematopoietic stem cell transplantation;
3. were diagnosed with hematological malignancy or end-stage tumor with kidney metastasis;
4. were tested antineutrophil cytoplasmic autoantibody (ANCA) or double-strand DNA (dsDNA) or anti-glomerular basement membrane (GBM) antibody positive before biopsy.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06606522
|
{
"brief_title": "A Clinical Diagnostic System for Intrinsic Acute Kidney Disease",
"conditions": [
"Acute Kidney Disease"
],
"interventions": [
"Diagnostic Test: Clinical model",
"Diagnostic Test: Urinary biomarkers"
],
"location_countries": [
"China"
],
"nct_id": "NCT06606522",
"official_title": "A Diagnostic System of Clincial Model and Urinary Biomarkers for Intrinsic Acute Kidney Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-06-30",
"study_completion_date(actual)": "2024-09-09",
"study_start_date(actual)": "2024-06-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-23",
"last_updated_that_met_qc_criteria": "2024-09-18",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-09-23",
"first_submitted": "2024-09-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study is composed of three paper self-questionnaires to be filled in by the patients included at distance (\> 6 months) from their diagnosis of metastatic breast cancer, in order to limit the impact of the announcement on the filling out the questionnaires.
After verification of the eligibility criteria, the medical oncologist will present the study to patients coming to the ICL for a follow-up consultation as part of their regular care. The patients will meet with a clinical research nurse so that she can explain the again and answer any questions they may have. She will also give the patients the questionnaires questionnaires and will give a presentation of the questions asked. After this meeting, the patients will be given sufficient time to reflect on, which may extend until their next visit to the ICL, in order to express, if they wish, their opposition to participating in the study. If she agrees to participate, the patient can then complete the questionnaires as well as the complementary questionnaire and place them in a closed envelope to be given to the clinical research nurse. The completion of the questionnaires will be completely anonymous. The data of those who object to the use of their data will be deleted from the database.
After the completion of the questionnaires, and in order to allow a benefit for the patient, a semi-directive interview in the form of a teleconsultation with a psycho-oncologist and sexologist will be offered. The interviews are not mandatory.
The time to fill in the self-questionnaires is estimated at 30 minutes and the semi-directive interview can last up to one hour. Finally, at the end of the study, as part of her subsequent care, each patient participating in the study will have the possibility to renew a teleconsultation with the psycho-oncologist and sexologist if she feels the need. As the subject of the study may generate personal questions and lead to a request for psychological and/or sexological care.
#Intervention
- BEHAVIORAL : Self-questionnaires and semi-structured interview
- Patients will fill these questionnaires : BISF-W, QLQ-C30, QLQ-BR23 and if they agree answer to a semi-structured interview composed of 5 questions
|
#Eligibility Criteria:
Inclusion Criteria:
* Major woman
* Patient with metastatic breast cancer, either initially or secondary metastatic breast cancer
* RH+/HER2- tumor
* Patient starting first line metastatic therapy or currently undergoing 1st line metastatic treatment
* Patient diagnosed with metastatic breast cancer 6 months or more
* WHO 1 or 2 patient
* Postmenopausal or not
* Patient able to understand the French language
Exclusion Criteria:
* Patient WHO>2
* Patient undergoing chemotherapy
* HER2+ or triple negative tumor
* Male
* Patient diagnosed with breast cancer less than 6 months ago
* Patient under guardianship, curatorship or safeguard of justice
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
|
NCT05577156
|
{
"brief_title": "SexoMBC2 Non Interventional Study",
"conditions": [
"Breast Cancer",
"Quality of Life",
"Sexual Behavior"
],
"interventions": [
"Behavioral: Self-questionnaires and semi-structured interview"
],
"location_countries": [
"France"
],
"nct_id": "NCT05577156",
"official_title": "Sexual Quality of Life and Metastatic Breast Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-05-17",
"study_completion_date(actual)": "2023-05-17",
"study_start_date(actual)": "2022-12-05"
},
"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)": "2023-07-28",
"last_updated_that_met_qc_criteria": "2022-10-10",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-13",
"first_submitted": "2022-10-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
There is an unmet medical need for monitoring sleep for multiple nights in a patient's home, without the inconvenience of traveling and staying overnight in a medical center, and without the need for a technician to set up a polysomnography (PSG) device at the patient's home. Several disorders, and particularly sleep disorders, are associated with insomnia symptoms, and longitudinal sleep assessment may support a better understanding and management of these patients, who currently seldom access sleep lab PSG.
On one hand, this study aims at demonstrating whether the final device's user interface supports safe and effective use when being used at home over multiple nights.
On the other, the study aims at confirming that stable and consistent data are measured in the device's actual use, for the records to be clinically usable in daily practice.
#Intervention
- DEVICE : Dreem 3 System vs WatchPAT One
- Dreem 3 System and WatchPAT One will be worn simultaneously during 3 nights by each study participant, in order to compare the TST automatically outputted by both devices.
- OTHER : Usability Questionnaire
- After having undergone the 3 nights of measurement, an end of Study Questionnaire will be performed on a separate day to obtain Usability feedback from participants who have undergone simultaneous recordings with the Dreem 3 + WatchPAT devices.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects must be >= 22 and <= 70 years inclusive, including:
* 8 subjects under 55 years.
* 7 subjects > 55 years.
* Subjects who are under the care of a sleep clinician for experiencing insomnia symptoms.
* Subjects have wifi connection at their home.
* Subjects have a smartphone where they can install the Alfin App.
* Subjects agree to not having abnormal drugs or alcohol consumption 24 hours before the start of the measurement, and during the 3 days of measurement.
* Able to read, understand and sign an informed consent form.
Exclusion Criteria:
* Under 22 and above 70 years inclusive.
* BMI >= 40.
* Obstructive sleep apnea diagnosis with ongoing CPAP therapy.
* Abnormal drugs or alcohol use during the measurement part of the study.
* Head circumference < 53 cm or device fitting issues as determined during training.
* Not able to read, understand and sign an informed consent form.
Sex :
ALL
Ages :
- Minimum Age : 22 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05611099
|
{
"brief_title": "Robustness and Usability of the Dreem 3 System for at Home Sleep Monitoring in an Insomnia Population.",
"conditions": [
"Insomnia, Secondary",
"Sleep Disturbance",
"Sleep",
"Sleep Initiation and Maintenance Disorders"
],
"interventions": [
"Other: Usability Questionnaire",
"Device: Dreem 3 System vs WatchPAT One"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05611099",
"official_title": "Assessment of the Stability, Robustness and Usability of the Dreem 3 System for EEG Sleep Monitoring in the Home Setting, in an Insomnia Population.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-31",
"study_completion_date(actual)": "2022-11-05",
"study_start_date(actual)": "2022-08-15"
},
"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)": "2022-11-28",
"last_updated_that_met_qc_criteria": "2022-11-07",
"last_verified": "2022-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-11-09",
"first_submitted": "2022-11-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this observational study is to compare to investigate the effect of dual task performance on straight and curved walking in elderly people with mild cognitive impairment.
The main question\[s\] it aims to answer are:
* The purpose of this study was to investigate the effect of dual task performance on the activity of the prefrontal cortex in the elderly with mild cognitive impairment during straight and curved walking.
* The purpose of this study was to investigate the effect of dual task performance on gait speed during straight and curved walking in elderly people with mild cognitive impairment.
Participants will: For mild cognitive impairment 65 and older who can do dual tasks.
* single task (motor task) : an exercise task, which will perform a 10-meter walking test and a figure-eight walking test.
* double task (motor task + cognitive task) : planned to perform a motor task and a cognitive task together. The cognitive task is scheduled to be a simple calculation problem so that it can be performed without great difficulty while walking.
Detailed Description
The goal of this observational study is to compare to investigate the effect of dual task performance on straight and curved walking in elderly people with mild cognitive impairment.
The main question\[s\] it aims to answer are:
* The purpose of this study was to investigate the effect of dual task performance on the activity of the prefrontal cortex in the elderly with mild cognitive impairment during straight and curved walking.
* The purpose of this study was to investigate the effect of dual task performance on gait speed during straight and curved walking in elderly people with mild cognitive impairment.
Participants will A total of 30 subjects will perform a single task (motor task) and a double task (motor task + cognitive task), four tasks per subject, and the order of examination will be randomly assigned. The subject's prefrontal cortex activity will be measured using fNIRS (NIRSIT, OBELAB).
The single task is an exercise task, which will perform a 10-meter walking test and a figure-eight walking test. The 10-meter walking test was developed to evaluate walking speed during short distance walking.
The total length was set to 14 m, and a distance of 2 m was placed at the beginning and end to avoid being affected by acceleration and deceleration. The figure-eight gait test requires a person to walk in a figure-eight shape around two cones placed as a tool to measure curved walking ability. In this study, in order to perform the exercise task at the same distance, a straight line of 14 m will be made into a random line and set in the shape of a figure 8.
Do not deviate more than 1 m from the object in the rotating section of the object. The dual task is planned to perform a motor task and a cognitive task together. The cognitive task is scheduled to be a simple calculation problem so that it can be performed without great difficulty while walking. The subject will perform a total of 3 repetitions and will have a 20-second break before starting each task.
#Intervention
- BEHAVIORAL : Seniors with mild cognitive impairment over 65 years of age
- A total of 30 subjects will perform four tasks per person for a single task (motor task) and a double task (motor task + cognitive task), and the test order will be randomly assigned. The subject's prefrontal cortex activity will be measured using fNIRS (NIRSIT, OBELAB).
The single task will be to perform a 10-meter walk test and an 8-way walk test as exercise tasks. as not affected by acceleration and deceleration. The dual task will be carried out together with the exercise task and the cognitive task. The cognitive task will be a simple calculation problem so that it can be performed without much difficulty when walking.Subjects will perform a total of three iterations and have a break of 20 seconds before each task begins.
|
#Eligibility Criteria:
Inclusion Criteria:
* A person with a Korean version of the Simplified Mental Status Test (K-MMSE-2) score of 18 <= age <= 23.
* A person who can walk using an auxiliary device.
Exclusion Criteria:
* A person who cannot walk 3 meters back and forth or stand up from a sitting position
* A person sensitive to infrared lasers
* A person with impaired vision and hearing
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05885867
|
{
"brief_title": "The Activation and Walking Speed of the Prefrontal Cortex of the Elderly Mild Cognitive Impairment During Dual Task.",
"conditions": [
"Mild Cognitive Impairment",
"Dual Task"
],
"interventions": null,
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT05885867",
"official_title": "The Effect of Dual Task Performance on the Activation and Walking Speed of the Prefrontal Cortex of the Elderly With Mild Cognitive Impairment During Straight and Curved Walking.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-05",
"study_completion_date(actual)": "2023-06-05",
"study_start_date(actual)": "2023-05-31"
},
"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)": "2023-09-06",
"last_updated_that_met_qc_criteria": "2023-05-23",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-06-02",
"first_submitted": "2023-04-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators will evaluate whether a system involving Female Community Health Volunteers (FCHVs) and facility-based community health workers (FB-CHWs) of Health Post (Auxiliary Health Workers, Auxiliary Nurse Midwives and Health Assistant) can contribute to improving hypertension care in rural Nepal. This study will be conducted in Rupa (active group) and Biruwa (comparison group) Rural Municipality of Gandaki province and enroll at least 736 hypertensive adults (322 in Rupa Rural Municipality and 414 in Biruwa Rural Municipality) who are aged 25-70 years, not taking antihypertensive medication, not pregnant and not breastfeeding, free of prior cardiovascular disease, chronic kidney disease, and diabetes. In Rupa Municipality, eligible participants will be able to receive amlodipine, one of the most frequently used antihypertensive medications, from FB-CHWs at Health Posts and five times (including baseline and end of study) of lifestyle counseling by FCHVs, whereas participants in Biruwa Municipality will receive the usual care plus three times (including baseline and end of study) of lifestyle counseling by FCHVs.
Detailed Description
Despite a large body of evidence on the effectiveness of hypertension treatment in reducing cardiovascular morbidity and mortality, the control rate of hypertension is low in many low and middle-income countries. The shortage of skilled workforce diagnosing and managing hypertension is one of the major barriers. A promising option is to involve community health workers (CHWs) in hypertension care, who have shown promising results for improving maternal and child health. However, the evidence on whether CHWs can diagnose and treat hypertension under the supervision of a physician has not been systematically tested.
Thus, this study will evaluate whether existing Facility Based-Community Health Workers (FB-CHWs) and Female Community Health Volunteers (FCHVs) of the Ministry of Health can safely and effectively diagnose hypertension and initiate/maintain protocol-based hypertension treatment. This study will be conducted in Rupa (active group) and the Biruwa (comparison group) Rural Municipality of Gandaki province. All adults aged 25-70 years of age who reside in the Rupa and Biruwa municipalities are eligible for the initial screening by data enumerators of the Nepal Development Society (NeDS). Only eligible participants who meet the inclusion criteria will participate in the study.
Rupa Rural Municipality will allow the initiation of antihypertensive medication (amlodipine) by FB-CHW at Health Posts under the supervision of a study physician. Biruwa Rural Municipality will follow usual care, which is a referral to healthcare facilities currently providing hypertension care. FCHVs will provide lifestyle counseling and follow up the adherence to hypertension treatment three times in Rupa Rural Municipality and once in Biruwa Rural Municipality.FCHV in Rupa Rural Municipality will make three home visits (at 3, 6, and 9 months) whereas FCHV in Biruwa Rural Municipality will make one home visit after 3 months of baseline. The end of the study survey will be carried out after one year by FCHV and NeDS data enumerators. The primary study outcome is a net change in systolic blood pressure among hypertensive participants 12-months after confirming hypertension in the active vs. the comparison group.
#Intervention
- DRUG : Amlodipine
- The facility-based community health worker will receive protocol-driven training to initiate amlodipine for hypertensive patients. These patients will receive lifestyle counseling by Female Community Health Volunteer through home visits (5 times \[including baseline and end of the study\] in the active municipality and 3 times \[including baseline and end of the study\] in the control municipality).
- BEHAVIORAL : Lifestyle counselling
- Female Community Health Volunteer will provide lifestyle counseling at the participant's home
|
#Eligibility Criteria:
Inclusion criteria
* Between 25 <= age <= 70 years
* Systolic blood pressure 140 <= age <= 179 mmHg or diastolic blood pressure 90 <= age <= 119 mmHg
* Do not have a plan to leave the study municipality within a year
Exclusion criteria
* Use of antihypertensive medication in the last two weeks
* History of stroke, heart attack, heart failure, or chronic kidney disease
* History of diabetes meritus
* Pregnant or any plan to be pregnant in a year
* Breastfeeding
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04521582
|
{
"brief_title": "Management of Hypertension Utilizing Trained Community Health Worker in Rural Municipalities of Nepal",
"conditions": [
"Hypertension,Essential"
],
"interventions": [
"Behavioral: Lifestyle counselling",
"Drug: Amlodipine"
],
"location_countries": [
"Nepal"
],
"nct_id": "NCT04521582",
"official_title": "Management of Hypertension Utilizing Trained Community Health Worker in Rural Municipalities of Nepal (MUTU) Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-20",
"study_completion_date(actual)": "2022-07-20",
"study_start_date(actual)": "2021-04-27"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-29",
"last_updated_that_met_qc_criteria": "2020-08-17",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-20",
"first_submitted": "2020-08-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients enrolled in the study underwent five assessments using the CRS-R(Coma Recovery Scale-Revised) within 10 days, along with an 18F-FDG-PET scan.
Detailed Description
Patients enrolled in the study underwent five assessments using the CRS-R (Coma Recovery Scale-Revised) within 10 days, along with an 18F-FDG-PET (18F-fluorodeoxyglucose-positron emission tomography) scan. The CRS-R evaluations were conducted by professionally trained and highly experienced personnel. During the CRS-R assessments, patients' behavioral responses were recorded in the domains of visual, auditory, motor, oromotor/verbal, communication, and arousal. Based on the optimal CRS-R results obtained within the 10-day period, patients were categorized into MCS (Minimally consciousness state, criteria: consistent command-following, reproducible responses to commands, object recognition, intelligible verbalization, partially accurate communication, object localization, visual pursuit and visual object localization, spontaneous motor responses, object manipulation, and/or localization to noxious stimulation) or UWS (Unresponsive wakefulness syndrome, criteria: preserved wakefulness accompanied by behavioral responses such as localization to sound, auditory startle, visual startle, withdrawal/flexion movements, abnormal posturing, vocalizations/oromotor movements, and reflexive oromotor responses). All patients exhibited stable vital signs. For data analysis, a healthy control group from Belgium was included to compare brain metabolism between patients with disorders of consciousness and healthy individuals.
|
#Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of disorders of consciousness after 5 CRS-R assessments;
* Age >18 years;
* Stable vital signs;
* No use of sedatives or neuromuscular blockers within 24 hours prior to enrollment.
Exclusion Criteria:
* Acute-phase patients (injury duration <28 days);
* Fewer than 5 CRS-R assessments completed within 10 days;
* Patients diagnosed with EMCS (Emerging Minimally Conscious State);
* Patients with unclear diagnoses (cases where experienced evaluators could not reach a consensus diagnosis);
* Patients with persistent seizures.
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:
Yes
|
NCT06770348
|
{
"brief_title": "Investigating the Localization of Consciousness Through Patients with Disorders of Consciousness: Anterior Vs. Posterior Cortex Debate",
"conditions": [
"Disorders of Consciousness"
],
"interventions": null,
"location_countries": [
"China"
],
"nct_id": "NCT06770348",
"official_title": "Exploring the Origin of Consciousness Through Disorders of Consciousness: a PET Study'",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-12-30",
"study_completion_date(actual)": "2024-12-30",
"study_start_date(actual)": "2021-04-01"
},
"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)": "2025-01-13",
"last_updated_that_met_qc_criteria": "2025-01-07",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2025-01-13",
"first_submitted": "2024-12-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The proposal of this study is to verify if it is feasible and effective to offer a home based cardiac rehabilitation program, that includes the components of health education and physical exercises mostly unsupervised and oriented by telephone and to compare the treatment adherence, the effects in the functional capacity, and the control of coronary risk factors in relation to the traditional cardiac rehabilitation offered mostly supervised and center based.
Detailed Description
This study will be developed with patients with coronary disease submitted to angioplasty or myocardial revascularization surgery, provided they are considered of low and moderate risk for the practice of physical exercise of moderate intensity, according to the risk stratification proposed by the American Association of Cardiovascular and Pulmonary Rehabilitation. Volunteers will be recruited at the outpatient at the University Hospital's Cardiac Rehabilitation Centre. The study will be made in conformity with the CONSORT guidelines for non-pharmacological interventions. After being invited to the study, the volunteer whose accept the participation and sign the consent form will be randomized into two different groups: Traditional cardiac rehabilitation (mostly supervised) and Telerehabilitation (mostly unsupervised). The randomization will be made through the www.randomization.com website in blocks of four volunteers each. A blind researcher will evaluate participants before and after test, and will fulfill the database.
Intervention The parameters for the exercise prescription will be the same for both groups. Exercise sessions will be constituted of 5-10 minutes of warm up, 40 minutes of aerobic activity with heart rate between 60 and 80% of the heart rate reserve, and 5-10 minutes of cool down. The educational sessions will be given to both groups in six meetings with 40 minutes each, and items regarding the control of risk factors and treatment of cardiovascular diseases will be approached. After the period of 12 weeks of intervention all participants will be stimulated to continue to practice physical exercises at home or at the community, and they will be invited to a re-evaluation after three months.
Groups:
Traditional cardiac rehabilitation as control group (CentreRehab) The CentreRehab group will be made supervised exercises and health educational activities, personally at cardiac rehabilitation centre. This intervention will last 12 weeks, with a total of 60 sessions: 24 supervised and 36 at home (to complete five exercise's sessions for week). The participants of this group will be oriented to fulfill a training diary with information regarding the frequency of the exercises, the presence of symptoms, and the use of the scale of perceived exertion during exercises at home.
Home-based cardiac rehabilitation (HomeRehab) The participants of the HomeRehab group will make the exercise mostly at home. There will be weekly phone calls, in person educational sessions, and monthly meetings to check the execution of the previous stage, solve doubts, or identify the presence of symptoms or undesirable effects. This intervention will have the duration of 12 weeks, with a total of 60 sessions: 2 supervised and 58 at home (to complete five exercise's sessions for week).
In the first week, all individuals of HomeRehab group will receive a training regarding the use of the monitoring equipment. A heart rate monitor with the heart rate zone individually calculated will be given to the participant at the first session of the face-to-face training to monitoring exercises at home. Furthermore, all participants of this group will use a step counter (pedometer) to stimulate the execution of the exercises as well as training diary to be fulfilled with information regarding the frequency of the exercises, the presence of symptoms during the exercise, the perceived exertion, and the number of daily steps. The monthly meetings will take place to the educational activity, and to verify if the exercises and fulfilment of the training diary are correct as well as to clarify any kind of the participant's doubts.
#Intervention
- OTHER : Home-based Rehab
- This intervention will have the duration of 12 weeks, with a total of 60 sessions: 2 supervised and 58 at home (to complete five exercise's sessions for week).
- OTHER : CentreRehab
- This intervention will last 12 weeks, with a total of 60 sessions: 24 supervised and 36 at home (to complete five exercise's sessions for week).
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with coronary disease submitted to angioplasty or myocardial revascularization surgery, or that had a heart attack, provided they are considered of a low and moderate risk for the practice of physical exercise of moderate intensity according to the stratification for the risk of events during a cardiovascular rehabilitation program
* Clinical stability, according with the medical evaluation;
* Residents of the Belo Horizonte's metropolitan region.
Exclusion Criteria:
* Recent cardiac event or clinical decompensation (<1month);
* Presence of peripheral arterial occlusive disease with limitation degree that prevents the test of maximum exercise (emergence of claudication before the maximum cardiorespiratory fatigue);
* Presence of chronic pulmonary disease (i.e. Chronic Obstructive Pulmonary Disease, pulmonary fibrosis, and pulmonary arterial hypertension of pre capillary etiology);
* History of ventricular fibrillation or sustained ventricular tachycardia in the last year;
* Presence of high risk criteria during the ergometric test;
* Physical, cognitive, or social limitation that prevent the participation in a physical exercise program, and the comprehension of the use of the monitoring device.
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
|
NCT03605992
|
{
"brief_title": "Home-based Cardiac Rehabilitation: Compliance and Effectiveness",
"conditions": [
"Cardiovascular Diseases",
"Coronary Disease",
"Cardiac Disease"
],
"interventions": [
"Other: CentreRehab",
"Other: Home-based Rehab"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT03605992",
"official_title": "Compliance, Viability and Effectiveness of Home Based Cardiac Rehabilitation: a Randomised Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-30",
"study_completion_date(actual)": "2019-10-30",
"study_start_date(actual)": "2018-02-26"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-07-24",
"last_updated_that_met_qc_criteria": "2018-07-27",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-30",
"first_submitted": "2018-03-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the study was to determine the effect of the psychiatric nursing approach based on the Tidal Model on coping and self-esteem in people with alcohol dependency.
#Intervention
- BEHAVIORAL : The Psychiatric Nursing Approach Based On The Tidal Model
- To provide individualized care for patients in the experimental group, the One-to-One Sessions were initiated and interventions were performed in line with the goals of the persons and the aims of the research. The interventions were selected from interventions regarding with coping and self-esteem from the Nursing Interventions Classification(NIC) system.The One-to-One sessions help the person recognize change and focus the person on achievement and goals.Taking into account the basic process of the Tidal Model, care stages, the following interview plan was drawn up, containing the details of the interviews to be carried out with people with alcohol dependency, and the One-to-One Sessions were held in line with this plan two times per week.
|
#Eligibility Criteria:
Inclusion Criteria:
* People with alcohol dependency were included in the study who were between 30 and 50 years who were admitted for treatment to the Alcohol and Substance Addiction Treatment clinic.
Exclusion Criteria:
* People with alcohol dependency who were severely depressed with a Beck Depression score of 41 or more and those with severe anxiety(a Beck Anxiety score of 26 or more) were not included in the study.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT02604758
|
{
"brief_title": "Tidal Model's Effect on Coping and Self-Esteem",
"conditions": [
"Alcoholism"
],
"interventions": [
"Behavioral: The Psychiatric Nursing Approach Based On The Tidal Model"
],
"location_countries": null,
"nct_id": "NCT02604758",
"official_title": "The Effect of the Psychiatric Nursing Approach Based on the Tidal Model on Coping and Self-esteem in People With Alcohol Dependency: A Randomized Trial",
"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)": "2013-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-11-13",
"last_updated_that_met_qc_criteria": "2015-11-12",
"last_verified": "2015-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-11-13",
"first_submitted": "2015-11-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This phase II trial studies the combination of pembrolizumab, bevacizumab, and low dose oral cyclophosphamide in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Monoclonal antibodies, such as pembrolizumab and bevacizumab, may block tumor growth in different ways such as boosting your own immune system to find, recognize and kill tumor cells as well as by blocking the growth of new blood vessels necessary for tumor growth and nutrition. Drugs used in chemotherapy, such as low dose oral cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, as well as by further enhancing your own body's immune response against cancer cells. As these three drugs have all been shown to improve the immune response against cancer cells giving pembrolizumab, bevacizumab, and cyclophosphamide together may work better in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate improvement in progression-free survival for patients treated with anti-programmed cell death 1 (anti-PD1) pembrolizumab in combination with intravenous (IV) bevacizumab and oral metronomic cyclophosphamide as compared to patients treated with other second line chemotherapeutic agents.
SECONDARY OBJECTIVES:
I. To obtain pilot data on clinical response rates using both Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and immune related response criteria (irRECIST).
II. To obtain data on changes in tumor microenvironment prior to and subsequent to therapy and, to screen for potential biomarkers to predict clinical benefit.
III. To determine the safety and tolerability of the treatment combination in the study population.
IV. To evaluate overall survival in patients treated with anti-PD1 pembrolizumab in combination with IV bevacizumab and oral metronomic cyclophosphamide.
V. To assess the impact of the combination of anti-PD1 pembrolizumab, IV bevacizumab and oral metronomic cyclophosphamide on anti-tumor immune responses in ovarian cancer.
OUTLINE:
Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 and cyclophosphamide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 3 weeks for up to 12 months (or 17 courses) in the absence of disease progression or unacceptable toxicity. Patients without evidence of disease progression may continue treatment in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, then every 3 months for 1 year, and every 12 weeks and 6 months thereafter.
#Intervention
- BIOLOGICAL : Bevacizumab
- Given IV
- Other Names :
- Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF
- DRUG : Cyclophosphamide
- Given PO
- Other Names :
- (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719
- OTHER : Laboratory Biomarker Analysis
- Correlative studies
- BIOLOGICAL : Pembrolizumab
- Given IV
- Other Names :
- Keytruda, Lambrolizumab, MK-3475, SCH 900475
|
#Eligibility Criteria:
Inclusion Criteria:
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Have measurable disease per RECIST 1.1 criteria present
* Participant may have serous, endometrioid, clear cell, mucinous or undifferentiated type of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
* Histologic confirmation of the original primary tumor is required via the pathology report
* Participant can be either platinum-sensitive (platinum free interval [PFI] >= 6 months prior to recent recurrence) or platinum-resistant (PFI < 6 months prior to recent recurrence). If the participant has a platinum sensitive disease, she may only enroll in this clinical trial if there is a contraindication for her to receive further treatment with platinum-based chemotherapy (such as serious, persistent toxicity or sever hypersensitivity to platinum agents or she declines standard of care).
* Participant must be willing to undergo core or excisional biopsy of a tumor lesion within 4 weeks (28 days) prior to initiation of treatment on day 1 and after 3 cyles of study treatment; participants for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the principal investigator
* Absolute neutrophil count (ANC): >= 1,500 /mcL
* Platelets: >= 100,000 / mcL
* Hemoglobin: >= 9 g/dL or 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
* Serum creatinine: =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance >= 60 mL/min for participant with creatinine levels > 1.5 X institutional ULN; glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (CrCl)
* Urine protein creatine ratio (UPCR) < 1 prior to enrollment
* Serum total bilirubin: =< 1.5 X ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 ULN
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase[SGOT]) and alanine transaminase (ALT) (serum glutamic pyruvic transaminase [SGPT]): =< 2.5 X ULN OR =< 5 X ULN for participants with liver metastases
* Albumin: > 2.5 mg/dL
* International normalized ratio (INR) or prothrombin time (PT): =< 1.5 unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
* Activated partial thromboplastin time (aPTT): =< 1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
* Participants of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year); should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately
* Participant has recovered from toxicities of prior chemotherapy or other therapy (to grade 2 or less)
* Participant may have received prior investigational therapy (including immune therapy)
* Participant may have received prior hormonal therapy
* Participant may have received bevacizumab (or other antiangiogenic agent) and/or cyclophosphamide in the past
* Participant has had at least 4 weeks of postoperative recovery from surgery prior to enrollment to ensure complete wound healing; participants with bowel resections at surgery should begin protocol at least 42 days after surgery
* Ability to swallow and retain oral medication
* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment or, is taking any other medication that might affect immune function
* Has a known history of active bacillus tuberculosis (TB)
* Hypersensitivity to bevacizumab, cyclophosphamide, pembrolizumab or any of its excipients
* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent
* Note: participants with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
* Note: if participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy and, has to be at least 28 days after the surgery
* Has a known additional malignancy that is progressing or requires active treatment: exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or cervical cancer in situ that has undergone potentially curative therapy
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
* Has active autoimmune disease that has required systemic treatment in the past 6 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
* Has known history of, or any evidence of active, non-infectious pneumonitis
* Has an active infection requiring systemic therapy
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
* Has received prior therapy with an anti-PD-1, anti-programmed cell death 1 ligand 1 (PD-L1), or anti-programmed cell death 1 ligand 2 (PD-L2) agent
* Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
* Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
* Has received a live vaccine within 30 days of planned start of study therapy
* Note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines, and are not allowed
* Active or history of inflammatory bowel disease (colitis, Crohn's), diverticulitis, irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener's granulomatosis
* Participant has clinical symptoms or signs of partial or complete gastrointestinal obstruction or, requires parenteral hydration and/or nutrition
* Participant requires, or is likely to require, more than a two-week course of corticosteroids for intercurrent illness; participant must complete the course of corticosteroids 2 weeks before screening to meet eligibility
* Participant has a serious, non-healing wound, ulcer, or bone fracture
* Participant has a clinically significant cardiovascular disease including:
* Uncontrolled hypertension, defined as systolic > 150 mmHg or diastolic > 90 mmHg
* Myocardial infarction or unstable angina within 6 months prior to enrollment
* New York Heart Association (NYHA) grade II or greater congestive heart failure
* Participant has a grade II or greater peripheral vascular disease
* Participant has a clinically significant peripheral artery disease (e.g. those with claudication, within 6 months)
* Participant has organ allografts
* Participant is receiving medication(s) that might affect immune function
* Unwilling or unable to follow protocol requirements
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
|
NCT02853318
|
{
"brief_title": "Pembrolizumab, Bevacizumab, and Cyclophosphamide in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer",
"conditions": [
"Fallopian Tube Clear Cell Adenocarcinoma",
"Fallopian Tube Endometrioid Adenocarcinoma",
"Fallopian Tube Mucinous Adenocarcinoma",
"Fallopian Tube Serous Adenocarcinoma",
"Ovarian Clear Cell Adenocarcinoma",
"Ovarian Endometrioid Adenocarcinoma",
"Ovarian Mucinous Adenocarcinoma",
"Ovarian Serous Adenocarcinoma",
"Primary Peritoneal Serous Adenocarcinoma",
"Recurrent Fallopian Tube Carcinoma",
"Recurrent Ovarian Carcinoma",
"Recurrent Primary Peritoneal Carcinoma",
"Undifferentiated Fallopian Tube Carcinoma",
"Undifferentiated Ovarian Carcinoma"
],
"interventions": [
"Biological: Bevacizumab",
"Other: Laboratory Biomarker Analysis",
"Biological: Pembrolizumab",
"Drug: Cyclophosphamide"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02853318",
"official_title": "A Phase II Evaluation of Pembrolizumab in Combination With IV Bevacizumab and Oral Metronomic Cyclophosphamide in the Treatment of Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-27",
"study_completion_date(actual)": "2021-06-30",
"study_start_date(actual)": "2016-09-01"
},
"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)": "2021-10-06",
"last_updated_that_met_qc_criteria": "2016-07-29",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-08-02",
"first_submitted": "2016-07-29",
"first_submitted_that_met_qc_criteria": "2020-10-15"
}
}
}
|
#Study Description
Brief Summary
The investigators aimed to compare the effects of tramadol and dexmedetomidine, which are commonly used in anesthesia, on preventing catheter-related bladder discomfort.
Detailed Description
Urinary catheterization is an attempt frequently used in many surgeries, emergency services or intensive care units, especially urinary surgeries to facilitate urine output or evaluate urine output. However, as a result of urinary catheter application, most patients may develop some symptoms like pain, burning sensation and the urge to urinate constantly in the suprapubic region that the investigators call this catheter-related bladder discomfort (CRBD).
The incidence of CRBD can increase 47 to 90% in the postoperative period. The main reason of CRBD is involuntary contractions caused by muscarinic receptors, especially type 3 (M3) receptors. Therefore, antimuscarinic drugs are used to prevent and treat CRBD. Studies have shown that many drugs such as ketamine, tolterodine, oxybutynin, gabapentin, pregabalin, butylscopolamine, tramadol, dexmedetomidine are effective in preventing CRBD. Their common feature is antimuscarinic effects. However, no definitive conclusion could be reached for routine use, due to the low number of samples in the studies, surgical differences or some anticholinergic and sedative side effects. Additionally, oxybutynin, tolterodine, gabapentin, and pregabalin are only preoperatively administered orally. So more research is needed to find the ideal agent to prevent CRBD.
Tramadol is frequently used for moderate pain in surgeries. It is a centrally acting synthetic opioid analgesic that has an inhibitory effect on M1 and M3 muscarinic receptors. Tramadol has proven to be effective in reducing the severity and frequency of ICBR in intraoperative use. However, like other opioids, it can have side effects such as nausea-vomiting and sedation.
Dexmedetomidine is a selective alpha-2 adrenoceptor agonist that has analgesic, sympatholytic and sedative properties. In recent studies, it has been reported that dexmedetomidine is associated with the pathophysiology of CRBD by inhibiting type-3 (M3) muscarinic receptor which has beneficial effects in preventing CRBD in intraoperative use. Dexmedetomidine decreases the frequency of CRBD by 30%.
The first purpose of the study is to compare the effects of dexmedetomidine and tramadol on CRBD. Secondarily, the investigators aimed to compare them for their side effects.
#Intervention
- DRUG : Tramadol
- tramadol and paracetamol will perform
- Other Names :
- Contramal
- DRUG : Dexmedetomidine
- dexmedetomidine and paracetamol will perform
- Other Names :
- precedex
- OTHER : control
- paracetamol will perform
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients between the ages of 18 and 70 years
* American Society of Anesthesiologists I or II
* Scheduled to undergo retrograde intrarenal surgery
* Scheduled to apply urinary catheter intraoperatively
Exclusion Criteria:
* History of bladder outlet obstruction (Bening prostatic hypertrophy)
* History of neurogenic bladder
* History of psychiatric illness
* Obese patient
* Patients whose urinary catheter cannot be inserted
* Patients who had previously urinary catheters
Sex :
MALE
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
|
NCT04314050
|
{
"brief_title": "Comparison of Tramadol and Dexmedetomidine in the Prevention of Urinary Catheter Discomfort in Urinary Surgery",
"conditions": [
"Catheter Related Complication"
],
"interventions": [
"Drug: Tramadol",
"Drug: Dexmedetomidine",
"Other: control"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04314050",
"official_title": "Comparison of Different Strategies in Preventing Discomfort Due to Urine Catheter in Urinary Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-10",
"study_completion_date(actual)": "2020-07-10",
"study_start_date(actual)": "2020-03-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-09",
"last_updated_that_met_qc_criteria": "2020-03-17",
"last_verified": "2021-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-18",
"first_submitted": "2020-03-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to test the safety and effectiveness of an extended release form of a medication called divalproex sodium (Depakote ER) for the treatment of people with alcohol dependence who have mood and/or anxiety symptoms. This medication has helped reduce symptoms of acute alcohol withdrawal as well as stabilize mood symptoms in bipolar disorder and other mental health disorders. This study will test the hypothesis that divalproex sodium will help reduce mood and anxiety symptoms during early abstinence from alcohol and in turn reduce relapse and craving for alcohol.
Detailed Description
Alcohol dependence afflicts 14 million individuals in the U.S. The alcohol related costs to society are enormous and alcohol dependence is a significant public health problem. Although pharmacotherapy for the treatment of alcohol dependence and relapse prevention has expanded, the identification of evidence based treatment strategies is of critical importance. Anticonvulsants, including the divalproex sodium (DVP) formulation of valproate, have established effectiveness for mood disorders, and therapeutic response of mood and anxiety symptoms to DVP has been demonstrated in a number of psychiatric conditions. While DVP has been demonstrated as a treatment option for the acute alcohol withdrawal syndrome, a clear treatment effect has not been found in studies examining DVP for ongoing relapse prevention in alcohol dependence. These latter studies had limited power and excluded subjects with co-morbid mood and anxiety disorders, individuals who may, by extension of the former studies, show the greatest response to treatment with DVP. Despite the exclusion of subjects with mood and anxiety disorders, alcohol dependent individuals treated with DVP compared to placebo showed greater improvement in irritability and a trend toward greater decreases on measures of impulsivity and aggression. A strategy integrating the above findings would target treatment with DVP more specifically to alcohol dependent individuals with mood and anxiety disturbances.
This randomized, double-blind clinical trial will examine the effectiveness of extended release DVP (Depakote-ER) in the treatment of co-morbid mood and anxiety disturbance in alcohol dependent subjects. The primary hypothesis is that subjects treated with Depakote-ER will have significantly lower scores on the Symptom Checklist (SCL-90-R) than will placebo treated subjects over the course of the study. Secondary hypotheses include: 1) Compared to placebo treated subjects, subjects treated with Depakote-ER will demonstrate significantly lower scores on additional measures of depression, anxiety, and irritability, 2) will have fewer alcohol use days and fewer drinks per drinking day, and 3) will evidence better retention in alcohol dependence treatment.
Eligible subjects will complete baseline assessments and a 7-day run on Depakote-ER prior to randomization. After the 7-day baseline period and run in with Depakote-ER, subjects will be randomized and then transition to either 12 weeks of Depakote-ER or placebo, to begin upon completion of the 7-day run-in baseline period. Valproic acid level obtained at the end of the baseline period will be used to adjust the dose of Depakote-ER (or matched placebo) as needed to target a valproic level of 70-120 ug/ml. Dose increase, if needed, will occur with the study medication dispensed at the next follow up visit (scheduled for the end of the 1st week of active study medication or placebo). Subjects with valproic acid levels \> 120 ug/ml at the end of the baseline period will be contacted as soon as possible and instructed to decrease their dose of Depakote-ER (or matched placebo) accordingly. Subjects randomized to the placebo condition will receive a placebo matched in number and appearance to the dosage of Depakote-ER prescribed during the 7-day baseline period. If needed, the number of placebo pills will be adjusted to match the change in the Depakote-ER dosage determined necessary based on the valproic acid level obtained at the end of the 7-day baseline period.
Duration of Subject Participation: Subjects will receive either divalproex sodium extended release (Depakote-ER) or matched placebo for 12 weeks. Subjects will continue to receive other 'treatment as usual' within the Addiction Treatment Center in accordance with their ongoing clinical program treatment plan. The standard expectation within the context of treatment as usual is for at least 6 months of treatment involvement. A limited number of psychotropic medications will be allowed during the study. A benzodiazepine (usually chlordiazepoxide or lorazepam, in accordance with standard practice and generally given in an as needed symptom triggered manner) can be prescribed during the acute detoxification period (first 7 days). Hydroxyzine can be prescribed PRN for anxiety, and zolpidem PRN (not to exceed 5 nights per week) for insomnia, throughout the course of the study.
#Intervention
- DRUG : divalproex sodium extended release
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant or nursing female age 18 <= age <= 65 old.
* Females of childbearing potential must agree to practice an acceptable form of birth control during the time enrolled in the study.
* Diagnosis of DSM-IV alcohol dependence (DSM-IV checklist).
* Sub-syndromal mood and/or anxiety symptoms (threshold score of 1 standard deviation above the mean for non-psychiatric population on the anxiety, depression, hostility, or global severity subscales of the SCL-90).
* Subjects must be able to understand and sign an informed consent approved by the center's Institutional Review Board.
Exclusion Criteria:
* Opioid dependence as the primary substance diagnosis.
* Clearly established non-substance related psychiatric disorder determined by administration of the Structured Clinical Interview for DSM-IV (SCID-IV) requiring immediate medication treatment.
* Concurrent need for ongoing treatment with a benzodiazepine, anticonvulsants, or medications with significant drug-drug interaction with DVP.
* Severe liver disease (ascites, jaundice, encephalopathy) suggested by physical exam.
* AST or ALT > 200 U/L; total bilirubin > 2.5 mg/dl.
* PT > 1.5X normal.
* Platelet count < 100,000/cubic mm, or WBC < 3,000/cubic mm.
* Pancreatitis (clinical signs and symptoms, not solely based on blood tests).
* Known allergy to DVP or valproic acid.
* Pregnancy.
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
|
NCT00202514
|
{
"brief_title": "Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms",
"conditions": [
"Alcoholism",
"Alcohol Related Disorders",
"Mood Disorders"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00202514",
"official_title": "Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-07",
"study_completion_date(actual)": "2006-07",
"study_start_date(actual)": "2004-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-10-08",
"last_updated_that_met_qc_criteria": "2005-09-12",
"last_verified": "2009-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-20",
"first_submitted": "2005-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This lab study is evaluating the feasibility of accomplishing productive office work while simultaneously pedaling a compact desk-based cycling device.
#Intervention
- BEHAVIORAL : Compact Cycling Device
- Participants pedaled a compact cycling device while simultaneously working at a desk.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 65 years
* Ability to type without looking at the keyboard
* Native English speaker
* Normal hearing
* Spend 6 or more hours per day sitting
* Less than 150 minutes of physical activity per week
Exclusion Criteria:
* Positive response on the Physical Activity Readiness Questionnaire indicating that low intensity pedaling could present safety risks
* Pregnancy
* Body mass index less than 18 or greater than 35
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03273361
|
{
"brief_title": "Desk Cycling Work Performance Evaluation",
"conditions": [
"Obesity",
"Physical Activity",
"Overweight"
],
"interventions": [
"Behavioral: Compact Cycling Device"
],
"location_countries": null,
"nct_id": "NCT03273361",
"official_title": "Desk-Compatible Elliptical Device: Feasibility Evaluation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09",
"study_completion_date(actual)": "2017-09",
"study_start_date(actual)": "2016-08-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-03-21",
"last_updated_that_met_qc_criteria": "2017-09-01",
"last_verified": "2018-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-09-06",
"first_submitted": "2017-09-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective is to determine the anti-tumor activity of the combination of apricoxib + either docetaxel (AP/DC) or pemetrexed (AP/PE) compared with placebo + either docetaxel (P/DC) or pemetrexed (P/PE) as measured by progression free survival in patients with Stage IIIb (pleural effusion)or Stage IV non-small cell lung cancer (NSCLC).
Detailed Description
Patients diagnosed with advanced non-small cell lung cancer that has not responded to platinum-based chemotherapy are eligible to particvpate in this study.
Current standard treatments for this type of lung cancer are generally not effective in preventing the cancer from growing. The purpose of this study is to see if adding the drug apricoxib to standard chemotherapy is effective in treting NSCLC. Apricoxib is an investigational drug. Investigational means that it is not approved by the Food and Drug Administration (FDA). Laboratory studies suggest that apricoxib may be useful in the treatment of cancer . This is seen particularly when it is combined with chemotherapy drugs. However, this has not been proven in humans.
Laboratory evidence indicates that apricoxib may benefit patients whose disease over-produces a substance called COX-2. COX-2 can be detected in the urine as a substance called PGE-M (prostaglandin E metabolite). It is thought that patients who have a PGE-M level in the urine that decreases by at least half after taking apricoxib may benefit more than patients whose urine PGE-M decreases by less than half after apricoxib.
This study evaluated whether adding apricoxib to standard chemotherapy treatment will improve outcomes in patients with non-small cell lung cancer whose urine PGE-M decreases at least 50% after taking apricoxib. Apricoxib or placebo was added to either docetaxel or pemetrexed treatment.
#Intervention
- DRUG : apricoxib
- Oral apricoxib tablets will be provided as white or off-white film-coated tablets available in 100mg strength to be taken every day
- DRUG : Placebo
- Oral placebo tablets will be provided as white or off-white film-coated tablets to be taken every day
- DRUG : Docetaxel or Pemetrexed
- Docetaxel 75mg/m2 or Pemetrexed 500mg/m2 given as an IV infusion every 21 days. TheTreating physician will determine chemotherapy drug as per his usual practice.
|
#Eligibility Criteria:
Inclusion Criteria:
* Pathologically determined stage IV non-small cell lung cancer (NSCLC), including stage IIIb (pleural effusion) (histology or cytology acceptable).
* Documented progression after 1 prior platinum-based chemotherapy. No more than one prior chemotherapy regimen is permitted. Patients may have also received erlotinib (before, after or concurrently with platinum based therapy).
* Measurable disease by RECIST criteria
* Age at least 18 years.
* ECOG performance status of 0 <= age <= 2.
* Required Laboratory Values (within 28 days before randomization) :
* Hb >= 9.0gm/dL; transfusions permitted
* ANC >= 1500/mm3
* Platelets >= 100,000/mm3
* INR <= 1.5
* Serum creatinine (Cr) within normal limits for laboratory OR Creatinine clearance greater than or equal to 45 ml/min. 24 hour measured CCr is also acceptable (calculated by the Cockcroft and Gault equation).
* SGOT and SGPT < 2 X the ULN; if liver metastases are present then must be < 5 X the ULN
* Bilirubin <= Institutional ULN
* Albumin >= or equal to 2.5 mg/dl
* May have been treated with anti-EGFR kinase therapy in addition to a platinum based therapy or concurrently with platinum therapy.
* Provide written informed consent and HIPAA authorization and agree to abide by the study restrictions and return for the required assessments.
* Women of child-bearing potential must have negative pregnancy test (serum B-HCG) with a sensitivity of at least 50 mIU/L within 7 days prior to the initiation of treatment and must have used effective contraception (recommended to be two reliable forms of contraception used simultaneously) or must have been sexually abstinent for at least 4 weeks prior to the negative pregnancy test through entry in the study.
* Female patients and male patients with female partners of child-bearing potential must agree to sexual abstinence or to practice effective contraception (recommended to be two reliable forms of contraception used simultaneously). At least one non-hormonal method strongly recommended. Male patients with female sexual partners who are pregnant, or of childbearing potential must agree to use condoms during and for at least 1 month after the last dose of apricoxib.
Exclusion Criteria:
* Pregnant or breast feeding
* Known hypersensitivity to apricoxib, docetaxel, other drugs formulated with polysorbate 80, pemetrexed, sulfonamides, aspirin, or other NSAIDs.
* Radiation therapy within 2 weeks or chemotherapy within 3 weeks or non-cytotoxic investigational agents within 3 weeks of initiating study treatment or patients who have not recovered from adverse effects due to agents administered > 3 weeks prior to initiating study treatment. Screening for urinary PGE-M suppression may begin during this time period.
* Evidence of New York Heart Association class III or greater cardiac disease. History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months.
* Concurrent severe or uncontrolled medical disease that could compromise the safety of the patient or compromise the ability of the patient to complete the study.
* Known HIV infection or AIDS. Testing not required.
* Symptomatic central nervous system metastases; the patient must be stable after radiotherapy for >= 2 weeks. Patients must be off all steroid or antiseizure medications for this indication for >= 2 weeks. Patients with CNS metastases that are untreated are eligible if there is no evidence of midline shift, requirement for steroids or antiseizure medications or neurologic symptoms.
* History of upper GI bleeding, ulceration, or perforation within the past 5 years.
* Concurrent use of COX-2 inhibitors or other NSAIDs for 2 days prior to the first dose of study treatment and during study, including aspirin for 7 days prior to the first dose of study treatment and during study.
* Previous COX-2 inhibitor therapy for this diagnosis.
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
|
NCT00771953
|
{
"brief_title": "0822GCC: Phase 2 Study of Efficacy and Safety of Apricoxib/Placebo With Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer",
"conditions": [
"Lung Cancer",
"Non Small Cell Lung Cancer"
],
"interventions": [
"Drug: Docetaxel or Pemetrexed",
"Drug: Placebo",
"Drug: apricoxib"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00771953",
"official_title": "0822GCC Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Either Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-05",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2008-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-30",
"last_updated_that_met_qc_criteria": "2008-10-14",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-10-15",
"first_submitted": "2008-10-10",
"first_submitted_that_met_qc_criteria": "2013-05-28"
}
}
}
|
#Study Description
Brief Summary
This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing Sepramesh at least 12 months before starting in this study.
The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.
|
#Eligibility Criteria:
Inclusion Criteria:
* Have undergone a laparoscopic ventral repair utilizing Sepramesh at least 12 months before starting in this study.
* Have signed an Informed Consent Form (ICF).
Exclusion Criteria:
* Underwent implantation of Sepramesh for any reason other than ventral hernia repair.
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
|
NCT01305473
|
{
"brief_title": "A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite",
"conditions": [
"Hernia"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01305473",
"official_title": "A Single Arm, Single-Center, Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-02",
"study_completion_date(actual)": "2011-02",
"study_start_date(actual)": "2010-08"
},
"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)": "2012-08-01",
"last_updated_that_met_qc_criteria": "2011-02-25",
"last_verified": "2012-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-02-28",
"first_submitted": "2011-02-25",
"first_submitted_that_met_qc_criteria": "2012-06-12"
}
}
}
|
#Study Description
Brief Summary
This study was a 4-year efficacy trial (cluster randomized trial) of a comprehensive school-based intervention (CSBI) for high-functioning elementary students with autism spectrum disorder (HFASD). The sample included children, in grades 1-5 with HFASD enrolled in public schools. School buildings were randomly assigned to either receive the CSBI or serve as the control comparison (business-as-usual \[BAU\]). School staff in the CSBI schools administered social skills groups (60-90 minutes per week), facial-emotion recognition computer instruction (60 minutes per week), therapeutic activities (40-60 minutes per week), a behavioral reinforcement system (across the school day), and parent training (60-90 minutes per month) during the school year. Children with HFASD in the BAU schools received their typical educational program. Implementation fidelity was assessed by research assistants throughout the school year in the CSBI schools using standardized fidelity monitoring sheets. The fidelity monitoring sheets were also completed by research assistants during observations in the BAU schools in order to identify the possible presence of any of the treatment elements in the control (BAU) schools. Outcome measures were completed for both groups at baseline (6 weeks into the school year prior to the initiation of the intervention) and at the end of the school year following completion of the intervention. Primary outcome measures included a test of emotion recognition and parent-teacher ratings of ASD symptoms and secondary measures included parent-teacher ratings of social/social-communication skills, a test of academic achievement skills, and a direct behavioral measure of social interaction skills (child testing and behavioral observations were completed by evaluators blinded to treatment condition; parent-teacher raters were not blinded to treatment condition). For the primary measures/analyses, it was hypothesized that students with HFASD who complete the CSBI will demonstrate significantly greater emotion-recognition skills and receive significantly lower parent-teacher ratings of ASD symptoms compared to controls. For the secondary measures/analyses, it was hypothesized that students with HFASD who complete the CSBI will receive significantly higher parent-teacher ratings of social/social-communication skills, demonstrate significantly higher academic skills, and exhibit significantly higher rates of social interactions with peers compared to controls.
Detailed Description
The efficacy of the comprehensive school-based intervention (CSBI) was evaluated in a cluster randomized trial (pretest-posttest control group design). A total of 96 students in grades 1-5 with HFASD from 32 public elementary schools were initially targeted for enrollment over the 4-year study period. Once students were screened and determined to meet eligibility criteria, individual schools (clusters) were randomly assigned to either the treatment condition (CSBI) or control condition (business-as-usual \[BAU\]). A block randomization design with stratification by school economic level was used to insure approximate balance among the treatment groups. Recruitment was conducted during the 4-8 months prior to the upcoming school year. School staff from the treatment schools completed a manualized 5-day training during the summer preceding the treatment year and demonstrated fidelity with the protocol (competence). Pretesting was completed 6 weeks into the school year (prior to the initiation of the intervention) and posttesting at the end of the school year following completion of the intervention. Children with HFASD in the CSBI schools received the CSBI intervention implemented by school staff during the school year and children with HFASD in the BAU schools received their typical special education programming. Implementation accuracy (fidelity) was assessed by research assistants throughout the school year in the CSBI schools using standardized fidelity monitoring sheets. The fidelity monitoring sheets were also completed by research assistants during observations in the BAU schools in order to identify the possible presence of any of the treatment elements in the BAU schools.
Treatment (CSBI) group protocol. The following is a description of the 5 treatment components (SSGs, IDN, MR, TAs, and PT) and fidelity protocol for the CSBI.
Social skills groups (SSGs). SSGs were conducted 2-3x/wk. for a total of 60-90 min./wk. by a designated member of the school team. Groups contained 3-6 students with social impairments. Each manualized SSG began with a review of rules and was then conducted according to the framework of Skillstreaming (Goldstein et al., 1997). Skillstreaming is a structured program for teaching interpersonal skills to children with social deficits using teaching, modeling, role-playing, performance feedback, and transfer of learning (McGinnis \& Goldstein, 1997). In the CSBI, 26 social skills were taught in a progression from basic to more complex. While the SSG protocol required active participation of every child each session, each child was required to be the primary role-player at least twice per 3 sessions. Each session ended with a short review and discussion of how to use the skill in future classroom activities. To ensure repeated practice and ongoing feedback, and promote generalization, 1) each participant had \>2 social targets on her/his IDN (see IDN section), 2) classroom teachers displayed a list of the social skills taught to date and the component steps of each social skill, and 3) parents were continually informed of target skills. Fidelity of implementation. SSG facilitators recorded the date, attendees, minutes of group instruction, and skill for each session on a tracking sheet and research assistants monitored fidelity at least 1x/wk. using a standardized fidelity sheet.
Individual daily note (IDN). The IDN was administered across the school day and was used to practice and reinforce newly learned skills, and reduce problem behaviors/ASD symptoms. It directed the student, school team, and parents to focus on specific skills/behaviors and performance criteria, and promoted communication between school and home. Each IDN consisted of 3-5 operationally-defined targets; to increase generalization \>2 were skills taught in the CSBI. Initially, IDN targets were identified by teachers and operationally defined, and base rate data were collected for 3-5 days to determine criteria for IDN goals. Each student's school day was then divided into intervals based on his/her reinforcement needs. At the end of each interval, the student could earn 1 point for each IDN target and must have earned \>75% of her/his daily points to receive a home reward (reinforcer). During each interval, the student received immediate verbal feedback and a tally was recorded on his/her IDN. At the end of each interval, the teacher provided feedback on the student's performance during that interval based on the targets and performance criteria. At the end of the day, the teacher informed the student of her/his overall performance (% earned), sent a copy of the IDN home, and retained a copy of the IDN. Fidelity of implementation. A copy of each child's IDN was kept by the classroom teacher and collected every 2 weeks. Adherence was assessed during at least two 60-min. observations each week using a standardized fidelity sheet.
Mind Reading (MR) computer instruction. MR was conducted 3x/wk. for a total of 60 min./wk. by a designated member of the school team. MR is an interactive software program designed to teach recognition of emotions in facial and vocal formats (Baron-Cohen et al., 2004). It features 412 emotions organized into 24 emotion groups and by 6 emotion levels. The program presents instruction and tasks in the Emotions Library, Learning Center, and Games Zone and reinforcing activities in the Rewards Zone. It also employs a token system to reinforce participants with access to the Rewards Zone using points earned for accurate completion of questions in MR. The CSBI included 100 MR emotions divided into 10 groups (10 emotions per group). Each week students were taught 1 group of emotions (repeated during the 3 lessons). After each emotion group was taught, students repeated the 10 emotion groups 2 more times for a total of 3 exposures to the 10 groups. Each session was manualized to ensure children met time parameters accessing areas of MR. School staff members monitored students to ensure they accessed program areas according to the protocol. Fidelity of implementation. Data on time using the software for each participant were collected by an internal chronometer in the software and research assistants monitored implementation accuracy at least once per week using a standardized fidelity sheet.
Therapeutic activities (TAs). TAs were conducted 2x/wk. for a total of 40-60 min./wk. by a designated member of the classroom team. TAs required \>2 students and were conducted to practice and reinforce social skills and face-emotion recognition, and promote interest expansion. Each TA was written as a lesson plan that described the activity, its purpose, skill targeted, materials needed, deficit addressed, and procedures for conducting the activity. TAs were conducted with general and/or special education peers. At the outset, facilitators reviewed the activity rules and quickly discussed the activity. The facilitator also discussed with the target student how she/he can use the target and previously taught skills during the activity. During TAs, facilitators maintained proximity to the target students and provided frequent reinforcement when students exhibited target skills and corrective feedback when necessary. Each TA ended with a quick debriefing (1-3 min.) including how students used target skills during the TA and how they can use these skills during the school day/week. Fidelity of implementation. TA facilitators recorded the date, attendees, minutes of instruction, and skill targeted for each session on a tracking sheet. Research assistants monitored fidelity at least 3x/month using a standardized fidelity sheet.
Parent training (PT). PT was conducted 1x/month for 60-90 min./session during the school year by at least 1 member of the school team. This served to increase home-school communication and integrate the CSBI across settings. It also fostered active parent participation in the establishment of home reinforcers for school performance on treatment targets and increased parental understanding of the CSBI. PT content and instructional procedures were manualized to ensure delivery of consistent content. Facilitators delivered content using detailed lesson plans and PowerPoint slides or showed a video recording of the session(s) (which covered the same lesson plans and PowerPoints). Each session was structured as follows: 1) Brief updates on CSBI and PT agenda; 2) Lesson content (delivered live or via video); 3) Discussion of content and integration of content into daily routine; and 4) Review of session content and implementation procedures. Fidelity of implementation. PT facilitators recorded the date, attendees, duration of session, and topic covered for each session on a tracking sheet. Research assistants monitored fidelity at least 1x per 2 PT sessions using a standardized fidelity sheet.
Consultation support. Consultants provided support for classroom teams via weekly meetings. Consultants generally consisted of graduate students with advanced training in assessment and treatment of ASD/HFASD. Most were recruited from prior psychosocial treatment trials for children with HFASD conducted by our team and, as such they had extensive training and experience in administering the active components of the CSBI, and the fidelity, data collection, and data entry procedures. Fidelity of implementation. Consultants met with teams at least 1x/wk. and documented meetings on a log which included the school/team, date, time, topic(s), and outcome. The logs were reviewed monthly and child progress was reviewed at weekly consultant case review meetings with the study's clinical director.
Comparison (BAU) group protocol. Research indicates that students with HFASD do not receive adequate, intensive, or comprehensive school interventions (White, Scahill et al., 2007). This suggested that students randomly assigned to the control (BAU) condition would not receive services that remotely approximated the intensity or scope of the CSBI. Given randomization at the school level, contamination was unlikely however we monitored the roles of school staff and excluded any staff member (e.g., related-service provider) who provided services across buildings. The services received by the control children (programming and services mandated on their IEPs) were also monitored to ensure they were sufficiently different from the CSBI group. Four procedures were used. 1) Each student's IEP was reviewed to identify and document the legally mandated services she/he received. 2) For those receiving counseling (group or individual) or speech-language services, the related-service provider completed a survey indicating specific treatment targets and the protocol for service provision (techniques used, number of trials, etc.). 3) Parents completed a monthly survey of any external therapeutic or social-communicative programming their child may have received. 4) Fidelity measures designed for the intervention group (with sequencing requirements removed) were completed for the control condition during two 60-minute classroom observations per week by research assistants.
#Intervention
- BEHAVIORAL : Comprehensive School-Based Intervention
- School staff administered the 5 components during the school year. Social Skills Groups were conducted 2-3x/wk. for a total of 60-90 min./wk.; each group contained 3-6 students with social impairments. The Individual Daily Note was administered across the school day to reinforce new skills and reduce problem symptoms. Students' performance on targets was linked to home rewards. Mind Reading computer instruction targeting emotion recognition skills was conducted 3x/wk. for a total of 60 min./wk. Therapeutic Activities were conducted 2x/wk. for a total of 40-60 min./wk.; these cooperative activities were designed to practice targeted skills. Parent Training was conducted 1x/month for 60-90 min./session in order to increase home-school communication and integrate the CSBI across settings.
|
#Eligibility Criteria:
Inclusion Criteria: (1) WISC-IV short form IQ>70 (and VCI or PRI>80); (2) CASL expressive or receptive language score >75; and (3) a score meeting ASD criteria on the ADI-R
Exclusion Criteria: Evidence of psychosis
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03338530
|
{
"brief_title": "Efficacy of a Comprehensive School-based Intervention for High-functioning Children With Autism Spectrum Disorder",
"conditions": [
"Autism Spectrum Disorder"
],
"interventions": [
"Behavioral: Comprehensive School-Based Intervention"
],
"location_countries": null,
"nct_id": "NCT03338530",
"official_title": "Efficacy of a Comprehensive School-based Intervention for High-functioning Children With Autism Spectrum Disorder",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07-31",
"study_completion_date(actual)": "2017-07-31",
"study_start_date(actual)": "2013-08-01"
},
"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)": "2017-11-09",
"last_updated_that_met_qc_criteria": "2017-11-08",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-09",
"first_submitted": "2017-11-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Clinical evaluation of 4 different bearings in THA. Primary parameter being prosthetic survival data.
#Intervention
- DEVICE : THA
|
#Eligibility Criteria:
Inclusion Criteria:
* >18 Willing to participate informed consents indication for THA
Exclusion Criteria:
* <18 other diseases in the lower extremities than the actual disorder of the hip
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
|
NCT00374946
|
{
"brief_title": "A Clinical Evaluation of Wear Couples in THA",
"conditions": [
"Articular Bearing Surface Wear of Prosthetic Joint",
"Wear of Articular Bearing Surface of Prosthetic Joint",
"Prosthesis Survival"
],
"interventions": [
"Device: THA"
],
"location_countries": null,
"nct_id": "NCT00374946",
"official_title": "A Randomised Controlled Clinical Study Ofbearing Surfaces in Four Hybrid Prosthesis - Results After 10 Years",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-01",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "2000-12"
},
"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)": "2017-03-24",
"last_updated_that_met_qc_criteria": "2006-09-11",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-09-12",
"first_submitted": "2006-09-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The reason for this study is to determine the recommended phase 2 dose of the study drug LY3295668 erbumine in participants with breast cancer that has spread to other parts of the body.
#Intervention
- DRUG : LY3295668 Erbumine
- Administered orally.
- DRUG : Endocrine therapy
- Administered according to label instructions.
- DRUG : Midazolam
- Administered orally.
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant must have hormone receptor positive and HER2 negative metastatic breast cancer
* Participant must have progressed on at least 1 line of endocrine therapy and 1 cyclin dependent kinase (CDK)4/6 inhibitor
* Participant must be able and willing to undergo mandatory tumor biopsy
* Participant must have normal organ function
* Participant must be able to swallow capsules
Exclusion Criteria:
* Participant must not have had prior chemotherapy for mBC. Chemotherapy in the adjuvant/neoadjuvant setting is permitted
* Participant must not be currently enrolled in a clinical study
* Participant must not have another serious medical condition
* Participant must not have previously received an aurora kinase inhibitor
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
|
NCT03955939
|
{
"brief_title": "A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body",
"conditions": [
"Metastatic Breast Cancer"
],
"interventions": [
"Drug: Endocrine therapy",
"Drug: Midazolam",
"Drug: LY3295668 Erbumine"
],
"location_countries": [
"Belgium",
"United States"
],
"nct_id": "NCT03955939",
"official_title": "A Phase 1b Study of Aurora A Kinase Inhibitor LY3295668 Erbumine in Monotherapy and Combination Therapy in Patients With Metastatic Breast Cancer Post CDK4/6 Inhibitor and Endocrine Therapy",
"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)": "2019-08-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-06-01",
"last_updated_that_met_qc_criteria": "2019-05-17",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-20",
"first_submitted": "2019-05-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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